Başlık:
Drying technologies for biotechnology and pharmaceutical applications
Yazar:
Ohtake, Satoshi.
ISBN:
9783527802104
9783527802098
Yayın Bilgileri:
Weinheim : Wiley-VCH, 2020.
Fiziksel Tanımlama:
1 online resource (397 pages)
Genel Not:
Chapter 5 Vaccines and Microorganisms
İçerik:
Cover -- Title Page -- Copyright -- Contents -- Chapter 1 Introduction -- Acknowledgement -- References -- Chapter 2 A Concise History of Drying -- 2.1 Introduction -- 2.2 History of Drying of Pharmaceutical Products -- 2.3 History of Selected Drying Technologies -- 2.3.1 Freeze Drying -- 2.3.2 Spray Drying -- 2.3.3 Fluidized-Bed Drying -- 2.3.4 Supercritical Drying -- 2.4 Concluding Remarks -- Acknowledgments -- References -- Part I Drug Product Development -- Chapter 3 Importance of Drying in Small Molecule Drug Product Development -- 3.1 Introduction -- 3.2 Drying Materials and Dryer Types
3.3 Directly Heated (Convective) Dryers -- 3.3.1 Tray Drying -- 3.3.1.1 Description -- 3.3.1.2 Utility -- 3.3.1.3 Drawbacks and Challenges -- 3.3.2 Fluidized-Bed Drying -- 3.3.2.1 Description -- 3.3.2.2 Determination of End Point of Drying -- 3.3.2.3 Advantages, Utility, and Drawbacks -- 3.3.3 Spray Drying -- 3.3.3.1 Description -- 3.3.3.2 Role in Formulation Development -- 3.4 Indirectly Heated (Conductive) Dryers -- 3.4.1 Rotary Drying -- 3.4.1.1 Description -- 3.4.1.2 Advantages and Drawbacks -- 3.4.2 Freeze Drying -- 3.4.2.1 Description -- 3.4.2.2 Advantages and Drawbacks
3.4.2.3 Role in Small Molecule Formulation Development -- 3.5 Emerging Drying Technologies -- 3.5.1 Supercritical Fluid (SCF) Drying -- 3.5.1.1 Description -- 3.5.1.2 Advantages and Drawbacks -- 3.5.1.3 Pharmaceutical Applications -- 3.5.2 Microwave Drying -- 3.5.2.1 Pharmaceutical Applications -- 3.6 Summary -- References -- Chapter 4 Drying for Stabilization of Protein Formulations -- 4.1 Protein Stability -- 4.1.1 Physical Instability of Proteins -- 4.1.2 Chemical Instability of Proteins -- 4.1.2.1 Disulfide Bond Formation -- 4.1.2.2 Deamidation -- 4.1.2.3 Oxidation -- 4.1.2.4 Glycation
4.1.3 Analysis of Protein Stability -- 4.1.3.1 Particle Analysis in Protein Formulations -- 4.1.3.2 Other Purity Tests for Proteins -- 4.1.3.3 Analysis of Higher-Order Structure -- 4.2 Protein Stability in the Dried State -- 4.2.1 Theoretical Considerations -- 4.2.1.1 Water Replacement Hypothesis -- 4.2.1.2 Glass Dynamics Hypothesis and Vitrification -- 4.2.2 Analysis of the Dried State -- 4.2.2.1 Investigation of Endo- and Exothermic Processes: Glass Transition and Crystallization -- 4.2.2.2 Sample Morphology: Crystalline or Amorphous Matrix? -- 4.2.2.3 Residual Moisture
Özet:
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.
Notlar:
John Wiley and Sons
Elektronik Erişim:
https://onlinelibrary.wiley.com/doi/book/10.1002/9783527802104Kopya:
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Kütüphane | Materyal Türü | Demirbaş Numarası | Yer Numarası | Durumu/İade Tarihi | Materyal Ayırtma |
|---|---|---|---|---|---|
Arıyor... | E-Kitap | 595800-1001 | TP363 | Arıyor... | Arıyor... |