Module Details

Module Code: ZPHA C4105
Module Title: Drug Stability
Title: Drug Stability
Module Level:: 8
Credits:: 5
Module Coordinator: Paula Rankin
Module Author:: Paula Rankin
Domains:  
Module Description: The aim of this module is to give students an overview of the scientific principles underpinning drug stability studies as used in the Pharma industry.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Assess the theory and application of methods for the analysis of pharmaceutical products, and the role of kinetics and the mechanism/pathway of degradation on formulation stability.
LO2 Evaluate the importance and requirements of FDA/EU regulation and compliance requirements for the analysis of related substances and for the validation of analytical methods.
LO3 Apply and evaluate analytical methods to assess the stability of pharmaceutical formulations and techniques to artificially accelerate the aging and degradation of pharmaceutical products.
Dependencies
Module Recommendations

This is prior learning (or a practical skill) that is recommended before enrolment in this module.
No recommendations listed
Co-requisite Modules
No Co-requisite modules listed
Additional Requisite Information
No Co Requisites listed
 
Indicative Content
Indicative content
1. Stability indicating methods (SIM): Hydrolysis, Oxidation, Photolysis and Photo stability studies, Realistic and focussed product degradation ,Stress testing and representative sampling, Over and under stressing, Thresholds for drug degradation as percentage of total daily intake (TDI), Investigation of Out of trend (OOT) and out of Specification (OOS) results, LOD, LOQ 2. Analytical methodologies: LC, GC, Spectroscopy, NIR, Raman Spectroscopy, UV Spectroscopy and Particle size analysis, dissolution testing. Determination of stability indicating methods. 3. Stability types Physical, Microbiological, therapeutic and toxicological, Stages in life cycle from Stage 1 to on-going i.e. clinical trial follow up stability trials. Photo stability studies. Extrapolation of data to indicate stability of product. Pharmaco-kinetics. 4. Container closure systems, packaging and dosage form and their impact of stability and shelf life. Bracketing and matrixing to reduce size of stability studies. SUPAC. Statements for label information and investigation of OOS results encountered during analysis. 5. Stability of Bio molecules
Module Content & Assessment
Assessment Breakdown%
Continuous Assessment10.00%
Practical30.00%
End of Module Formal Examination60.00%

Assessments

Full Time

Continuous Assessment
Assessment Type Examination % of Total Mark 10
Timing n/a Learning Outcomes 1,2
Non-marked No
Assessment Description
Mid semester and end of semester examination.
No Project
Practical
Assessment Type Practical/Skills Evaluation % of Total Mark 30
Timing Every Week Learning Outcomes 1,3
Non-marked No
Assessment Description
Written laboratory reports
End of Module Formal Examination
Assessment Type Formal Exam % of Total Mark 60
Timing End-of-Semester Learning Outcomes 1,2,3
Non-marked No
Assessment Description
End of module written assessment
Reassessment Requirement
Exam Board
It is at the discretion of the Examination Board as to what the qualifying criteria are.
Reassessment Description
At the discretion of the Exam Board

SETU Carlow Campus reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Workload Category Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Practicals Contact No Description 12 Weeks per Stage 3.00 36
Lecture Contact No Description 12 Weeks per Stage 3.00 36
Independent Learning Time Non Contact Self directed learning 12 Weeks per Stage 4.42 53
Total Weekly Contact Hours 6.00
 
Module Resources
Recommended Book Resources
  • Thorsteinn Loftsson. (2014), Drug Stability for Pharmaceutical Scientists, 1. Elsevier, [ISBN: 9780124115484].
  • Min Li. (2012), Organic chemistry of drug degradation., Royal society of chemistry, [ISBN: 978-1-84973-4].
Supplementary Book Resources
  • Jens T. Carstensen,Christopher Rhodes. (2000), Drug Stability, Third Edition, Revised, and Expanded, CRC Press, p.792, [ISBN: 9780824703769].
  • Muhammad Sajid Hamid Akash,Kanwal Rehman. (2020), Drug Stability and Chemical Kinetics, Springer Nature, p.284, [ISBN: 9789811564260].
This module does not have any article/paper resources
This module does not have any other resources
Discussion Note: