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Last Updated: March 28, 2024

Claims for Patent: 5,783,193


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Summary for Patent: 5,783,193
Title: Oral administration of therapeutic proteins for treatment of autoimmune disease, transplant rejection and infectious disease
Abstract:An orally administrable therapeutic protein is provided by combining the therapeutic protein with a stabilizing agent in an aqueous solution. The solution is coated onto nonpareils and microencapsulated with a water emulsifiable enteric coating composition. The microcapsules are orally administered. The coating protects the protein as it passes through the stomach. Upon reaching the small intestines, the basic pH of the intestinal juices will dissolve the coating, allowing the protein to be released and induce antigen specific immune response which has the specificity of the native molecule. The stabilizing agent protects the therapeutic protein from denaturation during the encapsulation process.
Inventor(s): Michael; J. Gabriel (Cincinnati, OH), Litwin; Allen (Cincinnati, OH)
Assignee: The University of Cincinnati (Cincinnati, OH)
Application Number:08/472,712
Patent Claims:1. An orally administrable immunogenic composition for activating the immune system of a warm-blooded animal comprising:

at least one immunogen of an autoimmune antigen microencapsulated in the complete absence of organic solvents with a water based enteric coating.

2. The composition claimed in claim 1 wherein said enteric coating is a water based emulsion of an ethylacrylate methacrylic acid copolymer.

3. The composition claimed in claim 1 wherein said autoimmune antigen is selected from the group consisting of myelin basic protein, collagen type I, collagen type II, collagenase, acetyl choline receptor, insulin and thyroid proteins.

4. A method of administering an immunogen for activating the immune system of a warm-blooded animal comprising orally administering to said animal an amount of the composition claimed in claim 1 effective for activating the immune system of said animal.

5. An orally administrable immunogenic composition for activating the immune system of a warm-blooded animal comprising:

at least one immunogen of a transplantation antigen microencapsulated in the complete absence of organic solvents with a water based enteric coating.

6. The composition claimed in claim 5 wherein said enteric coating is a water based emulsion of an ethylacrylate methacrylic acid copolymer.

7. The composition claimed in claim 5 wherein said transplantation antigen is an MHC antigen selected from the group consisting of MHC-I and MHC-II.

8. A method of administering an immunogen for activating the immune system of a warm-blooded animal comprising orally administering to said animal an amount of the composition claimed in claim 5 effective for activating the immune system of said animal.

9. The composition of claim 1 wherein said immunogen of an autoimmune antigen is selected from the group consisting of proteins, peptides and glycoproteins.

10. The composition of claim 1 wherein said composition further comprises an adjuvant which increases immunogenicity of said immunogen.

11. The composition of claim 1 wherein said immunogen is microencapsulated on particles of a pharmaceutically inert material having a first coating comprising said immunogen and a second coating comprising said enteric coating.

12. The composition of claim 11 wherein said first coating further comprises at least one of a stabilizing sugar, a binding agent to bind the immunogen to said particles, and a bioadhesive agent for adhering the immunogen in the gastrointestinal tract.

13. The composition of claim 12 wherein said stabilizing sugar comprises lactose.

14. The composition of claim 12 wherein said stabilizing sugar comprises trehalose.

15. The composition of claim 12 wherein said binding agent comprises polyvinylpyrrolidone.

16. The composition of claim 12 wherein said bioadhesive agent comprises polyvinylpyrrolidone.

17. The composition of claim 12 wherein said second coating further comprises a plasticizer.

18. The composition of claim 17 wherein said plasticizer comprises triethyl citrate.

19. An orally administrable immunogenic composition for activating the immune system of a warm-blooded animal comprising:

at least one immunogen of an autoimmune antigen microencapsulated in the complete absence of organic solvents with a water based enteric coating, wherein

said immunogen is microencapsulated on particles of a pharmaceutically inert material with

a first coating comprising

said immunogen,

trehalose, and

polyvinylpyrrolidone, and

a second coating comprising

said enteric coating and

triethyl citrate.

20. The composition of claim 5 wherein said immunogen of a transplantation antigen is selected from the group consisting of proteins, peptides and glycoproteins.

21. The composition of claim 5 wherein said composition further comprises an adjuvant which increases immunogenicity of said immunogen.

22. The composition of claim 5 wherein said immunogen is microencapsulated on particles of a pharmaceutically inert material having a first coating comprising said immunogen and a second coating comprising said enteric coating.

23. The composition of claim 22 wherein said first coating further comprises at least one of a stabilizing sugar, a binding agent to bind the immunogen to said particles, and a bioadhesive agent for adhering the immunogen in the gastrointestinal tract.

24. The composition of claim 23 wherein said stabilizing sugar comprises lactose.

25. The composition of claim 23 wherein said stabilizing sugar comprises trehalose.

26. The composition of claim 22 wherein said binding agent comprises polyvinylpyrrolidone.

27. The composition of claim 22 wherein said bioadhesive agent comprises polyvinylpyrrolidone.

28. The composition of claim 22 wherein said second coating further comprises a plasticizer.

29. The composition of claim 23 wherein said plasticizer comprises triethyl citrate.

30. An orally administrable immunogenic composition for activating the immune system of a warm-blooded animal comprising:

at least one immunogen of an transplantation antigen microencapsulated in the complete absence of organic solvents with a water based enteric coating, wherein

said immunogen is microencapsulated on particles of a pharmaceutically inert material with

a first coating comprising

said immunogen,

trehalose, and

polyvinylpyrrolidone, and

a second coating comprising

said enteric coating and

triethyl citrate.

31. Method of administering an immunogen of a virus to a warm-blooded animal, said method comprising orally administering to said animal an amount of a composition comprising an orally-administrable immunogenic composition for activating the immune system of a warm-blooded animal comprising at least one immunogen of a virus microencapsulated in the complete absence of organic solvents with a water-based enteric coating, wherein said immunogen does not replicate.

32. The method claimed in claim 31 wherein said immunogen of a virus is present in said composition in a form selected from the group consisting of proteins, peptides, glycoproteins and whole virus particles.

33. The method claimed in claim 32 wherein said immunogen is microencapsulated on particles of a pharmaceutically inert material with a first coating comprising said immunogen, a stabilizing sugar, polyvinylpyrrolidone, and a second coating comprising said enteric coating and triethylcitrate.

34. The method claimed in claim 31 wherein said composition further comprises an adjuvant which increases immunogenicity of said immunogen.

35. The method claimed in claim 34 wherein said adjuvant is an aluminum salt.

36. The method claimed in claim 33 wherein said stabilizing sugar comprises trehalose.

37. The method claimed in claim 31 wherein said virus is selected from the group consisting of influenza viruses, adenoviruses, paramyxoviruses, rubella viruses, polio viruses, hepatitis viruses, herpes viruses, rabies viruses, and papilloma viruses.

38. The method claimed in claim 37 wherein said virus is a paramyxovirus selected from the group consisting of mumps virus and measles virus.

39. The method claimed in claim 37 wherein said first coating further comprises at least one of a stabilizing sugar, a binding agent to bind the immunogen to said particles, and a bioadhesive agent for adhering the immunogen in the gastrointestinal tract.

40. The method claimed in claim 39 wherein said stabilizing sugar comprises lactose.

41. The method claimed in claim 39 wherein binding agent comprises polyvinylpyrollidone.

42. The method claimed in claim 39 wherein said bioadhesive agent comprises polyvinylpyrollidone.

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