Stable solid formulation of a gc-c receptor agonist...

A - Human Necessities – 61 – K

Patent

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Details

A61K 38/10 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/48 (2006.01) A61K 9/50 (2006.01) A61P 1/00 (2006.01)

Patent

CA 2732892

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") 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.

L'invention porte sur des formulations stables, solides, de linaclotide appropriées pour une administration orale, ainsi que sur des procédés pour préparer de telles formulations. Les formulations décrites ici contiennent un polypeptide constitué de la séquence d'acides aminés Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (« linaclotide ») ou un sel pharmaceutiquement acceptable de celui-ci. Les formulations de linaclotide décrites ici sont stables et ont une durée de conservation suffisante pour la fabrication, le stockage et la distribution du médicament.

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