This document outlines the course syllabus for Pharmaceutics II (Pharmaceutical Technology) at the University of Zambia School of Medicine Department of Pharmacy. The course deals with the physical and chemical properties of pharmaceutical systems and their applications. It aims to understand the basic physicochemical properties and has 7 objectives including describing polymeric and colloidal systems, sterilization processes, preformulation, dosage forms, radiopharmacy, and pharmaceutical biotechnology. The course involves 110 contact hours over terms 1-4 and assessments include two tests, assignments, laboratory reports, and a final examination. It covers topics such as polymeric systems, colloidal systems, sterile systems, preformulation, pharmaceutical technology, radiopharmaceutical systems, and
1. University of Zambia
School of Medicine
Department of Pharmacy
Terms I – 4
Period: 2015/2016
PMY 3020 Course Syllabus
Course Information
Course Title Pharmaceutics II (Pharmaceutical Technology)
Course Code PMY 3020
Prerequisites Pharmaceutics I
Course Website TBS (To be sourced)
Course Coordinator Dr. L.T.M Muungo
Total Teaching contact Hours 110 Hours
Course Description The Pharmaceutics II course deals with the physical and chemical properties of pharmaceutical systems.
The understanding of physicochemical properties of systems is vital for the design and manufacturing of
dosage forms.
A. 3.5 Credit Units
B. AIM: To understand the basic physicochemical properties of pharmaceutical systems
C. The OBJECTIVES of the course are to:
i. Describe the properties of polymeric and colloidal systems and their applications in pharmacy and Medicine
ii. Describe the sterilization processes and its applications in pharmacy and medicine
iii. Describe the importance of pharmaceutical preformulation and processes involved
iv. Describe all possible pharmaceutical dosage forms that can be compounded
v. Describe fundamental principles of radiopharmacy
vi. Analyze the effects of radiopharmacy in pharmaceutical systems
vii. Discuss important parameters in pharmaceutical Biotechnology
TEXTBOOKS
1. Book Title PHYSICAL PHARMACY: PHYSICOCHEMICAL PRINCIPLES IN THE PHARMACEUTICAL
SCIENCES
Author(s) Alfred Martin, Pilar Bustamante
Publisher B.I. Waverly Pvt Ltd
Year 1995
Edition Fourth
ISBN 81-7431-001-0
2. Book Title MARTIN’S PHYSICAL PHARMACY AND PHARMACEUTICAL SCIENCES
Editors Patrick J. Sinko, Yashveer Singh
Publisher Lippincot Williams and Wilkins
Year 2006
Edition Sixth
ISBN
3. Book Title PHYSICOCHEMICAL PRINCIPLES OF PHARMACY
Authors Alexander T Florence and David Attwood
Publisher Pharmaceutical Press
Year 2006
Edition Sixth
ISBN
2. 4. Book Title PHARMACEUTICS: THE SCIENCE OF DOSAGE FORM DESIGN
Author M. Aulton
Publisher Churchill Livingstone
Year 2002
Edition Second
ISBN
5. Book Title FUNDAMENTALS OF NUCLEAR PHARMACY
Author Gopal B. Saha
Publisher Springer
Year 2004
Edition Fifth
ISBN 0-387-40360-4
Other references 6. Pharmaceutical Biotechnology: Concepts and Applications, Gary Walsh, 2007
7. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems, 9th
Ed. 2011
8. Pharmaceutical Manufacturing Handbook: Production and Processes, Shayne CG, 2008
9. Martindale, The Extra Pharmacopoeia, Sean C. Sweetmam, 36th
Edition, Pharmaceutical Press
10. Pharmaceutical and Clinical Calculations, Mansoor A. Khan and Indra K. Reddy, 2nd
Edition
11. Pharmaceutical Dosage forms and Drug Delivery Systems, Allen Lloyd, 8th
Edition
12. British Pharmacopoeia
13. British Pharmaceutical Codex
14. Pharmaceutical Handbook of Excipients
Assessment
Assessment Due Date Percentage
Test 1 17/12/2016 15%
Test 2 29/04/2016 15%
Assignments TBC 5%
Laboratory Reports TBA 5%
Examination:
Main/Deferred/Supplementary
TBC 60%
Course Competences
THE EXPECTED COMPETENCES ARE:
1. Describes the polymeric and colloidal characteristics of pharmaceutical products
2. Describes the sterilization process for sterile production lines
3. Describes the importance of pharmaceutical preformulation and processes involved
4. Applies principles of preformulation to improve drug solubility and stability in compounding processes
5. Describes and distinguishes various pharmaceutical dosage forms that are available on the market Describe the importance of
pharmaceutical preformulation and processes involved
6. Describe all possible pharmaceutical dosage forms that can be compounded
7. Analyzes the effects of radiopharmacy in pharmaceutical systems
8. Describes the fundamental principles of radiopharmacy
9. Discusses the important parameters in pharmaceutical Biotechnology
Teaching & Learning Methods
1. Class lectures and lecture notes are designed to achieve the course objectives.
2. Students should read the assigned topics from recommended textbooks before class and participate in class.
3. Students should ask questions - Ask lots of questions.
4. Tutorials will be conducted to encourage discussions and further understanding of material taught in lectures.
5. Students are expected to have answers to tutorial questions for them to be allowed to attend.
6. All students must record 100% attendance in Tutorials
7. Students are expected to attend ALL lectures. Students with less than 85% attendance will not be allowed to write end of year
examinations*
8. Students should undertake ALL laboratory practicals
9. You are responsible for all material covered in this course.
10. Please communicate any concerns or issues either in class, or during the tutorials
3. COURSE CONTENT
UNIT
TOPICS
TIME (hours) REFERENCE
1. Polymeric Systems - General introduction to Polymeric
systems and nomenclature
- Properties of polymers
- Soluble polymers in pharmacy and
medicine
- Insoluble polymers in pharmacy and
medicine
- Applications of polymers in drug
delivery systems
10
3: Chapter 8
1: Chapter 20
2. Colloidal Systems - Introduction to colloidal systems
- Classification of colloids
- Properties of colloidal systems
- Physical stability of colloidal systems
- Coarse disperse systems:
- Suspensions
- Emulsions
- Controlled flocculation
- Theories of emulsion and suspension
stabilization
- Applications of colloidal systems and
theories
10 3: Chapter 7
1: Chapter 16, 17
3. Sterile Systems General Introduction
- Introduction to sterile systems
- Sterilization
- Methods of sterilization
- Aseptic techniques and Equipment
- Design, operations, classification and
monitoring of sterile rooms
- Medical uses of sterilization
- Pharmaceutical uses of sterilization:
Parenteral products
- Pyrogen and sterility testing
- Sterility evaluation of sterile products
Sterile drug dosage form systems
- Introduction to manufacturing of
sterile products
- Manufacturing plants
- Processes
- Packaging
- Quality assessment
30
8: Section VII
3: Chapter 7
1: Chapter 16, 17
4. Pharmaceutical
Preformulation
- Introduction to preformulation studies
- Preliminary evaluation of drug
compounds
- Organoleptic properties
- Purity
- Particle size and shape analysis
- Powder flow characterization
- Solubility analysis and strategies to
improve solubility
- Stability of drugs and drug products
- Stability kinetics
- Stability Testing:
- Accelerated stability Testing
- Pharmaceutical Applications:
- Shelf-life determination
10
9: Chapter 6
1: Chapter 14
3: Chapter 4-6
5. Pharmaceutical
Technology
- Introduction to pharmaceutical
technology
- Drug and dosage form development
- Pharmaceutical dosage forms:
- Solid dosage forms
- Liquid dosage forms
- Semi-solid dosage forms
- Gaseous dosage forms
- Packaging Process
10
8: Section I-IV
4: Chapter 27-30
9: Chapter 4, 6
4. 6. Pharmaceutical
Biotechnology
- Introduction to pharmaceutical
Biotechnology
- Pharmaceuticals, biologics and
biopharmaceuticals
- Protein structure
- Gene manipulation and recombinant
DNA technology
- The drug development process
- Sources and upstream processing
- Product analysis
- Therapeutic hormones
- Bioethics
- Protein and Peptide drug delivery
- Production of human insulin by
recombinant DNA technology
- Recombinant blood products and
therapeutic enzymes
- Antibodies, vaccines and adjuvants
10 6: Chapter 2, 3, 6, 7 and
7. Radiopharmaceutical
Systems
- Introduction to radiopharmacy
- Properties of ionizing particles
- Radioactive decay
- Decay of Radionuclides
- Spontaneous Fission
- Alpha (α), Beta (β-) Decay
- Radioactive Decay Equations
- Half-Life and Mean Life
- Calculations
- Instruments for Radiation Detection
and Measurement
- Radiopharmaceuticals and Methods of
Radiolabeling
- Ideal Radiopharmaceutical
- Design of New Radiopharmaceuticals
- Methods of Radiolabeling
- Characteristics of Specific
Radiopharmaceuticals
- Miscellaneous Radiopharmaceuticals
of Clinical Interest
- Quality Control of
Radiopharmaceuticals
10 7: Chapter 1-5, 7, 11, 13
Additional Notes
Examination Format Two papers: Paper I and Paper II: Exact format TBC to students at least 14 days before the
date of Examination
Supplementary Exams TBA by senate: Format will be similar to that of the main examination
Estimated end Date Lectures to end as soon as study period begins
Cheating / Unusual activities enPrePeaPr eaePei spPaesaeetfe rtisrevtns eet eaeseeseelP
Attendance 100% attendance in all activities is expected.
Lecture slides Lecture slides given in class should only be used as a guide for studying in textbooks and
other sources of information
Continuous Assessment [CA] Please take CA very seriously. Students with no CA will not be allowed to sit for final
examinations