Drug Stability for Pharmaceutical Scientists

by Thorsteinn Loftsson

Overview

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.

Product Details

ISBN-13:	9780124115484
Publisher:	Elsevier Science
Publication date:	01/22/2014
Pages:	170
Product dimensions:	5.90(w) x 8.90(h) x 0.40(d)

About the Author

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).

Table of Contents

I. Principles of drug degradation (the solution kinetics and mathematical treatment):1. Zero, first, second and third order reactions2. Complex reactions (e.g. reversible reactions, parallel reactions, consecutive reactions, steady state, enzyme kinetics etc.)3. Effect of temperature (e.g. Arrhenius, Q10-values, Collision theory, Transition state theory, Eyring equation etc.)4. Effect of pH (Specific acid/base catalysis, pH-rate profiles)5. Effect of buffer salts (General acid/base catalysis or buffer catalysis)6. Ionic strength7. Solvent effects (e.g. dielectric constant)8. Surface active compounds (micelle effect)9. Effect of complexation (e.g. cyclodextrins, metal ions and carbohydrates)10. Effect of light, oxygen and other catalytic compounds.II. Degradation pathwaysSelected examples of drug degradation with examples and mathematical calculations.1. Hydrolysis (aspirin, procaine, procainamide, acetaminophen, ß-lactam antibiotics, nitrogen mustards etc.)2. Oxidation (morphine, epinephrine, vitamin C, vitamin A, hydrocortisone, polyunsaturated fatty acids (autoxidation) etc.; antioxidants)3. Isomerization and racemization (ephedrine, tetracyclines, pilocarpine, vitamin A, thalidomide, etc.)4. Photodegradation5. Polymerization (ß-lactam antibiotics etc.)6. Decarboxylation and elimination (p-aminosalicylic acid)7. Dehydration (prostaglandins etc.)III. Drug degradation in semi-solid state1. Ointments2. Creams (o/w and w/o emulsions)3. GelsIV. Drug degradation in solid state1. Physical stability of drugs (crystallization of amorphous drugs, polymorph transitions, crystal growth, moisture absorption and vapor absorption, nitroglycerine)2. Chemical stability (hydrolysis (aspirin), etc.)V. Stability of peptide and proteinsVI. Stability testing1. Stability testing during preformulation studies.2. Stability testing of the final product 3. Regulations of stability testing (including ICH guidelines)Appendix

What People are Saying About This

From the Publisher

A practical and straightforward guide to drug stability that provides examples, step-by-step calculations and questions and answers to better aid learning and application

Editorial Reviews

"…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

From the Publisher