Crystalline methylthioninium chloride hydrates
AssigneeWisTa Laboratories Ltd.
InventorsRolf Hilfiker, Timo Rager
Life of this patent
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Abstract
Three dihydrate forms B, C and D and a monohydrate form E of methylthioninium chloride are described. Forms B, C, D and E can be prepared under controlled humidity and temperature from methylthioninium chloride with higher water content or conversion of a hydrate. The hydrates can be incorporated in pharmaceutical compositions.
Claims23
Crystalline methylthioninium chloride dihydrate as Form C.
Crystalline methylthioninium chloride monohydrate as Form E.
Crystalline methylthioninium chloride dihydrate as Form D.
Crystalline methylthioninium chloride dihydrate substantially as Form B.
A process for the preparation of methylthioninium chloride dihydrate substantially in form B, which comprises exposing solid methylthioninium chloride pentahydrate at about room temperature to an inert gas flow having a relative humidity from 8 to 15% for a time sufficient to generate essentially pure form B.
A pharmaceutical composition comprising methylthioninium chloride dihydrate form B, C or D or methylthioninium chloride monohydrate form E pharmaceutically acceptable carrier, excipient or diluent.
-25. (canceled)
A method of treatment of a tauopathy, Alzheimer's disease (AD), skin cancer, melanoma, Hepatitis C, HIV or West Nile virus in a patient, comprising administering to said patient a therapeutically-effective amount of methylthioninium chloride dihydrate form B, C or D or methylthioninium chloride monohydrate form E.
Dependencies are inferred from the claim text.