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Pharmaceutical compounds and compositions
专利权人:
Cipla Limited
发明人:
Lulla, Amar,Malhotra, Geena,Rao, Dharmaraj Ramchandra,Kankan, Rajendra Narayanrao,Chaudhary, Alka
申请号:
AU2005315337
公开号:
AU2005315337B2
申请日:
2005.12.19
申请国别(地区):
AU
年份:
2012
代理人:
摘要:
The invention provides three polymorphic forms of crystalline levosalbutamol sulphatedesignated herein as Forms (I), (II) and (III). Crystalline levosalbutamol sulphateForm 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 sulphateForm (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 formsand pharmaceutical compositions comprising them are also provided. A pharmaceuticalcomposition comprises a therapeutically effective isomer of salbutamol ora salt, solvate, ester, derivative or polymorph thereof, a glucocorticoid anda pharmaceutically acceptable carrier or excipient and optionally one or moreother therapeutic agents. Preferably the composition is an aerosol formulation comprisingthe drugs, a propellant and optionally one or more other ingredients, such asa surfactant, cosolvent, or bulking agent. Alternatively, DPI or inhalation suspensionsmay be used.
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