Market-Driven Development of Inhaled Drug Products

Translating Research Into Marketable Drug Products
Erscheinungsjahr 2027
ISBN: 978-0-443-44401-2
Verlag: Elsevier Science

Buch, Englisch, 400 Seiten, Format (B × H): 191 mm x 235 mm, Gewicht: 449 g

Market-Driven Development of Inhaled Drug Products: Translating Research into Marketable Drug Products addresses the rapidly evolving field of pulmonary drug delivery, which has gained prominence for treating respiratory diseases and systemic therapies, including COVID-19. Despite its promise, inhaled drug development faces complex challenges such as respiratory physiology constraints, limited excipient approvals, and the necessity for drug-device combination products. This reference fills a critical gap by translating cutting-edge research into practical product development strategies. The content spans foundational topics including inhalation dosimetry, pulmonary pharmacokinetics, and safety studies, progressing to drug discovery, device influence, preclinical models, and regulatory frameworks. It further covers excipient selection, patient compliance, device engineering innovations including 3D printing, and packaging considerations. Contributions from leading experts worldwide provide a multidisciplinary perspective essential for navigating the complexities of inhaled drug development. Market-Driven Development of Inhaled Drug Products: Translating Research into Marketable Drug Products benefits pharmaceutical scientists and engineers by offering an integrated approach to inhaled therapy development. It supports improving product development cycles, regulatory submissions, and clinical trial designs while addressing patient adherence challenges. This reference is an indispensable resource for advancing inhaled therapeutics from concept to market.

Autoren/Hrsg.

Gupta, Vivek

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie

Inhaltsverzeichnis

1. Introduction

Part I – Foundations of Inhaled Drug Product Development
2. Dosimetry in Inhaled Product Development
3. Inhalation Safety Studies
4. Pulmonary Drug Disposition
5. Pharmacokinetic-Pharmacodynamic Relationships in the Lung

Part II – Development of Inhaled Products
6. Drug Discovery and Drug Development
7. Influence of the Inhalation Delivery Device
8. Pre-Clinical Studies
9. Uses and Limitations of Animal Models
10. Regulatory Aspects

Part III – Practical Inhaled Drug Product Development
11. Excipient Selection
12. Excipient Safety and Toxicological Profile & Functional Excipients
13. Medicine Compliance
14. Device Development
15. Packaging and Distribution

Part IV – Conclusions
16. The Current Status of Inhaled Drug Product Development

Über Autor(innen)

Gupta, Vivek
Dr. Vivek Gupta received his Ph.D. in pharmaceutical sciences from Texas Tech University Health Sciences Center, Amarillo, TX. He is currently an assistant professor of industrial pharmacy and pharmaceutics at St. John’s University in New York City. He has more than 10 years of experience in formulation design for novel drug delivery systems for non-invasive delivery of therapeutics, pharmacokinetic and pharmacodynamic characterization of delivery systems for enhanced lung accumulation and bioavailability. Dr. Vivek Gupta’s current research is focused on drug discovery and delivery of novel therapeutic agents for rare disorders of the cardiopulmonary system including pulmonary fibrosis, pulmonary hypertension, and mesothelioma, a rare form of lung cancer associated with asbestos exposure. Dr. Gupta has published 45 journal articles and book chapters in his research field.