Novel Crystalline Salts of Montelukast
OwnerPaul O'Sheainventor
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Abstract
The present application relates to crystalline 1,2-ethanedisulfonic acid salt and N,N′-dibenzylethylenediamine salt of montelukast. The salts are useful as therapeutic agents for the treatment of leukotriene mediated diseases and disorders. This application also relates to processes and intermediates for preparing the said salts and pharmaceutical compositions comprising the salts and optionally other therapeutic agents.
Claims16
Crystalline montelukast 1,2-ethanedisulfonic acid salt.
Crystalline montelukast N,N-dibenzylethylenediamine salt.
A pharmaceutical composition which comprises a crystalline montelukast salt selected from crystalline montelukast 1,2-ethanedisulfonic acid salt and crystalline montelukast N,N′-dibenzylethylenediamine salt, and a pharmaceutically acceptable carrier.
A method for the treatment of leukotriene mediated diseases or disorders which comprises administering to a patient in need thereof a therapeutically effective amount of a crystalline montelukast salt selected from crystalline montelukast 1,2-ethanedisulfonic acid salt and crystalline montelukast N,N′-dibenzylethylenediamine salt.
A method for the treatment of respiratory disorders which comprises administering to a patient in need thereof an inhalation composition comprising a crystalline montelukast salt selected from crystalline montelukast 1,2-ethanedisulfonic acid salt and crystalline montelukast N,N′-dibenzylethylenediamine salt, and a pharmaceutically acceptable carrier.
A method for the treatment of respiratory disorders which comprises simultaneous, sequential or separate administration by inhalation to a patient in need thereof of therapeutically effective amounts of a crystalline montelukast salt selected from crystalline montelukast 1,2-ethanedisulfonic acid salt and crystalline montelukast N,N′-dibenzylethylene-diamine salt, and a second therapeutic agent selected from a beta agonist, a corticosteroid, a PDE-IV inhibitor and an anticholinergic.
-17. (canceled)
Dependencies are inferred from the claim text.