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 vial containing a sterile preparation of purified corticotropin, wherein the sterile preparation comprises 80 USP units per mL of the purified corticotropin, gelatin, and water for injection (WFI), wherein the purified corticotropin comprises a polypeptide having an amino acid sequence of SYSMEHFRWGKPVGKKRRPVKVYPNGAEDELAEAFPLEF (SEQ ID NO: 1), and wherein the vial is not terminally sterilized.
2 . The vial of claim 1 , wherein the sterile preparation comprises 0.5% w/w phenol and 15% w/w gelatin.
3 . The vial of claim 1 , wherein the sterile preparation has a pH of 3.0-7.0.
4 . The vial of claim 1 , wherein the sterile preparation comprises purified corticotropin comprising an extract from whole porcine pituitary gland including both anterior and posterior portions of the whole porcine pituitary gland, 0.5% w/w phenol, and 15% w/w gelatin.
5 . The vial of claim 1 , wherein the sterile preparation comprises about 15% w/w of the gelatin.
6 . The vial of claim 1 , wherein the sterile preparation comprises about 150 mg/ml of the gelatin.
7 . The vial of claim 6 , wherein the sterile preparation comprises about 0.1-1% w/w of phenol.
8 . The vial of claim 7 , wherein the sterile preparation comprises about 0.5% w/w of the phenol.
9 . The vial of claim 6 , wherein the sterile preparation comprises about 5 mg/ml of phenol.
10 . The vial of claim 1 , wherein the sterile preparation is preservative-free, antimicrobial-free, or preservative-free and antimicrobial-free.
11 . The vial of claim 1 , wherein the gelatin is type A gelatin.
12 . The vial of claim 1 , wherein the sterile preparation is free of acetic acid.
13 . The vial of claim 1 , wherein the gelatin is pyrogen-free.
14 . The vial of claim 1 , wherein
a) the sterile preparation is preservative-free, antimicrobial-free, or preservative-free and antimicrobial-free,
b) the gelatin is type A gelatin,
c) the sterile preparation is free of acetic acid,
d) the gelatin is pyrogen-free,
e) the sterile preparation comprises hydrochloric acid and sodium hydroxide,
f) the sterile preparation has a pH of 3.0-7.0, and
g) the sterile preparation comprises purified corticotropin comprising an extract from whole porcine pituitary gland including both anterior and posterior portions of the whole porcine pituitary gland, 0.5% w/w phenol, and 15% w/w gelatin.
15 . The vial of claim 1 , wherein the vial is a multiple-dose vial.
16 . The vial of claim 15 , wherein:
a) the sterile preparation is preservative-free, antimicrobial-free, or preservative-free and antimicrobial-free,
b) the gelatin is type A gelatin,
c) the sterile preparation is free of acetic acid,
d) the gelatin is pyrogen-free,
e) the sterile preparation comprises hydrochloric acid and sodium hydroxide,
f) the sterile preparation has a pH of 3.0-7.0,
g) the sterile preparation comprises purified corticotropin comprising an extract from whole porcine pituitary gland including both anterior and posterior portions of the whole porcine pituitary gland, 0.5% w/w phenol, and 15% w/w gelatin,
h) the sterile preparation comprises about 15% w/w of the gelatin,
i) the sterile preparation comprises about 150 mg/ml of the gelatin,
j) the sterile preparation comprises about 0.5% w/w of phenol, and/or
k) the sterile preparation comprises about 5 mg/ml of phenol.
17 . A method of treating a human subject comprising warming the vial containing the sterile preparation of purified corticotropin of claim 1 to a temperature of 18° to 26° C., and injecting 80 United States Pharmacopeia (USP) units of the sterile preparation of purified corticotropin into the human subject, wherein the human subject has systemic lupus erythematosus, acute exacerbations of multiple sclerosis (MS), acute gouty arthritis, severe psoriasis, atopic dermatitis, or allergic conjunctivitis.
18 . The vial of claim 1 , wherein the gelatin has a gel point in the range of 18 to 24° C.