The AAPS Journal

, Volume 17, Issue 3, pp 769–775 | Cite as

Pharmacokinetics of Orally Inhaled Drug Products

  • Günther Hochhaus
  • Stephen Horhota
  • Leslie Hendeles
  • Sandra Suarez
  • Juliet Rebello
Meeting Report Theme: Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products
Part of the following topical collections:
  1. Theme: Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products

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.

Keywords

Fluticasone Propionate Salmeterol European Medicine Agency Tiotropium Mucociliary Clearance 

Notes

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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Copyright information

© American Association of Pharmaceutical Scientists 2015

Authors and Affiliations

  • Günther Hochhaus
    • 1
  • Stephen Horhota
    • 2
  • Leslie Hendeles
    • 3
  • Sandra Suarez
    • 4
  • Juliet Rebello
    • 5
  1. 1.PharmaceuticsUniversity of FloridaGainesvilleUSA
  2. 2.Highly Distinguished Research FellowBoehringer Ingelheim PharmaceuticalsRidgefieldUSA
  3. 3.Pharmacotherapy and Translational ResearchUniversity of FloridaGainesvilleUSA
  4. 4.U.S. Food and Drug AdministrationSilver SpringsUSA
  5. 5.Clinical Research (Respiratory)CiplaMumbaiIndia

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