MUMBAI, India, Sept. 26 -- Intellectual Property India has published a patent application (202421014670 A) filed by Kalintis Healthcare Private Limited, Vadodara, Gujarat, on Feb. 28, 2024, for 'industrial improved process for preparation of cis cevimeline hydrochloride.'
Inventor(s) include Kachhadia, Bhikhulal M; and Bhatt, Ashutosh.
The application for the patent was published on Sept. 26, under issue no. 39/2025.
According to the abstract released by the Intellectual Property India: "The invention relates to an economical, eco-friendly, and industrially viable process 5 of preparing high-quality product cis-2-methylspiro(1,3-oxathiolane-5,3') quinuclidine hydrochloride known as Cis Cevimeline Hydrochloride prepared by isomerizing racemic cevimeline hydrochloride salt using a metal catalyst to produce Cis cevimeline base in situ, which is further reacted to produce an organic acid salt, preferably, pure p-nitro benzoic acid salt of Cis cevimeline. 10 Cis Cevimeline Hydrochloride so prepared contains i) Not more than 0.5 %, preferably not more than 0.3 % of Trans isomer. ii) Not more than 0.1 % of single largest unspecified impurity; and iii) Not more than 0.15 % of single largest specified impurity, including new Cevimeline impurity-1 and 2. 15 The invention also covers a pure mixture of Cevimeline impurity-1 and 2. Additionally, by subjecting Cis Cevimeline Hydrochloride to a solvent treatment, the desired particle size distribution is achieved."
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