PHA-20038 - Topical Formulation Development
Coordinator: Gary Moss Tel: +44 1782 7 34776
Lecture Time: See Timetable...
Level: Level 5
Credits: 15
Study Hours: 150
School Office:

Programme/Approved Electives for 2026/27

None

Available as a Free Standing Elective

No

Co-requisites

None

Prerequisites

None

Barred Combinations

None

Description for 2026/27

The module focuses on the unique nature of topical formulation design for pharmaceutical applications (in this context we are defining "topical" as relating to the skin). In many cases, efficacy of topical formulations can depend on many factors that do not necessarily affect other dosage forms to the same degree. Specifically, the patient perception of the product has been shown to significantly impact upon adherence and subsequent efficacy, impacting on outcomes. Consequently, an understanding of the formulation, development and testing of pharmaceutical products applied to the skin is slightly different to other pharmaceutical dosage forms. An example of this is the role of sensory evaluation and product in-use characterisation in understanding and optimising the application of products, thereby improving outcomes.
In this module you will develop an understanding, and gain key experience, of the development of topical pharmaceutical formulations applied to the skin. You will consider the endpoints of efficacy and safety of product , as well as the sensory evaluation of the proposed products in order to understand the role product design has in improving the adherence of topically applied products. You will consider this in terms of skin permeation in both intact and damaged skin (e.g. transdermal and topical drug delivery), the sciences that underpin formulation of pharmaceutical products for application to the skin and the safety and sensory testing of such products.
The underpinning aims of this module are to understand the needs of topical (skin) formulation design and how you will consider using appropriate data and statistical analysis to optimise all relevant endpoints, including efficacy and safety but also how product performance during use impacts on adherence and outcomes.

Aims
The module aims to focus on elements of topical (skin) formulation design that are often not considered when formulating dosage forms administered via different routes. This includes a detailed understanding of the science underpinning the design of topical (skin) dosage forms and how to use knowledge and information from related product types and sectors to develop and evaluate effective topical medicines.

Intended Learning Outcomes

demonstrate knowledge of patient need which underpins the use of topical formulations applied to the skin: 2
explain the underpinning theories in physical chemistry and materials science which underpin formulation development for products applied to the skin: 2
evaluate and select processes and formulations appropriate to the manufacture of topical (skin) dosage forms.: 1
explain how product evaluation, notably drug delivery and sensory evaluation of topical products, affects formulation design considerations including patient acceptability and product safety and efficacy: 1
demonstrate competence in calculations related to the design and evaluation of topical (skin) pharmaceutical formulations, including the application of appropriate methods of statistical analysis: 1
apply knowledge of appropriate safety considerations to the safe and effective development of laboratory skills in topical formulation development: 2

Study hours

Lecture-based teaching sessions: 40 hours
- skin permeation 4 hours
- topical and transdermal design of pharmaceutical products applied to the skin 4 hours
- rheology of topical products 2 hours
- interfacial phenomena and interactive forces in the development and formulation of emulsion products, ointments, gels and other novel topical formulations 20 hours
- sensory evaluation of topical (skin) pharmaceutical products 10 hours
Tutorials, including laboratory-based sessions, to support the assessments 10 hours, with no more than 6 hours based in the laboratory.
For independent study, 40 hours will be based on directed reading and 50 hours on independent reading. A further 10 hours is suggested for assessment preparation.

School Rules

None

Description of Module Assessment

1: Laboratory Book weighted 60%
Sensory evaluation of a pharmaceutical product
This assessment will focus on the role of sensory evaluation in pharmaceutical product development (for products intended for application to the skin). Students will be provided with data on the sensory testing of a novel pharmaceutical product, along with benchmark or reference data as appropriate. Students will be expected to statistically analyse this data and use the outcomes of that analysis to make a series of recommendations for the subsequent development of a novel formulation. A report of 1,000 words should include the key elements in this process, e.g. statistical analysis and interpretation of results, presentation of results using suitable visual models and recommendation of changes required to formulations in order to improve patient adherence.

2: Report weighted 40%
Interpretation of skin permeability data
Data on skin permeation of a topically applied drug will be provided to the students. This data will be analysed and drug release and potential safety considerations will be reported. 500 word report