Method Validation Study for the Preparation and Analysis of Ingredient-Specific Particle Sizing by Raman Chemical Imaging as it Relates to the Generic Nasal Spray Suspensions

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Presented at: The 2012 Inhalation and Nasal Technology Focus Group (INTFG) 18th Annual Fall Symposium
Authors: Oksana Olkhovyk and Ryan Priore – Gateway Analytical, 5316 William Flynn Highway, Gibsonia, PA 15044
Release Date: Sept. 6, 2012

Introduction:
Accurate, objective and precise drug particle size distribution (PSD) assessment is basis for safely expediting the approval of pharmaceuticals and reducing their development cost. The FDA’s Critical Path Initiative has identified a specific need to determine in vitro drug PSD in generic nasal spray formulations, indicating if such information were obtained in an accurate and precise manner, in vivo biostudies would be waived. Gateway Analytical has developed a cGMP-compliant, automated method of Ingredient-Specific Particle Sizing (ISPS) measurements utilizing wide-field Raman Chemical Imaging (RCI).

The purpose of this study was to challenge and demonstrate the reliability, suitability, accuracy and precision of ISPS data produced by the Falcon II™ Raman Chemical Imaging System as it relates to particle sizing analysis for the nasal spray suspension. The study was aimed to address the FDA’s Critical Path Opportunity for generic manufacturers of OINDP for BE submissions, specifically for in vitro drug PSD evaluation in generic nasal spray formulations.

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Dr. Oksana Olkhovyk Ph.D., plays an important role supporting analytical testing services as the Senior Scientist at Gateway Analytical. She has over 15 years experience in Raman spectroscopy, imaging and material characterization. Dr. Olkhovyk has worked to support hundreds of projects as a scientific liaison between Gateway Analytical and their customers, as well as academic and industrial collaborators.

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