Kits for preparing and delivering purified corticotropin
A kit and sterile preparation of purified corticotropin and methods relating thereto in which the preparation includes corticotropin extracted from a whole porcine pituitary gland including both anterior and posterior portions, and having proteins or peptides having a molecular weight higher than 4.6 kDa removed. Methods of manufacturing, testing, increasing stability, storage, and use of the purified corticotropin are also provided.
1. A kit comprising a vial and a sterile preparation of purified corticotropin, wherein the sterile preparation comprises 80 USP units per mL of corticotropin, phenol, type A gelatin, water for injection (WFI), hydrochloric acid, and sodium hydroxide, wherein the vial is not terminally sterilized, and
wherein the purified corticotropin comprises a polypeptide having an amino acid sequence of SYSMEHFRWGKPVGKKRRPVKVYPNGAEDELAEAFPLEF (SEQ ID NO: 1).
2. The kit of claim 1 , further comprising instructions for using a first needle having a first gauge size with a first diameter to draw up the sterile preparation, and for injecting the sterile preparation using a second needle having a second gauge size with a second diameter.
3. The kit of claim 1 , wherein the vial is a 5 mL multiple-dose vial.
4. The kit of claim 2 , wherein the first diameter is wider than the second diameter.
5. The kit of claim 2 , wherein the first gauge size is 20 G and the second gauge size is 23 G.
6. The kit of claim 1 , wherein the sterile preparation comprises 0.5% w/w phenol, 15.0% w/w gelatin, and water for injection (WFI).
7. The kit of claim 1 , wherein the sterile preparation comprises hydrochloric acid and sodium hydroxide.
8. The kit of claim 1 , wherein the sterile preparation has a pH of 3.0-7.0.
9. The kit of claim 1 , wherein the sterile preparation comprises purified corticotropin comprises an extract from whole porcine pituitary gland including both anterior and posterior portions of the whole porcine pituitary gland, 0.5% w/w phenol, 15% w/w gelatin type A, and water for injection (WFI).
10. The kit of claim 1 , wherein the sterile preparation comprises about 15% w/w of the type A gelatin.
11. The kit of claim 1 , wherein the sterile preparation comprises about 150 mg/ml of the type A gelatin.
12. The kit of claim 10 , wherein the sterile preparation comprises about 0.1-1% w/w of the phenol.
13. The kit of claim 12 , wherein the sterile preparation comprises about 0.5% w/w of the phenol.
14. The kit of claim 11 , wherein sterile preparation comprises about 5 mg/ml of the phenol.
15. The kit of claim 1 , wherein the kit further comprises instructions for use including washing hands and drying with a clean towel, removing the vial from a refrigerator, confirming that an expiration date on the vial has not passed, warming the gel in the vial from a solid gel to a liquid gel by rolling between hands for at least one minute, removing plastic cap from the top of the vial, wiping top of the vial stopper with a sterile alcohol wipe, using a sterile 20 G needle and syringe to draw up the warmed purified cortrophin gel from the vial, removing the 20 G needle, attaching a 23 G needle to the syringe, injecting the warmed purified cortrophin gel from the syringe into the subject.
16. The kit of claim 1 , wherein the sterile preparation is preservative-free, antimicrobial-free, or preservative-free and antimicrobial-free.
17. The kit of claim 1 , wherein the gelatin has a pH of 5.9 to 6.2.
18. The kit of claim 1 , wherein the sterile preparation is free of acetic acid.
19. The kit of claim 1 , wherein the gelatin is pyrogen-free.
20. The kit of claim 1 , wherein the sterile preparation comprises acidified WFI having a pH of 2.8 to 3.2.