Stable pharmaceutical compositions of desloratadine and processes for preparation of polymorphic forms of desloratadine
OwnerZoltan Toth, Piroska Kovacs +2inventors
InventorsZoltan Toth, Piroska Kovacs, Csaba Peto, Adrienne Kovacsne-Mezei
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Abstract
Provided are stable pharmaceutical compositions of desloratadine. Also provided are processes for preparing polymorphs of desloratadine
Claims25
A process for preparing a mixture of crystalline Form I and Form II of desloratadine comprising combining a solution of desloratadine in an organic solvent selected from the group consisting of a C2 to C5 alkyl acetate, butanol, isobutanol, toluene and chloroform with a C5 to C12 hydrocarbon to precipitate the mixture, recovering the mixture, wherein before combining, the solution has a temperature that is at least about 40° C. higher than the hydrocarbon.
A mixture of crystalline Form I and Form II of desloratadine, containing about 50 ppm to about 4000 ppm of any one of isobutyl acetate, n-heptane, n-hexane, ethyl acetate, butanol, isobutanol, toluene, chloroform and combinations thereof.
Dependencies are inferred from the claim text.