Claims for Patent: 11,975,047

Summary for Patent: 11,975,047

Title:	Methods for storing and warming purified corticotropin compositions
Abstract:	A method of storing and warming a sterile corticotropin composition by storing the sterile corticotropin composition in a multiple-dose vial comprising 80 USP units/mL of the sterile corticotropin composition, wherein the vial comprises a rubber stopper coated with cross-linked silicones, at a temperature of 2° to 8° C.; and warming the vial to a temperature of 18° to 26° 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.
Inventor(s):	Edward M. Desimone, III, Weijun Cheng, Zachary Holcomb
Assignee:	ANI Pharmaceuticals Inc
Application Number:	US18/495,932
Patent Claims:	1. A method of storing and warming a sterile corticotropin composition, comprising: a) storing the sterile corticotropin composition in a multiple-dose vial comprising 80 USP units/mL of the sterile corticotropin composition, wherein the vial comprises a rubber stopper coated with cross-linked silicones, at a temperature of 2° to 8° C.; and b) warming the vial to a temperature of 18° to 26° 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. 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 b) 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. The method of claim 1, 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 a naturally derived extract from a whole porcine pituitary gland including both anterior and posterior portions. 8. The method of claim 1, wherein the stopper comprises a coating comprising silicone oils of different molecular weights including polydimethylsiloxane. 9. The method of claim 1, wherein the multiple-dose vial is a 5 mL multiple-dose vial. 10. The method of claim 1, wherein the multiple-dose vial further comprises a removable cap covering the stopper. 11. The method of claim 1, wherein the multiple-dose vial comprises an aluminum seal. 12. The method of claim 1, wherein the multiple-dose vial is borosilicate glass. 13. The method of claim 1, wherein the sterile corticotropin composition further comprises about 10-20% w/w gelatin. 14. The method of claim 1, wherein the sterile corticotropin composition further comprises about 15% w/w gelatin. 15. The method of claim 1, wherein the sterile corticotropin composition further comprises about 0.1-1% w/w phenol. 16. The method of claim 1, wherein the sterile corticotropin composition further comprises about 0.5% w/w phenol. 17. The method of claim 1, wherein the sterile corticotropin composition further comprises water for injection (WFI). 18. The method of claim 1, wherein the sterile corticotropin composition further comprises water for injection (WFI), gelatin, and phenol. 19. The method of claim 18, wherein the sterile corticotropin composition comprises water for injection (WFI), 15% w/w gelatin, and 0.5% w/w phenol. 20. The method of claim 1, wherein the sterile corticotropin composition has not more than 0.05 USP Vasopressin Units/USP Corticotropin Units. 21. The method of claim 4, wherein the gelatin is pyrogen-free. 22. A method of storing and warming a sterile corticotropin composition, comprising: a) storing the sterile corticotropin composition in a multiple-dose vial comprising 80 USP units/mL of the sterile corticotropin composition, wherein the vial comprises a rubber stopper coated with cross-linked silicones, at a temperature of 2° to 8° C.; and b) warming the vial to a temperature of 18° to 26° C., wherein the sterile corticotropin composition comprises acidified WFI having a pH of 2.8 to 3.2. 23. The method of claim 1, wherein the sterile corticotropin composition further comprises gelatin and the gelatin is pyrogen-free. 24. The method of claim 1, wherein the vial comprises a stopper comprising a coating comprising silicone oils of different molecular weights. 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, further comprising injecting the sterile corticotropin composition into a human subject after step b). 29. The method of claim 28, wherein the human subject has multiple sclerosis, gouty arthritis, psoriasis, atopic dermatitis, rheumatoid arthritis, or allergic conjunctivitis. 30. The method of claim 22, further comprising injecting the sterile corticotropin composition into a human subject after step b).