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Unraveling the Pulmonary Fate of Fluticasone and Friends: Meeting the Physiologic and Pharmacokinetic Challenges

Hochhaus G, Chen M, Shur J, Kurumaddali A, Schilling U, Jiao Y, Drescher SK, Amini E, Seay B, Baumstein SM, Abu-Hasan MN, Hindle M, Wei X, Oguntimein O, Carrasco C, Winner L, Delvadia RR, Saluja B, Kandala B, Sandell D, Lee SL, Price R, Conti DS, Bulitta JB.

Respiratory Drug Delivery 2020. Volume 1, 2020: 139-146.


The ability of pharmacokinetic (PK) studies to evaluate the pulmonary fate and to assess pulmonary bioequivalence (BE) of fluticasone propionate (FP) inhalation products without the need to perform comparative clinical endpoint studies is still debated among stakeholders. This paper discusses the physiological basis and possible justification for using PK as a potential tool to assist in BE decision-making for FP inhalation products. Results of a study that evaluated the PK of three different FP dry powder inhaler (DPI) formulations through both non-compartmental and compartmental analysis are described. They showed agreement with the in vitro characteristics of the formulations, underlining that PK may be able to provide comparative information on the pulmonary available dose, pulmonary residence time and regional lung deposition (the key attributes for determining pulmonary BE) while relating observed PK differences to the in vitro properties of the formulations and their regional lung deposition, dissolution and permeability.

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