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 a powder formulation, the method comprising:
 mixing a peanut flour and a first diluent to form a first blend;   passing the first blend through a mesh screen and blending the first blend to form a second blend; and   adding one or more excipients selected from the group consisting of a glidant and a lubricant to the second blend to form a third blend, wherein the powder formulation comprises the third blend.   
     
     
         38 . The method of  claim 37  further comprising mixing a second diluent with the first blend before passing the first blend through the mesh screen. 
     
     
         39 . The method of  claim 38 , wherein at least one of the first and second diluents comprises at least one of starch, lactose, microcrystalline cellulose, or dicalcium phosphate. 
     
     
         40 . The method of  claim 37 , wherein the glidant comprises at least one of colloidal silicon dioxide or talc. 
     
     
         41 . The method of  claim 37 , wherein the lubricant comprises magnesium stearate. 
     
     
         42 . The method of  claim 37  further comprising encapsulating the powder formulation. 
     
     
         43 . The method of  claim 42 , wherein the encapsulating is done in a size 3, 00, or 000 Hydroxypropyl Methyl Cellulose capsule. 
     
     
         44 . The method of  claim 42  further comprising sampling the third blend prior to the encapsulating. 
     
     
         45 . The method of  claim 37 , wherein the peanut flour comprises peanut proteins Ara h1, Ara h2, and Ara h6. 
     
     
         46 . The method of  claim 37  further comprising passing the peanut flour through a mesh screen prior to mixing the peanut flour in the first blend. 
     
     
         47 . The method of  claim 37  wherein the powder formulation comprises about 0.5 mg, about 1 mg, about 10 mg, about 100 mg, or about 475 mg of a peanut protein comprising Ara h1, Ara h2, and Ara h6. 
     
     
         48 . A method of making a capsule formulation, the method comprising:
 mixing a peanut flour with one or more excipients selected from the group consisting of a diluent, a glidant and a lubricant to form a powder formulation; and   encapsulating the powder formulation.   
     
     
         49 . The method of  claim 48 , wherein the diluent comprises at least one of starch, lactose, microcrystalline cellulose, or dicalcium phosphate. 
     
     
         50 . The method of  claim 48 , wherein the glidant comprises at least one of colloidal silicon dioxide or talc. 
     
     
         51 . The method of  claim 48 , wherein the lubricant comprises magnesium stearate. 
     
     
         52 . The method of  claim 48 , wherein the peanut flour comprises peanut proteins Ara h1, Ara h2, and Ara h6. 
     
     
         53 . The method of  claim 48 , wherein the encapsulating is done in a size 3, 00, or 000 Hydroxypropyl Methyl Cellulose capsule. 
     
     
         54 . The method of  claim 48  further comprising passing the peanut flour through a mesh screen prior to mixing the peanut flour with the one or more excipients. 
     
     
         55 . The method of  claim 48  further comprising sampling the powder formulation prior to the encapsulating. 
     
     
         56 . The method of  claim 48 , wherein the capsule formulation comprises about 0.5 mg, about 1 mg, about 10 mg, about 100 mg, or about 475 mg of the peanut proteins.