Compositions and methods for treating epilepsy, seizures and other conditions
Inventors
Tu, Yu-Hsing • Perumal, Ashok • Kathala, Kalyan • BHATTACHARYA, Romona
Assignees
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Publication Number
US-11911362-B2
Publication Date
2024-02-27
Expiration Date
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.
Core Innovation
The invention relates to an oral liquid pharmaceutical composition formulated as a solution for oral administration. The composition comprises topiramate, or a pharmaceutically acceptable addition salt thereof, and a solvent component comprising one or more organic solvents consisting of glycerin and polyethylene glycol of molecular weight about 400. The composition is characterized by an oral liquid solution administered directly without adding water, and the topiramate amount is about 25 mg/ml in the liquid pharmaceutical composition.
The oral liquid solution further comprises one or more preservatives selected from parabens, benzyl alcohol, benzoic acid, sorbic acid, sodium benzoate, and ascorbic acid, and one or more sweeteners. The formulation is specified by solvent composition constraints for glycerin and polyethylene glycol 400 in defined ranges, and the solvent component amount is described as from about 80% to about 120% w/v in the liquid pharmaceutical composition. The composition is configured to be ready-to-use without dilution and without adding water, aqueous acid or base.
In addition, the invention includes a direct dosing device consisting of the oral liquid pharmaceutical composition for liquid for oral administration. The device is ready-to-use without dilution and is configured to be administered directly to a subject in need thereof without adding water, aqueous acid or base. The same composition concept is positioned for treating epilepsy, onset seizures, primary generalized tonic-clonic seizures, seizures associated with Lennox-Gastaut syndrome, and migraine, via orally administering the specified oral liquid pharmaceutical solution.
Claims Coverage
The document includes two independent claims. Across both independent claims, the core inventive features are the substantially anhydrous, solution-form oral liquid containing topiramate at about 25 mg/ml, the specified glycerin and polyethylene glycol 400 solvent system, inclusion of selected preservatives and sweeteners, and direct administration without adding water, or for the device, without adding aqueous acid or base.
Direct oral dosing of topiramate solution without adding water
Orally administering to a patient in need thereof a pharmaceutical composition as an oral liquid pharmaceutical composition formulated as a solution, comprising topiramate, or a pharmaceutically acceptable addition salt, in an amount of about 25 mg/ml, wherein the composition is administered directly to the patient without adding water.
Specified glycerin and polyethylene glycol 400 solvent component
Providing a solvent component comprising one or more organic solvents in an amount of from about 80% to about 120% w/v, 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.
Preservative and sweetener inclusion for the oral liquid solution
Including one or more preservatives selected from parabens, benzyl alcohol, benzoic acid, sorbic acid, sodium benzoate, and ascorbic acid, and including one or more sweeteners in the oral liquid pharmaceutical composition.
Direct dosing device for ready-to-use administration without adding water
Providing a direct dosing device consisting of a liquid pharmaceutical composition that 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.
Device composition with specified PEG and glycerin levels plus topiramate
Configuring the device liquid pharmaceutical composition to comprise polyethylene glycol in an amount of about 40% w/v to about 70% w/v; glycerin in an amount of about 60% to about 70% w/v; and topiramate, or a pharmaceutically acceptable addition salt thereof, in an amount of about 25 mg/ml, together with one or more preservatives, one or more sweeteners, and optionally a flavor component.
The claim set centers on a topiramate-containing oral liquid solution with a defined glycerin/PEG 400 solvent system and selected preservatives and sweeteners, presented as a ready-to-use composition administered directly without adding water. A separate independent claim covers a direct dosing device containing such a composition and configured for direct oral administration without adding water or aqueous acid/base.
Stated Advantages
Ready-to-use administration without dilution.
Direct administration without adding water.
Direct dosing device configured to be administered directly without adding water, aqueous acid or base.
Documented Applications
Treating epilepsy and onset seizures, including primary generalized tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome, by orally administering the specified topiramate oral liquid pharmaceutical composition.
Treating migraine by orally administering the specified topiramate oral liquid pharmaceutical composition.
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