Application of NIST-traceable Size Standards to Ingredient-Specific Particle Sizing

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Presented at: Drug Delivery to the Lungs 21
Authors: Linda Batykefer, Oksana Olkhovyk, Ryan Priore, Oksana Klueva and Michael Fuhrman
Release Date: December 6, 2010

Image of budesonide particles in a Rhinocort Aqua® droplet

Ingredient-specific particle size (ISPS™) based on wide-field Raman Chemical Imaging (RCI) is promising for accurate particle size determination and particle shape characterization to benefit the bioequivalence requirements for NDAs and ANDAs submissions for aqueous nasal spray suspension formulations. ISPS method was tested on NIST-traceable size standards. Calibration model was built and applied to a commercial nasal spray. Automated data acquisition and image processing produced objective, accurate
drug particle sizes with sufficient representative sampling required for product quality assessment.