| CODE | PHR4308 | ||||||||||||
| TITLE | Pharmaceutics 4 | ||||||||||||
| UM LEVEL | 04 - Years 4, 5 in Modular UG or PG Cert Course | ||||||||||||
| MQF LEVEL | 6 | ||||||||||||
| ECTS CREDITS | 6 | ||||||||||||
| DEPARTMENT | Pharmacy | ||||||||||||
| DESCRIPTION | - Dosage Form Design: Drug Absorption, Disintegration, Dissolution, Bioavailability and Bioequivalence. - Solid Oral Modified-Release Dosage forms and Drug Delivery Systems: Rationale for controlled-release pharmaceuticals, Terminology, Dosage forms, Delayed-Release oral dosage forms, Pharmacopoeia requirements and FDA guidance, packaging and storing. - Transdermal Drug Delivery Systems: Factors affecting percutaneous absorption, percutaneous absorption enhancers and models, design features, advantages and disadvantages, specific examples to explore the various available systems. - Radiopharmaceuticals: Background information, Diagnostic imaging, therapeutic use, radiopharmaceuticals, PET, antidote for radiation exposure, non-radioactive pharmaceutical use in nuclear medicine, regulatory process. - Biotechnology products: Techniques, Various products including biologics, clotting factors to vaccines, FDA guidance. - Novel Dosage forms and Drug Delivery Technologies: Composition, topical, oral and vaginal administration, ophthalmic, oropharynx, otic, parenteral administration, pegylated dosage forms, fusion protein and handling, implants, nanotechnology, liposomes, 3D printing. - Preparation and handling of cytotoxic drugs: Drugs for safe handling. - The quality principles on which the marketing of medicinal products is based in the EU. The fundamental basis and the wider implications of Good Practice in licensed pharmaceutical facilities and how it may be addressed in practice. - The discipline of Pharmaceutical Regulation. A regulatory guide to GMP, GDP, GLP and GCP. The aims of regulatory legislation and the functions of regulatory bodies, inspection and enforcement in the EU and USA. Achieving regulatory objectives and the relationship with regulatory bodies. - The essentials of Good Practice and the basic elements of GMP and GDP: legal requirements and issues, quality management and day-to-day applications. - Pharmacovigilance and patient safety. - The roles and responsibilities of the Qualified Person and the Responsible Person in the manufacture, whole sale dealing and post-marketing surveillance of medicinal products. - Laboratory Practicals. Study unit aims: - To expose students to particular requirements in the safe and effective manufacturing, distribution and handling of medicinal products and medical devices in speciality areas. Learning Outcomes: 1. Knowledge & Understanding By the end of this study unit, the student will be able to: - describe characteristics of solid oral modified release dosage forms and of trans-dermal drug delivery systems; - outline use of radiopharmaceuticals; - present techniques required in the handling of cytotoxic drugs; - review anti-infective drugs used in speciality and life threatening areas; - list roles and responsibilities of the Qualified Person and the Responsible Person. 2. Skills By the end of this study unit, the student will be able to: - describe implications of formulation characteristics of medicinal products on bioavailability of drugs; - examine design features for transdermal drug delivery systems; - manage the regulatory process of radio pharmaceutical products; - follow safe practice in handling cytotoxic drugs; - participate in regulatory processes for medicinal products and medical devices. Main texts: - Allen L. Ansel鈥檚 Pharmaceutical Dosage Forms and Drug Delivery Systems.11th ed. Williams & Wilkins. 2018. Supplementary Readings: - Sweetman SC. Martindale: The Complete Drug Reference. 39th ed. London: Pharmaceutical Press. 2017. - Crommelin DJA, Sindelar RD, Meibohm B. Pharmaceutical biotechnology: Fundamentals and Applications. 5th ed. New York: Springer International Publishing. 2019. - Sinko PJ. Martin's physical pharmacy and pharmaceutical sciences. 6th ed. USA: Lippincott Williams and Wilkins. 2011. - Jackson M, Lowey A. Handbook of extemporaneous preparation. London: Pharmaceutical Press. 2010. - Templar Smith B. Nuclear pharmacy. London: Pharmaceutical Press. 2010. - Theobald A. Sampson鈥檚 textbook of radiopharmacy. London: Pharmaceutical Press. 2010. - Medicines and Healthcare products Regulatory Agency. Rules and Guidance for Pharmaceutical Manufacturers and Distributors. London: Pharmaceutical Press. 2007. - Medicines and Healthcare products Regulatory Agency. Good Pharmacovigilance Practice Guide.. London: Pharmaceutical Press. 2008 - McGraw MJ, George AN, Shearn SP, Hall RL, Haws TF. Principles of Good Clinical Practice. London: Pharmaceutical Press. 2010. |
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| RULES/CONDITIONS | Before TAKING THIS UNIT YOU MUST TAKE PHR3309 | ||||||||||||
| ADDITIONAL NOTES | Please note that a pass in the Practical component is obligatory for an overall pass mark to be awarded. | ||||||||||||
| STUDY-UNIT TYPE | Lecture and Practical | ||||||||||||
| METHOD OF ASSESSMENT |
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| LECTURER/S | Nicolette Sammut Bartolo Lilian Wismayer Marie Claire Zammit |
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The University makes every effort to ensure that the published Courses Plans, Programmes of Study and Study-Unit information are complete and up-to-date at the time of publication. The University reserves the right to make changes in case errors are detected after publication.
The availability of optional units may be subject to timetabling constraints. Units not attracting a sufficient number of registrations may be withdrawn without notice. It should be noted that all the information in the description above applies to study-units available during the academic year 2025/6. It may be subject to change in subsequent years. |
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