Polymorphs of memantine hydrochloride
AssigneeTeva Pharmaceutical Fine Chemicals S.r.l.
InventorsValeriano Merli, Paola Daverio, Adrienne Kovacsne-Mezei, Judith Aronhime
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Abstract
A crystalline Form II of memantine hydrochloride, pharmaceutical compositions containing crystalline Form II, and methods of preparing crystalline Forms I and II of memantine hydrochloride are provided.
Claims32
Memantine hydrochloride crystalline Form II, characterized by at least one of an X-ray powder diffraction pattern having peaks at about 6.7, 13.3, and 20.2±0.2 degrees 2θ;
- an infrared spectrum having peaks at about 3446, 3396, 2056, 1650, 1621, 1532, 1521, 1384, 1190, 1162, 1061, 1030, 965, 934, and 721 cm−1, and a DSC thermogram having endothermic peaks at about 50° C., 90° C., and 341° C.
A method for producing memantine hydrochloride crystalline form characterized by X-ray powder diffraction peaks at about 6.3, 12.5, and 18.8±0.2 degrees 2θ, comprising:
- providing a solution of memantine hydrochloride in C1-4 alcohols;
- exposing the solution to an anti-solvent selected from the group consisting of C1-5 ketones or C1-5 alkyl esters to obtain a precipitate;
- and recovering memantine hydrochloride Form I
A method for producing a memantine hydrochloride form characterized by X-ray powder diffraction peaks at about 6.7, 13.3, and 20.2±0.2 degrees 2θ.±0.2 degrees 2θ, the method comprising:
- providing a solution of memantine hydrochloride in a solvent selected from the group consisting of water, C1-5 alcohols, DMF, and DMSO;
- and admixing an anti-solvent selected from the group consisting of C6-10 aromatic hydrocarbons, open or closed-chained C1-5 alkyl ethers, C1-5 ketones, C1-5 amides, carbonate, esters, and amides to cause formation of precipitation;
- and recovering memantine hydrochloride Form I.
A method for a producing memantine hydrochloride form characterized by X-ray powder diffraction peaks at about 6.7, 13.3, and 20.2±0.2 degrees 2θ.±0.2 degrees 2θ, the method comprising:
- providing a solution of memantine HCl in a solvent selected from the group consisting of water, C1-4 alcohols, C6-10 aromatic hydrocarbons, C1-4 halo-substituted hydrocarbons, esters, and C1-5 alkyl ethers;
- cooling the solution to initiate precipitation;
- and recovering memantine hydrochloride Form I.
A method for producing a memantine hydrochloride crystalline form characterized by X-ray powder diffraction peaks at about 6.7, 13.3, and 20.2±0.2 degrees 2θ.±0.2 degrees 2θ, comprising:
- concentrating a solution of memantine hydrochloride and a solvent selected from the group consisting of C1-4 alcohols and halo-substitution thereof;
- and recovering memantine hydrochloride Form I.
Dependencies are inferred from the claim text.