Industry News: “A Novel Approach for the In-Vitro Drug Release Testing of Metered Dose Inhalers”

In late June 2020, Bryan Crist, Scientific Affairs Manager for Agilent’s Dissolution business, in conjunction with the Controlled Release Society’s annual meeting, presented “A Novel Approach for the In-Vitro Drug Release Testing of Metered Dose Inhalers.” The presentation was based on the research performed by the National University of Singapore and utilized Agilent’s Enhancer Cell.

Abstract: Dissolution of inhalers have been previously tested in typical dissolution apparatus on un-fractioned powders and particles collected from the metered dose inhaler. In this study, full fine particle fractions (FPF) were collected with the use of a modified Anderson cascade impactor (ACI). The products consisting of the FPF were collected with the USP Cascade impactor with a polytetrafluoroethylene funnel (TF) a small collection plate (CP) modification. The fractions were mounted in an Agilent Enhancer Cell which conformed to USP <1724> Immersion Diffusion Cell - Model A and placed within the 200 mL vessel containing 50 mL of Gamble’s solution with 0.2% v/v Tween 80. The resulting dissolution profiles showed burst release of salbutamol sulfate while demonstrating a sustained release profile of fluticasone. The study performed at the National University of Singapore demonstrated a reproducible method which may be used for evaluation of the full FPF of orally inhaled products.

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