EGG PROTEIN FORMULATIONS AND METHODS OF MANUFACTURE THEREOF
The present technology relates generally to formulations comprising egg white protein, methods of manufacturing egg protein formulations and uses for egg protein formulations. In particular, several embodiments are directed to egg protein formulations for oral administration in immunotherapy of subjects affected by egg allergies.
1 . A pharmaceutical formulation comprising dried egg white protein powder, a diluent, a filling agent, and a glidant and/or lubricant.
2 . The pharmaceutical formulation of claim 1 , comprising: a) about 0.1% to 90% (w/w) egg white protein; b) about 40-90% of a diluent; c) about 1-30% of a filling agent; d) about 0.01%-10% of a lubricant or glidant; and a e) capsule shell or pouch.
3 . The pharmaceutical formulation of claim 1 , wherein levels of egg white protein in the egg white protein powder are stable in the pharmaceutical formulation for about 3, 6, 9, 11 or 36 months.
4 . The pharmaceutical formulation of claim 1 , wherein a concentration of one or more of ovomucoid, ovalbumin, and lysozyme proteins are stable for about 3, 6, 9, or 11 or 36 months in the pharmaceutical formulation.
5 . The pharmaceutical formulation of claim 1 , wherein the formulation comprises one or more diluents selected from the group consisting of alginic acid and salts thereof, a cellulose derivative; microcrystalline dextrose; amylose; magnesium aluminum silicate; polysaccharide acids; bentonites; gelatin; polyvinylpyrrolidone/vinyl acetate copolymer; crosspovidone; povidone; starch; pregelatinized starch; tragacanth; dextrin, a sugar; dicalcium phosphate; a natural or synthetic gum, polyvinylpyrrolidone, larch arabogalactan, Veegum®, polyethylene glycol, waxes, sodium alginate, a starch, sodium starch glycolate, a cross-linked starch; a cross-linked polymer; a cross-linked polyvinylpyrrolidone; alginate; a clay; sodium starch glycolate; bentonite; a natural sponge; a surfactant; a resin; citrus pulp; sodium lauryl sulfate; sodium laurel sulfate in combination with starch; and combinations thereof.
6 . The pharmaceutical formulation of claim 1 , wherein the formulation comprises one or more lubricants selected from the group consisting of stearic acid, calcium hydroxide, talc, corn starch, sodium stearyl fumerate, alkali-metal and alkaline earth metal salts, waxes, boric acid, sodium benzoate, sodium acetate, sodium chloride, leucine, a polyethylene glycol (PEG), a methoxypolyethylene glycol, propylene glycol, sodium oleate, glyceryl behenate, glyceryl palmitostearate, glyceryl benzoate, magnesium lauryl sulfate, sodium lauryl sulfate, and combinations thereof.
7 . The pharmaceutical formulation of claim 1 , wherein the formulation comprises one or more filling agents selected from the group consisting of lactose, calcium carbonate, calcium phosphate, dibasic calcium phosphate, calcium sulfate, microcrystalline cellulose, cellulose powder, dextrose, dextrates, dextran, starches, pregelatinized starch, sucrose, xylitol, lactitol, mannitol, sorbitol, sodium chloride, polyethylene glycol, and combinations thereof.
8 . The pharmaceutical formulation of claim 1 , wherein the egg white protein is in the range of about 0.1% to 21% (w/w).
9 . The pharmaceutical formulation of claim 1 , comprising about 0.1% egg white protein.
10 . The pharmaceutical formulation of claim 1 , wherein the egg white protein is in a weight range of about 0.2 mg to about 1000 mg per capsule or sachet.
11 . The pharmaceutical formulation of claim 1 , comprising about 0.2 mg egg white protein.
12 . The pharmaceutical formulation of claim 1 , comprising about 1.0 mg egg white protein.
13 . The pharmaceutical formulation of claim 1 , comprising about 10.0 mg egg white protein.
14 . The pharmaceutical formulation of claim 1 , comprising about 100.0 mg egg white protein.
15 . The pharmaceutical formulation of claim 1 , comprising about 200.0 mg egg white protein.
16 . The pharmaceutical formulation of claim 1 , comprising about 1000.0 mg egg white protein.
17 . The pharmaceutical formulation of claim 1 , wherein the diluent is Prosolv.
18 . The pharmaceutical formulation of claim 17 , wherein the Prosolv is a combination of Prosolv SMCC 50 and Prosolv HD90.
19 . The pharmaceutical formulation of claim 1 , wherein the filling agent is mannitol.
20 . The pharmaceutical formulation of claim 1 , wherein the lubricant is magnesium stearate.
21 . The pharmaceutical formulation of claim 1 , wherein the glidant is talc.
22 . A pharmaceutical formulation, comprising: a) about 0.1% to 50% (w/w) egg white protein; b) about 40-90% of Prosolv SMCC 50 and/or Prosolv HD90; c) about 1-30% of mannitol; d) about 0.01%-10% of magnesium stearate and/or talc; and a e) capsule shell or pouch.
23 . A method of identifying a pharmaceutical formulation for the treatment of egg allergy in a subject, comprising: a) determining the concentrations of ovomucoid, ovalbumin, and lysozyme proteins in a composition of egg white protein by one or more analytical methods; b) comparing the concentrations of the proteins to the concentrations of a reference standard; and c) identifying a composition for treatment of egg allergy in a subject, wherein the same contains at least the concentrations of ovomucoid, ovalbumin, and lysozyme protein as the reference standard.
24 . The method of claim 23 , wherein the analytical method is size exclusion chromatography.