Claims for Patent: 10,010,503

Summary for Patent: 10,010,503

Title:	Methods and compositions for oral administration
Abstract:	This invention provides compositions comprising a protein, an absorption enhancer, a protease inhibitor, method for treating diabetes mellitus, comprising administering same, and methods for oral administration of a protein with an enzymatic activity, comprising orally administering same.
Inventor(s):	Kidron; Miriam (Jerusalem, IL), Arbit; Ehud (Englewood, NJ)
Assignee:	Entera Bio Ltd. (Jerusalem, IL)
Application Number:	14/936,758
Patent Claims:	1. A pharmaceutical composition comprising for oral administration, the composition comprising a protein having a molecular weight of up to 100,000 Daltons, said protein being selected from the group consisting of an interferon gamma, an interferon alpha, a growth hormone, an erythropoietin, a granulocyte colony stimulating factor (G-CSF), omentin, calcitonin, PTH and PYY; a protease inhibitor; and a compound selected from the group consisting of N-(8-[2-hydroxybenzoyl] amino)caprylate (NAC), N-(10-[2-hydroxybenzoyl]amino)decanoate (NAD), a salt of said NAC or said NAD, and a combination thereof, said compound being in an effective amount to synergistically increase the bioavailability of said protein. 2. The composition of claim 1, being a solid composition. 3. The composition of claim 1, wherein said protease inhibitor and said compound act in synergy in increasing a bioavailability of said protein. 4. The composition of claim 1, wherein said protein is a recombinant protein. 5. The composition of claim 1, wherein said protein is PTH. 6. The composition of claim 1, wherein said protease inhibitor is selected from the group consisting of a serpin, a suicide inhibitor, a transition state inhibitor, a protein protease inhibitor, a chelating agent, a Cysteine protease inhibitor, a Threonine protease inhibitor, an Aspartic protease inhibitor, and a Metalloprotease inhibitor. 7. The composition of claim 6, wherein said protease inhibitor is a serpin, and said serpin is a trypsin inhibitor. 8. The composition of claim 1, wherein said protease inhibitor is selected from the group consisting of Lima bean trypsin inhibitor, Aprotinin, soy bean trypsin inhibitor (SBTI), and Ovomucoid. 9. The composition of claim 1, wherein said enhancer is a salt of said NAC or said NAD, and said salt is selected from the group consisting of a monosodium salt, a disodium salt, and a combination thereof. 10. The composition of claim 1, further comprising an omega-3 fatty acid. 11. The composition of claim 1, further comprising EDTA or a salt thereof. 12. The composition of claim 1, further comprising a coating that inhibits digestion of said composition in a stomach of a subject; an enteric coating; or a gelatin coating. 13. A method for oral administration of a protein having a molecular weight up to 100,000 Daltons to a subject in need thereof, the method comprising administering orally to said subject the pharmaceutical composition of claim 1. 14. The method of claim 13, wherein the composition is a solid composition. 15. The method of claim 13, wherein said protease inhibitor and said compound act in synergy in increasing a bioavailability of said protein. 16. The method of claim 13, wherein said protein is a recombinant protein. 17. The method of claim 13, wherein said protein is PTH. 18. The method of claim 13, wherein said protease inhibitor is selected from the group consisting of a serpin, a suicide inhibitor, a transition state inhibitor, a protein protease inhibitor, a chelating agent, a Cysteine protease inhibitor, a Threonine protease inhibitor, an Aspartic protease inhibitor, and a Metalloprotease inhibitor. 19. The method of claim 18, wherein said protease inhibitor is a serpin, and said serpin is a trypsin inhibitor. 20. The method of claim 13, wherein said protease inhibitor is selected from the group consisting of Lima bean trypsin inhibitor, Aprotinin, soy bean trypsin inhibitor (SBTI), and Ovomucoid. 21. The method of claim 13, wherein said enhancer is a salt of said NAC or said NAD, and said salt is selected from the group consisting of a monosodium salt, a disodium salt, and a combination thereof. 22. The method of claim 13, wherein the composition further comprises an omega-3 fatty acid. 23. The method of claim 13, wherein the composition further comprises EDTA or a salt thereof. 24. The method of claim 13, wherein the composition further comprises a coating that inhibits digestion of said composition in a stomach of a subject; an enteric coating; or a gelatin coating.

Details for Patent 10,010,503

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bayer Healthcare Pharmaceuticals Inc.	TRASYLOL	aprotinin	Injection	020304	December 29, 1993		2035-11-10