PHCY5611 Medicinal Product Formulation

6 points
(see Timetable)
Semester 2UWA (Perth)Face to face
This unit introduces students to the principles and processes of medicinal product formulation and production. Building on the foundations delivered in PHCY5610 Physical Pharmacy and Biopharmaceutics, this unit brings students through the formulation and production of major solid, semi-solid, liquid, aerosolised and controlled release drug formulations. Students are provided with an overview of common pharmaceutical excipients, and the principles for preservation, sterilisation and packaging of medicinal products. Tutorials require students to apply the formulation principles to discuss and resolve issues in case-based medicinal product development. The preparation of some medicinal products is undertaken in the laboratory with emphasis on both the science and art of extemporaneous compounding within legislative and professional practice frameworks. Students are also provided opportunities to visit TGA-approved, Perth-based manufacturing facilities of medicinal products. The focus, as in all the pharmacy units, is on the delivery of optimum patient care.
Students are able to (1) compare and contrast solid, semi-solid, liquid and aerosolised medicinal products and evaluate the appropriateness of their use in clinical settings; (2) evaluate the categories of pharmaceutical excipients, naming two to three examples in each category, that are required for the manufacture of specific medicinal products; (3) analyse the pharmaceutical principles underpinning the manufacture of safe and efficacious medicinal products; (4) analyse the means for achieving and validating the preservation and sterilisation of medicinal products; (5) demonstrate an advanced understanding of the principles for proper handling and disposal of cytotoxic medicinal products; (6) analyse the Therapeutic Goods Administration requirements for authorised medicinal products; (7) demonstrate an advanced understanding of the principles of Good Manufacturing Practice; (8) compare and contrast the packaging materials used for medicinal products; (9) apply mathematical principles to the preparation, and the safe and effective use of medicinal products in different patient populations; (10) prepare, label and record the extemporisation of a range of medicinal products in compliance with legislative and professional practice frameworks; and (11) demonstrate an advanced understanding of dosage form preferences in diverse patient groups (age, cultural, rural).
Indicative assessments in this unit are as follows: (1) ongoing assessments; (2) laboratory assessments; and (3) final written examination. Further information is available in the unit outline.

Supplementary assessment is not available in this unit.
Unit Coordinator(s)
Professor Lee Yong Lim
Unit rules
enrolment in the Master of Pharmacy (51500)
Contact hours
lectures and tutorials: 4 hours x 12 weeks; labs: 4 hours x 8 weeks; site visits: 1.5 hours x 2 weeks

Aulton, M. Pharmaceutics: The Design and Manufacture of Medicines, current edn: Churchill Livingstone  

Australian Pharmaceutical Formulary and Handbook, current edn: Pharmaceutical Society of Australia  

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