Claims for Patent: 12,102,662

Summary for Patent: 12,102,662

Title:	Methods for storing and warming purified corticotropin compositions
Abstract:	A method of warming a vial containing a sterile corticotropin composition from a temperature of 2° to 8° C. to a temperature of 18° to 26° C., withdrawing the sterile corticotropin composition from the vial with a first needle having a first gauge size with a first diameter, 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 injecting 80 (United States Pharmacopeia) USP units of the sterile corticotropin composition into a human subject.
Inventor(s):	Edward M. Desimone, III, Weijun Cheng, Zachary Holcomb
Assignee:	ANI Pharmaceuticals Inc
Application Number:	US18/634,717
Patent Claims:	1. A method comprising: a) warming a vial containing 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 from the vial 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diameter that is different from the first diameter; and d) injecting 80 (United States Pharmacopeia) USP units of the withdrawn sterile corticotropin composition through the second needle into a human subject after step c), wherein the corticotropin comprises amino acids 1-39 of SEQ ID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. 2. The method of claim 1, wherein the sterile corticotropin composition has physical properties such that it is a solid gel at 2° to 8° C. and is a liquid gel at 18° to 26° C. 3. The method of claim 1, wherein step a) comprises rolling the vial between two hands for at least two minutes. 4. The method of claim 1, wherein the sterile corticotropin composition further comprises 0.5 w/w % phenol, 15.0 w/w % gelatin, water, hydrochloric acid, and sodium hydroxide. 5. A method comprising: a) warming a vial containing 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 from the vial 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 80 (United States Pharmacopeia) USP units of 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, and wherein the sterile corticotropin composition has a pH of 3.0-7.0. 6. The method of claim 1, wherein the corticotropin comprises amino acids 1-39 of SEQ ID NO: 1. 7. The method of claim 1, wherein the corticotropin is from a whole porcine pituitary gland including both anterior and posterior portions. 8. The method of claim 1, wherein the vial comprises a rubber stopper comprising a coating comprising silicone oils of different molecular weights including polydimethylsiloxane. 9. The method of claim 8, wherein the vial further comprises a removable cap covering the rubber stopper. 10. The method of claim 1, wherein the vial comprises an aluminum seal. 11. The method of claim 1, wherein the vial is borosilicate glass. 12. The method of claim 1, wherein the sterile corticotropin composition further comprises about 10-20% w/w gelatin. 13. The method of claim 1, wherein the sterile corticotropin composition further comprises about 15% w/w gelatin. 14. The method of claim 1, wherein the sterile corticotropin composition further comprises about 0.1-1% w/w phenol. 15. The method of claim 1, wherein the sterile corticotropin composition further comprises about 0.5% w/w phenol. 16. The method of claim 1, wherein the sterile corticotropin composition further comprises water for injection (WFI). 17. The method of claim 1, wherein the sterile corticotropin composition further comprises water for injection (WFI), gelatin, and phenol. 18. The method of claim 17, wherein the sterile corticotropin composition comprises water for injection (WFI), 15% w/w gelatin, and 0.5% w/w phenol. 19. The method of claim 1, wherein the sterile corticotropin composition has not more than 0.05 USP Vasopressin Units/USP Corticotropin Units. 20. The method of claim 4, wherein the gelatin is pyrogen-free. 21. The method of claim 1, wherein step c) is performed subcutaneously or intramuscularly. 22. The method of claim 1, further comprising administering an anti-infective therapy to the human subject. 23. The method of claim 1, further comprising administering the sterile corticotropin composition to the subject for more than one month, and the method further comprises administering one or more corticosteroids to the subject. 24. The method of claim 1, wherein the sterile corticotropin composition further comprises gelatin and the gelatin is pyrogen-free. 25. The method of claim 1, wherein the sterile corticotropin composition has less than 6000 particles ≥10 μm and/or less than 600 particles ≥25 μm. 26. The method of claim 1, wherein the sterile corticotropin composition is free of acetic acid. 27. The method of claim 1, wherein the sterile corticotropin composition is preservative-free, antimicrobial-free, or both preservative-free and antimicrobial-free. 28. The method of claim 1, wherein the human subject has multiple sclerosis, gouty arthritis, psoriasis, atopic dermatitis, rheumatoid arthritis, or allergic conjunctivitis. 29. A method comprising: a) providing a filter-sterilized preparation of purified corticotropin comprising 80 USP units per mL of corticotropin, 0.5% w/w phenol, 15.0% w/w gelatin, water for injection (WFI), hydrochloric acid, and sodium hydroxide, wherein the gelatin is Type A; and b) injecting the filter-sterilized preparation into a human subject after step a), wherein the filter-sterilized preparation has been filter-sterilized before step a) and has not been terminally sterilized before step a), and wherein the purified corticotropin comprises amino acids 1-39 of SEQ ID NO: 1, or wherein the filter-sterilized preparation has not more than 0.05 USP Vasopressin Units/USP Corticotropin Units.