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-12290503-B2
Publication Date
2025-05-06
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 disclosed invention relates to ready-to-use, substantially anhydrous liquid oral pharmaceutical compositions containing topiramate or a pharmaceutically acceptable addition salt that exclude added water. The compositions have low water content and are described as stable at room temperature for at least 24 months and stable in atmospheric oxygen.
The liquid oral compositions include polyethylene glycol and glycerin in specified concentration ranges, together with one or more preservatives, and optionally one or more sweeteners and a flavor component comprising one or more flavor compounds. The composition is administered directly to a patient without dilution, using oral dosing units and direct dosing devices for dosing undiluted liquid.
The invention also provides treatment by orally administering the composition for epilepsy, partial-onset seizures, primary generalized tonic-clonic seizures, seizures associated with Lennox-Gastaut syndrome, and migraine. The document additionally describes relative bioavailability data indicating bioequivalence to TOPAMAX® 25 mg under fasting, including food-effect assessment.
Claims Coverage
The partial content identifies one independent claim. This claim centers on an orally administered undiluted liquid composition featuring topiramate concentration and defined PEG/glycerin composition parameters, together with preservatives and optional sweeteners and flavors, for specified neurological indications.
Direct oral administration without dilution of a specified topiramate liquid at 25 mg/ml
A method for treating a disease or disorder, or a symptom thereof, comprising orally administering a pharmaceutical composition directly without dilution to a patient, wherein the pharmaceutical composition comprises topiramate or a pharmaceutically acceptable addition salt thereof in an amount of about 25 mg/ml.
PEG and glycerin liquid composition with defined concentration ranges
A pharmaceutical composition wherein polyethylene glycol is present in an amount of about 40% w/v to about 60% w/v and glycerin is present in an amount of about 40% w/v to about 70% w/v.
Preservatives plus optional sweeteners and flavor component
A pharmaceutical composition comprising one or more preservatives and optionally one or more sweeteners, a flavor component comprising one or more flavor compounds, or a combination thereof.
Oral treatment indications limited to epilepsy/seizures and migraine
The disease or disorder, or symptom thereof, is selected from epilepsy, partial-onset seizures, primary generalized tonic-clonic seizures, seizures associated with Lennox-Gastaut syndrome, and migraine.
Across the identified independent claim, the inventive coverage is an undiluted direct oral dosing method using a liquid composition containing topiramate or a pharmaceutically acceptable addition salt thereof at about 25 mg/ml, combined with polyethylene glycol and glycerin in defined ranges, plus preservatives and optionally sweeteners and flavors, for the specified epilepsy/seizure disorders and migraine indications.
Stated Advantages
Improves room-temperature stability for at least 24 months.
Provides stability in atmospheric oxygen.
Documented Applications
Treatment of epilepsy, including partial-onset seizures and seizures associated with Lennox-Gastaut syndrome.
Treatment of primary generalized tonic-clonic seizures.
Prophylaxis/treatment for migraine.
Relative bioavailability/bioequivalence assessment to TOPAMAX® 25 mg under fasting, including evaluation with food-effect.
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