Stable Formulations of Botulinum Toxin in Hydrogels
AssigneeSolstice Neurosciences, Inc.
InventorsElizabeth Moyer, Pamela Hirtzer, George A. Digenis, Ahmad H. Malkawi
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Abstract
The invention includes liquid formulations of botulinum toxin, including hydrogel formulations that are stable to storage in liquid form at standard refrigerator temperatures for at least 1-2 years and to storage at higher temperatures for at least 6 months. The invention also includes methods of treatment using such formulations for various therapeutic and cosmetic purposes.
Claims31
A stable liquid pharmaceutical botulinum toxin formulation for therapeutic use in humans, comprising a pharmaceutically acceptable buffer capable of providing a buffered pH range between about pH 5 and pH 6;
- sodium chloride;
- a therapeutic concentration of a purified botulinum toxin suitable for use in humans, wherein said purified botulinum toxin has not been dried or lyophilized;
- and
- a hydrogel forming material;
- wherein said formulation is stable as a liquid for at least one year at a temperature between about 0 and 10 degrees centigrade
The formulation of claim 30, wherein said excipient protein is selected from the group consisting of serum albumin, human serum albumin, and gelatin.
Dependencies are inferred from the claim text.