1999 Pharmacy Handbook - Pharmaceutics II

Pharmaceutics II

Introduction
General objectives
Syllabus
Practical
Textbooks
Assessment

Introduction

Dr Christopher Porter
60 lectures, 10 tutorials and 57 hours of practical work.
The aim of the subject is to provide students with a detailed knowledge and understanding of the formulation of more complex dosage forms including solids and multiphase systems; the principles and factors affecting the delivery of oral dose forms; the concept of bioavailability and bioequivalence; and the basic concepts in pharmacokinetics.

General objectives

In this teaching program students are expected to develop:

understanding of the theoretical principles outlined in the syllabus in relation to dosage form design, oral drug delivery, bioavailability and pharmacokinetics;
abilities in applying their theoretical knowledge to the formulation of proprietary dosage forms discussed in this syllabus, understanding the manufacturing processes involved in the preparation of these dosage forms, and preparing selected, commonly-used extemporaneous dosage forms;
an appreciation of how to apply their theoretical knowledge to give advice to patients and other health care professionals.

Syllabus

Properties of polymers and excipients. Molecular weight and viscosity, thickening agents, phase separation, gel formulation, coacervation, ideal properties.
Properties of powders. Particle size and distributions, particle size determination, flow properties.
Unit operations. Particle size reduction, powder mixing, drying, fluidisation, powder handling.
Tabletting. Formulation and granulation of tablets, manufacturing processes, special tablets, weight, content and physical uniformity, excipient interaction, in vitro disintegration and dissolution tests and requirements.
Capsules. Hard and soft gelatin capsule walls, stability of macrocapsules, in vitro testing, in vitro/in vivo correlations. Manufacture of different types of microcapsules. Advantages and disadvantages of capsules.
Disperse systems. Colloidal systems, kinetic, optical, electrical properties of solid-liquid dispersions, electrical and steric stabilisation of solid-liquid dispersions, nucleation and ageing.
Foams. Stability of foams, choice of surfactant, antifoaming agents.
Aerosols. Liquified and compressed aerosol propellants; two-phase aerosols; three-phase aerosols; aerosol formulation; aerosol stability; non-pressure pack aerosols, atomisers, packaging, containers.
Stability. Physical stability of dosage forms including water adsorption, non-chemical loss, polymorphic transitions, dispersed system changes.
Biopharmaceutics. Structure and properties of membranes. Mechanisms of drug transfer across membranes. Effect of ionisation. pH-partition hypothesis. Bioavailability, bioequivalence, bioavailability studies, case studies.
Pharmacokinetics. Plasma level-time curves. Compartment models. Volume of distribution. Elimination. Clearance absorption. Physiological approach to clearance. IV bolus pharmacokinetics. Oral pharmacokinetics

Practical

Nineteen 3-hour practical sessions
Practical classes are designed to provide experience in the preparation of certain pharmaceutical dose forms and reinforcement of the principles of pharmaceutics covered in the lecture series.

Textbooks

Recommended texts

Florence A T and Attwood D Physicochemical principles of pharmacy 23rd edn, Macmillan, 1998
Martindale W The extra pharmacopoeia 31st edn, Pharmaceutical Press, 1996
Pharmaceutical Society of Australia Australian pharmaceutical formulary 16th edn, PSA, 1997
Pharmacy Board of Victoria Office consolidation 2nd edn and amendments, PBV (loose-leaf)
Pharmacy Board of Victoria Pharmacy board guidelines PBV, 1999
Shargel L and Yu A B C Applied biopharmaceutics and pharmacokinetics 3rd edn, Appleton and Lange, 1993
Shaw D J Introduction to colloid and surface chemistry 4th edn, Butterworths-Heinemann, 1992
Victorian College of Pharmacy Pharmaceutics II laboratory manuals VCP, 1999

Reference books

Avis K E and others Pharmaceutical dosage forms: Parenteral medications vol. 1, 2nd edn, Dekker, 1992
Aulton M E (ed.) Pharmaceutics, the science of dosage form design Churchill Livingstone, 1988
Collett D M and Aulton M E Pharmaceutical practice Churchill Livingstone, 1990
Gibaldi M Biopharmaceutics and clinical pharmacokinetics 4th edn, Lea and Febiger, 1991
Lachman L and others The theory and practice of industrial pharmacy 3rd edn, Lea and Febiger, 1986
Martin A N and others Physical pharmacy 4th edn, Lea and Febiger, 1993
Parrott E L Pharmaceutical technology Burgess, 1970
Pharmaceutical Press The pharmaceutical codex 12th edn, Pharmaceutical Press, 1994
USP United States pharmacopoeia 23rd revision, USP Convention, 1995

Journal references

Journal of Pharmaceutical Sciences
Pharmaceutical Research

Assessment

Subject assessment will reflect the learning objectives outlined above. Methods of assessment will include:

Mid-year examination (June) (2 hours): 35%
Practical work: 10%
End-of-year examination (3 hours): 55%