Pharmaceutical composition

Abstract

The present invention relates to pharmaceutical compositions having improved stability.

1 - 37 . (canceled) 
     
     
         38 . A liquid composition, comprising carbetocin or a pharmaceutically acceptable salt thereof;
 wherein the concentration of carbetocin or a pharmaceutically acceptable salt thereof is from 0.05 mg/mL to 0.5 mg/mL and the pH of the composition is from 5.1 to 5.9.   
     
     
         39 . The composition of  claim 38 , wherein the composition is an aqueous composition. 
     
     
         40 . The composition of  claim 38 , wherein the pH of the composition is from 5.2 to 5.65. 
     
     
         41 . The composition of  claim 38 , wherein the pH of the composition is from 5.26 to 5.8. 
     
     
         42 . The composition of  claim 38 , further comprising a buffering agent or a buffer. 
     
     
         43 . The composition of  claim 42 , wherein the buffering agent is succinic acid. 
     
     
         44 . The composition of  claim 42 , wherein the buffer is a succinate or citrate/phosphate buffer. 
     
     
         45 . The composition of  claim 42 , wherein only one buffer or buffering agent is present. 
     
     
         46 . The composition of  claim 38 , wherein the concentration of carbetocin or a pharmaceutically acceptable salt thereof is from 0.05 mg/mL to 0.1 mg/mL. 
     
     
         47 . The composition of  claim 38 , further comprising an anti-oxidant. 
     
     
         48 . The composition of  claim 47 , wherein the anti-oxidant is methionine, EDTA, or a combination of methionine and EDTA. 
     
     
         49 . The composition of  claim 47 , wherein the concentration of the anti-oxidant is from 0.05 mg/mL to 5 mg/mL. 
     
     
         50 . The composition of  claim 38 , further comprising an isotonicity agent. 
     
     
         51 . The composition of  claim 50 , wherein the isotonicity agent is mannitol. 
     
     
         52 . The composition of  claim 50 , wherein the concentration of the isotonicity agent is from 5 mg/mL to 75 mg/mL. 
     
     
         53 . The composition of  claim 38 , comprising:
 carbetocin or a pharmaceutically acceptable salt thereof at a concentration of from 0.05 mg/mL to 0.5 mg/mL;   an isotonicity agent at a concentration of 5 mg/mL to 75 mg/mL;   a buffering agent;   a pH adjusting agent; and   a pharmaceutically acceptable solvent.   
     
     
         54 . The composition of  claim 38 , comprising:
 carbetocin or a pharmaceutically acceptable salt thereof at a concentration of from 0.05 mg/mL to 0.5 mg/mL;   an anti-oxidant at a concentration of from 0.05 mg/mL to 5 mg/mL   an isotonicity agent at a concentration of 5 mg/mL to 75 mg/mL;   a buffering agent;   a pH adjusting agent; and   a pharmaceutically acceptable solvent.   
     
     
         55 . A kit, comprising:
 the liquid composition of  claim 38 ;   a container for the composition, optionally with separate injection means, optionally with instructions for administration of the composition.   
     
     
         56 . A method of treatment of uterine atony or excessive bleeding following vaginal delivery, comprising a step of administration to a patient in need thereof the composition of  claim 38 . 
     
     
         57 . The method of  claim 56 , wherein the method is for the treatment of uterine atony following vaginal delivery of an infant or delivery of an infant by Caesarean section, or in a patient who is at risk of developing post-partum haemorrhage.