White Paper Preview:
A recently introduced technique that uses Raman Chemical Imaging RCI) for ingredient-specific particle sizing (ISPS) provides a greatly improved method of analyzing 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.
Particle size distribution (PSD) of the active ingredient in a nasal spray suspension has a significant impact on its dissolution rate: larger particles will dissolve more slowly than smaller particles, affecting availability of the drug at the deposition site. As a result, establishing bioequivalence between an innovator and a reference drug requires the sponsor to establish that the drug PSDs of the two products are equivalent…
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