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US 12,146,003 B2Granted
Ultra-pure agonists of guanylate cyclase C, method of making and using same
AssigneeBausch Health Ireland Limited
InventorsKunwar Shailubhai, Stephen Comiskey, Rong Feng, Juncai Bai, Ruoping Zhang, Jun Jia, Junfeng Zhou, Qiao Zhao, Guoqing Zhang
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Abstract
The invention provides processes of purifying a peptide including a GCC agonist sequence selected from the group consisting of SEQ ID NOs: 1-251 described herein. The processes include a solvent exchange step before a freeze-drying (lyophilization) step.
Claims12
An oral formulation comprising a purified peptide comprising a Guanylate Cyclase-C(GCC) agonist of amino acid sequence of SEQ ID NO:
- 1, wherein the purified peptide has less than 0.25% alpha-Asp-9-plecanatide relative to the weight of the purified peptide.
An oral formulation comprising:
- (i) a purified peptide comprising a Guanylate Cyclase-C(GCC) agonist of amino acid sequence of SEQ ID NO:
- 1, wherein the purified peptide has less than 0.25% alpha-Asp-9-plecanatide relative to the weight of the purified peptide;
- and
- (ii) at least one pharmaceutically acceptable excipient, wherein the at least one pharmaceutically acceptable excipient comprises microcrystalline cellulose.
1 more element
Dependencies are inferred from the claim text.