Claims for Patent: 11,319,346

Summary for Patent: 11,319,346

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):	Shailubhai; Kunwar (Audubon, PA), Comiskey; Stephen (Doylestown, PA), Feng; Rong (Langhorne, PA), Bai; Juncai (North Augusta, SC), Zhang; Ruoping (North Augusta, SC), Jia; Jun (Shanghai, CN), Zhou; Junfeng (Shanghai, CN), Zhao; Qiao (Shanghai, CN), Zhang; Guoqing (Shanghai, CN)
Assignee:	Bausch Health Ireland Limited (Dublin, IE)
Application Number:	17/478,027
Patent Claims:	1. An oral formulation comprising: a purified peptide comprising the Guanylate Cyclase-C (GCC) agonist of amino acid sequence of SEQ ID NO: 1, wherein the formulation comprises less than 2% by weight of topoisomers relative to the weight of the purified peptide. 2. The oral formulation of claim 1, comprising less than 0.5% by weight of topoisomers relative to the weight of the purified peptide. 3. 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 microcrystalline cellulose. 4. The oral formulation of claim 1, comprising 0.01 mg to 10 mg of the purified peptide. 5. The oral formulation of claim 4, comprising 0.1 mg to 5 mg of the purified peptide. 6. The oral formulation of claim 5, comprising 3 mg of the purified peptide. 7. 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 further comprises magnesium stearate. 8. 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 0.1% 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 comprise microcrystalline cellulose. 9. The oral formulation of claim 8, comprising 0.01 mg to 10 mg of the purified peptide. 10. The oral formulation of claim 8, comprising 0.1 mg to 5 mg of the purified peptide. 11. The oral formulation of claim 8, comprising 3 mg of the purified peptide. 12. The oral formulation of claim 8, wherein the one or more pharmaceutically acceptable excipients further comprises magnesium stearate.