Undergraduate - UnitPSC3231 - Pharmaceutical Product Manufacture

This unit entry is for students who completed this unit in 2014 only. For students planning to study the unit, please refer to the unit indexes in the the current edition of the Handbook. If you have any queries contact the managing faculty for your course or area of study.

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6 points, SCA Band 2, 0.125 EFTSL

Refer to the specific census and withdrawal dates for the semester(s) in which this unit is offered, or view unit timetables.

Level	Undergraduate
Faculty	Faculty of Pharmacy and Pharmaceutical Sciences
Offered	Parkville First semester 2014 (Day)
Coordinator(s)	Dr Laurence Orlando

Notes

Note: this unit was previously title Product Development II with code PSC3201

Synopsis

This unit provides students with applied job-ready pharmaceutical formulation skills through understanding and application of preformulation and formulation according to ICH recommended statistical strategy of Design of Experiments, and subsequent manufacturing processes. Using a problem based learning approach the unit exposes students to enhance authentic industry activities and develops industry relevant attributes such as teamwork, communication, critical thinking and problem solving skills.

Outcomes

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

Identify, find and critically evaluate information about tableting (preformulation, excipients, process, testing) needed to solve a complex formulation problem
Write a literature review
Explain the importance of Design of Experiments (DoE) in the context of ICH and Quality by Design (QbD)
Use MS Excel to create a Plackett Burman design and a factorial design
Select relevant information from a literature review to create a DoE protocol to solve a formulation question
Operate tablet manufacturing and testing equipment
Compile, analyse, evaluate and interpret DoE results
Communicate results in a written report
Work effectively in teams and undertake a range of team roles.

Assessment

In-semester assessment 60%, final assessment 40%

Chief examiner(s)

Dr Laurence Orlando

Workload requirements

Contact hours for on-campus students:

32 hours practicals
40 hours workshops and feedback hours

Co-requisites

PSC3211 Industrial Formulation

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

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