Title
Medicine Design and Analysis for PCS
Code
CH241, CH242
Level
5
Credit rating
40 credits
Pre-requisites
Introduction to Chemical and Molecular Sciences. Fundamental
Chemical and Molecular Sciences. Either: Principles of
Pharmaceutical Analysis or Introduction to Analytical Chemistry.
Type
Compulsory
Aims
This integrated module covers the unit processes involved in
producing a medicine from raw materials, the physical pharmacy
underpinning this and the analytical processes used to assure quality
of the final product. The aims are:






Learning outcomes
to examine the sources and properties of raw materials, the
techniques and problems associated with their modification,
handling, processing and modification.
to provide an understanding of the physicochemical principles
underlying the characterisation and behaviour of medicinal
materials.
to provide an overview of primary processing procedures
required for, and the principles involved in, the
preparation/manufacture of pharmaceutical products.
to extend the understanding and application of analytical
instruments in qualifying and quantifying pharmaceutical raw
materials and products.
to provide an appreciation of the range of analytical techniques
and performance control procedures applicable to medicinal
substances and products.
to provide a practical appreciation of pharmaceutical
characterisation and analysis.
On completion of this module the student should be able to:







understand how the physical and chemical properties of
pharmaceutical materials relate to the properties and analysis of
medicinal products.
carry out laboratory measurements of physico-chemical
properties of pharmaceutical materials.
apply calculations relevant to the production, performance and
analysis of medicinal products.
understand and critically assess techniques associated with the safe
handling of materials in the manufacture of medicinal products.
understand and critically assess the rationale and implications of
product packaging and presentation.
show a thorough knowledge of the application of unit processes
to the production of dosage forms.
predict fitness for purpose of a variety of analytical techniques based
on the precision normally associated with the relevant technique.




Content
carry out a range of specialised instrumental analytical
methodologies and appreciate their constraints.
understand and critically select the most appropriate analytical
or characterisation technique for the quality assessment of
medicinal substances, products and by-products.
understand the interconnectivity between production processes
and analytical strategies.
accept responsibility for determining and achieving personal and
group outcomes.
The content of this module can be viewed as falling into three themes.
The properties of pharmaceutical materials and the underlying
basis for the assessment of their properties (normally 35 hours)
Illustration of the diversity, properties and application of
pharmaceutical molecules. Actives, excipients and contaminants.
Energetics: a review of the concepts of internal energy, enthalpy,
entropy and free energy and relations between them; free energy and
equilibria.
Kinetics: review of reaction orders and treatment for zero, first,
pseudo-first and second order reactions, effect of temperature, effect
of solvents and ions on rates, specific acid and base catalysis, enzyme
kinetics, competitive and non-competitive inhibition,; a brief
consideration of multiple processes.
Solids, liquids, gases and liquid crystals; crystal habits, polymorphs
and solvates.
Phase equilibria: phase rule, one and two component phase
diagrams, condensed phases and diagrams for solid/liquid and
liquid/liquid systems, eutectics and solid solutions, introduction to
three component systems; coacervation.
Solution properties: solubilities; Raoult's law and deviations,
application of Raoult's law to the formulation and production of
topical and inhaled aerosols; distillation of mixtures, azeotropes,
steam distillation; colligative properties.
Interfacial phenomena: adsorption at solid/liquid interfaces,
isotherms, factors affecting adsorption, interfacial tension and free
energy, adsorption at liquid interfaces, effect of surfactants on
interfacial tension, characteristics of surfactants, micellisation,
measurement of CMCs, micellar solubilisation, surface and
interfacial films. Emulsions and their stability, emulsifying agents,
HLB theory; electrical properties of interfaces, double layer, Nernst
and zeta potentials. Colloids. Suspensions and their stability. Effect
of formulation variables on the flow properties of emulsions and
suspensions.
Diffusion: Fick's law, application to dissolution and transport
across membranes.
An introduction to polymer science: types of polymers encountered
in pharmacy and their physicochemical properties.
Unit processes involved in medicines production (normally 34 hours)
COSHH and risk assessment; operator safety for noise, light, dust
and other hazards; hazard identification in processing. Material
transfer techniques; vacuum lift and pneumatic powder handling.
An introduction to the techniques and problems associated with
handling, processing and modification of the properties of raw
materials in order to improve the performance and clinical efficacy of
formulated drug compounds.
The principles of comminution for pharmaceutical materials.
The principles of heat transfer into liquid, solid and powdered
substances.
Drying pharmaceutical materials such as natural products and tablet
granules. The limitations and problems associated with the use of
convective drying in ovens, fluidised bed driers and the use of
radiation drying by infrared and microwaves, lyophilisation.
Mixing of solid, semisolid and liquid pharmaceutical formulations.
An assessment of the factors which affect each of these processes
with particular reference to finished products.
Filtration as a pharmaceutical process: a consideration of the factors
which affect this process and the problems which may arise with
particular reference to the production of pharmaceutical products.
The specific formulation requirements for tablets with particular
reference to granulation, compression, coating and testing.
Tabletting: the preparation and assessment of a batch of tablets
prepared in the class 10000 cleanroom working under GMP
conditions and completion of appropriate quality assurance
procedures and documentation.
Packaging: The properties and characteristics of materials used for
the primary packages and closures for pharmaceutical products.
Analytical methodologies for the quality assessment of medicines
(normally 35 hours)
The calculation of fitness for purpose relating the stated precision of
analytical techniques to compendial product specifications.
Calibration methods, standard additions, internal standards.
The characterisation of small particles including the determination of
size and surface area. An assessment of the methods and statistical
analytical techniques used to assess these parameters.
The measurement of the flow properties of powders. The effects of
variables which affect the flow (such as particle size, shape, cohesion,
moisture content, etc) in relation to the characterisation of
pharmaceutical systems (eg tablet granules, pharmaceutical
powders, capsule slugs).
The principles, practice and limitations of disintegration and
dissolution testing of various dosage forms.
Atomic absorption and flame photometry.
Principles, practice and limitations of chromatographic methods:
TLC, HPLC, GLC, size exclusion, ion exchange, affinity, capillary
electrophoresis and electrophoresis. Optimisation and system
suitability checks.
Radioanalytical techniques. radiochemical analysis, principles,
practice and limitations of competitive analysis procedures.
Elementary treatment and limitations of the following qualitative
methods: IR, NMR and MS in structural analysis.
Comparison of analytical techniques, selection of appropriate
methodologies for raw materials, medicinal products and impurities.
Validation of methods.
Teaching and learning
strategies
Normally 52 hours of lectures and 52 hours of laboratory-based
coursework supported by 176 hours of guided study and 120 hours
of independent study and assessment.
Learning support
Texts
Physicochemical Principles of Pharmacy, Florence A T and Attwood
D, 3rd Ed, Macmillan Press, 1998
Pharmaceutics: The Science of Dosage Form Design, Aulton, M E,
2nd Ed, Churchill Livingstone, 2002
Pharmaceutical Preformulation: The Physiochemical Properties of
Drug Substances, Wells, J I, 2nd Ed, Taylor & Francis, 1999
Pharmaceutical Dosage Forms and Drug Delivery Systems, Ansel, H
C and Allen, L V, 7th Ed, Williams and Wilkins, 1999
Pharmaceutical Analysis, Watson, D G, Churchill Livingston, 1999
Physical Pharmacy, 4th Ed, Martin, A, Lea & Febiger, 1993
Practical Pharmaceutical Chemistry Vol 1, Beckett, A H and Stenlake,
J B, 4th Ed, Athlone Press, 1988
Practical Pharmaceutical Chemistry Vol 2, Beckett, A H and Stenlake,
J B, 4th Ed, Athlone Press, 1988
Principles of Instrumental Analysis, Skoog, D A and Leary, J K, 5th
Ed, Saunders College, 1998
Chemistry for Pharmacy and the Life Sciences, Thomas, G, Prentice
Hall, 1996
The Theory and Practice of Industrial Pharmacy, 3rd Ed, Lachman, L,
Lieberman, H A and Kanig, J L, Lea & Febiger, 1986
Bentley’s Textbook of Pharmaceutics, 8th Ed, Rawlins, E A, Baillière
Tindall, 1977
Particle Size Measurement, 5th Ed, Allen, T, Chapman & Hall, 1996
Powder Surface Area and Porosity, 3rd Ed, Lowell, S and Shields, J E,
Chapman & Hall, 1991
Enlargement and Compaction of Particulate Solids, Stanley-Wood, N
G, Butterworth, 1983
CAL package
Elementary Radioactivity v 1.0, Kennedy, C and Drury, A, C-Cubed, 1995
Copies of laboratory based practical schedules.
Assessment
This unit of study will be assessed by means of:
PY241 Coursework (20 credits): manipulative laboratory and
interpretative exercises.
PY242 Examination (20 credits): 1 hour Semester 1 phase test and a 2
hour end of module examination containing 20 MCQ and 2 essays.
Brief description of module
This integrated module covers the unit processes involved in
producing a packaged medicine from raw materials, the physical
pharmacy underpinning this and the analytical processes used to
assure quality of the final product.
Area Examination Board
MPharm Pharmaceutical Sciences
Module authors
Drs A C Hunter, R W Daisley, G W J Olivier, K J Rutt, D K Sarkar, M
J Ingram M H Sosabowski, Mrs J Langford
Semester offered
1&2
Date of first approval
January 2003
Date of approval of this
version
October/November 2005
Version number
1
Replacement for previous
module
PY231/PY232, PY241, PY242
Course(s) for which module
is acceptable and status in
course
Compulsory for Pharmaceutical and Chemical Sciences
School home
School of Pharmacy and Biomolecular Sciences
External examiner
Dr S Murdan