Stable edaravone liquid formulations and method of its use
OwnerSandipkumar Arvindbhai Patelinventor
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Abstract
A Stable liquid pharmaceutical formulation of edaravone or pharmaceutically acceptable salt thereof is provided. The liquid formulation of edaravone comprises edaravone, a solubilizer, and one or more optional pharmaceutically acceptable excipients, wherein the formulation is solution at concentration of at least 5 mg/mL, preferably about 21 mg/mL of edaravone, and comprises very low amount of ethanol. The method of preparing the stable liquid edaravone formulation and the use of such formulation for the treatment of diseases treatable by edaravone is described.
Claims21
A stable liquid pharmaceutical formulation comprising:
- (a) edaravone at a concentration from about 10 mg/mL to about 50 mg/mL;
- (b) one or more pharmaceutically acceptable excipients;
- and
- (c) a pharmaceutically acceptable vehicle comprising:
- (i) propylene glycol, polyethylene glycol, glycerin or combination thereof, and
- (ii) less than about 10% w/v of ethanol;
- wherein the formulation is a single-phase solution essentially free from visible particles;
- and
- wherein upon storage for at least three months at room temperature, the edaravone in the formulation has a purity of at least about 95%.
A stable oral liquid pharmaceutical formulation comprising:
- (a) edaravone at a concentration of about 15 mg/mL to about 25 mg/mL;
- (b) a vehicle comprising propylene glycol, polyethylene glycol, or a mixture thereof, present at a concentration of at least about 50% w/v;
- (c) one or more stabilizers selected from the group consisting of L-cysteine, pharmaceutically acceptable salt of bisulfite, or combinations thereof;
- and (d) water;
- wherein the formulation provides a unit dose of about 105 mg of edaravone in a total volume of about 5 mL.
Dependencies are inferred from the claim text.