Last week at PITTCON, Gateway Analytical scientists, Dr. Ryan J. Priore and Dr. Oksana Olkhovyk, presented in the Pharmaceutical – LC, GC and Raman session on the validation of Ingredient-Specific Particle Sizing (ISPS) for nasal suspension products using Raman Chemical Imaging (RCI).
RCI combines the chemical identity and selectivity of Raman spectroscopy with digital imaging. Over the past few years, RCI has been applied to determine the particle size distribution (PSD) and aggregation/agglomeration of micronized drug in aqueous suspension formulation of Orally Inhaled and Nasal Drug Products (OINDP) for ISPS. The presentation summarized a validation study, conducted under cGMP controls, of ISPS applied to a nasal spray suspension formulation.
The purpose of the study was to validate the PSD measurement of the active pharmaceutical ingredient (API) of the formulation based on a wide-field RCI method. Elements of the validation, such as the system suitability, accuracy, precision, specificity, linearity (particle sizing) and limit of detection (particle sizing), were presented. PSD results of the nasal suspension validation methodology were also discussed.
For more information and to download the presentation slides, click on the link below.