Bioequivalence studies of suspension-based nasal sprays are challenging tasks for generic drug developers.Researchers should not only conduct consistency studies on the dosage and formulation characteristics of excipients in accordance with the requirements of the guidelines,but also need to use analytical tools to determine the consistency of key quality attributes such as particle size and particle size distribution of active pharmaceutical ingredients.This study explored the application of morphologically-directed Raman spectroscopy in the study of particle size distribution of nasal suspensions.The method has been approved by the U.S.FDA for the studies that substitute bioequivalence of clinical endpoints,which is critical for cost reduction and faster development for consistency evaluation of suspension-based nasal spray products.
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