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The document titled “The Role of In Silico Regional Deposition Modelling and Pharmacokinetic Profiling in the Development of a Generic Tiotropium Dry Powder Inhaler” presents a comprehensive study on the development of a generic Tiotropium Dry Powder Inhaler. The study employs realistic breathing profiles, in silico Regional Deposition Model (RDM), and a physiologically-based PK simulation model to compare a tiotropium generic formulation loaded in the Aptar Prohaler® with reference Spiriva® HandiHaler® DPI formulations. The document emphasizes the importance of detecting differences in the lung dose by comparing the area under the plasma concentration time curves (AUC0-inf) and the peak plasma concentrations (Cmax). It also discusses how formulation and device characteristics can impact these parameters. The study concludes that conventional compendial APSD testing can only partially predict in vivo product behavior and highlights significant batch to batch variability in the in vitro performance of the reference product Spiriva® HandiHaler®.
