Claims for Patent: 12,324,787

Summary for Patent: 12,324,787

Title:	Kits for preparing and delivering purified corticotropin
Abstract:	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.
Inventor(s):	Edward M. Desimone, III, Weijun Cheng, Zachary Holcomb
Assignee:	ANI Pharmaceuticals Inc
Application Number:	US18/905,498
Patent Claims:	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.