FIELD: medicine, pharmaceutics.
SUBSTANCE: claimed invention relates to two novel polymorphic forms of crystalline levosalbutamol sulfate (enantiometriccaly pure (R)-salbutamol, designated as Form (I) and Form (II). Crystalline Form I of levosalbutamol sulfate is characterised by roentgen powder diffractogram with peaks at 10.8, 11.9, 13.0, 18.3, 28.5±0.2 degrees 2-teta. Pharmaceutical composition can additionally contain therapeutically efficient amount of one or more additional glucorticoids, selected from fluticasone propionate, beclomethason dipropionate or budesonide. Preferably pharmaceutical composition can represent aerosol, dry powder composition or solution/suspension for inhalation and contain pharmaceutically acceptable excipients, suitable for said forms.
EFFECT: elaboration of methods of obtaining novel polymorphic forms and pharmaceutical compositions, containing said polymorphic forms.
54 cl, 6 dwg, 3 tbl, 14 ex
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