Vasopressin formulations for use in treatment of hypotension
AssigneePar Pharmaceutical, Inc.
InventorsMatthew Kenney, Vinayagam Kannan, Sunil Vandse, Suketu Sanghvi
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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.
Claims29
1-15. (canceled)
A method of increasing blood pressure in a human in need thereof, the method comprising:
- intravenously administering to the human a pharmaceutical composition that consists essentially of, in a unit dosage form:
- i) from about 0.1 μg/mL to about 2 μg/mL of vasopressin or a pharmaceutically-acceptable salt thereof;
- dextrose;
- acetic acid, sodium acetate, or a combination thereof;
- and iv) optionally hydrochloric acid or sodium hydroxide,
- 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;
- and
- the human is hypotensive.
A method of increasing blood pressure in a human in need thereof, the method comprising:
- a) storing at 5° C. for at least about one month a pharmaceutical composition for intravenous administration comprising, in a unit dosage form:
- i) from about 0.1 μg/mL to about 2 μg/mL of vasopressin or a pharmaceutically-acceptable salt thereof;
- dextrose;
- and acetic acid, sodium acetate, or a combination thereof,
- wherein the pharmaceutical composition exhibits no more than about 1% degradation of vasopressin or the pharmaceutically-acceptable salt thereof after the storage at 5° C. for about one month;
- and
- b) administering to the human the pharmaceutical composition,
- 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;
- and
- the human is hypotensive.
A method of increasing blood pressure in a human in need thereof, the method comprising:
- a) storing at 25° C. for at least about one month a pharmaceutical composition for intravenous administration comprising, in a unit dosage form:
- i) from about 0.1 μg/mL to about 2 μg/mL of vasopressin or a pharmaceutically-acceptable salt thereof;
- dextrose;
- and acetic acid, sodium acetate, or a combination thereof,
- wherein the pharmaceutical composition exhibits no more than about 2% degradation of vasopressin or the pharmaceutically-acceptable salt thereof after the storage at 25° C. for about one month;
- and
- b) administering to the human the pharmaceutical composition,
- 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;
- and
- the human is hypotensive.
Dependencies are inferred from the claim text.