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-11433046-B2
Publication Date
2022-09-06
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 invention relates to an oral liquid pharmaceutical composition formulated as a solution for oral administration, comprising topiramate or a pharmaceutically acceptable addition salt thereof in an amount of about 25 mg/ml. The composition is substantially anhydrous and includes a solvent component that consists of glycerin and polyethylene glycol of molecular weight about 400.
The liquid pharmaceutical composition further includes one or more preservatives selected from parabens, benzyl alcohol, benzoic acid, sorbic acid, sodium benzoate, and ascorbic acid. The composition also includes one or more sweeteners and a flavor component.
The method administers the composition to a patient in need thereof to deliver 25 mg/ml of topiramate or a pharmaceutically acceptable addition salt thereof. The method targets epilepsy, onset seizures, primary generalized tonic-clonic seizures, seizures associated with Lennox-Gastaut syndrome, and migraine.
Claims Coverage
The independent claim set includes one independent claim covering a method with four inventive features.
Orally administered substantially anhydrous topiramate oral liquid solution at about 25 mg/ml
A method for treating a disease or disorder, or symptom thereof, by orally administering an oral liquid pharmaceutical composition formulated as a solution, the composition consisting of topiramate or a pharmaceutically acceptable addition salt thereof at about 25 mg/ml and being substantially anhydrous.
Defined glycerin/PEG 400 solvent component
The liquid pharmaceutical composition includes a solvent component comprising one or more organic solvents, wherein the solvent component consists of glycerin and polyethylene glycol of molecular weight about 400.
Preservatives plus sweeteners and flavor component
The liquid pharmaceutical composition consists of one or more preservatives selected from parabens, benzyl alcohol, benzoic acid, sorbic acid, sodium benzoate, and ascorbic acid, plus one or more sweeteners and a flavor component.
Treatment of selected epilepsy and migraine disorders by oral dosing at 25 mg/ml
The method administers the pharmaceutical composition at 25 mg/ml of topiramate or a pharmaceutically acceptable addition salt, 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.
The claims center on an oral method using a substantially anhydrous topiramate oral liquid solution at about 25 mg/ml, with a glycerin and PEG 400 solvent system, selected preservatives, sweeteners, and a flavor component, for the listed epilepsy-related seizure indications and migraine.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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