This research paper delves into the evaluation of different setups to combine Spraytec and Unidose™ for assessing the particle size distribution of dry powder inhalers. The study is a significant stride in the field of respiratory drug delivery, focusing on the therapeutic effect of dry powder and the factors influencing its performance. The paper presents a detailed analysis of the impact of formulation physico-chemical and device factors on the fluidization of a static powder bed under patient air flow. It also introduces an apparatus, Unidose™, developed to capture the whole impactor sized mass (ISM) dose onto a filter for subsequent analysis in terms of microstructure, dissolution, and morphology directed Raman microscopy (MDRS). The research paper provides valuable insights into the particle size distribution of the ISM dose by laser diffraction and automated imaging, offering a comprehensive understanding of the subject matter. article focuses on the concept of structural Q3 equivalence for Orally Inhaled and Nasal Drug Products (OINDPs), a vital approach for the industry. It introduces SmartTrack, a process that combines the recording of inspiratory breath profiles with realistic aerodynamic particle size distribution performance testing. This approach provides the critical elements required to meet the alternative requirements and eliminate clinical endpoint bioequivalence studies, accelerating and de-risking generic product development. The article concludes by highlighting the benefits of this alternative approach, including reduced development time and cost, providing companies with a clear and compelling competitive advantage.
FDA’s Evolving Stance on In-Silico Studies in Bioequivalence Testing
The paper titled “Microstructural Characterization of Dry Powder Inhaler Formulations Using Orthogonal Analytical Techniques” explores the use of advanced analytical methods to improve our understanding of the performance of dry powder inhalers (DPIs).