Exploring the impact of extrinsic lactose fines, a USP modified sampling device and modified centrifuge tube on the delivered dose uniformity and drug detachment performance of a fluticasone propionate dry powder inhaler
作者： Piyush P Mehta , Shivajirao S Kadam , Atmaram P Pawar , None
DOI: 10.1016/J.JDDST.2020.101681
关键词:
摘要: Abstract The present study aimed to probe influences exerted by extrinsic lactose fines on drug detachment and delivered dose uniformity (DDU) of fluticasone propionate (FP) dry powder inhaler (DPI). Extrinsic (0–35%) containing pre-blends were formulated using a low shear 3D shaker mixer systematically analyzed for various physicochemical properties. Moreover, FP DPIs assessed force distribution concept the DDU two different sampling devices i.e. Dosage Unit Sampling Apparatus (DUSA) USP modified glass device (modified DUSA) coupled with Aerolizer® at 60 L/min. assessment control pre-blend samples displayed significant differences in particle size, surface roughness, degree irregularity flow monolayer-type across particles laser Raman spectroscopy acceptable content (~100%). Drug centrifuge tube showed profile. DPI 20% lowest (349.45 gf) as compared other samples. demonstrated mean (107.76 110.62 μg) coefficient variation DUSA DUSA, respectively. is first comprehensive summary devices. Accordingly, these observations may be high significance both intuitional industrial formulators.
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