Drying Technologies for Biotechnology and Pharmaceutical Applications

ISBN-13: 9783527341122 / Angielski / Twarda / 2020 / 400 str.

Satoshi Ohtake;Ken-ichi Izutsu;David Lechuga-Ballesteros

Opis

Focusing on the application of various drying technologies to the processing of pharmaceuticals and biologicals, this is a comprehensive technical overview of novel as well as standard methods, addressing such issues as why drying is required and what needs to be considered when implementing this process during drug product development. The editors are renowned experts from the pharmaceutical industry and have assembled here leaders from industry and academia to share their experiences and offer insights. The authors concentrate on industrial solutions, outlining various drying technologies from an application-oriented point of view and with regard to real-world challenges in the field of drug product development. They describe well established methods, including freeze and spray drying, alongside promising next-generation technologies, possible improvements, limitations, synergies and future directions.

Spis treści

Introduction1.Table of content2.Overview/Introduction Impact of water removal and critical physical properties 3.History of drying 4.Physical state of dried solids and impact of water Current applications of drying technologies5.Food industry and others Pharmaceutical applications6.Drug product development6.1.Key considerations for the development of liquid vs dry dosage forms 6.2.Small molecule APIs 6.3.Proteins 6.4.Vaccines and microorganisms 6.5.Drug delivery systems 7.Freeze-drying7.1.Theory 7.2.Current status, including survey of commercial products and limitations7.3.Future direction8.Spray drying 8.1.Theory8.2.Particle engineering8.3.Current status8.4.Future direction9.Next generation drying technologies9.1.Desired attributes and requirements for implementation 9.2.Spray freeze-drying 9.3.Microwave drying 9.4.Foam drying 9.5.Others Formulation considerations for solid dosage preparation10.Solid state stabilization and formulation considerations11.Impact of water on stability of dried pharmaceuticals 12.Reconstitution and high concentration formulations Implementation13.Challenges and considerations for new technology implementation 14.Synergy with development of process analytical technologies Future perspectives15.Future direction

O autorze

Satoshi Ohtake, PhD, is the Senior Principal Scientist in Pharmaceutical Research & Development, BioTherapeutics Pharmaceutical Sciences at Pfizer in St. Louis (USA), and a member of the Scientific Advisory Committee for the Journal of Pharmaceutical Sciences.Ken-ichi Izutsu, PhD, is a Section Chief Research Scientist at the National Institute of Health Sciences (Japan), and External Scientific Advisor of the Pharmaceuticals and Medical Devices Agency (Japan). David Lechuga-Ballesteros, PhD, is a Principal Scientist at Pearl Therapeutics (USA), and serves as a member of the Editorial Advisory Board of the Journal of Pharmaceutical Sciences.