Full Title:Preformulation of Pharmaceuticals
Module Code:PHAR S7004
 
Credits: 5
Valid From:Semester 1 - 2013/14 ( September 2013 )
Module Delivered in 1 programme(s)
Module Description:• To provide students with the theory, background and understanding into the diversity of dosage forms available and the principles used in their design and function in the pharmaceutical industry. • 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 the methods used for the formulation of the dosage forms. • To discuss the methods used to monitor the quality and to ensure reproducibility of the dosage forms in the pharmaceutical industry (as governed by the European/British Pharmacopoeia).
Learning Outcomes:
On successful completion of this module the learner should be able to
  1. Recognise the importance of cGMP as used in the pharmaceutical industry and the guidelines that dosage forms must adhere to.
  2. Discuss pharmaceutical preformulation studies, physicochemical properties and stability studies which are critical in dosage form design.
  3. Examine a wide variety of pharmaceutical dosage forms, their medical applications and analysis as governed by the European/British Pharmacopoeia.
  4. Use pharmacokinetic and pharmacodynamic considerations of dosage forms to investigate drug bioavailability.
  5. Examine a variety of raw materials 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.
 

Module Content & Assessment

Indicative Content
GMP and GLP
Introdution on reason for GMP and GLP in the pharmaceutical industry, ISO9001 versus Code of Federal Regulations (FDA: CFR's), applications, similaries and differences. Qualified person: their importance in the pharmaceutical industry. Standard operating procedures (SOP's).
Pharmaceutical preformulation studies
Pharmaceutical preformulation studies and the physicochemical properties of drug substances (solubility, dissolution, melting point, polymorphorism, particle size etc.).
Pharmaceutical excipients
Types of pharmaceutical excipients used in dosage forms and the examination of excipient compatibility.
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 Dosage forms
Types of drug administration including enteral, parenteral, pulmonary, topical and nasal. The specifics of each type of administration, advantages and disadvantages. Dosage form analysis including pharmacopoeia influence, production versus laboratory testing and specific tests required as governed by the European/British pharmacopoeia.
Drug bioavailability
Ideal drug, factors influencing bioavailability, drug action phases. Pharmacokinetics and pharmacodynamics. Formulation factors (excipient and final dosage form).
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. 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, laboratory notebook reporting and 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. 3rd practical (feedback week): the practical supervisor/lecturer will give detailed feedback on the students ability to perform the testing and checking excerises set. This will include both generic feedback and individual feedback. This 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.
Assessment Breakdown%
Course Work10.00%
Practical40.00%
End of Module Formal Examination50.00%

Full Time

Course Work
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Continuous Assessment In class test 1,2,3 10.00 0 0 Week 10 0
No Project
Practical
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Practical/Skills Evaluation 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. 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. 1,5 40.00 0 0 n/a 0
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Marks Out Of Pass Marks Assessment Date Duration
Formal Exam End-of-Semester Final Examination 1,2,3,4,5 50.00 0 0 End-of-Semester 0
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 & Resources

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture No Description 2.00 Every Week 2.00
Practical No Description 3.00 Every Week 3.00
Directed Reading No Description 2.00 Every Week 2.00
Independent Study No Description 2.00 Every Week 2.00
Total Weekly Learner Workload 9.00
Total Weekly Contact Hours 5.00
This course has no Part Time workload.
Resources
Recommended Book Resources
  • Aulton, M.E., Aulton's Pharmaceutics, The Science of Dosage Form Design, 3rd Ed., Churchill Livingstone [ISBN: 9780443101083]
  • Allen, L.V. , Popovich, N.G., Ansel, H.C. 2004, Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems, 8th Ed., Lippincott Williams and Wilkins [ISBN: 0781746124]
  • Kee, J., Hayes, E., McCuistion, L. 2006, Pharmacology A nursing process approach, 5th Ed., Elsevier [ISBN: 9780721639277]
  • Dale, M.M, Haylett, D.G 2009, Pharmacology Condensed, 2nd Ed., Churchill Livingstone [ISBN: 9780443067730]
Supplementary Book Resources
  • Wermuth, C 2008, The practice of medicinal chemistry, 3rd Ed., Academic Press [ISBN: 9780123741943]
  • Watson, D 2005, Pharmaceutical Analysis, 2nd Ed., Wiley [ISBN: 044074453]
This module does not have any article/paper resources
Other Resources
  • Website: Dr Chiara Mc DonaghLecture notes and other resources, DkIT Moodle
  • Reference text (used in practicals): European Pharmacopoeia, Council of Europe
  • Website: www.FDA.gov
  • Website: www.IMB.ie
  • Link: Library Catalogue

Module Delivered in

Programme Code Programme Semester Delivery
DK_SPHAR_7 Bachelor of Science in Pharmaceutical Science 5 Mandatory