Accurate, objective and precise drug particle size distribution (PSD) assessment is basis for safely expediting the approval of pharmaceuticals and reducing their development cost. The FDA’s Critical Path Initiative has identified a specific need to determine in vitro drug PSD in generic nasal spray formulations, indicating if such information were obtained in an accurate and precise manner, in vivobiostudies would be waived. Gateway Analytical has developed a cGMP-compliant, automated method of Ingredient-Specific Particle Sizing (ISPS) measurements utilizing wide-field Raman Chemical Imaging (RCI).
The purpose of this study was to challenge and demonstrate the reliability, suitability, accuracy and precision of ISPS data produced by the Falcon II™ Raman Chemical Imaging System as it relates to particle sizing analysis for the nasal spray suspension. The study was aimed to address the FDA’s Critical Path Opportunity for generic manufacturers of OINDP for BE submissions, specifically for in vitro drug PSD evaluation in generic nasal spray formulations.