Drug Technology Specs 09-10

8/8/2019 Drug Technology Specs 09-10

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Industrial Pharmacy

Course Specification

Programme(s) on which the course is given: Bachelor Degree in Pharmaceutical Sciences

Major or minor element of programmes: Single major

Department offering the programme: InterdisciplinaryDepartment offering the course: Drug Technology

Academic year / Level: Third professional year- first term

Date of specification approval: 7/10 /2009

Basic Information

Title: Industrial PharmacyCode: 451

Credit Hours: 3/ week

Lecture: 2/ week

Tutorial: - -

Practical: 3/week

Total: 5/ week

Professional Information

1 Overall Aims of Course

This course aims at explaining the principles of industrial pharmacy through

studying the flow of fluids, heat and mass as well as particulate solid

characteristics, importance of the unit operations such as evaporation,

distillation, drying, mixing, humidification, extraction, filtration,

centrifugation, crystallization, refrigeration, dehumidification & air

conditioning.

Faculty of Pharmacy


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2 Intended Learning Outcomes of Course (ILOS):

a- Knowledge and Understanding:The students should be able to:

1. Define and describe the basic concepts of different pharmaceutical unitoperations performed in pharmaceutical industry like filtration, mixing

crystallization, heat transfer, evaporation, drying, extraction,

centrifugation and distillation.

2. Enumerate the factors affecting different unit operations.

3. Describe the equipment used in pharmaceutical industry.

4. Mention the different units and dimensions used in the industry.

b- Intellectual SkillsThe students should be able to:

1. Determine the most suitable equipment used for each of the various unitoperations.

2. Estimate and solve problems emerging during technical operations withrespect to machine capacity and product quality.

3. Solve problems related to heat transfer, filtration and humidity using thesuitable dimensions and units.4. Interpret the breakdown of different pharmaceutical processes and their

flow sheets.

c- Professional and practical skills

The students should be able to:

1. Use the appropriate machines safely and effectively.2. Draw diagrams and sketches of different equipment used in

pharmaceutical industry.3. Use appropriate units, dimensions and scientific notation.4. Select the suitable equipment used for the different

pharmaceutical unit operations.

d- General and transferable skills


1. Demonstrate critical thinking, decision making, synthesisand interpretation of pharmaceutical information and data,


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production of pharmacy-specific scientific documentation,

and presentation of pharmaceutical information.

2. Keep up with the pharmaceutical literature and with newdevelopments of the pharmacy profession and

pharmaceutical industry and appreciate the need forindependent life-long continuing education, starting the day

after the student graduates.

3. Perform online computer search to develop informationtechnology skills and know how to retrieve information

from a variety of sources.

4. Adopt ethical, legal and safety guidelines,plan andimplement efficient and effective working environment in

different settings contributing to organization and

management of time.

5. Apply numeric and computation methods such as naturallogarithms, exponential and mathematical functionsincluding differentiation and integration.

3- Contents

Topic No. of hours Lecture Tutorial/Practical

Introduction to industrial pharmacy1 1 -

Breakdown of processes and flowsheets 1 1

Dimensions and units 3 - 3The fundamentals of heat transfer

8 2 6

Evaporation and evaporators5 2 3

Fluid flow and transportation of fluids5 2

2

Mixing8 2 6

Homogenization 2 2 -

Mass transfer and distillation5 2 3

Extraction4 2 2

Drying 7 4 3

5 2 3


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Humidity, air conditioning, refregeration andgas absorption

Crystallization 4 2 2

Filtration 5 2 3

Centrifugation2 2 -

4 Teaching and Learning Methods

Lectures (Tools: board, overhead projector, pc and data- showprojector)

Practical sessions Assignments (Report writing)

5- Student Assessment Methods

Written exams to assess the knowledge and understanding ofintellectual and professional skills.

Oral exams to assess intellectual, general skills of analysis,scientific thinking as well as scientific discussion.

Practical exam to assess professional and practical skills. Periodic exams to assess the knowledge, understanding,

intellectual and professional skills.

Assessment schedule

Assessment 1 Periodic exam Week 7

Assessment 2 Practical exam Week 13

Assessment3 Written exam Week15

Assessment 4 Oral exam Week 15

Weighting of assessments

Periodic Examination 10 %Final-term Examination 50 %Oral Examination 20 %Practical Examination 20%

Total 100%


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6- List of references

Course notes:Lecture notes and practical notes of industrial pharmacy prepared by the staff

members.

Essential books:

Recommended books:Pharmaceutics : the Science of Dosage Form Design by Michael E. Aulton

(1993).

Web sites :http://pharm.shams.edu.eg

7- facilities required for teaching and learning:

overhead projector , pc and data- show projector. Laboratory equipment and chemicals

Course coordinator:

Prof. Omaima Ahmed Sammour

Date: 7 /10 /2009


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INDUSTRIAL PHARMACY



Major or minor element of programmes: Single major

Department offering the programme: Interdisciplinary

Department offering the course: Drug Technology

Academic year / Level: Third professional year- second term/ 400

Date of specification approval 21/2/2010.

Basic Information

Title: Industrial pharmacy

Code: 472


Lecture: 2/ week

Tutorial: - -

Practical: 3/week

Total: 5/ week



Based upon the knowledge of students gained in industrial pharmacy 451

course, the students in this course will be familiar with elements

complementary to the principles of industrial pharmacy. This will be achieved

by following up on the topics of pharmaceutical operations like water

treatment & methods of particle size reduction enlargement, separation and

analysis. Applications of such knowledge is done through studying principles

of production of dosage forms with its different types including solids, liquids

& semisolids.

Faculty of Pharmacy


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2 Intended Learning Outcomes of Course (ILO):

c- Knowledge and Understanding:The students should be able to:

1. Describe the different machines used for the production ofpharmaceutical products.

2. Summarize and understand the whole production process of differentpharmaceutical products starting from raw materials ending with the

finished product brought into the market.3. Enumerate the factors affecting different manufacturing problems.d- Intellectual Skills


1. Solve problems encountered with the manufacture of tablets.2. Solve problems related to particle size analysis& flowability of powders.3. Estimate and solve problems emerging during technical operations with

respect to machine capacity and product quality.

c- Professional and practical skills


1. Design an appropriate experiment to measure theflowability of powders.

2. Manufacture and evaluate certain solid dosage forms liketablets.

3. Conduct standard industrial procedures and instrumentationprofessionally.

4. Use the appropriate machines safely and effectively.5. Draw diagrams and sketches of different machines used in

pharmaceutical industry.

d- General and transferable skills


1. Demonstrate critical thinking, decision making, synthesisand interpretation of pharmaceutical information and data,


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pharmaceutical industry and appreciate the need forindependent life-long continuing education, starting the day


3. Perform online computer search to develop informationtechnology skills and know how to retrieve information




management of time.

3- Contents

TopicNo. of hours Lecture Tutorial/Practical

The Pharmaceutical Industry:-Primary Pharmaceutical Production

-Secondary Pharmaceutical Production2 2

-

Size reduction 5 2 2

Size separation5 2 3

Particle size analysis8 2 6

Particle size enlargement

7 4 2

Powder flow4 1 3

Tablets ManufactureIntroductionTablet formulationManufacturingMachinaryStandards of quality(pharmacopoeial and non

pharmacopoeial tests)

14 5 12


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Parentral dosage forms manufacture1 2 -

Ophthalmic dosage forms manufacture6 2 -

Inhalation dosage forms manufacture 2 2 -

Suppositories manufacture 5 2 -

Capsules manufacture 5 2 -


Lectures (Tools: board , pc and data show projector) Discussion sessions. Assignments (Report writing)


Written exams to assess the knowledge and understanding ofintellectual and professional skills.

Oral exams to assess general skills of analysis, scientific thinkingas well as scientific discussion .

periodic exams to assess the knowledge and understandingintellectual and professional skills .

practical exam to assess professional and practical skills

Assessment schedule

Assessment 1 Periodic exam Week 7

Assessment 2 Practical exam Week 14

Assessment3 Written exam Week15




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Quizzes assignment 10 %Final-term Examination 50 %Oral Examination 20 %Practical Examination 20%

Total 100%


Course notes:Lecture notes and practical notes of industrial pharmacy prepared by

instructors.

Essential books:

Recommended books:1. Pharmaceutics : the Science of Dosage Form Design by Michael E.

Aulton 3rd

edition (2008).

2. Tablet and capsule machine instrumentation. Peter Ridgway and AntonyArmstrong. Pharm.Press (2008)

3. Pharmaceutical production facilities. Design and applications. GrahamC.Cole 2

ndedition (2006)

4. Handbook of pharmaceutical technology. L.K.Ghosh. CBS Publishersand distributors. (2006)

Web sites :http://pharm.shams.edu.eg

7- Facilities required for teaching and learning:

Pc and data show projector, laboratory equipment and chemicals

Course coordinator:


Head of department :


Date: 21/2/2010


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Good Manufacturing Practice (GMP)



Major or minor element of programs: Single major

Department offering the program: Interdisciplinary

Department offering the course: Drug Technology/ Analytical chemistry.

Academic year / Level: Fourth professional year- second term/ 500

Date of specification approval: 21/2/2010.

Basic Information

Title: Good Manufacturing Practice

Code: 542


Lecture: 2/ week

Tutorial: - 2/ term

Practical: -

Total: 2 hours/ week


1 Overall Aims of CourseThe aim of the course is to ensure that students have the necessary knowledge

about the inter-relationship between quality control, quality assurance and good

manufacturing practice, personnel (management, training, hygiene and health);

premises and contamination control; equipment qualification and sampling methods;

stability studies and validation as well as documentation and quality auditing in

pharmaceutical factories. Then after graduation the students should be capable to

participate with an active role in programs of good manufacturing of drugs and

assuring quality of pharmaceutical products.

Faculty of Pharmacy


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2 Intended Learning Outcomes of Course (ILOs):

e- Knowledge and Understanding:The students should be able to:

1. State the inter-relationship between QC, QA and GMP.2. Enumerate laws, ethics of practice of profession used during the manufacturing process.3. Illustrate the principles and basis of good manufacturing practice , regulations to be

followed in pharmaceutical plant in order to produce products with satisfying quality.

f- Intellectual SkillsThe students should be able to:

1. Assess the quality of the manufacturing operations involved inpharmaceutical industry.

2. Diagnose problems encountered in the manufacture processes and duringthe quality control of pharmaceutical preparations and finished products.

3. Comprehend and apply GPMP, GSP and GCP guidelines in pharmacypractice.

g- Professional and Practical SkillsThe students should be able to:

1. Ensure the standard quality of the finished product accurately.2. Apply validation aspects effectively.3. Perform quality auditing.4. Write different documentation required to ensure the different regulatory

requirements.

d-General and Transferable Skills



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1. Plan and implement efficient and effective working environments inpharmaceutical factories with regarding the GMP and GLP standards and

regulations.2. Demonstrate critical thinking, decision making, synthesis and

interpretation of pharmaceutical information and data, production of

pharmacy-specific scientific documentation, and presentation of

pharmaceutical information.

3. Keep up with the pharmaceutical literature and with new developmentsof the pharmacy profession and pharmaceutical industry and appreciate

the need for independent life-long continuing education, starting the day


4. Perform online computer search to develop information technology skillsand know how to retrieve information from a variety of sources.

3- Contents


Introduction.The inter relationship between quality control, quality assurance andGMP

1 1 -

Personnel. PERSONAL Management PERSONAL TrainingPERSONAL Hygiene and health

2 2 -

Premises and contamination control Premises: Location, design, structure, layout, services,

cleaningContamination types and sources

2 2 -

Documentation 2 2 -

Quality auditing 2 2

Regulatory aspects 1 1-

Validation Types of validation Applications Case studies

3 3 -

Technology transfer 1 1 -

High purity water 1 1 -

Introduction and sampling methods 3 3 -

Validation of analytical methods. 3 3 -


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Equipment qualification. 3 3 -

Drug stability, stability studies and stabilityindicating methods.

4 4 -


Lectures.(Tools: board, pc and data show). Discussion sessions. Assignments (Report writing).


o Written exam to assess knowledge and understanding of intellectualand professional skills detailed in items 2a, 2b&2c.

o Oral exams to assess general skills of analysis, scientific thinking aswell as scientific discussion detailed in item 2d.

o Periodic exam(quizzes) to assess knowledge and intellectual skillsdetailed in items 2a&2b.

Assessment schedule

Assessment 1 Periodic exam Week 7Assessment 2 Written exam Week 15



Periodic examination 20 %Final-term written examination 60 %Oral Examination 20 %Total 100%


- Course notes

Lecture notes on Good Manufacturing Practice prepared by instructors


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- Recommended books

Good Manufacturing Practice for Pharmaceuticals ( A plan for total qualitycontrol). By Sidney H. Willing, James R. Stoker, 1997, 4

thedition , Marcel

Dekker, U.S.A.

Pharmaceutical process validation. By R.A. Nash and A.H. Wachter, 2003,Marcel Dekker, U.S.A.

Quality in the manufacture of medicines and other health care products. ByJ. Sharp, 2000, Pharmaceutical press.

Pharmaceutical production facilities. Design and applications. GrahamC.Cole 2

nd

edition (2006)

Rules and guidance for pharmaceutical manufacturers and distributors, 2007Pharmaceutical press.

7- Facilities required for teaching and learning

Study halls, Data show, books, audiovisual tools & Internet

-Course coordinators:

Prof. Omaima Ahmed Sammour andProf. Amira El Kasas


Prof. Omaima Ahmed Sammour andProf. Amira El Kasas

Date: 21/2/2010


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Planning, Marketing and Economics of Drugs



Major or minor element of programs: Single major

Department offering the program: Interdisciplinary

Department offering the course: Drug Technology

Academic year / Level: Fourth professional year- second term/ 500

Date of specification approval: 21/2/2010

Basic Information

Title: Planning, Marketing and Economics of Drugs

Code: 603


Lecture: 3/ week

Tutorial: -

Practical: -

Total: 3 hours/ week



This course aims at deepening the concept of planning ,economics and marketing of

pharmaceutical products . Studying principles of planning, marketing and pharmacoecomics

and the application of such knowledge in the pharmaceutical market will be achieved by

studying aims ,strategies & procedures of planning. Then marketing will be handeled from the

perspective of characteristics of drug market , strategies of marketing , distribution of

pharmaceuticals and pricing of drugs in addition to methods of forecasting and assessment.

Faculty of Pharmacy


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This course also stresses on studying drug economics including some economical principles

related to drug product and the philosophy of products and services. Students will learn the

assessment of economical methods with necessary application in the field of drugs, drug

products and health together with some related problems to be solved. As well as practical

aspects of the subject.

2 Intended Learning Outcomes of Course (ILOs):

h- Knowledge and Understanding:The students should be able to:

1. Define the basic principles of marketing of pharmaceuticals.2. Compare and differentiate between the different economical assessment

methods applied in the field of pharmaceuticals and treatment

intervention.

3. Comprehend administrative and economical aspects of pharmaceuticals,marketing of medicines,principles of management, financial and human

resources, drug promotion as well as accounting.

4. Comprehend application of pharmacoeconomics to pharmacy servicesand medical therapeutics.

5. Comprehend social, behavioral and environmental sciences and healthpolicy relevant to pharmacy.

i- Intellectual SkillsThe students should be able to:

1. Apply different strategies of marketing to different pharmaceuticalproducts & evaluate the effectiveness of each strategy.

2. Implement marketing principles to position different pharmaceuticals tomaximize sales.

3. Implement pharmacoeconomic skills to solve relevant problems in thetreatment programmes.


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4. Apply the principles of pharmacoeconomics in promoting cost/ effectivepharmacotherapy.

j- Professional and Practical SkillsThe students should be able to:

1. Solve economical problems of drugs with amultidisciplinary and integrative approach.

d-General and Transferable Skills


1. Develop financial, sales and market management skills.2. Demonstratecritical thinking, decision making, synthesis

and interpretation of pharmaceutical information and data,




pharmaceutical industry and appreciate the need for

independent life-long continuing education, starting the

day after the student graduates.4. Perform online computer search to develop information

technology skills and know how to retrieve information


5. Apply numeric and computation methods such as naturallogarithms, exponential and mathematical functions

including differentiation and integration.



management of time.

3- Contents


The economic problems I 2 2 -

The economic problems II 2 2 -


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Economics of business I 2 2 -

Economics of business II 2 2 -

Pharmacoeconomics (overview) 2 2 -

Pharmacoeconomics (models) 2 2 -

Pharmacoeconomics(methodologies I) 2 2 -

Pharmacoeconomics (methodologies II) 2 2 -

Pharmacoeconomics (methodologies III) 2 2 -

Decision analysis I 2 2 -

Decision analysis II 2 2 -

Practical applications I 2 2 -

Practical applications II 2 2 -

Practical applications III 1 1 -

The pharmaceutical market 1 1 -

Marketing strategy 2 2 -

Distribution Strategy 2 2 -

Pricing strategy 2 2 -

Communication strategy 2 2 -

Forcasting, planning and evaluating marketingperformance

2 2 -

Practical aspects I 2 2 -

Consume behaviour 1 1

Practical aspects II 1 1 -


- Lectures (Tools: board, data show).

- Discussion sessions.


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- Assignments (Report writing)

5- Student Assessment Methods Written exams to assess the knowledge and understanding

intellectual and professional skills .

Oral exams to assess general skills of analysis, scientific thinkingas well as scientific discussion .

Periodic exams to assess knowledge and intellectual skills .

Assessment schedule

Assessment 1 Periodic exams Week 7

Assessment 2 Written exam Week 15



Periodic exams 20 %Final-term written Examination 60 %Oral Examination 20 %Total 100%


Course notes Hand outs of Planning, Marketing and Pharmacoeconomics prepared by

instructors.

Pharmaceutical Marketing by A.F. Taher Ph. Essentials of pharmacoeconomics. Karen L. Rascati. Lippincott Williams

and Wilkins (2009)

Essential books:

Recommended books.

7- Facilities required for teaching and learning

Study halls, audiovisual aids, books.

Course coordinator:


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Prof. Dr. A. Elshami


Prof. Dr. Omaima Ahmed Sammour

Date: 21/2/2010

Drug Technology Specs 09-10

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