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A PROCESS FOR PREPARING CRYSTALLINE LEVOSALBUTAMOL SULPHATE FORM-II
专利权人:
发明人:
LULLA AMAR,MALHOTRA GEENA,RAO DHARMARAJ RAMCHANDRA,KANKAN RAJENDRA NARAYANRAO,CHAUDHARY ALKA
申请号:
IN567/MUMNP/2006
公开号:
IN252884B
申请日:
2006.05.15
申请国别(地区):
IN
年份:
2012
代理人:
摘要:
The invention provides three polymorphic forms of crystalline levosalbutamol sulphate designated herein as Forms I, II and III. Crystalline levosalbutamol sulphate Form I is characterised by a powder XRD pattern with peaks at 10.8,11.9, 13.0, 18.3,28.5 ± 0.2 degrees 2 theta. Crystalline levosalbutamol sulphate Form II is characterised by a powder XRD pattern with peaks at 8.7, 9.6,15.2, 15.7, 19.1, 27.2, 30.7 ± 0.2 degrees 2 theta. Crystalline levosalbutamol sulphate Form III is characterised by a powder XRD pattern with peaks at 5.5, 6.9, 7.3, 18.7 ± 0.2 degrees 2 theta. Processes for making the new polymorphic forms and pharmaceutical compositions comprising them are also provided. A pharmaceutical composition comprises a therapeutically effective isomer of salbutamol or a salt, solvate, ester, derivative or polymorph thereof, a glucocorticoid and a pharmaceutically acceptable carrier or excipient and optionally one or more other therapeutic agents. Preferably the composition is an aerosol formulation comprising the drugs, a propellant and optionally one or more other ingredients, such as a surfactant, cosolvent, or bulking agent. Alternatively, DPI or inhalation suspensions may be used.
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