Vasopressin formulations for use in treatment of hypotension

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.

1 - 15 . (canceled) 
     
     
         16 . A method of increasing blood pressure in a human in need thereof, the method comprising treating the human with a kit, wherein the kit comprises:
 a) a container, wherein the container is a drip-bag; and   b) a unit dosage form contained in the drip-bag, wherein the unit dosage form comprises vasopressin or a pharmaceutically-acceptable salt thereof at a concentration of about 0.1 units/mL to about 1 unit/mL, and water;   
       wherein the treating the human with the kit comprises administering the unit dosage form to the human by intravenous drip. 
     
     
         17 . The method of  claim 16 , wherein the unit dosage form further comprises a pH-adjusting agent. 
     
     
         18 . The method of  claim 17 , wherein the pH-adjusting agent is sodium hydroxide. 
     
     
         19 . The method of  claim 17 , wherein the pH-adjusting agent is hydrochloric acid. 
     
     
         20 . The method of  claim 16 , wherein the unit dosage form further comprises acetate buffer. 
     
     
         21 . The method of  claim 16 , wherein the unit dosage form further comprises dextrose. 
     
     
         22 . The method of  claim 16 , wherein the administering of the unit dosage form to the human is over about one day. 
     
     
         23 . The method of  claim 16 , wherein the administering of the unit dosage form to the human is over about one week. 
     
     
         24 . The method of  claim 16 , wherein the administering of the unit dosage form to the human 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. 
     
     
         25 . The method of  claim 16 , wherein the human's mean arterial blood pressure is increased within 15 minutes of administering of the unit dosage form to the human. 
     
     
         26 . The method of  claim 16 , wherein the human is hypotensive. 
     
     
         27 . The method of  claim 26 , wherein the human's hypotension is associated with vasodilatory shock. 
     
     
         28 . The method of  claim 27 , wherein the vasodilatory shock is post-cardiotomy shock. 
     
     
         29 . The method of  claim 28 , wherein the administering of the unit dosage form to the human 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. 
     
     
         30 . The method of  claim 27 , wherein the vasodilatory shock is septic shock. 
     
     
         31 . The method of  claim 30 , wherein the administering of the unit dosage form 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. 
     
     
         32 . A kit comprising:
 a) a container, wherein the container is a drip-bag; and   b) a unit dosage form contained in the drip-bag, wherein the unit dosage form comprises vasopressin or a pharmaceutically-acceptable salt thereof at a concentration of about 0.1 units/mL to about 1 unit/mL, and water.   
     
     
         33 . The kit of  claim 32 , wherein the unit dosage form further comprises a pH-adjusting agent. 
     
     
         34 . The kit of  claim 33 , wherein the pH-adjusting agent is sodium hydroxide. 
     
     
         35 . The kit of  claim 33 , wherein the pH-adjusting agent is hydrochloric acid. 
     
     
         36 . The kit of  claim 32 , wherein the unit dosage form further comprises acetate buffer. 
     
     
         37 . The kit of  claim 32 , wherein the unit dosage form further comprises dextrose.