MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details

Year of entry: 2020

Course unit details:
Pre-formulation Studies 1 (PIAT 2)

Unit code PHAR71020
Credit rating 15
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Variable teaching patterns
Offered by Pharmacy
Available as a free choice unit? No

Overview

This module explains the need for preformulation. A number of solubility parameters are discussed including intrinsic solubility, dissolution rate, pKa and salts, solvents and partition coefficients, and also thermal properties of drug candidates. The concept of stability is explained, including degradation mechanisms, stability assessment and inhibition. Assay development to establish levels of actives are described. Particle properties and powder flow and compression properties are explained.

Aims

The unit aims to:

- Explain the rationale for measuring physicochemical properties during preformulation development of a drug substance

- Define the physicochemical properties to be measured and outline the experimental methods for doing so

- Show how the physicochemical data are interpreted with a view to making a ‘go/no go’ decision in respect of development of a particular drug substance

- Give a guide to interpretation of data from various analytical techniques, including thermal methods (DSC, TGA), chromatographies (HPLC and TGA) and spectroscopies (UV, IR).

- Discuss powder properties, including shape, compaction and flow

 

Teaching and learning methods

This module is delivered via distance-learning – printed material is provided to the student which they can read through. At various points there are self-test questions and the student can email the tutor at any time. Indicative reading is given throughout.

 

Knowledge and understanding

Students will be able to:

 
Understand the concept of preformulation within the context of developing a medicine and within this framework will know which physicochemical properties are most important to assess and how they correlate to and inform the likely developability of a drug substance

 

Intellectual skills

Students will be able to:

 
Critically analyse and interpret analytical data from a range of techniques and reach an informed decision as to whether a compound is likely to be developable into a medicine

 

Practical skills

Students will be able to: 

Design experiments to maximise the amount of physicochemical information from the minimum sample mass and critically interpret and evaluate experimental data from a range of analytical techniques.

Transferable skills and personal qualities

Students will be able to: 

Critically review data and information from a range of sources, design experimental series, prepare technical reports and review scientific literature

Assessment methods

Method Weight
Written exam 70%
Written assignment (inc essay) 30%

Assessment task

Length

How and when feedback is provided

Weighting within unit (if relevant)

 

Assignment

3000 words

Feedback returned by email within 15 working days

30%

Exam

2 hours

Mark sent after exam board

70%

 

Recommended reading

Gaisford, S. and Saunders, M. Essentials of pharmaceutical preformulation. ISBN: 9780470976364

Study hours

Scheduled activity hours
Assessment written exam 2
Independent study hours
Independent study 148

Teaching staff

Staff member Role
Simon Gaisford Unit coordinator

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