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• Undergraduate study:
• Courses
• Order a prospectus
• How to apply
• Information for applicants
• Why choose Kingston University
• Disability and mental health support
• Accommodation
• Undergraduate fees
• Fees, funding and payments
• Access, participation and inclusion

Making Medicines

• Module code: PY4030
• Year: 2018/9
• Level: 4
• Credits: 30
• Pre-requisites: None
• Co-requisites: None

Summary

The module introduces key concepts in the manufacture and use of medicines in pharmaceutics, microbiology and pharmacy practice. It provides you with an understanding of essential concepts and physico-chemical principles and techniques used in the design and production of various pharmaceutical dosage forms with links to the route of delivery into the body. The making and labelling of extemporaneous preparations are undertaken as relevant to the clinical practice of pharmacy. Fundamental concepts relevant to the clinical microbiology of disease-causing organisms, their manipulation, and use in manufacturing are also explored.

Aims

• To introduce the concept of dosage form design for the administration of drugs, including the biopharmaceutical aspects to ensure efficacy and patient compliance.
• To apply physico-chemical principles to the design and formulation of dosage forms, and to recognise the importance of rheological behaviour in characterising pharmaceutical preparations that are of clinical use (eg. extemporaneous preparations).
• To supply an introduction to the microbiology relevant to healthcare and to appreciate the undesirable effects of microbes (eg. spoilage of pharmaceutical preparations, development of bacterial resistance), strategies to prevent such problems and the beneficial aspects and pharmaceutical exploitation of microbes (eg. vaccination).
• To develop extemporaneous dispensing skills and to introduce the theoretical, professional, and practical aspects of dispensing extemporaneous preparations.

Learning outcomes

On successful completion of the module, students will be able to:

• Understand the relevance of physico-chemical principles and pharmaceutical technology techniques in the design, production and performance of dosage forms ranging from fluid to solid for external and internal use in patients according to pharmacopeial standards.
• Link the role of excipients (eg. surface active agents) in the preparation and stability of drug delivery systems for efficacious administration to patients, and show how adverse effects in patients and drug degradation are minimized by appropriate excipient choice.
• Describe the interaction of a physical system (ie. formulation or preparation) with the physiological environment, and particularly with biological membranes, linking this to efficacy of a range of examples of pro-drug/drug products.
• Understand the fundamental aspects of disease-causing microbial/viral organisms that are relevant to healthcare, their manipulation and identification, and the mathematical calculations and statistical test for data analysis and sample size calculations pertinent to clinical pharmacy.
• Conduct experimental procedures involving key aspects of pharmaceutics and basics of microbiology and practice, and generate reports where the outcomes are discussed in the light of the theory learnt in lectures/workshops.
• Carry out extemporaneous compounding of pharmaceuticals and produce suitable labels for the finished products

Curriculum content

• Introduction to pharmaceutical calculations and statistics with examples that are relevant to clinical pharmacy practice.
• Introduction to the different routes of administration (enteral, parenteral and topical) of medicinal products and their advantages and disadvantages.
• Descriptions of liquid dosage forms such as i) solutions, linctuses, elixirs, tinctures, inhalational (volatile oils) products, injectables and syrups ii) disperse systems: suspensions, emulsion, foams lotions, colloids/sols and aerosols.
• Introduction to physico-chemical science as applied to fluid-based medicinal dosage forms: i) pH-partition theory, solubility and dissolution (Noyes-Whitney), ii) pharmaceutical buffers, ionic strength iii) viscosity, diffusion and osmosis.
• The science of rheology as applied to the production, stability and behaviour of preparations: i) Newtonian and non-Newtonian fluids; ii) viscosity standardization for pharmaceutical preparations.
• Phase equilibria/diagrams; Raoult's law ideal/non-ideal liquids, miscibility, co-solvents. Gases and vapours: gas laws; therapeutic propellant based aerosols; anaesthetic gases; partial pressures
• The range, manufacture and clinical usage of semi-solid dosage forms such as creams, ointments, pastes, lotions, polymeric gels, pessaries and suppositories.
• Pre-formulation ie. the physico-chemical characterization of both drug and excipient eg. polymorphism, impurities, solvate, habit, salt form & solubility.
• The range and appropriate clinical usage of solid dosage forms (powders, granules, pellets, soft and hard capsules, tablets, lozenges, sublingual preparations), the processes of standard production methods and their limitations (eg. rotary tablet press, capsule filler, granulators, blenders, coating technology, dryers).
• The use of excipients and their possible interaction with the active ingredient in liquid, semi-solid and solid dosage forms: solvents/vehicles, co-solvents and types of water-soluble and lipophilic bases, suspending agents, viscosity enhancers, effects of macromolecules, tonicity modifiers, hydrotropes, organoleptics, de-flocculants, preservatives to prevent microbial contamination, antioxidants for the control of rancidity and preparation stability.
• Outline of the influences of thermodynamics and kinetics on stability.
• The critical relationship between partitioning of drugs across biological membranes and media with material properties: physico-chemical factors such as diffusivity, viscosity and surface activity; vehicle-drug interactions, HLB balance and bioadhesion.
• Biological membranes: routes of drug transport, diffusion gradients, membranes conditions and disorders.
• Official Standards: the British and European Pharmacopoeias, and information contained therein, the European Pharmacopoeia, compliance with standards to ensure quality. The use of the NPA diluent directory.
• Extemporaneous preparation and labelling of various dosage forms (eg. solutions, cream/ointment, emulsions, suppositories) against a prescription. Equipment and cleanliness of the environment; dilution and compounding techniques.
• Common pathological micro-organisms in disease and classification of microbial organisms. Structure and function of viruses, prokaryotic (bacteria) and eukaryotic (fungal; parasitic) cells.
• Manipulation, identification (staining, selective and differential media), laboratory-growth, and estimation (bio-burden) of microbes
• Pharmaceutical exploitation of bacteria eg. recombinant synthesis of peptides/proteins, isolation of antibacterial lead compounds, enzymatic/colonic degradation of polymer coatings, sterility, in-process and validation tests, vaccine production

Teaching and learning strategy

Lectures provide the essential information in each subject area and guide students in directed reading. Practical sessions include lab-based experiments and Computer­ Aided Learning (CAL) packages which are designed to consolidate students' understanding of the subject. Coursework assignments build in-depth knowledge of specific areas within pharmaceutics and microbiology and include the production of practical reports to develop written communication and calculation skills. Independent learning ability is developed through directed reading as a supplement to formal teaching.  Guided independent study includes consolidation of lecture notes with additional reading, production of experimental reports and preparation for test and the end-of-module examination.

Breakdown of Teaching and Learning Hours

Assessment strategy

The module includes feedback sessions at the end of each laboratory practical, which provide an opportunity for students to be formatively assessed (e.g. theory and manual dexterity will be discussed based on results achieved in the practical) and an occasion for staff to give students "feed forward" hints on how to achieve full potential in the exam. Student learning in practicals is encouraged with a portfolio of MCQs/SBAs mini tests based on the practicals. There are 5 of these mini tests each worth 5% of the overall module mark. Two of the test will take place in TB1 and will assess practical work in the 4 pharmaceutics practicals taking place in TB1. The remaining three will take place in TB2, and will assess work in the 2 pharmaceutics and 4 extemporaneous preparation practicals of TB2. The results of the mini tests will be fed back and these will give students, not only feedback on how to improve but feedback on how they are achieving.

An essay will be set on a topic in microbiology. As well as permitting students to demonstrate their knowledge and understanding of the topic, it will require them to use their literature searching skills and introduce them to the need for critical evaluation at the beginning of their course. In addition, it will introduce them to the principles of scientific writing and the need for developing good written communication skills.

The end of module exam will assess the students' knowledge and understanding of the module content and will be a combination of MCQ/SBA, short answer and Long answer questions.

Level 4 MPharm students are required to pass a synoptic OSCE style assessment and a synoptic calculations test before they can progress to Level 5. These are to assure that even at this Level the student is demonstrating the appropriate skills, knowledge, understanding and attributes to become a future pharmacist. Some of the learning in this module feeds forward into these synoptic assessments.

Mapping of Learning Outcomes to Assessment Strategy (Indicative)

Elements of Assessment

Achieving a pass

It is a requirement that the elements of assessment are passed separately in order to achieve an overall pass for the module.

Bibliography core texts

Aulton's Pharmaceutics: The Design and Manufacture of Medicines. M. E. Aulton, 3^rd edition, Churchill Livingstone (2007).

Brock's Biology of Microorganisms. M. Madigan, J. Martinko, D. Stahl & D. Clark, 13^th edition, Pearson Education (2011).

Bibliography recommended reading

Hugo and Russell's Pharmaceutical Microbiology.  S. P. Denyer, N. Hodges, S. P. Gorman & B. F. Gilmore (eds.), 8^th edition, Wiley-Blackwell (2011).

The physicochemical basis of pharmaceutics. H. Moynihan & A. Crean, 1^st edition, Oxford University Press (2009).

Physicochemical Principles of Pharmacy. A. Florence & D. Attwood, 5^th edition, Pharmaceutical Press (2011).