Manufacture of peanut formulations for oral desensitization

摘要

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.

主权项

1. A method of making a stable, allergenic encapsulated formulation, comprising:
(a) providing 12% defatted peanut flour; (b) characterizing the concentration of each of Ara h1, Ara h2 and Ara h6 in the 12% defatted peanut flour; (c) mixing the 12% defatted peanut flour comprising the characterized concentration of each of Ara h1, Ara h2 and Ara h6 with a diluent, a glident, and/or a lubricant to form a blended material; (d) discharging the blended material; (e) passing the blended material through a mesh screen; and (f) encapsulating the blended material, whereby the method provides an encapsulated allergenic formulation that is stable for at least about 18 to about 36 months.