A step-by-step guide to stability
‘Drug stability for pharmaceutical scientists’, by Thorsteinn Loftsson.
This short handbook describes the concepts of drug stability and degradation. Topics covered by the book include the underlying principles of drug degradation (including reaction orders, acid-base catalysis, ionic strength, solvent effects, and colloidal systems), degradation pathways, considerations for semi-solid and solid dosage forms, and considerations for stability of peptides and proteins.
A significant proportion of the book is turned over to equations and diagrams, providing a step-by-step guide to stability. Specific drug examples are provided to showcase formulation problems and degradation pathways. The examples shown are interesting and suitably illustrative of key points, although it is worth noting that the text does not focus on how to extrapolate the methodology and principles to new drug molecules.
The book suffers a little from a lack of context, with examples given little introduction or summation to highlight the particular importance of the reaction. However, this does serve to keep the book concise and allows it to focus on being a practical guide rather than a beginner’s guide. Thus, 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.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20065740
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