Injectable Botulinum Toxin Formulations
AssigneeRevance Therapeutics, Inc.
InventorsCurtis L. Ruegg, Hongran F. Stone, Jacob M. Waugh
Life of this patent
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Abstract
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.
Claims23
A method of administering botulinum toxin to achieve a therapeutic or cosmetic effect to an individual in need thereof, the method comprising
- injecting an effective amount of a composition into the individual to achieve a therapeutic or cosmetic effect,
- wherein the composition comprises
- a positively charged carrier comprising a positively charged backbone with a plurality of efficiency groups attached thereto,
- a botulinum toxin complex, reduced botulinum toxin complex, or botulinum toxin, and
- wherein the positively charged carrier is non-covalently associated with the botulinum toxin complex, reduced botulinum toxin complex, or botulinum toxin.
A method of preparing an injectable botulinum toxin formulation, the method comprising
- providing an effective amount of a botulinum toxin complex, a reduced botulinum toxin complex, or a botulinum toxin;
- providing a positively charged carrier comprising a positively charged backbone having a plurality of efficiency groups attached thereto;
- combining the botulinum toxin complex, a reduced botulinum toxin complex, or botulinum toxin with the positively charged carrier and a pharmaceutically acceptable diluent.
A sterile injectable composition comprising
- an effective amount of a botulinum toxin complex, a reduced botulinum toxin complex, or a botulinum toxin;
- and
- a positively charged carrier comprising a positively charged backbone having a plurality of efficiency groups attached thereto;
- wherein the botulinum toxin complex, reduced botulinum toxin complex, or botulinum toxin non-covalently associates with the positively charged carrier.
A syringe comprising
- an effective amount of a botulinum toxin complex, a reduced botulinum toxin complex, or a botulinum toxin;
- and
- a positively charged carrier comprising a positively charged backbone having a plurality of efficiency groups attached thereto;
- wherein the botulinum toxin complex, reduced botulinum toxin complex, or botulinum toxin non-covalently associates with the positively charged carrier.
A reconstituted botulinum toxin composition comprising
- an effective amount of a botulinum toxin complex, a reduced botulinum toxin complex, or a botulinum toxin;
- and
- a positively charged carrier comprising a positively charged backbone having a plurality of efficiency groups attached thereto;
- and
- a pharmaceutically acceptable aqueous liquid diluent,
- wherein the botulinum toxin complex, reduced botulinum toxin complex, or botulinum toxin non-covalently associates with the positively charged carrier,
- and wherein the reconstituted botulinum toxin composition has a viscosity in the range of about 0.4 to about 2.0 cP.
Dependencies are inferred from the claim text.