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 a water soluble cyclodextrin or a cyclodextrin derivative complex of alfaxalone and a buffer, excluding phosphate buffer pH 7.0, 0.1M mixed as defined in the British Pharmacopoeia 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 .