Back to results
US 11,911,362 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 method for treating a disease or disorder, or a symptom thereof, consisting of orally administering to a patient in need thereof a pharmaceutical composition,
- wherein the pharmaceutical composition is an oral liquid pharmaceutical composition, wherein the liquid pharmaceutical composition is formulated as a solution and wherein the pharmaceutical composition comprises:
- (i) topiramate, or a pharmaceutically acceptable addition salt thereof, in an amount of about 25 mg/ml in the liquid pharmaceutical composition;
- (ii) a solvent component comprising one or more organic solvents in an amount of from about 80% to about 120% w/v in the liquid pharmaceutical composition, wherein the solvent component consists of glycerin in an amount of 60% to 65% w/v and polyethylene glycol of molecular weight about 400 in an amount of 45% to 55% w/v;
- (iii) one or more preservatives selected from parabens, benzyl alcohol, benzoic acid, sorbic acid, sodium benzoate, and ascorbic acid;
- (iv) one or more sweeteners;
- and
- wherein the liquid pharmaceutical composition is administered to the patient at 25 mg/ml of topiramate, or a pharmaceutically acceptable addition salt thereof,
- wherein the liquid pharmaceutical composition is administered directly to the patient without adding water, and
- wherein the disease or disorder, or symptom thereof, is selected from:
- epilepsy, onset seizures, primary generalized tonic-clonic seizures, seizures associated with Lennox-Gastaut syndrome, and migraine.
7 more elements
A direct dosing device consisting of a liquid pharmaceutical composition, wherein the liquid pharmaceutical composition comprises:
- (a) polyethylene glycol in an amount of about 40% w/v to about 70% w/v;
- (b) one or more preservatives selected from parabens, benzyl alcohol, benzoic acid, sorbic acid, sodium benzoate, and ascorbic acid;
- (c) glycerin in an amount of about 60% to about 70% w/v;
- (d) topiramate, or a pharmaceutically acceptable addition salt thereof, in an amount of about 25 mg/ml;
- (e) one or more sweeteners;
- and
- (f) optionally, a flavor component comprising one or more flavor compounds;
- wherein the liquid pharmaceutical composition is ready-to-use without dilution and configured to be administered directly to a subject in need thereof without adding water, aqueous acid or base;
- and
- wherein the liquid pharmaceutical composition is a liquid for oral administration.
7 more elements
Dependencies are inferred from the claim text.