crystalline levosalbutamol sulfate (form i), crystalline levosalbutamol sulfate (form ii), crystalline levosalbutamol sulfate (form iii), process for preparing crystalline levosalbutamol sulfate form i, process for preparing crystalline levosalbutamol sulfate form ii , process for preparing levosalbutamol sulfate form iii, pharmaceutical composition, compound, combination, dry inhaler powder, process for preparing a dry inhaler powder, process for preparing a pharmaceutical composition, process for manufacturing a pharmaceutical composition, method for treatment of a mammal, and use of a combination of salbutamol

摘要

LEVOSALBUTAMOL CRYSTALINE SULPHATE (FORM I), CRYSTALINE LEVOSALBUTAMOL SULPHATE (FORM II), CRYSTALINE LEVOSALBUTAMOL SULPHATE, PROCESS TO PREPARE FORMULA SULPHATE FOR LEVALOUS PROPHALOS , PROCESS FOR PREPARING LEVOSALBUTAMOL SULPHATE FORM III, PHARMACEUTICAL COMPOSITION, COMPOUND, COMBINATION, DRYER FOR INHALER, PROCESS FOR PREPARING A DRYER INHALER FOR PHARMACEUTICAL PHARMACEUTICAL COMPOSITION, PHARMACEUTICAL COMPOSITION TREATMENT OF A MAMMER AND USE OF A SALBUTAMOL COMBINATION ". The invention provides three polymorphic forms of crystalline levosalbutamol sulfate referred to herein as Form (I), Form (II) and Form (III). Crystalline levosalbutamol sulfate Form I is characterized by an XRD powder pattern with peaks at 10.8, 11.9, 13.0, 18.3, 28.5 sym 0.2 degrees 2-Theta. II of crystalline levosalbutamol sulfate is characterized by an XRD powder pattern with peaks at 8.7, 9.6, 15.2, 17.7, 19.1, 27.2, 30.7 sym 0.2 degrees 2-Theta. Form III of crystalline levosalbutamol sulfate is characterized by an XRD powder pattern with peaks at 5.5, 6.9, 7.3, 18.7 sym 0.2 degrees 2-Theta. The process for preparing the new polymorphic forms and pharmaceutical compositions comprising them is 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 drug, a propellant and optionally one or more other ingredients, such as a surfactant, co-solvent, or bulking agent. Alternatively, DPI or inhalation suspensions may be used.