Last modified: 31 May 2022 13:05
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.
| Study Type | Postgraduate | Level | 5 |
|---|---|---|---|
| Term | Second Term | Credit Points | 15 credits (7.5 ECTS credits) |
| Campus | Aberdeen | Sustained Study | No |
| Co-ordinators |
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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.
Information on contact teaching time is available from the course guide.
| Assessment Type | Summative | Weighting | 75 | |
|---|---|---|---|---|
| Assessment Weeks | Feedback Weeks | |||
| Feedback |
10 short answer questions (@2 marks), 2 from 3 extended answer questions (@20 marks). Written feedback. |
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| Knowledge Level | Thinking Skill | Outcome |
|---|---|---|
| Procedural | Analyse | Gain an appreciation of common formulation packaging methods and be able to select an appropriate method for a given drug. |
| Procedural | Evaluate | Ability to develop a stability protocol for the drug substance and drug product. |
| Procedural | Understand | Understand the application of stability protocol and stability limits to the formation of toxic impurities. |
| Procedural | Understand | Understand solvent and reagent classification, and acceptable pharmaceutical limits. |
| Assessment Type | Summative | Weighting | 25 | |
|---|---|---|---|---|
| Assessment Weeks | 31 | Feedback Weeks | 31,32 | |
| Feedback |
Student led workshops on predefined topics Feedback will be written and in person. |
|||
| Knowledge Level | Thinking Skill | Outcome |
|---|---|---|
| Procedural | Analyse | Gain an appreciation of common formulation packaging methods and be able to select an appropriate method for a given drug. |
| Procedural | Evaluate | Ability to develop a stability protocol for the drug substance and drug product. |
| Procedural | Understand | Understand the application of stability protocol and stability limits to the formation of toxic impurities. |
| Procedural | Understand | Understand solvent and reagent classification, and acceptable pharmaceutical limits. |
There are no assessments for this course.
| Assessment Type | Summative | Weighting | 75 | |
|---|---|---|---|---|
| Assessment Weeks | Feedback Weeks | |||
| Feedback |
10 short answer questions (@2 marks), 2 from 3 extended answer questions (@20 marks) written feedback |
|||
| Knowledge Level | Thinking Skill | Outcome |
|---|---|---|
| Procedural | Analyse | Gain an appreciation of common formulation packaging methods and be able to select an appropriate method for a given drug. |
| Procedural | Evaluate | Ability to develop a stability protocol for the drug substance and drug product. |
| Procedural | Understand | Understand the application of stability protocol and stability limits to the formation of toxic impurities. |
| Procedural | Understand | Understand solvent and reagent classification, and acceptable pharmaceutical limits. |
| Assessment Type | Summative | Weighting | 25 | |
|---|---|---|---|---|
| Assessment Weeks | 31 | Feedback Weeks | 31,32 | |
| Feedback |
Written and in person |
|||
| Knowledge Level | Thinking Skill | Outcome |
|---|---|---|
| Procedural | Analyse | Gain an appreciation of common formulation packaging methods and be able to select an appropriate method for a given drug. |
| Procedural | Evaluate | Ability to develop a stability protocol for the drug substance and drug product. |
| Procedural | Understand | Understand the application of stability protocol and stability limits to the formation of toxic impurities. |
| Procedural | Understand | Understand solvent and reagent classification, and acceptable pharmaceutical limits. |
| Knowledge Level | Thinking Skill | Outcome |
|---|---|---|
| Procedural | Understand | Understand solvent and reagent classification, and acceptable pharmaceutical limits. |
| Procedural | Understand | Understand the application of stability protocol and stability limits to the formation of toxic impurities. |
| Procedural | Evaluate | Ability to develop a stability protocol for the drug substance and drug product. |
| Procedural | Analyse | Gain an appreciation of common formulation packaging methods and be able to select an appropriate method for a given drug. |
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