Formulations of deoxycholic acid and salts thereof
AssigneeKythera Biopharmaceuticals, Inc.
InventorsRobert Emil Hodge, Jeffrey Douglas Webster
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Abstract
The present application is directed to an aqueous pharmaceutical formulation comprising less than about 5% w/v sodium deoxycholate maintained at a pH sufficient to substantially inhibit precipitation of the sodium deoxycholate. Also disclosed herein, are methods for inhibiting precipitation of sodium deoxycholate in an aqueous solution comprising less than about 5% w/v of sodium deoxycholate, said method comprising maintaining pH of the solution of from at least about 8.0 to about 8.5.
Claims35
An aqueous pharmaceutical formulation comprising about 0.5% w/v to about 1.5 w/v sodium deoxycholate wherein the formulation is maintained at a pH sufficient to substantially inhibit precipitation of the sodium deoxycholate.
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A method for inhibiting precipitation of sodium deoxycholate in an aqueous solution comprising about 0.5% w/v to about 1.5 w/v of sodium deoxycholate, said method comprising maintaining pH of the solution from about 8.0 to about 8.5.
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A composition comprising sodium deoxycholate, said composition comprising:
- an aqueous solution buffered to a pH of from about 8 to about 8.5;
- sodium deoxycholate in a concentration of about 1% w/v;
- and,
- optionally benzyl alcohol, wherein said sodium deoxycholate at said concentration is stabilized for at least one year at 25° C. in said composition.
Dependencies are inferred from the claim text.