Monash University Pharmacy handbook 1995

Copyright © Monash University 1995
Enquiries to publishing@udev.monash.edu.au

Pharmaceutics I

Dr Louis Roller

A course of 40 lectures, 16 tutorials and 39 hours of practical work

The aim of the course is to provide students with a detailed knowledge and understanding of certain aspects of the physical, chemical and biological sciences which relate to the formulation of drugs and their distribution in the body.

General objectives

In this teaching program students are expected to develop

understanding of the weights, measures and calculations used in pharmacy practice; the principles of drug administration; the principles of dosage form design; the formulation of liquid pharmaceutical products; the factors influencing drug stability; the containers used for pharmaceutical products;

abilities in the areas of performing pharmaceutical calculations; the preparation of certain pharmaceutical dose forms;

an appreciation of the need for accuracy and thoroughness in manufacture of pharmaceutical products; the factors which influence the design of pharmaceutical dose forms.

Syllabus

Weights, measures and calculations. The metric system of weights and measures, pharmaceutical calculations, mass-volume relationships, alcohol and acid dilutions, percentage formulae, wet and dry attenuations, alligation. Introduction to the Weights and Measures Act. The prescription balance, sensitivity, legal tolerances in weighing and measuring, calculation of per cent error in weighing.

Principles of drug administration. Effects of varying biological factors, children's dose rules, the doses and uses of some common drugs. The role of the pharmacist in dealing with inappropriate dosages.

Dose forms. The oral, rectal, parenteral and topical routes of drug administration. Bulk powders, individual powders, capsules, pills, tablets, ointments, creams, emulsions, solutions, suspensions, drops (eye, ear and nose), suppositories and pessaries.

Isotonic solutions. Osmotic injury of tissues, freezing point depression and osmotic pressure, osmotic calculations. The Wells Approximate Liso values. The limitations of physico-chemical methods of adjusting isotonicities, the haemolytic method of Husa, the haematocrit method of Setnikar and Telmelcou.

Milliequivalents, millimoles and milliosmoles. The electrolytes of normal serum, electrolyte solutions for intravenous use, notation in prescriptions, calculations.

Introduction to biopharmaceutics. Rate limiting steps, the importance of the dose form.

Solution formulation. Principles of formulation; pharmaceutical solvents; solutes, mechanisms of solution, concentration. Factors effecting solubility, including temperature, pH, complexation, solubilisation and cosolvency. Pharmaceutical colouring, flavouring and preserving agents.

Dissolution. Factors affecting dissolution rate, theory of dissolution, Noyes-Whitney equation, Hixson-Crowell; in vitro/in vivo correlation.

Buffering in pharmaceuticals. Chemical and biological buffer systems; physiological aspects of buffering and drug solubility, stability and action, formulation of pharmaceutical buffers.

Solution dose forms. Oral solutions, parenteral solutions, ophthalmic and nasal solutions.

Filtration. Factors affecting filtration rate, mechanisms of filtration, procedures, types of filters, filter aids.

Stability of pharmaceuticals. Forms of instability; modes of chemical degradation, hydrolysis, oxidation, photolysis, dehydration, racemisation; prevention of degradation, use of antioxidants; modes of physical degradation; shelf-life, stability testing.

Pharmaceutical containers. Glass, plastics, metals; interactions between product and packaging; influence of packaging on product stability.

Rheology. Shear stress, strain and strain rate. Newtonian, plastic, pseudoplastic and dilatant flow. Thixotropy.

Surface properties. Surface energy and surface tension. Wetting and capillarity. Surfactants, micellisation, solubilisation and detergency. Insoluble films.

Liquid-in-liquid systems. Theories of emulsification; emulsion type; HLB; emulsion stability; formulation and applications.

Practical

Thirteen 3-hour practical sessions

Practical classes are designed to provide experience in the preparation of pharmaceutical dose forms to reinforce the principles covered in the lecture course

Textbooks

Recommended texts

Florence A T and Attwood D Physicochemical principles of pharmacy 2nd edn, Chapman and Hall, 1988

Pharmaceutical Society of Australia Australian pharmaceutical formulary 15th edn, PSA, 1992

Victorian College of Pharmacy Pharmaceutics I/Pharmacy practice I laboratory manual VCP, 1995

Reference books

Aulton ME Pharmaceutics: The science of dosage form design Livingstone, 1988

Burns D M and MacDonald S G G Physics for biology and pre-medical students 2nd edn, Addison-Wesley, 1975

Collett D M and Aulton M E Pharmaceutical practice Churchill Livingstone, 1990

Martin A N and others Physical pharmacy 4th edn, Lea and Febiger, 1993

Martindale W The extra pharmacopoeia 30th edn, Pharmaceutical Press, 1993

Parrott E L Pharmaceutical technology Burgess, 1970

Pharmaceutical Press The pharmaceutical codex 12th edn, Pharmaceutical Press, 1979

Pharmaceutical Press Pharmaceutical handbook 19th edn, Pharmaceutical Press, 1980

Shaw D J Introduction to colloid and surface chemistry 4th edn, Butterworths, 1992

Journal references

Australian Journal of Hospital Pharmacy

Australian Journal of Pharmacy

Australian Pharmacist

Assessment

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

Progress examination (May) (1.5 hours): 10%

Practical work: 10%

End-of-year examination (2.5 hours): 80%



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