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PIAT Modules


MODULE STRUCTURE

and

SUMMARY of CONTENTS

The modules of the PIAT Programme are designed to be used for the study of individual subjects and as an integrated programme which can lead to the award of a University qualification. There is deliberate overlapping of content between some of the modules to ensure that they meet both of these requirements. The emphasis of the presentation is different and complementary and should reinforce the learning process for those studying a programme of modules.

If you require more detailed information please contact the PIAT office.

1. BASIC PRINCIPLES
Author:- D Attwood.

Aims and Objectives:-To ensure that the underlying physicochemical principles on which the development of dosage forms are based, are understood and can be applied.

Module Contents:-

Stability of drugs in solid and liquid dosage forms Properties of drugs in the solid state

Principles of stability testing Stability testing

Interfacial phenomena Solubility of drugs

Rheological properties Partitioning phenomenon

Ionisation of drug in solution

2. PREFORMULATION STUDIES 1 - PHYSICOCHEMICAL ASPECTS
Author:- M E Aulton.

Aims and Objectives:- To provide an understanding of the methods used for the characterisation of drug substances and excipients and the relevance of physicochemical properties in the development of formulations and manufacturing processes.

Module Contents:-

The Need for Preformulation Studies Drug Stability

Drug and Dosage Form Design Microscopy Crystal Morphology and Optics

Solubility and Dissolution Particle Size Analysis

Thermal Properties and Polymorphism Assay Development

Powder Flow and Compression Properties Excipient Compatibility


3. PREFORMULATION STUDIES 2 - BIOPHARMACEUTICAL ASPECTS
Author:- A D'Emanuele and O Cassidy

Aims and Objectives - To provide an understanding of the effects of the formulation and manufacturing processes on the absorption, pharmacokinetics and therapeutic effects of drug substances and to apply this knowledge in product and process development.

Module contents:-

Introduction to Biopharmaceutics Routes of Drug Administration

The Absorption of Drugs Release and Absorption from Dosage Forms

Pharmacokinetics and Data Handling Selection of Dosage Forms

In Vitro Testing Bioequivalence of Products.

DOSAGE FORM MODULES

Aims and Objectives:- Modules dealing with specific dosage forms and the Packaging Module are designed to enhance the ability to develop formulations, processes and presentations which will result in the production of stable, effective and elegant products.

4. SOLID ORAL DOSAGE FORMS
Author:- J Fell

Module Contents:-

Powder Technology Specialised Tablet Systems.

Consolidation of Powders Hard Shell Capsule Manufacture

Granulation Formulations and Filling of Capsules

Compression Studies Soft Shell Capsules

Coating Evaluation of Formulations

Materials Statistical Approaches to Design

Expert Systems

5. LIQUIDS AND SEMI-SOLID DOSAGE FORMS
Author:- K C James.

Module Contents:-

Solutions Colloids and Surface Active Agents

Suspensions and Emulsions Perfumes, Flavours and Colours

Foams, Dry Syrups and Injections SemiSolids

Suppositories Preservation

Product Testing

6. STERILE DOSAGE FORMS
Authors:- N Halls and S Poole

Module Contents:-

Physicochemical Principles of Formulation Aseptic Processing Facilities

Formulation for Specific Routes HEPA Filters

Use of Sterile Products Quality Assurance

Packaging Pyrogens, Endotoxins, the LAL Test

Freeze Drying Sterilisation Processes.

Preservation

7. CONTROLLED RELEASE DOSAGE FORMS
Author:- J H Collett

Module Contents:

Rationale for Controlled Release Dosage Forms Oral Delivery Systems

Factors Affecting the Design of Delivery Systems Transdermals

Properties of Drugs Ocular Systems

Characterisation of Excipients Novel Systems

Routes of Administration and Absorption Mechanisms In Vitro and In Vivo Assessment

Pharmacokinetic Aspects

8. OPERATIONS MANAGEMENT Author:-
J G Kenworthy

Aims and Objectives:-To enable students to formulate and implement strategies for the manufacture, control and supply of medicines to customers.

Module Contents:-

The Manufacturing Control Problem Bills of Materials

Achieving Control of the Business Sales Forecasting

Master Production Scheduling Capacity Planning and Scheduling

Manufacturing Orders and Policies Optimised Production Technology

Lead Times and Safety Stocks Just in Time and Continuous Improvement

Manufacturing Control Systems

9. QUALITY CONTROL AND QUALITY ASSURANCE
Author:- J Sharp

Aims and Objectives:-To increase the level of assurance of product quality by providing a critical appraisal of the basic concepts, practices and management.

Module Contents:-

Basic Principles and Concepts Sampling, Statistical Process Control, Parametric Release

Inter-relationships of QC, QA AND GMP Quality Auditing

GMP - Personnel and Training Quality of Design BS 5750 / ISO 9000

- Documentation Total Quality Management

- Premises and Equipment Regulatory Aspects

- Recovery, Re-work, Complaints and Recall Validation,

- Sterile Products, Contract Work and Packaging QC and GLP

10. PACKAGING
Author:- I H Hall.

Module Contents:-

Packaging Legislation Paper, Adhesives and Printing

Consumer Aspects Sterile Products

Glass Devices

Plastics Storage and Transportation

Metals Testing

Flexible Materials Product Security

Closures

11. REGULATORY AFFAIRS
Author:- F G Farrell

Aims and Objectives:- To enable personnel involved in product development, manufacturing and control processes to understand the requirements of Health Authorities in controlling the development, manufacturing and marketing of medicinal products, and to relate these requirements to their workplace tasks.

Module Contents:-

History of Medicines Regulation

Assessment of Marketing Authorisations - Safety, Quality and Efficacy

Clinical Trials and Marketing of New Drugs - UK, EC, Japan and USA.

Chemistry and Pharmacy Requirements

Marketing Applications for Established Drugs, Bioequivalence and Drug Master Files

GMP, GLP and GCP

Manufacture, Import and Supply - Manufacturers' Licences and Qualified Person Requirements

Regulatory/QA Interface, Compliance, Change Management and Additional Formulations

Future Developments in Regulatory Compliance.

12. PHARMACEUTICAL ENGINEERING
Author:- G Cole

Aims and Objectives:- To enable engineers working in and supplying the pharmaceutical industry to understand and achieve the design, construction, commissioning and operational requirements of the industry. This module will also be useful for other disciplines working with engineers on projects and manufacturing operations.

Module Contents:-

Introduction Facility Design

Project Design and Management - laboratories

Site Selection - solid dosage forms

Process Flow Diagrams and Documentation - pilot plants

Process Utilities - parenteral products

GMP Packaging System Automation

Validation

13. ANALYTICAL DEVELOPMENT
Author:- G Phillips

Aims and Objectives:- To enable personnel involved in product development and quality control to establish drug substance and dosage form specifications and to develop and validate appropriate analytical methods.

Module Contents:-

Description of Drug Substances Dosage Form Specifications

Analytical Control Metabolites

Spectroscopic Characterisation Labelled Species

Chromotographic Assessment Reference Material

Stereochemistry Validation

Physical Form and Polymorphism Sampling

Drug Substance Specifications

14. HEALTH SAFETY AND ENVIRONMENT
Author:- P Smith

Aims and Objectives:- To ensure that all personnel understand the concepts and legislation covering safety, health and environmental issues, and can discharge their responsibilities.

Module Contents:-

Legislation Human Factors

General Safety Management Environment

Hazards and Risks Auditing

Systems Therapeutic Substances

Health at Work Laboratory Safety

15. INHALATION DOSAGE FORMS.
- Glaxo Group Research

Module Contents:-

Formulation of Multi-Dose Inhalations

Lung Morphology, Particle Deposition and Assessment of Activity

Measurement of Sprays

Micronisation

Valves and Pumps

Breath Activated Devices

Manufacturing Processes

Devices

Specifications, QC and Regulatory Aspects

16. PRODUCT DEVELOPMENT PROCEDURES
- Several Authors

Aims and Objectives:- To improve the effectiveness of the overall process by which products are developed for the market to reduce product development lead time and optimise the use of key resources.

Module Contents:-

Introduction Clinical Trials

Compound Selection Analytical Development

Market Research Chemical Process Development

Regulatory Aspects Formulation and CT Supplies

Intellectual Property Package Development

Safety Testing Production Development

Metabolism and Pharmacokinetics Marketing

Clinical Pharmacology Safety, Health and Environment

Project Management Lead Time Reduction

17. STERILISATION OF MEDICAL DEVICES
- Several Authors

Aims and Objectives:- To develop competencies in the design, selection, operation and control of process to sterilise medical devices.

Module Contents:-

Introduction Dry Heat

Sterilisation Kinetics Radiation

Control of Manufacturing Processes Ethylene Oxide

Method Selection Aseptic Processing

Packaging Chemical Sterilisation

Steam


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Principles of stability testing Stability testing

Interfacial phenomena Solubility of drugs

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