Drug Stability for Pharmaceutical Scientists - 1st Edition - ISBN: 9780124115484, 9780124115620

Drug Stability for Pharmaceutical Scientists

1st Edition

Authors: Thorsteinn Loftsson
Paperback ISBN: 9780124115484
eBook ISBN: 9780124115620
Imprint: Academic Press
Published Date: 30th January 2013
Page Count: 170
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Drug Stability for Pharmaceutical Scientists is a clear and easy-to-follow guide on drug degradation in pharmaceutical formulation. This book features valuable content on both aqueous and solid drug solutions, the stability of proteins and peptides, acid-base catalyzed and solvent catalyzed reactions, how drug formulation can influence drug stability, the influence of external factors on reaction rates and much more. Full of examples of real-life formulation problems and step-by-step calculations, this book is the ideal resource for graduate students, as well as scientists in the pharmaceutical and related industries.

Key Features

  • Illustrates important theoretical concepts with numerous examples, figures, calculations, learning problems and questions for self-study and retention of material
  • Provides answers and explanations to test your knowledge
  • Enables you to better understand key concepts such as rate and order of reaction, reaction equilibrium, complex reaction mechanisms and more
  • Includes an in-depth discussion of both aqueous and solid drug solutions and contains the latest international regulatory requirements on drug stability


The book is intended for graduate students taking courses in physical pharmacy or drug stability as well as for pharmaceutical scientists in industry (drug formulators, drug registration etc.) and for individuals working in related fields (e.g. cosmetics).

Table of Contents


Chapter 1. Introduction

Chapter 2. Principles of Drug Degradation

2.1 Zero-Order Reactions

2.2 First-Order Reactions

2.3 Second-Order Reactions

2.4 Third-Order Reactions

2.5 Determination of the Order of a Reaction

2.6 Complex Reactions

2.7 Effect of Temperature

2.8 Specific Acid/Base Catalysis and pH-Rate Profiles

2.9 General Acid/Base Catalysis or Buffer Catalysis

2.10 Effects of Ionic Strength (Salt Effects)

2.11 Solvent Effects

2.12 Disperse Colloidal Systems (Micelle Effect)

2.13 Effect of Complexation

2.14 Effect of Light (Photodegradation) and Oxygen


Chapter 3. Degradation Pathways

3.1 Hydrolysis

3.2 Oxidation

3.3 Isomerization

3.4 Photochemical Degradation

3.5 Decarboxylation

3.6 Dehydration

3.7 Polymerization


Chapter 4. Drug Degradation in Semisolid Dosage Forms

4.1 Tretinoin

4.2 Betamethasone 17-valerate


Chapter 5. Stability of Peptides and Proteins

5.1 Physical Degradation

5.2 Chemical Degradation

5.3 Insulin


Chapter 6. Drug Degradation in Solid State

6.1 Chloramphenicol Palmitate

6.2 Nitroglycerin

6.3 Chemical Degradation


Chapter 7. Stability Testing

7.1 Guidelines for Stability Testing

7.2 Dorzolamide Eye Drops


Chapter 8. Problems

8.1 Racemization of (R)-Oxazepam

8.2 Consecutive Degradation of Prostaglandin

8.3 Effect of Buffer Salts on Lomustine Degradation

8.4 pH-rate Profile for Amoxicillin

8.5 Effect of Glucose on Amoxicillin Degradation

8.6 pH-rate Profile and Specific Acid/Base Catalysis

8.7 Aztreonam Polymerization

8.8 Aqueous Drug Suspension

8.9 Racemization of Ropivacaine

8.10 Degradation of Scopolamine

8.11 Primary Salt Effect

8.12 Leaving Groups

8.13 The Shelf-Life of Tetracycline Under Acidic Conditions

8.14 Parenteral Formulation Containing β-Lactam Antibiotic



Answers to Learning Questions and Problems

Answers to Problems in Chapter 8:



No. of pages:
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About the Author

Thorsteinn Loftsson

Dr. Thorsteinn Loftsson is a Professor of Physical Pharmacy at the University of Iceland in Reykjavik. He received his MS Pharm degree from University of Copenhagen and his MS and PhD degrees from the Department of Pharmaceutical Chemistry at the University of Kansas. Dr. Loftsson has authored or co-authors over 200 papers in peer-reviewed journals, numerous book chapters and 20 patents and patent applications. His main research areas include the pharmaceutical applications of cyclodextrins, marine lipids, prodrugs and soft drugs. He has conducted over 100 lectures and is a Fellow of the American Association of Pharmaceutical Scientists (AAPS). Dr. Loftsson is also a member for the editorial board of Journal of Pharmaceutical Sciences, International Journal of Pharmaceutics, Journal of Pharmacy and Pharmacology, die Pharmazie and Journal of Drug Delivery Science and Technology (formerly STP Pharma Sciences).

Affiliations and Expertise

MS Pharm, MSc, PhD, Faculty of Pharmaceutical Sciences, Professor of Physical Pharmacy, University of Iceland, Reykjavik, Iceland


"…a good foundation in chemistry is assumed, making this text most useful for science graduate students and scientists in the pharmaceutical industry. Students or newcomers to the field of drug stability should find the ‘problem’ section useful, with questions and answers based on real data provided."--PharmaceuticalJournal.com, July 18, 2014
"…describes the stability of pharmaceutical products as the capacity of the product or a given drug substance to remain within established specifications of identity, potency, and purity during a specified time period…topics are principles of drug degradation, degradation pathways, drug degradation in semi-solid dosage forms…"--ProtoView.com, April 2014