module specification

This module provides an advanced understanding of drug formulation technologies.

The aim of this module is to provide an in-depth understanding of current and emerging formulation technologies for optimising dosage forms. To identify and critically evaluate the key factors and stages involved in designing formulations.

LO 1 - 6

Pharmaceutical pre-formulation, excipient selection and formulation of conventional and emerging dosage forms including oral (for example, immediate release, controlled release) parenteral (sterile), transdermal/dermal, pulmonary/nasal, ocular delivery, intra-uterine system and biotechnology products.
Age appropriate formulation design and evaluation of the associated key factors.
Implement design and formulation strategies to render insoluble drugs more amenable for formulation.
Statistical design approaches to formulation development – Design of Experiments (DOE).
Physico-chemical stability of formulations including drug-excipient interactions.
Principles of biopharmaceutics (drug absorption, distribution, metabolism and excretion).
In-vitro testing of pharmaceutical dosage forms and in-vivo correlation.
Drug formulation design case studies.

Students will be provided with the opportunity to acquire knowledge of the subject matter through lectures (16 hours), workshops (16 hours), practicals (12 hours) and tutorials (4 hours). The ability to undertake scientific and critical appraisal of data will be encouraged through directed reading and workshop discussions. Students will be expected to reflect upon taught material in order to demonstrate their understanding of the aspects of drug formulation technologies covered in this module.

PDP: on completion of this module students’ will provide an 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 students will be able to:
1. Define and provide a detailed explanation of the role of pre-formulation in formulation design.
2. Critically evaluate strategies for formulation development with reference to specific routes of administration and target patient populations.
3. Research and critically evaluate emerging and cutting edge drug delivery technologies for optimising dosage forms.
4. Discuss in detail the anatomical and physiological factors that affect drug bioavailability.
5. Demonstrate an in-depth understanding of the methodologies for in-vitro testing of pharmaceutical dosage forms and the interrelationship with in-vivo measurements.
6. Define, distinguish, and evaluate the various modes of decomposition of drugs.

The module will be summatively assessed by means of coursework in the form of a practical assessment (1500 word report, based on practicals, 40% of the overall mark) and an unseen examination (2 hours, 60% of the overall mark).

To pass the module students need to achieve a minimum aggregate mark of 50%.

Component                   Learning outcomes
Practicals                      1, 2, 4, 5, 6
Exam                             1, 2, 3, 4, 5, 6

Students will receive oral formative feedback during and following participation in tutorials, practical sessions and workshops. Written summative feedback is provided on both assessment items of the module.

Where the resource is in the library, the classmark is given in bold. The library contains a large number of texts relevant to all aspects of this module. Those given in the list below are a selection.

Books:
Aulton M. and Tayor K. (2017). Pharmaceutics: The Design and manufacture of medicines, 5th edition, Elsevier.
Florence A.T. and Atwood D (2015). Physico-Chemical Principles of Pharmacy, 6th edition, Taylor & Francis.
Gibson G.G. and Skett P. (2001). Introduction to Drug Metabolism, 3rd edition, Nelson Thornes.
Washington N., Washington, C. and Wilson C.G. (2001). Physiological Pharmaceutics: Barriers to Drug Absorption, Taylor Francis.

Review Articles:
Gaurav Tiwari, Ruchi Tiwari, Birendra Sriwastawa, L Bhati, S Pandey, P Pandey, Saurabh K Bannerjee. Drug delivery systems: An updated review. International Journal of Pharmaceutical Investigation, 2012 (2).
Richard Bayford, Tom Rademacher, Ivan Roitt, Scarlet, Xiaoyan Wang. Emerging applications of nanotechnology for diagnosis and therapy of disease: a review. Physiol. Meas. 38 (2017) R183–R203.
Shahrzad Missaghi, Piyush Patel, Thomas P. Farrell, Hiep Huatan, Ali R. Rajabi-Siahboomi. Investigation of Critical Core Formulation and Process Parameters for Osmotic Pump Oral Drug Delivery. AAPS PharmSciTech, Vol. 15, No. 1, 2014.
Dongwei Zhang, Diganta B. Das, Chris D. Rielly. Potential of microneedle-assisted micro-particle delivery by gene guns: a review. Drug Delivery, 21:8, 571-587, 2014.
Asher Mullard. Do you want chips with that? Nature reviews, drug discovery, volume 14, 2015.
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.