Low-Dose Stable Formulations of Linaclotide
AssigneesIronwood Pharmaceuticals, Inc., Forest Laboratories Holdings Limited
InventorsYun Mo, Caroline Kurtz
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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.
Claims33
A low dose pharmaceutical composition comprising linaclotide, Ca2+ and histidine.
A pharmaceutical composition comprising linaclotide;
- Ca2+;
- histidine;
- and polyvinyl alcohol (PVA), wherein the molar ratio of Ca2+:histidine:linaclotide is between 30-80:80-120:1.
A pharmaceutical composition comprising coated beads, wherein the beads are coated with a coating solution comprising linaclotide, wherein the coating solution comprises:
- linaclotide;
- Ca2+;
- histidine;
- and
- polyvinyl alcohol (PVA),
- wherein the molar ratio the of Ca2+:histidine:linaclotide is between 30-80:80-120:1.
The unit dosage form of claim 390, wherein the PVA is present in an amount of 840 or 1670 μg.
Dependencies are inferred from the claim text.