A process for the preparation of mixed oxybate salts and polymorphs thereof
AssigneeAlkem Laboratories Limited
InventorsJayprakash Ajitsingh PARIHAR, Prashant Pandurang PAWAR, Praveen Raosaheb SUPEKAR, Ashutosh Akhilesh RAGHUWANSHI, Vaibhav Vilas TATTE
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Abstract
The present invention provides an improved scalable process for preparation of mixed oxybate salts. More particularly, the present invention provides a process of preparation of a mixture of sodium, potassium, magnesium and calcium oxybate salts. Further, the present invention provides polymorphs of each of the individual salts and the mixed salt along with the methods of preparation of each.
Claims23
A process for preparing a mixed oxybate salt or a polymorph thereof, wherein the process comprises:
- (i). mixing at least one oxybate in a solvent and stirring at a temperature range from 0-30° C. to obtain a reaction mixture, wherein, at least one oxybate is selected from sodium oxybate, potassium oxybate, magnesium oxybate, or calcium oxybate;
- (ii). filtering the reaction mixture followed by washing with the solvent to obtain the mixed oxybate salt or the polymorph thereof;
- and
- wherein, the mixed oxybate salt or the polymorph thereof comprises at least one or a combination of a sodium oxybate or a polymorph thereof present in an amount of 8±0.5% by wt., potassium oxybate or a polymorph thereof present in an amount of 26±0.5% by wt., magnesium oxybate or a polymorph thereof present in an amount of 19.2±0.5% by wt., or calcium oxybate or a polymorph thereof is present in an amount of 46.8±0.5% by wt.
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Dependencies are inferred from the claim text.