Monash University Handbook 2010 Undergraduate - Unit

Synopsis

This unit provides the conceptual and intellectual foundation for further studies in Formulation Science units in 3rd year. Broad areas covered include detailed study of chemical and physical stability in liquid and in solid pharmaceutical systems; overview of biotechnologically produced proteins, including their manufacture, characterisation, stability and delivery; the design and formulation of lyophilised solids for reconstitution; and a survey of polymeric excipients.

This will involve:

• Overview of reaction kinetics (general consequences; basic equations)
• Effects of physicochemical properties on reaction rates; acid-base equilibria of functional groups
• pH-rate profiles
• Nucleophilic reaction mechanisms
• Free radical reactions (oxidation; photodegradation)
• Solid state degradation (chemical degradation; moisture uptake; physical changes)
• Lyophilisation
• Advanced Degradation mechanisms
• Protein therapeutics
• Poplymer excipients

Objectives

At the end of this unit students will be able to:

1. Understand and competently use standard methods for quantitative analysis of concentration-time profiles, to obtain degradation rate constants, half-lives and shelf-lives
2. Understand the physicochemical factors that influence reaction rates, especially the roles of temperature and acid-base equilibria
3. Understand mechanisms for chemical degradation of typical organic drugs and excipients, and their applicability to new situations, with emphasis on:
   1. nucleophilic reactions; and
   2. free radical reactions
4. Understand and apply methods for minimising the extent of degradation reactions, thus leading to increased life-times of formulated products
5. Appreciate the complex kinetics involved in oxidation, photochemical and solid state degradation
6. Understand the key physicochemical issues for therapeutic proteins
7. Understand the key aspects of protein formulation by lyophilisation
8. Show a broad understanding of polymer types, properties and uses in formulations

Assessment

Final exam (2.5 hour): 80%; practical assessments: 15%; mini-exam: 5%.

Chief examiner(s)

Dr Richard Prankerd

Contact hours

32 hours of lectures; 10 hours of tutorials; six 3 hour practical classes

Prerequisites

PSC1021 Organic Chemistry I
PSC1022 Organic Chemistry II
PSC1071 Physical Chemistry I
PSC1072 Physical Chemistry II

Additional information on this unit is available from the faculty at:

http://www.monash.edu.au/muso/support/