king saud university · 2017-11-16 · master of science in pharmaceutics (thesis option) ......
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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.