Study-Unit Description

Study-Unit Description


CODE PHR3309

 
TITLE Pharmaceutics 3

 
UM LEVEL 03 - Years 2, 3, 4 in Modular Undergraduate Course

 
MQF LEVEL 6

 
ECTS CREDITS 8

 
DEPARTMENT Pharmacy

 
DESCRIPTION The study-unit will be looking at the principles of sterilisation in pharmaceutics, particularly preparation of parenteral products, ophthalmic preparations, total parenteral nutrition, the use of water for injection, sterility testing and the closures and containers used. Relevant calculations and calculations for TPN formulations and concentrations are presented.

Pharmaceutical aspects of clean rooms requirements for pharmaceutical admixtures and within the pharmaceutical Industry: air quality monitoring, environmental and plant hygiene are discussed.

The requirement of a marketing authorisation and the roles and responsibilities of the applicant/marketing authorisation holder and the competent authority are presented. Procedures required for IMPs, the compilation of a dossier and its risk-benefit assessment are elaborated. Pre- and post-marketing issues related to medicines, the objectives of surveillance and the importance of pharmacovigilance are highlighted.

Good Practice and the licensing of pharmaceutical activities including clinical trials, laboratory practice, manufacturing, importation, wholesale dealing and parallel-trading are presented. The different roles and responsibilities of the Qualified Person in this context and the importance of inspection and enforcement as part of the regulatory process are presented.

Principles in Tablet and Capsule Manufacturing: processes, excipients used, tablet and capsule design, parameters monitored are discussed. Aspects of engineering in the pharmaceutical industry particularly related to the HVAC, water systems, solvents are highlighted.
- Practical sessions in the pharmaceutical industry.
- Practicals in extemporaneous preparation.

Study-Unit Aims:

- To introduce concepts of parenteral and ophthalmic product manufacture;
- To consider aspects of sterility and sterilisation in pharmacy;
- To describe principles in the regulation of medicinal products related to marketing authorisation and post-marketing issues;
- To provide students with an overview of quality assurance aspects in the manufacture and distribution of medicines;
- To gain an appreciation of pharmacist activities within the pharmaceutical industry;
- To give the student an insight and understanding to the many stages involved in tablet and capsule formulation and manufacturing processes in order to produce tablets and capsules of high standard in accordance with the specifications laid down by the European and British Pharmacopoeia.

Learning Outcomes:

1. Knowledge & Understanding
By the end of the study-unit the student will be able to:

- outline the specific requirements of parenteral product manufacture;
- describe characteristics of sterile preparations;
- outline various sterilisation processes and identify risks and limitations of each process;
- understand the various physicochemical changes that occur at each stage of manufacture of tablets and capsules;
- distinguish between the various processes and wide range of equipment used in industry in accordance to the characteristics of the API and the excipients and the physical characteristics of the finished solid oral dosage form;
- recognise aspects of engineering in the pharmaceutical industry processes.

2. Skills
By the end of the study-unit the student will be able to:

- describe requirements for the compilation of the Common Technical document;
- define pharmacovigilance and describe processes required;
- perform calculations of TPN reconstitutions and administration;
- follow steps in formulations development for sterile products, TPN and controlled release dosage forms;
- perform quality assurance aspects in manufacture and distribution of medicines;
- prepare documentations relevant to application and maintenance of marketing authorisation;
- elaborate on Rules Governing Medicines in the EEC with respect to clinical trials laboratory practice, transportation, wholesale decision and parallel trading;
- identify the critical parameters of the various stages within the manufacture of tablets and capsules;
- list the characteristics and properties of the various excipients used and the criteria on which these excipients are selected.

Main Text/s and any supplementary readings:

- Taylor K, Aulton M. Aulton's Pharmaceutics: The design and manufacture of medicines. 6th ed. 2021. Churchill Livingstone.
- Allen LV, Popovich NG, Ansel HC. Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems 2017. Lippincott, Williams & Wilkins.
- Gennaro, A. Remington: The Science and Practice of Pharmacy. 2012. Lippincott, Williams & Wilkins.
- Florence AT, Siepmann J. Modern Pharmaceutics, Fifth Edition, Volume 1: Basic Principles and Systems (Drugs and the Pharmaceutical Sciences). 2009. Informa Healthcare.
- Shrewsbury R. Applied Pharmaceutics in Contemporary Compounding. 2009. Morton Publishing.
Ridgway Watt P, Armstrong A. Tablet and Capsule Machine Instrumentation, London: Pharmaceutical Press. 2007.
- Lieberman HA, Lachman L, Schwartz JB, eds. Pharmaceutical Dosage Forms: Tablets. New York , NY : Marcel Dekker; 1989:1-73.
- Nema S and Ludwig JD (editors). Pharmaceutical Dosage Forms: Parenteral Medications; Boca Raton, CRC Press; 2010.

Supplementary Readings:

- British Pharmacopoeia Commission Secretariat of the Medicines and Healthcare products Regulatory Agency. British Pharmacopoeia 2012. London: The Stationery Office.
- Cad SC (ed). Pharmaceutical Manufacturing Handbook: Production and Processes. New Jersey: Wiley-Interscience. 2008.

 
RULES/CONDITIONS Before TAKING THIS UNIT YOU MUST TAKE PHR2305

 
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
Assessment Component/s Assessment Due Sept. Asst Session Weighting
Practical [See Add. Notes] SEM2 Yes 5%
Examination (2 Hours) SEM2 Yes 95%

 
LECTURER/S Nicolette Sammut Bartolo
Edwina V. Brejza
Maresca Attard Pizzuto

 

 
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The availability of optional units may be subject to timetabling constraints.
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It should be noted that all the information in the description above applies to study-units available during the academic year 2024/5. It may be subject to change in subsequent years.

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