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US 11,142,549 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.
Claims6
An oral formulation comprising:
- (a) a purified peptide comprising the Guanylate Cyclase-C(GCC) agonist of amino acid sequence of SEQ ID NO:
- 1, wherein the purified peptide comprises less than 0.05% trifluoroacetic acid (TFA) by weight of the purified peptide;
- and
- (b) one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprises microcrystalline cellulose.
1 more element
Dependencies are inferred from the claim text.