PHRM07013 2019 Pharmaceutical Formulation
Full Title
Pharmaceutical Formulation
Transcript Title
Pharmaceutical Formulation
Code
PHRM07013
Attendance
N/A %
Subject Area
PHRM - Pharmaceutical Science
Department
LIFE - Life Sciences
Level
07 - Level 7
Credit
10 - 10 Credits
Duration
Semester
Fee
€
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Declan Shelly, Tom Patton
Programme Membership
SG_SPHAR_B07 201900 Bachelor of Science in Pharmaceutical Science with Drug Development
SG_SPHAR_H08 201900 Bachelor of Science (Honours) in Pharmaceutical Science with Drug Development
Description
This module aims to provide the student with an in-depth understanding of the fundamental activities and processes underpinning the formulation design, the bulk product manufacture and quality control activities of the primary 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.
Select and justify appropriate excipients for use in various conventional dosage forms.
4.
Outline and Discuss the production activities, key process parameters and quality attributes specific to the manufacture of some major conventional dosage forms.
5.
Identify relevant compendial tests and specifications for QC of conventional dosage forms.
6.
Propose and prepare appropriate pharmaceutical formulation based on end use and relate preformulation activities to dosage form design, development and manufacture to solve formulation problems
7.
Demonstrate an awareness of current advances in drug delivery and formulation Design.
8.
Generate and follow Standard Operating procedures (SOP's) in the execution of key manufacturing and QC processes
Teaching and Learning Strategies
This module will be delivered full time. This will include lectures, laboratory practicals, and site visits augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as a potential means of assessment (e.g. quizzes, uploading assignments and journals).
Module Assessment Strategies
This module will be assessed using a combination of end of semester final exam (35%), continuous assessment and course work (65%).
The continuous assessment and course work will involve two assignments where students will be required to (i) demonstrate an understanding of the core module concepts, and (ii) a presentation of a topic which demonstrates the student's ability to critically evaluate an aspect of the subject area.”
The student must reach an assigned gate (mark) in the final exam and achieve 40% overall to pass the subject.
Repeat Assessments
Repeat Continuous Assessment and/or Final Exam.
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.
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 Select and justify appropriate excipients for use in various conventional dosage forms.
4 Outline and Discuss the production activities, key process parameters and quality attributes specific to the manufacture of some major conventional dosage forms.
5 Identify relevant compendial tests and specifications for QC of conventional dosage forms.
6 Propose and prepare appropriate pharmaceutical formulation based on end use and relate preformulation activities to dosage form design, development and manufacture to solve formulation problems.
7 Demonstrate an awareness of current advances in drug delivery and formulation Design.
8 Generate and follow Standard Operating procedures (SOP's) in the execution of key manufacturing and QC processes.
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
65 %
End of Semester / Year Formal Exam
35 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Laboratory Practical | Practical | Practical Evaluation | 50 % | OnGoing | 1,2,3,4,5,6,8 |
| 2 | Assignment Short Answer Questions/Multiple Choice Questions/Assignment Work | Coursework Assessment | Assignment | 15 % | OnGoing | 1,3,4,7 |
End of Semester / Year Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Final exam. | Final Exam | Closed Book Exam | 35 % | End of Term | 1,3,4,5,6,7 |
Full Time Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Flat Classroom | Lecture | 3 | Weekly | 3.00 |
| Practical / Laboratory | Science Laboratory | Laboratory Practical | 3 | Weekly | 3.00 |
| Independent Learning | Not Specified | Self Study | 7 | Weekly | 7.00 |
Total Full Time Average Weekly Learner Contact Time 6.00 Hours
Required & Recommended Book List
Recommended Reading
2013 Aulton's Pharmaceutics Elsevier Health Sciences
ISBN 9780702042904 ISBN-13 0702042900
2013 Aulton's Pharmaceutics Elsevier Health Sciences
ISBN 9780702042904 ISBN-13 0702042900
Pharmaceutics is one of the most diverse subject areas in all of pharmaceutical science. In brief, it is concerned with the scientific and technological aspects of the design and manufacture of dosage forms or medicines. An understanding of pharmaceutics is therefore vital for all pharmacists and those pharmaceutical scientists who are involved with converting a drug or a potential drug into a medicine that can be delivered safely, effectively and conveniently to the patient. Now in its fourth edition, this best-selling textbook in pharmaceutics has been brought completely up to date to reflect the rapid advances in delivery methodologies by eye and injection, advances in drug formulations and delivery methods for special groups (such as children and the elderly), nanomedicine, and pharmacognosy. At the same time the editors have striven to maintain the accessibility of the text for students of pharmacy, preserving the balance between being a suitably pitched introductory text and a clear reflection of the state of the art. provides a logical, comprehensive account of drug design and manufacture includes the science of formulation and drug delivery designed and written for newcomers to the design of dosage forms New to this edition New editor: Kevin Taylor, Professor of Clinical Pharmaceutics, School of Pharmacy, University of London. Twenty-two new contributors. Six new chapters covering parenteral and ocular delivery; design and administration of medicines for the children and elderly; the latest in plant medicines; nanotechnology and nanomedicines, and the delivery of biopharmaceuticals. Thoroughly revised and updated throughout.
Recommended Reading
2017-11 Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems LWW
ISBN 1496347285 ISBN-13 9781496347282
2017-11 Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems LWW
ISBN 1496347285 ISBN-13 9781496347282
Succeed in your course with Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems, the most comprehensive source on this subject available today!
Recommended Reading
2017-08-11 Handbook of Pharmaceutical Excipients
ISBN 0857112716 ISBN-13 9780857112712
2017-08-11 Handbook of Pharmaceutical Excipients
ISBN 0857112716 ISBN-13 9780857112712
The Handbook of Pharmaceutical Excipients contains essential data on the physical properties of excipients, their safe use and potential toxicity.
Recommended Reading
2016-04-19 Pharmaceutical Preformulation and Formulation CRC Press
ISBN 9781420073188 ISBN-13 1420073184
2016-04-19 Pharmaceutical Preformulation and Formulation CRC Press
ISBN 9781420073188 ISBN-13 1420073184
Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the need for advanced information for drug preformulation and formulation and addresses the current trends in the continually evolving pharmaceutical industry. Topics include: Candidate drug selection Drug discovery and development Preformulation predictions and drug selections Product design to commercial dosage form Biopharmaceutical support in formulation Development The book is ideal for practitioners working in the pharmaceutical arenaincluding R&D scientists, technicians, and managersas well as for undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology.
Recommended Reading
2013 Remington
ISBN 0857111051 ISBN-13 9780857111050
2013 Remington
ISBN 0857111051 ISBN-13 9780857111050
Provides a concise yet detailed resource covering all aspects of pharmaceutics, from the scientific fundamentals to the dosage forms and drug delivery systems to drug product analyses. Assists with integrating the science of pharmacy into practice. Chapters from the original parent text Remington: The Science and Practice of Pharmacy 22nd edition were specifically selected to create this new edition. The text pulls heavily from the Pharmaceutics and Pharmaceutical Dosage Forms sections. Various delivery systems and dosage forms are covered as well as parenterals, sterilization processes, and sterile compounding. One chapter addresses pharmaceutical excipients and another discusses pharmaceutical packaging. Pharmaceutical analysis, product characterization, quality control, stability, bioavailability, and dissolution are also covered. Fundamental scientific concepts including thermodynamics, ionic solutions and electrolyte equilibria, tonicity, chemical kinetics, rheology, complex formation and interfacial phenomenon are presented.The text also provides an introduction to pharmacokinetics and pharmacodynamics and the principles of absorption, distribution, metabolism and excretion.In addition, some introductory concepts on drug discovery and drug product approval as well as information resources in pharmacy and the pharmaceutical sciences are presented.
Module Resources
Non ISBN Literary Resources
N/A
Journal Resources
The International Journal of Pharmaceutics - (Elsevier publishers Ltd)
URL Resources
http://sciencedirect.com/science/journal/03785173
Other Resources
None
Additional Information
None