Formulations of guanylate cyclase C agonists and methods of use
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-038/10
A61K-009/48
A61K-009/00
A61K-038/12
C07K-007/54
A61K-009/16
A61K-009/20
A61K-045/06
A61K-031/192
A61K-031/501
A61K-031/519
A61K-031/53
A61K-031/765
A61K-031/78
출원번호
US-0845644
(2015-09-04)
등록번호
US-9610321
(2017-04-04)
발명자
/ 주소
Comiskey, Stephen
Feng, Rong
Foss, John
Shailubhai, Kunwar
출원인 / 주소
SYNERGY PHARMACEUTICALS, INC.
대리인 / 주소
Kozakiewicz, Cynthia
인용정보
피인용 횟수 :
3인용 특허 :
26
초록▼
The invention provides low-dose formulations of guanylate cyclase-C (“GCC”) agonist peptides and methods for their use. The formulations of the invention can be administered either alone or in combination with one or more additional therapeutic agents, preferably an inhibitor of cGMP-dependent phosp
The invention provides low-dose formulations of guanylate cyclase-C (“GCC”) agonist peptides and methods for their use. The formulations of the invention can be administered either alone or in combination with one or more additional therapeutic agents, preferably an inhibitor of cGMP-dependent phosphodiesterase or a laxative.
대표청구항▼
1. A method for treating chronic constipation in a human subject comprising orally administering to said human subject a composition consisting of a per unit dose of 3 mg or 6 mg of a peptide consisting of SEQ ID NO:1 wherein the peptide is a [4,12; 7,15] bicycle, an inert low moisture carrier, and
1. A method for treating chronic constipation in a human subject comprising orally administering to said human subject a composition consisting of a per unit dose of 3 mg or 6 mg of a peptide consisting of SEQ ID NO:1 wherein the peptide is a [4,12; 7,15] bicycle, an inert low moisture carrier, and a lubricant, and wherein the peptide has a chromatographic purity of no less than 91% after storage for at least three months. 2. The method of claim 1, wherein the constipation is associated with irritable bowel syndrome or chronic idiopathic constipation. 3. A method of treating or alleviating a symptom associated with chronic idiopathic constipation or irritable bowel syndrome in a human subject comprising orally administering to said human subject a composition consisting of a per unit dose of 3 mg or 6 mg of a peptide consisting of SEQ ID NO:1 wherein the peptide is a [4,12; 7,15] bicycle, an inert low moisture carrier, and a lubricant, and wherein the peptide has a chromatographic purity of no less than 91% after storage for at least three months. 4. The method of claim 3, wherein the symptom is constipation or abdominal pain. 5. The method of claim 1, further comprising administering to said patient an effective dose of an inhibitor of cGMP-dependent phosphodiesterase either concurrently or sequentially with said guanylate cyclase receptor agonist. 6. The method of claim 5, wherein said inhibitor of cGMP-dependent phosphodiesterase is selected from the group consisting of sulindac sulfone, zaprinast, and motapizone. 7. The method of claim 1, further comprising administering to said patient an effective dose of a laxative. 8. The method of claim 3, further comprising administering to said patient an effective dose of an inhibitor of cGMP-dependent phosphodiesterase either concurrently or sequentially with said guanylate cyclase receptor agonist. 9. The method of claim 8, wherein said inhibitor of cGMP-dependent phosphodiesterase is selected from the group consisting of sulindac sulfone, zaprinast, and motapizone. 10. The method of claim 3, further comprising administering to said patient an effective dose of a laxative. 11. The method of claim 1, wherein the inert low moisture carrier is microcrystalline cellulose. 12. The method of claim 1, wherein the lubricant is magnesium stearate. 13. The method of claim 1, wherein the inert low moisture carrier is microcrystalline cellulose and the lubricant is magnesium stearate. 14. The method of claim 3, wherein the inert low moisture carrier is microcrystalline cellulose. 15. The method of claim 3, wherein the lubricant is magnesium stearate. 16. The method of claim 3, wherein the inert low moisture carrier is microcrystalline cellulose and the lubricant is magnesium stearate.
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Shailubhai, Kunwar; Jacob, Gary S., Agonists of guanylate cyclase useful for the treatment of gastrointestinal disorders, inflammation, cancer and other disorders.
Shailubhai, Kunwar; Jacob, Gary S., Agonists of guanylate cyclase useful for the treatment of gastrointestinal disorders, inflammation, cancer and other disorders.
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