Injectable botulinum toxin formulations
This invention provides novel injectable compositions comprising botulinum toxin that may be administered to a subject for various therapeutic, aesthetic and/or cosmetic purposes. The injectable compositions contemplated by the invention exhibit one or more advantages over conventional botulinum toxin formulations, including reduced antigenicity, a reduced tendency to undergo unwanted localized diffusion following injection, increased duration of clinical efficacy or enhanced potency relative, faster onset of clinical efficacy, and/or improved stability.
1. A sterile injectable composition comprising
a protein consisting of a botulinum toxin complex, a reduced botulinum toxin complex, or a botulinum toxin; and
a positively charged carrier with the amino acid sequence RKKRRQRRRG-(K) 15 -GRKKRRQRRR (SEQ ID NO: 5);
wherein the botulinum toxin component non-covalently associates with the positively charged carrier, and
wherein the composition is formulated for injection and has a viscosity in the range of about 0.4 to about 2.0 cP.
2. The sterile injectable composition of claim 1 , wherein the botulinum toxin component is a 150 kD Type A botulinum toxin.
3. The sterile injectable composition according to claim 1 , wherein the botulinum toxin component is obtained from serotype A of C. botulinum.
4. The sterile injectable composition according to claim 1 , wherein the positively charged carrier stabilizes botulinum toxin against degradation.
5. The sterile injectable composition according to claim 1 , wherein the positively charged carrier reduces local diffusion of botulinum toxin following injection.
6. A syringe comprising a composition comprising
a protein consisting of a botulinum toxin complex, a reduced botulinum toxin complex, or a botulinum toxin; and
a positively charged carrier with the amino acid sequence RKKRRQRRRG-(K) 15 -GRKKRRQRRR (SEQ ID NO: 5);
wherein the composition comprises an effective amount of the botulinum toxin component and the botulinum toxin component non-covalently associates with the positively charged carrier, wherein the composition is disposed in the syringe and formulated for injection.
7. The syringe of claim 6 , wherein the botulinum toxin component is a 150 kD Type A botulinum toxin.
8. The syringe of claim 6 , wherein the composition comprises 50 U to 200 U of botulinum toxin.
9. The syringe according to claim 6 , wherein the botulinum toxin component is obtained from serotype A of C. botulinum.
10. The syringe according to claim 6 , wherein the positively charged carrier stabilizes botulinum toxin against degradation.
11. The syringe according to claim 6 , wherein the positively charged carrier reduces local diffusion of the botulinum toxin following injection.
12. A reconstituted botulinum toxin composition comprising
a protein consisting of a botulinum toxin complex, a reduced botulinum toxin complex, or a botulinum toxin; and
a positively charged carrier with the amino acid sequence RKKRRQRRRG-(K) 15 -GRKKRRQRRR (SEQ ID NO: 5); and
a pharmaceutically acceptable aqueous liquid diluent,
wherein the botulinum toxin component non-covalently associates with the positively charged carrier,
wherein the composition is formulated for injection, and
wherein the reconstituted botulinum toxin composition has a viscosity in the range of about 0.4 to about 2.0 cP.
13. The reconstituted botulinum toxin composition of claim 12 , wherein the composition comprises 50 U to 200 U of botulinum toxin.