US2018325985A1PendingUtilityA1

Vasopressin formulations for use in treatment of hypotension

78
Assignee: PAR PHARMACEUTICAL INCPriority: Jan 30, 2015Filed: Jul 24, 2018Published: Nov 15, 2018
Est. expiryJan 30, 2035(~8.6 yrs left)· nominal 20-yr term from priority
Inventors:Matthew KenneyVinayagam Kannan
A61K 45/06G01N 2030/027A61K 9/08A61K 47/10A61K 38/11A61K 47/02A61K 31/045A61K 9/0019A61K 47/12G01N 30/74A61K 47/26A61K 38/095
78
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Claims

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.

Claims

exact text as granted — not AI-modified
1 - 15 . (canceled) 
     
     
         16 . A pharmaceutical composition comprising:
 0.1 unit/mL or 1 unit/mL vasopressin, or a pharmaceutically acceptable salt thereof;   a peptide of SEQ. ID. NO. 2 at an amount of about 0.1% to about 0.8% by mass of vasopressin;   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. 
     
     
         17 . The pharmaceutical composition of  claim 16 , wherein the peptide of SEQ. ID. NO.: 2 is about 0.1% by mass of vasopressin. 
     
     
         18 . The pharmaceutical composition of  claim 16 , wherein the peptide of SEQ. ID. NO.: 2 is about 0.2% by mass of vasopressin. 
     
     
         19 . The pharmaceutical composition of  claim 16 , wherein the peptide of SEQ. ID. NO.: 2 is about 0.3% by mass of vasopressin. 
     
     
         20 . The pharmaceutical composition of  claim 16 , wherein the peptide of SEQ. ID. NO.: 2 is about 0.4% by mass of vasopressin. 
     
     
         21 . The pharmaceutical composition of  claim 16 , wherein the peptide of SEQ. ID. NO.: 2 is about 0.5% by mass of vasopressin. 
     
     
         22 . The pharmaceutical composition of  claim 16 , wherein the peptide of SEQ. ID. NO.: 2 is about 0.6% by mass of vasopressin. 
     
     
         23 . The pharmaceutical composition of  claim 16 , wherein the peptide of SEQ. ID. NO.: 2 is about 0.7% by mass of vasopressin. 
     
     
         24 . The pharmaceutical composition of  claim 16 , wherein the peptide of SEQ. ID. NO.: 2 is about 0.8% 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 0.1% 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 0.5% 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 0.6% 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 0.7% 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 0.8% by mass of vasopressin. 
     
     
         30 . 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. 
     
     
         31 . 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. 
     
     
         32 . 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. 
     
     
         33 . 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. 
     
     
         34 . 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. 
     
     
         35 . 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. 
     
     
         36 . The pharmaceutical composition of  claim 16 , wherein the purity of vasopressin is at least 97% by HPLC. 
     
     
         37 . The pharmaceutical composition of  claim 16 , wherein the purity of vasopressin is at least 98% by HPLC. 
     
     
         38 . The pharmaceutical composition of  claim 16 , wherein the pharmaceutical composition is at a pH of about 3.5. 
     
     
         39 . The pharmaceutical composition of  claim 16 , wherein the pharmaceutical composition is at a pH of about 3.6. 
     
     
         40 . The pharmaceutical composition of  claim 16 , wherein the pharmaceutically acceptable excipient is acetic acid. 
     
     
         41 . The pharmaceutical composition of  claim 16 , wherein the pharmaceutically acceptable excipient is acetate. 
     
     
         42 . The pharmaceutical composition of  claim 16 , wherein the pharmaceutically acceptable excipient is a combination of acetic acid and acetate.

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