A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals
Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development.
Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments.
-Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions
-Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development
-Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia
Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.
Auflage
Sprache
Verlagsort
Zielgruppe
Illustrationen
87
11 s/w Tabellen, 87 s/w Abbildungen
Maße
Höhe: 24.4 cm
Breite: 17 cm
Dicke: 2.3 cm
Gewicht
ISBN-13
978-3-527-34112-2 (9783527341122)
Schweitzer Klassifikation
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.
Introduction
1.Table of content
2.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 technologies
5.Food industry and others
Pharmaceutical applications
6.Drug product development
6.1.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-drying
7.1.Theory
7.2.Current status, including survey of commercial products and limitations
7.3.Future direction
8.Spray drying
8.1.Theory
8.2.Particle engineering
8.3.Current status
8.4.Future direction
9.Next generation drying technologies
9.1.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 preparation
10.Solid state stabilization and formulation considerations
11.Impact of water on stability of dried pharmaceuticals
12.Reconstitution and high concentration formulations
Implementation
13.Challenges and considerations for new technology implementation
14.Synergy with development of process analytical technologies
Future perspectives
15.Future direction
