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 administering to the human a unit dosage form, wherein the unit dosage form comprises:
 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; and   c) water;   
       wherein the unit dosage form has a pH of 3.7 to 3.9. 
     
     
         17 . The method of  claim 16 , wherein the pH-adjusting agent is hydrochloric acid. 
     
     
         18 . The method of  claim 16 , wherein the pH-adjusting agent is sodium hydroxide. 
     
     
         19 . The method of  claim 16 , wherein the unit dosage form further comprises acetate buffer. 
     
     
         20 . The method of  claim 16 , wherein the unit dosage form further comprises dextrose. 
     
     
         21 . The method of  claim 16 , wherein the administration is intravenous. 
     
     
         22 . The method of  claim 16 , wherein the administration to the human is over about one day. 
     
     
         23 . The method of  claim 16 , wherein the administration to the human is over about one week. 
     
     
         24 . The method of  claim 16 , 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. 
     
     
         25 . The method of  claim 16 , wherein the human's mean arterial blood pressure is increased within 15 minutes of administration. 
     
     
         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 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. 
     
     
         30 . The method of  claim 27 , wherein the vasodilatory shock is septic shock. 
     
     
         31 . The method of  claim 30 , 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. 
     
     
         32 . A pharmaceutical composition for intravenous administration comprising, in a unit dosage form:
 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; and   c) water,   
       wherein the unit dosage form has a pH of 3.7 to 3.9. 
     
     
         33 . The pharmaceutical composition of  claim 32 , wherein the pH-adjusting agent is hydrochloric acid. 
     
     
         34 . The pharmaceutical composition of  claim 32 , wherein the pH-adjusting agent is sodium hydroxide. 
     
     
         35 . The pharmaceutical composition of  claim 32 , wherein the unit dosage form further comprises acetate buffer. 
     
     
         36 . The pharmaceutical composition of  claim 32 , wherein the unit dosage form further comprises dextrose. 
     
     
         37 . The pharmaceutical composition of  claim 36 , wherein the dextrose is present in the unit dosage form at a concentration of about 5% dextrose.