Aerodynamic characteristics of dry powder inhaler (DPI) single-dose combination of budesonide with formoterol in vitro study validation

Background : The aerodynamic properties of dry powder inhalers are essential for drug efficacy. Despite the availability of several devices, few studies have measured aerodynamic characteristics of the drug delivery using their proper device. Aim: To describe the aerodynamic characteristics of the combination dry powder inhaler (DPI) Alenia® single-dose AeroCaps®(AA), which contains budesonide (BUD) and formoterol fumarate (FF) when compared with Foraseq® Aerolizer®(FA) as the reference combination drug. Methods: They were assessed using quantitative sample analysis by high pressure liquid chromatography (HPLC), dose uniformity sampling apparatus (DUSA) and Andersen cascade impactor (ACI) to confirm the presence of active ingredients as well as the uniformity of released dose and the aerodynamic diameter of particles produced by their proper devices. Results: Table 1 summarize the experiments. Alenia showed microbial quality control within acceptable Conclusions: Alenia® and Foraseq® had active ingredients, dose uniformity and appropriate aerodynamic diameter to their respective dry powder inhalers. Funded by Ache Laboratorios.