When it comes to oral dosage form development, Bhavishya Mittal has strong credentials, having worked for many years in formulation sciences for a pharmaceutical company and he is now a staff fellow at the Office of Pharmaceutical Quality at the US Food and Drug Administration (FDA).
He has applied his knowledge of the complexities involved in formulation design to produce a concise guide to the principles and practicalities guiding formulation development. Though a relatively short book, it is clearly written and well illustrated, and covers a myriad of topics, from biopharmaceutics and stability, through preformulation, quality by design, unit operations (e.g. high-shear granulation, roller compaction, coating), and process development.
Although concise, readers will get a good overview of each topic, alongside practical advice and illustrative case studies. Decision trees and reference tables are particularly useful. Mittal also makes a point of addressing ‘the big picture’ of pharmaceutical development, highlighting the importance of relationships with other aspects of the business, which are necessary to drive formulation development in the most efficient way.
This excellent book provides a great introduction for anyone starting a career in formulation science, and is a perfect starting point for trouble shooting issues throughout the formulation development process. Pharmacy students should also find its clear descriptions of important concepts useful for the study of pharmaceutics.
How to develop robust solid oral dosage forms: from conception to post-approval, by Bhavishya Mittal. Pp xxii+168 Price £42.99. London: Elsevier; 2016. ISBN 978 0 12 804731 6