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The study titled “In Vitro and In Silico Comparison of Indacaterol and Glycopyrrolate Pulmonary Deposition between a Single-Unit Dose and a Multi-Unit Dry Powder Inhaler” focuses on the comparison of pulmonary delivery performance of a reference capsule-based dry powder inhaler (DPI) and a multi-unit dose DPI. The objective of the study was to evaluate the interchangeability of these devices in terms of being bioequivalent.The study begins with an introduction to Chronic Obstructive Pulmonary Disease (COPD), a major cause of morbidity and mortality worldwide, with around three million deaths annually. The COPD pharmaceutical market is valued at $32 billion, with an additional indirect cost of $20.4 billion, mainly related to COPD exacerbations. The study mentions the Ultibro® Breezhaler® (Novartis), a fixed-dose combination of indacaterol maleate and glycopyrronium bromide, intended to reduce exacerbations in patients with COPD through once-daily maintenance treatment. However, the use of a capsule-based single-unit low resistance DPI presents many disadvantages, such as capsule handling and device loading problems for young and elderly, and the relatively large amount of inspiratory flow required to extract the formulation, which can reduce therapeutic efficacy and patients’ adherence and compliance.In the study, each blister pocket of a Wixela™ Inhub™ device (Mylan, USA) was manually filled with 12.5 mg of reclaimed Ultibro® formulation. In-line particle size distribution (PSD) measurements were carried out using a Spraytec (Malvern Panalytical Ltd, UK). The regional deposition of the aerosolised dose from the DPI devices was modelled for various regions of the lung.The results and discussion section of the study reveals that the Spraytec PSD measurements of the aerosol emitted from the two devices tested were comparable. The general aerodynamic performance of the two devices was not significantly different in terms of Mass Median Aerodynamic Diameter (MMAD), Geometrical Standard Deviation (GSD), and Fine Particle Mass (FPM) <5 µm. Furthermore, there was no significant difference in the emitted dose (ED) from the two DPI devices.In conclusion, the pulmonary delivery performance of the two devices were comparable. There was no significant difference in the in vitro aerodynamic distribution of the single-unit and the multi-unit DPI. These data supported the similar in silico regional deposition modelling of the fate of the respirable dose. These preliminary results support the possibility of achieving clinical bioequivalence between these single-unit dose and multi-unit dose DPIs, and thus opening the door to a possible switch to a more patient-friendly and efficient multi-unit device.
