Methods for storing and warming purified corticotropin compositions
AssigneeANI Pharmaceuticals, Inc.
InventorsEdward M. DeSimone, III, Weijun Cheng, Zachary Holcomb
Life of this patent
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Abstract
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.
Claims30
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.
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- d) injecting the withdrawn sterile corticotropin composition through the second needle into a human subject after step c),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.
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.
Dependencies are inferred from the claim text.