2016/17 Taught Postgraduate Module Catalogue
CAPE5360M Pharmaceutical Formulation and Analysis
30 creditsClass Size: 30
Module manager: Professor J Blacker
Email: j.blacker@leeds.ac.uk
Taught: Semesters 1 & 2 (Sep to Jun) View Timetable
Year running 2016/17
Module replaces
PEME5365M 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.Pharmaceutical Analytical Techniques- Review of concepts including: quality assurance in the pharmaceutical industry and validation of processes.- Purpose of analytical techniques: quantification of content and determination of physical properties; experiment design and statistical analysis; accuracy and precision; repeatability and reproducibility; standard operating procedures.- Chemical analysis and physical characterisation: elemental analysis, determination of physical properties - melting point, density and refractive index; derivitisation; overview of titrimetric methods - aqueous and non-aqueous methods, complexometric, redox, potentiometric and Karl Fischer titrations.- Mass spectrometry: physical principle, instrumentation, fragmentation mechanisms.- Characterising physical properties: thermal methods, review of phase transitions; instrumentation and techniques (differential scanning calorimetry (DSC) and thermo-gravimetric analysis (TGA)); application to pharmaceutical materials.- Optical and diffraction methods: optical microscopy and hot stage microscopy for the characterisation of crystal habit, particle size distributions and phase transitions; X-ray single crystal and powder diffraction for determination of crystal structure and polymorphic forms; application to pharmaceutical materials.- Spectroscopic methods: introduction to spectroscopy - interaction of electromagnetic radiation and matter, characterisation of electromagnetic radiation (wavelength, wavenumber, frequency, energy), principles of spectroscopic techniques - emission and absorption, schematic set-up of equipment.- Spectroscopic techniques: UVvis, FTIR, Mid-IR, NIR, RAMAN, NMR techniques together with the principles of measurement, spectral interpretation, application in QC and PAT.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 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.
- Understand the unit operations in drug manufacture and be aware of the main criteria for formulation route selection.
- Understand the purpose of analytical techniques as a method of quantifying the quality and properties of product.
- Place the need for chemical analysis within the requirements of the regulatory framework.
- Define the nature of analysis of chemical content and the measurement of physical properties.
- Understand the fundamental chemistry and physics underpinning a range of experimental techniques and be able to identify the type of information various analytical techniques (i.e. spectroscopic, chemical analysis, thermal) contain and be able to interpret the data resulting from these techniques.
Learning outcomes
Provides students with a domain knowledge of:
- Importance and details of chemical and physical analysis associated with 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.
- Pharmaceutical analytical techniques and their need for ensuring product quality.
Teaching methods
| Delivery type | Number | Length hours | Student hours |
| Lecture | 22 | 2.00 | 44.00 |
| Tutorial | 22 | 1.00 | 22.00 |
| Private study hours | 234.00 | ||
| Total Contact hours | 66.00 | ||
| Total hours (100hr per 10 credits) | 300.00 | ||
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 | Assignment | 10.00 |
| Essay | Essay | 10.00 |
| Assignment | Assignment | 10.00 |
| Assignment | Assignment | 10.00 |
| Total percentage (Assessment Coursework) | 40.00 | |
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) | 3 hr | 60.00 |
| Total percentage (Assessment Exams) | 60.00 | |
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: 18/08/2016
Browse Other Catalogues
- Undergraduate module catalogue
- Taught Postgraduate module catalogue
- Undergraduate programme catalogue
- Taught Postgraduate programme catalogue
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