Handbook of Preformulation : Chemical, Biological, and Botanical Drugs, Second Edition book cover
2nd Edition

Handbook of Preformulation
Chemical, Biological, and Botanical Drugs, Second Edition

ISBN 9781138297555
Published April 15, 2019 by CRC Press
574 Pages 12 Color & 68 B/W Illustrations

USD $240.00

Prices & shipping based on shipping country


Book Description

Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development.

Entirely focused on preformulation principles, this fully revised and updated Handbook of Preformulation: Chemical, Biological, and Botanical Drugs, Second Edition provides detailed descriptions of preformulation methodologies, gives a state-of-the-art description of each technique, and lists the currently available tools useful in providing a comprehensive characterization of a new drug entity.


  • Addresses the preformulation studies of three different types of new active entities - chemical, biological, and botanical, which is the latest established class of active ingredient classified by the FDA
  • Illustrates the activities comprised in preformulation studies and establishes a method of tasking for drug development projects
  • Includes extensive flow charts for characterization decision making
  • Gives extensive theoretical treatment of principles important for testing dissolution, solubility, stability, and solid state characterization
  • Includes over 50% new material

Table of Contents

Preface to the Second Edition

Other Selected Books by Author


1. Drug Discovery Trends

2. Intellectual Property Considerations

3. The Scope of Preformulation Studies

4. Dissociation, Partitioning, and Solubility

5. Release, Dissolution, and Permeation

6. Solid-State Properties

7. Dosage Form Considerations in Preformulation

8. Chemical Drug Substance Characterization

9. Characterization of Biopharmaceuticals

10. Botanical Drugs


View More



<a href="https://www.niazi.com/">Sarfaraz K. Niazi, Ph.D.</a>, a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines. He is Founder and Executive Chairman of Adello Biologics, LLC, (formerly, Therapeutic Proteins International, LLC), a biosimilar products company located in Chicago, IL, Piscataway, NJ and Cashel, Ireland. As an entrepreneur, Niazi has raised hundreds of millions of dollars and became recognized as an inductee into the Chicago Entrepreneur Hall of Fame.Niazi began his career teaching pharmaceutical sciences at the University of Illinois, College of Pharmacy where he was tenured before entering the industry at Abbott International. He departed Abbott as an Abbott Volwiler Fellow to pursue his passion, first through global consulting and later through the founding a biosimilar products company.

A prolific inventor with scores of patents, most prominently in the field of bioprocessing technology, Niazi is currently the largest single holder of bioprocess technology patents. His other inventions span a broad category of technologies, new chemical entities, new formulations, new analytical methodologies, and much more. He has hands on experience in developing chemical, botanical and biological products, from discovery to regulatory approval. With over 50 ISBNs under his name, Niazi has authored many landmark books in the field of pharmaceutical sciences.

He currently serves as Adjunct Professor at the University of Illinois College of Pharmacy, Ad Hoc faculty at the University of Houston, Texas, the HEJ Research Institute, Karachi, and the National University of Science and Technology, Islamabad. He has also served as a Foreign Professor at the HEJ Research Institute, Karachi. He serves on the editorial board of the journal MOJ Proteomics & Bioinformatics (MOJPB) and starting 2017, as Chief Editor of International Journal of Biosimilars. He also serves as Member of National Advisory Board of the College of Pharmacy, University of Illinois. He is a Fellow of the Pakistan Academy of Medical Sciences, Fellow National Academy of Clinical Biochemistry and Institute of Biology. He served as a TOKTEN Fellow to India (Transfer of Knowledge Through Expatriate Nationals (UNDP). In 2013, he received the one of the highest civilian awards, Star of Distinction in Engineering, from the Pakistani President. He has hosted a radio show at Voice of America (US State Department) on a weekly basis for more than 5 years with audience into billions.