module specification

This module provides an advanced understanding of drug formulation technologies.

No pre-requisite module is required

 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

• 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’ 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 practical assessment (1500 word report, based on all 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

Books:
Aulton M. E. ed (2007). Pharmaceutics: The Science of Dosage Form Design, 3rd edition, Churchill Livingston.
Florence A.T. and Atwood D (2006).  Physico-Chemical Principles of Pharmacy, 4th 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:
Crowley P and Martini L.G. (2001). Drug-excipient interactions. Pharmaceutical Technology. March: 26-31.
Fiese E.F. (2003). General Pharmaceutics - The new physical pharmacy. Journal of Pharmaceutical Sciences, 92 (7): 1331-1342.
Gabrielle P and Amighi K. (2010).  Formulation strategy and use of excipients in pulmonary drug delivery.  International Journal of Pharmaceutics, 392 (1-2): 1-19.
Godin B and Touitou E. (2007).  Transdermal skin delivery: Predictions for humans from in vivo, ex vivo and animal models. Advanced Drug Delivery Reviews, 59, (11): 1152-1161
Rakhmanina N.Y. and van den Anker J.N. (2006). Pharmacological research in paediatrics: From neonates to adolescents.  Advanced Drug Delivery Reviews, 58, (1): 4-14.