Patent No. EP3785702 (titled "Microparticulate Varenicline Citrate") was filed by Alfred E Tiefenbacher on Mar 6, 2020. The application was issued on Jul 20, 2022.
A new form of varenicline citrate, a drug used to treat nicotine addiction, that provides consistent properties and uniform dosing. The new form is a microparticulate hydrate of varenicline citrate, obtained by precipitating the salt from a solvent mixture. This avoids the need for micronization to achieve uniformity, as the microparticles form spontaneously. The new form has a consistent water content, around 1.5-5%, and X-ray diffraction pattern. It enables uniform batch, blend, and dosage form properties for varenicline citrate, simplifying manufacture and dosing consistency.

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