SOLID STATE FORMS OF TRISODIUM SALT OF VALSARTAN/SACUBITRIL COMPLEX AND SACUBITRIL

The present invention describes an amorphous form of trisodium salt of valsartan sacubitril complex and a process for the preparation of same comprising: reacting sacubitril sodium and valsartan disodium or sacubitril and valsartan in the presence of a sodium ion source in one or more solvents to ob...

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Hauptverfasser: THAKER, Tirth Harikrishna, SINGH, Kumar Kamlesh, DIWAKAR, Santosh Devidas, JADHAV, Shankar Dada, VINCHHI, Kishorkumar Maneklal
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creator THAKER, Tirth Harikrishna
SINGH, Kumar Kamlesh
DIWAKAR, Santosh Devidas
JADHAV, Shankar Dada
VINCHHI, Kishorkumar Maneklal
description The present invention describes an amorphous form of trisodium salt of valsartan sacubitril complex and a process for the preparation of same comprising: reacting sacubitril sodium and valsartan disodium or sacubitril and valsartan in the presence of a sodium ion source in one or more solvents to obtain a solution; and obtaining the trisodium salt of valsartan sacubitril complex by the removal of the solvent from the solution or by adding an anti-solvent to the solution. The crystalline form of sacubitril sodium is characterized by x-ray powder diffraction pattern having characteristic peaks expressed in terms of 2-theta at about 6.3°, 12.0°, 13.8°, 16.5°, 18.3°, 20.0° and 23.8°±0.2° (2θ). La présente invention concerne une forme amorphe de sel trisodique d'un complexe de valsartan et sacubitril et un procédé pour la préparation de celui-ci consistant à : faire réagir sacubitril sodique et du valsartan disodique ou du sacubitril et du valsartan en présence d'une source d'ions sodium dans un ou plusieurs solvants pour obtenir une solution; et obtenir le sel trisodique d'un complexe de valsartan et de sacubitril par l'élimination du solvant de la solution ou par l'ajout d'un anti-solvant à la solution. La forme cristalline du sacubitril sodique est caractérisée par un diagramme de diffraction des rayons X sur poudre ayant des pics caractéristiques exprimés en termes de 2-thêta à environ 6,3°, 12,0°, 13,8°, 16,5°, 18,3°, 20,0° et 23,8° ± 0,2° (2θ).
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La forme cristalline du sacubitril sodique est caractérisée par un diagramme de diffraction des rayons X sur poudre ayant des pics caractéristiques exprimés en termes de 2-thêta à environ 6,3°, 12,0°, 13,8°, 16,5°, 18,3°, 20,0° et 23,8° ± 0,2° (2θ).</abstract><oa>free_for_read</oa></addata></record>
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subjects CHEMISTRY
HETEROCYCLIC COMPOUNDS
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
METALLURGY
ORGANIC CHEMISTRY
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS
title SOLID STATE FORMS OF TRISODIUM SALT OF VALSARTAN/SACUBITRIL COMPLEX AND SACUBITRIL
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