Form of irbesartan, processes for obtaining the said and pharmaceutical compositions containing it
AssigneeSanofi-Aventis
InventorsBruno Franc, Christian Hoff, San Kiang, Mark D. Lindrud, Olivier Monnier, Chenkou Wei
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Abstract
The invention relates to a novel crystalline form of irbesartan to pharmaceutical compositions containing it, to processes for preparing it, and to a method for treating cardiovascular diseases utilizing it.
Claims34
A process for preparing a compound of formula:
- having a crystal habit such that the ratio between the length and the width of the crystals is between 1:1 and 10:1 wherein a crystalline suspension of a compound of formula (I) is subjected to at least one sonication episode and at least one temperature oscillation episode.
A process for preparing a compound of formula:
- having a crystal habit such that the ratio between the length and the width of the crystals is between 1:1 and 10:1 wherein a crystalline suspension of irbesartan of acicular habit form A is subjected to at least one sonication episode and at least one temperature oscillation episode.
A process for preparing a compound of formula:
- having a crystal habit such that the ratio between the length and the width of the crystals is between 1:1 and 10:1 comprising the steps of:
- a) preparing a solution of irbesartan acicular habit form A in an alcohol, under concentration and temperature conditions which allow the total solubility of the irbesartan;
- b) cooling the said solution to a temperature selected as a function of the concentration of the solution, such that the solution is in the metastable zone;
- c) seeding with irbesartan crystals of brick habit;
- d) cooling the irbesartan solution to a temperature of between about 20° C. and 5° C.;
- e) subjecting the crystalline suspension thus formed to a mechanical shearing using a shearing machine;
- f) heating the crystalline suspension to a temperature of between about 40° C. and 60° C. to dissolve the fine particles;
- g) cooling the crystalline suspension to a temperature of between about 20° C. and 5° C.;
- h) filtering off the crystals of brick habit thus formed.
A process for preparing a compound of formula:
- having a crystal habit such that the ratio between the length and the width of the crystals is between 1:1 and 5:1 wherein a crystalline suspension of a compound of formula (I) is subjected to at least one sonication episode and at least one temperature oscillation episode.
A process for preparing a compound of formula:
- having a crystal habit such that the ratio between the length and the width of the crystals is between 1:1 and 5:1 wherein a crystalline suspension of irbesartan of acicular habit form A is subjected to at least one sonication episode and at least one temperature oscillation episode.
A method for the treatment of cardiovascular diseases which comprises administering to a patient in need of such treatment a compound of formula:
- having a crystal habit such that the ratio between the length and the width of the crystals is between 1:1 and 10:1.
A method for the treatment of cardiovascular diseases which comprises administering to a patient in need of such treatment a compound of formula:
- having a crystal habit such that the radio between the length and the width of the crystals is between 1:1 and 5:1.
Dependencies are inferred from the claim text.