Reducing Time Requirements for Morphologically Directed Raman Spectroscopy Based In Vitro Bioequivalence Studies

DDL 2023 Slide Request

IVBE studies have formed part of increasing numbers of abbreviated new drug applications (ANDAs) for generic nasal drug products (OINDPs) over the past decade. Morphologically directed Raman spectroscopy (MDRS) can selectively measure the particle size and morphology of separate species within multi-component blends and suspensions, enabling the characterization of the size of a drug particle, and inferring the dissolution characteristics to a level where clinical endpoint studies may be entirely bypassed when demonstrating bioequivalence for certain products. MDRS measurements, however, can take many hours so the approach can be limiting considering a typical full IVBE study may involve a minimum of 60 replicates.

In his presentation, our expert, Ben Stafford, Scientist, describes how optimisation of the MDRS approach using a highly API-selective microscopy-only analysis can confidently measure comparative particle size distributions without full Raman ID for every replicate. This could allow for a reduction in the time and financial requirements when conducting future IVBE studies for generic nasal drug products.

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