Claims for Patent: 11,433,046

Summary for Patent: 11,433,046

Title:	Compositions and methods for treating epilepsy, seizures and other conditions
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.
Inventor(s):	Tu; Yu-Hsing (West Windsor, NJ), Perumal; Ashok (Monmouth Junction, NJ), Kathala; Kalyan (Monroe, NJ), Bhattacharya; Romona (Franklin Park, NJ)
Assignee:	Tulex Pharmaceuticals Inc. (Cranbury, NJ)
Application Number:	17/308,910
Patent Claims:	1. 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 consists of: (1) 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 (v) a flavor component; 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 pharmaceutical composition is substantially anhydrous, 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. 2. The method of claim 1 wherein the composition is administered to the patient from a direct dosing device. 3. The method of claim 2, wherein the direct dosing device is a measuring device with graduations. 4. The method of claim 2, wherein the direct dosing device is an oral syringe. 5. The method of claim 1, wherein the patient is not a pediatric patient. 6. The method of claim 1, wherein the patient is from 2-16 years old. 7. The method of claim 1, wherein the patient is an adult. 8. The method of claim 2, further comprising the step of filling the direct dosing device with the composition by withdrawing said composition from a dosage dispensing unit. 9. The method of claim 8, wherein the amount of the liquid pharmaceutical composition transferred to the direct dosing device is sufficient to provide from 12 mg to 1000 mg of topiramate or a pharmaceutically acceptable addition salt thereof. 10. The method of claim 1, wherein the liquid pharmaceutical composition consists of the following components: (i) polyethylene glycol 400 in an amount of about 50% w/v; (ii) one or more parabens in an amount of about 2.4% w/v; (iii) glycerin in an amount of 60% w/v to 65% w/v; (iv) topiramate, or a pharmaceutically acceptable addition salt thereof, in an amount of about 25 mg/ml; (v) one or more sweeteners in an amount of about 1% w/v; and (vi) a flavor component comprising one or more flavor compounds, the flavor component being in an amount of about 0.2% w/v. 11. The method of claim 1, wherein the liquid pharmaceutical composition has one or more of the following features: (a) a refractive index of from about 1.3 to about 1.38; (b) a viscosity of 300-600 cps; or (c) a density of 1.1-1.3. 12. The method of claim 1, wherein the topiramate is in the form of a free acid. 13. The method of claim 1, wherein the solvent component consists of: polyethylene glycol 400 in an amount of about 50% w/v; and glycerin in an amount of about 63% w/v. 14. The method of claim 1, wherein the disease or disorder, or symptom thereof, is partial-onset seizures. 15. The method of claim 1, wherein the disease or disorder, or symptom thereof, is a primary generalized tonic-clonic seizure. 16. The method of claim 1, wherein the disease or disorder, or symptom thereof, is a seizure associated with Lennox-Gastaut syndrome. 17. The method of claim 1, wherein the disease or disorder, or symptom thereof, is migraine.