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US 7,582,789 B2Granted
Ibandronate polymorph
AssigneeHoffmann-La Roche Inc.
InventorsUwe Eiermann, Bernd Junghans, Bernhard Knipp, Tim Sattelkau
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Abstract
The present invention relates to a new crystalline polymorph of 3-(N-methyl-N-pentyl) amino-1-hydroxypropane-1,1-diphosphonic acid monosodium salt monohydrate (Ibandronate) with the following formula
Claims6
A process for the preparation of a crystalline ibandronate polymorph B having an X-ray powder diffraction pattern having characteristic peaks expressed in angle 2-theta at approximately
- Angle 2-theta
- 9.7°
- 12.2°
- 14.4°
- 16.8°
- 25.8°
- comrising dissolving 3-(N-methyl-N-pentyl) amino-1-hydroxypropane -1,1-diphosphonic acid monosodium salt, a monohydrate, a polymorph or a mixture of polymorphs thereof at a temperature between 10° C. and 45° C. in a polar solvent and adding a polar aprotic solvent to initialize the crystallization.
4 more elements
A process for the preparation of a crystalline Ibandronate polymorph B having an X-ray powder diffraction pattern having characteristic peaks expressed in angle 2-theta at approximately
- Angle 2-theta
- 9.7°
- 12.2°
- 14.4°
- 16.8°
- 25.8°
- comprising dissolving 3-(N-methyl-N-pentyl) amino-1-hydroxypropane-1,1-diphosphonic acid monosodium salt, a monohydrate, a polymorph or a mixture of polymorphs thereof at a temperature from 10° C. to 55° C. in a polar solvent and adding a cyclic ether to initialize the crystallization.
4 more elements
Dependencies are inferred from the claim text.