| CODE | PHR3307 | |||||||||
| TITLE | Pharmaceutical Formulations | |||||||||
| UM LEVEL | 03 - Years 2, 3, 4 in Modular Undergraduate Course | |||||||||
| MQF LEVEL | Not Applicable | |||||||||
| ECTS CREDITS | 4 | |||||||||
| DEPARTMENT | Pharmacy | |||||||||
| DESCRIPTION | Pharmaceutical Formulations Types of formulations, why different formulations are needed, increase compliance of patients, standards and principles of manufacture Sterilised products Parenteral preparations, different routes of parenteral preparations, tonicity, advantages and disadvantages of parenteral preparations, Vehicles used for parenteral products Water for injection (WFI) Closures and containers – glass, rubber and plastic, advantages and disadvantages Total parenteral nutrition (TPN) Indications for TPN, types of TPN, Components of TPN and their formulations Production process, filling, labeling and storage Calculations for TPN formulations and concentrations Advantages and Disadvantages of TPN Sterilisation processes and methods The concept of sterility Types and methods of sterilization processes – Heat, Steam, Radiation, Gas, Filtration The autoclave, types of autoclaves Tests for sterility, endotoxin and pyrogen testing Clean rooms Controlled release dosage forms Factors influencing sustained release, bioavailability Formulation methods of achieving sustained release Types of sustained release Advantages of sustained release Ophthalmic preparations Importance of sterility, sterilization of ophthalmic preparations Types of ophthalmic preparations, solutions, suspension, ointments, creams, gels Occular inserts Handling and administration of eye drops, eye creams, ointments or gels Characteristics of ophthalmic preparations Relevant calculations Demonstration of hands-on application of principles underlying bulk properties of powders, dry granulation and angle of repose, flow factor, grinding and sieving, microscopical methods and the Andreason pipette method to determine particle size. The regulation of medicinal products. The requirement of a marketing organisation and the roles and responsibilities of the applicant/marketing authorisation holder and the competent authority. Placing a medicinal product on the market in the EU and the basic elements of safety, quality and efficiency. Research and development, the compilation of a dossier and its risk-benefit assessment. Pre- and post marketing issues related to medicines, the objectives of surveillance and the importance of pharmacovigilance. The differences and similarities between new chemical entities, generics and parallel-traded products. Good Practise and the licensing of pharmaceutical activities including clinical trials, labratory practise, manufactoring, importation, wholesale dealing and parallel-trading. The different roles and responsibilities of the Qualified Person in this context. The importance of inspection and enforcement as part of the regulatory process. Basic aspects of the procedures available to place a medicinal product on the market in the European Union including the national, mutual recognition, decentralised and centralised procedures. The Committee for Medicinal Products for Human Use, the European Medicines Agency and their terms of reference. A brief outline of the Rules governing Medicines in the EEC and the principles on which the main directives have developed. The Common Technical Document and the Summary of Product Characteristics – examples of the harmonisation initiative, The need for transposition and the basis of derogation. Study unit aims: o to expose the student to the various aspects which have to be considered when formulating preparations for use as medicines, how these aspects of formulation are influenced by the proposed route of administration, as well as how these same aspects effect the therapeutic profile of the drugs in use. o to expose the student to the hands on application of principles of pharmaceutical formulation. o to consider special features of controlled release dosage forms and factors influencing their formulation. o To provide students with an overview of quality assurance aspects in the manufacture and distribution of medicines. Learning Outcomes: 1. Knowledge & Understanding By the end of this study unit, the student will be able to: o describe characeristics of sterile preparations o ouline various steralisation processes and identify risks and limitations of each process 2. Skills By the end of this study unit, the student will be able to: o list formulation methods adopted for the preparation of slow release formulations o describe requirements for the competitors of Common Technical document o define pharmacovigilance and describe processes required o perform calculations of TPN reconstitutions and administration o follow steps in formulations development for sterile products, TPN and controlled release dosage forms o perform quality assurance aspects in manufacture and distribution of medicines o prepare documentations relevant to application and maintenance of marketing authorisation o elaborate on Rules Governing Medicines in the EEC with respect to clinical trials laboratory practice, transportation, wholesale decision and parallel trading Main texts: o Aulton, M. Pharmaceutics: The Science of Dosage Form Design. 2001. Churchill Livingstone. o Gennaro, A. Remington: The Science and Practice of Pharmacy. 1997. Mack Publishing Company. (18th edition). |
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| ADDITIONAL NOTES | Pre-Requisites PHR1301 and PHR2304. | |||||||||
| STUDY-UNIT TYPE | Lecture and Practical | |||||||||
| METHOD OF ASSESSMENT |
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| LECTURER/S | Lilian Wismayer |
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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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