Linaclotide compositions
AssigneeForest Laboratories Holdings Limited
InventorsRitesh Sanghvi, Matthew Miller, Andreas Grill, Yun Mo, Mohammad Mafruhul Bari, Matthew Ronsheim, Joseph Stainkamp
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Abstract
The present invention is directed to stable linaclotide compositions and methods of treating gastrointestinal disorders in patients in need thereof by providing the stable linaclotide compositions.
Claims27
A linaclotide composition comprising linaclotide, a sterically hindered primary amine, a divalent metal cation and a formaldehyde scavenger compound.
A linaclotide composition comprising a formaldehyde scavenger compound and an oral pharmaceutical dosage form comprising about 145 μg or about 29 μg of linaclotide or a pharmaceutically acceptable salt thereof, Ca2+ or a salt thereof, leucine, and a peptide having the structure of formula (I) or a pharmaceutically acceptable salt thereof:
The composition of claim 23, wherein the formaldehyde scavenger compound is selected from the group consisting of leucine, glycine, aspartame, d-meglumine, histidine, asparagine, proline, or a mixture thereof.
The composition of claim 28, wherein the formaldehyde scavenger compound is present in the linaclotide composition in molar ratio of formaldehyde scavenger compound to linaclotide between 3:1 and 1:1.
Dependencies are inferred from the claim text.