A quinolone compound in solid forms and processes for the preparation thereof
OwnerKumar Kamlesh SINGH, Rajiv SHARMA +4inventors
InventorsKumar Kamlesh SINGH, Rajiv SHARMA, Santosh Devidas DIWAKAR, Jitendra Maganbhai GAJERA, Sumer Singh CHUNDAWAT, Jayesh Anilkumar SHARMA
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Abstract
The present invention relates to novel crystalline forms of a quinolone compound of Formula (I). The invention also relates to processes for the preparation crystalline forms of the compound of Formula (I). Further the disclosure provides a process for the preparation of compound of Formula (I), intermediates, impurities and pharmaceutical compositions thereof.
Claims38
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A crystalline form of compound of Formula (I),
- characterized by X-ray powder diffraction pattern having at least four peaks expressed in degrees 2θ±0.2° selected from 10.2°, 11.1°, 14.6°, 18.9°, 19.6°, 21.6°, 27.0° and 28.1°.
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A crystalline form of compound of Formula (I),
- characterized by X-ray powder diffraction pattern having peaks expressed in degrees 2010.2° at 8.1°, 9.0°, 10.2°, 11.1°, 14.6°, 18.9°, 19.6°, 21.6°, 27.0° and 28.1°;
- or a X-ray powder diffraction pattern substantially same as depicted in FIG. 2.
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A process for the preparation of a compound of Formula (I),
- the process comprising:
- (a) reacting a compound of Formula (VII),
- with a compound of Formula (VII),
- wherein,
- L is a leaving group;
- to obtain a compound of Formula (IX);
- wherein,
- G is selected from CN, —COORa and —CONRbRc;
- Ra is selected from alkyl, cycloalkyl, heterocycloalkyl, aryl and heteroaryl;
- wherein
- Ra is optionally further substituted with one or more of chloro, bromo, iodo, cyano, hydroxy, nitro, amino, alkylamino, carbonyl, aminocarbonyl, thio, alkylthio, alkyl, cycloalkyl, heterocycloalkyl, aryl or heteroaryl;
- and
- Rb and Rc each independently is hydrogen or Ra;
- and,
- (b) converting the compound of Formula (IX) to the compound of Formula (I).
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A compound of Formula (VII),
- wherein,
- G is selected from CN, —COORa and —CONRbRc,
- Ra is selected from alkyl, cycloalkyl, heterocycloalkyl, aryl and heteroaryl;
- wherein Ra is optionally further substituted with one or more of chloro, bromo, iodo, cyano, hydroxy, nitro, amino, alkylamino, carbonyl, aminocarbonyl, thio, alkylthio, alkyl, cycloalkyl, heterocycloalkyl, aryl or heteroaryl;
- and
- Rb and Rc each independently is hydrogen or Ra.
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A composition comprising a compound of Formula (I)
- having a purity of about 99% or more, and one or more of compounds of Formulae C, D or E in an amount less than about 0.15% by area percentage of HPLC relative to the compound of Formula (I),
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Dependencies are inferred from the claim text.