Module Details

Module Code: CHEI7001
Title: Formulation
Long Title: Formulation
NFQ Level: Intermediate
Valid From: Semester 1 - 2016/17 ( September 2016 )
Duration: 1 Semester
Credits: 5
Field of Study: 4422 - Inorganic Chemistry
Module Delivered in: 1 programme(s)
Module Description: The principles and science of pre-formulation including the factors that affect formulation design, dissolution and stability are addressed in this module. Design of stability programme and shelf life determination is also covered.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Apply the principles of pre-formulation, including correct use of excipients to simple mixtures to produce stable formulations.
LO2 Measure key solid state properties of materials and explain their impact on formulation design.
LO3 Describe dissolution apparatus and corresponding analysis techniques and determine drug release.
LO4 Design a stability programme for a drug product and explain the concept of stability profiles.
Dependencies
Module Recommendations

This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named MTU module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
843 CHEO6002 Organic & Inorganic Chemistry
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
No incompatible modules listed
Co-requisite Modules
No Co-requisite modules listed
Requirements

This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.
No requirements listed
 
Indicative Content
Introduction to Preformulation
Principles of formulation. Drug delivery systems. Pharmaceutical dosage forms. Methods of administration and factors influencing choice of dosage forms.
Excipients
Types and purposes of common pharmaceutical excipients. Regulatory requirements for excipients. Specifications for excipients, antimicrobial preservatives, antioxidants and Water For Injection. Excipient compatibility.
Solid State Properties
Bulk properties of material, crystal habit, polymorphism, hydroscopicity, fine particle characterisation, bulk density, powder flow characteristics, particle size analysis, solubility analysis, pKa, pKa determination, solubility profile, solubilisation.
Dissolution
Dissolution Theory. Dissolution apparatus. Methods of measurement and dissolution profiles. Sustained release products.
Stability
Design of stability and accelerated stability programmes. Physical aspects; visual appearance, colour matching, rheology, dissolution testing and container integrity. Chemical stability; reaction kinetics, arrhenius equation, photochemical degradation, analysis of active ingredients, degradation products, antioxidants, antimicrobial preservatives. Microbiological stability: preservative efficacy tests, challenge tests. Shelf life determination. ICH requirements and conditions. Manufacturing issues affecting stability.
Laboratory Programme -examples
Measurement of particle size and bulk density of excipients. Investigate the effects of different particle size excipients on dissolution. Formulate a simple pharmaceutical product. Purity determination by TLC. Investigation of the effect of packaging on product stability. Design of experiment for shelf life determination. Dissolution profile of a drug product.
Module Content & Assessment
Assessment Breakdown%
Coursework40.00%
End of Module Formal Examination60.00%

Assessments

Coursework
Assessment Type Short Answer Questions % of Total Mark 15
Timing Week 6 Learning Outcomes 1,2
Assessment Description
Written Examination
Assessment Type Practical/Skills Evaluation % of Total Mark 25
Timing Week 11 Learning Outcomes 1,2,3
Assessment Description
Laboratory Practicals and report writing
End of Module Formal Examination
Assessment Type Formal Exam % of Total Mark 60
Timing End-of-Semester Learning Outcomes 1,2,3,4
Assessment Description
End-of-Semester Final Examination
Reassessment Requirement
Repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.

The University reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Classroom Instruction Every Week 2.00 2
Lab Contact Practicals and Report Writing Every Second Week 1.00 2
Independent & Directed Learning (Non-contact) Non Contact Study Every Week 4.00 4
Total Hours 8.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Classroom Instruction Every Week 2.00 2
Lab Contact Practicals and report writing Every Second Week 1.00 2
Independent & Directed Learning (Non-contact) Non Contact Student Study Every Week 4.00 4
Total Hours 8.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
 
Module Resources
Recommended Book Resources
  • Humphrey A. Moynihan and Abina M. Crean. (2009), The physicochemical basis of pharmaceuticals, 1st. Oxford University Press, United Kingdom, [ISBN: 978-0-19-923284-0].
  • Jack Zheng (Ed). (2009), Formulation and analytical development for low-dose oral drug products, John Wiley & Sons, Hoboken, N.J., [ISBN: 978-0-470-05609-7].
Supplementary Book Resources
  • Gibson, M.. (2001), Pharmaceutical Preformulation and Formulation: A practical guide from candidate drug selection to commercial dosage, Taylor and Francis, [ISBN: 1574911201].
  • Ray, C.. (2003), Handbook of Pharmaceutical Excipients, Pharmaceutucal Press, [ISBN: 0853694729.].
  • (2005), US Pharmacopoeia, 29th Edition. United States Pharmacopoeial Convention, [ISBN: 1889788392].
  • British Pharmacopoeia Commission. (2007), BP Pharmacopoeia, [ISBN: 0113227256].
  • European Pharmacopoeia Commission. (2003), EU Pharmacopoeia, [ISBN: 9287151040].
This module does not have any article/paper resources
Other Resources
 
Module Delivered in
Programme Code Programme Semester Delivery
CR_SGMPR_7 Bachelor of Science in Good Manufacturing Practice and Technology 1 Elective