PHRM07009 2013 PHARMACEUTICAL FORMULATION

General Details

Full Title
PHARMACEUTICAL FORMULATION
Transcript Title
PHARMACEUTICAL FORMULATION
Code
PHRM07009
Attendance
N/A %
Subject Area
PHRM - Pharmaceutical Science
Department
ASCI - Applied Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2013 - Full Academic Year 2013-14
End Term
9999 - The End of Time
Author(s)
Tom Patton
Programme Membership
SG_SPHAR_J07 201300 Bachelor of Science in Pharmaceutical Science SG_SPHAD_B07 201800 Bachelor of Science in Pharmaceutical Science
Description

This module aims to provide the student with an understanding of the fundamental activities and processes underpinning the design, manufacture and quality control of the major pharmaceutical dosage forms (formulations).

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Summarise the process and main objectives in designing and developing a formulated drug product.

2.

Illustrate product profiles for a selection of dosage forms on the market including biopharmaceuticals.

3.

Describe the activities which comprise an effective Preformulation programme in the process of Pharmaceutical Development and identify the techniques used for these activities.

4.

Select and justify appropriate excipients for use in various conventional dosage forms.

5.

Outline and Discuss the process activities and quality attributes specific to the manufacture of some major conventional dosage forms.

6.

Identify some relevant compendial tests and specifications for QC of conventional dosage forms.

7.

Relate preformulation activities to dosage form design, development, manufacture and biopharmaceutics to solve formulation problems.

8.

Demonstrate an awareness of current advances in drug delivery and formulation Design.

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

Indicative Syllabus

The objectives of the formulation process and dosage form design and development study. Properties of the types of dosage forms currently utilised and the biological properties of such dosage forms, these include physical and chemical stability (to assure potency, safety, and consistent drug delivery performance over the use-life of the product), the ability to be economically mass produced in a manner that assures the proper amount of drug in each dosage unit and batch produced (to reduce costs and provide reliable dosing), and, to the extent possible, patient acceptability (i.e., reasonable size and shape, taste, colour, etc. to encourage patient compliance with the prescribed dosing regimen). Drug product development is to design a system that maximizes the therapeutic potential of the drug substance and facilitates its access to patients utilising preformulation studies, Finished product formulation, Manufacture and QC of Solid dosage forms, liquid dosage forms, semi-solid dosage forms. Formulation of Proteins; Coating and Controlled release technologies. Advanced technologies - nanotechnology, polymers etc.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
40 %
End of Semester / Year Formal Exam
60 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Assignment Continuous Assessment UNKNOWN 0 % OnGoing 1,2,3,4,5,6,7
2 Case Study on Current advances in Drug Delivery and Formulation Design Continuous Assessment UNKNOWN 40 % OnGoing 8
             

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Written exam. Final Exam UNKNOWN 60 % End of Term 1,3,4,5,6,7,8
             
             

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Flat Classroom Lecture 2 Weekly 2.00
Group Learning Flat Classroom Group Learning 1 Weekly 1.00
Independent Learning UNKNOWN Self Study 4 Weekly 4.00
Total Full Time Average Weekly Learner Contact Time 3.00 Hours

Module Resources

Non ISBN Literary Resources

Aulton‘s Pharmaceutics : the design and manufacture of medicines (4th Ed) Elsevier Health Sciences, 2013. ISBN 0702042900, 9780702042904.

Ghosh, T. and Jasti, B. Theory and practice of contemporary pharmaceutics. (2nd Ed) Taylor & Francis, 2010. ISBN 0415288630, 9780415288637

Gibson M.; Pharmaceutical preformulation and formulation : a practical guide from candidate drug selection to commercial dosage form, (2nd Ed) Informa Healthcare, 2009. ISBN 1420073176, 9781420073171.

Other Resources

None

Additional Information

None