Ingredient-Specific Particle Size Analysis


As nasal and inhaled drug delivery products become more common, so too does the opportunity for pharmaceutical companies and contract research organizations to expand market share. With this opportunity comes a challenge - especially for nasal spray suspensions - to measure ingredient-specific particle size (ISPS) distribution within the drug product.

ChemImage's patented technology provides simultaneous spatial information (size, distribution, shape) and spectral information (chemical identification of particles) that are key to measuring the drug particle size distribution within nasal and inhalable products, semi-solids like creams and gels and more.

Obtain this information by bringing the technology into your lab, or take advantage of our lab services.  We are happy to work with our customers to build a case for purchase of this innovative technology or on a project or on-going contract basis. 

Raman Chemical Imaging (RCI) Applications:

For Generics

Bioequivalence testing of nasal spray suspensions are achieved through a number of measurements including droplet size distribution, plume geometry, and spray pattern; clinical equivalence studies; pharmacokinetic studies to demonstrate equivalence of systemic exposure, according to the U.S. Food & Drug Administration (FDA). 1

Without a validated method for drug particle size distribution measurements within the drug product, potential approvals and patents can slow dramatically. ChemImage’s technology can especially help generic drug makers be the first to market due to increased speed of test methods and accuracy of overall information for bioequivalence testing.

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For Innovators

Innovative formulators can also utilize Raman chemical imaging technology to develop one-of-a-kind, hard to duplicate formulations. The value of the chemical image comes from the importance of knowing where drug particles are in relation to other materials and how they are distributed. This provides a wholesale opportunity for drug development and product advances that translates to real competitive advantages. What’s more, this technology can also be used as part of batch release testing.

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1U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. April 2003, Draft Guidance for Industry, Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action.