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CM5540: STABILITY, FORMULATION AND PACKAGING OF PHARMACEUTICAL INGREDIENTS (2021-2022)

Last modified: 31 May 2022 13:05


Course Overview

ICH stability requirements and stability evaluation will be at the heart of this course and how issues concerning the formulation and packaging of drugs plays a role. Emphasis will be focused upon how packing is often dependent on the intended patient group.

Course Details

Study Type Postgraduate Level 5
Session Second Sub Session Credit Points 15 credits (7.5 ECTS credits)
Campus Aberdeen Sustained Study No
Co-ordinators
  • Dr Rainer Ebel
  • Dr Rebecca Walker

What courses & programmes must have been taken before this course?

  • Any Postgraduate Programme

What courses cannot be taken with this course?

  • CM5940 Stability, Formulation and Packaging of Pharmaceutical Ingredients (Studied)

Are there a limited number of places available?

No

Course Description

The design of a stability protocol will be explained and its implication with respect to API tox data and shelf-life will be highlighted. Topics to be discussed will include kinetics of decomposition, toxicity issues, implication of impurities, classification of solvents and their toxicities, acceptable levels of impurities and LD50 values, and classes of genotoxins. Common formulation methods will be introduced including tableting, capsule manufacture, creams, liquid dosage forms, injectibles, and inhaled and liquid dosages. The key issues in packaging design will be discussed in relation to patient group, indication and stability. Issues of patient compliance will be discussed in relation to packaging and presentation.

This course will include a site visit to a pharmaceutical company.


Details for second half-session courses, including assessments, may be subject to change until 23 December 2022.

Contact Teaching Time

Information on contact teaching time is available from the course guide.

Teaching Breakdown

More Information about Week Numbers


Details for second half-session courses, including assessments, may be subject to change until 23 December 2022.

Summative Assessments

Exam

Assessment Type Summative Weighting 75
Assessment Weeks Feedback Weeks

Look up Week Numbers

Feedback

10 short answer questions (@2 marks), 2 from 3 extended answer questions (@20 marks).

Written feedback.

Learning Outcomes
Knowledge LevelThinking SkillOutcome
ProceduralAnalyseGain an appreciation of common formulation packaging methods and be able to select an appropriate method for a given drug.
ProceduralEvaluateAbility to develop a stability protocol for the drug substance and drug product.
ProceduralUnderstandUnderstand solvent and reagent classification, and acceptable pharmaceutical limits.
ProceduralUnderstandUnderstand the application of stability protocol and stability limits to the formation of toxic impurities.

Tutorial/Seminar Participation

Assessment Type Summative Weighting 25
Assessment Weeks 31 Feedback Weeks 31,32

Look up Week Numbers

Feedback

Student led workshops on predefined topics

Feedback will be written and in person.

Learning Outcomes
Knowledge LevelThinking SkillOutcome
ProceduralAnalyseGain an appreciation of common formulation packaging methods and be able to select an appropriate method for a given drug.
ProceduralEvaluateAbility to develop a stability protocol for the drug substance and drug product.
ProceduralUnderstandUnderstand solvent and reagent classification, and acceptable pharmaceutical limits.
ProceduralUnderstandUnderstand the application of stability protocol and stability limits to the formation of toxic impurities.

Formative Assessment

There are no assessments for this course.

Resit Assessments

Exam

Assessment Type Summative Weighting 75
Assessment Weeks Feedback Weeks

Look up Week Numbers

Feedback

10 short answer questions (@2 marks), 2 from 3 extended answer questions (@20 marks)

written feedback

Learning Outcomes
Knowledge LevelThinking SkillOutcome
ProceduralAnalyseGain an appreciation of common formulation packaging methods and be able to select an appropriate method for a given drug.
ProceduralEvaluateAbility to develop a stability protocol for the drug substance and drug product.
ProceduralUnderstandUnderstand solvent and reagent classification, and acceptable pharmaceutical limits.
ProceduralUnderstandUnderstand the application of stability protocol and stability limits to the formation of toxic impurities.

Tutorial/Seminar Participation

Assessment Type Summative Weighting 25
Assessment Weeks 31 Feedback Weeks 31,32

Look up Week Numbers

Feedback

Written and in person

Learning Outcomes
Knowledge LevelThinking SkillOutcome
ProceduralAnalyseGain an appreciation of common formulation packaging methods and be able to select an appropriate method for a given drug.
ProceduralEvaluateAbility to develop a stability protocol for the drug substance and drug product.
ProceduralUnderstandUnderstand solvent and reagent classification, and acceptable pharmaceutical limits.
ProceduralUnderstandUnderstand the application of stability protocol and stability limits to the formation of toxic impurities.

Course Learning Outcomes

Knowledge LevelThinking SkillOutcome
ProceduralUnderstandUnderstand solvent and reagent classification, and acceptable pharmaceutical limits.
ProceduralUnderstandUnderstand the application of stability protocol and stability limits to the formation of toxic impurities.
ProceduralEvaluateAbility to develop a stability protocol for the drug substance and drug product.
ProceduralAnalyseGain an appreciation of common formulation packaging methods and be able to select an appropriate method for a given drug.

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