Claims for Patent: 12,233,105

Summary for Patent: 12,233,105

Title:	Methods for storing and warming purified corticotropin compositions
Abstract:	A method of storing a sterile corticotropin composition at a temperature of 2° to 8° C., warming the sterile corticotropin composition to a temperature of 18° to 26° C., injecting 80 United States Pharmacopeia (USP) units of the sterile corticotropin composition into a human subject, wherein the corticotropin comprises amino acids 1-39 of SEQ ID NO: 1, or wherein the sterile corticotropin composition has not more than 0.05 USP Vasopressin Units/USP Corticotropin Units, or wherein the sterile corticotropin composition comprises acidified WFI having a pH of 2.8 to 3.2.
Inventor(s):	Edward M. Desimone, III, Weijun Cheng, Zachary Holcomb
Assignee:	ANI Pharmaceuticals Inc
Application Number:	US18/818,974
Patent Claims:	1. A method comprising: a) storing a sterile corticotropin composition at a temperature of 2° to 8° C.; b) warming the sterile corticotropin composition to a temperature of 18° to 26° C.; c) injecting 80 United States Pharmacopeia (USP) units of the sterile corticotropin composition into a human subject after step b), wherein the corticotropin comprises amino acids 1-39 of SEQ ID NO: 1, or wherein the sterile corticotropin composition has not more than 0.05 USP Vasopressin Units/USP Corticotropin Units, or wherein the sterile corticotropin composition comprises acidified WFI having a pH of 2.8 to 3.2. 2. The method of claim 1, wherein the sterile corticotropin composition is stored as a solid gel composition and the sterile corticotropin composition is a liquid gel after step b). 3. The method of claim 1, comprising withdrawing the sterile corticotropin composition from a vial with a first needle having a first gauge size with a first diameter after step b), and injecting the sterile corticotropin composition into the human subject with a second needle having a second gauge size with a second diameter in step c), and wherein the first gauge size is 20G. 4. The method of claim 1, comprising withdrawing the sterile corticotropin composition from a vial with a first needle having a first gauge size with a first diameter after step b), and injecting the sterile corticotropin composition into the human subject with a second needle having a second gauge size with a second diameter in step c), and wherein the second gauge size is 23G. 5. The method of claim 1, wherein the corticotropin is from a whole porcine pituitary gland including both anterior and posterior portions. 6. The method of claim 1, wherein the human subject has systemic lupus erythematosus, acute exacerbations of multiple sclerosis (MS), acute gouty arthritis, severe psoriasis, atopic dermatitis, or allergic conjunctivitis. 7. A method comprising: a) warming a sterile corticotropin composition from a temperature of 2° to 8° C. to a temperature of 18° to 26° C.; b) withdrawing the sterile corticotropin composition with a first needle having a first gauge size with a first diameter; c) replacing the first needle with a second needle having a second gauge size with a second diameter that is different from the first diameter; and d) injecting the withdrawn sterile corticotropin composition through the second needle into a human subject after step c), wherein the corticotropin comprises amino acids 1-39 of SEQ ID NO: 1, or wherein the sterile corticotropin composition has not more than 0.05 USP Vasopressin Units/USP Corticotropin Units, or wherein the sterile corticotropin composition comprises acidified WFI having a pH of 2.8 to 3.2. 8. The method of claim 7, wherein the sterile corticotropin composition of purified corticotropin comprises 80 USP units/mL of the sterile corticotropin composition. 9. The method of claim 7, wherein the injecting is subcutaneously or intramuscularly. 10. The method of claim 9, further comprising administering an anti-infective therapy to the human subject. 11. The method of claim 7, wherein the sterile corticotropin composition further comprises about 0.1-1% w/w phenol. 12. The method of claim 7, wherein the sterile corticotropin composition further comprises about 10-20% w/w gelatin. 13. The method of claim 7, wherein the sterile corticotropin composition further comprises 0.5 w/w % phenol, 15.0 w/w % gelatin, water, hydrochloric acid, and sodium hydroxide. 14. The method of claim 7, wherein the sterile corticotropin composition has less than 6000 particles ≥10 μm and/or less than 600 particles ≥25 μm. 15. The method of claim 7, wherein the sterile corticotropin composition is preservative-free, antimicrobial-free, or both preservative-free and antimicrobial-free. 16. The method of claim 7, wherein the human subject has systemic lupus erythematosus, acute exacerbations of multiple sclerosis (MS), acute gouty arthritis, severe psoriasis, atopic dermatitis, or allergic conjunctivitis. 17. The method of claim 7, wherein the sterile corticotropin composition is administered daily for up to 5 days and a second therapeutic agent is administered daily for at least 7 days. 18. The method of claim 7, further comprising: step e) verifying adrenal responsiveness after administering the sterile corticotropin composition for a first time, wherein the adrenal responsiveness is verified by a rise in urinary corticosteroid values and plasma corticosteroid values. 19. The method of claim 18, wherein the adrenal responsiveness is verified by injecting 20 to 80 USP units/ml of the sterile corticotropin composition into the human subject. 20. The method of claim 19, wherein the 20 to 80 USP units/ml of the sterile corticotropin composition is administered over a series of two or more injections. 21. The method of claim 18, wherein the subject has a rise in urinary corticosteroid values and plasma corticosteroid values after administering the sterile corticotropin composition for a first time subcutaneously or intramuscularly. 22. A method of delivering a sterile corticotropin composition to a human subject, comprising withdrawing the sterile corticotropin composition from a vial with a first needle having a first gauge size with a first diameter, and injecting the human subject with the sterile corticotropin composition using a syringe having a second needle having a second gauge size with a second diameter, wherein the corticotropin in the sterile corticotropin composition comprises amino acids 1-39 of SEQ ID NO: 1, and wherein the corticotropin is from a whole porcine pituitary gland including both anterior and posterior portions and the sterile corticotropin composition has not more than 0.05 USP Vasopressin Units/USP Corticotropin Units, or wherein the sterile corticotropin composition comprises acidified WFI having a pH of 2.8 to 3.2. 23. The method of claim 22, the corticotropin is from a whole porcine pituitary gland including both anterior and posterior portions and wherein the sterile corticotropin composition has not more than 0.05 USP Vasopressin Units/USP Corticotropin Units. 24. The method of claim 23, wherein the sterile corticotropin composition comprises acidified WFI having a pH of 2.8 to 3.2. 25. The method of claim 22, wherein the sterile corticotropin composition comprises 80 USP units/mL of the corticotropin. 26. The method of claim 25, wherein the human subject has systemic lupus erythematosus, acute exacerbations of multiple sclerosis (MS), acute gouty arthritis, severe psoriasis, atopic dermatitis, or allergic conjunctivitis. 27. The method of claim 22, wherein the sterile corticotropin composition further comprises about 0.1-1% w/w phenol. 28. The method of claim 22, wherein the sterile corticotropin composition further comprises about 10-20% w/w gelatin. 29. The method of claim 28, wherein the gelatin is Type A gelatin, and wherein the gelatin is pyrogen-free. 30. The method of claim 22, wherein the sterile corticotropin composition further comprises 0.5 w/w % phenol, 15.0 w/w % gelatin, water, hydrochloric acid, and sodium hydroxide.