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The Science of Medicines

  • Module code: PY5130
  • Year: 2019/0
  • Level: 5
  • Credits: 30
  • Pre-requisites: None
  • Co-requisites: None

Summary

This module is core in the Foundation Degree in Pharmaceutical and Chemical Sciences for students who wish to progress onto the MPharm. It introduces key concepts in the manufacture and use of medicines in pharmaceutics. It provides you with an understanding of the links between fundamental physicochemical properties of drugs, the formulations of dosage forms and the route of delivery of drugs into the body. The making and labelling of extemporaneous preparations are undertaken as relevant to the clinical practice of pharmacy.

Aims

  • To introduce the concept of dosage form design for the administration of drugs to patients
  • To apply physico-chemical principles in the design and formulation of disperse dosage forms (emulsions, suspensions, aerosols) with variation in rheological properties (creams, ointments, pastes)
  • To introduce the theory of formulation of dosage forms with various excipients for the various routes of administration
  • To introduce the concept 'medicinal product', and the extemporaneous preparation of medicines.
  • 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 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 and appropriate choice of excipients (e.g. surface active agents) in the preparation and stability of drug delivery systems for efficacious and safe administration to patients.
  • Describe the critical interaction of a physical system (i.e. formulation or preparation) with the physiological environment, and particularly with biological membranes correlating this to efficacy of a range of examples of pro-drug/drug products
  • Carry out extemporaneous compounding of pharmaceuticals according to formulary or pharmacopeial master formulae, produce suitable labels for the finished products and understand their indications in specific patients. 
  • Conduct practical experimental procedures and generate reports where the outcomes are related to the theory learnt in lectures and workshops

Curriculum content

  • 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, linctus, elixirs, tinctures, inhalational (volatile oils) products, injectables and syrups ii) disperse systems: suspensions, emulsion, foams lotions, colloids/sols and aerosols.
  • The range, manufacture and clinical usage of semi-solid dosage forms such as creams, ointments, pastes, lotions, polymeric gels, pessaries and suppositories
  • 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).
  • Introduction to the different routes of administration (enteral, parenteral and topical) of medicinal products and their advantages and disadvantages.
  • Pre-formulation ie. the physico-chemical characterization of both drug and excipient eg. polymorphism, impurities, solvate, habit, salt form & solubility.
  • Introduction to physico-chemical science as applied to fluid-based medicinal dosage forms:
    • pH-partition theory, solubility and dissolution (Noyes-Whitney),
    • pharmaceutical buffers, ionic strength
    • viscosity, diffusion and osmosis
    • interfacial phenomenon, including adsorption
  • The science of rheology as applied to the production, stability and in vivo behaviour of semi-solid preparations
    • Newtonian and non-Newtonian fluids
    • Viscosity standardization for pharmaceutical preparations
  • The importance of excipients, and possible interaction with the active ingredient, in pharmaceutical preparations, as exemplified by semi-solid preparations:
    • Vehicle, co-solvents and types of water-soluble and lipophilic bases
    • Judicious choice of preservatives to prevent microbial contamination
    • Antioxidants for the control of rancidity and preparation stability
  • The thermodynamic role of emulsifying and wetting agents in the stability of concentrated disperse systems, maintenance of phase equilibria and sol-gel transformation
  • Overview of excipients in liquid pharmaceuticals: solvents/vehicles, aqueous/non-aqueous, suspending agents, viscosity enhancers, effects of macromolecules, tonicity modifiers, hydrotropes, organoleptics, de-flocculants
  • Phase equilibria/diagrams; Raoult's law ideal/non-ideal liquids, miscibility, co-solvents
  • Gases and vapors: therapeutic propellant based aerosols; anesthetic gases; partial pressures
  • The critical relationship between partitioning of drugs across biological membranes and media (eg. skin) with material properties:
    • Physico-chemical factors such as diffusivity, viscosity and surface activity; vehicle-drug interactions, HLB balance and bioadhesion
    • Biological membrane and dermatological factors, routes of drug transport, diffusion gradients, skin condition and disorders.
  • Introduction to pharmaceutical calculations and statistics with examples that are relevant to clinical pharmacy practice.

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 include the assessments to develop written communication and calculation skills. Independent learning ability is developed through directed reading as a supplement to formal teaching. Directed 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

Definitive UNISTATS Category Indicative Description Hours
Scheduled learning and teaching 21 two hours keynote lectures 20 one hour workshops 15 practical sessions of 3 hours each 42 20 45
Guided independent study Student independent study 193
Total (number of credits x 10) 300

Assessment strategy

The module includes feedback sessions at the end of each laboratory practical, which provide an opportunity for students to be formatively assessed (eg. theory and manual dexterity will be discussed based on results achieved in the practical), get feedback and an occasion for staff to give students "feed forward" hints on how to achieve their full potential in exams and assessments. There will also be a feedback session after the in class test (in module assessment) so that students can learn from their performance in the assessment, and gauge how they are performing overall.

Practical work is summatively assessed through a portfolio of practical reports worth 20% of the module. These will be 4 short reports on pharmaceutics and extemporaneous preparation each worth 5%. They will generally be made up of a report form to be filled in with results and calculations, a graph in most cases, and 2 or 3 questions relating findings to theory. In addition to developing students' knowledge and understanding of the practical work, these short reports will also develop students' ability to analyse and present data.

An in module assessment, in the form of an in class test, will be used not only as a summative assessment but also to give students feedback on their progress and performance to date.

The 3 hour 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 5 Foundation Degree students are required to pass a synoptic OSCE style assessment and a synoptic calculations test before they can transfer direct to Level 5 MPharm. This is the same requirement as for Level 4 MPharm students. These assessments are to assure that even at this Level the student is demonstrating the appropriate skills, knowledge, understanding and attributes to become a future pharmacist. Learning in this module, with particular regard to the calculations elements, feeds forward into these synoptic assessments.

Mapping of Learning Outcomes to Assessment Strategy (Indicative)

Learning Outcome Assessment Strategy
1) 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 Formative assessment in workshops. In class test End-of-module examination paper.
2) Link the role and choice of excipients (eg. surface active agents) in the preparation and stability of drug delivery systems for efficacious and safe administration to patients. Formative assessment in workshops. In class test End-of-module examination paper.
3). Describe the interaction of a physical system (ie. formulation or preparation) with the physiological environment, and particularly with biological membranes, correlating to efficacy of a range of examples of pro-drug/drug products. Formative assessment in workshops. In class test End-of-module examination paper.
4) To reinforce and contextualise basic mathematical concepts fundamental to clinical pharmacy calculations Formative assessment in workshops. In module assessment End-of-module examination paper. Also assessed in synoptic calculations test necessary to pass top progress to MPharm
5) Conduct practical experimental procedures and generate reports where the outcomes are related to the theory learnt in lectures and workshops Summative assessment in assessed practicals. Questions in end of module examination paper
6) Carry out extemporaneous compounding of pharmaceuticals according to formulary/pharmacopeial master formulae, produce suitable labels for the finished products and understand their indications in specific patients. Summative assessment in assessed practicals. Questions in end of module examination paper

Elements of Assessment

Description of Assessment Definitive UNISTATS Categories Percentage
Written exam End of module exam 50%
Written exam In class test (In module assessment) 30%
Practical assessment Portfolio of practical assessments (4 x 5%) 20%
Total (to equal 100%) 100%

Achieving a pass

It IS NOT a requirement that any element of assessment is passed separately in order to achieve an overall pass for the module. All students are subject to Fitness to Practice regulations in addition to the University Students Disciplinary procedures. To progress onto level 5 MPharm, students must pass both the module and the end of module exam component of each module.

Bibliography core texts

Aulton's Pharmaceutics: The Design and Manufacture of Medicines. M. E. Aulton, 4th edition, Churchill Livingstone (2013).

Bibliography recommended reading

  • The physicochemical basis of pharmaceutics. H. Moynihan & A. Crean, 1st edition, Oxford University Press (2009).
  • Physicochemical Principles of Pharmacy. A. Florence & D. Attwood, 5th edition, Pharmaceutical Press (2011).
  • Introduction to Pharmaceutical Calculations, Judith A Rees, Ian Smith and Brian Smith. 2nd Edition. Pharmaceutical Press (2005).ISBN 0853696039
  • MCQs in Pharmaceutical Calculations. Ryan F Donnelly, Johanne Barry 1st edition, Pharmaceutical Press (2009) ISBN 9780853698364

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