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01 Aug 2020

Raman Spectroscopy for Nasal Suspension Drugs


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.

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Nanopharm Announces Exclusive Collaboration With Fluidda To Accelerate Regulatory Pathway For OINDP Using SmartTrack

Crystal Lake, Illinois, September 22, 2022 – Nanopharm, an Aptar Pharma company and leader in contract research and development services for orally inhaled and nasal drug products (OINDPs), today announced an exclusive collaboration with Fluidda, a leader in the field of Functional Respiratory Imaging. The companies will leverage their respective proprietary technology platforms to help accelerate U.S. Food & Drug Administration (FDA) approvals for orally inhaled generic products (OIDPs) via the alternative bioequivalence pathway. Nanopharm was acquired by Aptar (NYSE: ATR) in 2019, as part of the company’s strategy to expand its services offerings and partner with pharmaceutical companies earlier in the drug development process.

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