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Details for Patent: 5,958,457

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Details for Patent: 5,958,457

Title: Compositions for the delivery of antigens
Abstract:The present invention relates to compositions and methods for orally delivering antigens. The antigen and an adjuvant are combined with an acylated amino acid or polyamino acid and, a sulfonated amino acids or polyamino acid, or a salt of the foregoing.
Inventor(s): Santiago; Noemi B. (Hawthorne, NY), Haas; Susan (Monsey, NY), Leone-Bay; Andrea (Ridgefield, CT)
Assignee: Emisphere Technologies, Inc. (Tarrytown, NY)
Filing Date:May 10, 1995
Application Number:08/438,644
Claims:1. A composition comprising:

(a) an antigen;

(b) an adjuvant;

(c) at least one carrier comprising a member selected from the groups consisting of:

(i) an acylated amino acid or a salt thereof;

(ii) a poly amino acid comprising at least one acylated amino acid or a salt thereof;

(iii) a sulfonated amino acid or a salt thereof;

(iv) a poly amino acid comprising at least one sulfonated amino acid or a salt thereof; or

(v) any combination thereof;

wherein said adjuvant is selected from the group consisting of purified protein derivative (PPD), poly adenylic acid (poly A), polyuridylic acid (poly U), muramyl dipeptides, inulin, zymosan, levamisol, Corynebacterium parvum, polyphophazenes, bacterial toxins, bacterial toxin subunits, bacterial toxoids, or any combination thereof.

2. A composition as defined in claim 1, comprising a mixture.

3. A composition as defined in claim 1, comprising a microsphere.

4. A composition as defined in claim 1, wherein said antigen comprises a peptide.

5. A composition as defined in claim 1, wherein said adjuvant comprises a mucosal adjuvant.

6. A composition as defined in claim 1, wherein said carrier comprises an acylated amino acid or a salt thereof.

7. A composition as defined in claim 1, wherein said carrier comprises a poly amino acid comprising at least one acylated amino acid or a salt thereof.

8. A composition as defined in claim 1, wherein said carrier comprises a sulfonated amino acid or a salt thereof.

9. A composition as defined in claim 1, wherein said carrier comprises a poly amino acid comprising at least one sulfonated amino acid or a salt thereof.

10. A composition as defined in claim 1, wherein said carrier is selected from the group consisting of, N-cyclohexanoyl arginine; a mixture of N-cyclohexanoyltyrosine and N-cyclohexanoylleucine; a mixture of N-phenylsulfonylvaline, N-phenylsulfonylleucine, N-phenylsulfonylphenylalanine, N-phenylsulfonyllysine, and N-phenylsulfonylarginine; and a mixture of N-benzoylvaline, N-benzoylleucine, N-benzoylphenylalanine, N-benzoyllysine, and N-benzoylarginine.

11. A composition comprising:

(a) ovalbumin;

(b) cholera toxin; and

(c) at least one carrier comprising a member selected from the groups consisting of:

(i) an acylated amino acid or a salt thereof;

(ii) a poly amino acid comprising at least one acylated amino acid or a salt thereof;

(iii) a sulfonated amino acid or a salt thereof;

(iv) a poly amino acid comprising at least one sulfonated amino acid or a salt thereof; or

(v) any combination thereof.

12. A composition comprising:

(a) Infectious Bursal Disease Virus;

(b) cholera toxin;

(c) cholera toxin .beta.-subunit; and

(d) at least one carrier comprising a member selected from the groups consisting of:

(i) an acylated amino acid or a salt thereof;

(ii) a poly amino acid comprising at least one acylated amino acid or a salt thereof;

(iii) a sulfonated amino acid or a salt thereof;

(iv) a poly amino acid comprising at least one sulfonated amino acid or a salt thereof; or

(v) any combination thereof.

13. A composition as defined in claim 12, comprising a microsphere.

14. A composition as defined in claim 12, wherein the carrier comprises a mixture of N-phenylsulfonylvaline, N-phenylsulfonylleucine, N-phenylsulfonylphenylalanine, N-phenylsulfonyllysine, and N-phenylsulfonylarginine; and a stabilizer.

15. A composition as defined in claim 14, wherein said stabilizer comprises sodium 2-cyclohexylbutyrate.

16. A composition comprising:

(a) an antigen;

(b) an adjuvant;

(c) at least one carrier comprising at least one (i) amino acid or polyamino acid modified by reaction with an amino acid reactive modifying agent selected from the group consisting of benzene sulfonyl chloride, benzoyl chloride, hippuryl chloride and amino acid carbodiimide, or (ii) a salt of (i);

wherein said adjuvant is selected from the group consisting of polypeptide derivative (PPD), polyadenyic acid (poly A), polyuridylic acid (poly U), muramyl dipeptides, inulin, zymosan, levamisol, Corynebacterium parvum, polyphophazenes, bacterial toxins, bacterial toxin subunits, bacterial toxoids, or any combination thereof.

17. A composition as defined in claim 16, comprising a mixture.

18. A composition as defined in claim 16, comprising a microsphere.

19. A composition as defined in claim 16, wherein said antigen comprises a peptide.

20. A composition as defined in claim 16, wherein said adjuvant comprises a mucosal adjuvant.

21. A composition as defined in claim 16, wherein said carrier comprises an acylated amino acid or a salt thereof.

22. A composition as defined in claim 16, wherein said carrier comprises a poly amino acid comprising at least one acylated amino acid or a salt thereof.

23. A composition as defined in claim 16, wherein said carrier comprises a sulfonated amino acid or a salt thereof.

24. A composition as defined in claim 16, wherein said carrier comprises a poly amino acid comprising at least one sulfonated amino acid or a salt thereof.

25. A composition as defined in claim 16, wherein said carrier is selected from the group consisting of, N-cyclohexanoyl arginine; a mixture of N-cyclo-hexanoyltyrosine and N-cyclohexanoylleucine; a mixture of N-phenylsulfonylvaline, N-phenylsulfonylleucine, N-phenylsulfonylphenylalanine, N-phenylsulfonyllysine, and N-phenylsulfonylarginine; and a mixture of N-benzoylvaline, N-benzoylleucine, N-benzoyl-phenylalanine, N-benzoyllysine, and N-benzoylarginine.

26. A composition comprising:

(a) ovalbumin;

(b) cholera toxin; and

(c) at least one carrier comprising at least one (i) amino acid or polyamino acid modified by reaction with an amino acid reactive modifying agent selected from the group consisting of benzene sulfonyl chloride, benzoyl chloride, hippuryl chloride and amino acid carbodiimide, or (ii) a salt of (i).

27. A composition comprising:

(a) Infectious Bursal Disease Virus;

(b) cholera toxin;

(c) cholera toxin .beta.-subunit; and

(d) at least one carrier comprising at least one (i) amino acid or polyamino acid modified by reaction with an amino acid reactive modifying agent selected from the group consisting of benzene sulfonyl chloride, benzoyl chloride, hippuryl chloride and amino acid carbodiimide, or (ii) a salt of (i).

28. A composition as defined in claim 27, comprising a microsphere.

29. A composition as defined in claim 28, wherein said carrier is selected from the group consisting of a benzene amide of an amino acid and a benzene sulfonamide of an amino acid.

30. A dosage unit form comprising

(A) a composition according to claim 16; and

(B) (a) an excipient,

(b) a diluent,

(c) a disintegrant,

(d) a lubricant,

(e) a plasticizer,

(f) a colorant,

(g) a dosing vehicle, or

(h) any combination thereof.

31. A dosage unit form according to claim 30 comprising a tablet, a capsule, or a liquid.

32. A method for administering an antigen to an animal, said method comprising orally administering a composition as defined in claim 16.

33. A method for immunizing chickens, said method comprising orally administering a composition as defined in claim 27.

34. A method for preparing a composition as defined in claim 16, said method comprising mixing an antigen, an adjuvant, and a carrier comprising at least one carrier comprising at least one

(i) amino acid or polyamino acid modified by reaction with an amino acid reactive modifying agent selected from the group consisting of benzene sulfonyl chloride, benzoyl chloride, hippuryl chloride and amino acid carbodiimide, or

(ii) a salt of (i);

wherein said adjuvant is selected from the group consisting of purified protein derivative(PPD), polyadenylic acid (poly A), polyuridylic acid (poly U), muramyl dipeptides, inulin, zymosan, levamisol, Corynebacterium parvum, polyphophazenes, bacterial toxins, bacterial toxin subunits, bacterial toxoids, or any combination thereof.

35. A method for preparing microspheres, said method comprising:

(A) solubilizing, in a solvent, at least one carrier to provide a carrier solution; and

(B) contacting said carrier solution with an antigen, an adjuvant, and a precipitator solution in which said carrier is insoluble;

wherein said carrier comprises at least one carrier comprising at least one

(i) amino acid or polyamino acid modified by reaction with an amino acid reactive modifying agent selected from the group consisting of benzene sulfonyl chloride, benzoyl chloride, hippuryl chloride and amino acid carbodiimide, or

(ii) a salt of (I);

wherein said adjuvant is selected from the group consisting of purified protien derivative (PPD), polyadenylic acid (poly A), polyuridylic acid (poly U), muramyl dipeptides, inulin, zymosan, levamisol, Corynebacterium parvum, polyphophazenes, bacterial toxins, bacterial toxin subunits, bacterial toxoids, or any combination thereof.

36. A method as defined in claim 35, wherein said carrier solution has a pH within a first range and said precipitator solution has a pH within a second range, said first range being different than said second range.

37. A composition as defined in claim 27, wherein the carrier comprises a mixture of N-phenylsulfonylvaline, N-phenylsulfonylleucine, N-phenylsulfonylphenylalanine, N-phenylsulfonyllysine, and N-phenylsulfonylarginine; and a stabilizer.

38. A composition as defined in claim 37, wherein said stabilizer comprises sodium 2-cyclohexylbutyrate.

39. A composition as defined in claim 1, wherein said adjuvant is selected from the group consisting of E. coli heat labile enterotoxin (LT-OA), cholera toxin, diphtheria toxin, cholera toxin .beta.-subunits, E. coli heat labile enterotoxin subunits, or any combination thereof.

40. A composition as defined in claim 16, wherein said adjuvant is selected from the group consisting of E. coli heat labile enterotoxin (LT-OA), cholera toxin, diphtheria toxin, cholera toxin .beta.-subunits, E. coli heat labile enterotoxin subunits, or any combination thereof.

41. A method as defined in claim 34, wherein said adjuvant is selected from the group consisting of E. coli heat labile enterotoxin (LT-OA), cholera toxin, diphtheria toxin, cholera toxin .beta.-subunits, E. coli heat labile enterotoxin subunits, or any combination thereof.

42. A method as defined in claim 35, herein said adjuvant is selected from the group consisting of E. coli heat labile enterotoxin (LT-OA), cholera toxin, diphtheria toxin, cholera toxin .beta.-subunits, E. coli heat labile enterotoxin subunits, or any combination thereof.
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