Claims for Patent: 12,146,003

Summary for Patent: 12,146,003

Title:	Ultra-pure agonists of guanylate cyclase C, method of making and using same
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.
Inventor(s):	Kunwar Shailubhai, Stephen Comiskey, Rong Feng, Juncai BAI, Ruoping ZHANG, Jun Jia, Junfeng Zhou, Qiao Zhao, Guoqing Zhang
Assignee:	AMBIOPHARM Inc , Bausch Health Ireland Ltd
Application Number:	US18/511,852
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,146,003
Patent Claims:	1. 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. 2. The oral formulation of claim 1, wherein the formulation further comprises at least one pharmaceutically acceptable excipient, wherein the at least one pharmaceutically acceptable excipient comprises magnesium stearate. 3. The oral formulation of claim 1, comprising 0.01 mg to 10 mg of the purified peptide. 4. The oral formulation of claim 1, comprising 0.1 mg to 5 mg of the purified peptide. 5. The oral formulation of claim 1, comprising 3 mg of the purified peptide. 6. The oral formulation of claim 1, comprising 0.15% to 0.25% by weight of alpha-Asp-9-plecanatide relative to the weight of the purified peptide. 7. 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. 8. The oral formulation of claim 7, comprising 0.01 mg to 10 mg of the purified peptide. 9. The oral formulation of claim 7, comprising 0.1 mg to 5 mg of the purified peptide. 10. The oral formulation of claim 7, comprising 3 mg of the purified peptide. 11. The oral formulation of claim 7, wherein the at least one pharmaceutically acceptable excipient further comprises magnesium stearate. 12. The oral formulation of claim 7, comprising 0.15 to 0.25% by weight of alpha-Asp-9-plecanatide relative to the weight of the purified peptide.