Non-protein stabilized clostridial toxin pharmaceutical compositions

Abstract

A Clostridial toxin pharmaceutical composition comprising a Clostridial toxin, such as a botulinum toxin, wherein the Clostridial toxin present in the pharmaceutical composition is stabilized by a non-protein excipient such as a polyvinylpyrrolidone, a disaccharides, a trisaccharide, a polysaccharide, an alcohol, a metal, an amino acid, a surfactant and/or a polyethylene glycol.

1 - 8 . (canceled) 
     
     
         9 . A lyophilized or vacuum dried pharmaceutical composition comprising:
 (a) a botulinum toxin, wherein the botulinum toxin is not stabilized by a protein excipient, (b) polyvinylpyrrolidone, and (c) a disaccharide, wherein the potency of the botulinum toxin after reconstitution is at least 40% of the theoretical maximum potency of the botulinum toxin prior to lypophilization.   
     
     
         10 . The pharmaceutical composition of  claim 9 , wherein the botulinum toxin is selected from the group consisting of the botulinum toxins types A, B, C, D, E, F, and G. 
     
     
         11 . The pharmaceutical composition of  claim 9 , wherein the botulinum toxin is a botulinum toxin type A. 
     
     
         12 . A pharmaceutical composition according to  claim 9 , wherein the potency of the botulinum toxin after reconstitution is at least 50% of the theoretical maximum potency of the botulinum toxin prior to lyophilization. 
     
     
         13 . A pharmaceutical composition according to  claim 12 , wherein the potency of the botulinum toxin after reconstitution is at least 60% of the theoretical maximum potency of the botulinum toxin prior to lyophilization. 
     
     
         14 . A pharmaceutical composition according to  claim 13 , wherein the potency of the botulinum toxin after reconstitution is at least 70% of the theoretical maximum potency of the botulinum toxin prior to lyophilization. 
     
     
         15 . A lyophilized or vacuum dried pharmaceutical composition comprising: (a) a botulinum toxin, wherein the botulinum toxin is not stabilized by a protein excipient, (b) a compound selected from the group consisting of a first monosaccharide, a first disaccharide, a first trisaccharide, and a first alcohol made by reducing the first monosaccharide, and; (c) a compound selected from the group of compounds consisting of a second monosaccharide, a second disaccharide, a second trisaccharide, a metal, a second alcohol, and an amino acid, wherein the second monosaccharide, the second disaccharide and the second trisaccharide are different from respectively the first monosaccharide, the first disaccharide, and the first trisaccharide, wherein the potency of the botulinum toxin after reconstitution is at least 40% of the theoretical maximum potency of the botulinum toxin prior to lyophilization. 
     
     
         16 . A lyophilized or vacuum dried pharmaceutical composition comprising: (a) a botulinum toxin, wherein the botulinum toxin is not stabilized by a protein excipient, (b) a polyethylene glycol, and; (c) a compound selected from the group of compounds consisting of a monosaccharide, a disaccharide, a trisaccharide, a metal, and an amino acid, wherein the potency of the botulinum toxin after reconstitution is at least 20% of the theoretical maximum potency of the botulinum toxin prior to lyophilization. 
     
     
         17 . A pharmaceutical composition according to  claim 16 , wherein the potency of the botulinum toxin after reconstitution is at least 30% of the theoretical maximum potency of the botulinum toxin prior to lyophilization. 
     
     
         18 . A pharmaceutical composition according to  claim 17 , wherein the potency of the botulinum toxin after reconstitution is at least 40% of the theoretical maximum potency of the botulinum toxin prior to lyophilization. 
     
     
         19 . A pharmaceutical composition according to  claim 18 , wherein the potency of the botulinum toxin after reconstitution is at least 50% of the theoretical maximum potency of the botulinum toxin prior to lyophilization. 
     
     
         20 . A pharmaceutical composition according to  claim 19 , wherein the potency of the botulinum toxin after reconstitution is at least 60% of the theoretical maximum potency of the botulinum toxin prior to lyophilization. 
     
     
         21 . A pharmaceutical composition according to  claim 20 , wherein the potency of the botulinum toxin after reconstitution is at least 70% of the theoretical maximum potency of the botulinum toxin prior to lyophilization. 
     
     
         22 . An animal protein free botulinum toxin pharmaceutical composition comprising:
 a botulinum toxin,   a first compound selected from the group consisting of a first monosaccharide, a first disaccharide, and a first trisaccharide, and   a second compound which is an amino acid,   
     
     
         23 . A pharmaceutical composition according to  claim 22 , wherein the amino acid is methionine.