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.
The results of this study will be presented at the upcoming RDD 2014 Puerto Rico in a poster session titled, “Chemically Specific Analysis of OINDP: Differentiation of Drug Particle Agglomeration by Raman Imaging”, authored by Oksana Olkhovyk from Gateway Analytical, and Diem Ngo and William H. Doub from the FDA/CDER/Division of Pharmaceutical Analysis.
In a recent Q&A interview on OINDP News, Bill Doub the Lead Chemist, R&D in the FDA’s Division of Pharmaceutical Analysis discussed the partnership that ChemImage (Gateways parent company) and Gateway Analytical have had over the past 8 years, mainly focused on chemically specific particle size analysis using Raman Chemical Imaging. You can find out more about Gateways chemically specific analysis capabilities in the whitepaper: Chemically Specific Analysis of Aggregates in Nasal Spray Suspensions.
More details on the poster will be released after its presentation at RDD, and a download link will be made available on Gateways Website. If you have questions about the poster or would like to talk to Oksana Olkhovyk please contact us.