This research article explores the systematic development of the Morphologically-Directed Raman Spectroscopy (MDRS) methodology, a novel approach for characterizing nasal suspension drug products. The study is a significant stride in the pharmaceutical industry, as it provides a comprehensive understanding of the particle size distribution (PSD) of Active Pharmaceutical Ingredients (APIs) in nasal suspension formulations.
The article discusses the application of MDRS in the analysis of four different particle size fractions of the API Mometasone Furoate Monohydrate (MFM), which were formulated into four nasal suspension formulations. The study reveals that the API particle sizes chosen in these manufactured batches did not significantly impact the in vitro characteristics measured, suggesting that an additional technique, such as MDRS, is necessary to characterize Particle Size Distribution of the API once formulated.
The research also highlights the importance of comparing automated imaging results via MDRS with a more sensitive technique such as laser diffraction. This comparison ensures that both techniques are providing comparable results and measures the API PSD using MDRS prior to and after manufacturing the nasal suspension formulation batches to track any changes in the API PSD caused by the manufacturing process.
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.
