81 lectures and 55 hours of combined practical work and tutorials
The aim of the subject is to provide students with a detailed knowledge of the interaction between the dose 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; factors affecting bioavailability; measurement of bioavailability; biological and dose-form related factors affecting the delivery of drug via common routes; factors affecting dose-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 dose forms; the importance of proper evaluation of dose forms.
Syllabus
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, pharmacokinetics in pregnancy, effects of age on pharmacokinetics, drugs in milk.
Therapeutic drug monitoring. Prediction of dosage, use of population parameters, bayesian and probability methods.
Bioavailability. Definition, measurement of bioavailability, design of bioavailability studies, generic equivalence, dissolution testing.
Biopharmaceutics of the following dose routes. Peroral, buccal, rectal, percutaneous, occular, nasal, vaginal, parenteral.
Drug interactions. Pharmacokinetics of drug interactions involving absorption, distribution, metabolism and excretion.
Industrial pharmacy. The role of the pharmacist in the pharmaceutical industry. The code of `Good Manufacturing Practice'. Total quality management. Statistical process control.
Drug stability. Physical stability of selected dose forms, non-chemical loss; shelflife, storage conditions, accelerated stability testing, stability trial design; chemical stability, pH-rate profiles, hydrolysis, profiles of esters and amides; oxidation, photolysis; procedures for stabilisation; parenteral formulation design.
Practical
Practical classes are designed to provide experience in sterile dispensing, formulation exercises and biopharmaceutics.
Textbooks
Recommended texts
Students should retain textbooks utilised in earlier years of the course
Assessment
Subject assessment will reflect the learning objectives outlined above. Methods of assessment will include:
Practical work: 10%
End-of-year examination (3 hours): 90%