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 - 36 . (canceled)
37 . A method of making an encapsulated peanut flour formulation, comprising:
(a) mixing 12% defatted peanut flour comprising a characterized concentration of each of Ara h1, Ara h2 and Ara h6, with a diluent, a glidant and/or lubricant to form a blended material;
(b) discharging the blended material;
(c) passing the blended material through a mesh screen; and
(d) encapsulating the blended material,
whereby the method provides an encapsulated peanut flour formulation that is stable for at least about 18 to about 36 months.
38 . The method of claim 37 , wherein the encapsulated peanut flour formulation comprises about 10 mg to about 100 mg peanut protein.
39 . The method of claim 37 , wherein the concentration of Ara h1, Ara h2 and Ara h6 is characterized by Reverse Phase-High Performance Liquid Chromatography (RP-HPLC).
40 . The method of claim 37 , wherein the encapsulated peanut flour formulation is stable for at least about 36 months.
41 . The method of claim 37 , wherein the encapsulated peanut flour formulation is stable at a temperature from about 2° C. to about 8° C.
42 . The method of claim 37 , wherein the encapsulated peanut flour formulation is stable at a temperature of about 25° C.
43 . The method of claim 37 , wherein the encapsulated peanut flour formulation is stable at a temperature from about 20° C. to about 30° C.
44 . The method of claim 37 , wherein the encapsulated peanut flour formulation is allergenic to a subject diagnosed with a peanut allergy.
45 . A method of making an encapsulated formulation, comprising:
(a) mixing peanut flour, a diluent, a glidant and/or lubricant to form a blended material;
(b) discharging the blended material;
(c) passing the blended material through a mesh screen; and
(d) encapsulating the blended material,
whereby the method provides an encapsulated formulation that comprises peanut flour.
46 . The method of claim 45 , wherein the peanut flour comprises approximately 50% peanut protein w/w.
47 . The method of claim 45 , wherein the peanut flour is 12% defatted peanut flour.
48 . The method of claim 45 , wherein the encapsulated formulation is stable for at least about 18 to about 36 months.
49 . The method of claim 45 , wherein the encapsulated formulation is stable for at least about 36 months.
50 . The method of claim 45 , wherein the peanut flour comprises a characterized concentration of each of Ara h1, Ara h2 and Ara h6.
51 . The method of claim 50 , wherein the concentration of Ara h1, Ara h2 and Ara h6 is characterized by Reverse Phase-High Performance Liquid Chromatography (RP-HPLC).
52 . The method of claim 45 further comprising characterizing the concentration of one or more of Ara h1, Ara h2 and Ara h6 in the peanut flour.
53 . The method of claim 45 , wherein the encapsulated formulation comprises about 10 to about 100 mg peanut protein.
54 . The method of claim 45 , wherein the encapsulated formulation comprises about 0.5 to about 1.0 mg peanut protein.
55 . The method of claim 45 , wherein the encapsulated formulation comprises about 10 mg to about 1000 mg peanut protein.
56 . The method of claim 45 , wherein the encapsulated formulation comprises about 0.5 mg, about 1.0 mg, about 10 mg, about 100 mg, about 475 mg, or about 1000 mg peanut flour.
57 . The method of claim 45 , wherein the encapsulated formulation is allergenic to a subject diagnosed with a peanut allergy.
58 . A method of making a stable, allergenic encapsulated formulation, comprising:
(a) mixing 12% defatted peanut flour comprising a characterized concentration of each of Ara h1, Ara h2 and Ara h6, with a diluent, a glidant and/or lubricant to form a blended material;
(b) discharging the blended material;
(c) passing the blended material through a mesh screen; and
(d) encapsulating the blended material,
whereby the method provides an encapsulated formulation that is stable for at least about 12 months at a temperature from about 20° C. to about 30° C.
59 . The method of claim 58 , wherein the encapsulated formulation is stable for at least about 18 months to about 36 months.