Nov 18 2009
Obtaining drug particle size information in respiratory products is important to understand the deliverable drug load, respirable fraction, and overall quality as well as from a cost perspective. Prior to entering clinical trials, this additional data can provide invaluable information, raising confidence and lowering risk of failure in vivo biostudies. The value and importance of gaining this information before taking the expensive step of beginning clinical development cannot be emphasised enough.
“We are excited to be able to provide our customers with information that can both improve the quality of their respiratory products as well as save them time and money in the long run,” said Dr. Thomas Voigt, Executive Vice President of ChemImage Corporation.
The technique uses ChemImage’s unique technology combination of Raman chemical imaging, optical microscopy, and semi-automated data gathering and analysis software to identify particles based on their unique chemistry (for example active pharmaceutical ingredient(s) versus excipients) as well as to analyse the particle size distribution in one step. Chemical information is based on the component chemistry identified by the unique Raman signature. This technique addresses the need for a fundamental understanding of API particles in the presence of other undissolved excipients in the formulation and can be used to study ISPS, aggregation and dispersion characteristics.
“We see a growing trend in the pharmaceutical industry of orally inhaled and nasal drug products with more than one active pharmaceutical ingredient,” said Dr. Voigt. “In this case, morphological indications will not be enough to identify chemistry of particles in these formulations. Raman chemical imaging provides a much more objective method for ingredient-specific particle sizing.”
As one of the premiere meeting venues for the inhalation community, DDL provides an avenue for ChemImage to interface with researchers and business representatives regarding their product development challenges. ChemImage will be available at booth #9 to discuss chemical imaging product and service offerings.
Source: http://www.chemimage.com/