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Pharmaceutical Inhalation Aerosol Technology, Third Edition

8112 грн

Автор: Anthony J. Hickey, Sandro R. da Rocha
Издательство: CRC Press
Год издания: 2019
Страниц: 746
Склад: Под заказ

This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease. It focuses on the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery. The expanded scope considers previously unaddressed aspects of pharmaceutical inhalation aerosol technology and the patient interface by including aerosol delivery, lung deposition and clearance that are used as measures of effective dose delivery. Key Features: Provides a thoroughly revised and expanded reference with authoritative discussions on the physiologic,pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosols Emphasizes the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery Addresses the physics, chemistry and engineering principles while establishing disease relevance Expands the ‘technology’ focus of the original volumes to address the title more directly Offers an impressive breadth of coverage as well as an international flavour from outstanding editors and contributors

1. Introduction

Anthony J. Hickey and Sandro R.P. da Rocha

Section I Discovery (pharmacology/physiology/anatomy, etc)

2. Physiology of the Airways

Anthony J. Hickey and David C. Thompson

3. Drug Targeting to the Lung: Chemical and Biochemical Considerations

Peter A. Crooks, Narsimha R. Penthala, and Abeer M. Al-Ghananeem

Section II Aerosol Critical Attributes (aerodynamic

behaviour, lung deposition, and clearance)

4. Aerosol Physics and Lung Deposition Modelling

Warren H. Finlay

5. Practical Aspects of Imaging Techniques Employed to Study Aerosol Deposition and

Clearance Myrna B. Dolovich

6. Pharmacokinetics and Pharmacodynamics of Drugs Delivered to the Lung

Stefanie K. Drescher, Mong-Jen Chen, Jürgen B. Bulitta, and Günther Hochhaus

Section III Active Pharmaceutical

Ingredient/Drug Product Manufacturing

7 Small Molecules: Process Intensification and Continuous Synthesis

Thomas D. Roper

8 Biologic Drug Substance and Drug Product Manufacture

Ajit S. Narang, Mary E. Krause, Shelly Pizarro, and Joon Chong Yee

9 Scale-Up Considerations for Orally Inhaled Drug Products

Jeremy Clarke and S. van den Ban

10 Quality by Control Helen N. Strickland and Beth Morgan

Section IV Particle Engineering/Processing (milling/blending,

spray drying, supercritical fluid, nano, etc.)

11. Milling and Blending: Producing the Right Particles and Blend Characteristics for

Dry Powder Inhalation Bernice Mei Jin Tan, Lai Wah Chan, and Paul Wan Sia Heng

12. Engineering Stable Spray Dried Biologic Powder for Inhalation

Nicholas Carrigy and Reinhard Vehring

13 Supercritical Fluid Manufacture

Ana Aguiar-Ricardo and Eunice Costa

14 Particle Engineering Technology for Inhaled Therapies

David Lechuga-Ballesteros, Susan Hoe, and Ben Maynor

Section V Drug Product Formulation

15 Emerging Pulmonary Delivery Strategies in Gene Therapy: State of the Art and

Future Considerations G. Costabile and Olivia M. Merkel

16 Genome Editing for Genetic Lung Diseases

Ying Zhang and Hao Yin

17 Inhalation Drug Products Containing Nanomaterials

Sandro R.P. da Rocha, Rodrigo S. Heyder, Elizabeth R. Bielski, Ailin Guo, Martina

Steinmaurer, and Joshua J. Reineke

Section VI Devices (design and performance)

18. Pressurized Metered-Dose Inhalers

Sandro R. P. da Rocha, Balaji Bharatwaj, Rodrigo S. Heyder, and Lin Yang

19. Dry Powder Inhalation

A. H. de Boer and F. Grasmeijer

20. Nebulisers John N. Pritchard, D. von Hollen, and R. H. M. Hatley

21. Soft Mist Sprays

Stefan Leiner, David Cipolla, Joachim Eicher, Wilbur de Kruijf, and Herbert Wachtel

Section VII Drug Product Testing (physico-chemical properties,

aerodynamic particle size, delivered dose, etc.)

22 Quality by Design Considerations

William Craig Stagner and Anthony J. Hickey

23 Solid State Testing of Inhaled Formulations

Philip Chi Lip Kwok and Hak-Kim Chan

24 Aerodynamic Particle Size Testing

Jolyon Mitchell

Section VIII Regulatory Considerations (CMC)

25. Scanning the Intricate Regulatory Landscape and Trying to Peek Over the Horizon

Steve T. Horhota, Stefan Leiner, and A. T. Horhota

26. Pharmacopeial and Regulatory Guidances on Product Quality and Performance

Anthony J. Hickey

27. The European Union Regulatory Scene

Steven C. Nichols and Dennis Sandell

Section IX Preclinical Testing (dosing for cells and animals)

28. Cell- and Tissue-Based (Reconstituted) 2D In Vitro Models to Study Drug Transport

Processes across the Air-Blood Barrier Nicole Schneider-Daum, Patrick Carius, Justus C. Horstmann, and Claus-Michael Lehr

29. 3D In Vitro/Ex Vivo Systems

Bethany M. Young, Alexandria Ritchie, Laleh Golshahi, and Rebecca L. Heise

30. Preclinical Models for Pulmonary Drug Delivery

J. P. Ibrahim, R. J. Bischof, and M. P. McIntosh

Section X Clinical Testing (concepts of bioequivalence)

31. Bioequivalence of Orally-Inhaled Drug Products: Challenges and Opportunities

Jayne E. Hastedt and Elise Burmeister Getz

32. General Conclusions

Anthony J. Hickey and Sandro R. P. da Rocha

Index

ISBN: 9781138063075
Язык издания: EN
Обложка: Тверда
Размер: 170 х 240 мм
Вес: 1,538г

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