Vasopressin antagonist formulation and process
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United States of America Patent
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Mar 5, 2002
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N/A
app pub date -
Sep 25, 2000
filing date -
Sep 27, 1999
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Abstract
This invention provides novel formulations for N-[4-(5H-pyrrolo[2,1-c][1,4]benzodiazepin-10(11H)ylcarbonyl)-3-chlorophenyl]-5-fluoro-2-methyl-benzamide, or a pharmaceutically acceptable salt thereof, and processes for making them, the formulations comprising from about 1% to about 20% of active ingredient, from about 1% to about 18% of a surfactant component, from about 50% to about 80% of a component of one or more polyethylene glycols, from about 1% to about 20% of a component of one or more sucrose fatty acid esters and/or polyvinylpyrrolidone and, optionally, one or more pharmaceutically acceptable preservatives or antioxidants
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