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With RCI you can now obtain ingredient-specific particle size information of your pharmaceutical nasal spray suspensions, aerosols and other metered-dose inhalers. This measurement gives you critical information to compare the specific size, shape and distribution of one or more active ingredient(s) when testing for bioequivalence.
- Easily determine the particle size of an active ingredient
- Provides a spectroscopic basis for discriminating nasal spray ingredients based on the chemical makeup of the individual components
- Provides the ability to identify drug/drug or drug/excipient aggregates and particle size distribution (PSD)
- Investigate changes that may occur in the formulation as a result of particle agglomeration
- Provides necessary information for conclusive in vitro BE comparison of drug PSD
ISPS Instrumentation
ChemImage utilizes the FALCON II™ Wide-Field Raman Chemical Imaging System for all ISPS applications and laboratory services. Combining optical microscopy with chemical imaging provides information about the size and chemistry of the formulation ingredients. Chemical images, rather than single point spectra, are obtained over a normal microscope’s field-of-view, reducing time to obtain this information on a statistically significant number of drug particles. This method also enables the investigation of agglomerates and their chemical makeup, which current optical microscopy and spectroscopy alone cannot do.
A joint research paper between ChemImage and FDA personnel titled “Raman Chemical Imaging for Ingredient-Specific Particle Size Characterization of Aqueous Suspension Nasal Spray Formulations” has been written on this effort.
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