Manufacture of peanut formulations for oral desensitization

Abstract

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.