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AssigneeActavis Group Ptc Ehf
InventorsVenkata Subbarao Athukuri, Saidugari Swamy, Mayur Devjibhai Khunt, Nitin Sharadehandra Pradhan
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Provided herein are solid state forms of ranolazine salts. Also provided is a stable amorphous form of ranolazine hydrochloride having a water content of less than about 0.5% by weight. Further provided are amorphous co-precipitates of ranolazine or a pharmaceutically acceptable salt thereof with povidone. Processes for the preparation of ranolazine forms, pharmaceutical compositions, and methods of treating thereof are also included. The solid state forms of ranolazine salts are useful for preparing ranolazine in high purity.
Solid state form of a salt of 1-[3-(2-methoxyphenoxy-2-hydroxypropyl]-4-[(2,6-dimethylphenyl)aminocarbonylmethyl]piperazine (ranolazine salt), wherein the salt of ranolazine is an oxalate salt, a maleate salt, a fumarate salt, a besylate salt, a tosylate salt, or a dihydrobromide salt.
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The process of claim 65, wherein the solvent used in step-(a) is selected from the group consisting of water, methanol, ethanol, isopropyl alcohol, acetone, methylene chloride, and mixtures thereof;
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A process for preparation of ranolazine or a dihydrochloride salt thereof, comprising converting a solid state form of a ranolazine salt to ranolazine or a dihydrochloride salt thereof, wherein the salt of ranolazine is an oxalate salt, a maleate salt, a fumarate salt, a besylate salt, a tosylate salt or a dihydrobromide salt.
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The process of claim 265, wherein the solid state form of ranolazine salt is the ranolazine dihydrobromide salt in a crystalline form, prepared by a process comprising:
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An amorphous co-precipitate comprising ranolazine or a pharmaceutically acceptable salt thereof and povidone (polyvinylpyrrolidone), wherein the pharmaceutically acceptable salt of ranolazine is a dihydrochloride salt, a dihydrobromide salt, an oxalate salt, a maleate salt, a fumarate salt, a besylate salt, a tosylate salt or a tartrate salt.
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Dependencies are inferred from the claim text.