Peanut formulations and uses thereof

1. A composition comprising:

(a) peanut flour comprising plus or minus 0.1%-10% of 0.5 mg to plus or minus 0.1%-10% of 500 mg peanut protein;

(b) one or more diluents in an amount of from 1% to 99% w/w, from 60% to 90% w/w, or from 5% to 20% w/w of the composition;

(c) one or more gliders in an amount of from 0.01% to 10% w/w of the composition; and

(d) one or more lubricants in an amount of from 0.01% to 10% w/w of the composition.

2. The composition of claim 1 , wherein the composition comprises:

peanut flour comprising plus or minus 0.1%-5% of 0.5 mg to plus or minus 0.1%-5% of 500 mg peanut protein;

one or more diluents in an amount of from plus or minus 0.1%-5% of 1% to plus or minus 0.1%-5% of 99% w/w, from plus or minus 0.1%-5% of 60% to plus or minus 0.1%-5% of 90% w/w, or from plus or minus 0.1%-5% of 5% to plus or minus 0.1%-5% of 20% w/w of the composition;

one or more gliders in an amount of from plus or minus 0.1%-5% of 0.01% to plus or minus 0.1%-5% of 10% w/w of the composition; and

one or more lubricants in an amount of from plus or minus 0.1%-5% of 0.01% to plus or minus 0.1%-5% of 10% w/w of the composition.

3. The composition of claim 2 , wherein the composition comprises:

peanut flour comprising plus or minus 0.1%-2% of 0.5 mg to plus or minus 0.1%-2% of 500 mg peanut protein;

one or more diluents in an amount of from plus or minus 0.1%-2% of 1% to plus or minus 0.1%-2% of 99% w/w, from plus or minus 0.1%-2% of 60% to plus or minus 0.1%-2% of 90% w/w, or from plus or minus 0.1%-2% of 5% to plus or minus 0.1%-2% of 20% w/w of the composition;

one or more gliders in an amount of from plus or minus 0.1%-2% of 0.01% to plus or minus 0.1%-2% of 10% w/w of the composition; and

one or more lubricants in an amount of from plus or minus 0.1%-2% of 0.01% to plus or minus 0.1%-2% of 10% w/w of the composition.

4. The composition of claim 1 , wherein the composition is formulated in a dose of about plus or minus 0.1%-10% of 0.5 mg, plus or minus 0.1%-10% of 1.0 mg, plus or minus 0.1%-10% of 10.0 mg, plus or minus 0.1%-10% of 100 mg, plus or minus 0.1%-10% of 475 mg, or plus or minus 0.1%-10% of 500 mg of peanut protein.

5. The composition of claim 1 , wherein the composition comprises peanut flour in a concentration from plus or minus 0.1%-10% of 8% to plus or minus 0.1%-10% of 15% w/w, or from plus or minus 0.1%-10% of 9% to plus or minus 0.1%-10% of 12% w/w.

6. The composition of claim 4 , wherein the composition is formulated in a dose of plus or minus 0.1%-5% of 0.5 mg, plus or minus 0.1%-5% of 1.0 mg, plus or minus 0.1%-5% of 10.0 mg, plus or minus 0.1%-5% of 100 mg, plus or minus 0.1%-5% of 475 mg, or plus or minus 0.1%-5% of 500 mg of peanut protein.

7. The composition of claim 4 , wherein the composition is formulated in a dose of plus or minus 0.1%-2% of 0.5 mg, plus or minus 0.1%-2% of 1.0 mg, plus or minus 0.1%-2% of 10.0 mg, plus or minus 0.1%-2% of 100 mg, plus or minus 0.1%-2% of 475 mg, or plus or minus 0.1%-2% of 500 mg of peanut protein.

8. The composition of claim 1 , wherein the one or more diluents is selected from the group consisting of alginic acid and salts thereof; a cellulose derivative; microcrystalline dextrose; amylose; magnesium aluminum silicate; polysaccharide acids; bentonite; gelatin; polyvinylpyrrolidone/vinyl acetate copolymer; crosspovidone; povidone; starch; pregelatinized starch; tragacanth; dextrin; a sugar; dicalcium phosphate; a natural or synthetic gum; polyvinylpyrrolidone; larch arabogalactan; Veegum®; polyethylene glycol; waxes; sodium alginate; sodium starch glycolate; a cross-linked starch; a cross-linked polymer; a cross-linked polyvinylpyrrolidone; alginate; a clay; sodium starch glycolate; a natural sponge; a surfactant; a resin; citrus pulp; sodium lauryl sulfate; sodium lauryl sulfate in combination with starch; and combinations thereof.

9. The composition of claim 1 , wherein the one or more gliders is selected from the group consisting of colloidal silicon dioxide, talc, and combinations thereof.

10. The composition of claim 1 , wherein the one or more lubricants is selected from the group consisting of stearic acid, calcium hydroxide, talc, corn starch, sodium stearyl fumerate, alkali-metal and alkaline earth metal salts, waxes, boric acid, sodium benzoate, sodium acetate, sodium chloride, leucine, a polyethylene glycol (PEG), a methoxypolyethylene glycol, propylene glycol, sodium oleate, glyceryl behenate, glyceryl palmitostearate, glyceryl benzoate, magnesium lauryl sulfate, sodium lauryl sulfate, and combinations thereof.

11. The composition of claim 1 , wherein the composition is formulated as a capsule, a tablet, a mini-tablet, a powder, or a sprinkle.

12. The composition of claim 11 , wherein the composition is a capsule comprising HPMC capsule shell.

13. The composition of claim 1 , wherein the composition is formulated for oral administration.

14. The composition of claim 1 , wherein the one or more characterized peanut proteins comprise Ara h 1, Ara h2, Ara h6, or a combination thereof.

15. The composition of claim 1 , further comprising a food product.

16. A composition comprising:

(a) peanut flour comprising plus or minus 0.1%-10% of 1 mg to plus or minus 0.1%-10% of 1000 mg peanut protein;

(b) one or more diluents in an amount of from 1% to 99% w/w, from 60% to 90% w/w, or from 5% to 20% w/w of the composition;

(c) one or more gliders in an amount of from 0.01% to 10% w/w of the composition; and

(d) one or more lubricants in an amount of from 0.01% to 10% w/w of the composition.

17. The composition of claim 16 , wherein the composition is formulated for oral administration.

18. The composition of claim 16 , wherein the composition is formulated as a capsule, a tablet, a mini-tablet, a powder, or a sprinkle.

19. The composition of claim 18 , wherein the composition is a capsule comprising HPMC capsule shell.

20. The composition of claim 16 , wherein the one or more diluents is selected from the group consisting of alginic acid and salts thereof; a cellulose derivative; microcrystalline dextrose; amylose; magnesium aluminum silicate; polysaccharide acids; bentonite; gelatin; polyvinylpyrrolidone/vinyl acetate copolymer; crosspovidone; povidone; starch; pregelatinized starch; tragacanth, dextrin, a sugar; dicalcium phosphate; a natural or synthetic gum; polyvinylpyrrolidone; larch arabogalactan; Veegum®; polyethylene glycol; waxes; sodium alginate; sodium starch glycolate; a cross-linked starch; a cross-linked polymer; a cross-linked polyvinylpyrrolidone; alginate; a clay; sodium starch glycolate; a natural sponge; a surfactant; a resin; citrus pulp; sodium lauryl sulfate; sodium lauryl sulfate in combination with starch; and combinations thereof.

21. The composition of claim 16 , wherein the one or more gliders is selected from the group consisting of colloidal silicon dioxide, talc, and combinations thereof.

22. The composition of claim 16 , wherein the one or more lubricants is selected from the group consisting of stearic acid, calcium hydroxide, talc, corn starch, sodium stearyl fumerate, alkali-metal and alkaline earth metal salts, waxes, boric acid, sodium benzoate, sodium acetate, sodium chloride, leucine, a polyethylene glycol (PEG), a methoxypolyethylene glycol, propylene glycol, sodium oleate, glyceryl benzoate, magnesium lauryl sulfate, sodium lauryl sulfate, and combinations thereof.

23. The composition of claim 16 , wherein the composition is formulated in a dose of plus or minus 0.1%40% of 1.0 mg, plus or minus 0.1%-10% of 10.0 mg, plus or minus 0.1%-10% of 100 mg, plus or minus 0.1%-10% of 475 mg, plus or minus 0.1%-10% of 500 mg, or plus or minus 0.1%-10% of 1000 mg of peanut protein.

24. The composition of claim 16 , wherein the composition comprises peanut flour in a concentration from plus or minus 0.1%-10% of 8% to plus or minus 0.1%-10% of 15% w/w, or from plus or minus 0.1%-10% of 9% to plus or minus 0.1%-10% of 12% w/w.

25. The composition of claim 16 , wherein the composition comprises:

peanut flour comprising plus or minus 0.1%-5% of 1 mg to plus or minus 0.1%-5% of 1000 mg peanut protein;

one or more diluents in an amount of from plus or minus 0.1%-5% of 1% to plus or minus 0.1%-5% of 99% w/w, from plus or minus 0.1%-5% of 60% to plus or minus 0.1%-5% of 90% w/w, or from plus or minus 0.1%-5% of 5% to plus or minus 0.1%-5% of 20% w/w of the composition;

one or more gliders in an amount of from plus or minus 0.1%-5% of 0.01% to plus or minus 0.1%-5% of 10% w/w of the composition; and

one or more lubricants in an amount of from plus or minus 0.1%-5% of 0.01% to plus or minus 0.1%-5% of 10% w/w of the composition.

26. The composition of claim 16 , wherein the composition comprises:

peanut flour comprising plus or minus 0.1%-2% of 1 mg to plus or minus 0.1%-2% of 1000 mg peanut protein;

one or more diluents in an amount of from plus or minus 0.1%-2% of 1% to plus or minus 0.1%-2% of 99% w/w, from plus or minus 0.1%-2% of 60% to plus or minus 0.1%-2% of 90% w/w, or from plus or minus 0.1%-2% of 5% to plus or minus 0.1%-2% of 20% w/w of the composition;

one or more gliders in an amount of from plus or minus 0.1%-2% of 0.01% to plus or minus 0.1%-2% of 10% w/w of the composition; and

one or more lubricants in an amount of from plus or minus 0.1%-2% of 0.01% to plus or minus 0.1%-2% of 10% w/w of the composition.

27. The composition of claim 16 , wherein the composition is formulated in a dose of plus or minus 0.1%-5% of 1.0 mg, plus or minus 0.1%-5% of 10.0 mg, plus or minus 0.1%-5% of 100 mg, plus or minus 0.1%-5% of 475 mg, plus or minus 0.1%-5% of 500 mg, or plus or minus 0.1%-5% of 1000 mg of peanut protein.

28. The composition of claim 16 , wherein the composition is formulated in a dose of plus or minus 0.1%-2% of 1.0 mg, plus or minus 0.1%-2% of 10.0 mg, plus or minus 0.1%-2% of 100 mg, plus or minus 0.1%-2% of 475 mg, plus or minus 0.1%-2% of 500 mg, or plus or minus 0.1%-2% of 1000 mg of peanut protein.

29. The composition of claim 16 , further comprising a food product.

30. A method for treating a subject for desensitization of peanut allergy, comprising administering to the subject the composition of claim 1 .

31. A method of identifying a composition for treatment for desensitization of peanut allergy in a subject, comprising:

(a) determining the amounts of Ara h1, Ara h2 and Ara h6 in a sample of peanut flour by RP-HPLC;

(b) comparing the amounts of Ara h1, Ara h2 and Ara h6 in the sample to amounts of Ara h 1, Ara h2 and Ara h6 in a reference standard; and

(c) identifying a composition for desensitization of peanut allergy in a subject, wherein the composition includes:

peanut flour containing at least the amounts of Ara h1, Ara h2 and Ara h6 of the reference standard, and wherein a total characterized peanut protein amount is from plus or minus 0.1%-10% of 0.5 mg to plus or minus 0.1%-10% of 500 mg peanut protein;

one or more diluents in an amount of from 1% to 99% w/w, from 60% to 90% w/w, or from 5% to 20% w/w of the composition;

one or more gliders in an amount of from 0.01% to 10% w/w of the composition; and

one or more lubricants in an amount of from 0.01% to 10% w/w of the composition.

32. The method of claim 31 , further comprising administering the composition to a subject.

33. The method of claim 31 , further comprising comparing samples from one or more lots of peanut flour to determine the amounts of Ara h 1, Ara h2 and Ara h6 in the samples.