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.
Gateway Analytical has been working with customers for the last two years to help realize this opportunity. For this CPO, the benefit to the generic drug manufacturers is that, if drug particle size is measured with sufficient accuracy and precision, in vivo bio-studies may be waived saving millions of dollars in clinical trials and helping to decrease the time to market! Currently a validated method for in vitro drug particle size distribution measurements does not exist. As a result, potential approvals can slow dramatically and require costly and time consuming in vivo biostudies.
Gateway Analytical, along with its parent company ChemImage Corp., has done extensive studies with the FDA using the Falcon II instrument for Ingredient-Specific Particle Sizing™ as it applies to the CPO. The technology driving the Falcon II is based on wide-field Raman Chemical Imaging.
Using this method, we can provide our customers with the necessary empirical data about the drug particle size distribution for a specific drug product, as part of establishing bioequivalence for generic formulations. As part of this offering, Gateway Analytical scientists develop a validation protocol for the specific drug product. This protocol is then implemented all the way through to testing for bio-equivalency of the drug product, and used for submission of the generic drug product to help prove bio-equivalency as stated in the FDA CPO.
For additional information on the CPO offered by the FDA follow the links below: