SCI07021 2019 Pharmaceutical Pre-Formulation Studies

General Details

Full Title
Pharmaceutical Pre-Formulation Studies
Transcript Title
Pharmaceutical Pre-Formulation
N/A %
Subject Area
SCI - Science
LIFE - Life Sciences
07 - NFQ Level 7
05 - 05 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Declan Shelly, Tom Patton
Programme Membership
SG_SPHAR_B07 201900 Bachelor of Science in Pharmaceutical Science SG_SPHAR_H08 201900 Bachelor of Science (Honours) in Pharmaceutical Science

This module aims to provide the student with an understanding of the techniques employed in the early phase of research & development, in which pre-formulation studies focus on assessing the physical and chemical properties of a drug molecule that affect the molecules performance and activity. This provides important information for formulation design or supports the need for molecular modification prior to the compounding process that will assist in developing a stable, safe and effective formulation with maximum bioavailability.

Learning Outcomes

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


Report on the terminology and concepts to establish the physicochemical parameters of a new/existing drug entity


Describe the thermodynamics of Colloidal Systems and the stability of dispersed systems


Illustrate the principles to determine a molecules physical characteristics, kinetic stability


Examine methods to establish a compounds compatibility with common excipients


Explain different processing strategies to support the dosage form design, drug processing and storage

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 Short Answer Questions/Multiple Choice Questions/Assignment Work where students will be required to (i) demonstrate an understanding of core module concepts, and (ii) presentations on topics 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.

Module Dependencies


Indicative Syllabus

1 Report on the terminology and concepts to establish the physicochemical parameters of a new/existing drug entity

Explain the role of pre-formulation studies in drug product development.

Identify and describe the activities which comprise an effective Pre-formulation programme in the process of Pharmaceutical Development.

Determine important physicochemical parameters using appropriate laboratory techniques and interpret results in relation to authoritative literature.

2 Describe the thermodynamics of Colloidal Systems and the stability of dispersed systems

Outline the practical challenges in assessing stability and the scientific basis of instability through the attractive forces, the nature of charged interfaces and how these interact to provide a stabilising mechanism for colloids.

3 Illustrate the principles to determine a molecules physical characteristics, kinetic stability

Identify and describe the techniques used for these activities with respect to various factors.

Discuss the solid state properties of a drug that may influence its action.

Investigate the major degradative pathways for active ingredients in formulations.

4 Examine methods to establish a compounds compatibility with common excipients

Design typical compatibility studies, organoleptic properties of the drug, Powder flow properties.

5 Explain different processing strategies to support the dosage form design, drug processing and storage

Propose and prepare an appropriate solution formulation based on a drug’s pre-formulation data.

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 Assignment Short Answer Questions/Multiple Choice Questions/Assignment Work Continuous Assessment Assessment 15 % OnGoing 1,2,3
2 Laboratory Practical Practical Practical Evaluation 50 % OnGoing 1,2,3,4,5

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 1,2,3,4,5

Full Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Flat Classroom Theory 2 Weekly 2.00
Laboratory Practical Science Laboratory Laboratory Practical 2 Weekly 2.00
Independent Learning Not Specified Self Study 3 Weekly 3.00
Total Full Time Average Weekly Learner Contact Time 4.00 Hours

Required & Recommended Book List

Recommended Reading
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

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
2012-12-26 Essentials of Pharmaceutical Preformulation John Wiley & Sons
ISBN 0470976365 ISBN-13 9780470976364

Essentials of Pharmaceutical Preformulation: A study guide for students and researchers in pharmacy and pharmaceutical sciences describes basic principles of pharmaceutical preformulation for undergraduate level pharmacy students and newly employed workers in the pharmaceutical field who do not have a pharmaceutical background. Successful preformulation requires knowledge of a number of concepts (solubility, partition coefficient, acid dissociation), familiarity with a range of analytical techniques and their application to dosage form design. This text takes these concepts and explains them in the context of pharmaceutical development .Special focus is given to the principles and use of analytical apparatus, providing a core set of transferable knowledge skills. The material is presented in the order that would be followed when developing a medicine and maps onto the indicative syllabus of pharmacy from the Royal Pharmaceutical Society It is divided into three sections: Basic concepts, Solid-state properties and Macroscopic properties and includes easy to follow text highlighted with relevant pharmaceutical examples

Recommended Reading
2010-04-26 Colloid Science Wiley-Blackwell
ISBN 1444320203 ISBN-13 9781444320206

Colloidal systems are important across a range of industries, such as the food, pharmaceutical, agrochemical, cosmetics, polymer, paint and oil industries, and form the basis of a wide range of products (eg cosmetics & toiletries, processed foodstuffs and photographic film). A detailed understanding of their formation, control and application is required in those industries, yet many new graduate or postgraduate chemists or chemical engineers have little or no direct experience of colloids. Based on lectures given at the highly successful Bristol Colloid Centre Spring School, Colloid Science: Principles, Methods and Applications provides a thorough introduction to colloid science for industrial chemists, technologists and engineers. Lectures are collated and presented in a coherent and logical text on practical colloid science.

Recommended Reading
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.

Required Reading
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.

Module Resources

Non ISBN Literary Resources



Journal Resources

The International Journal of Pharmaceutics - (Elsevier publishers Ltd)

URL Resources


Other Resources


Additional Information