Process for the preparation of piroxicam: b-cyclodextrin inclusion compounds
AssigneeChiesi Farmaceutici S.p.A.
InventorAndrea Capocchi
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Abstract
The present invention relates to a process for the preparation of inclusion compounds of piroxicam with β-cyclodextrin. More particularly, according to the process of the invention, the aqueous solution of two components is subjected, before drying, to a freezing process at very high rate. The resulting products have physico-chemical characteristics as well as technological and biopharmaceutical properties which are advantageous compared with those obtained according to the prior art processes. The resulting products are suitable for preparing pharmaceutical compositions for the oral administration.
Claims10
A process for the preparation of piroxicam:β-cyclodextrin inclusion compounds, comprising the following steps:
- a) dissolving piroxicam and β-cyclodextrin in the presence of ammonium hydroxide in a suitable tank containing water at a temperature of at least 60° C.;
- b) bringing the solution to a temperature of at least about −10° C.;
- c) further lowering the temperature of the frozen solution to at least −20° C. and preferably to between −30° and −40° C.;
- d) drying the frozen solution under vacuum.
Dependencies are inferred from the claim text.