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US 2017/0290880 A1Published application
Vasopressin formulations for use in treatment of hypotension
AssigneePar Pharmaceutical, Inc.
InventorsMatthew Kenney, Vinayagam Kannan, Sunil Vandse, Suketu Sanghvi
Life of this patent
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Abstract
Provided herein are peptide formulations comprising polymers as stabilizing agents. The peptide formulations can be more stable for prolonged periods of time at temperatures higher than room temperature when formulated with the polymers. The polymers used in the present invention can decrease the degradation of the constituent peptides of the peptide formulations.
Claims19
1-15. (canceled)
A method of increasing blood pressure in a human in need thereof, the method comprising:
- a) providing a pharmaceutical composition for intravenous administration comprising:
- i) from about 0.01 mg/mL to about 0.07 mg/mL of vasopressin or a pharmaceutically acceptable salt thereof;
- acetate buffer;
- and water,
- wherein the pharmaceutical composition is provided in a container;
- b) puncturing a dispensing region of the container a first time and drawing from the container a portion of the pharmaceutical composition;
- c) intravenously administering the portion of the pharmaceutical composition to the human,
- wherein the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically acceptable salt thereof per minute,
- wherein the human is hypotensive;
- d) puncturing the dispensing region of the container a second time and drawing from the container a second portion of the pharmaceutical composition,
- wherein the second time that the dispensing region of the container is punctured occurs at least 48 hours after the first time that the dispensing region of the container is punctured;
- e) intravenously administering the second portion of the pharmaceutical composition to the human,
- wherein the administration of the second portion of the pharmaceutical composition provides to the human from about 0.01 units of vasopressin or the pharmaceutically acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically acceptable salt thereof per minute.
10 more elements
A method of increasing blood pressure in a human in need thereof, the method comprising:
- a) providing a pharmaceutical composition for intravenous administration comprising:
- i) from about 0.01 mg/mL to about 0.07 mg/mL of vasopressin or a pharmaceutically acceptable salt thereof;
- acetate buffer;
- and water,
- wherein the pharmaceutical composition is provided in a container;
- b) puncturing a dispensing region of the container a first time and drawing from the container a portion of the pharmaceutical composition;
- c) intravenously administering the portion of the pharmaceutical composition to the human,
- wherein the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically acceptable salt thereof per minute,
- wherein the human is hypotensive;
- d) puncturing the dispensing region of the container a second time and drawing from the container a second portion of the pharmaceutical composition,
- wherein the second time that the dispensing region of the container is punctured occurs at least about 30 days after the first time that the dispensing region of the container is punctured;
- and
- e) intravenously administering the second portion of the pharmaceutical composition to the human,
- wherein the administration of the second portion of the pharmaceutical composition provides to the human from about 0.01 units of vasopressin or the pharmaceutically acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically acceptable salt thereof per minute,
- wherein the container is stored at about room temperature from the first time that the dispensing region of the container is punctured to the second time that the dispensing region of the container is punctured,
- wherein the pharmaceutical composition comprises no more than about 2% total impurities at the second time that the dispensing region of the container is punctured.
13 more elements
Dependencies are inferred from the claim text.