MSc Pharmaceutical Industry Advanced Training (PIAT) / Course details

Year of entry: 2021

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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 unit 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

Students are provided with the learning material in soft copy form. The learning material comprises 9 chapters covering all the key areas of preformulation. Each chapter contains a number of exercises together with suggested answers for students to check their learning as they progress through the unit. A reference list of further reading is provided for each chapter allowing the student to investigate the subject area more deeply, and the unit tutor is available to answer queries and provide guidance as required. The face-to-face workshop at the annual workshop event explores key areas of the unit through a range of hands-on exercises and practical demonstrations.

 

Knowledge and understanding

Students will be able to:

•    Understand the concept of preformulation within the context of developing a medicine 
•    Determine, within this framework, which physicochemical properties are most important to assess and how they correlate to and inform the likely development-potential of a drug substance

Intellectual skills

Students will be able to:

•    Critically analyse and interpret analytical data from a range of techniques
•    Reach an informed decision as to whether a compound is likely to be suitable for development into a medicine

 

Practical skills

Students will be able to: 

•    Design experiments to maximise the amount of physicochemical information from the minimum sample mass 
•    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
  • Review scientific literature

Assessment methods

Method Weight
Written assignment (inc essay) 100%

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

100%

 

Feedback methods

Feedback returned by email within 15 working days.

Recommended reading

•    Gaisford, S. and Saunders, M. Essentials of pharmaceutical preformulation. ISBN: 9780470976364 
•    S.M. Paul, D.S. Mytelka, C.T. Dunwiddie, C.C. Persinger, B.H. Munos, S.R. Lindborg,
•    A.L. Schacht. How to improve R&D productivity: The pharmaceutical industry’s grand challenge. Nat. Rev. Drug Disc. 9 (2010) 203-­¿214.
•    C.F. Poole, N.C. Dias. Practitioner’s guide to method development in thin-­¿layer chromatography. J. Chromatogr. A. 892 (2000) 123-­¿142.
•    M. Reading, A. Luget, R. Wilson. Modulated differential scanning calorimetry. Thermochim. Acta 238 (1994) 295-­¿307.
•    M. Reading, D.Q.M. Craig, J.R. Murphy, V.L. Kett. Modulated temperature differential scanning calorimetry. In; D.Q.M. Craig, M. Reading (Eds). Thermal analysis of pharmaceuticals. 2007, CRC Press (Boca Raton), ISBN 0-­¿8247-­¿5814-­¿5.
•    J.I. Wells. Pharmaceutical preformulation. The physicochemical properties of drug substances. John Wiley and Sons (Chichester), 1988, ISBN 0-­¿470-­¿21114-­¿8.

Study hours

Independent study hours
Independent study 150

Teaching staff

Staff member Role
Michael Tobyn Unit coordinator

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