Anaesthetic composition

Abstract

A stable anaesthetic composition is described which is particularly suitable for use in cats and dogs. The composition comprises an aqueous solution of an anaesthetically effective amount of water soluble cyclodextrin or a cyclodextrin derivative complex of alfaxalone and a bugger, excluding phosphate buffer pH 7.0, 0.1 M mixed as defined in the British Pharmadopoeia 1998, such that the pH of the solution is from 6.0-8.0.

1 . An anaesthetic composition, comprising:
 an aqueous solution of an anaesthetically effective amount of a water soluble cyclodextrin or a cyclodextrin derivative complex of alfaxalone and buffer effective to stabilise the alfaxalone and provide a pH in the composition of from about 6.5 to about 7.0, wherein
 crystalline material does not form in the composition within about 7 days when stored at 40° C., and 
 the water soluble cyclodextrin or cyclodextrin derivative is 2-hydroxypropyl beta-cyclodextrin, and 
 the concentration of alfaxalone is 7-15 mg/mL. 
   
     
     
         2 . The anaesthetic composition of  claim 1 , wherein the pH in the composition is from 6.5 to 7.0. 
     
     
         3 . A sterile ready-to-use dosage of an anaesthetic comprising a package which includes an anaesthetic composition as claimed in  claim 1 . 
     
     
         4 . A sterile ready-to-use dosage of an anaesthetic further including one or more antimicrobial agents. 
     
     
         5 . A sterile dosage of an anaesthetic composition, comprising:
 a first package containing in dry form, an anaesthetically effective amount of a water soluble cyclodextrin or a cyclodextrin derivative complex of alfaxalone and a buffer effective to stabilise the alfaxalone; and   a second package of sterile water, the buffer being selected such that a solution formed by dissolving the contents of the first package with contents of the second package has a pH of from about 6.5 to about 7.0, wherein
 crystalline material does not form in the composition within about 7 days when stored at 40° C., 
 the water soluble cyclodextrin or cyclodextrin derivative is 2-hydroxypropyl beta-cyclodextrin, and 
 the concentration of alfaxalone is 7-15 mg/mL in the solution formed by dissolving the contents of the first package with contents of the second package. 
   
     
     
         6 . The sterile dosage of  claim 5 , wherein the contents of the second package has a pH of from 6.5 to 7.0. 
     
     
         7 . A sterile dosage of an anaesthetic composition, comprising:
 a first package containing in dry form, an anaesthetically effective amount of a water soluble cyclodextrin or a cyclodextrin derivative complex of alfaxalone; and   a second package containing a sterile aqueous solution of a buffer, the buffer being selected such that a solution formed by dissolving the contents of the first package with contents of the second package has a pH of from 6.5-7.0 and the buffer is effective to stabilise the alfaxalone, wherein
 crystalline material does not form in the composition within about 7 days when stored at 40° C., 
 the water soluble cyclodextrin or cyclodextrin derivative is 2-hydroxypropyl beta-cyclodextrin, and 
 the concentration of alfaxalone is 7-15 mg/mL in the solution formed by dissolving the contents of the first package with contents of the second package. 
   
     
     
         8 . The sterile dosage of  claim 7 , wherein the contents of the second package has a pH of from 6.5 to 7.0. 
     
     
         9 . A sterile dosage of an anaesthetic composition, comprising:
 a package containing in dry form for reconstitution with sterile water;   an anaesthetically effective amount of a water soluble cyclodextrin or a cyclodextrin derivative complex of alfaxalone; and   a buffer, the buffer being selected such that a solution formed by dissolving the contents of the package with sterile water has a pH of from about 6.5 to about 7.0 and the buffer is effective to stabilise the alfaxalone, wherein
 crystalline material does not form in the composition within about 7 days when stored at 40° C., 
 the water soluble cyclodextrin or cyclodextrin derivative is 2-hydroxypropyl beta-cyclodextrin, and 
 the concentration of alfaxalone is 7-15 mg/mL in the solution formed by dissolving the contents of the first package with contents of the second package. 
   
     
     
         10 . The sterile dosage of  claim 9 , wherein the contents of the package has a pH of from 6.5 to 7.0. 
     
     
         11 . A method of anaesthetising warm-blooded animals comprising administering to said animals an anaesthetically effective amount of a composition as claimed in  claim 1 . 
     
     
         12 . A method of anaesthetising warm-blooded animals comprising administering to said animals an anaesthetically effective amount of the dosage of  claim 3 .