1999 Pharmacy Handbook - Pharmaceutics III

Pharmaceutics III

Introduction
General objectives
Syllabus
Practical
Textbooks
Assessment

Introduction

Professor Barry Reed
55 lectures, 10 tutorials and 30 hours of practical work.
The aim of the subject is to provide students with a detailed knowledge of the interaction between the dosage form and the patient and to provide a knowledge of the factors affecting drug product stability.

General objectives

In this teaching program students are expected to develop:

understanding of the use of pharmacokinetics to control administration of drugs; biological and dosage form related factors affecting the delivery of drug via common routes; factors affecting dosage form stability;
abilities in the areas of performing pharmaceutical and pharmacokinetic calculations; the preparation of sterile dosage forms;
an appreciation of the importance of understanding the dose-form in optimising use of drugs; the importance of understanding the physiology and anatomy of the patient in optimising the use of dosage forms; the importance of proper evaluation of dosage forms.

Syllabus

Dosage form design. Formulation of injectables, preformulation, containers and closures, pharmaceutical principles for products of biotechnology.
Drug stability. Shelf-life, storage conditions, accelerated stability testing, stability trial design; chemical stability, pH-rate profiles, hydrolysis, profiles of esters and amides; oxidation, photolysis; strategies for stabilisation, stability issues for proteins.
Applied pharmacokinetics. Model-independent pharmacokinetics, physiological modelling, drug metabolism, non-linear pharmacokinetics, drug dosage in renal failure, drug dosage in liver disease, kinetics of haemodialysis, multi-dose pharmacokinetics, pharmacokinetics in pregnancy, effects of age, drugs in milk.
Drug interactions. Pharmacokinetics of drug interactions involving absorption, distribution, metabolism and excretion.

Practical

Practical classes are designed to provide experience in sterile dispensing, formulation exercises and biopharmaceutics.

Textbooks

Recommended texts

Florence A T and Atwood D Physicochemical principles of pharmacy 2nd edn, Macmillan, 1988
Shargel L and Yu A B C Applied biopharmaceutics and pharmacokinetics 3rd edn, Appleton and Lange, 1993

Students should also retain textbooks utilised in earlier years of the course

Reference books

Banker G S and Rhodes C T Modern pharmaceutics 3rd edn, Marcel Dekker, 1996
Gibaldi M Biopharmaceutics and clinical pharmacokinetics 4th edn, Lea and Febiger, 1991
Rowland M and Tozer T N Clinical pharmacokinetics: Concepts and applications 3rd edn, Williams and Wilkins, 1995

Assessment

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

Mid-year examination (June) (2 hours): 25%
Practical work: 5%
End-of-year examination (3 hours): 70%