New RTI Press book discusses essential considerations for the development of inhaled drug products

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RESEARCH TRIANGLE PARK, NC – Decades of innovations in inhaled pharmaceutical product development show the benefits of inhaled drug therapy to treat diseases such as asthma and cystic fibrosis. A new book, “Inhaled Pharmaceutical Product Development Perspectives: Challenges and Opportunities,” discusses the current state of the science of inhalation technology and its potential as a route of drug administration for a broader range of diseases. The book offers researchers and others in the field a comprehensive look at the current landscape and also discusses the limitations they may have to overcome in the pursuit of future innovation.

Published by Elsevier and RTI Press and written by Anthony J. Hickey, PhD, DSc, a Distinguished Fellow at RTI International, this new book brings together emerging analytical and inhalation technologies, providing perspectives on formulation and device design, development, regulatory compliance, and practice.

Hickey addresses areas for consideration and the corresponding challenges and opportunities that scientists encounter when developing inhaled pharmaceuticals, including:

  • Diseases: Variations in disease targets preclude consideration of product development for specific pharmacodynamic or clinical outcomes.
  • Dosage forms: While there are four primary dosage forms that are currently the standard, new technical processes can facilitate design and scale-up.
  • Preclinical and clinical considerations: Scientists must consider the possibility of making quantitative measures that correlate significantly with therapeutic outcomes and limit the dependence on insensitive physiological outcomes.
  • Regulatory strategy: The Food and Drug Administration (FDA) has responded to urgent public needs, but its regulatory strategy must continue to evolve to address current and future challenges related to issues such as ozone depletion and antibiotic-resistant diseases.

As inhaled drug therapy continues to be a critical approach for treating disease, we should not lose sight of the importance of these considerations learned over decades of research,” said Hickey. “The framework outlined in this book will be a useful guide to those developing inhaled drug products going forward, and will help scientists meet the goal of treating diseases as effectively as possible.”

With more than 30 years of academic and research experience, Hickey is currently a Distinguished Fellow, Aerosol and Nanomaterials Engineering (appointed in 2012), at RTI International. The founder and president of Cirrus Pharmaceuticals, Inc., Hickey holds 17 patents and has written numerous books, book chapters and journal articles.

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