Manufacture of peanut formulations for oral desensitization
The present application relates to a method for managing the development and manufacturing process of a therapeutically effective formulation. Peanut proteins are characterized from peanut flour and encapsulated formulations made using the peanut flour for oral immunotherapy of peanut allergies.
1. A method of making an allergenic powdered peanut flour formulation, comprising:
(a) providing defatted peanut flour;
(b) characterizing a concentration of each of Ara h1, Ara h2, and Ara h6 in the defatted peanut flour; and
(c) mixing the defatted peanut flour with a lubricant, a glidant, or a diluent to form the allergenic powdered peanut flour formulation.
2. The method of claim 1 , wherein characterizing the concentration of each of Ara h1, Ara h2, and Ara h6 in the defatted peanut flour comprises determining a relative concentration of each of Ara h1, Ara h2, and Ara h6 compared to a total peanut protein content in the defatted peanut flour.
3. The method of claim 1 , wherein characterizing the concentration of each of Ara h1, Ara h2, and Ara h6 in the defatted peanut flour comprises determining a relative concentration of each of Ara h1, Ara h2, and Ara h6 compared to each other in the defatted peanut flour.
4. The method of claim 1 , wherein the concentration of each of Ara h1, Ara h2, and Ara h6 are characterized by Reverse Phased-High Performance Liquid Chromatography (RP-HPLC).
5. The method of claim 1 , further comprising monitoring lot-to-lot consistency of Ara h1, Ara h2, and Ara h6.
6. The method of claim 1 , further comprising packaging the allergenic powdered peanut flour formulation in a pharmaceutical dosage form.
7. The method of claim 6 , wherein the pharmaceutical dosage form comprises about 0.5 mg to about 1000 mg of peanut protein.
8. The method of claim 1 , further comprising encapsulating the allergenic powdered peanut flour formulation in a capsule.
9. The method of claim 8 , wherein the capsule comprises about 0.5 mg to about 1000 mg of peanut protein.
10. The method of claim 1 , wherein the defatted peanut flour is about 10% to about 15% defatted peanut flour.
11. The method of claim 1 , wherein the defatted peanut flour is about 12% defatted peanut flour.
12. A method of making an allergenic powdered peanut flour formulation, comprising:
(a) mixing a defatted peanut flour with a lubricant, a glidant, or a diluent to form the allergenic powdered peanut flour formulation; and
(b) characterizing a concentration of each of Ara h1, Ara h2, and Ara h6 in the allergenic powdered peanut flour formulation.
13. A method of making an allergenic peanut flour formulation, comprising:
(a) providing defatted peanut flour;
(b) characterizing a concentration of each of Ara h1, Ara h2, and Ara h6 in the defatted peanut flour by Reversed Phased-High Performance Liquid Chromatography (RP-HPLC);
(c) mixing the defatted peanut flour with a lubricant, a glidant, or a diluent to form the allergenic peanut flour formulation; and
(d) packaging the allergenic peanut flour formulation in a pharmaceutical dosage form.
14. The method of claim 13 , wherein the pharmaceutical dosage form comprises about 0.5 mg to about 1000 mg of peanut protein.
15. The method of claim 13 , wherein characterizing the concentration of each of Ara h1, Ara h2, and Ara h6 in the defatted peanut flour comprises determining a relative concentration of each of Ara h1, Ara h2, and Ara h6 compared to a total peanut protein content in the defatted peanut flour.
16. The method of claim 13 , wherein the method further comprises monitoring lot-to-lot consistency of Ara h1, Ara h2, and Ara h6.
17. The method of claim 13 , wherein characterizing the concentration of each of Ara h1, Ara h2, and Ara h6 in the defatted peanut flour comprises determining a relative concentration of each of Ara h1, Ara h2, and Ara h6 compared to each other in the defatted peanut flour.
18. The method of claim 13 , wherein the pharmaceutical dosage form is a capsule.
19. The method of claim 13 , wherein the defatted peanut flour is about 10% to about 15% defatted peanut flour.
20. A method of making an allergenic peanut flour formulation, comprising:
(a) mixing a defatted peanut flour with a lubricant, a glidant, or a diluent to form the allergenic peanut flour formulation;
(b) characterizing a concentration of each of Ara h1, Ara h2, and Ara h6 in the allergenic peanut flour formulation;
(c) packaging the allergenic peanut flour formulation in a pharmaceutical dosage form.
21. The method of claim 12 , wherein characterizing the concentration of each of Ara h1, Ara h2, and Ara h6 in the allergenic powdered peanut flour formulation comprises determining a relative concentration of each of Ara h1, Ara h2, and Ara h6 compared to a total peanut protein content in the allergenic powdered peanut flour formulation.
22. The method of claim 12 , wherein characterizing the concentration of each of Ara h1, Ara h2, and Ara h6 in the allergenic powdered peanut flour formulation comprises determining a relative concentration of each of Ara h1, Ara h2, and Ara h6 compared to each other in the allergenic powdered peanut flour formulation.
23. The method of claim 12 , wherein the concentration of each of Ara h1, Ara h2, and Ara h6 are characterized by Reverse Phased-High Performance Liquid Chromatography (RP-HPLC).
24. The method of claim 12 , further comprising monitoring lot-to-lot consistency of Ara h1, Ara h2, and Ara h6.
25. The method of claim 12 , further comprising packaging the allergenic powdered peanut flour formulation in a pharmaceutical dosage form.
26. The method of claim 25 , wherein the pharmaceutical dosage form comprises about 0.5 mg to about 1000 mg of peanut protein.
27. The method of claim 12 , further comprising encapsulating the allergenic powdered peanut flour formulation in a capsule.
28. The method of claim 27 , wherein the capsule comprises about 0.5 mg to about 1000 mg of peanut protein.
29. The method of claim 12 , wherein the defatted peanut flour is about 10% to about 15% defatted peanut flour.
30. The method of claim 12 , wherein the defatted peanut flour is about 12% defatted peanut flour.
31. The method of claim 20 , wherein the pharmaceutical dosage form comprises about 0.5 mg to about 1000 mg of peanut protein.
32. The method of claim 20 , wherein characterizing the concentration of each of Ara h1, Ara h2, and Ara h6 in the allergenic peanut flour formulation comprises determining a relative concentration of each of Ara h1, Ara h2, and Ara h6 compared to a total peanut protein content in the allergenic peanut flour formulation.
33. The method of claim 20 , wherein the method further comprises monitoring lot-to-lot consistency of Ara h1, Ara h2, and Ara h6.
34. The method of claim 20 , wherein characterizing the concentration of each of Ara h1, Ara h2, and Ara h6 in the allergenic peanut flour formulation comprises determining a relative concentration of each of Ara h1, Ara h2, and Ara h6 compared to each other in the allergenic peanut flour formulation.
35. The method of claim 20 , wherein the pharmaceutical dosage form is a capsule.
36. The method of claim 20 , wherein the defatted peanut flour is about 10% to about 15% defatted peanut flour.