PSC2222 - Formulation chemistry - 2018

This unit provides the conceptual and intellectual foundation for further studies in B Pharm Science (formulation stream) 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, characterization, stability and delivery; and a survey of the main pharmaceutical excipients.

On completion of the unit students will:

1. Solve problems using standard methods for quantitative analysis of concentration-time profiles, to obtain degradation rate constants, half-lives and shelf-lives;
2. Solve problems involving the physicochemical factors that influence reaction rates, especially the roles of temperature and acid-base equilibria;
3. Describe the common mechanisms for chemical degradation of typical organic drugs and excipients, and their applicability to new situations, with emphasis on
   1. nucleophilic reactions
   2. free radical reactions
4. Solve problems requiring application of methods for minimising the extent of degradation reactions, thus leading to increased life-times of formulated products;
5. Identify the conditions under which the kinetics involved in oxidation, photochemical and solid state degradation reactions can be separated into simple and complex models;
6. Describe the key physicochemical issues for therapeutic proteins, including formulation by lyophilisation;
7. Describe a wide range of common pharmaceutical excipient types, their physicochemical properties and their roles in formulations.

Assessment will use a written examination (120mins; 60%); marked lab class reports (20%); written assignment (5%); in-semester testing 15%

Contact hours for on-campus students:

• Three lectures per week
• One workshop
• Eighteen hours of laboratory
• Three hours of directed study per week

See also Unit timetable information

http://www.monash.edu/pharm/current/