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. ____________________________________________________________________________________ MPharm student handbook 2002-03 102 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 ____________________________________________________________________________________ MPharm student handbook 2002-03 103 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 ____________________________________________________________________________________ MPharm student handbook 2002-03 104 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 ____________________________________________________________________________________ MPharm student handbook 2002-03 105