Gateway Analytical has teamed up with researchers from the Division of Pharmaceutical Analysis at FDA/CDER to present new findings on temperature-mediated agglomeration assessment in Orally Inhaled and Nasal Drug Products. This study was performed to address aqueous nasal spray suspensions stability during long-term shipping/storage. During the study, suspension formulations were subjected to temperatures that may possibly be reached inside shipping containers during hottest and coldest months in St. Louis, MO.
During this recent webinar, Dr. Oksana Olkhovyk presented on the benefits of this novel method of particle sizing that automatically measures particle size distribution. She also discussed specific references to FDA bioequivalence guidance documentation, innovative product design and intellectual property benefits.
Gateway Analytical will be offering a new webinar series for scientists, focused on chemical imaging, June though September of this year. This webinar series is designed for scientists developing and manufacturing various types of pharmaceutical products; including nasal, inhalation, semi-solid, solid, and controlled release drug delivery.
In 2004, the FDA launched the Critical Path Initiative as a national strategy to drive innovation in development, evaluation and manufacturing of medical products1. As part of this initiative, the FDA identified a number of Critical Path Opportunities (CPOs) for generic drugs. Namely the CPO for Bioequivalence of Nasal Sprays, which identifies a need for direct measurement of particle size equivalence in suspension nasal sprays2.
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).