Pharmacokinetics of Orally Inhaled Drug Products

The AAPS Journal
Günther HochhausJuliet Rebello

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.

References

Oct 1, 1992·British Journal of Clinical Pharmacology·M Hindle, H Chrystyn
Oct 1, 1994·The European Respiratory Journal·L ThorssonT B Conradson
Oct 24, 2007·Pulmonary Pharmacology & Therapeutics·Staffan EdsbäckerJarl Ingelf
Feb 6, 2010·Journal of Aerosol Medicine and Pulmonary Drug Delivery·Wallace P AdamsLawrence Yu
Apr 2, 2011·Journal of Aerosol Medicine and Pulmonary Drug Delivery·Dennis O'ConnorSandra Suarez Sharp

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Citations

Aug 25, 2015·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·K SouleleV Karalis
Apr 5, 2017·Biopharmaceutics & Drug Disposition·Konstantina SouleleVangelis Karalis
Sep 8, 2018·Therapeutic Delivery·Rodrigo CristofolettiAndrea Diniz
Jun 27, 2019·AAPS PharmSciTech·Marcia Cavallin SilvaGustavo Mendes Lima Santos
Jul 4, 2019·Drug Metabolism and Disposition : the Biological Fate of Chemicals·Donglu ZhangS Cyrus Khojasteh
Apr 26, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Astrid BaclePascal Le Corre
Aug 20, 2021·AAPS PharmSciTech·Elise Burmeister GetzLeslie Z Benet

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