Chemically Specific Analysis of Aggregates in Nasal Spray Suspensions

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A recently introduced technique that uses Raman Chemical Imaging (RCI) for chemically specific particle sizing provides a greatly improved method for the analysis of aggregates and agglomerates in nasal spray suspension formulations.

Performed in a GMP environment by skilled analysts who develop validated methods for each individual formulation, the RCI technique has the potential to address the FDA’s Critical Path Opportunity (CPO) for direct measurement of particle size equivalence in nasal spray suspensions, possibly allowing for a waiver of in vivo biostudies and savings of millions of dollars in development costs and up to half of the time required for clinical studies.