Methods for storing and warming purified corticotropin compositions
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.
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.