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 pharmaceutical composition comprising:
 0.1 unit/mL or 1 unit/mL vasopressin, or a pharmaceutically acceptable salt thereof;   a pharmaceutically acceptable excipient which is acetic acid, acetate, or a combination thereof;   optionally chlorobutanol;   about 0.9% sodium chloride or about 5% dextrose; and   water,   
       wherein the pharmaceutical composition is at a pH of about 3.5 to about 4.1, and the purity of vasopressin is at least 97% by HPLC. 
     
     
         17 . The pharmaceutical composition of  claim 16 , wherein the purity of vasopressin is at least 98% by HPLC. 
     
     
         18 . The pharmaceutical composition of  claim 16 , further comprising a peptide of SEQ. ID. NO.: 2 at an amount of about 0.1% by mass of vasopressin. 
     
     
         19 . The pharmaceutical composition of  claim 16 , further comprising a peptide of SEQ. ID. NO.: 2 at an amount of about 0.2% by mass of vasopressin. 
     
     
         20 . The pharmaceutical composition of  claim 16 , further comprising a peptide of SEQ. ID. NO.: 2 at an amount of about 0.5% by mass of vasopressin. 
     
     
         21 . The pharmaceutical composition of  claim 16 , further comprising a peptide of SEQ. ID. NO.: 2 at an amount of about 0.6% by mass of vasopressin. 
     
     
         22 . The pharmaceutical composition of  claim 16 , further comprising a peptide of SEQ. ID. NO.: 2 at an amount of about 0.7% by mass of vasopressin. 
     
     
         23 . The pharmaceutical composition of  claim 16 , further comprising a peptide of SEQ. ID. NO.: 2 at an amount of about 0.8% by mass of vasopressin. 
     
     
         24 . The pharmaceutical composition of  claim 16 , further comprising a peptide of SEQ. ID. NO.: 4 at an amount of about 0.1% by mass of vasopressin. 
     
     
         25 . The pharmaceutical composition of  claim 16 , further comprising a peptide of SEQ. ID. NO.: 4 at an amount of about 0.5% by mass of vasopressin. 
     
     
         26 . The pharmaceutical composition of  claim 16 , further comprising a peptide of SEQ. ID. NO.: 4 at an amount of about 0.6% by mass of vasopressin. 
     
     
         27 . The pharmaceutical composition of  claim 16 , further comprising a peptide of SEQ. ID. NO.: 4 at an amount of about 0.7% by mass of vasopressin. 
     
     
         28 . The pharmaceutical composition of  claim 16 , further comprising a peptide of SEQ. ID. NO.: 4 at an amount of about 0.8% by mass of vasopressin. 
     
     
         29 . The pharmaceutical composition of  claim 16 , further comprising a peptide of SEQ. ID. NO.: 4 at an amount of about 0.9% by mass of vasopressin. 
     
     
         30 . The pharmaceutical composition of  claim 16 , further comprising a peptide of SEQ. ID. NO.: 3 at an amount of less than about 0.1% by mass of vasopressin. 
     
     
         31 . The pharmaceutical composition of  claim 16 , further comprising a peptide of SEQ. ID. NO.: 3 at an amount of about 0.1% by mass of vasopressin. 
     
     
         32 . The pharmaceutical composition of  claim 16 , further comprising a peptide of SEQ. ID. NO.: 3 at an amount of about 0.2% by mass of vasopressin. 
     
     
         33 . The pharmaceutical composition of  claim 16 , further comprising a peptide of SEQ. ID. NO.: 7 at an amount of about 0.2% to about 0.3% by mass of vasopressin. 
     
     
         34 . The pharmaceutical composition of  claim 16 , further comprising a peptide of SEQ. ID. NO.: 10 at an amount of about 0.3% to about 0.4% by mass of vasopressin. 
     
     
         35 . The pharmaceutical composition of  claim 16 , wherein the pharmaceutical composition is at a pH of about 3.5. 
     
     
         36 . The pharmaceutical composition of  claim 16 , wherein the pharmaceutical composition is at a pH of about 3.6. 
     
     
         37 . The pharmaceutical composition of  claim 16 , wherein the pharmaceutically acceptable excipient is acetic acid. 
     
     
         38 . The pharmaceutical composition of  claim 16 , wherein the pharmaceutically acceptable excipient is acetate. 
     
     
         39 . The pharmaceutical composition of  claim 16 , wherein the pharmaceutically acceptable excipient is a combination of acetic acid and acetate.