Inhaled Pharmaceutical Product Development Perspectives

Inhaled Pharmaceutical Product Development Perspectives

Challenges and Opportunities

1st Edition - November 23, 2017

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  • Author: Anthony Hickey
  • eBook ISBN: 9780128123362
  • Paperback ISBN: 9780128122099

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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


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

Table of Contents

  • 1. Introduction–Historical Perspective
    Inhaled Products
    Scientific Advances
    Technical Advances
    Regulatory Advances
    2. Dosage Forms
    Metered Dose Inhalers
    Dry Powder Inhalers
    Other Products
    Specialized Formulations
    Performance Criteria
    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
    4. Preclinical and Clinical Considerations
    Lung Deposition Imaging
    Lung Deposition Modeling
    Animal Models
    Cell Culture
    5. Regulatory Strategy
    International Regulations
    United States Regulations
    General Principles
    6. General Conclusion

Product details

  • No. of pages: 110
  • Language: English
  • Copyright: © Elsevier 2017
  • Published: November 23, 2017
  • Imprint: Elsevier
  • eBook ISBN: 9780128123362
  • Paperback ISBN: 9780128122099

About the Author

Anthony Hickey

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

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