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US 11,633,374 B2Granted
Compositions and methods for treating epilepsy, seizures and other conditions
AssigneeTulex Pharmaceuticals Inc.
InventorsYu-Hsing Tu, Ashok Perumal, Kalyan Kathala, Romona Bhattacharya
Life of this patent
Estimating the term…
Abstract
Compositions are provided for the liquid oral administration of topiramate and its salts. The invention further provides methods for treating diseases and disorders using the compositions.
Claims20
A direct dosing device consisting of a liquid pharmaceutical composition, wherein the liquid pharmaceutical composition consists of:
- (a) polyethylene glycol 400 in an amount of about 45% w/v to about 55% w/v;
- (b) one or more parabens in an amount of about 1.2% w/v to about 2.5% w/v;
- (c) glycerin in an amount of about 60% to about 65% w/v;
- (d) topiramate, or a pharmaceutically acceptable addition salt thereof, in an amount of about 25 mg/ml;
- (e) one or more sweeteners in an amount of about 0.5% w/v to about 2% w/v;
- and
- (f) optionally, a flavor component comprising one or more flavor compounds, the flavor component being in an amount of about 0.1% w/v to about 0.5% w/v;
- wherein:
- the total amount of water present in the composition is 0.35% w/w or less;
- wherein the liquid pharmaceutical composition is ready-to-use without dilution and configured to be administered directly to a subject in need thereof,
- the liquid pharmaceutical composition does not contain any added water, aqueous acid or base;
- and
- the liquid pharmaceutical composition is a liquid for oral administration.
10 more elements
A direct dosing device consisting of a liquid pharmaceutical composition, wherein the liquid pharmaceutical composition consists of:
- (a) polyethylene glycol 400 in an amount of about 45% w/v to about 55% w/v;
- (b) one or more parabens in an amount of about 1.2% w/v to about 2.5% w/v;
- (c) glycerin in an amount of about 60% to about 65% w/v;
- (d) topiramate, or a pharmaceutically acceptable addition salt thereof, in an amount of about 25 mg/ml;
- (e) one or more sweeteners in an amount of about 0.5% w/v to about 2% w/v;
- and
- (f) optionally, a flavor component comprising one or more flavor compounds, the flavor component being in an amount of about 0.1% w/v to about 0.5% w/v;
- wherein:
- the total amount of water present in the composition is 0.35% w/w or less;
- wherein the direct dosing device is a measuring device with graduations, and wherein the direct dosing device is selected from a group consisting of a syringe, a dosing cup, an ampoule, a vial, a spoon, a dropper, and a pipette;
- the liquid pharmaceutical composition does not contain any added water, aqueous acid or base;
- and
- the liquid pharmaceutical composition is a liquid for oral administration.
10 more elements
Dependencies are inferred from the claim text.