CY6011 - Formulation and Quality Assurance of Medicines (2021/22)
|Module specification||Module approved to run in 2021/22|
|Module title||Formulation and Quality Assurance of Medicines|
|Module level||Honours (06)|
|Credit rating for module||30|
|School||School of Human Sciences|
|Total study hours||300|
|Running in 2021/22||
Description: This module will introduce students to scientific principles underlying the formulation, industrial manufacture and quality assurance of commonly used pharmaceutical formulations. Students will learn a body of technical knowledge and acquire practical skills in the design, manufacture and quality evaluation of various pharmaceutical products.
Prior learning requirements
Drugs: Delivery and Actions (CY5011)
The different stages of drug formulation and development: laboratory to industrial manufacture; regulation of drug use, drug safety and pharmacovigilance. LO1,LO2,LO3,LO4,LO5,LO6
Pharmaceutical formulation and manufacturing procedures of various types of pharmaceutics, the rationale behind their selection, composition and testing, with emphasis on quality, safety and efficacy for:
• Solid dosage forms.
• semi-solid dosage forms.
• Non-sterile liquid preparations.
• Sterile liquid preparations. LO2,LO3,LO4
Pharmaceutical formulation development (process development and scale up) which include:
• Quality Assurance (QA).
• Good Manufacturing Practice (GMP).
• Introduction to pharmaceutical regulatory agencies (European Medicines Agency (EMA); Medicines and Healthcare products Regulatory Agency (MHRA) and Food and Drug Administration (FDA)).
• Standard operating procedures (SOPs).
• Pharmacopoeia standards for drug substances and drug products.
• Good Manufacturing Practice (cGMP).
• Quality control of selected pharmaceutical formulations (solutions, suspensions, emulsions, powders, granules and tablets). LO1,LO2,LO3,LO4,LO5,LO6
Contemporary pharmaceutical formulation and manufacture of nanoparticles, microcapsules, liposomes, insoluble plastic matrices, soluble and bioerodable polymers. LO4,LO5
Concepts and design of drug packaging. LO3,LO6
Balance of independent study and scheduled teaching activity
Students will be provided with a range of activities to accommodate different learning styles. The module delivery will consist of lectures (39 hours), workshops (6 hours), practicals (32 hours) and tutorials (20 hours).
Lecture and tutorial sessions will include ‘punctuated lectures’ and ‘minute papers’ thus providing opportunities for ‘active engagement’ and to reflect on what has or has not been understood during the sessions. In-class verbal feedback will be provided and students encouraged and directed towards relevant subject matter material. The tutorial sessions will include numerical problems with emphasis on the principles to solve problems of various types as well descriptive/discussion elements. Students will be expected to prepare in advance for these sessions (59 hours – directed).
Workshops will discuss case studies of typical formulations, with emphasis placed on interpretation of information and problem solving. Students will be expected to reflect on the learning experience and develop their own understanding of the topics covered in a study group environment (6 hours – directed).
Practical sessions will stress the importance of organisational proficiency by group working and will augment practical skills to produce reliable experimental data. Students will be expected to interpret the experimental data within context. These sessions will be summative assessed via four written exams (32 hours – directed).
To develop and enhance student engagement a series of progress tests (quizzes) will be provided with a mixture of both formative and summative assessments. Quizzes designed for formative assessment will be provided with ‘instantaneous’ feedback and the time constrained summative assessments will only be available once the formative elements have been completed. Background links and literature linked to quizzes will be provided via Weblearn (resource centre) and the students will be expected to utilise this when completing the on-line (formative) quizzes (20 hours – directed).
PDP: on completion of this module students provide an on-line evaluation of how the module allowed them to develop skills such as information technology, organisational skills, team building, communication, time management and working under pressure.
On successful completion of this module, a student will be able to:
1. Describe and critically analyse the different stages of drug development.
2. Explain the strategies behind the preparation and usage of solid, semisolid and liquid dosage forms.
3. Attain a critical overview of the compliance behind method development of medicines regarding impurities, excipients, manufacturing procedures and packaging.
4. Design basic formulations, specifying the materials used and their roles.
5. Critically discuss issues related to the design, manufacture and performance of drug formulations by stablishing relationships between formulation, drug delivery and therapeutic effectiveness.
6. Critically appraise the importance of Pharmacopoeia monographs, Standard Operating Procedures (SOP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) guidelines.
The module will be summative assessed in the following order: first semester, four unseen written exams (12.5% per exam); second semester, one coursework report (50%).
All unseen written exams will examine the specific material covered during that particular part of the semester (e.g. exam 1 will cover material between TW 1 – 3, exam 2 will cover material between TW 4 – 5, exam 3 will cover material between TW 4 – 7 and exam 4 will cover material between TW 8 – 12). The exams will be comprised of SAQs last 30 minutes.
A coursework report exercise (50%) will summative assess the student ability to interpret and manipulate industrial pharmaceutical formulation control and development. This will be preceded by exercises designed to provide formative feedback.
To pass the module, students need to achieve a minimum aggregate mark of 40%. There will be an attendance requirement for the practical sessions. If the module is passed on reassessment, then the maximum mark awarded will be 40%.
Core Texts: Aulton, M. E. (2013). Aulton's Pharmaceutics: The Design and Manufacture of Medicines, 4th Edition. London: Churchill Livingston.
Other texts: Ansel, H. C., Popovich, N. G. and Allen, L. V. (2005) Pharmaceutical Dosage Forms and Drug Delivery System, 8th Edition. Lippincott Williams and Wilkins.
Florence, A. T. and Attwood, D. (2006) Physicochemical principles of pharmacy, Pharmaceutical Press.
Karsa D. R. and Stephenson, R. (2002) Excipients and Delivery Systems for Pharmaceutical Formulations Royal Society of Chemistry.
Nally J. D. (2007) Good Manufacturing Practices for Pharmaceuticals. Informa Healthcare.
McVay, D. Wylie (2016). Pharmaceutical Process Design and Management. Gower Publishing.
Online resources: http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/ (GMP).
http://www.pharmacopoeia.co.uk (British Pharmacopoeia).
http://www.edqm.eu (European Directorate for the quality of Medicine and Healthcare (EDQM)).
http://www.ema.europa.eu (The European Medicines Agency (EMA)).
http://www.mhra.gov.uk (Medicines and Healthcare products Regulatory Agency (MHRA)).
www.pubmed.com (data base).