API Polymorphic Forming

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Efficient Method for Finding New API Polymorphic Forms and Establishing Polymorph Composition Density Gradient Technology for Separating APIs into Crystalline Forms Technology Overview The patented technology has the unique capability to physically separate crystalline active pharmaceutical ingredients (API) in their crystalline solid form revealing the presence of previously unknown forms and permitting subsequent characterization or use as seed crystals. The method uses a density gradient formed by a pair of non-aqueous liquids, with API polymorph separation based on density differences. The densities of known polymorphic forms are available if their crystal structures have been determined, aiding rapid development of the method for the specific API for suitable separation of its forms. The density gradient can be adjusted to enhance separation for API forms differing only slightly in density. Current methods of detection of polymorphic crystal forms in API preparations are dependent on prior determination of characteristic properties for detection in a mixture. Advantages Easy scale-up Gradients are stable for several days Efficient method to find new polymorphic forms Enables testing with non-aqueous solutions to prevent dissolving in the gradient Permits study as is or as seed crystals for making more of same polymorphic form Only current method that separates particulates into or as polymorphic forms and keeps them at crystalline level Limitations Not useful for APIs that dissolve rapidly in non-polar solvents Other Information The method is usefully employed in early API development when polymorphic forms are being sought, to establish the polymorphic form profile in Quality by Design process and in product shelf-life determinations in regard to change in polymorphic form. Suggested Uses The market is the pharmaceutical sector, including generic manufacturing, process science, and analytical laboratories, and law enforcement and regulatory agencies (FDA, DEA) that have purity testing facilities. Development Stage development Technology Sectors Health and Safety Therapeutic Drug Discovery Medical Chemicals Devices Tags Pharmaceutical, polymorphic form, density gradient, Crystalline APIs, API, efficient devices File Number 100621 IP Protection Patent Number(s): 9,089,850 Publications no available publications specified Inventors Bruce Hudson