IEC UNIVERSITY BADDI (SOLAN) H.P. B.Pharm + M.Pharm (P ......IEC University, offers the B.Pharm +...

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IEC UNIVERSITY, BADDI (SOLAN) H.P.

B.Pharm + M.Pharm (Pharmacology)

five years Integrated course

INFORMATION BOOKLET

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INDEX

S. No. CONTENT

1. Programme Objectives

2. Programme Outcomes

3. Academic Regulations

4. Proposed Scheme of Evaluation

5. Detailed Syllabus Semester Wise

6. Extract of Rules & Regulations

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PROGRAMME OBJECTIVES

As we enter into the 21st century, the priorities and challenges facing pharmacy andhealthcare, in general, have changed considerably in all parts of the world. TheWHO estimates that by 2020, leading causes of the burden of diseases are likely tobe ischaemic heart disease, depression and road traffic accidents, while health trendsare likely to be dominated by four factors; the ageing of the world’s population, theunfolding of HIV epidemic, the epidemic of tobacco-related mortality and disabilityand the expected decline in the childhood mortality from infectious diseases.Pharmacy is most exciting and significant medical professions for the 21st Century.It promises to have the potential to solve a wide variety of challenges faced by themodern society including the supply of quality food materials, pharmaceuticals,healthcare, forensic science, environmental concepts & security need. In all,Pharmaceutical Sciences is revolutionizing the way we live our day-to-day lives. AtIEC University, the primary objectives of Pharmaceutical Education are to providescientific / technological education & training in all aspects relating to identification,standardization, formulation, preparation, distribution, quality assurance and use ofdrug and medicines, dissemination of drug information and management of diseases,misuse of drugs and implementation of laws governing drug misuse etc. At IECUniversity, M.Pharm program is an approach to reach new horizons in pharmacyprofession and research.

The IEC School of Pharmacy is going to start M.Pharm (Pharmacology). It is a well-equipped department, with adequate infrastructure for undergraduate andpostgraduate. The post-graduates leaving the college after completing their programfind immediate placement in industry or academics, some even securing admissionfor advanced studies in US and other advanced countries. The thrust research areasof the department are: cancer, metabolic disorders, pharmacology of tissue repairand inflammation and radioprotection

Pharmacy School of IEC University has introduced in its curriculum new innovativeexperiments based on technical research methodologies used in Industries. Schoolwill routinely organize technical sessions for students to make presentation ondifferent scientific topics of their syllabus so that all the students should be benefitedfrom these knowledge sharing academic activities. Our program offers anindividualized and supportive environment for professional development, educationand research.

Goals of the School of Pharmacy IEC University are:

1. To prepare graduates of the professional program to apply the pharmaceutical, social,

administrative, and clinical sciences in order to deliver pharmaceutical care in a manner that

promotes positive health outcomes and in an interdisciplinary role.

2. To test student’s genuine comprehension of a subject and not just the power of memory. To

tap the students' potential – both hidden and obvious – and offer a platform to explore their

talents.

3. To foster intellectual curiosity and a commitment to lifelong learning.

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4. To nurture a scientific spirit and excellence among the students.

5. To provide programs, services, and resources that foster an environment for the personal

and professional growth of students, alumni, practitioners and faculty.

6. To contribute to the advancement of the clinical, basic medical and pharmaceutical

sciences.

7. To contribute to the advancement of pharmacy practice through research and scholarship

and by service to the profession.

8. To ensure right mix of theoretical and practical knowledge to act as a node in the global

technological landscape highly regarded and valued by the industry.

9. To understand the dynamics of change and reach the zenith of success, students are trained

and equipped to take on the world and leave their mark in the corporate world.

10. To have a good network of academic institutions R&D centers and industries to utilize their

services through R&D, consultancy and training.

11. To inculcate a spirit of respect for diversity and good citizenship.

PROGRAMME OUTCOMES

“Today’s Accomplishment is Tomorrow’s Asset” with this idea and attitude Vocational

Education and Foundation had established IEC University in 1212 at Baddi (Solan), Himachal

Pradesh with mission and philosophy to impart innovative industry oriented pragmatic education

for excellence in the field of Conventional and Technical Education. Masters of Pharmacy

(M.Pharm) program is conceived to offer students ever-glowing career in the domain of

Pharmaceutical / Life Science both nationally and internationally. The education system of IEC

University will enable pharmacy graduates to apply scientific methods, thoughts, technology and

his / her expertise to fulfill position of responsibility in education, pharmaceutical production, drug

control and research. More importantly we would build student confidence for their next career

challenges, be that further education as seeking employment in the ever-growing Pharmaceutical

industry. The student can

Join Pharmaceutical Industry in manufacturing, analysis and R&D.

Join Industry for Medical Writing, Medical Transcriptions, Clinical Research, clinical

Trials, Medical coding etc.

Engage in discovering new molecules for various diseases.

Can proceed for specialization in subjects like pharmaceutics, medicinal chemistry,

pharmacology and pharmacognosy etc. in India and abroad.

Get involved in marketing and medical detailing in pharmaceutical companies

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Start a new retail pharmacy or open a chain of medical stores.

Set up commercial analytical laboratories for testing the quality and purity of medicines.

For good placement in Industries, IEC School of Pharmacy will be maintaining strong

interaction with industries to have first-hand information of their needs and current market trend.

Institute is directly dealing with Ranbaxy Laboratories, Eli-Lily Healthcare, Novartis

Pharmaceuticals, Johnson & Johnson Healthcare, Dr. Ready’s Laboratories, Jubilant

Pharmaceuticals, Panacea Biotech, Torrent Pharmaceuticals, Piramal Healthcare, Dabur Research

Foundation, Wockhardt Pharmaceuticals, Aimil Pharmaceuticals and Genotech Biotech, USA.

. ACADEMIC REGULATIONS

PREAMBLE

The Indian Pharmaceutical Industry today is in the front rank of India’s science-based

industries with wide ranging capabilities in the complex field of drug manufacture and technology.

A highly organized sector, the Indian Pharma industry is estimated to be worth $7.5 billion.

Growing at about 8 to 9 percent annually.

As per the expert opinion the pharmaceutical industry in India caters around 70% of the

country’s demand for bulk drugs, drug intermediates, pharmaceutical formulations, chemicals,

tablets, capsules, orals and injectables. There are about 250 large units and about 8000 Small Scale

Units (SSU), which form the core of the pharmaceutical industry in India (including 5 Central

Public Sector Units). These units produce the complete range of pharmaceutical formulations and

chemicals having therapeutic value and used for production of pharmaceutical formulations.

The driving force for its growth is the technical manpower. Pharma industry is poised to

zoom. According to industry estimates, the Contract Research and Manufacturing (CRAMS)

market in India was valued at $532 million in 2005, of which contract manufacturing accounted for

84 %, while the remaining 16 % was accounted for by contract research excluding clinical trials.

Both the segments of CRAMS have registered a robust growth of over 40 %.

A study paper brought out by the Associated Chambers of Commerce and Industry

(ASSOCHAM) says that higher growth would be driven largely by new launches. This is also

borne out by the fact that the number of applicants from India lining up to get approval for Drug

Master Files (DMF) from the US Food & Drug Administration (USFDA) continues to remain the

largest amongst all countries, accounting for about 39 % of total filings so far.

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Campus

A sprawling campus has been meticulously planned in number of functionalbuilding blocks integrated by lush green grass lawns. The campus has beenaesthetically designed in a pollution free complex to become a self-containedacademic township. Our aesthetically built modern campus equipped with the stateof the art presentation tools has been specifically designed to create a stimulatinglearning environment. Naturally lighted & airy large corridors, a large green centralcourt facilitate interaction and make learning a pleasure. The academic complexprovides complete requirements of Lecture rooms, Tutorial rooms, Drawing hall,Faculty rooms, Director’s Office, Laboratories and Workshops. Elegantly designedcomfortable furniture in the spacious well-ventilated and well-lighted classroomsprovides the students the comfort needed for a stimulating learning experience. Airconditioned library stacked with books and journals on a wide range of subjectsoffer a treat to the serious minded. All basic amenities like safe drinking water,electricity, power back-up and communication facilities, etc. have been provided.

SPECIAL FEATURE

1. Highly Qualified & Professional Management.

2. 100% Concentration in grooming the students.

3. Hi-Tech Computer Lab & e-Library, Internet facility for all.

4. Excellent faculty.

5. Fully residential and having separate Boys and Girls hostels with all amenities.

6. Excellent sports facility.

7. Industrial Seminars

8. Job Placement Cell

9. Co-curricular activities ensuring a well rounded and relevant education.

10. Strong alumni network.

MAJOR STRENGTHS

The Faculties are esteemed group of scholars from reputed Universities of India. They are

academically / professionally skilled and well recognized in the profession because to their

academic achievements.

All laboratories of Pharmacy Department in IEC University are well equipped with modern

scientific instruments of excellent quality which are useful for analysis and research. Each

laboratory is having sufficient space to perform experimental work. Laboratories are also

well furnished with machines / equipments as per AICTE and PCI requirements.

Laboratories are also rich with all chemicals / materials and peripheral devices to carry out

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the experiments. Curiosity based laboratory activities on selected subjects such as

pharmaceutics, pharmaceutical chemistry, pharmacology, pharmacognosy, microbiology,

biotechnology etc.

Lecture halls are having ample space for sitting and supplemented with modern teaching

aids like slide & OHP projector. There are tutorial rooms where the students can interact

with their Faculty.

Computer Room is well furnished with latest version of computers, software, and online

Internet facility.

The Library is well stocked with a huge collection of books in all the related fields. It also

subscribes a wide range of National / International Journals, magazines, periodicals,

newspapers and information bulletins. In addition to print materials the library contains

wide range of information in the form of CD-ROMS and online access of scientific

journals.

About the Program

IEC University, offers the B.Pharm + M.Pharm (Pharmacology) five years Integrated.

ADMISSION AND ENROLMENT OF STUDENTS

• Admission shall be done on the basis of merit, providing for reservations in accordance with

the Act.

• The merit shall be determined by the marks obtained by the candidates in qualifying

examination.

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ELIGIBILITY CRITERIA FOR ADMISSION

• For Admission to Ist Year of B.Pharm + M.Pharm (Pharmacology) five years Integrated

program, in IEC University, a candidate must have clearly passed 10+2 from any recognized

Board/University and securing minimum 45% marks.

NOTE: The candidates appearing in the qualifying examination are also eligible to apply,

subject to the condition that they must fulfill the eligibility criteria as given above at the time of

registration in the programme.

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MEDIUM OF INTRUCTION AND EXAMINATIONS

The medium of instructions and examination shall be English in all the programmes, except

in language courses where it is necessary to use the corresponding mediums.

UNIVERSITY FEE

Every student has to deposit his total Fee, other charges and dues, if any, in the beginning of

the semester at the time of Registration, failing which he will not be permitted for registration in the

programme.

FELLOWSHIPS, SCHOLARSHIPS, STIPENDS, MEDALS AND PRIZES

Fellowships, Scholarships, Stipends, Medals and Prizes may be instituted by the University

and awarded as per rules.

REGISTRATION

• Every Student will register every semester for courses that he wishes to pursue in that

semester.

• A non-registered student will not be allowed to attend classes and take examination even if

he has paid the fees.

• The late registration of a freshman who is admitted after the start of the semester may be

done at the time of admission by the authorized official.

Adding and Dropping of Courses

• A student may be permitted to add or drop course(s) within two weeks of the beginning

of the semester.

• In case a student has been allowed to change the course or programme during the

current semester by the University, the classes attended in the previous course may

also be considered in calculation of attendance to determine the eligibility for

appearing in ESE.

MID – TERM MIGRATION OF STUDENTS

• Inter-university migration shall not be allowed in normal circumstances.

• Under exceptional circumstances, mid-term transfer of a student from any other

University to IEC University may be permitted on a case to case basis. In all such

cases, the approval on the transfer of relevant credits the student has already earned in

that University may be granted by the Academic Council.

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TRANSFER OF PROGRAMME

A student once admitted and registered in a programme will not be allowed to change

the programme under any circumstances.

ACADEMIC SYSTEM

The University will follow semester system in all of its PG/ Integrated programmes.

SUMMER SEMESTER

• The Vice Chancellor may decide to hold a Summer semester on the

recommendation of the Academic Advisory Committee.

• Summer semester is a special privilege to be offered at the discretion of the

University, and the University will not be under any obligation to offer Summer

semester every year.

• Summer semester, if offered, may be allowed only for students who are not on

disciplinary probation.

• A list of courses to be offered in the Summer semester is brought out during the

even semester before the ESE. Only a few selected courses as decided by the

University may be offered during the Summer semester.

• A course may be offered in the Summer semester if there are a minimum of ten

students registering for it.

• Unless prescribed otherwise in the Regulations of any specific programme, the

Summer semester is a fast-paced semester where all the rules for the normal

semester shall apply but the registration shall be limited to three courses having

total credits not exceeding 12.

• The Summer semester may be of about seven to eight weeks duration and each

course may run on about two times the normal load, thus imparting equivalent to

about 16 weeks of teaching, but at an accelerated pace.

• Whenever possible, the deficient students may be allowed to register for backlog

courses and/ or marginal courses (in which they have obtained D grade) in the

Summer semesters on payment of necessary fees per course.

• A student can normally register only for backlog or marginal courses for the

Summer semester.

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• In view of the short duration of the Summer semester, late registration and

adding and dropping of courses are not permitted beyond three days of the start of

classes.

Academic Counselor

• Upon joining the University, each student will be assigned an Academic Counselor.

• The Academic Counselor will discuss with the student his academic performance in

previous semester(s) and suggest the number and nature of courses the student should

register during the ensuing semester, within the framework of that Programme

curriculum.

• The Academic Counselor may advice students having many backlog courses to register

for lesser number of credits (subject to the minimum credits specifications) and prepare

a revised plan of study for the student with a slower pace.

Syllabus

• A course syllabus is a document that explains what a student is going to study in that

course.

• Each course will have a course code, course title, Lecture- Tutorial- Practical- Credit

(LTPC) distribution indicating the weightage of the course, version of syllabus

revision, course pre-requisites/ anti-requisites/ co-requisites (if any), course objectives,

expected outcome, short and detailed description of the topics, suggested text and

reference books, the mode of evaluation adopted, the effective date of application of

the revised version of the syllabus.

Course Plan

• A course plan consists of a list of lectures/ experiments carried out in each instructional

class/ lab by the course teacher during the semester as per the LTPC of the course, with

details like mode of delivery, reference material used, etc.

• One hour of lecture/ tutorial classes or two hours of laboratory work/ seminar/

practical/ group discussion per week constitutes ONE credit for the course. Separate

course plans need to be prepared for the theory and laboratory portions of any course, if

the course has an embedded lab component.

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Example:

An LTPC of 2-1-2-4 means 2 hour of class room lecture; one hour of tutorial and one hour

of laboratory, all delivered within a calendar week. This course will have 4 credits.

Course Flowchart

• A flowchart describes how various courses under OC, OE, PC and PE are connected

through prerequisites.

• Standard pictorial representations are adopted to indicate various types of courses.

• They may be grouped to indicate the proposed semester of offering.

• Necessary pre-, anti- and co- requisite requirements may also be included in the flow

chart.

Minimum no of credits = 343

Industrial / Practical Training

• Wherever required in the programme, all students of that programmes shall be required

to undergo industrial/ practical training in a reputed relevant industry, during the 4th

semester of study.

• Students who have successfully completed their training are required to register for

industrial/ practical training in the following semester for award of grades.

Project/ Thesis/ Dissertation:

• Wherever required in the PG/ Integrated programme, all students of that programmes

should successfully complete Project/ Thesis/ Dissertation work.

• A student has to select a thesis supervisor at the beginning of the last semester of the

programme, if not done earlier.

• A student shall not normally have more than two supervisors at any given time.

• Thesis supervisor(s) of a student will normally be appointed from amongst the faculty

members of the University using modalities decided by the departments.

• A student can have a co-supervisor from outside the University on the recommendation

of the Supervisor and with approval of the Director of the Institute.

• In case there has been a change/addition in the supervisor(s), the thesis will not be

submitted earlier than three months from the date of such change.

• Normally, a faculty member shall not supervise more than five individual PG

candidates. However the department may evolve a transparent policy for the distribution

of PG students amongst the faculty members in the department.

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• In case a faculty member is suspended / debarred for indulging in lowering the prestige

of the University in any manner, he shall cease to be a thesis supervisor.

• If a supervisor resigns/ expires/ leaves the University, alternative/ caretaker

supervisor be appointed by the Departmental Postgraduate Committee (DPGC.)

• Submitting a thesis that was bought (purchased)/ borrowed/ thesis submitted in

another University/ Institution shall be considered as examination malpractice and will

be awarded an ‘F’ grade.

• Students have the responsibility to decide on the specific thesis area and title, and carry

out substantial portion of the literature survey at the beginning of their final year.

• Various time limits specified for monitoring and evaluation of performance of the

student, to be announced by the University in each semester, should be strictly

followed.

Minimum/ Maximum Credit Limits for Course Registration

• The Average Academic Load in a regular semester will be of 27 credits.

• However, a fast pace student can register for a maximum of 36 credits.

• Similarly a slow pace student can register for a minimum of 29 credits in a regular

semester (other than during Summer semester).

• Under no circumstances, a student will be permitted to cross these limits.

• A student carrying out the last registration of his Programme will be permitted to

register less than 22 credits if the minimum credit requirements for the completion of

Programme so require.

• The average number of credits a student can register during a Summer semester shall

be between 6 and 8, or 2 courses.

• However, in special cases, the student may be permitted to register a maximum of 12

credits during a Summer semester.

• There is no minimum number of credits fixed for course registration during Summer

semester.

Course Prerequisites / Anti-requisites/ C-requisites

• Some courses may have specific prerequisites to be met before a student can register

for the course in the current semester.

• Students who had received an ‘F’ grade in a prerequisite course are also permitted to

register the next level course by assuming that they had attained the required

‘exposure’ by attending that course.

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• This stand is adopted so that the student can make further progress towards earning

credits and his progress need not be pulled down by backlog courses. Thus, concurrent

registration of a prerequisite and next level course becomes a possibility.

• Similarly, a course may have an anti-requisite and/ or co-requisite.

• When two courses having almost similar/ same course contents and considered as

equivalent are made available to a student to choose within a group, and to prevent

students crediting both the courses, the anti-requisite option can be used.

• Similarly, an independent laboratory course can be coupled with a theory alone course

through a co-requisite thereby forcing a student to register both the courses together.

PG Teaching Experience

To provide an opportunity to Final year students having current CGPA 8.50 or more, value-addition

schemes are available in the University.

• Such students may be awarded tutoring assignments in the lower year courses.

• Such contributions will be duly recognized by providing financial support and making a

mention in the Grade sheets.

Vice Chancellor’s List

• Students who maintain a CGPA of 9.50 and above, starting from the beginning of 3rd

semester results and subsequently, having no ‘F’ grade to their credit, having never

debarred for lack of attendance in any ESE or indiscipline, will be placed on Vice

Chancellor’s List for their meritorious performance.

• Their name will be removed from the Vice Chancellor’s List if their CGPA falls below

9.50 or they receive an ‘F’ grade or are debarred due to lack of attendance in any ESE or

an act of indiscipline subsequently.

• Such students will be accorded benefits/ recognition as per rules.

Conversion Factor for Converting CGPA into Marks Equivalent

If a conversion to marks is required, the following formula may be used to calculate the

same:

The Equivalent Percentage of Marks = CGPA* 9.0 + 5

ATTENDANCE REQUIREMENTS

A student must have 75% or more attendance in aggregate of delivered classes, in all

registered courses of theory (lectures plus tutorial) and practicals (including

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workshops training, seminar, projects, industrial training etc.) of the concerned

semester.

Only such students who fulfill the above 75% attendance criteria will be permitted to

appear in End Semester Examination (ESE).

The cases of students having attendance less than 75% but more than or equal to 60%

shall be reviewed by the University on a case to case basis as per the Ordinance.

If a student’s attendance falls below 60%, for any reason including medical, he will not be

allowed to appear in the ESE of any course registered in the semester. He will be awarded

‘F’ grades in all the courses of that semester.

Calculation of attendance for determining the eligibility to appear in ESE will be based

on the date of actual registration of the candidate, if late registration is permitted by the

University.

COMPONENTS OF EVALUATION

• In general, a course will have three components of evaluation viz. Continuous A ssessment

(CA), Mid-Semester Exams (MSE), and End- semester Exam (ESE),

• CA will carry 10 Marks [Assignments-05 Marks, and Case studies/ Viva voce -05 Marks]

• MSE will carry 15 marks.

• First MSE to be held after completion of 35% - 40% course coverage.

• Second MSE to be held after completion of 70% - 80% course coverage.

• ESE will carry 75 marks.

SYSTEM OF EVALUATION BASED ON BROAD BAND GRADES

• The University shall follow the Broad-band Grades systems for various PG programmes as

specified in the respective Programme detail.

• The course credit (C), number of lectures, tutorials, practicals (L), (T), (P) in a course are

related as C = (L + T + 0.5 P).

• The students will be awarded grades using relative grading in a course and result cards

will show individual course grades, the course credits and the overall weighted

performance indices such as SGPA (Semester Grade Point Average) and CGPA (Cumulative

Grade Point Average).

• The following broadband letter grades will be used to report a student’s performance on a 10-

point scale.

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• The letter grades and their numerical equivalents on a 10-point scale (called Grade Points) are

as follows:

Letter Grade A AB B BC C D F

Grade Points 10 9 8 7 6 4 0

In addition to the above, there are three letter grades viz., I, S, and X which stands for

Incomplete, Satisfactory, and Unsatisfactory, respectively.

For courses with zero weightage (audit) only satisfactory (S)/ Unsatisfactory (X) grades

are awarded.

No student shall be awarded ‘A’ grade in any course unless he has secured a minimum of

80% marks in the total of all components of evaluation in that course.

No students shall be awarded ‘F’ grade in any course if he has secured a minimum of 40%

marks in the total of all components of evaluation in that course.

In case a student repeats a particular course during summer semester along with his

juniors, he will be awarded only up to a maximum of AB grade based on his current

performance and the grade he obtained earlier.

The statistical method shall invariably be used with marginal adjustment for the natural cut

off if the number of students appearing in a course is 60 or more. The mean and

standard deviation (σ) of marks obtained of all the students in a course shall be calculated

and the grades shall be awarded to a student depending upon the marks and the mean and

the standard deviation as per Table given below:

Lower Range of Marks Grade Upper Range of Marks

A ≥ Mean + 2.5 σ

Mean + 1.5 σ ≤ AB < Mean + 2.5 σ

Mean + 0.5 σ ≤ B < Mean + 1.5 σ

Mean - 0.5 σ ≤ BC < Mean + 0.5 σ

Mean - 1.5 σ ≤ C < Mean - 0.5 σ

Mean - 2.5 σ ≤ D < Mean - 1.5 σ

F < Mean - 2.5 σ

• If the number of students appearing in any course is less than 60, the grades in that

course will be awarded in the following manner :

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Marks Obtained in a course out of 100 (M) Letter Grade

85 <= M <= 100 A

75 <= M <= 84 AB

65 <= M <= 74 B

55 <= M <= 64 BC

50 <= M <= 54 C

40 <= M <= 49 D

M <= 39 F

Incomplete I

• A student may be awarded the grade ‘I’ (Incomplete) in a course if he has missed the ESE

for a genuine reason.

• This grade must, however, be converted by the Faculty-In-Charge into an appropriate

letter grade within ten days from the completion of ESE.

• Any ‘I’ grade still outstanding two days after the prescribed last date, shall be

automatically be converted into ‘F’ grade.

• The course(s) in which a student has earned ‘F’ grade will be termed as back-log

course(s), which he has to improve by repeating/ replacing the course(s) as per the rules.

• ‘F’ grade is also awarded to a student who is not allowed to/ do not appear in

ESE in a particular subject due to shortage of attendance, though he might have

undergone other components such as MSE, assignments, class tests, projects, etc.

• Such a student will be required to repeat the course in the Summer semester in

which he has secured ‘F’ grade.

• The Semester Grade Point Average is a weighted average of the grade points

earned by a student in all the courses credited and describes his academic performance

in a Semester. If the grade point associated with the letter grades awarded to a student

are say, g1, g2, g3,………. and the corresponding weightage is (credits) are say, w1,

w2, w3,………. the SGPA is given by:

The Cumulative Grade Point Average indicates overall academic performance of a

student in all the courses registered up to and including the latest completed

Semester. It is computed in the same manner as SGPA, considering all the

courses (say, n), and is given by:

CGPA=∑ {credit of semester*SGPA of semester}/total credits

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• The minimum CGPA requirement for the award of an Post Graduate degree/

diploma/ certificate will be 5.5 subject to getting ‘D’ or above grade in each of the

courses individually.

• A minimum of 4.5 SGPA in a UG programme is required in each semester for

moving to the higher semester.

• A student will not be allowed to move to higher Semester without clearing the

backlog courses so as to obtaining the required minimum SGPA and/ or CGPA.

• A student will be required to get grade ‘D’ or above in a course for passing in the

course.

• A student will be issued a Cumulative Grade Card at the end of each semester

indicating the grades secured for all the registered courses up to and including the last

semester.

EXAMINATION

• The period of Examination(s) (Mid semester and End semester) shall be as specified in the

Academic Calendar.

•All students who have registered for a particular course are eligible to write the ESE of that

course, except if he is declared ineligible due to one or more of reasons listed below.

1. Shortage of attendance

2. Acts of indiscipline

3. Withdrawal of a course from Registration

• Make-up examinations are special examinations conducted for students who could not

take regularly scheduled examination and have been awarded the ‘I’ grade or

‘Incomplete’ result.

• Make–up examination is a special privilege to be offered at the discretion of the

University and the University will not be under any obligation to allow a student a

make-up examination. The student(s) shall have no right to cite the non-availability of

this facility as an excuse for his/ their poor performance.

• Make-up Examination for MSE and/ or ESE may not be allowed to students on

disciplinary probation

• A student, who has missed one or more papers in a regular examination because of a

genuine medical reason, may be permitted in Make-up Examination as per rules.

• A student appearing in a make up examination for ESE and/ or MSE in any course shall

not be awarded ‘A’ grade in that course.

• After valuation of MSE answer scripts, they will be handed over to students.

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•Recounting of ESE answer scripts is permitted.

•There is no provision of re-evaluation of ESE answer scripts.

TERMINATION OF THE PROGRAMME

A student will be declared “Not Fit for the Programme (NFP)” and shall have to discontinue

if he does not satisfy following conditions :

After the completion of the First Year the student should have passed a minimum of

forty percent (40%) courses prescribed in the first year to be calculated after the summer

semester, if any.

Second Year onwards, the academic performance of a student is reviewed at the end of

every semester by the Academic Advisory Committee, and the decision is taken on a case

to case basis as per rules.

MAXIMUM DURATION FOR THE COMPLETION OF THE PROGRAMME

(i) The maximum duration for completion of the degree/ diploma, for the completion of the

course, subject to other conditions, shall be as follows:

Normal Duration Maximum Duration Allowed

5 Years 7 Years

RESULT AND DIVISION

• A student will be issued a Cumulative Grade Card at the end of each semester

indicating the grades secured for all the registered courses up to and including the last

semester.

• The minimum CGPA requirement for the award of an Post Graduate degree/

diploma/ certificate/ integrated programme will be 5.5 subject to getting ‘D’ or above

grade in each of the courses individually.

• The result of a student may be withheld if,

(1) he has not paid all the dues, or

(2) if there is a case of indiscipline or use of unfair means or of academic

misconduct pending against him, or

(3) for any other reason as deemed fit by the University.

• Four divisions as defined below shall be awarded:

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Division CGPA

First with Honors and Certificate of Merit > = 9.0

First with Honours > = 8.0 < 9.0

First > = 6.5 < 8.0

Second > = 5.0 < 6.5

• For securing degree/ diploma/ certificate in First Division with Honors and First Division

with Honors and certificate of Merit , a student shall have passed all the courses (Theory

and Practical) of the programme in the first attempt, i.e., without ever being awarded a Re-

appear or a Fail.

MAINTENANCE OF DISCIPLINE AMONG STUDENTS

• All powers relating to maintenance and enforcement of discipline in the University and

taking disciplinary action against the students and employees of the University shall vest in

the Vice-Chancellor, which he may delegate as he deems proper.

• All acts given in details in Ordinance shall amount to acts of indiscipline or misconduct or

ragging on the part of a student of the University and colleges / institutions.

• The University Authority in the exercise of the powers, order or direct that any

student –

(a) be expelled from the University, college or institution, or

(b) be, for a stated period, rusticated or

(c) be not, for a stated period, admitted to a course or courses of study of the

University; or

(d) be imposed with the fine of a specified amount of money;

(e) be debarred from taking a University examination or examinations for one or more

years.

ACADEMIC MISCONDUCT AND USE OF UNFAIR MEANS

• Plagiarism, collusion and cheating are all forms of academic misconduct and

use of unfair means as defined in the Examination Ordinances.

• In case the student has come to examination under the influence of any

intoxicating material, misbehaves with one or more members of the supervisory

staff, it will also be treated as an act of Unfair Means and academic misconduct .

20

• In relation to continuous assessment, Academic misconduct and use of Unfair

Means is classified as Major Misconduct or Minor Misconduct as described below:

(1) Major Misconduct: Where plagiarism, collusion or cheating is detected in

Thesis, Dissertation or Major Project of a programme.

(2) Minor Misconduct: All other academic misconduct excluding those

defined in major misconduct will be regarded as a minor misconduct and will be

dealt accordingly.

• If the Unfair Means Board (UFMB) finds the student guilty, one of the following

actions may be taken:

(1) The student may be disqualified for one or more semester, or

(2) The student may be rusticated for one or more semester, or

(3) The academic programme of the student may be terminated.

(4) Any other action as deemed fit by the UMB.

RESIDUAL PROVISION

In case of any dispute/ difference of interpretation of provisions made in the Ordinances andRegulations, the decision of the Chancellor shall be final.

Proposed Course Structure of five year Dual Degree in Pharmacy (Pharmacology)

The proposed curriculum has been carefully designed to meet the objectives of the IEC

University. We understand that in order to cater the demands of the industry & research and to

meet the challenges of the future the curriculum can be modified as and when required.

B.Pharm Degree (Four Years) Curriculam

First Semester

S. No. Sub Code Subject ContactHours

Credits

1. IEC-PHARM-111M

/ PHARM-111B

Remedial Mathematics – I / Remedial

Biology

4 3

2. IEC-PHARM-

112

Pharmaceutical Analysis 4 3

3. IEC-PHARM-

113

Pharmaceutical Inorganic Chemistry 4 3

4. IEC-PHARM- General Pharmacy 4 3

21

114

5. IEC-PHARM-

115

Human Anatomy & Physiology-I 4 3

6. IEC-PHARM-

116

Basic English & Grammer 4 3

7. IEC-PHARM-

112P

Pharmaceutical Analysis Practical 4 3

8. IEC-PHARM-

113P

Pharmaceutical Inorganic Chemistry

Practical

4 3

9. IEC-PHARM-

114P

General Pharmacy Practical 4 3

10. IEC-PHARM-

115P

Human Anatomy & Physiology-I Practical 4 3

Total 40 30

Second Semester


Credits

1. IEC-PHARM-

121/HUM-102

Foundation English - II 3 2

2. IEC-PHARM-

122

Pharmaceutical Organic Chemistry – I 4 3

3. IEC-PHARM-

123

Physical Chemistry 4 3

4. IEC-PHARM-

124

Introduction to Computers Fundamentals

& Programming

4 3

5. IEC-PHARM-

125

Advanced Mathematics 4 3

6. IEC-PHARM-

126

Human Anatomy & Physiology-II 4 3

7. IEC-PHARM-

127

General Pharmacology- I 4 3

8. IEC-PHARM-

122P

Pharmaceutical Organic Chemistry – I

Practical

4 3

22

9. IEC-PHARM-

123P

Physical Chemistry Practical 4 3

10. IEC-PHARM-

124P

Introduction to Computers Fundamentals

& Programming Practical

4 3

Total 41 29


Third Semester


Credits

1. IEC-PHARM-

231

Unit Operation – I 4 3

2. IEC-PHARM-

232

Pharmaceutical Organic Chemistry – II 4 3

3. IEC-PHARM-

233

Microbiology 3 3

4. IEC-PHARM-

234

Human Pathophysiology-I 4 3

5. IEC-PHARM-

235

Community Pharmacy 4 3

6. IEC-PHARM-

236

Pharmaceutical Biostatistics and ComputerApplications

4 3

7. IEC-PHARM-

231P

Unit Operation – I Practical 4 3

8. IEC-PHARM-232P Pharmaceutical Organic Chemistry – II

Practical

4 3

9. IEC-PHARM-

233P

Microbiology Practical 4 3

10. IEC-PHARM-

234P

Human Pathophysiology Practical 4 3

11. IEC-PHARM-

235P

Community Pharmacy Practical 4 3

Total 43 33

23

Fourth Semester


Credits

1. IEC-PHARM-

241

Biochemistry 4 3

2. IEC-PHARM-242 Pharmacognosy-I 4 3

3. IEC-PHARM-

243

Unit Operation – II 4 3

4. IEC-PHARM-

244

Pharmaceutical Analysis – II 4 3

5. IEC-PHARM-

245

Human Pathophysiology-II 4 3

6. IEC-PHARM-

241P

Biochemistry Practical 4 3

7. IEC-PHARM-

242P

Pharmacognosy-I Practical 4 3

8. IEC-PHARM-

243P

Unit Operation – II Practical 4 3

9. IEC-PHARM-

244P

Pharmaceutical Analysis – II Practical 4 3

10. IEC-PHARM-

245P

Human Pathophysiology-II Practical 4 3

Total 40 30

B.Pharm Degree (Four Years) Curriculum

Fifth Semester


Credits

1. IEC-PHARM-

351

Pharmaceutical Jurisprudence 4 3

2. IEC-PHARM-

352

Industrial Pharmacy-I 4 3

3. IEC-PHARM-

353

Physical Pharmacy 4 3

4. IEC-PHARM- Pharmaceutical Medicinal Chemistry-I 4 3

24

354

5. IEC-PHARM-

355

Pharmacology-I 4 3

6. IEC-PHARM-

356

Environment & Ecology 2 NC

7. IEC-PHARM-

357

Basic Principles of Toxicology-I 4 3

8. IEC-PHARM-352P Industrial Pharmacy-I Practical 4 3

9. IEC-PHARM-

353P

Physical Pharmacy Practical 4 3

10. IEC-PHARM-

354P

Pharmaceutical Medicinal Chemistry-I

Practical

4 3

11. IEC-PHARM-

355P

Pharmacology-I Practical 4 3

Total 40 30

Sixth Semester


Credits

1. IEC-PHARM-

361

Drug Regulatory Affairs & IPR 4 3

2. IEC-PHARM-362 Industrial Pharmacy-II 4 3

3. IEC-PHARM-

363

Pharmaceutical Medicinal Chemistry-II 4 3

4. IEC-PHARM-

364

Pharmacology-II 4 3

5. IEC-PHARM-

365

Pharmacognosy-II

(Chemistry of Natural Products)

4 3

6. IEC-PHARM-

366

Industrial Training 4 3

7. IEC-PHARM-

367

Scientific & Technical Writing 4 2

8. IEC-PHARM-

362P

Industrial Pharmacy-II Practical 4 3

9. IEC-PHARM- Pharmaceutical Medicinal Chemistry-II 4 3

25

263P Practical

10. IEC-PHARM-

364P

Pharmacology-II Practical 4 3

11. IEC-PHARM-

365P

Pharmacognosy-II Practical 4 3

Total 42 32


Seventh Semester


Credits

1. IEC-PHARM-

471

Biopharmaceutics & Pharmacokinetics 4 3

2. IEC-PHARM-

472

Pharmaceutical Analysis –III 4 3

3. IEC-PHARM-

473

Pharmaceutical Medicinal Chemistry-III 4 3

4. IEC-PHARM-

474

Pharmacology-III 4 3

5. IEC-PHARM-

475

Pharmacognosy-III

(Industrial Pharmacognosy)

4 3

6. IEC-PHARM-

471P

Biopharmaceutics & Pharmacokinetics

Practical

4 3

7. IEC-PHARM-

472P

Pharmaceutical Analysis –III Practical 4 3

8. IEC-PHARM-

473P

Pharmaceutical Medicinal Chemistry-III

Practical

4 3

9. IEC-PHARM-

474P

Pharmacology-III Practical 4 3

10. IEC-PHARM-

475P

Pharmacognosy-III Practical 4 3

Total 40 30

Eighth Semester


Credits

26

1. IEC-PHARM-

481

Pharmaceutical Biotechnology 4 3

2. IEC-PHARM-482 Pharmaceutical Industrial Management 4 3

3. IEC-PHARM-

483

Hospital & Clinical Pharmacy 4 3

4. IEC-PHARM-

484

Open Electives (any one) : Herbal Drug

Technology, Drug Design, Clinical

Toxicology, Pharmaceutical Marketing,

Novel Drug Delivery Systems (NDDS),

GMP-Quality Assurance & Validation

4 3

5. IEC-PHARM-

485

Advanced Pharmacology-II 4 3

6. IEC-PHARM-

485P

Advanced Pharmacology-II Practical 4 3

7. IEC-PHARM-

481P

Pharmaceutical Biotechnology Practical 4 3

8. IEC-PHARM-

483P

Hospital & Clinical Pharmacy Practical 4 3

9. IEC-PHARM-

484P

Project on Open Electives 4 6

Total 36 30

Ninth SemesterS. No. Sub Code Subject Contact

HoursCredits

1. IEC-MPHARM-511

Modern Analytical Techniques (MAT)-I 4 8

2. IEC-MPHARM-512

Advanced Pharmacology-I 4 8

3. IEC-MPHARM-513

Drug Design and Molecular modeling – I 4 8

4. IEC-MPHARM-511P

Modern Analytical Techniques (MAT)-ILab

4 8

5 IEC-MPHARM-512P

Advanced Pharmacology-I Practical 4 8

6 IEC-MPHARM-513P

Drug Design and Molecular modeling – IPractical

4 8

Total 32 48

27

Tenth SemesterS. No. Sub Code Subject Contact

HoursCredits

1. IEC-MPHARM-521

Dissertation Project 36 14

2. IEC-MPHARM-522 Seminar 2 103. IEC-MPHARM-523 Dissertation Presentation / viva-voce -- 24

Total44 48

Total credits of the Whole Course = 343

First Semester

IEC-PHARM-111M: Remedial Mathematics – I

Unit-I: Algebra: Equations reducible to quadratics, Cramer’s Rule Algebra of matrics-

1. Addition

2. Subtraction

3. Multiplication

4. Inverse of matrices, Simultaneous equation by matrices.

Unit-II: Certain co-ordinates, distance between two parts, area of triangle, locus of points, straight

line, intercept form in normal.

Unit-III: Differential Calculus-

1. Limit and function

2. Definition and formulation of differential calculus.

3. Rules of standard form of differential calculus.

4. Chain Rule, Parametric rule.

Unit-IV: 1. Standard form of Integral calculus

2. Partial fraction of Integral

3. Trigonometric function of Integral calculus.

Unit-V: Linear differential equation of order greater than one with constant coefficient

complimentary function, and particular Integral (Xneax, Trignometric ( sin/ cos ex )

BOOKS RECOMENDED

1. A textbook of Mathematics for XI-XII Students, NCERT Publication Vol. I-IV.2. Loney, S.L “Plane Trigonometry” AITBS Publishers.3. Loney, S.L “The elements of coordinate geometry” AITBS Publishers.4. Gupta S.P. Statistical Methods, Sultan Chand and Co., New Delhi5. Narayan Shanti, Integral calculus , Sultan Chand & Co.6. Prasad Gorakh Text book on differential calculus, Pothishala Pvt. Ltd., Allahabad.7. Narayan Shanti, Differential calculus , Shyamlal Charitable Trust, New Delhi.8. Prasad Gorakh Text book on integral calculus , Pothishala Pvt. Ltd., Allahabad.

28

9. Vishal Mehta, “ Remedial Mathematics for Pharmacy’.10. Shyam, Patkar “ Comprehensive remedial mathematics”.

IEC-PHARM-111B: Remedial Biology

THEORY

Unit-I:General survey of Animal Kingdom. Structure and life history of parasites as illustrated byamoeba,entamoeba, trypanosoma, plasmodium, taenia, ascaris, schistosoma, oxyuris andancyclostoma. [08]

Unit-II

General structure and life history of insects like mosquito, house fly, mites and silk worm. [08]

Unit-III

Morphology and histology of root, stem, bark, wood, leaf, flower, fruit and seed, modification ofstems and roots. [12]

Unit-IV

Plant cell: Its structure and non living inclusions, mitosis and meiosis, different types of planttissues and their functions. Basic concept of molecular biology (DNA,RNA) [08]

Unit-V

Methods of classification of plants. [04]

REMEDIAL BIOLOGY PRACTICAL

1. Morphology of plant parts indicated in theory.2. Care, use and type of microscopes.3. Gross identification of slides of structures and life cycle of lower plants/animals mentioned intheory.4. Morphology of plant parts indicated in theory.5. Preparation, microscopic examination of stem, root and leaf of monocot and dicot plants.6. Structure of human parasites and insects mentioned in theory with the help of specimens.Note: There shall be no University Examination for Remedial Biology Practical.

BOOKS RECOMMENDED

1. Dutta A.C. “ Botany for Degree students” Oxford.2. Marshall & Williams “Text Book of Zoology” CBS Publishers & Distrubutors, Delhi.3. Fahn “Plant Anatomy” Aditya Books Private Limited, New Delhi.4. Weiz, Paul B “Laboratory Manual in Science of Biology” Mc Graw-hill book company.

29

IEC-PHARM-112: Pharmaceutical AnalysisTHEORYUnit-1 :Significance of quantitative analysis in quality control different techniques of analysis,preliminaries and definitions, precision and accuracy. Fundamentals of volumetric analysis,methods of expressing concentration, primary and secondary standards. [06]

Unit-II: Acid Base Titrations:

Acid base concepts, role of solvent, relative strengths of acids and bases, ionization, law of massaction, common-ion effect, ionic product of water, pH, hydrolysis of salts, Henderson- Hasselbachequation, buffer solution, neutralization curves, acid base indicators, theory of indicators, choice ofindicators, mixed indicators, polyprotic system. [10]

Unit-III: Oxidation reduction Titrations:

Concepts of oxidation and reduction, redox reactions, strengths and equivalent weights of oxidizingand reducing agents, theory of redox titrations, redox indicators, oxidation reduction curves,iodimetry and iodometry, titrations involving ceric sulphate, potassium iodate, potassium bromate,potassium permanganate. [10]

Unit-IV: Precipitation Titrations:

Precipitation reactions, solubility products, effect of acids, temperature and solvent uponthe,solubility of precipitate. Argentometric titrations and titrations involving ammoniumor,potassium thiocyanate, mercuric nitrate indicators, Gaylussac method, Mohr’s method,Volhard’s method and Fajan’s method. [06]

Unit-V: Gravimetric Analysis:

Precipitation techniques, solubility products, the colloidal state, supersaturation, coprecipitation,post-precipitation, digestion, washing of the precipitate, filtration, filter papers and crucibles,Ignition, thermogravimetric curves, specific examples like barium as barium sulphate, aluminiumas aluminium oxide, organic precipitants. [08]

IEC-PHARM-112P: Pharmaceutical Analysis Practical

The students should be introduced to the main analytical tools through demonstration. They shouldhave a clear understanding of a typical analytical balance, the requirements of a good balance,weights, care & use of balance, methods of weighing, and errors in weighing. The students shouldalso be acquainted with the general apparatus requiring various analytical procedures.

1. Standardization of analytical weights and calibration of volumetric apparatus.

2. Acid Base Titrations : Preparation and Standardization of acids and bases, some exercises relatedwith determination of acids and bases separately or in mixture form, some official assayprocedures, e.g. boric acid, should also be covered.

3. Oxidation Reduction Titrations : Preparation & standardization of some redox titrants e.g.potassium permanganate, potassium dichromate, iodine, sodium thiosulphate etc. Some exercises

30

related to determinations of oxidizing & reducing agents. Exercises involving potassium iodate,potassium bromate, iodine solution and ceric ammonium sulphate.

4. Precipitation Titrations: Preparation and standardization of titrants like silver nitrate andAmmonium thiocyanate, titrations according to Mohr’s, Volhards and Fajan’s methods.

5. Gravimetric Analysis : Preparation of gooch crucible for filtration and use of sintered glasscrucible. Determination of water of hydration, some exercise related to gravimetric analysis shouldbe covered.

BOOKS RECOMMENDED :1. Mendhanm J, Denny R.C., Barnes J.D.,Thomas M, Jeffery G.H., “Vogel’s Textbook ofQuantitative Chemical Analysis”, Pearson Education Asia.2. Conners K.A., “A Text book of Pharmaceutical Analysis”, Wiley Inter-science.3. Beckett, A.H., and Stenlake, J.B., Practical Pharmaceutical Chemistry, Vol. I&II. The AtherdenPress of the University of London.4. British Pharmacopocia, Her Majesty’s Stationary Office, University Press, Cambridge.5. Alexeyev V. “Quantitative Analysis”. CBS Publishers & Distributors6. The Pharmacopoeia of India

IEC-PHARM-113: Pharmaceutical Inorganic ChemistryUnit-IA. Sources of impurities & their control, limit test for iron, arsenic, lead, heavy metals, chloride &sulphateB. An outline of methods of preparation, uses, sources of impurities, tests of purity andidentification and special tests, if any, of the following classes of inorganic pharmaceuticalsincluded in Indian Pharmacopoeia. (1996)Gases and Vapors : Inhalants (Oxygen), Anaesthetics( Nitrous oxide).

Pharmaceutical aids and necessities: water (purified water, water for injection and sterile waterfor injection), pharmaceutical acceptable glass, acids and bases (Sodium hydroxide, phosphoricacid).

Topical Agents : Protectives (Calamine, titanium dioxide, talc, kaolin), astringents(Zinc oxide,Zinc Sulphate) and anti infectives (Boric Acid, Hydrogen peroxide, Iodine, Povidone Iodine,Potassium permanganate, Silver nitrate).

Dental Products : Dentrifices- anti-caries agents (Sodium fluoride). [08]

Unit-II:Gastrointestinal Agents : Acidifying agents (Dilute Hydrochloric acid), antacids(Bismuthsubcarbonate, Aluminium hydroxide, Calcium carbonate, Magnesium hydroxide, Magnesiumoxide{ light and heavy}, Magnesium carbonate{ light and heavy}, Magnesium trisilicate ),cathartics ( disodium hydrogen phosphate, Magnesium sulphate and other Magnesium compounds),protective and adsorbents( Activated Charcoal, Light Kaolin, Aluminium sulphate

Miscellaneous Agents: Expectorants (Ammonium chloride, Potassium Iodide), antioxidants(Sodium metabisulphite). [08]

31

Unit-III : Major intra and extra- cellular electrolytes : Physiological ions, Electrolytes used forreplacement therapy, acid-base balance & combination therapy( Calcium chloride, Calciumgluconate, Calcium lactate, Calcium levulinate, Sodium dihydrogen phosphate, sodium acetate,sodium bicarbonate, sodium chloride, potassium chloride, magnesium chloride). Cationic andanionic components of inorganic drugs useful for systemic effects. [08]

Unit-IV : Essential and Trace Elements : Transition elements and their compounds ofpharmaceutical importance. Iron and haematinics (Ferrous fumarate, Ferrous gluconate, Ferroussulphate, Ferric Ammonium citrate), mineral supplements (Cu, Zn, Cr, Mn, Sb, S, I).

Co-ordination compounds and complexation- study of such compounds used in therapyincluding poison antidotes (Calcium folinate, Sodium thiosulphate). [08]

Unit-V: Inorganic Radio-Pharmaceuticals: Nuclear radio pharmaceuticals, nomenclature,methods of obtaining, standards and units of activity, measurement of activity, clinical applicationand dosage,hazards andprecautions[08]

IEC-PHARM-113P: Pharmaceutical Inorganic Chemistry PracticalList of Experiments1. To perform limit test of chloride, sulphate, Iron, Heavy metal and 5 arsenic in the given sample.2. Salt analysis3. Preparation of following compounds:- 3 Boric acid Magnesium sulphate Heavy magnesiumarbonate Calcium Carbonate Alum Zinc sulphate

BOOKS RECOMMENDED :1. Block, J.H. Roche, E, Soine, T and Wilson, C., “Inorganic, Medicinal & PharmaceuticalChemistry”, Lea & Febiger.2. Discher, C.A.,et.al Modern Inorganic Pharmaceutical Chemistry, waveland press.3. Pharmacopoceia of India, 1996 edition.4. Atherden L.M., Bentley and Drivers’ “Text Book of Pharmaceutical Chemistry”, OxfordUniversityPress,London

IEC-PHARM-114: General Pharmacy

Unit-I : History of Pharmacy: Origin & development of pharmacy, scope of pharmacy,introduction to pharmacopoeias with special reference to IP, BP, USP & InternationalPharmacopoeia. [04]Pharmaceutical Additives: Colouring, flavouring & sweetening agents, Cosolvents, preservatives,surfactants antioxidants. & their applications. [03]

Unit-II: Size Reduction : Definition,Principles and laws Governing size reducts factors affectingsize reduction, principles, laws & factors affecting energy requirements, for size reduction differentmethods of size reduction, study of hammer mill, ball mill, fluid energy mill & disintegrator,various methods & equipments employed for size separation e.g. sieving, sedimentation, cycloneseparator, elutriation methods. [06]

Unit-III: Pharmaceutical calculations : Posology, calculation of doses for infants, adults andelderly patients; Enlarging and reducing receipes,reducing recepercentage solutions, alligation,alcohol dilution, proof spirit. [10]

32

Unit-IV: Extraction & Galenicals: Extraction processes, study of infusion, decoction, digestion,percolation, maceration & their modifications, applications in the preparation of tinctures &extracts. Factors affecting selection of extraction processes. [07]

Unit-V: Mixing: Theory of mixing, solid-solid, solid-liquid & liquid-liquid mixing equipments.[03]

Introduction to Pharmaceutical Dosage Forms: A brief theory of : Solutions, mixtures, spirits,aromatic waters, glycerins, paints, syrups, elixirs, mouth washes, mucilages, lotions, liniments,pastes, inhalations and powders. [07]

IEC-PHARM-114P: General Pharmacy Practical

I: Preparation of following classes of Pharmaceutical dosage forms (involving the use ofCalculations in metrology) as official in IP, BP, USP/NF.

a) Aromatic Waters1. Chloroform water BP2. Camphor Water BP3. Rose Water NF

b) Solutions1. Lysol solution IP2. Strong Ammonium Acetate solution BP

c) Syrups1. Simple syrup BP/USP/IP

d) Elixirs1. Aromatic Elixirs USP/NF

e) Spirits1. Aromatic Ammonia spirit BP

f) Powders1. ORS Powder IP2. Absorbable dusting powder USP/Ng) Lotions

1. Calamine lotion IP2. Amino benzoic acid lotion BP

h) Liniments1. Methyl salicylate liniment BP2. Turpentine liniment BP

i) Mucilage 1. Starch Mucilage IPj) Glycerins 1. Kaolin Poultice BPk) Inhalation 1. Benzoin Inhalation BPl) Tinctures & Extracts

1. Infusion of Tea2. Decoction of Senna3. Compound benzoin tincture BP4. Strong Ginger tincture BP5. Liquorice liquid extract BP.

II: Experiments to illustrate principles of size reduction using Ball Mill. _ Effect of size of balls,number of balls and time on the efficiency of ball mill.III: Experiments to illustrate mixing efficiency. _ Solid-Solid mixing.

33

BOOKS RECOMMENDED:1. Pharmacopoeia of India, The Controller of Publications, Delhi.2. British Pharmacopoeia, Her Majesty’s Stationary Office, University Press, Cambridge.3. Carter S.J., “Cooper and Gunn’s Tutorial Pharmacy”, CBS Publishers, Delhi.4. Rawlins E.A., “Bentley’s Text Book of Pharmaceutics”, ELBS Bailliere Tyndall.5. Lachman L,Liberman H.A and Kanig J.L., “Theory and Practice of Industrial Pharmacy”, Leaand Febiger.6. Cooper and Gunn’s Dispensing for Pharmaceutical Students, CBS Publishers, New Delhi.7. Aulton, M.E, Text Book of Pharmaceutics, Vol., I & II. Churchill Livingstone.8. United States Pharmacopoeia (National Formulary).9. Remington – “The science and practice of pharmacy” Vol. I & II. Mack Publishing Co.,Pennsylvania.

IEC-PHARM-115: Human Anatomy & Physiology-IUnit –Ia. Introduction to human body & organisation of human body.b. Functional & structural characteristics of cell.c. Detailed structure of cell membrance & physiology of transport process. Structural & functionalcharacteristics of tissues- epithelial, connective, muscle and nerve. [08]

Unit-II Skeletal systemStructure, composition & functions of skeleton. Classification of joints, types of movements ofjoints. [08]Unit-IIIAnatomy & physiology of skeletal & smooth muscle, neurotransmission, physiology of skeletalmuscle contraction, energy metabolism, types of muscle contraction, muscle tone. [08]Unit-IVHaemopoietic system: Composition & function of blood & its elements, erythopoesis, bloodgroups, blood coagulation. [08]

Unit-Va) Concepts of health & disease: Disease causing agents & prevention of disease.b) Classification of food requirements: Balanced diet, Nutritional deficiency disorders, theirtreatment & prevention, specification for drinking water. [08]

IEC-PHARM-115P: Human Anatomy & Physiology-I Practical

1. Study of human skeleton.2. Microscopic study of different tissues.3. Estimationof haemoglobin in blood, Determination of bleeding time, clotting time, R.B.C,Count, Total leucocyte count, D.L.C. and E.S.R.4. Recording of body temperature, pulse rate and blood pressure, basic understanding ofElectrocardiogram – PQRST waves and their significance.

BOOKS RECOMMENDED:1. Ranade VG, “Text Book of Practical Physiology”, Pune Vidyarthi Griha Prakashan, Pune.2. Difore S.H. “Atlas of Normal Histology” – Lea & Febiger Philadelphia.3. Guyton AC, Hall JE., “Text book of Medical Physiology”, WB Saunders Company.4. Chatterjee C.C. “Human Physiology”, Medical Allied Agency, Calcutta.

34

5. Ross & Wilson “Anatomy & Physiology in Health & Illness”, Churchill Livingstone.6. Tortora GJ, & Anagnodokos NP “Principles of Anatomy & Physiology”, Harper & RowPublishers, New Delhi.7. Parmar N.S. “Health Education & Community Pharmacy” CBS Publishers, Delhi.8. Shalya Subhash “Human Physiology” CBS Publishers & Distributors.9. Keele, C.A., Niel, E and Joels N, Samson Wright’s Applied Physiology, Oxford UniversityPress.

IEC-PHARM-116: Basic English & GrammerUNIT-IEnglish Grammar Parts of speech, Articles, Preposition, Tenses, Active-Passive voice, Direct-Indirect, speech. [12]

UNIT-IILetter writing, Précis and Essay writing Comprehension Speed reading, scanning & swimming.[08]

UNIT-IIIWorking on accent neutralisation, pauses, stresses, non words, voice modulation, eye contact forsmall & large groups. [08]

UNIT-IVPresentation techniques, - Tips. Importance of non-verbal communication, debates, Role plays. [06]

UNIT-VPersonality types. Decision making Motivation Attitude Thinking [06]

BOOKS RECOMMENDED1. Wren P.C and Martin H., “High School Grammar and Composition”, S. Chand & Co.2. Robbins, S “Organisational Behaviour”

Second Semester

IEC-PHARM-121 Presentation & Communication Skills

UNIT-I

1. Written skills: Proposal writings formats, Report writings, Business letters, Applications,

Covering letters, Curriculum Vitae Designing [10]

UNIT-II

1. Productivity, Time Management simulation exercise

2. Leadership Skills.

3. Team work ‘BSC’ – Boss, Subordinates & Collegues [06]

UNIT-III

Group Discussions (G.D), Tips, GD [08]

35

UNIT-IV

Corporate behaviour, corporate expectation, office etiquettes.

Extempore [06]

UNIT-V

Interview Tips:- What student is supposed to do before the interview, during the interview, after

the interview & on the day of interview. Various questions that may be asked in an interview.

Model interview (Video-shooting & displaying optional), Exit Interview [10]

BOOKS RECOMMEDNDED

1. Raman, Meenakshi & Sharma Sangeeta, Technical Communications- Principles & Practice,

Oxford University Press.

IEC-PHARM-122: Pharmaceutical Organic Chemistry – IUnit-I : Structure and Properties : Atomic Structure, atomic orbital, molecular orbital,hybridization, sigma & Pi bond, covalent, electrovalent and co-ordinate bond, inductive effect,resonance, Classification & Nomenclature of organic compounds. [08]

Unit-II: Isomerism, geometrical isomerism, Stereochemistry including optical activity,stereoisomerism, specification of configuration and conformational analysis. [08]

Unit-III : Important methods of preparation, reactions with special reference to mechanism of thefollowing classes of compounds: Alkanes, alkenes, alkynes & dienes, free radical substitutionreaction, alkyI halides, Alcohols. [08]

Unit-IV: Aromatic Compounds, aromatic character, structure of benzene, resonance, orientation ofaromatic substitution, arenes, amines (aliphatic & aromatic), phenols, aryl halides. [08]

Unit-V: Aldehydes and ketones (aliphatic & aromatic), carboxylic acids & their derivatives, di &tricarboxylic acids, hydroxy acids. Organometallic Compounds- Grignard reagent, organolithiumcompounds, their preparation &synthetic application. [08]

IEC-PHARM-122P: Pharmaceutical Organic Chemistry – I Practical

SUGGESTED LIST OF PRACTICALS1. Identification of elements and functional groups in given sample.2. Purification of solvents like Benzene, chloroform, acetone and preparation of absolute alcohol.3. Synthesis of compounds involving benzoylation, acetylation, bromination, reduction &oxidation.Synthesis of following compounds Picric acid Aniline Acetanilide Aspirin Hippuric acid P-Bromoacetanilide Iodoform Oxalic Acid

BOOKS RECOMMENDED:1. Mann, F.G, & Saunders, B.C., Practical Organic Chemistry, ELBS/ Longman.2. Vogel A.I., Textbook of Practical Organic Chemistry, ELBS/Longman.3. Morrison, R.T., and Boyd R.N., Organic Chemistry, Prentice Hall of India Pvt. Ltd, New Delhi.4. Finar, I.L., Organic Chemistry, Vol. I & II, ELBS/Longman.5. Jain, M.K. Organic Chemistry, Sohan Lal Nagin Chand & Co. 60 B, Bunglaw Road, Delhi.6. Hendrikson, Organic Chemistry.

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7. Godly, E.W. “ Naming organic compounds”.8.Kalsi,” Organic reactions Stereochemistry & Mechanism".

IEC-PHARM-123: Physical ChemistryUnit-I1. Behaviour of gases : Kinetic theory of gases, deviation from ideal behaviour and explanation.2. The liquid state : Physical properties (surface tension, parachor, viscosity, rheochor, refractiveindex, optical rotation, dipole moment) and chemical constituents.3. Amorphous and crystalline solids : geometry & symmetry of crystals, Millers indices, types ofcrystals, Physical properties of crystals, crystal diffraction. [08]

Unit-II4. Thermodynamics: Fundamentals, first, second, third and zeroth law, Joule-Thompson’s effect,absolute temperature scale.5. Thermo chemistry : Definition & conventions, heat of reaction, heat of formation, heat ofsolution, heat of neutralisation, heat of combustion, Hess law of constant summation, Bombcalorimeter, bond energies, Kirchoffs equation. [08]

Unit-III6. Solutions : Ideal and real solutions, solutions of gases in liquids, colligative properties.7. pH: determination of PH buffers, theory of buffers.8. Adsorption: Freurdlich and Gibbs adsorption Isotherms, Langmuir theory of adsorption. [08]

Unit-IV9. Electro chemistry : Faraday’s laws of Electrolysis, Electric conductance & its measurement,molar & equivalent conductivity and its variation with dilution. Kohlrausch law, Arrhenius theory,degree of ionisation & Ostwald dilution law. Transport number & migration of ion, Hittorfstheoretical device, theory of strong elecrolytes (Debye Huckle theory). [08]

Unit-V10. Chemical kinetics : Zero, first and second order reaction, complex reactions, elementary ideaof reaction kinetics, characteristics of homogenous and heterogeneous catalysis, acid base andenzyme catalysis.11. Phase equilibria : Phase, component, degree of freedom, phase rule (excluding derivation).Cooling curves & Phase diagrams for one & two component system involving eutectics, congruent& incongruent melting point (examples-water, sulphur, KI-H2O, NaCI-H2O system). Distributionlaw & application to solvent extraction. [08]

IEC-PHARM-123P: Physical Chemistry Practical1. Determination refractive index of given liquids.2. Determination of specific rotation of sucrose at various concentrations and determine theintrinsic rotation.3. Determination of rate constant of simple reaction.4. Determination of cell constant, verify Ostwald dilution law and perform conductometrictitrations.5. Determination of surface tension.6. Determination of partition co-efficient.

37

7. Determination of viscosity.8. pH determination by different methods.9. Determination of solubility.

BOOKS RECOMMENDED:1. Pali S.R., and Prabartak, S.K.D.E., Practical Physical Chemistry, Haltone Limited, Calcutta.2. Shoemaker, D.P. Garland, C.W., Experiments of Physical Chemistry, MC Graw Hill Book Co.3. Bahl B.S., Tuli G.D. & Bahl Arun, Essential of Physical Chemistry, S. Chand & Co.4. Negi A.S. & Anand S.C.“Textbook of Physical Chemistry” Wiley Eastern Ltd.5. Glasstone S. & Lewis D, Elements of Physical Chemistry, Macmillan Education.6. Atkins P & Paula, J.D. “Atkins Physical Chemistry” Oxford University Press

IEC-PHARM-124: Introduction to Computers Fundamentals & ProgrammingUnit-1: Definition and Overview of Computer, Computer classification, Computer Organization,Computer code, computer classification of Boolean algebra. Input Devices Out put devices, Storagedevices. Computer Software, Types of software. Overview of Computer Networks, LAN, MAN,WAN, Internet, Intranet, network topology. Internetworking: Bridges, Repeaters and Routers.

Unit-2: Introduction: Operating system and function, Evolution of operating system, Batch,Interactive, Time sharing and Real Time System. Single User Operating System and Multi-userOperating system, Compare MS-DOS vs. UNIX, Various window features. Internal and Externalcommands in MS-DOS.Unit- 3: Introduction to MS-OFFICE-2003, word 2003 Document creation, Editing, formattingtable handling, mail merge, Excel-2003, Editing, working Retrieval, Important functions, short cutkeys used in EXCEL.

Unit 4 : MS-Power point 2003-Job Profile, Elements of Power point , ways of deliveringPresentation, concept of Four P’s (Planning , Preparation, Practice and Presentation) ways ofhandeling presentations e.g. creating, saving slides show controls, Adding formatting, animationand multimedia effects. Database system concepts, Data models schema and instance , Databaselanguage, Introduiction to MS-Access 2003, main components of Access tables, Queries, Reports,Forms table handeling, working on Query and use of database.

Unit- 5: Computer applications in Pharmaceutical and clinical studies, uses of Internet inPharmaceutical Industry

BOOKS RECOMMENDED:1. Sinha, R.K., Computer Fundamentals, BPB Publications.2. Raja Raman, V, Computer Programming in ‘C’, PHI Publication.3. Hunt N and Shelley J. “Computers and Common Sense” Prentice Hall of India.4. N.K.Tiwari,” Computer fundamentals with Pharmacy Applications”.5. G.N.Rao, “ Biostatistics & computer Applications”.

IEC-PHARM-124P: Introduction to Computers Fundamentals & Programming PracticalSoftware Lab to be used for the following:-1. Windows, Managing Windows, Working with Disk , Folders and files.2. MS-Office 2003 (MS Word, MS Power point, MS Excel, MS Access).3. Computer Operating System Like DOS and Windows.4. Internet Features (E-mail, Browser etc.)

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IEC-PHARM-125: Advanced MathematicsUnit-I1. Method of collective data2. Diagramatic representation of data (Pie,Histogram, Bar, Circular diagranm)3. Classification and Tabulation of data.4. Sampling-Types of sampling Merits and limitations of sampling Sampling errors and nonsampling errors.

Unit-II- Measure of central tendency for decrete and continuous data.a. Mean, Types of means.b. Medianc. Mode- Measure of dispersiona. Quartile deviationb. Mean deviationc. Standard error of Mean (SEM)

Unit-IIIa. Srewness and Kurtosisb. Correlation and regression analysisc. Method of least square in straight line

Unit-IV-Statistical Inferences- Confidence (feucidial ) limit. Testy- Hypothesis- t-test z-test X2 –test F- test (variance ratio) Analysis of variances- one way and two way classification, Nonlin(ANOVA)

Unit-V-1. Theory of Probability- Simple Probability Addition Probabilty Multiplication Probabilitty2. Binomial distribution- Fit of Binomial3. Poisson distribution- Fit of Poisson4. Normal distribution –Fit of Normal

BOOKS RECOMMENDED1. A textbook of Mathematics for XI-XII Students, NCERT Publication Vol. I-IV.2. Gupta S.P. Statistical Methods, Sultan Chand and Co., New Delhi.3. Greval B.S., Higher Engineering Mathematics, Khanna Publication, New Delhi.4. Boltan’s Pharmaceutical Statistics, Practical and Clinical Application, Marcel Dekker, N.Y.5. Khan, Khanum,” Biostatistics for Pharmacy”.

IEC-PHARM-126: Human Anatomy & Physiology-IIUnit-ICentral Nervous System: Functions of different parts of brain and spinal cord. Neurohumoraltransmission in the central nervous system, reflex action, electroencephalogram, specializedfunctions of the brain. Cranial nerves and their functions. [06]Autonomic Nervous System : Physiology and functions of the autonomic nervous system.Mechanism of neurohumoral transmission the A.N.S. [04]

Unit-IISense Organs : Basic anatomy and physiology of the eye (vision), ear (hearing), taste buds, nose(smell), and skin (superficial receptors). [06]

Unit-IIILymphatic System: Composition , formation and circulation of lymphs, lymph node and spleen.[05]

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Unit-IV.Demography and Family Planning, Medical termination of pregnancy.First Aid: Emergency treatment of shock, snake bites, burns, poisoning, fractures and resuscitationmethods. [07]

Unit-VCommunicable Diseases: Brief outline, their causative agents, modes of transmission andprevention (Chicken pox, measles, influenza, diphtheria, whooping cough, tuberculosis,poliomyelities, helminthiasis, malaria, filariasis, rabies, trachoma, tetanus, leprosy, syphillis,gonorrhoea, and AIDS). [12]

BOOKS RECOMMENDED:1. Ranade VG, Text Book of Practical Physiology, Pune Vidyarthi Griha Prakashan, Pune.2. Difore SH, “Atlas of Normal Histology” Lea & Febiger Philadelphia.3. Guyton AC, Hall JE., Text book of Medical Physiology, WB Saunders Company.4. Chatterjee C.C. Human Physiology, Medical Allied Agency, Calcutta.5. Ross & Wilson, Anatomy & Physiology in Health & Illness, Churchill Livingstone.6. Tortora GJ, & Anagnodokos NP, Principles of Anatomy & Physiology, Harper & RavePublishers, New Delhi.7. Parmar N.S., Health Education & Community Pharmacy CBS Publishers, Delhi.8. Shalya Subhash, Human Physiology, CBS Publishers & Distributors.9. Keele, C.A., Niel, E and Joels N, Samson Wright’s Applied Physiology, Oxford UniversityPress.

IEC-PHARM-127 General Pharmacology- I

UNIT –IDrug discovery process: Principles techniques and statergies used in new drug discovery. Highthroughout screening. Human genomies robotics and economics of drug discovery, Regulations, forlaboratory animal care and ethical requirements.Bioassays : Basic principles of bioassays official bioassays, experimental models and statisticaldesigns employed in biological standardization. Biological standardization of vaccines and serawith certain examples with reference to IP. Development of new bio assay methods.

UNIT – IIPreclinical models employed in the screening of new drugs belonging to following categories.Antifertility agents, sympathomimetics, parasympathomimetics, muscle relaxants (both central andperipheral). Sedatives, hypnotics, antiarrhythmic agents, cardiac stimulants, cardiotonic agentsbronohodilators, antihistaminics, eicosanoids.Antipsychotic agents, antianxiety agents nootropic drugs antidepressant drugs; antiparkinsonismagents, anticpileptics; analgesics and anti-inflammatory agents; antiulcer agents; infarction;antiatherosclerotic drugs; antidiabetics; models for status epilepticus drugs. cerebroventricular andother newer techniques of drug administration and development; transgenic animals and othergenetically prone animal models.

UNIT – IIIAlternatives to animal screening procedures, cell-line handling and maintenance and propagationof cell lines, patch-clamp technique, in-vitro cell line based assays diabetics and arthraitis models,molecular biology techniques.

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UNIT – IVPrinciples of toxicity evaluations, ED50, LD50 and TD values, International guidelines (ICHEthics and animal experimentation recommendations).Guidelines and regulatory agencies –CPCSEA,OECD,FDA, FHSA,EPA,EEC,WHO etc,

UNIT – VIntroduction to biostatistics, parametric and non-parametric tests. Regression and correlation:

Linear regressions, Method of least squares; correlation coefficients, rank correlation, multipleregression Tests of significance: testing hypotheses, tests of significance based on normaldistribution. t-test; significance of correlation coefficient. F-test and Analysis of Variance: 1-Way,2-Way and 3-way classification, Chi-square test of (i) Variance of a normal population (ii)Goodness of fit, (iii) Independence in contingency tables. Non parametric tests, order statistics, signtest, run test, Median test.

Books recommended1. Pre – Clinical Drug Development , Rogge2. Basic and clinical Pharmacology, Katzung3. Pharmacological screening methods, N.S. Parmer and Shivkumar4. Pharmacological screening methods, N.S. Parmer and Shivkumar5. Calculations for Pharmaceutical Practice , Winfield6. Pharmacoepidemiology , Storm7. CPCSEA, OECD, FDA, WHO, ICH guidelines from respective website downloads.8. Drug discovery and pharmacological evaluations, G.Vogel, Springer publications.

IEC-PHARM-127 P General Pharmacology- I Lab

List of Experiments1. Biological standardization of drugs like acetylcholine/Histamine2. Experiments on CNS. General screening methods of drugs on CNSCNS stimulants and depressants, anxiogenics and anxiolytics, amnestics and nootropics, anticonvulsants, analgesics, safety pharmacology.3. Drugs acting on Gastrointestinal tractGeneral screening methods for the anti ulcer activity, intestinal motility, and anti-diarrhoeals.4. Experiments on CVSGeneral screening procedure of anti-arrhythmic agents, anti-hypertensives, anti-ischemics.5. Experiments on Local anestheticsGeneral methods for evaluating local anesthetic activity6. Experiments on General Pharmacology

Enzyme induction activity, drug dependence and withdrawl effects.7. Experiments on Diuretics

General screening methods for evaluating the diuretic activity.8. Screening procedure for antidiabetic drugs.9. Experiments on analgesic and anti-inflammatory agentsGeneral methods of screening for the evaluation of analgesics and anti inflammatory agents, [bothacute and chronic models]10. General methods for evaluating the antimicrobial activities of chemotherapeutic agents.11. Estimation of biochemical and free radical scavengers.

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Third SemesterIEC-PHARM-231: Unit Operation – IUnit-I1. Unit Operations : Introduction, basic laws.2. Fluid Flow : Types of flow, Reynold’s number, Viscosity, Concept of boundary layer, basicsituations of fluid flow, valves, flow meters, manometers and measurement of flow and pressure.

Unit-II3. Water systems – Raw water, soft water, purified water, water for injection , quality requirementand treatment of water. washing, cleaning and standardisation of cleaning.4. Filtration and Centrifugation : Theory of filtration, filter aids, filter media, industrial filtersincluding filter press, rotary filter, edge filter. Factors affecting filtration, Principles ofcentrifugation, industrial centrifugal filters, and centrifugal sedimenters. [10]

Unit-III5. Crystallization : Characteristics of crystals like-purity, size, shape, geometry, habit, forms sizeand factors affecting them, Solubility curves and calculation of yields. Material and heat balancesaround Swenson Walker Crystallizer. Supersaturation theory and its limitations, Nucleationmechanisms, crystal growth, Study of various types of Crystallizer, Tanks, agitated batch, SwensonWalker, Single vacuum, circulating magma and Krystal crystallizer, Caking of crystals and itsprevention. [08]

UNIT – IV6. Heating, Ventilation & AC Systems: Basic concepts and definition, wet bulb and adiabaticsaturation temperatures, Psychrometric chart and measurement of humidity, application of humiditymeasurement in pharmacy, equipment for dehumidification operations. Principles and applicationsof refrigeration and air conditioning. [08]

Unit-V7. Material of Construction : General study of composition, corrosion, resistance, Properties andapplications of the materials of construction with special reference to stainless steel and glass.8. Industrial Hazards and Safety Precautions : Mechanical, Chemical, Electrical, fire and dusthazards. Industrial dermititis, Accident record. [06]

IEC-PHARM-231P: Unit Operation – I Practical1. Measurement of rate of flow of fluids and pressure by:

a) Simple and differential manometersb) Venturimeterc) Orifice meter

2. Determination of Reynold Number.3. Study of factors affecting rate of filtration

a) Effect of different filter mediab) Effect of viscosity of filtratec) Effect of pressured) Effect of thickness of cakee) Effect of filter aids.

4. Study principle of centrifugation fora) Liquid –Liquid separation and stability of emulsions.b) Solid – liquid separation and stability of suspension.

5. Determination of dry bulb and wet bulb temperatures and use of Psychrometric charts.6. Study of characteristics of crystals

42

7. Study of solubility curve of crystals.

BOOKS RECOMMENDED1. Badger W.L. and Banchero J.T. Introduction to Chemical Engineering Mc Graw HillInternational Book Co., London.2. Perry R.H. & Chilton C.H. Chemical Engineers Handbook, Mc Graw Kogakusha Ltd.3. McCabe W.L. and Smith J.C. Unit Operation of Chemical Engineering Mc Graw HillInternational Book Co., London.4. Sambhamurthy, Pharmaceutical Engineering, New Age Publishers.5. Gavhane, K.A. “Unit Opeation-I”, Nirali Prakashan.

IEC-PHARM-232: Pharmaceutical Organic Chemistry – IIUnit-IUnsaturated carbonyl compounds, cycloaddition. Compounds containing active methylene groupand their synthetic importance- Acetoacetic ester and malonic ester. [08] Polynuclearhydrocarbons-Napthalene, anthracene and phenantherene.

Unit - IIHeterocyclic Compound – Nomenclature, Chemistry, preparation, properties and pharmaceuticalimportance of pyrrole, furan, thiophene, pyridine, pyrimidine, imidazole, pyrazole, thiazole,benzimidazole, indole, phenothiazines. [08]

Unit-IIIName reactions – Definition, reaction mechanism and synthetic application of Merwin –Pondorff,Verley reduction, Oppeneaur oxidation, Bechmann rearrangement, Mannich reaction, Diel’s alderreaction, Michel, Reformatsky, Knoevanegal reaction, Benzoin condensation. [08]

Unit-IVClassification, structure, reactions, structure elucidation, identification of:a) Carbohydrates

i) Monosaccharides – Glucose and fructose.ii) Disaccharides – Sucrose, lactose and maltose.iii) Polysaccharides – Starch.

Unit-VClassification, identification, general methods of preparation and reactions of amino acids andproteins Structure of Nucleic Acids. Chemistry & identification of oils, fats and waxes. Polymersand polymerisation.

IEC-PHARM-232P: Pharmaceutical Organic Chemistry – II Practical1. Identification of organic compounds and their mixture with derivatization.2. Synthesis of Organic Compounds involving two steps.3. Determination of Iodine value , sap value, Acid value, Ester value of oils, fats and waxes.

BOOKS RECOMMENDED1. Mann P G & Saunders B C, Practical Organic Chemistry, ELBS/ Longman, London.2. Furniss B S, Hannaford A J, Smith P W G and Tatehell A R, Vogel’s Textbook of PracticalOrganic Chemistry, The ELBS/ Longman, London.3. Morrison, T.R. and Boyd, R.N., Organic Chemistry, Prentice Hall of India, Private Limited, NewDelhi.4. Finar, I.L., Organic Chemistry Vol. I & II, ELBS/Longman.5. Jain, M.K. and Sharma S.C, Organic Chemistry, Shoban Lal Nagin Chand & Co., Delhi.

43

6. Kalsi,” Organic Reactions Stereochemistry & Mechanism”.

IEC-PHARM-233: MicrobiologyUnit-I1. Introduction to the scope of microbiology.2. Structure of bacterial cell.3. Classification of microbes and their taxonomy: Bacteria and viruses. [08]

Unit-II4. Identification of Microbes : Stains and types of staining techniques, electron microscopy.5. Nutrition, cultivation & isolation of bacteria & viruses. [08]

Unit-III6. Control of microbes by physical and chemical methods.A. Disinfection, factors influencing disinfectants, dynamics of disinfection, disinfectants Andantiseptics and their evaluation.B. Sterilization, different methods, validation of sterilization methods & equipments. [08]

Unit-IV7. Sterility testing as per I.P.8. Preservative efficacy

Unit-V9. Microbial assays of antibiotics, vitamin B12.10. Factory and hospital hygiene- control of microbial contamination during manufacture,manufacture of sterile products- clean and aseptic area, nosocomial infection, control of hospitalinfections.

IEC-PHARM-233P: Microbiology PracticalExperiments devised to prepare various types of culture media, sub-culturing of common aerobicand anaerobic bacteria, fungus and yeast, various staining methods, various methods of isolationand identification of microbes, sterilization techniques and their validation, validation ofsterilization techniques, evaluation of antiseptics and disinfectants, testing the sterility ofpharmaceutical products as per I.P. requirements, microbial assay of antibiotics and vitamins.SUGGESTED PRACTICALS1. Study of sterilization methods & equipments

• Dry heat• Moist heat

2. Preparation of various types of culture media.3. Isolation of bacteria.4. Sub-culturing of common bacteria, fungi, yeast.5. Identification and staining of bacteria.

• Simple staining• Gram staining• Acid fast staining• Hanging drop preparation

6. Evaluation of disinfectants and antiseptics• Phenol coefficient test, minimum inhibitory concentration.

7. Test for sterility of pharmaceutical products as per IP.8. Microbial assay of antibiotics as per IP.

44

BOOKS RECOMMENDED :1. Aneja K.R. Experiments in Microbiology, Plant Pathology, Tissue Culture & MushroomCultivation, Vishwa Prakashan.2. Gunasekaran P, Lab Mannual of Microbiology, New Age Publishers.3. Davis, Dulbetco, Eisen Microbiology.4. Stanier R.Y., Ingraham, J.L., Wheelis M.L. & Painter P.R. General Microbiology, MacmillanPress Limited.5. Hugo and Russell, Pharmaceutical Microbiology, Black Well Scientific Publication, Oxford.6. Prescott L.M., Harley J.P. & Klien D.A. Microbiology, McGraw Hill.7. Sykes, Disinfection and Sterilization.8. Pelczar & Reid, Microbiology, Tata Mc Graw Hill, Delhi.9. Virella G. Microbiology and Infectious Diseases, William & Wilkins.10. Ananthanarayan R & Paniker CKJ, Textbook of Microbiology, Orient Longman

IEC-PHARM-234: Human Pathophysiology-IUnit-I –Respiratory System – Anatomy & function of respiratory structures, Mechanism of respiration,regulation of respiration, pathophysiology of Asthma, Pneumonia, Bronchits, Emphysema,Tuberculosis. [08]

Unit-II –Cardiovascular System – Functional Anatomy of heart, conducting system of heart, cardiac cycle,ECG (Electro cardiogram). Pathophysiology of hypertension, Angina, CHF, myocardial infarction,cardiac arrhythmias, Ischaemic heart disease, Arteriosclerosis. [10]

Unit-III –Cell injury & Adaptation – Courses of cell injury, pathogenesis & morphology of cell injury.Cellular Adaptation – Atropy, hypertropy, aplasia, metaplasia, & dysplasia, intracellularaccummulation & pathophysiology of Neoplasm. [08]

Unit IV –Basic mechanisms involved in the process of inflammation and repair Alterations in vascularpermeability and blood flow, migration of WBC’s , mediaters of inflammation. Brief outline of theprocess of repair [08]

Unit-V-Pathophysiology of Joints disorder – Arthritis, gout, myasthenia gravis, spasticity, tetany, fatigue.Pathophsiology of anaemia, AIDS, hypersensitivity, allergic conditions, physhosis, epilepsy,Parkinson & Alzeimer’s diseases pathophysiology of cataract, glaucoma etc. [06]

BOOKS RECOMMENDED1. Difore SH, “Atlas of Normal Histology” Lea & Febiger Philadelphia.2. Chaurasia B.D, Human Anatomy, Regional & Applied Part I, II & III, CBS Publishers &Distributors, New Delhi.3. Guyton AC, Hall JE., Text book of Medical Physiology, WB Saunders Company.4. Chatterjee C.C. Human Physiology, Medical Allied Agency, Calcutta.5. Ross & Wilson, Anatomy & Physiology in Health & Illness, Churchill Livingstone.6. Tortora GJ, & Anagnodokos NP, Principles of Anatomy & Physiology, Harper & RavePublishers, New Delhi.7. Parmar N.S., Health Education & Community Pharmacy CBS Publishers, Delhi.8. Shalya Subhash, Human Physiology, CBS Publishers & Distributors.

45

9. Keele, C.A., Niel, E and Joels N, Samson Wright’s Applied Physiology, Oxford UniversityPress.10. Dipiro JL, Pharmacotherapy – A Pathophysiological Approach, Elsevier.11. Robbins SL, Kumar V, Basic Pathology, WB Saunders.

IEC-PHARM-234P: Human Pathophysiology-I PracticalUnit-I1. Definition, scope of community pharmacy Roles and responsibilities of Community pharmacist,code of Ethics.2. Community Pharmacy Management

i) Selection of site, Space layout, and designii) Staff, Materials- coding, stockingiii) Legal requirementsiv) Maintenane of various registersv) Use of Computers

Unit-II3. Prescriptions- parts of prescription, legality & identification of medication related problems likedrug interactions incompatibility.4. Inventory control in community pharmacy. Definition, various methods of Inventory Control.ABC, VED, EOQ, Lead time, safety stock [08]

Unit-III5. Pharmaceutical care Definition and Principles of Pharmaceutical care.6. Communication skills and Patient counselling Need for good communication, Keycommunication skills. Strategies to overcome barriers Patient information leaflets- content, design,& layouts, advisory labels7. Patient compliance Definition, Factors affecting compliance, role of pharmacist in improving thecompliance. [10]

Unit-IV8. Health screening services Definition, importance, methods for screening Blood pressure/ bloodsugar/ lung function And Cholesterol testing. [06]9. OTC Medication- Definition, OTC medication list & Counseling

Unit-V10. Health Education WHO Definition of health, and health promotion, care for children, pregnant& breast feeding women, and geriatric patients. Role of Pharmacist in family planning, preventionof communicable diseases, nutrition.11. Pharmacoepidemiology & Pharmacoeconomics – Brief introduction12. Rational drug therapy – Brief introduction [10]

IEC-PHARM-235: Community PharmacyUnit-I

1. Definition, scope of community pharmacy Roles and responsibilities of Community pharmacist,

code of Ethics.

2. Community Pharmacy Management

i) Selection of site, Space layout, and design

ii) Staff, Materials- coding, stocking

iii) Legal requirements

46

iv) Maintenane of various registers

v) Use of Computers

Unit-II

3. Prescriptions- parts of prescription, legality & identification of medication related problems like

drug interactions incompatibility.

4. Inventory control in community pharmacy. Definition, various methods of Inventory Control.

ABC, VED, EOQ, Lead time, safety stock

Unit-III

5. Pharmaceutical care Definition and Principles of Pharmaceutical care.

6. Communication skills and Patient counselling Need for good communication, Key

communication skills. Strategies to overcome barriers Patient information leaflets- content, design,

& layouts, advisory labels

7. Patient compliance Definition, Factors affecting compliance, role of pharmacist in improving the

compliance.

Unit-IV

8. Health screening services Definition, importance, methods for screening Blood pressure/ blood

sugar/ lung function And Cholesterol testing.

9. OTC Medication- Definition, OTC medication list & Counseling

Unit-V

10. Health Education WHO Definition of health, and health promotion, care for children, pregnant

& breast feeding women, and geriatric patients. Role of Pharmacist in family planning, prevention

of communicable diseases, nutrition.

11. Pharmacoepidemiology & Pharmacoeconomics – Brief introduction

12. Rational drug therapy – Brief introduction

IEC-PHARM-235P: Community Pharmacy Practical1. Categorization and storage of Pharmaceutical products bases on legal requirements of labellingand storage.2. Project report on visit to the nearby Community for Counseling on the rational use of drugs andaspects of health care.3. Prescription handling and identification of drug interactions, incompatibilities.4. Health screening services and study of equipments for:-

_ Blood glucose determination (Glucometer)

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_ Blood pressure (BP apparatues)_ Lung function test (Peak flow meter)

5. Design of community pharmacy to incorporate all pharmaceutical care services (as per scheduleN).6. Study of OTC medications List & Available brands7. Interpretation of various pathological report of blood and urine.

BOOKS RECOMMENDED :1. Carter S.J. Cooper and Gunn’s Dispensing for Pharmaceutical Students, CBS Publishers, Delhi.2. Ansel H.C., Introduction to Pharmaceutical Dosage Forms, K.M. Varghese & Co., Bombay.3. Aulton M.E. Pharmaceutics – The Science of Dosage Form Design, ELBS/ ChurchilLivingstone.4. Remington Pharmaceutical Sciences, Mack Publishing Co., Pennslyvannia.5. I.P., Govt of India Publication.6. B.P., Her Majesty’s Stationary Office, Cambridge.7. Carter S.J., Cooper and Gunn’s Tutorial Pharmacy, CBS Publishers, Delhi.8. Drugs & Cosmetics Act & Rules.9. Parmar N.S. Community Pharmacy & Health Education, CBS Publishers.

IEC-PHARM-236 Pharmaceutical Biostatistics and Computer ApplicationsUnit - 1Methods of collection of data, classifications and graphical representation of data. Binomial andnormal probability distribution. Polygon, histogram, measure of central tendency. Significance ofstatistical methods, probability, degree of freedom, measures of variation - Standard deviation,Standard error.

Unit - 2Sampling, sample size and power. Statistical inference and hypothesis. Tests for statisticalsignificance: student t-test , Chi-square test, confidence level, Null hypothesis.

Unit - 3Linear regression and correlation. Analysis of Variance (one way and two way). Factorial designs(including fraction factorial design). Theory of probability, Permutation and Combination , Ratios,Percentage and Proportion. Two way ANOVA and Multiple comparison procedures.Unit - 4Non-parametric tests, Experimental design in clinical trials, Statistical quality control, Validation,Optimization techniques and Screening design. Correlation and regression, least square method,significance of coefficient of correlation, nonlinear regression.Unit - 5Bioassays-calculations of doses response relationships, LD

50, ED

50, probit analysis.

Applications of software for statistical calculation viz. SPSS, foxtron.Application of computers in Pharmaceutical sciences.

Book Recommended:1. Bolton, Pharmaceuticals Statistics- Practical & Clinical Applications, Marcel & Dekker, New

York.2. Fisher, R.A., Statistical Methods for Research Works, Oliver & Boyd, Edinburgh.3. Chow, Statistical Design and Analysis of Stability Studies, Marcel Dekker, New York.4. Buncher, Statistics in the Pharmaceutical Industry, Marcel Dekker, New York.5. Finney, D.J., Statistical Methods in Biological Assays, Hafner, New York.

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Fourth SemesterIEC-PHARM-241: BiochemistryUnit-I1. Enzymes :Nomenclature, enzymes-kinetics and mechanism of action, mechanism of inhibitionof enzymes and isoenzymes in chemical diagnosis.2. Co-enzymes:Vitamins as co-enzymes and their significance. Metals as co-enzymes and theirsignificance. [08]

Unit-II3. Carbohydrate metabolism : Glycolysis, Gluconeogenesis and Glycogenolysis. Metabolism ofgalactose and galactosemia. Role of sugar nucleotides in biosynthesis and pentose phosphatepathway.4. The citric acid cycle, significance, reactions and energetics of the cycle. [08]

Unit-III5. Lipid metabolism : Oxidation of fatty acid & energetics, Biosynthesis of ketone bodies andtheir utilization, Biosynthesis of saturated and unsaturated fatty acids., regulation of lipidmetabolism, essential fatty acids.6. Biological Oxidation : The respiratory chain, its role in energy capture & control, Energetics ofoxidative phosphorylation, mechanism of oxidative phosphorylation. [08]

Unit-IV7. Biosynthesis of amino acids, catabolism of amino acids and conversion of amino acids tospecialized products, biosynthesis of purine and pyrimidine., formation of deoxyribonucleotides.8. Biosynthesis of RNA, DNA replication, Carcinogensis & DNA repair mechanism. [08]

Unit-V9. Genetic Code and Protein synthesis, components of protein synthesis, inhibition of proteinsynthesis.10. Regulation of gene expression. (Prokaryote and Eukaryote) [08]

IEC-PHARM-241P: Biochemistry Practical1. Preparation of standard buffers (citrate, phosphate and carbonate) and measurement of pH.2. Titration curve for amino acids.3. Separation of amino acids by chromatography.4. Separation of lipids by TLC.5. Quantitative estimation of amino acids.6. Determination of glucose by means of the enzyme glucose oxidase.7. Enzymatic hydrolysis of glycogen by α & β amylase.8. Effects of temperature on the activity of alpha amylase.9. Estimation of cholesterol in Blood.10. Estimation of Glucose in blood & urine.11. Estimation of Urea in blood.12. Estimation of ketone bodies in blood.13. Qualitative analysis of inorganic as well as organic constituents of Urine.

BOOKS RECOMMENDED :1. Jayaraman J., Laboratory Manual in Biochemistry, Wiley Eastern Limited.2. Plummer, David J., An Introduction to Practical Biochemistry, Mc Graw Hill, New Delhi.3. Singh S.P., Practical Manual to Biochemistry, CBS Publisher, New Delhi.

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4. “Harpers Review of Biochemistry” Lange Medical Publication.5. Conn E.E. & Stumph P.K., Outline of Biochemistry, John Willery & sons, New York.6. Nelson DL & Cox MM, Lehninger Principles of Biochemistry, Macmillan Worth Publishers.7. Stryer L., Biochemistry, WH, Freeman & Company, San Francisco.8. Harrow B. & Mazur A., Text book of Biochemistry, W.B. Saunders Co., Philadephia.9. Narayanan P., Bioinformatics- A Premier, New Age International Publishers Delhi.10. Nelson, L.David, ‘ Lehninger , Principles of Biochemistry”.

IEC-PHARM-242: Pharmacognosy-IUnit-IDefinition history, scope & development of Pharmacognosy. [02]1. Source of Drug : Biological, marine, mineral and plant tissue cultures as source of drugs.Marine pharmacognosy, Novel medicinal agents from marine sources. [04]2. Classification of Drugs : Alphabetical, Morphological, taxonomical, chemical &pharmacological. [02]

Unit-II3. Plant taxonomy : Study of following families with special reference to medicinally importantplants – Apocynacae, Solanaceae, Rutaceae, Umbelliferae, Leguminosae, Rubiaceae, Liliaceae,Labitae, Acanthaceae, Compositae, Papaveraceae. [04]

Unit-III4. Cultivation, Collection, Processing & Storage of crude drugs:

A. Factors influencing cultivation of medicinal plants, Type of Soils & fertilizers ofcommon use.

B. Pest & Pest Management ,natural pest control agents. [02]C. Plant hormones and their applications. [01]D. Polyploidy, Mutation & hybridization with reference to medicinal plants. [02]E. Poly Houses/ Green Houses for cultivation.

Unit-IV5. Quality Control of crude drugs : Adulteration of crude drugs and their detection by o

rganoleptic, microscopic, physical, chemical and biological methods of evaluation includingQ uantitative microscopy. WHO guidelines for standardisation of medicinal plants. [08]Unit-V6. Systematic pharmacognostic study of following :

a) Carbohydrates & derived products : Agar, Guar gum, acacia, Honey, Isabgol, pectin,starch, sterculia & tragacanth. [07]b) Lipids – Beeswax, castor oil, Cocabutter, Kokum butter, hydnocarpus oil, Codliver oil,shark liver oil, Linseed oil, wool fat, Rice-bran oil, Lard & Suet. [08]

IEC-PHARM-242P: Pharmacognosy-I Practical1. Morphological characteristics of plant families mentioned in theory.2. Microscopical Measurements of cell & cell contents Starch grains, Calcium oxalate Crystals &Phloem Fibres.3. Determination of leaf Constants such as Stomatal index, Stomatal number, Vein islet number,Vein determination number and palisade ratio.4. Identification of crude drugs belonging to carbohydrates & lipids.5. Preparation of herbarium sheets.

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SUGGESTED PRACTICALS1. Study of Plants belonging to family Solanacae.2. Study of Plants belonging to family Rutacae.3. Study of Plants belonging to family Liliacae4. Study of Plants belonging to family Umbilliferae.5. Microscopical measurements of starch grains (Wheat, Maize).6. Microscopical measurements of starch grains (Rice, Potato).7. Various types of calcium-oxalate crystals, their study and microscopical measurements(Rhubarb, Senna, Liquorice etc.)8. Study of various types of phloem fibres.9. Determination of stomatal number with the help of camera lucida along with the working ofinstrument.10. Determination of stomatal index.11. Determination of vein-islet and vein termination number.12. Determination of palisade ratio.13. Chemical Tests of Agar, Acacia, Sterulia and Tragacanth.14. a) Chemical tests of Pectin, Starch and Honey.

b) Swelling factor of Isapaghula husk.c) Average weight of Ispaghula husk.

15. Physical characteristics of Caster oil, Cod-liver oil, Shark-liver oil and Linseed oil.

BOOKS RECOMMENDED1. Trease, G.E. & Evans, W.C., “Pharmacognosy” Bailleire Tindall East bourne, U.K.2. Wallis, T.E., Text book of Pharmacognosy, J.A. Churchill, Ltd3. Wallis T.E., Analytical Microscopy, J&A Churchill Limited, London.4. Brain K.R. and Turner T D. “The Practical Evaluation of Phyto Pharmaceutical”, Wright,Scientechnica- Bristol.5. Schewer PJ, “Marine Natural products”, Academic press, London.6. Mohammed Ali, “ Pharmacognosy & Phytochemistry”.

IEC-PHARM-243: Unit Operation - IIUnit-IStoichiometry : Unit proceses material and energy balances, molecular units, mole fraction, tiesubstance, gas laws, mole volume, primary and secondary quantities, equilibrium state, rateprocess, steady and unsteady states, dimensionless equations, , dimensionless formulae,dimensionless groups, different types of graphic representation. [08]

Unit-IIEvaporation : Basic concepts of phase equilibria, factor affecting evaporation, evaporator, filmevaporators, single effect and multiple evaporator. [08]

Unit -IIIDistillation : Raoult’ s law , Phase Diagrams , volatility, simple steam and flash distillations ,principles of rectification, Mccabe thiele method for the calculations of number of theoreticalplates, Azeotropic and extractive distillation . [08]

Unit –IVDrying : Moisture content and mechanism of drying , rate of drying and time of dryingcalculations, classification and type of dryers , dryers used in pharmaceutical industries – Traydryer, Fluidized bed dryer, spray dryer and special drying methods. [08]

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Unit-VAutomated Process Control Systems : Process variables, temperature, pressure, flow level andvacuum and their measurements. Elements of automatic process control and introduction toautomatic process control systems. Elements of computer aided manufacturing (CAM) . Reactorsand fundamentals of reactor design for chemical reactions. [08]

IEC-PHARM-243P: Unit Operation - II Practical1. Determination of overall heat transfer coefficient.2. Study of factors affecting rate of evaporation :-

a) Effect of surface areab) Effect of temperature

3. Study of factors affecting rate of dryinga) Surface areab) Temperature

4. Determination of rate of drying, free moisture content and bound moisture content.5. Experiments based on

a) Steam distillationb) Extractive distillationc) Azeotropic distillation6. Elementary knowledge of engineering drawing_ Alphabets/ letter writing_Scales_ Orthographic projections – First and third angle projection methods_ Simple Isometric views

BOOKS RECOMMENDED :1. Badger W.L. and Banchero J.T. Introduction to Chemical Engineering Mc Graw HillInternational Book Co., London.2. Perry R.H. & Chilton C.H. Chemical Engineers Handbook, Mc Graw Kogakusha Ltd.3. McCabe W.L. and Smith J.C. Unit Operation of Chemical Engineering Mc Graw HillInternational Book Co., London.4. Gavhane, K.A. “Unit Operation-II”, Nirali Prakashan.5. Sambhamurthi Pharmaceutical Engineering, New Age Publishers.

IEC-PHARM-244: Pharmaceutical Analysis – IIUnit-ITheoretical considerations and application in drug analysis and quality control by the followinganalytical techniques (assays included in the Indian Pharmacopia 1996)

(A) Non-aqueous titrations(B) Complexometric titration. [08]

Unit-II(A) Miscellaneous methods of analysis : Diazotization titrations, Kjeldahl method of Nitrogenestimation, Karl- Fischer titration, Alcohol estimation in galenicals Potentiometry (B)Radioassays.[08]

Unit-IIIDemistrometry – Introduction, Dielectric cell, electrode potential, Nernst equation, salt bridge,standard potential, reference and indicator electrodes, measuring the relative voltage of cell.

A. Potentiometry : General principles, instrumentation and applications.B. Conductometry : General Principles, instrumentation and applications. [08]

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Unit-IVPolarography and Amperlometry- General principles, Instrumentation and Applications [08]

Unit-VPrinciple, instrumentation and pharmaceutical applications.Paper column, Chromatography, TLC[08]

IEC-PHARM-244P: Pharmaceutical Analysis – II Practical1. Non-aqueous Titrations : Preparation and standardization of perchloric acid andsodium/potassium methoxide solutions, Estimation of some pharmacopoeial products.2. Complexometric Titrations : Preparation and standardization of EDTA solution some exerciserelated to pharmacopoeial assays by Complexometric titrations.3. Miscellaneous Determinations : Exercise involving Diazotization, Kjeldahil, Karlfisher.4. Exercise based on acid base titration in aqueous and non-aquous media, oxidation reductiontitrations using potentiometric technique, determination of acid base dissociation constants andplotting of titration curves using pH meter.5.Exercises involving conductometric titrations.6. Exercises based on paper, column and thin- layer chromatography.BOOKS RECOMMENDED :1. Beckett, A H and Stenlake, J.B, Practical Phamaceutical Chemistry, Vol, I and II, The AthlonePress of the University of London.2. Pharmacopoeia of India, published by The Controller of Publications, Delhi.3. British Pharmacopoeia, Her Majesty’s Stationary Office, University Press, Cambridge.4. Mendham J, Denny RC, Barnes, J.D. Thomas M.J.K. “Vogel’s Text Book of Quantitativechemical” Pearson Education Asia.5.Connors KA, A Textbook of Pharmaceutical Analysis, Wiley Intescience, New York.6. G.Vidya Sagar,” Instrumental Methods of drug Analysis”.

IEC-PHARM-245: Human Pathophysiology-IIUnit-IRespiratory System – Anatomy & function of respiratory structures, Mechanism of respiration,regulation of respiration, pathophysiology of Asthma, Pneumonia, Bronchits, Emphysema,Tuberculosis. [08]

Unit-IICardiovascular System – Functional Anatomy of heart, conducting system of heart, cardiac cycle,ECG (Electro cardiogram). Pathophysiology of hypertension, Angina, CHF, myocardial infarction,cardiac arrhythmias, Ischaemic heart disease, Arteriosclerosis. [10]

Unit-IIICell injury & Adaptation – Courses of cell injury, pathogenesis & morphology of cell injury.Cellular Adaptation – Atropy, hypertropy, aplasia, metaplasia, & dysplasia, intracellularaccummulation & pathophysiology of Neoplasm. [08]

Unit IVBasic mechanisms involved in the process of inflammation and repair Alterations in vascularpermeability and blood flow, migration of WBC’s , mediaters of inflammation. Brief outline of theprocess of repair [08]

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Unit-VPathophysiology of Joints disorder – Arthritis, gout, myasthenia gravis, spasticity, tetany, fatigue.Pathophsiology of anaemia, AIDS, hypersensitivity, allergic conditions, physhosis, epilepsy,Parkinson & Alzeimer’s diseases pathophysiology of cataract, glaucoma etc. [06]

BOOKS RECOMMENDED1. Difore SH, “Atlas of Normal Histology” Lea & Febiger Philadelphia.2. Chaurasia B.D, Human Anatomy, Regional & Applied Part I, II & III, CBS Publishers &Distributors, New Delhi.3. Guyton AC, Hall JE., Text book of Medical Physiology, WB Saunders Company.4. Chatterjee C.C. Human Physiology, Medical Allied Agency, Calcutta.5. Ross & Wilson, Anatomy & Physiology in Health & Illness, Churchill Livingstone.6. Tortora GJ, & Anagnodokos NP, Principles of Anatomy & Physiology, Harper & RavePublishers, New Delhi.7. Parmar N.S., Health Education & Community Pharmacy CBS Publishers, Delhi.8. Shalya Subhash, Human Physiology, CBS Publishers & Distributors.9. Keele, C.A., Niel, E and Joels N, Samson Wright’s Applied Physiology, Oxford UniversityPress.10. Dipiro JL, Pharmacotherapy – A Pathophysiological Approach, Elsevier.11. Robbins SL, Kumar V, Basic Pathology, WB Saunders.

FIFTH SEMESTERIEC-PHARM-351: Pharmaceutical JurisprudenceUnit-1 : Introduction

1. Pharmaceutical Legislations – A brief review.2. Drugs & Pharmaceutical Industry – A brief review.3. Pharmaceutical Education – A brief review.4. Pharmaceutical Ethics: [06]

Unit-II : An elaborate study of the following:(A) Pharmacy Act 1948(B) Drugs and Cosmetics Act 1940 and Rules 1945 [14]

Unit-III :(C) Medicinal & Toilet preparations (Excise duties Act 1955)(D) Narcotic Drugs & Psychotropic Substances Act 1985 & Rules.(E) Drugs Price Control Order 1995. [08]

Unit-IV:A brief study of the following with special reference to the main provisions.

(A) Poisons Act 1919(B) Drugs and Magic remedies (Objectionable Advertisements) Act 1954.(C) Medical termination of Pregnancy Act 1970 & Rules 1975.(D) Prevention of Cruelty to Animals Act 1961.(E) States Shops & Establishments Act & Rules. [05]

Unit-V :(F) A.I.C.T.E. Act 1987(G) Patents Act 1970(H) Weight and Measures Act(I) Package and Commodity Act(J) U.S Food and Federal D&C Act [07]

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Note : The teaching of all the above Acts should cover the latest amendments.

BOOKS RECOMMENDED :1. B.M., Mittal, Textbook of Forensic Pharmacy, National Book Centre, Dr. Sundari MohanAvenue, Calcutta.2. Relevant Acts & Rules Published by the Govt. of India.3. N.K. Jain, A Textbook of Forensic Pharmacy, Vallabh Prakashan, N. Delhi.4. Singh, Harkishan “History of Pharmacy in India- Vol.-I, II & III” Vallabh Prakashan.

IEC-PHARM-352: Industrial Pharmacy-IUnit-IPreformulation studies : Study of physical properties of drug like physical form, particle size,shape, density, wetting, dielectric constant, Solubility, dissolution and organoleptic properties andtheir effect on formulation, stability and bioavailability. [08]

Unit-IILiquid Dosage Forms : Introduction, types of additives used in formulations, vehicles, stabilizers,preservatives, suspending agents, emulsifying agents, solubilizers, colors, flavours and others,Manufacturing packaging & evaluation of clear liquids, suspensions and emulsions. [08]

Unit-IIISemisolid Dosage Forms : Definitions, types, mechanisms of drug penetration, factors fluencingpenetration, semisolid bases and their selection, General formulation of semisolids, clear gels &manufacturing procedure, evaluation and packaging. [08]

Unit-IVSuppositories : Ideal requirements, bases, manufacturing procedure, packaging and evaluation.Pharmaceutical Aerosols: Definition, Propellants, general formulation, manufacturing andpackaging methods, pharmaceutical applications. [08]

Unit-VCosmetology and cosmetic Preparations : Structure of skin, formulation of cold cream,vanishingcream, cleansing cream, all purpose cream, protective cream, antiperspirants, deodorant,facepowder. Hair structure, Shampoos, Conditioner, Shaving and after shaving products, Dentifrice &Mouthwash, Lipstick, Nail lacquer. [08]

IEC-PHARM-352P: Industrial Pharmacy-I Practical1. Preparation of cold cream, vanishing cream, cleansing lotion and creams. Moisturising creams,Skin tonics, Hair creams, Hair Conditioners, Shampoos, Shaving creams and sticks. Tooth powder,Tooth pastes, After shave lotion and other cosmetic preparations.2. Preparation, evaluation and packing of liquid orals like solutions, suspensions and emulsions,ointments, suppositories, eye drops, eye ointments etc.

SUGGESTED PRACTICALS1. Preparation, evaluation, and packing of (10 preparations =5 labs)I- Liquid Orals

a) Solutions : Strong Sodium salicylate oral solution BP Chloral hydrate oral solution BPb) Suspensions : Magnesium sulphate oral suspension BP Milk of magnesia IP Aluminiumhydroxide gel IPc) Emulsions : Liquid paraffin oral emulsion BP

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II – Semi-Solidsd) Ointments Salicylic acid ointment BP Whitfield ointment BP Compound benzoic acid

ointmentIII - Suppositories

e) Suppositories : Glycerin suppositories BP Lactic acid suppositories BP3. Preparation of cosmetic preparations (30 preparation = 10 labs)

1) Cold cream 16) Cream shampoo2) Vanishing cream 17) Clear liquid shampoo3) Cleansing cream 18) Shaving cream4) All purpose cream 19) Brushless shaving cream5) Protective cream 20) After shave lotion6) Foundation lotion 21) Hair fixer gel7) Sunscreen lotion 22) Tooth powder8) Face powder 23) Tooth paste9) Body powder 24) Mouth wash10) Hand cream 25) Hair conditioner11) Face pack 26) Anti dandruff shampoo12) Deodorant 27) Depilatory cream13) Antiperspirant 28) Bleach cream14) Shampoo- powder 29) Hair setting lotion15) Oily shampoo 30) Tooth gel

BOOKS RECOMMENDED1. Remington’s Pharmaceutical Sciences, Vol. I & Vol. – II, Mack Publishing Co., U.S.A.2. J.W. Cooper, & G. Gunn, Tutorial Pharmacy, Petman Books Ltd., London.3. Lachman L., Lieberman H.A, Kanig J.L, Theory and Practice of Industrial Pharmacy, Lea &Febiger, Philadelphia, U.S.A.4. H.C. Ansel, Introduction to Pharmaceutical Dosage Forms, Lea & Febiger, Philadelphia, U.S.A.5 R.L. Juliano, Drug Delivery Systems, Oxford University Press, Oxford.6. Harrys Cosmetology7. Balsam and Sagarin, Cosmetics: Science and Technology.8. Thomssen E.G. Modern Cosmetics, Universal Publishing Corporation.9. Mittal B.M. & Saha R.N.-a handbook of cosmetics, Vallabh Prakashan.10. Harry G.Brittain,” Polymorphin in Pharmaceuticals Solids”.

IEC-PHARM-353: Physical PharmacyUnit-I(A) Matter, properties of Matter : States of matter, change in the state of matter, latent heat andvapor pressure, sublimation critical point, Eutectic mixtures, gases, relative humidity, liquidcomplexes, liquid crystals, glassy state, solids-crystalline, amorphous and polymorphism. [02](B) Kinetics and Drug Stability : General considerations & concepts, Degradative path56 ways,half life determination, Influence of temperature, light, solvent, catalytic species and other factors,Accelerated stability study, expiration dating. ICH guidelines for stability. [05](C) Buffers: Buffer equations and buffer capacity in general, buffers in pharmaceutical systems,preparation, stability, buffered isotonic solutions, measurements of tonicity, calculations andmethods of adjusting is tonicity. [02]

Unit-IIMicromeritics and Powder rheology: Particle size and distribution, average particle size, numberand weight distribution, particle number, methods for determining particle volume, opticalmicroscopy, sieving, sedimentation, measurement, particle shape, specific surface, methods for

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determining surface area, permeability, adsorption, derived properties of powders, porosity,packing arrangement, densities, bulkiness & flow properties. [07]

Unit-IIISurface and Interfacial Phenomenon : Liquid interface, surface and interfacial tension, surfacefree energy, measurement of surface and interfacial tension, spreading coefficient, adsorption atliquid interfaces, Surface active agents, HLB classification, solubilization, detergency, adsorptionat solid interfaces, solid- gas and solid-liquid interfaces, complex films,electrical properties ofinterface. [08]

Unit-IVViscosity and rheology : Newtonian systems, Law of flow, kinematic viscosity, effect oftemperature, non-Newtonian systems, pseudoplastic, dilatant, plastic, thixotrophy, thixotropy informulation, determination of viscosity, capillary, falling ball, rotational viscometers.Complexation : Classification of complexes, methods of preparation and analysis, applications.[08]

Unit-VDispersion Systems : Colloidal Dispersions : Definition, types, properties of colloids, protectivecolloids, application of colloids in pharmacy; Suspensions and Emulsions; Interfacial properties ofsuspended particles, settling in suspensions, theory of sedimentation, effect of Brownianmovement, sedimentation of flocculated particles, sedimentation parameters, wetting of particles,controlled flocculation, flocculation in structured vehicles, rheological considerations;Emulsions-types, theories, physical stability. [08]

IEC-PHARM-353P: Physical Pharmacy Practical1. Determination of particle size, Particle size distribution and surface area using various methodsof particle size analysis.2. Determination of derived properties of powders like density, porosity, compressibility, angle ofrepose etc.3. Determination of surface/ interfacial tension, HLB value and critical micellar concentration ofsurfactants.4. Study of rheological properties of various types of systems using different Viscometers.5. Studies of different types of colloids and their properties.6. Preparation of various types of suspensions and determination of their sedimentation parameters.7. Preparation and stability studies of emulsions.8. Studies of different types of complexes and determination of their stability constants.9. Determination of half-life, rate constant and order of reaction.10. To study the influence of various factors on the rate of reaction.11. Accelerated stability testing, shelf-life determination and expiration dating of pharmaceuticals.12. Preparation of pharmaceutical buffers and determination of buffer capacity.13. Experiments involving tonicity adjustments.

BOOKS RECOMMENDED :1. Martin A, Bustamante P. & Chun A.H.C- Physical Pharmacy, Lea & Febiger, Philadelphia.2. Shotten E & Ridgaway K, Physical Pharmaceutics, Oxford University Press, London.3 D.V.Derle ,” Essentials of Physical Pharmacy”.

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IEC-PHARM-354: Pharmaceutical Medicinal Chemistry-IUnit-IBasic Principles of Medicinal Chemistry: Physicochemical aspects (Optical, geometric andbioisosterism) of drug molecules and biological action. Drug-receptor interaction includingtransduction mechanism, concept of prodrug. [08]Mode of action, uses, structure activity relationship of the following classes of drugs(Synthetic procedures of individually mentioned drugs only)

Unit-IIDrugs acting at Synaptic and neuro-effector junction sites: Cholinergic, Anticholinergic &Anticholinesterases-Neostigmine, Physostigmine, Methacholine, Pilocarpine, Atropine. AdrenergicDrugs-Ephedrine, Amphetamine, Salbutamol, Adrenaline.[08]

Unit-IIIDrugs acting on the Central Nervous System : [08]General Anaesthetics-Thiopental, Ketamine, Methohexital.Local Anaesthetics-Lignocaine, Benzocaine.Sedatives and Hypnotics-Phenobarbitone, Alprazolam.Opioid Analgesics-Pethidine, Methadone, Pentazocine.

Unit-IVAntitussives-Cramiphen, Dextromethorphen. [08]Anticonvulsants-Phenytoin, Carbamazepine, Ethosuximide, Valproic Acid.Antiparkinsonism drugs-Carbidopa, Levodopa.CNS Stimulants-Caffeine, Nikethamide.

Unit-VPsychopharmcological Agents : [08]Antianxiety drugs- Diazepam, chlordiaze Poxide.Antidepressants – Imipramine, Amitriptyline Fluoxetine.Antispasmodic and Antiulcer drugs-Dicyclomine, Ranitidine, Omeprazole.Skeletal muscle Relaxants– Gallamine Mephenesin,Antipsychotic- Chlorpromazine, Haloperidol.

IEC-PHARM-354P: Pharmaceutical Medicinal Chemistry-I Practical1. Synthesis of selected drugs from the course content involving two or more steps.2. Establishing the pharmacopoeial standards of the drugs synthesized.

SUGGESTED PRACTICALS1. Synthesis of Methyl salicylate.2. To establish pharmacopoeial standards of Methyl salicylate.3. Synthesis of Paracetamol.4. To establish pharmacopoeial standards of Paracetamol.5. To synthesize Benzocaine.6. To establish pharmacopoeial standards of Benzocaine.7. Synthesis of Phenytoin.8. To establish pharmacopoeial standards of Phenytoin.9. Synthesis of Barbituric acid desivatives.10.To establish pharmacopoeial standards.

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BOOKS RECOMMENDED :1. Mann P G & Saunders B C, Practical Organic Chemistry, ELBS/Longman, London.2. Furniss B A, Hannaford A J, Smith P W G and Tatehell A R, Vogel’s Textbook of PracticalOrganic Chemistry, The ELBS/ Longman, London.3. Pharmacopoeia of India, Minsitry of Health, Govt. of India.4. Wolff ME. Ed. Burger’s Medicinal Chemistry, John Wiley & Sons, New York.5. Degado J.N. and Remers W A R, 10th eds., Wilson and Giswold’s Text book of OrganicMedicinal and Pharmaceutical Chemistry, Lippincott, William & Wilkins.6. Foye W C. Principles of Medicinal Chemistry, Lea & Febiger, Philadelphia.7. Singh Harkrishan and Kapoor, V.K., Organic Pharmaceutical Chemistry, Vallabh Prakashan,Delhi.8. Nogrady T, Medicinal Chemistry – A Biochemical Approach, Oxford University Press, NewYork, Oxford.9. Finar I L. Organic Chemistry, Vol I & II, ELBS/ Longman, London.10. Lednicer, D. The Organic Chemistry of Drug Synthesis Vol. I-V, John Wiley & Sons Inc. NewYork.

IEC-PHARM-355 : Pharmacology-IUnit-I General Pharmacology – Introduction to pharmacology, routes of drug administration,combined effect of drugs,factors modifying drug action. Bioassay of drugs & Biologicalstandardization. Discovery & development of new drugs. [07]

Unit-IIBasic Concepts of Pharmacokinetics- Absorption, Distribution, Metabolism, ExcretionPharmacodynamics, Principles of drug action ,Mechanism of drug action , Receptors, DoseResponse curve,Therapeutics index -LD 50 & ED50,. Adverse drug reactions & treatment ofpoisoning. Drug interactions, [07]

Unit-IIIPharmacology of ANSDrug acting on autonomic nervous systemI-Cholinergic system-Parasympathomimetic (Cholinergic ) drugs.Parasympatholytic (anti Cholinergic) drugs.Drug acting on autonomic ganglia (Stimulants and blocking agents)II-Adrenergic systemSympathomimetic (Adrenergic) drugsSympatholytic (Anti-adrenergic) drugs [08]

Unit-IVPharmacology of CNSGeneral Anaesthetics, Alcohols & disulfiram, Sedative hypnotics, Psychopharmacological agents-anti anxiety agents ,antipsychotics, antidepressants. Antiepileptic drugs, Antiparkinsonism drugs,Analgesics & antagonists. [12]

Unit-VDrugs acting on PNSLocal anaesthetics. Skeletal muscle Relaxants Peripherally and Centrally acting muscle Relaxants

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IEC-PHARM-355P: Pharmacology-I Practical1. Use of computer simulated CDs or Video cassetes for pharmacology practical where possible.2. Preparation of different solutions for experiments. Drug dilutions, use of molar and w/v solutionsin experimental pharmacology. Common laboratory animals and anesthetics used in animal studies.Commonly used instruments in experimental pharmacology. Some common and standardtechniques.3. Study of different routes of administration of drugs in mice/rats. To study the effect of hepaticmicrosomal enzyme inhibitors and induction on the pentobarbitone sleeping time in mice, usingsoftware alternative to use of animals.

BOOKS RECOMMENDED :1. Ghosh, MN; Fundamentals of Experimental Pharmacology, Scientific Book Agency, Calcutta.2. Grover J.K., Experiments in Pharmacy & Pharmacology, CBS Publishers, New Delhi.3. Kulkarni S.K., Hand Book of Experimental Pharmacology, Vallabh Prakashan, Delhi.4. Barar F.S.K: Text Book of Pharmacology, Interpoint, New Delhi.5. Goodman & Gilman, The Pharmacological basis of Therapeutics, Editors: J.G. Hardman, L.E.Limbird, P.B. Molinos, R.W. Ruddon and A.G. Gil, Pergamon press.6. Katzung, B.G. Basic & Clinic Pharmacology, Prentice Hall, International..7. Rang MP, Dale MM, Riter JM, Pharmacology Churchill Livingstone.8. Tripathi, K.D. Essentials of Medical Pharmacology, Jay Pee Publishers, New Delhi.9. Satoskar & Bhandarkar; Pharmacology & Pharmacotheropeutics., Popular Prakashan Pvt. Ltd.Bombay.10. Singh, Saundar, Essentials of Pharmacology; Academia Publishers, Delhi.11. Sheffield Biocsience Programs, U.K., ISBN 1-874758-02-6

IEC-PHARM-356: Environment & EcologyUnit-IEnvironment studies

A- Definition, scope & importanceB- Natural Resources – renewable & non renewableC- Use, utilization, exploitation and associated problems of forests, Water resources,Mineral resources, Food resources, Energy resources, Land resources.D- Equitable use of resources for sustainable life style, role of an individual in conservation.

Unit-IIEcosystems

A. Introduction, types features & functions of difference ecosystems- Forest Grassland,Desert and Aquatic.B. Biodiversity & its conservation with special reference to India.

Unit-IIIEnvironmental pollution- Air, Water, Soil, Marine, Noise, Thermal, Nuclear- Introduction causesand control measures.

Unit IVLaw related to Environmental ProtectionAir (Prevention and Control of pollution )Act 1987Water prevention & Control of Pollution Act. 1974

Unit-VEnvironmental Protection Act -1986Noise PollutionHazardous WastesHazardous Chemical

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Hazardous MicroorganismBiomedical WasteProvisions applicable to drugs and cosmetic.

Reference1. Principles of Environmental Studies, C. Manoharachary, P. Jyaranama Reddy, Pharma BookSyndicate, Hyderabad.2. Handbook of Environmental Laws, Acts, Guidelines, Compliances & Standards Vol. I &II.R.K.Trivedy, Pharma Book Syndiacte, Hyderabad3. Relevant Acts & Rules published by Govt. of India with latest amendments.4. Reddy, M.Anji , ‘ Text Book of Environmental Sciences & Techgnology”.

IEC-PHARM-357 Basic Principles of Toxicology-I

Unit – IGeneral principal of regulatory toxicology. Use of animals in preclinical toxicology studies, role ofpreclinical toxicology in drug discovery and development process. Experimental considerations forassessing possible human risk. Flow chart for development of preclinical testing. Dose conversionfactors, clinical signs toxicity.Unit – IISingle dose and repeat dose toxicity studies; Factors influencing such studies such as species, sex,size, route ,dose level; Data evaluation and regulatory requirements. Determination of MaximumTolerated Dose (MTD) and LD 50 as per revised OECD guidelines. Allergenicity testing, dermaltoxicity, immunotoxicology and in vitro methods of toxicology.

Unit – IIIReproductive toxicology assessment of male reproductive toxicity, spermatogenesis; Riskassessment in male reproductive toxicity; Female reproductive toxicology; Oocyte toxicity;alterations in reproductive endocrinology; Relationship between maternal and developmentaltoxicity.

Unit – IVMutagenicity; Mechanisms of mutagenesis, point mutations,; Individual chromosomes andcomplete genome mutations, germ cell mutations, somatic cell mutation; Tests systems in vitro,chromosome damage and chromosomal aberration test, gene mutation, in vivo micronucleus testsin rodents, metaphase analysis.

Unit – VPreclinical toxicological requirements for biologicals and biotechnological products; safetyanalysis; problems specific to recombinant products, toxicokinetics, principles of GLP as perOECD guidelines for conducting preclinical toxicity studies

Books Recommended1. Drug safety Evaluation, Shayne C Gad, Wiley Interscience

2. The toxicologist’s pocket handbook, Michael J derelanko 2nd

Ed,2008, CRC press3. Relevant OECD guidelines (Internet resources)

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Sixth SemesterIEC-PHARM-361: Drug Regulatory Affairs & IPRUNIT – IPatents and Intellectual Property Rights (IPR): definition, scope, objectives, source of patientinformation, patent processing and application. Patents, copyrights, trademarks, silent features,trade related aspects (TRIPS), international and regional agreements.UNIT – IIGATT and WTO: GATT – historical, prospectives, objectives, fundamental principles, impact ondeveloping countries. WTO-objectives, scope, functions, structure, status, membership andwithdrawal, dispute settlement, impact on globalization, India-tasks & challenges.UNIT – IIIRegulatory Affairs: Indian context – requirements and guidelines of GMP, understanding of drugsand cosmetics act 1940 and rules 1945 with reference to schedule M, U and Y.UNIT – IVRelated Quality Systems: Objectives and guidelines of USFDA, WHO and ICH. Introduction toISO series.UNIT – VDocumentation: Documentation types related to pharmaceutical industry, protocols, harmonizingformulation development for global filings, NDA, ANDA, CTD, dealing with post-approvalchanges – SUPAC, handling and maintenance including electronic documentation.

Books Recommended:1. Willing, S.W., & Stoker, Good Manufacturing Practices for Pharmaceuticals, Marcel Dekker,

New York.2. Guarino, R.A., New Drug Approval Process, Marcel Dekker, New York.3. Drug & Cosmetic Act.4. Patents Act.5. Consumer Protection Act.6. Environmental Protection Act.7. Federal Food, Drug & Cosmetic Act.8. Bansol, IPR Guidelines for Pharm students and Researchers.9. Pisano-FDA Regulatory Affairs.10. Phillip W. Grubb, Patents for Chemicals, Pharmaceuticals and Biotechnology.11. Das P, Das G. Protection of industrial property rights.12. Katju SN. Laws and drugs. Law Publishers.13. Original Laws published by Government of India.14. Hussain. Law of drugs in India.15. Websites: www.fda.org ; www.wipo.int , www.ich.org , www.cder.org .

IEC-PHARM-362: Industrial Pharmacy-IIUnit-I1. Capsules: Advantages and disadvantages of capsule dosage form, material for production ofhard gelatin capsule, size of capsules, methods of capsule filling, soft gelatine capsule shell andcapsule content, importane of base adsorption and minim/gm factors in soft capsule, qualitycontrol, stability testing and storage of capsule dosage forms.2. Micro-encapsulation : Types of microcapsule, importance of microencapsulation in pharmacy,microencapsulation by phase co-acervation separation, , multi orifice, spray drying, spraycongealing, polymerisation, complex, formulation, emulsion, air suspension technique, coating panand other techniques, evaluation of micro capsules. [8]

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Unit-IITablets : (A) Formulation of different types of tablets, granulation technology on large-scale byvarious techniques, physics of tablets making, different types of tabletcompression machinery andthe equipments employed, evaluation of tablets.(B) Coating of Tablets : Types of coating, film forming materials, formulation of coating solution,equipments for coating process, evaluation of coated tablet. Stability kinetics and quality assurance.[09]

Unit-III :(A) Approaches to Sustained and controlled release dosage forms. In-vitro methods of evaluation.(B) Formulation and evaluation of Opthalmic, Nasal and Ear products. [08]

Unit-IV : Parenteral Products :Preformulation factors, routes of administration, water for injection, pyrogenicity, nonaqueousvehicles. Formulation details, containers and closures and their selection. Prefilling treatment,washing of containers and closures, preparation of solution and suspensions, filling and sealing ofampoules, vial, infusion fluids, lyophilization & preparation of sterile powders, equipment for largescale manufacture and evaluation of parenteral products. [07]

Unit-V : Surgical ProductsDefinition, primary wound dressing, absorbents, surgical cotton, surgical gauzes etc, bandages,adhesive type, protective cellulosic hemostasis, official dressings, absorbable and non absorbablesutures, ligatures and catguts.Packaging of Pharmaceutical Products : Packaging component types, specifications and methodsof evaluation, stability aspects of packaging equipments, factors influencing choice ofcontainers,legal and other official requirements for containers, package testing. [08]

IEC-PHARM-362P: Industrial Pharmacy-IIP1. Experiments to illustrate preparation, stabilization & physical evaluation of pharmaceuticalproducts like powders, capsules, tablets, parenterals & microcapsules.2. Evaluation of Materials used in pharmaceutical packaging.

SUGGESTED PRACTICALSI – Preparation, Evaluation, Packing of the following dosage forms.

a) Capsules : Chloramphenicol capsules IPb) Microcapsules : Coacervation Phase separation (Temperature change)c) Tablets : Uncoated – Paracetamol tablets IPd) Tablets : Film coated – Ibuprofen tablets IPse) Tablets : Enteric coated – Aspirin tabletsf) Parenteral : Disodium EDTA injection IP (vials)g) Parenteral : Dextrose – NaCl IV infusion IP (Infusion boilers)h) Parentrals : Water for infection IP (Ampoule)i) Eye drops : Zinc sulphate IPj) Eye ointment : Sulphacetamide Sodium IP

II - Formulation and evaluation of sustained release dosage forms – Aspirin Extended release(Matrix embedding method, Granules USP/NF coating of granules)III - Evaluation of packages – containers & closures.

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BOOKS RECOMMENDED1. Remington: The Science and Practice of Pharmacy Pharmaceutical Sciences Vol. I & III, MackPublishing Company, U.S.A.2. R.E. Avis, Pharmaceutical Dosage Forms : Parenteral Medication, Vol-I, Marcel Dekker-Inc,New York & Basel.3. H.C. Ansel, Introduction to Pharmaceutical Dosage Forms, Lea & Febiger, Philadelphia, U.S.A.4. R.C. Juliano, Drug Delivery Systems, Oxford University Press, Oxford.5. Herbert A. Liebermann & Leon Lachman, Theory & Practice of Industrial Pharmacy, Lea &Febiger, Philadelphia, U.S.A.6. Manohar A.Potdar,’ C,GMP for Pharmaceuticals”.

IEC-PHARM-363: Pharmaceutical Medicinal Chemistry-IIUnit-I-Drug DesignBasic concept of drug design, Introduction to Analogues based drug design, Structure based drugdesign, Introduction to QSAR & Computer aided drug design. [08]

Unit- IICordiac glycosides & drug used for CHF-Digitoxin Antiarrhythmic drugs-Propranolol,ProcainamideAntianginal drugs- Isosorbide mononitrate Antihypertensive drugs-Captopril, methyldopa,Nifedipine. [08]Anticoagulants- Heparin, worfarin Antihyperlipedmics- Lovastatin, Clofibrate

Unit-IIIAnti cancer drugs Alxylating Agents- Chlorambucid, Carmustine Antimetabolites- Methotaxate .mercaptopurine . Fluorouracil . [08]

Unit-IV : Analgesics and Antipyretics – Aspirin, Mefeanamic Acid, Ibuprofen,Diclofenac,Paracetamol.Antibacterials – Sulphamethoxazole, Sulphadiazine, Sulphacetamide, Nalidixic acid. [08]

Unit-V: Diuretics – Acetazolamide, Chlorthiazide; Furosemide, Spironolactone.

IEC-PHARM-363P: Pharmaceutical Medicinal Chemistry-II Practical1. Synthesis of selected drugs from the course content involving two or more steps.2. Establishing the pharmacopoeial standards of the drugs synthesized.3. Spectral analysis of the drugs synthesized.

BOOKS RECOMMENDED :1. Mann P G & Saunders B C, Practical Organic Chemistry, ELBS/ Longman, London.2. Furniss B S, Hannaford A J, Smith P W G and Tathell A R, Vogel’s Textbook of PracticalOrganic Chemistry, The ELBS/ Longman, London.3. Pharmacopoeia of India, Ministry of Health, Govt. of India.4. Wolff ME, Ed. Burger’s Medicinal Chemistry, John Wiley & Sons, New York.5. Delagado J N and Remers W A R, Eds., Wilson And Gisworld’s Text book of OrganicMedicinal and Pharmaceutical Chemistry, J. Lippincott Co., Philadelphia.6. Foye W C, Principles of Medicinal Chemistry, Lea & Febiger, Philadelphia.7. Singh Harkishan and Kapoor, V.K., Organic Pharmaceutical Chemistry, Vallabh Prakashan,Delhi.8. Nogrady, T, Medicinal Chemistry – A Biochemical Approach, Oxford University Press, NewYork, Oxford.

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9. Finar I L, Organic Chemistry, Vol I & II, ELBS/ Longman, London.10.Thomas J..Perun,” Computer –aided Drug Design methods applications’.11. Pandi Veerapandian,” Structure-Based Drug Design”.

IEC-PHARM-364: Pharmacology-IIUnit-I :Pharmacology of CVS: Cardiac glycosides, Antihypertensive drugs, Antianginal drugs,Antiarrhythmics, Antihyperlipidemics, [09]

Unit-II :Drugs Acting on Haemopoeitic System Haematinics, Vit. K & anticoagulants, Fibrinolytics &antiplatelet drugs, Plasma Volume expanders.Drugs Acting on Respiratory System Anti-asthmatic drugs, Anti-tussives & Expectorants,Respiratory Stimulants. [08]

Unit-III :NSAIDS & Anti-gout Drugs.Diuretics [08] Unit-IV : Autocoids: Histamine, 5HT and theirantagonists, Prostaglandins, Thromboxane, Leukotrienes, Angiotensin and Bradykinin [08]

Unit-V :Drugs acting on GIT Antacids and Antiulcer drugs, Laxatives and antidiarrhoeal Agents, Emeticsand antiemetics [07]

IEC-PHARM-364P: Pharmacology-II Practical1. To record the dose response curve (DRC) of Acetylcholine using ileum of Chicken ilium.2. To study the parallel shift of DRC in presence of competitive antagonist on DRC of Ach usingChicken ileum.3. To study effect of physostigmine on DRC of each on Chicken ileum.4. To study the CRC of histamine on guinea pig on ileum preparation & study the effect ofAntihistaminics using software.

BOOKS RECOMMENDED:1. Ghosh, MN; Fundamentals of Experimental Pharmacology, Scientific Book Agency, Calcutta.2. Grover J.K., Experiments in Pharmacy & Pharmacology, CBS Publishers, New Delhi.3. Kulkarni S.K., Hand Book of Experimental Pharmacology, Vallabh Prakashan, Delhi.4. Barar FSK : Text Book of Pharmacology, Interprint, New Delhi.5. Goodman & Gilman, The Pharmacological basis of Therapeutics, Editors:-JG Hardman, LeLimbird,PB Molinoss, RW Ruddon & AG Gil, Pergamon Press.6. Katzung, B.G. Basic & Clinical Pharmacology, Prentice Hall, International.7. Laurence, DR & Bannet PN; Clinical Pharmacology, Churchill Livingstone.8. Rang MP, Date MM, Riter JM, Pharmacology Churchill Livingstone.9. Tripathi, K.D. Essentials of Medical Pharmacology, Jay Pee Publishers, New Delhi.10. Satoskar & Bhandarkar; Pharmacology & Pharmacotherapeutics, Popular Prakashan Pvt. Ltd.,Bombay.11. Craig, C.R. and Stitzel, R.R., Modern Pharmacology, Little Brown and Co., 1994.12. Sheffield Bioscience Programms, U.K., ISBN,1-874758-02-6

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IEC-PHARM-365: Pharmacognosy-II (Chemistry of Natural Products)UNIT-I:1. Chemical & Spectral approaches to simple molecules of natural origin.2. Biogenetic Investigations and basic metabolic pathways, (alkaloids, terpenes, steroids) Briefintroduction to biogenesis of secondary metabolites of Pharmaceutical importance. [08]UNIT-IIExtraction, Isolation & Chemistry of –i) Glycosides - Digitoxin, Digoxin, Hecogenin, Diosgenin & Sarasapogeninii) Lignansiii) Quassinoidsiv) Flavonoids (Quercetin) [08]UNIT-III :Alkaloids – Atropine & related compounds, quinine, reserpine, morphine, papaverine,ephedrine, ergot,and Vinca Alkaloids.Natural Allergens, Photosensitizing agents and fungal toxins. [08]UNIT-IV:Extraction, Isolation & Characterisation of –Terpenoids- Camphor, Menthol, Citral, β- Carotene, α -Tocopherol, α-Pinene. [03]UNIT-V :Herbal Cosmetics and their formulation. [02]Recent developments of natural products used as anticancer agents, antidiabetics andimmunomodulators. 80PHARM-365P, NATURAL PRODUCTS PRACTICAL1. Laboratory experiments on Isolation, separation, purification of various groups of chemicalConstituents of Pharmaceutical significance.2. Exercises on paper & thin layer chromatographic evaluations of herbal drug constituents.3. Extraction of volatile oils & theirs chromatographic profiles.SUGGESTED PRACTICALS1. Isolation of caffeine from Tea leaves.2. Isolation of piperine from Black Pepper.3. Isolation of Hesperidin from Orange Peel.4. Isolation of Clove oil from clove.5. Isolation of Caraway oil from caraway.6. Isolation of cumin oil from cumin.7. To study the TLC profile of extracted oils.8. To perform the column chromatography of herbal drug.9. To study the paper chromatographic profile of glycone portion separated from senna.10. To Isolate the active constituent of any available drug with the help of preparative TLC.11. Quantitative determination of Ascorbic acid present in Amla. (Fresh/ Dry).BOOKS RECOMMENDED1. Brain, K.R., & Turner T.D, The Practical evaluation of phytopharmaceutical, Wright, Bristol.2. Sim, Medicinal Plant Alkaloids & Glycosides.3. Kokate C.K., “Practical Pharmacognosy” Vallabh Prakashan, New Delhi.4. Stahl E. “Thin layer chromatography” A Laboratory Hand Book, Springer Verlag, Berlin.5. Harborne, J.B. Phytochemical Methods Chapman & Hall, International Ed, London.6. Pharmacopoeia of India.7. I.L. Finar “Organic chemistry” Vol. I & II ELBS, London.8. O.P. Agarwal, “Chemistry of Organic Natural Product” Vol. I & II Goel Pub. House, Meerut.9. Trease G.E. & Evan, W.C., “Pharmacognosy” Bailleire tindall East bourne, U.K.10. Tyler V.E. etal “Pharmacognosy” Lea & Febiger Philadelphia.11. Qadry, J.S.,” Pharmaconosy “B.S.Shah Prakashan. 81

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12. Pridham JB & Swain T. Biosynthetic pathway Higher plants, Academic Press, New York.13. Sharma PP, Cosmetics formulation, Manufacturing & Quality control, 3rd Ed., VandanaPublishers, Delhi.14. Abraham DJ, Berger’s Medicinal Chemistry & Drug Discibery, John Wiley & Sons, NewJersey.15. Indian Pharmacopoeia

IEC-PHARM-367 Scientific & Technical Writing

UNIT – I: COLLECTION AND EVALUATION OF INFORMATIONIdentification, sources, searching information, classifying information under fact/opinion,tabulating information, summarizing a text and presenting sequence of topics in different forms.

UNIT – II: WRITING AS A MEANS OF COMMUNICATION- Different forms of scientific and technical writing.- Articles in journals, Research notes and reports, Review articles, Monographs, Dissertations,Bibliographies.How to formulate outlines: The reasons for preparing outlines

• as a guide for plan of writing• as skeleton for the manuscript

Kinds of outline: topic outlines, conceptual outline, sentence outlines and combination of topic andsentence outlines

UNIT – III: DRAFTING TITLES, SUB TITLES, TABLES, ILLUSTRATIONS- Tables as systematic means of presenting data in rows and columns and lucid way of indicatingrelationships and results.- Formatting Tables: Title, Body stab, Stab Column, Column Head, Spanner Head, Box Head- Appendices: use and guidelinesThe Writing process: Getting started, Use outline as a starting device, Drafting, Reflecting and Re-readingChecking: Organization, Headings, Content, Clarity and GrammarBrevity and Precision in writing - Drafting and Re-drafting based on critical evaluation

UNIT - IV: PARTS OF DISSERTATION/RESEARCH REPORT/ARTICLEIntroduction, Review of Literature, Methodology, Results and DiscussionAsk questions related to: content, continuity, clarify, validity internal consistency and objectivityduring writing each of the above parts.

UNIT – V: WRITING FOR GRANTS- Clearly state the question to be addressed- Rationale and importance of the question being address- Emperial and theoretical conceptualization- Presenting pilot study/data- Research proposal of method- Clarity, specificity of method.- Clear organization- Outcome of study and its implications- Budgeting- Available infra-structure and recourses

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- Executive summary

References

1. APA (1984): Publication Manual of American Psychological Association (3rd

Edition),Washington: APA.

2. Cooper, H.M. (1990): Integrating Research: A Guide for Literature Reviews (2nd

Edition).California: Sage.

3. Dunn, F.V & Others.(Ed.) (1984): Disserninating Research: Changing Practice. NY:Sage.

SEVENTH SEMESTERIEC-PHARM-471: Biopharmaceutics & PharmacokineticsUnit-1 :Introduction to Biopharmaceutics and Pharmacokinetics and their role in formulationdevelopment and clinical setting.Biopharmaceutics :(A) Passage of drugs across biological barrier (passive diffusion, active transport, facilitateddiffusionand pinocytosis).(B) Factors influencing absorption – Physicochemical, physiological and pharmaceutical.(C) Drug distribution in the body, plasma protein binding. [08]

Unit-II : Pharmacokinetics :(A) Significance of plasma drug concentration measurement.(B) Compartment model and Non-compartment model. Definition and Scope.(C) Pharmacokinetics of drug absorption – zero order and first order absorption rate constant usingWagner – Nelson, Loo-Reigelman method. [08]

Unit-III:(A) Volume of distribution and distribution coefficient.(B) Compartment kinetics – One compartment and Preliminary information of multicompartmentmodels. Determination of pharmacokinetic parameters from plasma and urine data after drugadministration by intravascular and oral route.(C) Clinical Pharmacokinetics : Definition and scope [08]

Unit-IV:(A) Dosage adjustment in patients with and without renal and hepatic failure.(B) Pharmacokinetic drug interactions and their significance in combination therapy.Unit-V :Bioavailability and Bioequivalence :(A) Measures of bioavailability, C-max, and area under the curve (AUC).(B) Review of regulatory requirements for conduction of bioequivalent studies. [08]

IEC-PHARM-471P: Biopharmaceutics & Pharmacokinetics Practical1. Experiments designed for the estimation of various pharmacokinetic parameters with given data.2. In vitro evaluation of different dosage forms for drug release.3. Absorption studies – in vitro.4. Statistical treatment of pharmaceutical data.

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SUGGESTED PRACTICALS1. In-vitro drug release study of the given powder dosage form using various dissolution media.2. In-vitro drug release study of the given uncoated tablet dosage form using different dissolutionmedia.3. In-vitro drug release study of the given capsule dosage form using various dissolution media.4. In-vitro drug release study of the given film coated dosage form using various dissolution media.5. In-vitro dissolution study of the given sustained release dosage form.6. In-vitro dissolution study of the given fast release (M.D, Dispersible etc.) dosage form.7. To study the effect of hardness of tablet on dissolution rate.8. To study the effect of various diluents on dissolution rate of dosage form (Tablets, Capsules,Ointment etc.).9. To study the effect of formulation on drug release (powder, suspension etc.).10. To determine the % protein binding of the given drugs.11. To determine the effect of protein binding on drug bioavailability.12. To calculate various Pharmacokinetic parameters from the given zero order drug release data.13. To calculate various Pharmacokinetic parameters from the given first order drug release data.14. To calculate the various Pharmacokinetic parameters from the given blood data of I.V bolusinjection (one compartment model).15. To calculate various Pharmacokinetic parameters from the given urinary excretion data of I.Vbolus.injection using both methods (Rate of elimination & sigma minus method one compartmentmodel).16. To study the in-vitro drug- drug interaction.17. To study the passive diffusion of the given drug using cellophane membrane.18. To study the passive diffusion of the given drug using egg or goat membrane.19. To determine the various Pharmacokinetic parameters from the given blood data of oraladministration of dosge form.DEMONSTRATION EXPERIMENTS1. Dissolution Apparatus.2. Preparation of Buffers & membranes.3. Use of semilog paper.4. Operation of colorimeter & U.V spectrophotometer.

BOOKS RECOMMENDED :1. Notari, R.E, Biopharmaceutics and Pharmacokinetics – An introduction Marcel Dekker Inc. N.Y.2. Rowland M, and Tozer T.N. Clinical Pharmacokinetics, Lea and Febriger, N.Y.3. Wagner J.G. Fundamentals of Clinical Pharmacokinetics, Drugs Intelligence Publishers,Hamilton.4. Wagner J.G. Pharmacokinetics for the Pharmaceutical Scientist, Technomic Publishing A.G.Basel, Switzerland.5. Gibaldi, Milo’ Biopharmaceutics & Clinical pharcokinatics”.6. Robert , Rodriguezdiaz,” Analytical Techniques for Biopharmaceuticals Development”.7. John. G.Wagner,” Pharmacokinetics for the Pharmaceutical Scientist’.8. Curry, StephenH., “ Drug Disposition & Pharmacokinetics”.

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IEC-PHARM-472: Pharmaceutical Analysis -IIIUnit-I :Colorimetric Method- Chemistry, Instrumentation and applications Ultra violet and Visible-Electronic excitation, Spectrophotometry, quantitative laws, deviation from Beer’s law,instrumentation, single and double beam spectrophotometry. [08]

Unit-IIInfra-Red spectrophotometry-Theory, instrumentations,Inter pretation of IR , spectra ofsimple compounds, FTIR, applications in pharmaceutical analysis. Fluorimetric Analysis- Theory,Instrumentation and applications.

Unit-IIINMR Spectroscopy- Theory of 1H.NMR, chemical shift, Shielding & Desheilding, spin spincoupling, spin spin splitting spectra of CH3-CH2-OH, CH3-CHO,CH3-(CH2)4 CH3, C6 H6, CH3C6 H5.Mass Spectroscopy –Theory, Instrumentation & Applications, mass spectra of some simplecompounds. [10]

Unit-IVFlame photometry-Theory , instrumentation and applications. Atomic absorption spectroscopy,instrumentation and applications [08]

Unit-VBasic Principles. Instrumentation and application of GLC & HPLC. [06]

IEC-PHARM-472P: Pharmaceutical Analysis -III Practical1. Assay of at least 10 official formulation containing single and more active ingredients usinginstrumental techniques.2. Interpretation of a few spectra.

BOOKS RECOMMENDED1. Pharmacopoeia of India, Ministry of Health, Govt of India.2. Becket A.H. and Stenlake J.B. Practical Pharmaceutical Chemistry Vol. I and II, The AthlonePress of the University of London.3. Chatten L.G. A text book of Pharmaceutical Chemistry Vol. I & II Marcel, Dekker, New York.4. Willard H.H. and Merrit L. Jr and Dean J.A., Instrumental methods of analysis Van NostrandRenhold, New York.5. Obonson J.W.R. Undergraduate Instrumental Analysis, Marcel Dekker Inc, New York, 1970.6. Parikh V.H. Absorption Spectroscopy of Organic Molecules Addison-Wesley Publishing Co.,London 1974.7. Silver stein RM & Webster FX, Spectrometric Identification of Organic Compounds, John Wiley& Sons.8. Skoog V, Principles of Instrumental Analysis, Holler-Neimen

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IEC-PHARM-473: Pharmaceutical Medicinal Chemistry-IIIMode of action, uses , structure-activity relationship of the following classes of drug (Syntheticprocedures of individually mentioned drugs only).Unit-I :1. Steroids and related drugs : Introduction, Classification, Nomenclature, Stereochemistry

(A) Androgens and Anabolic steroids – Testosterone, Stanazolol.(B) Estrogens and Progestogens – Progesterone, Estradiol.(C) Adrenocorticoids – Prednisolone, Dexamethasone, Betamethasone. [08]

Unit-II :Antibiotics-Penicillin, Semi-synthetic penicillins, streptomycin, tetracyclines, Cephalosporins,Chloramphenicol, Fluroquinolones.Antimycobacterial Agents:PAS, Ethambutol, Isoniazid, DapsoneAntimalarials: Cholroquine, Primaquine, Pyrimethamine.Antiamoebics: Metronidazole, Tinidazole, Diloxanide

Unit-III:Antiseptics & Disinfectants – Benzalkonium chlorideAnthelmintics- MebendazoleAntifungals :- Griseoflain and Clotrimazole [08]

Unit-IV : –Anti- HIV agents-Zidovudine, Zalcitabine,Saquinavir.Antivirals –Amantadine, Acyclovir, Lamivudine. Prostaglandins –Misoprostol, Carboprost. [08]

Unit-V :-Thyroid and Antithyroids – Carbimazole, Levothyroxine, Propylthiouracil, Methimazole.Hypoglycaemics - Insulin Chlorpropamide, Metformin, Tolbutamide,Glibenclamide. [08]

BOOKS RECOMMENDED :1. Pharmacopoeia of India, Ministry of Health, Govt. of India.2. Wolff ME, Ed. Burger’s Medicinal Chemistry, John Wiley & Sons, New York.3. Delagado J N and Remers W A R, Eds., Wilson And Gisworld’s Text book of OrganicMedicinal and Pharmaceutical Chemistry, J. Lippincott Co., Philadelphia.4. Foye W C, Principles of Medicinal Chemistry, Lea & Febiger, Philadelphia.5. Singh Harkrishan and Kapoor, V.K., Organic Pharmaceutical Chemistry, Vallabh Prakashan,Delhi.6. Nogrady T, Medicinal Chemistry – A Biochemical Approch, Oxford University Press, NewYork,Oxford.7. Finar I L, Organic Chemistry, Vol. I & II, ELBS/ Longman, London.8. Hanch C, Comprehensive Medicinal Chemistry, Vol. IV, Quantitative Drug Design, PergamonPress,Oxford.

IEC-PHARM-473P: Pharmaceutical Medicinal Chemistry-III PracticalUnit-I : Pharmacology of Endocrine SystemHypothalamic & pituitary hormones, Thyroid hormones & Thyroid Drugs, Parathormone,Calcitonin & Vitamin D, Insulin, oral hypoglycemic agents & glucagon. [07]

Unit-II : ACTH & Cortico steroids, Androgens & anabolic steroids, Estrogens, Progesterone &Oral Contraceptives, Drugs acting on uterus. [08]

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Unit-III : ChemotherapyGeneral Principles of Chemotherapy, Sulfonamides, Cotrimoxazole, Quinolones, Antibiotics –Penicillins, Cephalosporins, Chloramphenicol, Tetracyclines, Macrolides. [08]Unit-IV: Chemotherapy of Parasitic infections, Tuberculosis, Leprosy, Malaria, Fungal infections,Viral diseases, Introduction to Immunondulators and Chemotherapy of Cancer. [10]

Unit-V: Principles of ToxicologyDefinition of poison, general principles of treatment of poisoning with particular reference tobarbiturates, opioids, organophosphorous & atropine poisoning, Heavy metal Anatagonists. [07]

IEC-PHARM-474: Pharmacology-III

UNIT-I : Pharmacology of Endocrine SystemHypothalamic & pituitary hormones, Thyroid hormones & Thyroid Drugs, Parathormone,Calcitonin & Vitamin D, Insulin, oral hypoglycemic agents & glucagon.[07]

UNIT-II : ACTH & Cortico steroids, Androgens & anabolic steroids, Estrogens, Progesterone &Oral Contraceptives, Drugs acting on uterus.[08]

UNIT-III : ChemotherapyGeneral Principles of Chemotherapy, Sulfonamides, Cotrimoxazole, Quinolones, Antibiotics –Penicillins, Cephalosporins, Chloramphenicol, Tetracyclines, Macrolides.[08]

UNIT-IV : Chemotherapy of Parasitic infections, Tuberculosis, Leprosy, Malaria, Fungalinfections, Viral diseases, Introduction to Immunondulators and Chemotherapy of Cancer. [10]

UNIT-V : Principles of ToxicologyDefinition of poison, general principles of treatment of poisoning with particular reference tobarbiturates, opioids, organophosphorous & atropine poisoning, Heavy metal Anatagonists. [07]

IEC-PHARM-474P: Pharmacology-III Practical

1. To calculate the pA2 value of Atropine & chlorpheniramine.2. Bioassay of Ach, histamine & oxytocin on suitable isolated preparations using matching assay,bracketing assay, three point assay & four point assay.3.Bioassay of histamine and acetylcholine using matching and interpolation method on rat guineapig . All experiments will be conducted using software wherever possible.

BOOKS RECOMMENDED :1. Ghosh M.N. Fundamentals of Experimental Pharmacology, Scientific Book Agency, Calcutta.2. Grover J.K., Experiments in Pharmacy & Pharmacology, CBS Publishers, New Delhi.3. Kulkarni S.K., Hand Book of Experimental Pharmacology, Vallabh Prakashan, Delhi.4. Barar F.S.K : Text Book of Pharmacology, Interprint, New Delhi.5. Goodman & Gilman, The Pharmacological basis of Therapeutics, Pergamon Press.6. Editors :- J.G. Hardman, Le Limbird, PB Molinoss, RW Ruddon & AG Gil, Pergamon Press.7. Katzung, B.G. Basic & Clinical Pharmacology, Prentice Hall, International.8. Laurene, DR & Bennet PN; Clinical Pharmacology, Churchill Livingstone.9. Rang MP, Dale MM, Riter JM, Pharmacology Churchill Livingstone.10. Tripathi, K.D. Essentials of Medical Pharmacology, Jay Pee Publishers, New Delhi.

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11. Satoskar & Bhandarkar : Pharmacology & Pharmacotheropeutics, Popular Prakashan Pvt. Ltd.,Bombay.12. Paul. L., Principles of Pharmacology, Chapman and Hall.13. Singh, Surender; Essentials of Pharmacology, Academa Publishers, Delhi.14. Sheffield Bioscience Programs, U.K., ISBN. 1-874758-02-6.

IEC-PHARM-475 Pharmacognosy-III (Industrial Pharmacognosy)

Unit - 1Scope of plant drugs cultivation, factors affecting quality of plant and animal drugs. Substitutionand adulteration of crude drugs.

Unit - 2WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants.

Unit - 3Problems and recent trends in pest management, scope of biological control and use of environmentfriendly pesticides especially plant derived products, Pyrethroids, pheromones and juvenilehormones.

Unit - 4Cultivation and management of medicinal plants: Dioscorea, Belladonna, Hyoscyamus, Cinchona,Opium, Digitalis, Senna, Plantago, Mentha, Rauwolfia, Lemmon Grass, Basil, Geranium.Utilization of waste product of herbal industries.

Unit - 5Methods of preparation of herbal cosmetics for skin, hair and dental care. Determination of shelflife of raw drugs, powered drugs, extracts, fractions and finished products.

Books Recommended:1. Atal, C.K., Kapur, B.M., Cultivation and Utilization of Medicinal and Aromatic Plants,

R.R.L. Jammu.2. Farooqui, A.A., Sreeramu, B.S., Cultivation of Medicinal and Aromatic Plants University

press, 2001.

3. Yoganasimhan, S.N., Medicinal Plants of India, 1st

Edition, Interlive Publishing Pvt. Ltd.4. Medicinal and Aromatic Plant abstracts (MAPA) CSIR, New Delhi.5. Evans, W.C., Trease and Evans Pharmacognosy, W.B. Saunder & co., London.6. Wallis, T.E., Text Book of Pharmacognosy.7. Indian Herbal Pharmacopoeia.8. Kalia, A.N., Textbook of Industrial Pharmacognosy.9. Mohammad Ali, Pharmacognosy and Phytochemistry.10. Bruneton Jean, Pharmacognosy and Phytochemistry of Medicinal Plants.11. Kaufmann, Natural Products from Plants, CRC Press, New York.12. Butler, M., Poucher’s Perfumes, Cosmetics and Soaps.13. Panda, Herbal Soaps and Detergents.14. Vimladevi, Text Book of Cosmetics.15. D’Amelio, Botanicals, A Phytocosmetic Desk reference.

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IEC-PHARM-475 P Pharmacognosy-III (Industrial Pharmacognosy)

Experiments based on theory syllabus

IGHTH SEMESTERIEC-PHARM-481: Pharmaceutical BiotechnologyUnit-I : Immunology and Immunological preparations : Principles, Antigen and haptens,immune system, Cellular, and humoral immunity, immunological tolerance,antigen-antibodyreactions and their applications, standardization and storage of BCG. [08]

Unit-II : Genetic Recombination Transformation, conjugation, transduction, protoplast fusion andgene cloning and their applications,development of hybridoma for monoclonal antibodies, study ofdrugs produced by biotechnology such as Activase, Insulin, Somatotropin. [08]

Unit-III : Antibiotics : Historical development of antibiotics, Screening of soil for organismsproducing antibiotics Antimicrobial spectrum and methods used for their standardization.Fermentor, its design and control of different parameters. Isolation of mutants and factors affectingmutation. [08]

Unit-IV : Microbial Transformation : Introduction, types of reactions mediated bymicroorganisms, Design of Bio-transformation process, selection of organisms, biotranformationprocesses and its improvements with special reference to steroids. [08]

Unit-V : Enzyme immobilization : Techniques of immobilization of enzymes, factors affectingenzyme kinetics, study of enzymes such as hyaluronidase, penicillinase, streptokinase andstreptodaranse, amylases and proteases Immobilization of Bacteria and plant cells. [08]

BOOKS RECOMMENDED :1. S.P. Vyas and V.K. Dixit, Pharmaceutical Biotechnology, CBS Publication, New Delhi.2. Prescott and Dunn’s Industrial Microbiology, 4th Ed, 1987, CBS Publishers and Distributors,Delhi.3. P.F. Stanbury & A. Ahhitar Principles of Fermentation Technology.4. K. Kieslich Ed. Biotechnology Vol. 69 Verleg Chernie Switzerland 1984.5. P.F. Standury & A. Whitaker & Hall S.J. Principles of Fermentation, Aditya Book PrivateLimited, New Delhi.6. Crueger W. & Crueger A, Biotechnology-A Textbook of Industrial Microbiology, PanimaPublishing Corporation, Delhi.7. Johan, D.Souza,” Biotechnology & Fermentation”

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IEC-PHARM-482: Pharmaceutical Industrial ManagementUNIT-I:1. Concept of Management: Administrative Management (Planning, Organising StaffingDirecting and Controlling). Entrepreneurship development, Operative Management (Personnel,Materials, Production, Financial, Marketing, Time/space, Margin/ Morale) Principles ofManagement (Coordination, Communication, Motivation, Decision making, leadership, InnovationCreativity, Delegation of Authority / Responsibility. Record Keeping), Identification of key pointsto give maximum thrust for development and perfection. [12]

Unit-II : Economics :Principles of economics with special reference to the Laws of demand and supply, demandschedule, demand curves labor welfare, general principles of insurance and inland and foreigntrade, procedure of exporting and importing goods. [03]Accountancy : Principles of Accountancy, Ledger posting and book entries preparation of trialbalance, columns of a cash book, Bank reconciliation statement, rectification of errors, profits andloss account, balance sheet, purchase, keeping and pricing of stocks, treatment of cheques bills ofexchange, promissory notes and bundles documentary bills. [04]UNIT-IIIPharmaceutical Marketing : Functions, buying, selling, transportation, storage financed feedbackinformation, channels of distribution, wholesale, retail, department store, multiple shop and mailorder business.[04]Salesmanship : Principle of sales promotion, advertising, ethics of sales, merchandising, literature,detailing, Recruitment, training, evaluation , compensation to the pharmacist. [04]UNIT-IVMarket Research(A) Measuring & Forecasting Market Demand - Major concept in demand measurement,Estimating current demand Geo-demo-graphic analysis. Estimating industry sales, Market shareand future demand.(B) Market segmentation & Market targeting [06]UNIT-VMaterials Management : A brief exposure of basic principles of management major areas, scope,purchase, stores, inventory control and evaluation of materials management. [04]Production Management : A brief exposure of the different aspects of Production Management ,Visible and Invisible inputs, Methodology of Activities Performance Evaluation TechniqueProcess –Flow, Process Know-how, Maintenance Management.[03]

IEC-PHARM-483: HOSPITAL & CLINICAL PHARMACY

UNIT-I: Organization and Structure: Organization of a hospital and hospital pharmacy,Responsibilities of a hospital pharmacist. Pharmacy and therapeutic committee, Budgetpreparation and implementation.Hospital Formulary: Contents, preparation and revision of hospital formulary.UNIT-II : Drug Store Management and Inventory Control: Organization of drug., Types ofmaterials stocked, storage conditions. Purchase and Inventory control: Principles, purchaseprocedures, purchase order, procurement and stocking.Unit-III : Central Sterile Supply Unit and their Management: Types of materials forsterilization, packing of materials prior to sterilization, sterilization equipments, Supply of sterilematerials. Manufacture of Sterile and Nonsterile Products: Policy making of manufacturable items,demand and costing, personnel requirements, manufacturing practice, Master formula record ,Production control, Manufacturing records.

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UNIT-IV: Drug information service: Sources of information on drugs, treatment schedules,procurement of information, computerized services (e.g. MEDLINE), Retrieval of information,Medication error. Records and Reports : Prescription filling drug profile, Patient medicationprofile, case on drug interaction & adverse reactions, idiosyncratic cases etc.UNIT-V: Drug distribution systems in Hospitals : Out-patient dispensing, methods adopted,Dispensing of drugs to in-patients. Types of drug distribution systems Charging Policy, labeling,Dispensing of drugs to ambulatory patients, Dispensing of controlled drugs.

Nuclear Pharmacy : Introduction to Radiopharmaceutics- radio-active half life, Units ofradioactivity. Production of radio pharmaceuticals, methods of isotonic tagging, preparation ofradioisotopes in laboratory using radiation dosimetry, radio-isotope generators, permissibleradiation dose level, Radiation hazards and their prevention, specifications for radio-activelaboratory.BOOKS RECOMMENDED1. Hasan, Hospital Pharmacy, Lea & Febiger, Philadelphia.2. Merchant H.S. and Qadry J.S. Text Book of Hospital Pharmacy, B.S. Shah Prakashan,

IEC-PHARM-484: OPEN ELECTIVES:

Any one of the following:(A) Standardization of herbal drugs.(B) Drug design.(C) Clinical; Pharmacy and Drug interactions(D) Pharmaceutical marketing.(E) Pharmaceutical Packaging(f) Novel drug delivery system(G) GMP, Quality Assurance & Validation

(A) STANDARDISATION OF HERBAL DRUGSUnit I – Commerce and quality control of natural medicinal plants products, organoleptic,microscopical, physical & chemical evaluation of crude drugs [08]

Unit-II - Standardisation of plant material as per WHO guidelines. [08]

Unit-III -Methods of extraction and modern techniques for the isolation, purification, separationestimation and characterisation of active plant constituents.[08]

Unit-IV -Analysis of official formulations derived from crude drugs including some ayurvedicpreparations.[08]

Unit-V -General methods of screening of natural products for following biological activity:a) Anti-inflammatory b) Hypoglycaemic c) Antibacterial d) Antifertility e)

Psychopharmacological [08]

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BOOK RECOMMENDED1. Trease, G.E. Evans W.C,. Pharmacognosy ELBS.2. Tyler Varro. E., Brady Lynn. R. Robbers J.E. Pharmacognosy3. Wallis T.E..Text book of Pharmacognosy4. Harborne Phytochemical methods of chemical analysis .5. Pharmacoepial standards for Ayurvedic formulations CCRAS, Delhi.6. Vapoorte, Swendson Chromatography of alkaloids.7. Lala P.K., Elements of chromatography8. Mottal.A.C. Clerk’s isolation & identifications of drugs9. Dhavan B.N. & Srimal R.C, The use of pharmacological techniques for evaluation of naturalproducts. CDRI Lucknow.10. Brain K.R. and Turner T.D, The practical evaluation of phytopharmaceuticals11. Peach K. & Tracey MV, Modern methods of plant analysis12. British herbal phamacopocia.13. Indian herbal pharmacopocia.14. Chaudhary.R.R., Herbal drug industry

(B) DRUG DESIGNUNIT-IIntroduction to Drug Design, Lead Discovery, Interactions(Forces) involved in drug receptorcomplex, Physiochemical properties in relation to biological action, Sterochemical aspects in drugdesign, Bioisosterism. [08]

UNIT-IIDrug metabolism-Phase I & Phase II Metabolic Reactions, Prodrugs & Soft drug concepts [08]

UNIT-IIIAnalogoues based drug design concept with suitable examples Structure Based drug designconcept with examples. [08]

UNIT-IVCombinatorial chemistry-Introduction, Parallel and Split & Mixed synthesis. [08]Computer Aided Drug Design-Introduction & Softwares used in CADD

UNIT-V QSARIntroduction, parameters, Quantitative models- Hansch method & Soft ware’s in QSAR. [08]

BOOKS RECOMMEDED:1. E.J, Ariens: Drug Design, Academic Press, New York (1975).2. S.H. Salkovisky, A.A. Sinkula and S.C. Valvani, Physical Chemical Properties of Drugs,Marcel Dekker Inc. New York.3. M.E. Wolff, Burger’s Medical Chemistry, John Willey and Sons, New York.4. R.F, Doerge, Wilson and Gisvold’s Text Book of Organic Medicinal and PharmaceuticalChemistry,J. Lippincott Co, Philadelphia.5. Olson, Edward C “Computer Assisted Drug Design (American Chemical Society).6. Burger A “A guide to chemical basis of Drug Design “John Wiley & Sons”.7. Thomas J.Perun <’ Computer aided Drug Design methods Applications”.8. Pandi Veerapandian,” Structure Based Drug Design”.

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(C) CLINICAL PHARMACY AND DRUG INTERACTIONS

UNIT-I Introduction To Clinical PharmacyDefinition, development and scope

UNIT-II Patient Data AnalysisThe patient’s case history, its structure and use in evaluation of drug therapy, Communication skillsincluding patient medication history interview, patient counseling. Hematological, Liver function,renal function, Tests associated with cardiac disorders. Adverse drug reactionEpidemiology,Classification, Risk factors, Monitoring an detecting adverse drug reactions, Assessing causality,Reporting adverse drug reactions.

UNIT-III DAILY ACTIVITIES OF CLINICAL PHARMACISTSDrug therapy monitoring (Medication chart view, clinical review, TDM pharmacist interventions.Ward round participation Drug utilization evaluation (DUE) and review (DRU).Quality assuranceof clinical Pharmacy services.

UNIT-IV RESEARCH DESIGN AND CONDUCT OF CLINICAL TRIALSResearch support including planning and execution of clinical trials. Guidelines for good clinicalresearch practice and ethical requirements. Various phases of clinical trials. Categories of Phase IVstudies.

UNIT- V CLINICAL PHARMACOKINETICSPhysiological determinants of drug clearance and volumes of distribution. Renal and non-renalclearance.Estimation and determinants of bioavailability.Calculation of loading and maintenancedoses.Dose adjustment in renal failure, hepatic dysfunction, geriatric and paediatric patients.

REFERENCES1. Basic skills in interpreting laboratory data- Scott LT, American Society of Health SystemPharmacists, Inc., USA.2. Practice Standrds and Definitions- The Society of Hospital Pharmacists of Australia, 1997.3. Clinical Pharmacokinetics-Rowland and Tozer, Williams and Wilkins Publication.4. Biopharmaceutics and Applied Pharmacokinetics-Leon Shargel, Prentice Hall publication.5. Relevant review articles from recent medical and pharmaceutical literature.6. Parthasarthi G, Nyfort-Hansen K, Nahata M.C., A Text book of Clinical Pharmacy Practice –Essential Concepts and Skills, Orient Longman.7. Davisson’s Pranciples and Practice of Medicine, ELBS/Churchill Livingstone.8. Herfindal E.T. and Hirashman J.L., Clinical Pharmacy and Therapeutics Williams and Wilkins9. John g.Wagner,” Pharmacokinetics for the Pharmaceutical Scientist”. 8810. Gibaldi, Milo,” Biopharmaceutics& clinical pharmacokinatics’.11. Curry, Stephen,H. “ Drug Disposition & Pharmacokinetics”.

(D) PHARMACEUTICAL MARKETING

UNIT-IPrinciples of marketing management, Introduction to pharmaceutical marketing, Identification ofthe marketing, Market behaviour, Prescribing habits of physician, Patient motivation, Marketanalysis [08]

UNIT-IIDrug development and the marketing research interface, Diversification and specialisation,Marketing generic drugs. [08]

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UNIT-IIIEconomic and competitive aspects of pharmaceutical industry- Advertising, Detailing, Retailcompetition, International marketing. [08]

UNIT-IVDistribution channels in pharmaceutical marketing – Manufacuturer, Wholesaler, Retailer, Hospital& Government agencies, Selection of stockists and distributors. [08]

Unit-VControls- Internal control and external control. [08]

BOOKS RECOMMENDED

1. Smith, Mickey C, “Principles of pharmaceutical marketing”, CBS Publishers & Distributors.2. Kotler, Philip “Marketing Management”. Pearson Education Asia.

(E) PHARMACEUTICAL PACKAGINGUNIT-I1. New concepts in pharmaceutical packaging.2. Package systems, package design research. [08]

Unit-II1. Packaging materials with special reference to polymers, metals, glass and plastics, control ofpackaging materials.2. Blister and strip packaging. [08]

UNIT-III1. Testing of containers & closures, Pharmacopoeial tests and specifications, Defects inpackages.2. Stability of package and packaging material.3. Ancillary materials used in packaging. [08]

Unit-IV1. Sterilization of packaging materials.2. Packaging of Parenterals, Ophthalmic and aerosols. [08]Unit-V10. Corrugated fibre board materials, Pointing requirements, label and leaflets preparation, Legalrequirement. [08]

BOOKS RECOMMENDED:

1. Ross, Packaging of Pharmaceuticals.2. Joseph D.O. Brien, Medical Device Packaging Handbook.3. Griffin, Drug and cosmetic Packaging.4. Barail, Packaging Engineering.5. Harburn, Quality-Control of Packaging Materials in Pharmaceutical Industry.6. Kac Chensney, Packaging of Cosmetics and Toiletories.

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(F) NOVEL DRUG DELIVERY SYSTEM

UNIT-I1. Theory of controlled release drug delivery systems.2. Release and diffusion of drugs from C.D.D.S., General methods of design and evaluation of.D.D.S. [08]

UNIT-II1 Carriers for drug delivery systems, Prodrugs, Physical, chemical and biomedical engineeringapproach to achieve controlled drug delivery.2. Microencapsulation: Methods, kinetics of drug release from microcapsules technology andapplications. [08]

UNIT-III1. Transdermal drug delivery systems: Theory, formulation and evaluation, ionotophoresis.2. Implants and inserts: Types, design and evaluation methods, Osmotic pumps. [08]

UNIT-IVTargeted Drug delivery systems: Concept of drug targeting, importance in therapeutics, methods indrug targeting, drug immobilization techniques, nanoparticles, liposomes, neosomes,pharmacosomes and erythrocytes. [08]

UNIT-VAdvances in drug delivery systems. An Introduction to buccal, nasal, ocular, pulmonary colonicdelivery, etc. [08]

BOOKS RECOMMENDED

1. Roiche, Design of Biopharmaceutical Properties Through Produrugs and Analogs.2. Jolles and Wooldbridge, Drug Design: Facts or Fantasy.3. Julian, Drug Delivery Systems.4. Robinson and Vincent, Controlled Drug Delivery.5. Robinson, Sustained and Conrolled Drug Delivery Systems.6. Noxon, Microencapsulation.7. Chien, Novel Drug Delivery Systems.8. Deasy, Microencapsulation and Related Processes.9. Gutcho, Microencapsulation and Related Processes.10. Lisbeth, Illum & Davis, Polymers in Controlled Drug Delivery.11. Ghosh, Premamoy<’ Polymer Science & Technology”.

(G) GMP, QUALITY ASSURANCE & VALIDATION

UNIT-I1. Requirements of GMP, CGMP, GLP, USFDA, WHO guidelines and ISO 9000 series. [08]Unit-IIDocumentation- Protocols, Forms and maintenance of records in Pharmaceutical industry.Preparation of documents for new drug approval and export registration. [08]

UNIT-IIIBasic concept of quality assurance, Quality assurance systems, Sources and control of qualityvariation- raw materials, containers, closures, personnel, environment etc [08]

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UNIT-IVConcepts in validation, validation of manufacturing and analytical equipment, Process validationin manufacturing dosage formulations, applications of process validation.

UNIT-VIn process quality control tests, IPQC problems in pharmaceutical industries. Sampling plans,Sampling and operating characteristics curves. [08]

BOOKS RECOMMEDED:

1. Willing, Tuckerman and Hitchings, Good Manufacturing Practices for Pharmaceuticals.2. OPPI, Quality Assurance.3. Loftus and Nash, Pharmaceutical Process Validation.4. Florey, Analytical Profile of Drugs (All volumes).5. Indian Pharmacopoeia.6. United States Pharmacopoeia.7. British Pharmacopoeia.8. Garfield, Quality Assurance Principles for Analytical Laboratories.`9. Manohar A. Potdar,” C.GMP for Pharmaceuticals’.

IEC-PHARM-484P: Project on Elective

IEC-PHARM-485 Advanced Pharmacology-I

UNIT –IReceptor PharmacologyGeneral aspects of receptor pharmacology, structural and functional aspects of receptors, regulationof receptors, isolation, classification and characterization of receptors.

UNIT – IINeurotransmission PharmacologyGeneral aspects and steps involved in neurotransmissionNeurohumoral transmission in autonomic nervous system.Neurohumoral transmission in central nervous systemNon-adrenergic non-cholinergic transmission [NANC].

UNIT – IIIA detailed study of the mechanism of action, pharmacology of drugs used inANS-Parasympathomimetics and lytics, sympathomimetics and lytics, agents acting atneuromuscular junction and ganglia.CNS- General anaesthetics, sedatives, hypnotics. Drugs used to treat anxiety, depression,psychosis, mania, epilepsy, neurodegenerative deseases, drug dependence and addiction.CVS- diuretics, anti ischemics, antihypertensives, antiarrythmics, drugs for heart failure anddyslipieiemia.

UNIT – IVA detailed study of the mechanism of action, pharmacology of drugs used inAutocoid pharmacology- a study of the mechanisms involved in the formation, release,pharmacological actions and possible physiological role of histamine, serotinine, kinins,prostaglandins, opioidautocoids and cyclic 3’ – 5’ AMP. Systemic pharmacology of drugs acting asagonists and antagonists to the autocoids.GIT Pharmacology – anti ulcer,prokinetics,antiemetics, antidiarrhoeal and drugs for constipation

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and irritable bowel syndrome.Hormone and hormone antagonists.Anti biotics and chemotherapeutic agents.Analgesics and anti-inflammatory agents.

UNIT – VGeneration of free radicals, role of free radicals in etiopathology of various diseases, protectiveactivity of certain important antioxidants. Cell and biochemical mediators involved in allergy,immunomodulation and inflammation. Classification of hypersensitivity reactions and diseasesinvolved. Therapeutic agents for allergy, asthma, COPD and other immunological diseases withemphasis on immunomodulators.

Recommended books1. Clinical Pharmacology by D.R. Lawrnce and P.N.Bennette2. Pharmacology and Pharmacotherapeutics R.S. Satoskar and S.D. Bhandarkar.

3. The Pharmacology basis of therapeutics. 10th

edition by Louis S.Goodman and Altred Gillman4. Pharmacology by H.P. Rang and M.A. Dale5. Biopharmaceutics and Pharmacokinetics and introduction by E. Notary6. Drug Metabolism by Berhard Tests and Peter Jenner.7. Principles of Drug action by Goldstein, Aranow and Kolman.8. Pharmacokinetics : Regularory Industrial Academic Perspectives, Second Edition, edited byPeter G.Welling and Francis L.S.Tse9. The Drug Development Process: Increasing Efficiency and cost Effectiveness, edited by PeterG.Welling, louis Lasagna and Umesh V. Banakar10. Pharmaceutical Practice , Win field

IEC-PHARM-485P Advanced Pharmacology-I Lab

List of Experiments.1. Experiments for studying the effects of the more important biogenic agents like histamine,acetylcholine, 5HT, oxytocin and their effect in the presence of antagonist on suitable isolatedtissue preparations.2. Estimation of PA2 values of various antagonists under suitable isolated tissue preparations.3. Experiments on CVS- effect of various drugs on isolated heart preparations on various animalmodels under normal arrhythmic and hypo dynamic conditions.4. Drugs acting on Gastro intestinal tract. To study the drug activity on oesophagal motility.5. Monitoring of drug concentrations in saliva/urine/blood.6. Action of CNS stimulants and depressants using suitable experimental model.7. Evaluation of antidepressant and anti anxiety drugs.8. Drug absorption and elimination studies.9. Any other experiment based on the topics mentioned in theory,10. Virtual and stimulated experiments are permitted.

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NINTH SEMESTER

IEC-MPHARM-411 : Modern Analytical Techniques (MAT)-I

UNIT – Ia) UV-Visible Spectroscopy: Basic principles, interaction of electromagnetic radiation with matterand its effects (electronic transitions). Concept of chromophore and auxochrome, effect ofconjugation, solvent and pH. Instrumentation (components and their significance). Absorptionspectra of organic compounds and complexes illustrating the phenomenon and its utilization inqualitative and quantitative studies of drugs including multicomponent analysis. Woodward-Fieserrules for calculating absorption maximum for unsaturated hydrocarbons. Difference and derivativespectra.b) Infra-Red Spectroscopy: Interaction of infrared radiation with organic molecules and it’seffects on bonds. Instrumentation- Dispersive IR spectrophotometers and Fourier transformspectrophotometers. Sample handling for IR spectroscopy. Interpretation of IR spectra. Brief noteon ATR.

UNIT – IINuclear Magnetic Resonance Spectroscopy: Fundamental principles of NMR, instrumentation(components and their significance). Chemical shifts concept, spin- spin coupling, spin-spindecoupling, shielding and deshielding, solvents. signal multiplicity phenomena in high resolutionPMR. Interpretation of PMR spectra.Brief introduction about Carbon-13 NMR and 2D NMR Spectroscopy.

UNIT – IIIMass Spectrometry: Basic principles and instrumentation (components and their significance).Ionization techniques, mass spectrum and its characteristics, molecular ion, metastable ions,fragment ions; fragmentation processes, fragmentation patterns and fragment characteristics inrelation to parent structure and functional groups. Relative abundances of isotopes and theircontribution to characteristic peaks.

UNIT – IVChromatographic Techniques: Classification of chromatographic methods based on mechanismof separation and their basic principles. Gas chromatography: Instrumentation, column efficiencyparameters, derivatisation methods, applications in pharmaceutical analysis. Liquidchromatography: Comparison of GC and HPLC, instrumentation in HPLC, normal and reversedphase packing materials, column selection, mobile phase selection, efficiency parameters,applications in pharmaceutical analysis. Instrumentation and applications of HPTLC, ion exchangechromatography, gel permeation chromatography, chiral chromatography, flash chromatography,and supercritical fluid chromatography (SFC).

UNIT – VElectrophoresis: Principles, instrumentation and applications of moving boundary electrophoresis,zone electrophoresis (ZE), isotachphoresis, isoelectric focusing (IEF), continuous electrophoresis(preparative) and capillary electrophoresis. SDS gel electrophoresis and blotting techniques.Radio immunoassay and ELISA: Principle, instrumentation, applications and limitations.

Recommended Books

1. Skoog, DA, Holler, FJ, Crouch, SR. Principles of instrumental analysis. 6th

ed., Baba BarkhaNath printers, Haryana, 2007.

2. Silverstein, RM, Webstar, FX. Spectrometric identification of organic compounds. 6th

ed., John

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Wiley & Sons (Asia) Pvt. Ltd., Singapore, 2005.

3. William Kemp. Organic spectroscopy, 3rd

ed., Palgrave, New York, 2006.

4. Jag Mohan, Organic spectroscopy: Principles and Applications, 2nd

ed., Narosa publishing housePvt Ltd., New Delhi, 2005.

5. Conners KA. A Text book of pharmaceutical analysis, 3rd

ed., John Wiley & Sons, Singapore,2004.

6. Willard HH, Merritt LL, Dean JA, Settle FA. Instrumental methods of analysis, 7th

ed., CBSPublishers & Distributors, New Delhi, 1986.

7. Pavia DL, Lampman GM, Kriz GS, Vyvyan JA. Introduction to spectroscopy. 4th

ed.,Brookescole publishers, California, 2008.

8. Sharma BK. Instrumental methods of chemical analysis, 25th

Ed., Goel Publishing house,Meerut, 2006.

9. Beckett, AH, Stenlake, JB. Practical pharmaceutical chemistry, Part I & II, 4th

ed., CBSPublishers & distributors, New Delhi, 2004.

10. Ewing, GW. Instrumental methods of chemical analysis, 5th

ed., McGraw Hill Book Company,New York, 1985.

IEC-MPHARM-411P : Modern Analytical Techniques (MAT)-I LabList of Experiments1. UV/Visible spectrum scanning of a few organic compounds for UV- absorption and correlationsof structures (5 compounds) and isosbestic point in case of mixtures.2. Effect of solvents and pH on UV spectrum of drugs.3. Estimation of multicomponent formulation by UV- Spectrophotometer in formulations.4. Experiments based on the application of derivative spectroscopy.5. Experiments based on HPLC (Isocratic and Gradient elution) techniques.6. Interpretation of drugs by IR spectra.7. Workshop of spectroscopy: (UV, IR, NMR, MASS) structural elucidation of at least 5compounds.8. Separation of protein drug substances by electrophoresis.9. Any other relevant experiments based on theory.

IEC-MPHARM-412 : Advanced Pharmacology-II

UNIT -1Bioavailability and Bioequivalence: Objectives, bioavailability & variations, measurements ofbioavailability, enhancing bioavailability, concepts of equivalents, official bioequivalence protocols& therapeutic equivalence.

UNIT -2Drug Absorption: General consideration, absorption / drug transport mechanisms, role factorsaffecting absorption, absorption of drug non-peroral routes, methods of determining absorption-in-vitro, in-situ, and in-vivo methods.Drug Distribution: Factors affecting, protein & tissue binding, kinetics, determination of rateconstants & different plots (direct, Scatchard, & reciprocal).

UNIT -3Pharmacokinetics: Parameters & determination, pharmacokinetic models – one compartment,multi compartment in IV bolus, IV infusion & extra vascular, drug & metabolites levels in blood,

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urine and other biological fluids. Integration of kinetics.Application of pharmacokinetics in new drug development, design of dosage forms and novel drugdelivery systems.

UNIT - 4Drug Disposition and Excretion: Biotransformation, factors affecting biotrasformation, Phase I& Phase-II reactions.Clearance: Concept, renal, non-renal clearance, mechanism, determination, % drug metabolized,different volume of distribution.

UNIT – 5Pharmacokinetics of Multiple Dosing: Various terminology, determination, adjustment ofdosage in renal & hepatic impairment, individualization of therapy, therapeutic drug monitoring.Non-linear kinetics: Cause of non-linearity, estimation of various parameters, bioavailability ofdrugs that follow non-linear kinetics. Chronopharmacokinetics & pharmacokinetics of elderly andinfants.

Recommended books1. Biopharmaceutics and Clinical Pharmacokinetics, Mile Gibaldi, Lea and Febriger, Philadelphia.2. Current concepts in Pharmaceutical Sciences, Swarbrick, Lea and Febriger, Philadelphia.3. Theory & Practice of Industrial Pharmacy, L.Lachman, Varghese Publ, Bombay.4. Clinical Pharmacokinetics, Rowland and Tozer, Lea and Febriger, Philadelphia.5. Biopharmaceutics and Clinical Pharmacokinetics, Niazi, Prentice Hall, London.6. Remingtons Pharmaceutical Sciences, Mack & Co.7. Biopharmaceutics & Clinical Pharmacokinetics, DM Brahmankar, Vallabh, Delhi.8. C.V.S.Subrahmanyam, Textbook of Biopharmaceutics and Pharmacokinetics, 2009, VallabhPrakashan.

IEC-MPHARM-412P : Advanced Pharmacology-II Lab1. Comparative dissolution studies on different dosage forms for drugs.2. Effect of pH / particle size on dissolution studies.3. Plasma protein binding studies on different drugs.4. Estimation of pharmacokinetic parameters in urine / serum samples.5. Estimation of creatinine clearance.6. Estimation of pharmacokinetic parameters for the given urinary excretion data.7. Estimation of pharmacokinetic parameters for the given oral absorption data.

IEC-MPHARM-413 : Drug Design and Molecular Modeling – I

UNIT –I

Pharmacokinetics approach to New Drug DiscoveryBasic concepts and Defination, importance of ADME parameters in disposition, therapeutics anddevelopment their implication on drug discovery.

UNIT-IIOverview on computer aided Drug design (CADD) including QSAR, Combinational Chemistry,

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High Throughout screening (RTS)

UNIT-IIIMolecular Basis of Drugs Action: Cell signaling, communication between cells and theirenvironment, ion-channels, organizations of signal transduction pathways, third messengers,biosensors.Drug Latentiation :Basic concept, Prodrugs of functional groups, Bio-precurssor prodrugs,chemical delivery system.

UNIT – IVBiotechnology in Drug Discovery: Cloning of DNA, Expression of cloned DNA, Manipulation ofDNA sequence information, New Biological Targets for Drug Development Novel Drug Screeningstrategies, Novel Biological Agents, Antibodies, Antisense eligonucleotide therapy, Gene therapy.

UNIT – VHerbal Neutracauticals as new source for medicines.Study of Advanced drugs from natural sources of following groups:Anticancer, Anti AIDS, Hepatoprotectives, Antidiabetics, Brain Toni cs, Anti urolithiates,Antifilarial, Antihyperlipidimics.Modern phytochemical screening techniques and evaluation of herbal drugs and their extracts andformulations, Concept of Reverse Pharmacognosy.

Books recommended1. Comprehensive Medicinal chemistry Vol-4 Ed.C. Hanseh, Pergamon Press, New York.2. Comprehensive Biotechnology, Ed. Murray Moo-Young, Pergamon Press, New York.3. Comprehensive Biotechnology information publication.4. Dewick Paul M. Medicinal Natural Products-A Biosynthetic Approach.5. Chakravarty T.K. “ Herbal Options”.

IEC-MPHARM-413P : Drug Design and Molecular modeling – I LabList of Experiments.

1. Experiments based on Pharmacokinetics studies of drugs.2. Experiments based on CADD.3. Experiments on Pharmacological Screening.

Tenth Semester

IEC-MPHARM-421 Dissertation ProjectIEC-MPHARM-422 SeminarIEC-MPHARM-423 Dissertation Presentation / viva-voce

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