Vasopressin formulations for use in treatment of hypotension
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.
1. A method of increasing blood pressure in a human in need thereof, the method comprising providing a unit dosage form, wherein the unit dosage form consists essentially of:
a) from about 0.1 units/mL to about 1 unit/mL of vasopressin or a pharmaceutically-acceptable salt thereof;
b) a pH-adjusting agent;
c) an acetate buffer;
d) about 0.9% NaCl; and
e) water;
wherein the unit dosage form has a pH of from about 3.5 to about 3.7, storing the unit dosage form for at least about 24 hours at from about 0.1 units/mL to about 1 unit/mL vasopressin or the pharmaceutically-acceptable salt thereof;
after the storing, intravenously administering the unit dosage form to the human;
wherein the unit dosage form that is administered to the human comprises from about 0.1 units/mL to about 1 unit/mL of vasopressin or the pharmaceutically-acceptable salt thereof.
2. The method of claim 1 , wherein the pH-adjusting agent is hydrochloric acid.
3. The method of claim 1 , wherein the pH-adjusting agent is sodium hydroxide.
4. The method of claim 1 , wherein the administration to the human is over about one day.
5. The method of claim 1 , wherein the administration to the human is over about one week.
6. The method of claim 1 , 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.
7. The method of claim 1 , wherein the human's mean arterial blood pressure is increased within 15 minutes of administration.
8. The method of claim 1 , wherein the human is hypotensive.
9. The method of claim 8 , wherein the human's hypotension is associated with vasodilatory shock.
10. The method of claim 9 , wherein the vasodilatory shock is post-cardiotomy shock.
11. The method of claim 10 , wherein the administration provides to the human from about 0.03 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.
12. The method of claim 9 , wherein the vasodilatory shock is septic shock.
13. The method of claim 12 , wherein the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.07 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute.