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.
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).