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AssigneeCipla Limited
InventorsAmar Lulla, Geena Malhotra, Dharmaraj Ramachandra Rao, Rajendra Narayanrao Kankan, Alka Chaudhary
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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.
1-37. (canceled)
A pharmaceutical composition comprising 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.
A process for the manufacture of a pharmaceutical composition comprising a therapeutically effective isomer of salbutamol or a salt, solvate, ester, derivative or polymorph thereof and a glucocorticoid in a propellant, which process comprises mixing the said ingredients to form said composition.
The use of a combination of salbutamol or a physiologically acceptable salt thereof and a glucocorticoid for treatment in the long-term management of asthma and COPD.
A combination comprising a therapeutically effective isomer or salbutamol or a salt, solvate, ester, derivative or polymorph thereof and a glucocorticoid and optionally at least one pharmaceutically acceptable carrier;
Dependencies are inferred from the claim text.