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Details for Patent: 6,610,329

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Details for Patent: 6,610,329

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. (Boqueron, PR), Haas; Susan (Monsey, NY), Leone-Bay; Andrea (Ridgefield, CT), Milstein; Sam J. (Larchmont, NY), Barantsevitch; Evgueni (Scarsdale, NY)
Assignee: Emisphere Technologies Inc. (Tarrytown, NY)
Filing Date:May 21, 2001
Application Number:09/862,013
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.

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-benzoylphenyl-alanine, N-benzoyllysine, and N-benzoylarginine.

11. A dosage unit form comprising (A) a composition according to claim 1; 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.

12. A dosage unit form according to claim 11 comprising a tablet, a capsule, or a liquid.

13. A method for administering an antigen to an animal, said method comprising orally administering a composition as defined in claim 1.

14. A method for preparing a composition as defined in claim 1, said method comprising mixing an antigen, an adjuvant, and a carrier comprising a member selected from the group 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.
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