Preparation and Use of a Stable Formulation of Allosteric Effector Compounds
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United States of America Patent
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app pub date -
May 16, 2007
filing date -
Apr 10, 2002
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Abstract
A pharmaceutical composition of 2-[4-[2-[(3,5-dimethylphenyl)amino]-2-oxoethyl]phenoxy]-2-methyl-propioni-c acid or its physiologically acceptable salts suitable for parenteral administration includes an aqueous formulation of 2-[4-[2-[(3,5-dimethylphenyl)amino]-2-oxoethyl]phenoxy]-2-methyl-propioni-c acid or its physiologically acceptable salt and a buffer to maintain the pH from about 6 to about 11. The composition in accordance with the invention reduces the amount of particulate matter that forms in solution after heat sterilization. The invention also includes a process for making a pharmaceutical composition of 2-[4-[2-[(3,5-dimethylphenyl)amino]-2-oxoethyl]phenoxy]-2-methyl-propioni-c acid or its physiologically acceptable salt that has a shelf life in excess of thirty days and is useful in parenteral administration.
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