Stable pharmaceutical composition of freeze-dried tetrodoxin powder
AssigneeWex Medical Limited
InventorsWeiyang Lin, Xiao Zhang, Xiaoyan Huang
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Abstract
This invention relates to a stable pharmaceutical composition of freeze-dried tetrodotoxin powder which contains trace amount of tetrodotoxin, substances which can stabilizes tetrodotoxin, including disaccharide(s) or polyglucose(s) or analogues thereof and solvent(s), and solvents which can help tetrodotoxin dissolve.
Claims29
A stable freeze-dried pharmaceutical composition prepared by a process comprising freeze-drying a solution, wherein the solution that is freeze-dried has a pH in the range from 3.0 and 6.0 and contains one or more doses of bioactive tetrodotoxin, and a stabilizer, wherein the stabilizer is selected from the group consisting of disaccharides, ficolls and dextrans, and wherein the freeze-dried pharmaceutical composition, upon reconstitution with a pharmaceutically acceptable aqueous solution, retains said one or more doses of bioactive tetrodotoxin.
A stable freeze-dried pharmaceutical composition prepared by a process comprising freeze-drying a solution, wherein the solution that is freeze-dried has a pH in the range from 3.0 to 6.0 and contains one or more doses of bioactive tetrodotoxin, and a stabilizer, and wherein the stabilizer aids in reducing the epimerization of the C-4 hydroxyl of a tetrodotoxin molecule during the process of freeze drying so as to retain said one or more doses of bioactive tetrodotoxin.
A method for preparing a freeze-dried composition which, upon reconstitution with a pharmaceutically acceptable aqueous solution, contains one or more doses of bioactive tetrodotoxin, comprising the steps of (a) preparing a solution comprising tetrodotoxin, stabilizer, and water, wherein the solution has a pH in the range from 3.0 to 6.0 and wherein the stabilizer is selected from the group consisting of disaccharides, ficolls and dextrans, and (b) freeze-drying the solution.
An injectable solution prepared by a process comprising (a) providing a solution which has a pH in the range from 3.0 to 6.0 and contains one or more doses of bioactive tetrodotoxin, and a stabilizer, wherein the stabilizer is selected from the group consisting of disaccharides, ficolls and dextrans;
- (b) freeze-drying the solution;
- and (c) reconstituting the resulting composition into a pharmaceutically acceptable aqueous solution suitable for injection, using pharmaceutically acceptable, pyrogen-free water, wherein the resulting injectable solution retains said one or more doses of bioactive tetrodotoxin.
A method for preparing a freeze-dried composition which, upon reconstitution with a pharmaceutically acceptable aqueous solution, contains one or more doses of bioactive tetrodotoxin, comprising the steps of (a) preparing a solution comprising tetrodotoxin, a stabilizer, and water, wherein the solution has a pH in the range from 3.0 to 6.0 and wherein the stabilizer aids in reducing the epimerization of the C-4 hydroxyl of a tetrodotoxin molecule, and (b) freeze-drying the solution.
An injectable solution prepared by a process comprising (a) providing a solution which has a pH in the range from 3.0 to 6.0 and contains one or more doses of bioactive tetrodotoxin, and a stabilizer, wherein the stabilizer aids in reducing the epimerization of the C-4 hydroxyl of a tetrodotoxin molecule, (b) freeze-drying the solution and (c) reconstituting the resulting composition, using a pharmaceutically acceptable aqueous solution, wherein the resulting injectable solution retains said one or more doses of bioactive tetrodotoxin.
Dependencies are inferred from the claim text.