Methods for storing and warming purified corticotropin compositions

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).