module specification

This module will introduce students to scientific principles underlying the formulation, manufacture and quality control of commonly used pharmaceutical dosage forms. Students will learn a body of technical knowledge and acquire practical skills in the design, manufacture and quality evaluation of various pharmaceutical products.

CH5011

The aims of this module are aligned with the qualification descriptors within the Quality Assurance Agency’s, Framework for Higher Education Qualifications.

The module aims to consolidate and expand on concepts introduced at prerequisite module (CH5011 Drugs:  Delivery and Action) to ensure students have a solid scientific grasp of physico-chemical and biopharmaceutical factors that influence formulation, manufacture and stability of pharmaceuticals. The module will enable students to understand the characteristics and rationalise the design of major pharmaceutical drug dosage forms.  Furthermore, the module will expand the students’ practical skills in pre-formulation studies, physical and chemical testing, bioavailability considerations, excipient selection and production methods to ensure quality, safety and drug efficacy. In addition, the module aims to encourage critical awareness of the pharmacopoeia and regulatory requirements associated with the manufacture of pharmaceuticals.

This module covers:
The stages of drug development: laboratory to clinical trials; regulation of drug use, drug safety and pharmacovigilance. Formulation and Manufacturing procedures of various types of pharmaceutics, the rationale behind their selection, composition and testing with emphasis on quality, safety and efficacy; e.g. Solid dosage forms; Semi-solid dosage forms; Non-sterile liquid preparations; Sterile liquid preparations; and Inhalation products; aerosols, nasal and pulmonary administration
1. Preformulation:
2. Formulation development: Process development and scale up
3. Quality Assurance (QA),  Good Manufacturing Practice (GMP), Quality Control(QC); Introduction to the regulatory agencies in Europe; European Medicines Agency (EMA), in UK; Medicines and Healthcare products Regulatory Agency (MHRA) and in USA; Food and Drug Administration (FDA)  Facilities and personnel management, Standard operating procedures (SOPs) Pharmacopoeia standards for drug substances and drug products, Current Good Manufacturing Practice (cGMP); a risk based approach, Quality by design
4. Quality assessment of selection of dosage forms:
a) Solutions:
b) Suspensions and Emulsions
c) Particulates (Powders and granules):
d) Tablets:
5. Contemporary pharmaceutical formulation and manufacture; nanoparticles; microcapsules; liposomes; insoluble plastic matrices; soluble and bioerodable polymers.
6. Design, manufacture and protective function of drug packaging.

The module is delivered through a range of different mechanisms including practical work, workshops, tutorials, lectures, on-line material and directed course work.

Teaching and learning sessions consist of lectures, tutorials and practicals.  
Lectures (48h) are used to deliver subject material and are linked to tutorials (20h) and practical sessions (6x5h = 30h). Tutorials discuss case studies of typical formulations, with emphasis placed on interpretation of information and problem solving, allowing development of the capabilities.
Students will be expected to reflect on the learning experience and develop their own understanding of the topics covered (60h) in a study group environment. Students also expected to work on the assignments (72h) practical portfolio and product formulation portfolio.

The module is supported by a website on WebLearn which includes a number of electronic learning aids. Students would be expected to use the site for assisted study (70h).

Students’ study responsibilities are articulated in the FLS Staff/Student Agreement which is available via the Faculty Web site.

On successful completion of this module, students are expected to:

1. Describe and critically analyse the stages of drug development
2. Explain the strategies behind the preparation and usage of solid, semisolid and liquid dosage forms
3. Give a critical account of the stability of a drug with regard to the possible influence of factors such as impurities, excipients, production methods and packaging.
4. Design basic formulations and specify the materials used and their relative proportions.
5. Discuss critically issues relating to the design, manufacture and performance of drug dosage forms and the inter-relationship 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.

Assessment will consist of: 100% Coursework; a series of practical work, quizzes through the module and a product development case study based around examples of pharmaceutical formulations.
There will be student centred, journal based quizzes on lecture topics to give formative assessment. There will be 12 quizzes relating to topics discussed this will form part of the formative assessment.

Practical Portfolio (50%)  
The laboratory practical exercises will develop student’s laboratory skills and student’s ability to interpret results in a meaningful way. Students expected to produce satisfactory reports of laboratory experiments and data interpretation with clear records of data. Datasheets (30%) will be submitted in two sets (3 + 3) for 6 practicals (week 15 and 27).
There will be practical related; pre read scientific article based, 6 time-constrained in class tests (20%), this will assess the ability of student’s comprehension of scientific information and to describe accurately the principles of pre-formulation and formulation testing.  This element will provide both summative and formative assessment.

Product Formulation Portfolio (50%)
The product formulation portfolio introduces students to the research process, enabling their novel ideas to be justified and developed using information from existing research publications. This element will provide both summative and formative assessment.
This coursework will have two components; Product evaluation pro-forma (10%); includes evaluation of all the ingredients of selected product for their chemical and physical characteristics, their role in the formula, toxicological and safety profile. It will develop information retrieval and analysis skills. Product formulation report (40%); students will show their ability to critically evaluate the drug development process in relation to the underlying scientific principles by developing a hypothetical pharmaceutical product. Ethical, financial and regulatory implications of product formulation must be considered.

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%.

Ansel, H.C., Popovich, N.G. and Allen, L.V. (2004) Pharmaceutical Dosage Forms and Drug Delivery System, Lippincott Williams and Wilkins
Aulton, M. E. (2007) Aulton's pharmaceutics: the design and manufacture of medicines, Churchill Livingstone
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,

Good Manufacturing Practice (GMP) training http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/
British Pharmacopoeia, annual, http://www.pharmacopoeia.co.uk
European Pharmacopoeia, annual,  http://www.edqm.eu/en/European-Pharmacopoeia-1401.html
European Directorate for the quality of Medicine and Healthcare (EDQM) http://www.edqm.eu
The European Medicines Agency (EMA) http://www.ema.europa.eu
Medicines and Healthcare products Regulatory Agency (MHRA) http://www.mhra.gov.uk