Inhaled Pharmaceutical Product Development Perspectives
1st Edition
Challenges and Opportunities
Table of Contents
1. Introduction–Historical Perspective
Inhaled Products
Scientific Advances
Technical Advances
Regulatory Advances
Conclusion
References
2. Dosage Forms
Metered Dose Inhalers
Dry Powder Inhalers
Nebulizers
Other Products
Specialized Formulations
Manufacturing
Performance Criteria
Conclusion
References
3. Quality and Performance Tests
Physical Tests for Drup And EXcipient Characterization
Aerodynamic Particle Size Distribution
Delivered Dose and Uniformity
Other Factors
IVIVC Considerations
Statistical Parameters
Stability
Conclusion
References
4. Preclinical and Clinical Considerations
Lung Deposition Imaging
Lung Deposition Modeling
Animal Models
Cell Culture
Pharmacokinetics
Pharmacodynamics
Conclusion
References
5. Regulatory Strategy
International Regulations
United States Regulations
General Principles
Conclusion
References
6. General Conclusion
Appendices
Index
Description
Inhaled Pharmaceutical Product Development Perspectives: Challenges and Opportunities describes methods and procedures for consideration when developing inhaled pharmaceuticals, while commenting on product development strategies and their suitability to support regulatory submission. It bridges the gap between the aspirations of scientists invested in new technology development and the requirements that must be met for any new product.
The book brings together emerging analytical and inhalation technologies, providing perspectives that illuminate formulation and device design, development, regulatory compliance, and practice. Focusing on underlying scientific and technical principles known to be acceptable from the current regulatory perspective, this monograph will remain useful as a high-level guide to inhaled product development for the foreseeable future.
Key Features
- Discusses development strategies and best practices in the context of regulatory requirements
- Written by a broadly qualified expert drawing on the knowledge and critical opinions of key individuals in the field
- Includes a foreword by Charles G. Thiel
Readership
Pharmaceutical scientists, formulation scientists, analytical chemists in the pharmaceutical sciences, regulatory officers, medical practitioners, patients and health scientists, graduate level pharmaceutical sciences students
Details
- No. of pages:
- 110
- Language:
- English
- Copyright:
- © Elsevier 2018
- Published:
- 23rd November 2017
- Imprint:
- Elsevier
- eBook ISBN:
- 9780128123362
- Paperback ISBN:
- 9780128122099
Ratings and Reviews
About the Authors
Anthony Hickey Author
Anthony J. Hickey, PhD, DSc, currently serves as a distinguished fellow and senior research pharmacologist at RTI International. He has more than 30 years of academic and research experience in the areas of pulmonary biology, aerosol physics, powder dynamics, pharmacokinetics and drug disposition, formulation design, and device development. His research has focused on improving understanding of the physiology, pharmacology, and immunology of the lungs. Throughout his career, Dr. Hickey has worked on intranasal and inhaled vaccine development and drug delivery for diseases affecting the respiratory tract, including asthma, chronic obstructive lung disease, tuberculosis, and cystic fibrosis. He has also studied the performance of powders and particles in drug and vaccine delivery systems. He received his PhD and DSc degrees in pharmaceutical sciences from the University of Aston in Birmingham, a master’s degree in toxicology from the University of Birmingham, and a bachelor’s degree in biology from Portsmouth Polytechnic.
Affiliations and Expertise
RTI International, Research Triangle Park, NC, USA