2018/19 Taught Postgraduate Module Catalogue
CAPE5325M Pharmaceutical Formulation
15 creditsClass Size: 30
Module manager: Professor K Roberts
Email: k.j.roberts@leeds.ac.uk
Taught: Semester 2 (Jan to Jun) View Timetable
Year running 2018/19
Module replaces
CAPE5360M Pharmaceutical Formulation and AnalysisThis module is not approved as an Elective
Module summary
The Pharmaceutical Industry- The pharmaceutical industry, the drug discovery and development process including clinical trials and the regulatory issues associated with new drug approval.- Patent definitions, protection and its importance to the pharmaceutical industry.Pharmaceutical Sciences- Drug action, bioavailability and the aqueous/lipid solubility balance, the BCS classification system and a review of routes of drug delivery.- Overview of dosage forms: tablets, capsules, suppositories, aerosols, dry powder inhalers and nasal sprays, parenterals, drops, patches, ointments and creams, long-term deposits together with their relative importance to the pharmaceutical industry.- Core concepts including solubility, dissolution, crystallography, crystallisation, acid base equilibrium, physical and chemical stability.- Solid forms including their selection as polymorphs, hydrates/solvates, salts, co-crystals etc, control of phase transformations between forms.- Drug product formulation and design including dosage form versus API content, use of excipients and their function.Manufacture of Drug Products- Unit operations for pharmaceutical formulation including:- Comminution: influence of particle shape and size on product properties, control of particle size, methods of size reduction; equipment for size reduction.- Blending: purpose of blending, excipients in the manufacture of tablets, quality control in blending, equipment for blending.- Granulation: the purpose of granulation, review of physical basis of granulation, techniques: dry and wet granulation, equipment for granulation.- Drying: review of physical basis of drying and engineering design of drying equipment, equipment for drying.- Compression: tabletting, infuence of the tabletting process on product properties, physical principles of tabletting, the role of excipients in tabletting, mechanical properties of tablets, tabletting equipment.- Coating: methods for coating tablets: film coating, crystallisation coating, product protection and control of drug release, equipment for coating.- Pharmaceutical route selection: wet granulation, dry granulation and direct compression options and their inter-relationship with API dose levels.Objectives
On completion of this module, students should be able to:- Have a good appreciation of the pharmaceutical industry, the drug discovery and development process, regulatory issues and protection of intellectual property.
- Understand the basic principles of drug molecule design and delivery together with displaying a working knowledge of methods for drug delivery.
- Understand the need for different dosage forms and the engineering challenges in manufacturing them.
- Appreciate the fundamental solution, solid-state and surface science underpinning drug development, design and manufacture and be aware of various different dosage forms as well as of cultural differences and preferences for particular dosage forms.
- Have an appreciation on the importance of solid form selection and the advantages and disadvantages of the various options involved and the analytical techniques used to facilitate these processes.
- Understand the role of excipients in drug product design.
- Understand the unit operations in drug manufacture and be aware of the main criteria for formulation route selection.
Learning outcomes
Provides students with a domain knowledge of:
- Importance and details of pharmaceutical materials development.
- Pharmaceutical product R&D processes together with the fundamental science underpinning this.
Syllabus
An overview of:
- The pharmaceutical industry together with drug discovery, development, regulation and protection processes.
- The core pharmaceutical sciences that underpin drug action and product formulation.
- Pharmaceutical formulation practice and route selection together with an overview of the associated unit operations.
Teaching methods
| Delivery type | Number | Length hours | Student hours |
| Lecture | 11 | 2.00 | 22.00 |
| Tutorial | 11 | 1.00 | 11.00 |
| Private study hours | 117.00 | ||
| Total Contact hours | 33.00 | ||
| Total hours (100hr per 10 credits) | 150.00 | ||
Private study
132 hours for reading of lecture materials and material from reading list (3 hours per lecture)72 hours for completing two coursework exercises
30 hours for two basic research work, literature searching and essay preparation and review.
Opportunities for Formative Feedback
Formative feedback during tutorials and through coursework.Methods of assessment
Coursework
| Assessment type | Notes | % of formal assessment |
| Assignment | Tutorial questions | 10.00 |
| Essay | Essay | 20.00 |
| Total percentage (Assessment Coursework) | 30.00 | |
Normally resits will be assessed by the same methodology as the first attempt, unless otherwise stated
Exams
| Exam type | Exam duration | % of formal assessment |
| Standard exam (closed essays, MCQs etc) | 2 hr | 70.00 |
| Total percentage (Assessment Exams) | 70.00 | |
Normally resits will be assessed by the same methodology as the first attempt, unless otherwise stated
Reading list
The reading list is available from the Library websiteLast updated: 30/04/2018
Browse Other Catalogues
- Undergraduate module catalogue
- Taught Postgraduate module catalogue
- Undergraduate programme catalogue
- Taught Postgraduate programme catalogue
Errors, omissions, failed links etc should be notified to the Catalogue Team.PROD