Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration
AssigneesIronwood Pharmaceuticals, Inc., Forest Laboratories Holdings Limited
InventorsAngelika Fretzen, Steven Witowski, Alfredo Grossi, Hong Zhao, Mahendra Dedhiya, Yun Mo
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Abstract
Solid, stable formulations of linaclotide suitable for oral administration are described herein as are methods for preparing such formulations. The formulations described herein contain a polypeptide consisting of the amino acid sequence Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (“linaclotide”; SEQ ID NO:1) or a pharmaceutically acceptable salt thereof. The linaclotide formulations described herein are stable and have a sufficient shelf life for manufacturing, storing and distributing the drug.
Claims26
A solid pharmaceutical composition for oral administration comprising a pharmaceutically acceptable carrier, linaclotide, a Ca2+ cation and leucine, wherein linaclotide has the amino acid sequence Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (SEQ ID NO:1) and activates the guanylate cyclase C (GC-C) receptor.
Dependencies are inferred from the claim text.