For the third consecutive year Gateway had the pleasure of exhibiting at the AAPS Annual Meeting, which was held this year in San Antonio, at the very large Henry B. Gonzalez Convention Center. AAPS members and attendees come from a wide range of areas within pharmaceutical drug development and biopharmaceuticals. In addition to offering free popcorn daily and an open bar on Tuesday night, this year, our focus was to promote analytical services that not only support drug product formulation development but also address manufacturing issues such as particulate contamination and source determination.
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.
This year at Respiratory Drug Delivery 2012, Dr. Oksana Olkhovyk will be presenting a poster with Christopher Vernall from the University of Bath which is located in the UK. This year’s poster topic, titled: “Investigation of the Microstructure of Combination Dry Powder Inhaler Formulations by Atomic Force Microscopy and Raman Chemical Imaging”, aims to investigate the microstructure of commercial Seretide® Accuhaler® using RCI and the cohesive-adhesive balance (CAB) approach to colloid probe AFM.
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).