Process for the preparation of desloratadine polymorph mixtures
OwnerMayur Devjibhai Khunt, Srinivasa Reddy Madduriinventors
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Abstract
The present application provides a process for the preparation of mixture of polymorphic Form I and Form II of desloratadine in any desired ratio.
Claims21
A process for preparing an intimate mixture of desloratadine crystalline Form I and crystalline Form II having a desired ratio, comprising:
- a) providing a solution of desloratadine in a hydrocarbon solvent;
- b) concentrating the solution obtained in step (a) to a specific volume;
- and
- c) isolating the desired mixture of forms.
An intimate mixture of desloratadine crystalline Form I and crystalline Form II having a mean particle size of below about 50 μm.
An intimate mixture of desloratadine crystalline Form I and crystalline Form II having a mean particle size of below about 30 μm.
An intimate mixture of desloratadine crystalline Form I and crystalline Form II having a bulk density of less than about 0.5 g/ml.
A pharmaceutical composition comprising an intimate mixture of desloratadine crystalline Form I and Form II in a desired ratio, and at least one pharmaceutical excipient.
Dependencies are inferred from the claim text.