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Pharmacokinetics of Orally Inhaled Drug Products

  • Meeting Report
  • Theme: Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products
  • Published:
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Abstract

The presentations at the Orlando Inhalation Conference on pharmacokinetic (PK) studies indicated that PK is the most sensitive methodology for detecting formulation differences of oral inhaled drug products (OIDPs) that have negligible gastrointestinal bioavailability or for which oral absorption can be prevented (e.g., ingestion of charcoal). PK studies, therefore, may represent the most appropriate methodology for assessing local and systemic bioequivalence (BE). It was believed by many (but not all participants) that potential differences between formulations are more likely to be detected in healthy adult volunteers, as variability is reduced while deposition to peripheral areas is not restricted. A study design allowing assessment and statistical consideration of intra-subject and inter-batch variability within the evaluation of BE studies was suggested, while optimal inhalation technique during PK studies should be enforced to decrease variability. Depending on the drug and in vitro method, in vitro tests may not detect differences in PK parameters. Harmonization of BE testing requirements among different countries should be encouraged to improve global availability of low cost OIDPs and decrease industry burden.

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Conflict of Interest

Dr. Hochhaus is the PI on research grants to the University of Florida for the FDA, Astra-Zeneca, and Compleware. Dr. Horhota is an employee of Boehringer-Ingelheim. Dr. Hendeles is the PI on research grants to the University of Florida for GlaxoSmithKline, Teva, and Novartis. Dr. Suarez has no conflicts. Dr. Rebello is an employee of Cipla.

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Authors and Affiliations

  1. Pharmaceutics, University of Florida, PO Box 100494, Gainesville, FL, 32610-0494, USA

    Günther Hochhaus

  2. Highly Distinguished Research Fellow, Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA

    Stephen Horhota

  3. Pharmacotherapy and Translational Research, University of Florida, Gainesville, FL, USA

    Leslie Hendeles

  4. U.S. Food and Drug Administration, Silver Springs, MD, USA

    Sandra Suarez

  5. Clinical Research (Respiratory), Cipla, Mumbai, India

    Juliet Rebello

Authors
  1. Günther Hochhaus
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  2. Stephen Horhota
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  3. Leslie Hendeles
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  4. Sandra Suarez
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  5. Juliet Rebello
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Corresponding author

Correspondence to Günther Hochhaus.

Additional information

Guest Editors: Lawrence Yu, Sau L. Lee, Guenther Hochhaus, Lana Lyapustina, Martin Oliver, and Craig Davies-Cutting

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Hochhaus, G., Horhota, S., Hendeles, L. et al. Pharmacokinetics of Orally Inhaled Drug Products. AAPS J 17, 769–775 (2015). https://doi.org/10.1208/s12248-015-9736-6

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  • DOI: https://doi.org/10.1208/s12248-015-9736-6

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