Inhaled Pharmaceutical Product Development Perspectives

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

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.

• 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

Pharmaceutical scientists, formulation scientists, analytical chemists in the pharmaceutical sciences, regulatory officers, medical practitioners, patients and health scientists, graduate level pharmaceutical sciences students