Title_Product Performance and Quality

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Title
Site-Specific Drug Delivery Systems and Pharmaceutical Biotechnology
Code
PY 422
Level
6
Credit rating
10 points
Prerequisites
Stage 3 modules
Type
Extensive
Aims
•
To examine the current state-of-art and future applications of carrier
systems for site-specific delivery of drugs, genetic materials and
diagnostic imaging agents.

To examine and assess the present and future applications of
biotechnology in the pharmaceutical industry.

To develop an understanding of the processes by which genetic
engineering is used for the production of biopharmaceuticals.
Learning outcomes
On completion of this module the student should be able to:
•
discuss current limitations of drug therapy and the need for therapeutic optimisation
through site-specific delivery and targeting.

critically examine the biological barriers associated with site-specific
targeting.

critically discuss current technologies available for site-specific
administration.

outline the basis and problems associated with gene therapy and discuss
strategies for gene-transfer and delivery.

discuss how biotechnology has contributed to the development of
biopharmaceuticals.

explain the process by which biopharmaceuticals may be produced,
isolated and identified using genetic engineering techniques.

discuss the application of genetic engineering techniques in drug
discovery and diagnostics.

discuss the use of cell culture as a pharmaceutical/biological tool.

discuss the application of enzymes and microbial systems in the
pharmaceutical industry.

discuss the use of biosensors for biological monitoring.

discuss the ethical issues associated with the use of biotechnology and
describe how the use of biotechnology is controlled through present
legislation.
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
speculate on the future developments in the field of drug delivery systems
and biotechnology.
Content
This module comprises 39 hours of lectures and will be supported by 39 hours
of guided reading.
Rational for site-specific targeting of drugs and diagnostic agents; biological
opportunities for site-specific delivery and targeting; selectivity in targeting;
carriers for drug delivery and targeting; passive and active targeting (the
reticuloendothelial system, macrophages, endocytosis and phagocytosis,
protein adsorption and opsonization processes); pathophysiological and
immunological issues with regard to targeting via parenteral routes.
Colloidal systems: liposomes as drug carriers; liposome design, type and
morphology; interaction of liposomes with biological milieu; liposome stability;
advanced and smart liposome formulations (eg pH-sensitive, temperaturesensitive, target-sensitive, and light-sensitive vesicles).
Design of long circulating nanoparticles; rational and applications.
Macromolecular systems in site-specific drug delivery.
Targeting of lymphoid tissues with nanoscale carrier systems (spleen and
lymph nodes).
Drug delivery to neonates (routes of delivery, drawbacks, possible solutions).
Pulmonary drug delivery: physiology of human respiratory tract; mechanisms
of particle deposition in lungs; delivery of therapeutics and devices for delivery.
Gene therapy: genetic disorders; identification of therapeutic targets;
strategies for design of gene-transfer systems.
Introduction to biotechnology and biotechnological products including proteins,
peptides, oligonucleotides, antibodies, cells, etc.
Genomics: approaches to genetic engineering using eukaryotic and
prokaryotic systems; gene amplification (PCR), isolation and identification;
identification of therapeutic targets and the development of therapeutic
diagnostic kits; human genome project.
Proteins and peptides as therapeutic agents: production, isolation,
characterisation and purification; challenges of effective patient compliance
and delivery.
Industrial production of biopharmaceuticals: quality control and assessing the
product stability.
Antibody technology: production, isolation and characterisation using standard
techniques and laboratory based genetically engineered systems;
applications: catalytic antibodies, targeting, diagnostics, biological purification
etc.
Cell culture systems: techniques; applications of cell culture for investigating
the physiological basis of disease, assessing biocompatibility etc; application
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of cell culture and genetic engineering for the production of plant products of
pharmaceutical importance.
Future directions: bioregulated delivery of biopharmaceutical under circadian
control, effective gene therapy.
Teaching and
learning strategies
The content of this module will be delivered by way of lectures (39 hrs) and will
be supported by guided reading (39 hrs).
Learning support
Texts
Advanced Drug Delivery Reviews, Elsivier, ISSN 0169-409X
Trends in Biotechnology, Purton, M (Ed), Elsevier, ISBN 0-167-7799
Pharmaceutical Design and Development: A Molecular Biology Approach,
Ramabhadran, T V (Ed), Ellis Horwood, 1994, ISBN 0-13-553884-X
Molecular Biology and Biotechnology, Walker, J M and Rapley, R (Eds), 4th
Ed, Royal Society of Chemistry, 2000, ISBN 0-854-046-062
Assessment
End of module written examination.
Brief description of
module and/or aims
This module is intended to provide an introduction to:

rational for site-specific drug delivery and biological opportunities for
targeting.

role of biotechnology in the development of biopharmaceuticals and its
wider applications across all areas of pharmaceutical sciences.
Area examination boards Pharmaceutical Sciences
Module team/authors
Dr G W Hanlon, Dr S M Moghimi and Dr S L James.
Semester offered
2 (Stage 4)
Timetable slots(s)
Site where delivered
Moulsecoomb
Date of first approval
August 1999
Date of last revision
September 2001
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Date of approval of
this version
May 2002
Version number
3
Replacement for
previous module
PY406
Field for which module is
acceptable and status in
that field
Course(s) for which module
is acceptable and status
in course
MPharm. Compulsory.
BSc (Hons) Pharmaceutical and Chemical Sciences. Optional.
Departmental home
Pharmacy
External examiner
Professor M Aulton
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