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MALAYSIA
Pharmaceutics IV
(BPH3014)
Module Guide
(22 June 2009 2 October 2009)
TITLE: PHARMACEUTICS IV
LEVEL: SEMESTER 5
CONTENT SYNOPSIS
The rapidly evolving science of drug delivery faces the twin challenges of developing better
delivery systems for existing drugs, and new methods for new drugs, many of which are
proteins. For example modified release delivery can dramatically improve the therapeutic
performance of dosage forms and provide solutions to therapeutic problems by increasing the
duration of action of the active agent, reducing dosing frequency and encouraging adherence to
drug therapy. The systemic delivery of proteins demands increasingly accurate delivery
systems which can protect against gastric hydrolytic attack. Fundamental concepts of
biopharmaceutics were introduced in Pharmaceutics I, Semester 2 and more applications are
discussed in this Module.
The Module also describes principles of Current Good Manufacturing Practice (CGMP) and
Good Laboratory Practice (GLP) and their applicability to the production and quality assurance
of pharmaceuticals. Ethical considerations relevant to the evaluation of drug products in humans
are discussed, covering provisions of the Declaration of Helsinki and of Good Clinical Practice
(GCP). The final part of the Module familiarises students with pharmaceutical industrial practice.
OBJECTIVES
The objectives of this module are to1.
describe dosage form drug release mechanisms and the kinetics of release;
2.
describe controlled or sustained release systems;
3.
describe particulate delivery systems; pro-drugs and antibody targeted delivery systems;
4.
describe gastrointestinal transit monitoring; in-vitro absorption studies;
5.
describe the concept of bioequivalence in pharmaceutical products; its achievement and
assessment;
6.
describe principles of CGMP and GLP and their application to pharmaceutical production
and the quality evaluation of pharmaceutical products;
7.
describe management controls in pharmaceutical production;
8.
discuss ethical principles relevant to the evaluation of drug products in humans, as stated
in the Declaration of Helsinki; and to
9.
provide insights into industrial pharmaceutical production.
LEARNING OUTCOMES
On completion of this module, the students should be able to describe or discuss1.
the concepts of CGMP; GLP and GCP in the context of the production and evaluation of
dosage forms;
2.
relevant ethical issues associated with the evaluation of dosage forms in human subjects;
3.
dosage form drug release mechanisms and the kinetics of release; controlled or sustained
release systems;
4.
particulate delivery systems; pro-drugs and antibody targeted delivery systems;
5.
gastrointestinal transit monitoring; in-vitro absorption studies;
6.
the concept of bioequivalence in pharmaceutical products; its achievement and
assessment;
7.
the production and quality control of common dosage forms.
LEARNING HOURS:
Lectures
Workshops
Model Industry
PBL
TOTAL LEARNING HOURS
13 hours
6 hours
70 hours
3 hours
92 hours
ASSESSMENTS:
Coursework
PBL
Simulated Industry Reports
Written examination
Degree Paper, 3 hours
SAQ (1 hour, 2 out of 3 questions)
Essay (2 hours; 2 of 3 questions
5%
25%
20%
50%
3.
4.
5.
6.
7.
Learning issues include the need for bioequivalence; clinical implications; the
assessment of bioequivalence.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
READING LIST
1.
Florence A.T. and Attwood, D. (2005) Physicochemical Principles of Pharmacy, 4th Edition,
Pharmaceutical Press
2.
Rowland, M and Tozer T.N. (1995), Clinical Pharmacokinetics: Concepts and Applications
3rd edition. Williams and Wilkins
3.
Shargel, L. and Yu, A.B.C. (1999), Applied Biopharmaceutics and Pharmacokinetics 4th
edition, Appleton and Lange.
4.
Banker, G.S. & Rhodes, C.T. (1996), Modern Pharmaceutics 3rd edition. Marcel Dekker.
5.
Chien,Y.W. (1996), Novel Drug Delivery Systems Marcel Dekker.
6.
International Ethical Guidelines for Biomedical Research Involving Human Subjects,
Geneva, 1993.
7.
World Medical Association Ethical Principles for Medical Research Involving Human
Subjects (2008) http://www.wma.net/e/policy/b3.htm
8.
Good Clinical Practices Guidelines (1993) 5th edition. Brookwood Medical Publications
9.
Watson, D.G. (1999) Pharmaceutical Analysis Churchill Livingstone
10. Anisfield, M.H. (1993) International Drug GMP. Interpharm Press
11. Ministry of Health Malaysia (1999) Malaysian Guidelines for Good Clinical Practice (1999)
12. Ministry of Health Malaysia (2000) Malaysian Guidelines for the Conduct of Bioavailability
Studies (2000)
13. Lachman, L; Lieberman, H.A. and Kanig; J.L. (1986) The Theory and Practice of Industrial
Pharmacy, Lea & Febiger
14. US Food and Drug Administration Center for Drug Evaluation and Research. Guidance
Documents http://www.fda.gov/cder/guidance/index.htm
15. US Food and Drug Administration Center for Drug Evaluation and Research (2005)
Bioequivalence Studies http://www.fda.gov/cder/bioequivdata/index.htm