units

PSC3201

Faculty of Pharmacy and Pharmaceutical Sciences

Undergraduate - Unit

This unit entry is for students who completed this unit in 2012 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.

print version

6 points, SCA Band 0 (NATIONAL PRIORITY), 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.

LevelUndergraduate
FacultyFaculty of Pharmacy and Pharmaceutical Sciences
OfferedParkville First semester 2012 (Day)
Coordinator(s)Dr Laurence Orlando

Synopsis

This unit aims to provide the student with applied "job-ready" pharmaceutical and non-pharmaceutical formulation skills through understanding and applying concepts like preformulation, formulation with ICH recommended statistical strategy of 'Design of Experiments', and subsequent manufacturing processes.

This unit covers:

  • Milling and mixing
  • Filling
  • Material drying and handling
  • Packaging and labelling operation
  • Powder properties and material of construction
  • Fundamental and derived properties of solid powders
  • Preformulation principles
  • Tabletting theory and practice
  • Design of experiments principles and application
  • Sterile products manufacture principles

Outcomes

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

  1. Understand the importance of Design of Experiments (DoE) in the ICH and Quality By Design (QbD) context in each stages of product development;
  2. Understand and manipulate high level Excel functions to produce an automatic calculation programs;
  3. Apply these functions to elaborate a DoE program to automatically run Plackett Burman screening DoEs and factorial plans that can be applied in the context of this unit, other units in the curriculum (PSC3202) as well as in Industries during their placement (PSC3252) and ultimately in their future professional activity;
  4. Interpret DoE results that are collected by the students during the tablet formulation practicals in this unit and draw conclusions about identification of critical process parameters;
  5. Write a report based on scientific publications including DoEs found in the literature;
  6. Enumerate and understand the various tests used in preformulation;
  7. Discuss the industrial context and purpose for, as well as the basic theory of processes for: particle size reduction, powder blending, material drying, material handling and transport;
  8. Appreciate the types of industrial equipment that may be used in manufacturing a range of formulated products including mixers, mills, material transport and filling machines, labeling machines, pumps and packaging machines, and be able to discuss factors associated with identifying the most appropriate equipment, and materials of construction as well as formulation factors that may be influenced by such different types of manufacturing machinery;
  9. Identify the specificities of sterile manufacturing;
  10. Have a basic appreciation of fine powder behaviour and characteristics, and material properties influencing formulation;
  11. Discuss the role and general properties to consider as well as applications of various types of packaging and various label types, and discuss methods/operations involved in production of packaging and labels;
  12. Manufacture spray dried powders and appreciate the different parameters involved in the quality of the resulting product.

Assessment

Final exam (2 hour): 70%; practical assessments: 10%; tutorial assessment: 20%.

Chief examiner(s)

Dr Laurence Orlando

Contact hours

24 hour lectures, 28 hour practical, 20 hours tutorials.

Prerequisites

PSC2202 Product development I (formerly PSC2102)

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

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