Claims for Patent: 10,512,686

Summary for Patent: 10,512,686

Title:	Peanut formulations and used thereof
Abstract:	The present application relates to compositions for oral immunotherapy of peanut allergies. Further, the present application relates to methods for the preparation of the compositions for immunotherapy, and their use in immunotherapy.
Inventor(s):	Walser; Bryan (Menlo Park, CA), Raff; Howard V. (Mill Valley, CA)
Assignee:	Aimmune Therapeutics, Inc. (Brisbane, CA)
Application Number:	16/289,370
Patent Claims:	1. A pharmaceutical composition comprising: (a) peanut flour comprising 90 mg to 110 mg peanut protein; (b) one or more diluents comprising microcrystalline cellulose in an amount from 60% w/w to 90% w/w of the composition; (c) one or more glidants comprising colloidal silicon dioxide in an amount from 0.01% w/w to 1.0% w/w of the composition; and (d) one or more lubricants comprising magnesium stearate in an amount from 0.01% w/w to 1.0% w/w of the composition. 2. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is encapsulated. 3. The pharmaceutical composition of claim 2, wherein the pharmaceutical composition is encapsulated in a capsule. 4. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is packaged in a solid dosage form comprising 200 mg peanut protein or 300 mg peanut protein, and wherein the solid dosage form is a multiple capsule dosage form. 5. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is mixed with a food product. 6. The pharmaceutical composition of claim 3, wherein the capsule is sized 3, 00, or 000. 7. A pharmaceutical composition comprising: (a) peanut flour comprising 0.45 mg to 550 mg peanut protein; (b) a plurality of diluents comprising pregelatinized starch and microcrystalline cellulose; (c) one or more glidants comprising colloidal silicon dioxide; and (d) one or more lubricants comprising magnesium stearate. 8. The pharmaceutical composition of claim 7, wherein the pharmaceutical composition is encapsulated. 9. The pharmaceutical composition of claim 8, wherein the pharmaceutical composition is encapsulated in a capsule. 10. The pharmaceutical composition of claim 7, wherein: (a) the peanut flour comprises 0.45 mg to 0.55 mg peanut protein; (b) the plurality of diluents comprises (i) pregelatinized starch in an amount from 5% w/w to 20% w/w of the composition, and (ii) microcrystalline cellulose in an amount from 60% w/w to 90% w/w of the composition; (c) the one or more glidants comprise colloidal silicon dioxide in an amount from 0.01% w/w to 1.0% w/w of the composition; and (d) the one or more lubricants comprise magnesium stearate in an amount from 0.01% w/w to 1.0% w/w of the composition. 11. The pharmaceutical composition of claim 10, wherein the pharmaceutical composition is encapsulated. 12. The pharmaceutical composition of claim 11, wherein the pharmaceutical composition is encapsulated in a capsule. 13. The pharmaceutical composition of claim 7, wherein: (a) the peanut flour comprises 0.9 mg to 1.1 mg peanut protein; (b) the plurality of diluents comprises (i) pregelatinized starch in an amount from 5% w/w to 20% w/w of the composition, and (ii) microcrystalline cellulose in an amount from 60% w/w to 90% w/w of the composition; (c) the one or more glidants comprise colloidal silicon dioxide in an amount from 0.01% w/w to 1.0% w/w of the composition; and (d) the one or more lubricants comprise magnesium stearate in an amount from 0.01% w/w to 1.0% w/w of the composition. 14. The pharmaceutical composition of claim 13, wherein the pharmaceutical composition is encapsulated. 15. The pharmaceutical composition of claim 14, wherein the pharmaceutical composition is encapsulated in a capsule. 16. The pharmaceutical composition of claim 7, wherein: (a) the peanut flour comprises 9 mg to 11 mg peanut protein; (b) the plurality of diluents comprises (i) pregelatinized starch in an amount from 5% w/w to 20% w/w of the composition, and (ii) microcrystalline cellulose in an amount from 60% w/w to 90% w/w of the composition; (c) the one or more glidants comprise colloidal silicon dioxide in an amount from 0.01% w/w to 1.0% w/w of the composition; and (d) the one or more lubricants comprise magnesium stearate in an amount from 0.01% w/w to 1.0% w/w of the composition. 17. The pharmaceutical composition of claim 16, wherein the pharmaceutical composition is encapsulated. 18. The pharmaceutical composition of claim 17, wherein the pharmaceutical composition is encapsulated in a capsule. 19. The pharmaceutical composition of claim 7, wherein the pharmaceutical composition is packaged in a solid dosage form comprising a dose of 0.5 mg peanut protein, 1 mg peanut protein, 1.5 mg peanut protein, 3 mg peanut protein, 6 mg peanut protein, 12 mg peanut protein, 20 mg peanut protein, 80 mg peanut protein, 120 mg peanut protein, 160 mg peanut protein, 200 mg peanut protein, 240 mg peanut protein, or 300 mg peanut protein. 20. The pharmaceutical composition of claim 19, wherein the solid dosage form is a single capsule. 21. The pharmaceutical composition of claim 19, wherein the solid dosage form is a multiple capsule dosage form. 22. The pharmaceutical composition of claim 7, wherein the pharmaceutical composition is mixed with a food product. 23. The pharmaceutical composition of claim 22, wherein the pharmaceutical composition is mixed with the food product at a dose of 0.5 mg peanut protein, 1 mg peanut protein, 1.5 mg peanut protein, 3 mg peanut protein, 6 mg peanut protein, 12 mg peanut protein, 20 mg peanut protein, 80 mg peanut protein, 120 mg peanut protein, 160 mg peanut protein, 200 mg peanut protein, 240 mg peanut protein, or 300 mg peanut protein. 24. The pharmaceutical composition of claim 9, wherein the capsule is sized 3, 00, or 000.

Details for Patent 10,512,686

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
United Therapeutics Corporation	UNITUXIN	dinutuximab	Injection	125516	March 10, 2015	10,512,686	2039-02-28
Aimmune Therapeutics, Inc.	PALFORZIA	peanut (arachis hypogaea) allergen powder-dnfp	Powder	125696	January 31, 2020	10,512,686	2039-02-28

International Patent Family for US Patent 10,512,686

Country	Patent Number	Estimated Expiration
Australia	2014240404
Australia	2016231523
Australia	2018222980