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-11633374-B2
Publication Date
2023-04-25
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 a direct dosing device consisting of a liquid pharmaceutical composition for oral administration. The liquid pharmaceutical composition consists of polyethylene glycol 400, one or more parabens, glycerin, topiramate or a pharmaceutically acceptable addition salt thereof, one or more sweeteners, and optionally a flavor component. The total amount of water present in the composition is 0.35% w/w or less.
The liquid pharmaceutical composition is ready-to-use without dilution and is 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 is a liquid for oral administration.
The direct dosing device is a measuring device with graduations and is selected from a group consisting of a syringe, a dosing cup, an ampoule, a vial, a spoon, a dropper, and a pipette. Storage stability is described as the liquid pharmaceutical composition being stable for at least 24 months at controlled room temperature and/or at 20–25°C.
The document further provides examples consistent with the defined composition system and the associated oral direct dosing devices, including formulations with polyethylene glycol 400, methylparaben and propylparaben, glycerin, topiramate, sucralose, and optionally a flavor component. The disclosed performance includes stability at room temperature conditions and bioequivalence to TOPAMAX® 25 mg capsules based on AUC criteria.
Claims Coverage
The document provides two independent claims, each covering a direct dosing device for an oral liquid pharmaceutical composition containing topiramate or a pharmaceutically acceptable addition salt, with low water content and no added water or aqueous acid/base. The inventive features are the specific formulation composition constraints and, for the second independent claim, the device configuration and selection of measuring devices with graduations.
Low-water ready-to-use topiramate oral liquid composition
A direct dosing device consisting of a liquid pharmaceutical composition for oral administration, wherein the liquid pharmaceutical composition consists of polyethylene glycol 400, one or more parabens, glycerin, topiramate or a pharmaceutically acceptable addition salt thereof, one or more sweeteners, and optionally a flavor component; 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.
Graduated measuring-device direct dosing device for the low-water composition
A direct dosing device consisting of a liquid pharmaceutical composition for oral administration, wherein the liquid pharmaceutical composition consists of polyethylene glycol 400, one or more parabens, glycerin, topiramate or a pharmaceutically acceptable addition salt thereof, one or more sweeteners, and optionally a flavor component; 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 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.
Overall, claim coverage centers on a direct dosing device delivering a substantially low-water, ready-to-use topiramate-containing oral liquid with no added water and no aqueous acid/base, and, under the second independent claim, delivering that composition via a graduated measuring device selected from specified direct dosing formats.
Stated Advantages
Stable for at least 24 months at controlled room temperature.
Stable for at least 24 months at 20–25°C.
Ready-to-use without dilution and configured to be administered directly to a subject in need thereof.
Bioequivalence to TOPAMAX® 25 mg capsules based on AUC criteria (AUC 0–∞ and AUC 0-t).
Documented Applications
Treating epilepsy and seizures, including partial-onset and generalized tonic-clonic seizures, and Lennox-Gastaut.
Treating or preventing migraine headaches.
Treating mood disorders including depression, bipolar/manias, and borderline personality.
Treating obesity and eating disorders.
Treating antipsychotic-induced weight gain.
Treating post-traumatic stress disorder.
Treating Type II diabetes.
Tobacco cessation.
Alcohol dependence.
Treating neuropathic pain.
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