Hydrate forms of alendronate sodium, processes for manufacture thereof, and pharmaceutical compositions thereof
AssigneeTeva Pharmaceutical Industries Ltd.
InventorsNina Finkelstein, Ramy Lidor-Hadas, Judith Aronhime
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Abstract
New hydrate forms of alendronate sodium, having water content of between about one and about twelve percent, and processes for their manufacture, are disclosed. New crystalline forms of alendronate sodium B, D, E, F, G and H, and processes for manufacturing them, are also disclosed. These new forms of alendronate sodium are suitable for incorporation into pharmaceutical compositions for combating bone resorption in bone diseases.
Claims22
Crystalline monosodium alendronate monohydrate.
Crystalline monosodium alendronate monohydrate characterized by its stability against dehydration at temperatures up to about 150° C.
Crystalline monosodium alendronate monohydrate characterized by peaks in the powder x-ray diffraction pattern at values of two theta of 9.3±0.2, 12.4±0.2, 13.5±0.2, 26.3±0.2 and 30.0±0.2.
Dependencies are inferred from the claim text.