Foundation degrees

Course Information

Pharmaceutics

Module summary

Module code: PHAR1005
Level: 5
Credits: 30
School: Engineering and Science
Department: Pharm, Chemical and Envi Sci.
Module Coordinator(s): Vivek Trivedi

Specification

Aims

• To have an understanding of the morphology and biological character of viruses, bacteria and fungi.
• To introduce the control of these organisms, and aseptic working.
• Preservatives and preservative testing.
• To be able to relate the design of a product with the pharmacokinetic parameters of the active agent
• To introduce the concepts of thermodynamic stability and kinetic stability.
• Calculate pharmacokinetic constants from plasma and urine data and interpret the findings
• To appreciate the importance of pre-formulation issues.
• To appreciate the use of colloids and colloid stability in pharmaceutical formulation.
• To gain an appreciation of the factors involved in the production of a formulated product to a specification
• To be able to describe the characteristics and uses of the main dosage forms, such as tablets, capsules, pulmonary aerosols, injectables and transdermal delivery systems.

Learning outcomes

On completing this course successfully you will be able to:

1. Present a broad understanding of preformulation and formulation and the impact of regulatory control on drug development.
2. Present an appreciation of the multidisciplinary nature of pharmaceutical research and development.
3. Apply relevant chemical and physical principles to pharmaceutical product formulation.
4. Demonstrate an understanding of how drugs are handled by the body and apply the fundamental pharmacokinetic principles.
5. Demonstrate problem-solving skills in the areas of pharmaceutical product formulation, quality control & quality assurance.

Indicative content

Physical chemistry of formulation: Thermodynamic stability and kinetic stability. Solids, liquids, colloids, emulsions, suspensions and semi-solids. Dosage forms: A consideration of the major classes of dosage forms. In each case formulation, production and quality aspects will be studies. Morphology and biological character of viruses, bacteria and fungi. Control of these organisms and aseptic working. Preservatives and preservative testing. Routes of drug administration. Transport mechanisms, Fick's law, partition, permeability. Bioequivalence and bioavailability. Drug distribution, Volume of distribution, compartments. Mathematical modelling of pharmacokinetics. Establishment of pharmacological/toxicological data, through pre-clinical and clinical trials. Sources of valid pharmacological information. Basic Regulatory control from various perspectives: FDA, EMEA, MHRA, ICH. Basic understanding of API and FDF production equipment (typically: reactor vessels, distillation, production scale chromatography, isolation, drying, liquid/solid handling and measurement, emissions treatment, tableting and packaging).

Teaching and learning activity

Students will be taught using lectures and seminar-workshop sessions. Seminars will be student-based integrating scientific knowledge and communication skills. The main themes of the courses will be supported through an integrated laboratory programme and the use of computer-learning packages.

Learning Time (1 credit = 10 hours)

Scheduled contact hours:

Note: include in scheduled time: project supervision, demonstrations, practical classes and workshops, supervised time in studio or workshop, scheduled lab work , fieldwork, external visits.
lectures 66;
seminars 0;
supervised practical sessions 24;
tutorials 3;
formative assessment 0;
other scheduled time 0;
Guided independent study

Note: include in guided independent study preparation for scheduled sessions, follow up work, wider reading or practice, revision:
Independent coursework 25;
Independent laboratory work 25;
other non-scheduled time 157.
Placements & year abroad:
Work placements 0;
Work based learning 0;
Year abroad 0;
Other placement 0.
Total hours (’Should be equal to credit x 10’) 300

Assessment

Essay - 10%
Literature Review Assignment -“What is DICLOFENAC”

Phase Test - 10%
2x 50min phase tests.

Laboratory Practical - 30%
Grading of lab notebook for GLP plus assessment of selected written lab reports.

Final Exam - 50%
3 hours at the end of the term

Minimum pass mark 40%.