Influence of modified induction port, modified DUSA assembly and device air-inlet geometry on the aerosolization pattern of a dry powder inhaler

Abstract

The objective of the present investigation was to study the effect of inhaler air-inlet size, induction port (IP) geometry and modified dose unit sampling apparatus (DUSA) on the aerodynamic behavior of fluticasone propionate (FP) dry powder inhaler (DPI). The physicochemical properties of FP and inhalation grade lactose particles, such as particle size distribution, moisture content and surface morphology were assessed while developed FP DPI was assessed using energy-dispersive X-ray spectrometry. Afterward, the aerodynamic outcome of the FP DPI was evaluated by using Andersen cascade impactor (ACI) equipped with USP modified IP and inhaler devices with different air-inlet size. Likewise, modified DUSA assembly was used to assess the delivered dose uniformity (DDU) of FP DPI. Micronized irregular shaped FP (d90; 3.30) particles and lactose carriers (d90; 130.84) showed particle size suitable for inhalation. Furthermore, formulated FP FPI achieved good content uniformity (>97%). ACI analysis exhibited a remarkable difference in the stage-wise drug deposition pattern. In terms of FPF, Lupihaler® (uniform air-inlet) displayed 1.12-fold superior performance as compared to Lupihaler-T® (t-shaped air-inlet) device. Moreover, modified DUSA assembly exhibited consistent and reproducible delivered dose using both devices. This research work is a first thorough report of FP DPI using a USP-modified IP inhaler with devices signify the opposite ends of air inlet size. Hence, it can be of budding significance for both institutional and industrial research.