Equivalent Lung Dose and Systemic Exposure of Budesonide/Formoterol Combination via Easyhaler and Turbuhaler

Journal of Aerosol Medicine and Pulmonary Drug Delivery
Satu LähelmäMerja Kirjavainen

Abstract

Easyhaler(®) device-metered dry powder inhaler containing budesonide and formoterol fumarate dihydrate (hereafter formoterol) for the treatment of asthma and chronic obstructive pulmonary disease has been developed. The current approvals of the product in Europe were based on several pharmacokinetic (PK) bioequivalence (BE) studies, and in vitro-in vivo correlation (IVIVC) modeling. Four PK studies were performed to compare the lung deposition and total systemic exposure of budesonide and formoterol after administration of budesonide/formoterol Easyhaler and the reference product, Symbicort Turbuhaler. The products were administered concomitantly with oral charcoal (lung deposition) and in two of the studies also without charcoal (total systemic exposure). Demonstration of BE for lung deposition (surrogate marker for efficacy) and non-inferiority for systemic exposure (surrogate marker for safety) were considered a proof of therapeutic equivalence. In addition, IVIVC models were constructed to predict study outcomes with different reference product fine particle doses (FPDs). In the first pivotal study, the exposure and lung dose via Easyhaler were higher compared to the reference product (mean comparison estimates between 1.07...Continue Reading

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Citations

Apr 14, 2016·Expert Opinion on Pharmacotherapy·Ole D Wolthers
Feb 6, 2020·Expert Review of Respiratory Medicine·Henry Chrystyn, Federico Lavorini
Jul 19, 2021·International Journal of Pharmaceutics·Snezana RadivojevEleonore Fröhlich
Aug 20, 2021·AAPS PharmSciTech·Elise Burmeister GetzLeslie Z Benet
Aug 31, 2021·Advanced Drug Delivery Reviews·Michael Yee Tak ChowPhilip Chi Lip Kwok

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Methods Mentioned

BETA
contraception

Software Mentioned

SAS
Easyhaler
WinNonlin

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