Module Details

Module Code: PHAR S8014
Full Title: Pharmacopoeial Characterisation
Valid From:: Semester 1 - 2018/19 ( September 2018 )
Language of Instruction: 
Duration: 1 Semester
Credits:: 7.5
Module Owner::  
Departments: Unknown
Module Description: • To provide students with the background and understanding into the pharmaceutical characterisation of dosage forms as governed by the European/British Pharmacopoeia.
• To explain the chemical, biological and physical properties that are involved in dosage form design.
• To ensure that the students understand the importance and significance of stability and bioavailability of dosage forms.
• To discuss the pharmacopoeia analysis methods used to monitor the quality and to ensure reproducibility of the dosage forms in the pharmaceutical industry.
 
Module Learning Outcome
On successful completion of this module the learner will be able to:
# Module Learning Outcome Description
MLO1 Recognise the importance of pharmaceutical drug solubility to the overall bioavailability of the drug.
MLO2 Discuss pharmaceutical preformulation studies, physicochemical properties and stability studies which are critical in dosage form design.
MLO3 Use pharmacokinetics, excipient and formulation considerations of dosage forms to investigate drug bioavailability.
MLO4 Discuss a wide variety of pharmaceutical analytical tests as governed by the European/British Pharmacopoeia.
MLO5 Examine a variety of raw materials (API) as governed by the European/British Pharmacopoeia (including analysis, pharmaceutical paperwork completion and cross-checking of paperwork) to mimic the pharmaceutical quality control set-up.
Pre-requisite learning
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 DkIT module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
No recommendations listed
 
Module Indicative Content
Pharmaceutical drug solubility
Solubility importance. Biopharmaceutical Classification System (BCS). Techniques for solubility enhancement (physical and chemical modification, formulation methods and other techniques).
Pharmaceutical preformulation studies
Pharmaceutical preformulation studies and the physicochemical properties of drug substances (physical description, dissolution, melting point, polymorphism, particle size, partition affinity, membrane permeability).
Pharmaceutical excipients
Types of pharmaceutical excipients used in dosage forms. Effect of excipients on pharmaceutical drug bioavailability. Examination of excipient compatibility.
Pharmaceutical stability studies
Drug and product stability (physical, chemical and microbiological). Objectives of stability testing. Accelerated stability testing and drug shelf-life prediction. Mechanisms of drug degradation.
Pharmaceutical drug bioavailability
Ideal drug, factors influencing bioavailability, drug action phases. Pharmacokinetics. Effect of formulation factors on bioavailability.
Pharmacopoeia analysis
Pharmacopoeia influence (primarily European/British pharmacopoeia). Analysis of raw materials (API) - including identification tests and limit tests. Analysis of final dosage forms - including production/on-line tests and laboratory/QC control tests
Practical
The students will be given the opportunity to follow the guidelines of the European/British Pharmacopoeia to mimic the pharmaceutical quality control set up for raw materials (API) testing. This will be achieved over a number of weekly practical sessions with the following specific set up. 1st practical (testing week): The student must follow the analysis of a specific raw material as governed by the EP/BP. The student must have the ability to work within a group to complete the raw material testing paperwork while also working as an individual to complete and document correctly the results of the specific tests required. 2nd practical (checking week): The student must cross-check all the raw material testing results, analyst book reporting and instrument log paperwork completion of another students work during the 1st practical. This will give the student the opportunity to follow the quality control process for releasing a raw material including analysis, pharmaceutical paperwork completion and cross-checking of paperwork. This testing and checking process will be repeated over the course of all the practical sessions with the student learning the overall quality control process required in the pharmaceutical industry to release a raw material for use. A feedback week will be provided after the first testing and checking cycle. The practical supervisor/lecturer will give detailed feedback on the students ability to perform the testing and checking exercises set. This will include both generic feedback and individual feedback.
Module Assessment
Assessment Breakdown%
Course Work10.00%
Practical40.00%
Final Examination50.00%
Module Special Regulation
 

Assessments

Full Time On Campus

Course Work
Assessment Type Continuous Assessment % of Total Mark 10
Marks Out Of 0 Pass Mark 0
Timing S1 Week 10 Learning Outcome 1,2
Duration in minutes 0
Assessment Description
In class test
No Project
Practical
Assessment Type Practical/Skills Evaluation % of Total Mark 40
Marks Out Of 0 Pass Mark 0
Timing Every Week Learning Outcome 5
Duration in minutes 0
Assessment Description
Three hour practical sessions will provide the student with the opportunity to follow the guidelines of the European/British Pharmacopoeia to mimic the pharmaceutical quality control set up for raw materials (API) testing. The student will have the opportunity (over a number of practicals) to follow the quality control process for releasing a raw material including analysis, pharmaceutical paperwork completion and cross-checking of paperwork.
Final Examination
Assessment Type Formal Exam % of Total Mark 50
Marks Out Of 0 Pass Mark 0
Timing End-of-Semester Learning Outcome 1,2,3,4
Duration in minutes 0
Assessment Description
End-of-Semester Final Examination
Reassessment Requirement
A 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.

DKIT reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time On Campus
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact No Description Every Week 2.00 2
Practical Contact No Description Every Week 3.00 3
Directed Reading Non Contact No Description Every Week 2.00 2
Independent Study Non Contact No Description Every Week 2.00 2
Total Weekly Learner Workload 9.00
Total Weekly Contact Hours 5.00
This module has no Part Time On Campus workload.
 
Module Resources
Recommended Book Resources
  • Thomas, G. Medicinal Chemistry; an introduction, 2nd. Wiley, [ISBN: 9780470025987].
  • Gaisford, S, Saunders, M. Essentials of Pharmaceutical Preformulation, 1st. Wiley-Blackwell, [ISBN: 9780470976364].
  • Aulton, M.E.. Aulton's Pharmaceutics, The Science of Dosage Form Design, 3rd. Churchill Livingstone, [ISBN: 9780443101083].
  • Allen, L.V. , Popovich, N.G., Ansel, H.C.. (2004), Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems, 8th. Lippincott Williams and Wilkins, [ISBN: 0781746124].
  • Hansen, S.H, Pedersen-Bjergaard, S, Rasmussen, K.E. Introduction to Pharmaceutical Analysis, 1st. Wiley, [ISBN: 9780470661222].
  • Watson, D. (2005), Pharmaceutical Analysis, 2nd. Wiley, [ISBN: 044074453].
Supplementary Book Resources
  • Mahato, R.I, Narang, A.S. Pharmaceutical Dosage forms and Drug Delivery, 2nd. CRC Press, [ISBN: 9781439849187].
  • Wermuth, C. (2008), The practice of medicinal chemistry, 3rd. Academic Press, [ISBN: 9780123741943].
  • Kee, J., Hayes, E., McCuistion, L.. (2006), Pharmacology A nursing process approach, 5th. Elsevier, [ISBN: 9780721639277].
  • Dale, M.M, Haylett, D.G. (2009), Pharmacology Condensed, 2nd. Churchill Livingstone, [ISBN: 9780443067730].
This module does not have any article/paper resources
Other Resources
  • Website, Dr Chiara Hanlon. Lecture notes and other resources, DkIT Moodle.
  • Reference text (used in practicals), European Pharmacopoeia, Council of Europe.
  • Website, European Pharmacopoeia (European Directorate for the Quality of Medicines). www.edqm.eu.
  • Website, British Pharmacopoeia. www.pharmacopoeia.com.
  • Website, Health Products Regulatory Authority. www.HPRA.ie.
  • Website, US Food and Drug Administration. www.FDA.gov.
  • Link, Library Catalogue,
    http://tinyurl.com/k683276