Claims for Patent: 12,440,542

Summary for Patent: 12,440,542

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:	US19/199,523
Patent Claims:	1. A syringe containing a sterile preparation of purified corticotropin, wherein the sterile preparation comprises 80 USP units per mL of the purified corticotropin, phenol, type A gelatin, water for injection (WFI), hydrochloric acid, and sodium hydroxide, and wherein the purified corticotropin comprises a polypeptide having an amino acid sequence of (SEQ ID NO: 1) SYSMEHFRWGKPVGKKRRPVKVYPNGAEDELAEAFPLEF. 2. The syringe of claim 1, wherein the sterile preparation comprises 0.5% w/w phenol, 15.0% w/w gelatin, and water for injection (WFI). 3. The syringe of claim 1, wherein the sterile preparation comprises hydrochloric acid and sodium hydroxide. 4. The syringe of claim 1, wherein the sterile preparation has a pH of 3.0-7.0. 5. The syringe 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). 6. The syringe of claim 1, wherein the sterile preparation comprises about 15% w/w of the type A gelatin. 7. The syringe of claim 1, wherein the sterile preparation comprises about 150 mg/ml of the type A gelatin. 8. The syringe of claim 7, wherein the sterile preparation comprises about 0.1-1% w/w of the phenol. 9. The syringe of claim 8, wherein the sterile preparation comprises about 0.5% w/w of the phenol. 10. The syringe of claim 7, wherein the sterile preparation comprises about 5 mg/ml of the phenol. 11. The syringe of claim 1, wherein the sterile preparation is preservative-free, antimicrobial-free, or preservative-free and antimicrobial-free. 12. The syringe of claim 1, wherein the gelatin has a pH of 5.9 to 6.2. 13. The syringe of claim 1, wherein the sterile preparation is free of acetic acid. 14. The syringe of claim 1, wherein the gelatin is pyrogen-free. 15. The syringe of claim 1, wherein the sterile preparation comprises acidified WFI having a pH of 2.8 to 3.2. 16. A method comprising warming a sterile preparation of purified corticotropin from a solid gel to a liquid gel, and injecting the liquid gel using a syringe into a human subject, wherein the sterile preparation comprises 80 USP units per mL of the purified corticotropin, phenol, type A gelatin, water for injection (WFI), hydrochloric acid, and sodium hydroxide, and wherein the purified corticotropin comprises a polypeptide having an amino acid sequence of (SEQ ID NO: 1) SYSMEHFRWGKPVGKKRRPVKVYPNGAEDELAEAFPLEF. 17. The method of claim 16, wherein the sterile preparation is warmed for at least 2 minutes before performing the injecting step. 18. The method of claim 16, further comprising confirming that an expiration date of the sterile preparation has not passed before performing the injecting step. 19. The method of claim 16, wherein the sterile preparation comprises 0.5% w/w phenol, 15.0% w/w gelatin, and water for injection (WFI). 20. The method of claim 16, wherein a) the sterile preparation is preservative-free, antimicrobial-free, or preservative-free and antimicrobial-free, b) the gelatin has a pH of 5.9 to 6.2, c) the sterile preparation is free of acetic acid, d) the gelatin is pyrogen-free, e) the sterile preparation comprises acidified WFI having a pH of 2.8 to 3.2, f) the sterile preparation comprises hydrochloric acid and sodium hydroxide, g) the sterile preparation has a pH of 3.0-7.0, h) 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), i) the sterile preparation comprises about 15% w/w of the type A gelatin, j) the sterile preparation comprises about 150 mg/ml of the type A gelatin, k) the sterile preparation comprises about 0.5% w/w of the phenol, and/or l) the sterile preparation comprises about 5 mg/ml of the phenol.