Registry

Module Specifications

Current Academic Year 2012 - 2013
Please note that this information is subject to change.

Module Title	Formulation and Regulation
Module Code	CS312
School	School of Chemical Sciences
Online Module Resources
Module Co-ordinator	Semester 1: Kieran Nolan Semester 2: Kieran Nolan Autumn: Kieran Nolan
Module Teacher	Kieran Nolan
NFQ level	8	Credit Rating	5
Pre-requisite	None
Co-requisite	None
Compatibles	None
Incompatibles	None

Description

Part 1.To introduce students to the fundamental physiochemical properties of drug raw materials, additives, surfactants and polymers. To introduce concepts of bioavailability and how this dictates formulation design. An introduction to various formulation types; tablets, capsules, topicals and aerosols. To introduce concepts of dissolution profiling as a performance measurement for a given formulation.Part 2.To introduce students to the world of regulation, especially the areas of quality control, quality assurance and validation. To give an understanding of relevant guidelines and practices in relation to chemistry in industry. (Part 2 is taught conjointly with Regulation in CS306)

Learning Outcomes

1. Understand the full impact of regulation on the modern pharmaceutical industry.
2. Work in professional regulated environments.
3. Value the importance of formulation in the drug development process.
4. Develop basic oral therapeutic dosages.

Workload	Full-time hours per semester
*Type*	*Hours*	*Description*
Lecture	33	No Description
Tutorial	19	No Description
Independent learning time	73	No Description
Total Workload: 125

All module information is indicative and subject to change. For further information,students are advised to refer to the University's Marks and Standards and Programme Specific Regulations at: http://www.dcu.ie/registry/examinations/index.shtml

Indicative Content and Learning Activities

Part 1..
Formulation of Therapeutics..

Part 2..
Quality Control Quality Assurance Method validation Process validation The Food and Drug Administration (FDA) Good Manufacturing Practice (GMP) Good Laboratory Practice (GLP) h) Accreditation".

Assessment Breakdown
Continuous Assessment	100%	Examination Weight	0%

Course Work Breakdown
Type	Description	% of total	Assessment Date
Assignment	The assignment includes the researching of topics in modern formulation	50%	n/a

Reassessment Requirement
Resit arrangements are explained by the following categories; 1 = A resit is available for all components of the module 2 = No resit is available for 100% continuous assessment module 3 = No resit is available for the continuous assessment component
This module is category 2

Indicative Reading List

Other Resources

None

Array

Programme or List of Programmes

BSc in Chemical and Pharmaceutical Sc.

BSSA

Study Abroad (DCU Business School)

BSSAO

Study Abroad (DCU Business School)

ECSA

Study Abroad (Engineering & Computing)