King Saud University

Deanship of Graduate Studies

Vision

To be a world class university and a leader in building the knowledge society

Mission

To provide distinctive education, produce creative research, serve society and contribute in

building the knowledge economy and community through learning, creative thinking

environment, the optimal use of technology and effective international partnership.

Values Based on our Islamic and cultural values, we uphold:

Quality and excellence We measure ourselves according to challenging criteria, honoring high ambitions and the

pursuit of distinctiveness through our commitment to the highest intellectual standards in

teaching, learning and innovation.

Leadership and teamwork We remain committed to promoting individual and institutional leadership roles that drive

social development upholding professionalism, responsibility, and innovation.

Freedom of inquiry Rigorous and honest intellectual exploration is fundamental to our academic traditions, and it

is reflected in all the dimensions of our scholarly activities.

Fairness and integrity We abide by the principles of social justice, equal opportunity and cultural diversity,

consequently holding the members of our community to the highest standards of honesty,

respect, and professional ethics.

Transparency and accountability We remain committed to expose our thinking and ideas for society and scholars to judge our

contributions to global knowledge, and we hold accountable everybody in our community

for respecting and upholding our values in all forms of their scholarly activities.

Lifelong learning We are committed to lifelong learning inside and outside the KSU community, enhancing

continued intellectual growth and welfare of the society.

Master of Science in Pharmaceutics (Thesis Option)

Program Objectives:

The program has been designed to accomplish the following objectives:

1. The major goal is to provide graduate instructions and individualized research training

of the highest quality leading to the Master of Science degree (M.S.) in pharmaceutics.

2. To qualify the recipient for a research-oriented career in industry, academia,

government service or health care institutions.

3. To strengthen the scientific background of the candidate in all areas of pharmaceutics.

4. To fulfill the growing demand for higher education in the Saudi society.

Admission Requirements:

1. The admission requirements enumerated in the 15th article of the unified law organizing

the graduate studies in Saudi universities.

2. Has an adequate score in the entrance exam.

3. Pass successfully the interview in the Department of Pharmaceutics.

Degree Requirements:

A. Successful completion of at least 26 credit hours of graduate courses distributed as

follows:

1. The 20 credit hours core courses.

2. Six (6) credit hours from the selective courses.

B. Completion and successful defense of a thesis.

General Notes:

The duration for obtaining a master degree is a minimum of four semesters and a

maximum of eight; summer sessions are not counted within this period.

The minimum passing grade in a graduate course is an average of “Good”.

The student shall only graduate on having completed all program requirements,

provisionally with a minimum cumulative grade average of “Very Good”.

Master’s theses’ subjects and/or themes should be characterized by novelty and

originality.

The student should submit (where applicable) a thesis proposal to the department.

The procedure is permissible after meeting all admission requirements and completing

at least fifty percent (50%) of the course work with a cumulative average of at least

“Very Good”.

Once the proposal is recommended by an appropriate review for approval, the

Department Council shall select Master student’s supervisor(s) (and a co-supervisor

where applicable) of the thesis.

Theses should be supervised by the university faculty members with an academic rank

of full professor and/or associate professor. Assistant Professor, holding this rank

for two years, may supervise master’s theses only on having published (or obtained

acceptance for publication of two research papers (in student’s area of

specialization) in peer-reviewed journals.

Program Structure: Twenty six credit hours and a thesis are required:

Item required Credit Hours

Core Courses 20

Elective Courses 6

Thesis -

Total 26

Program Schedule

1. First Semester

Course code Course title Credit hours

PHT 539 Advanced biopharmaceutics 2 (2+0)

PHC 523 Methods of drug analysis 3 (2+1)

PHT 541 Advanced physical pharmacy I 2 (2+0)

PHT 545 Advanced pharmaceutical technology 2 (2+0)

PHT 585 Seminar I 1 (1+0)

PHT 596 Research methods 1 (1+0)

PHT 540 Drug delivery systems 2 (2+0)

Total 13

2. Second Semester

Course code Course title Credit hours

PHT 542 Advanced physical pharmacy II 2 (2+0)

PHL 541 Pharmacometrics 3 (3+0)

PHT 555 Quality control & quality assurance

in pharmaceutical industry

2 (2+0)

To be selected by the department

from the list of electives

6

Total 13

Elective Courses

Course code Course title Credit hours

PHT 535 Drug targeting 2 (2+0)

PHT 560 Pharmaceutical biotechnology 2 (2+0)

PHT 537 Drug metabolism 2 (2+0)

PHT 595 Seminar II 1 (1+0)

PHT 582 Pharmaceutical microbiology II 3 (2+1)

PHCL 510 Advanced clinical pharmacokinetics 2 (1+1)

Total Select 6 hrs

3. Third Semester

Course code Course title Credit hours

PHT 598 Research Proposal 1

4. Fourth Semester

Course code Course title Credit hours

PHT 600 Master Thesis research 1

PHT 539 Advanced Biopharmaceutics 2 (2+0)

Overview of the factors affecting drug absorption from the gastrointestinal tract – Overview

of some biopharmaceutical aspects in non-oral medications – Estimation of absorption kinetics

– Mechanisms of drug absorption – Drug distribution patterns – Factors affecting drug

distribution – Pharmacokinetic drug-drug interactions – Individualization and major sources

of pharmacokinetic variabilities – Biopharmaceutical classification system –

Biopharmaceutics considerations in regulatory assessment of different drugs.

Syllabus

Week Topics

1 Overview of the factors affecting drug dissolution from the gastrointestinal tract

2 Mechanisms of drug absorption (overview)

3 Mechanisms of drug absorption (factors affecting drug permeability)

4 Biopharmaceutical classification system and Biopharmaceutical considerations in

regulatory assessment of different drugs

5 Methods applied to enhance dissolution and absorption of drugs through the oral

route

6 Evaluation methods of dissolution and absorption of drug through oral route

7 Midterm exam

8 Overview of biopharmaceutical aspects in some non-oral routes (Nasal route,

Transdermal route, Ocular route)

9 Biopharmaceutic considerations (Pharmacodynamic Considerations, Drug

Considerations, Drug Product Considerations, Dose Considerations, Patient

Considerations)

10 Bioavailability, Bioequivelence, and Biowaviers for BCS

11 Moment distribution method (non-compartmental analysis)

12 Individualization and Pharmacokinetics variability

13 Pharmacogenomics

14 Final exam

PHT 541 Advanced Physical Pharmacy I 2 (2+0)

Topics of pharmaceutical interests including - properties of drugs in the different state of

matter – phase equilibria and phase rule, phase diagram – solubility and distribution

phenomena – thermodynamics and chemical equilibria.

Syllabus

week Topics

1,2 Fundamental concepts of thermodynamics, First law, enthalpy, second and third

law, Entropy concept and definition, application of entropy. Free Energy and its

properties, Heat of reaction and heat capacity.

3 Gaseous state of matter:

Basic gas laws, theory & equation of state for ideal gases, Deviation from gas

theory, Vander Waal equation for real gases.

4 Solution of Non-electrolytes and Electrolyte, Properties and types of solutions.

5,6 Fundamental concept of chemical equilibrium and its condition.

6,7

Introduction to crystallization:

A. Crystal parameters, crystal forms, habits, lattice angle.

B. Methods of crystal analysis: X-Ray Diffraction , DSC.

C. Polymorphism: Definition, Different shapes of polymorphs, Example and

its Pharmaceutical applications.

D. Glass transition temperature.

8 Midterm exam

9 Phase Rule:

Gibbs phase rule, phase diagrams and its pharmaceutical application

10

Solubility:

A. Solute-solvent interactions,

B. Factors affecting solubility

C. Solubility of gases in liquids

D. Solubility of liquids in liquids (ideal and real solutions)

11,12

Solubility of solids in liquids

A. Solubility of strong electrolytes

B. Solubility of slightly soluble electrolytes

C. Solubility of weak electrolytes

D. Influence of pH, solvents and combined effect of pH and Solvents.

13 Distribution phenomenon and its application:

14 Final exam

PHT 545 Advanced pharmaceutical technology 2 (2+0)

Heat flow or heat transfer – Evaporation – Size reduction – Drying – Lyophilization (freeze-

drying) – Mixing of solids , semisolids, and liquids – Filtration – Crystallization – Nano-

pharmaceuticals and their techniques – Pharmaceutical applications of super critical fluid

technology.

Syllabus

Week Topics

1 Overview of different types and excipients of tablets

2 Methods of tablet manufacture: Direct compression

3 Methods of tablet manufacture: Wet granulation

4 Tablet evaluation (Quality control tests)

5 Controlled release drug delivery systems I

6 Orally disintegrating tablet

7 Midterm exam

8&9 Solubility and solubilization

10 Overview and strategy for solubilization

11 Spray drying techniques

12&13 Lyophilization and super critical fluid techniques

14 Final exam

PHT 585 Seminar I 1(1+0)

The student is requested to present a short review on a selected topic or specialized article

topic of current interest in the field of pharmaceutics. Evaluate and criticize a scientific paper

in the area of pharmaceutics and final evaluation occurs through an open discussion.

Syllabus

Week Topics

4 Introduction to the course via discussion boards at LMs during the lecture time.

All of us should be online

6 Submission of research article to faculty members

9 Journal club (all groups)

11 Submission of seminar outline and abstract

14 Final seminar presentation

PHT 596 Research methods 1 (1+0)

Basics of research starting from sources of information – proper literature review – reading

and analyzing literatures – intellectual property –structuring of a research proposal – proper

experimental design including in vitro and in vivo experiments – data collection - presentation

of data– preparation of scientific reports – writing research articles – applications to funding

bodies are to be covered.

Syllabus

Week Topics

1 Introduction

2 Proper literature review

3 Reading and analyzing literatures

4 Intellectual property

5 Structuring of a research proposal

6 Proper experimental design including in vitro and in vivo experiments

7 Data collection

8 Data collection

9 Presentation of data

10 Preparation of scientific reports

11 Writing research articles

12 Writing research articles

13 Applications to funding bodies

14 Submission of the final draft

PHT 540 Drug Delivery Systems 2 (2+0)

Fundamentals of controlled release drug delivery -Per-oral drug delivery systems – Buccal

drug delivery systems – Nasal drug delivery systems – Ocular drug delivery systems –

Transdermal drug delivery systems – Vaginal drug delivery systems – Implantable drug

delivery systems – Pulmonary or inhalation drug delivery systems - Introduction to drug

targeting.

Syllabus

Week Topics

1 Fundamentals of Controlled Release Drug Delivery

2 Drug Targeting Strategies

3 Common Drug Delivery Systems

4 Macromolecules Drug Delivery System

5 Ocular Drug Delivery System

6 Cancer and vaccine Drug Delivery System

7 Midterm exam

8 Transdermal Drug Delivery System

9 Nasal Drug Delivery System

10 Parenteral Drug Delivery System

11 Biosimilars

12 Implantable and Pulmonary Drug Delivery System

13 Vaginal Drug Delivery System

14 Final exam

PHT 542 Advanced Physical Pharmacy II

2 (2+0)

Theoretical aspects of simple and complex chemical reactions in homogeneous and

heterogeneous systems – Environmental and preformulation factors that influence drug

stability - Elucidation of the mechanism of drug degradation and procedure designed to

enhance drug stability – Analysis of kinetic data and shelf - life prediction – Dissolution

theories and factors influencing dissolution rates – Mathematical treatment of ionic equilibria

of strong and weak acids and bases as well as complex solution equilibria encountered in

pharmaceutical systems – Application of the laws of diffusion to membrane transport – and

release of drugs from dosage forms – Topics including different types of complexes and their

relation to drug action as well as thermodynamic treatment of stability constants.

Syllabus

Week Topics

1 Introduction to kinetics laws and order of reaction

2 Factors affecting drug degradation in solution

A. Temperature ( Arrhenius equation , collision and transition state theories)

B. Ionic strength ( salt effect )

C. Solvent effect ( dielectric constant )

3 Mechanisms of degradation

4 Stability prediction of pharmaceutical Dosage form and its thermodynamic

treatment

5 Complexation

A. Types of complex ( molecular , organic and inclusion)

B. Properties of cyclodextrin and protein binding

C. Complexation and drug action

D. Determination of stability constant of complex.

6 Introduction to Diffusion Theories, Fick's first and second laws and steady state

conditions

7 Midterm exam

8 Dissolution

A. Dissolution rate

B. Dissolution of powder, tablets, granules and capsules

9 Drug release from polymer matrices and Higuchi model

10 Release from granular matrices

11 Multilayer diffusion (membrane and aqueous diffusion layer control) and

Korsmeyer–Peppas equation and its application

12 Diffusion principles in biological systems and pH partition theory

13 Similarity factor for dosage forms

14 Final exam

PHT 555 Quality control & quality assurance in pharmaceutical industry

2 (2+0)

Quality control of raw materials – Quality control of finished products (Tablets – capsules –

syrups – ointments & creams – parentrals aerosols) – Quality control of packaging materials

– Principles of GMP regulations – Standard operation procedures (SOPs) – Documentation in

pharmaceutical industry – Auditing and inspection – Validation and its application in

pharmaceutical industry – National and international requirements for registration of

pharmaceuticals

Syllabus

Week Topics

1 Pharmacopoeias and Harmonization of USP/JP/EP (ICH Q4A and ICH Q4B)

2 Pharmacopoeia and QC ,, General Chapters:

1. Chart 1: Non Complex Active Drug Substance

2. Chart 3: Excipients

3. Chart 4: Non Complex Active Drug Products

4. Chemical Tests and Assays

5. Uniformity of dosage Units

6. Dissolution Testing (4 USP Methods)

3 Pharmacopoeia and QC ,, General Chapters (cont.):

7. Physicochemical properties

8. Impurities

9. Residual Solvents

10. Reagents (Buffers)

4 Pharmacopoeia and QC ,, General Chapters (cont.):

11. Reference Standards

12. Drug Substance Monograph (e.g.)

13. Drug Products Monograph (e.g.)

5 GMP : Principal of GMP regulations based on specific guidelines ICH Q7

6&7 Process : Process validation and its application in pharmaceutical industry

8 Midterm exam

9 Inspection & Audit : Laboratory inspection and audit

10 QC vs. QA : Introduction about Quality Control vs. Quality Assurance

11 e-CTD (electronic-Common technical document)

12 Quality Club and students’ presentations

ICH Q2(R1): Validation of Analytical Procedures

ICH Q6A: Specifications: Test Procedures And Acceptance Criteria For

New Drug Substances And New Drug Products: Chemical Substances

13 Quality Club and students’ presentations

ICH Q1A(R2): stability testing of new drug substances and products

ICH Q1B, ICHQ1C, ICHQ1D

14 Final exam

PHT 535 Drug targeting 2 (2+0)

Terminology of drug targeting – chemical, pharmaceutical and biological approaches to drug

targeting technology – Organ or specific tissue targeting – Specific cell and receptor targeting

– development of suitable formulations for targeted drug delivery – biotechnology and

molecular biology produced intelligent targeted drug delivery systems.

Syllabus

Week Topics

1 Introduction to TDDS 1

2 Introduction to TDDS 2

3 Biological-based TDDS 1

4 Biological-based TDDS 1

5 Biotechnology-Based TDDS

6 Chemical-Based TDDS

7 Midterm exam

8 Chemical-Based TDDS

9 Receptor Based Drug Target

10 Cell Based Drug Target

11 Organ Drug Target 1

12 Organ Drug Target 2

13 Organ Drug Target 3

14 Final exam

PHT 560 Pharmaceutical biotechnology 2 (2+0)

Introduction [definition-application-tools] – Molecular biology of nucleic acids [DNA and

RNA structure – the genome – replication and transcription – Isolation and identification –

Amplification by PCR – gene bank] – Cloning – Molecular biology of protein – Isolation and

characterization of protein – production of recombinant protein by expression systems –

Biotechnologically developed pharmaceutics [biosimilars – monoclonal antibodies – vaccines

– gene therapy – antisense technology] – Regulatory affairs of biopharmaceuticals and

bioethics.

Syllabus

Week Topics

1&2 Overview, Pharmaceutical Biotechnology

3 Recombinant DNA Technology

4 Fermentation Technology

5 Genetics in Drug Therapy

6 Vaccines

7 Midterm exam

8 Monoclonal Antibodies

Stem Cell-Based Research

9 Background, Cell and Molecular Biology

10 Protein Structure

11 Pharmaceutical and Microbiological Considerations

12 Recent Advances in Biological Products and its Clinical Applications

13 Regulatory Affairs of Biopharmaceuticals and Bioethics

14 Final exam

PHT 595 Seminar II 1 (1+0)

The student is requested to orally present a short review on a selected topic or specialized

article topic of current interest in the field of pharmaceutics related to the subject of his

research proposal. The final evaluation occurs through an open discussion.

Syllabus

Week Topics

1-3

Introduction of the course, aspects

Briefing session and engaging students in instant presentation (part of the

assessment)

4-5 Topic selection for the research proposal (submission deadline)

5-9

Submission of Abstract, Key words, Running title, Introduction, Materials &

Methods, Results/discussion, Conclusion, Declaration, Acknowledgment,

Reference

10-13 How to develop professional presentation skills, article selection for critical

analysis, group discussion, endnote selection

13-14 Final seminar presentation

PHT 582 Pharmaceutical microbiology II 3 (2+1)

Microbial instability of pharmaceutical products and the responsible micro-organisms –

Methods of preservation of pharmaceutical preparations – How to use biological safety

cabinets? –Methods of sterilization of pharmaceutical preparations – Applied procedures in

microbiological quality control of pharmaceutical preparations including vaccines.

Syllabus

Week Topics

1 Ecology micro-organisms Aseptic Area

2 Factory Hygiene

3 Culture Media

4 Identification & Sampling

5 Enumeration & Detection

6 Midterm exam

7 Sterile Product

8 Pyrogen

9 QC Of Immunological Products

10,11 Preservation and Preservative efficacy

12&13 Antibiotics assay

14 Final exam

PHT 537 Drug metabolism 2 (2+0)

Introduction to drug metabolism - Major pathways of drug metabolism – modulation of drug

metabolism (induction and inhibition) – different factors affecting drug metabolism – genetic

polymorphisms and pharmacogenomics – genotyping and phenotyping - some in vitro and in

vivo techniques commonly used in studying drug metabolism – metabolism drug interactions

and clinical relevance of drug metabolism – other recent topics related to the area.

PHL 541 Pharmcometrics 3 (3+0)

Introduction and descriptive statistics- Probability distributions - Tests of hypothesis-

Comparison of two means and two variances – Analysis of variance – The Chi-square test –

Linear regression and correlation – Distribution-free methods.

PHCL 510 Advanced Clinical Pharmacokinetics 2 (1+1)

Bioavailability, Methods of estimations – Concept of clearance – Factors affecting drug

clearance – Michaelis-Menton kinetics – Effect of protein binding on volume of distribution

and drug elimination – Detoxification and dialysis – Pharmacodynamic models and their

selection – Drug interactions – Model-independent kinetics – Use of NONLIN and SIMKIN

and others in determination of pharmacokinetic parameters.

PHC 523 Methods of drug analysis 3 (2+1)

Different methods of separation of compounds and their corresponding methods of analysis

– High Pressure Liquid Chromatography (HPLC) methods – their application in analysis of

drugs and pharmaceutical preparations.