US2018325989A1PendingUtilityA1

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 9/0019A61K 9/08G01N 2030/027A61K 31/045A61K 47/10A61K 38/11G01N 30/74A61K 47/26A61K 47/12A61K 47/02A61K 45/06A61K 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 method for increasing blood pressure in a subject in need thereof, the method comprising
 a) providing a pharmaceutical composition comprising:
 20 units/mL vasopressin, or a pharmaceutically acceptable salt thereof; 
 a peptide of SEQ. ID. NO. 4 at an amount of about 0.1% to about 0.9% by mass of vasopressin; 
 a pharmaceutically acceptable excipient which is acetic acid, acetate, or a combination thereof; 
 optionally chlorobutanol; and 
 water, 
   wherein the pharmaceutical composition is at a pH of about 3.5 to about 4.1.   b) diluting the pharmaceutical composition with a diluent to provide a concentration from 0.1 units/mL to 1 unit/mL vasopressin, or a pharmaceutically acceptable salt thereof, wherein the diluent is about 0.9% sodium chloride or about 5% dextrose;   c) intravenously administering the diluted pharmaceutical composition to the subject.   
     
     
         17 . The method of  claim 16 , wherein the peptide of SEQ. ID. NO.: 4 in the pharmaceutical composition is about 0.1% by mass of vasopressin. 
     
     
         18 . The method of  claim 16 , wherein the peptide of SEQ. ID. NO.: 4 in the pharmaceutical composition is about 0.2% by mass of vasopressin. 
     
     
         19 . The method of  claim 16 , wherein the peptide of SEQ. ID. NO.: 4 in the pharmaceutical composition is about 0.3% by mass of vasopressin. 
     
     
         20 . The method of  claim 16 , wherein the peptide of SEQ. ID. NO.: 4 in the pharmaceutical composition is about 0.4% by mass of vasopressin. 
     
     
         21 . The method of  claim 16 , wherein the peptide of SEQ. ID. NO.: 4 in the pharmaceutical composition is about 0.5% by mass of vasopressin. 
     
     
         22 . The method of  claim 16 , wherein the peptide of SEQ. ID. NO.: 4 in the pharmaceutical composition is about 0.6% by mass of vasopressin. 
     
     
         23 . The method of  claim 16 , wherein the peptide of SEQ. ID. NO.: 4 in the pharmaceutical composition is about 0.7% by mass of vasopressin. 
     
     
         24 . The method of  claim 16 , wherein the peptide of SEQ. ID. NO.: 4 in the pharmaceutical composition is about 0.8% by mass of vasopressin. 
     
     
         25 . The method of  claim 16 , wherein the peptide of SEQ. ID. NO.: 4 in the pharmaceutical composition is about 0.9% by mass of vasopressin. 
     
     
         26 . The method of  claim 16 , wherein the pharmaceutical composition further comprises a peptide of SEQ. ID. NO.: 2 at an amount of about 0.1% by mass of vasopressin. 
     
     
         27 . The method of  claim 16 , wherein the pharmaceutical composition further comprises a peptide of SEQ. ID. NO.: 2 at an amount of about 0.2% by mass of vasopressin. 
     
     
         28 . The method of  claim 16 , wherein the pharmaceutical composition further comprises a peptide of SEQ. ID. NO.: 2 at an amount of about 0.5% by mass of vasopressin. 
     
     
         29 . The method of  claim 16 , wherein the pharmaceutical composition further comprises a peptide of SEQ. ID. NO.: 2 at an amount of about 0.6% by mass of vasopressin. 
     
     
         30 . The method of  claim 16 , wherein the pharmaceutical composition further comprises a peptide of SEQ. ID. NO.: 2 at an amount of about 0.7% by mass of vasopressin. 
     
     
         31 . The method of  claim 16 , wherein the pharmaceutical composition further comprises a peptide of SEQ. ID. NO.: 2 at an amount of about 0.8% by mass of vasopressin. 
     
     
         32 . The method of  claim 16 , wherein the pharmaceutical composition further comprises a peptide of SEQ. ID. NO.: 3 at an amount of less than about 0.1% by mass of vasopressin. 
     
     
         33 . The method of  claim 16 , wherein the pharmaceutical composition further comprises a peptide of SEQ. ID. NO.: 3 at an amount of about 0.1% by mass of vasopressin. 
     
     
         34 . The method of  claim 16 , wherein the pharmaceutical composition further comprises a peptide of SEQ. ID. NO.: 3 at an amount of about 0.2% by mass of vasopressin. 
     
     
         35 . The method of  claim 16 , wherein the pharmaceutical composition further comprises a peptide of SEQ. ID. NO.: 7 at an amount of about 0.2% to about 0.3% by mass of vasopressin. 
     
     
         36 . The method of  claim 16 , wherein the pharmaceutical composition further comprises a peptide of SEQ. ID. NO.: 10 at an amount of about 0.3% to about 0.4% by mass of vasopressin. 
     
     
         37 . The method of  claim 16 , wherein the purity of vasopressin in the pharmaceutical composition is at least 97% by HPLC. 
     
     
         38 . The method of  claim 16 , wherein the purity of vasopressin in the pharmaceutical composition is at least 98% by HPLC. 
     
     
         39 . The method of  claim 16 , wherein the pharmaceutical composition is at a pH of about 3.5. 
     
     
         40 . The method of  claim 16 , wherein the pharmaceutical composition is at a pH of about 3.6. 
     
     
         41 . The method of  claim 16 , wherein the pharmaceutically acceptable excipient in the pharmaceutical composition is acetic acid. 
     
     
         42 . The method of  claim 16 , wherein the pharmaceutically acceptable excipient in the pharmaceutical composition is acetate. 
     
     
         43 . The method of  claim 16 , wherein the pharmaceutically acceptable excipient in the pharmaceutical composition is a combination of acetic acid and acetate. 
     
     
         44 . The method of  claim 16 , wherein the subject has a hypotension associated with vasodilatory shock. 
     
     
         45 . The method of  claim 44 , wherein the vasodilatory shock is post-cardiotomy shock or septic shock.

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