Stable formulations of linaclotide
AssigneesIronwood Pharmaceuticals, Inc., Forest Laboratories Holdings Limited
InventorsYun Mo, Angelika Fretzen, Brian Cali, Mahendra Dedhiya
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Abstract
The present invention relates to stable pharmaceutical compositions comprising linaclotide or pharmaceutically acceptable salts thereof, as well as to various methods and processes for the preparation and use of the compositions.
Claims20
A method of treating a gastrointestinal disorder in a patient, the method comprising administering to a patient in need thereof, a pharmaceutical composition comprising linaclotide, Ca2+ or pharmaceutically acceptable salt thereof and histidine, wherein the composition has a molar ratio of Ca2+:histidine of less than 1.5:1 and a molar ratio of histidine:linaclotide is between 120:1 and 80:1, wherein the gastrointestinal disorder is selected from the group consisting of irritable bowel syndrome, chronic constipation, and opioid induced constipation.
Dependencies are inferred from the claim text.