US 11,911,362 B2
Compositions and methods for treating epilepsy, seizures and other conditions
Yu-Hsing Tu, West Windsor, NJ (US); Ashok Perumal, Monmouth Junction, NJ (US); Kalyan Kathala, Monroe, NJ (US); and Romona Bhattacharya, Franklin Park, NJ (US)
Assigned to TULEX PHARMACEUTICALS INC., Cranbury, NJ (US)
Filed by TULEX PHARMACEUTICALS INC., Cranbury, NJ (US)
Filed on Jul. 14, 2023, as Appl. No. 18/222,061.
Application 17/308,910 is a division of application No. 16/999,772, filed on Aug. 21, 2020, abandoned.
Application 18/222,061 is a continuation of application No. 18/126,551, filed on Mar. 27, 2023.
Application 18/126,551 is a continuation of application No. 17/850,050, filed on Jun. 27, 2022, granted, now 11,633,374, issued on Apr. 25, 2023.
Application 17/850,050 is a continuation of application No. 17/308,910, filed on May 5, 2021, granted, now 11,433,046, issued on Sep. 6, 2022.
Claims priority of provisional application 62/946,260, filed on Dec. 10, 2019.
Prior Publication US 2023/0355574 A1, Nov. 9, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/357 (2006.01); A61K 9/08 (2006.01); A61K 47/34 (2017.01); A61K 47/10 (2017.01); A61J 1/06 (2006.01); A61J 7/00 (2006.01); A61K 9/00 (2006.01); A61K 47/69 (2017.01); A61P 25/00 (2006.01); A61K 9/48 (2006.01); A61K 38/00 (2006.01); A61K 47/20 (2006.01); A61K 47/26 (2006.01); A61K 47/36 (2006.01); A61K 47/42 (2017.01); A61K 9/14 (2006.01); A61K 31/047 (2006.01); A61K 31/235 (2006.01); A61K 31/25 (2006.01); A61K 31/7008 (2006.01)
CPC A61K 31/357 (2013.01) [A61J 1/06 (2013.01); A61J 7/0023 (2013.01); A61J 7/0046 (2013.01); A61J 7/0053 (2013.01); A61K 9/0053 (2013.01); A61K 9/08 (2013.01); A61K 9/14 (2013.01); A61K 9/48 (2013.01); A61K 31/047 (2013.01); A61K 31/235 (2013.01); A61K 31/25 (2013.01); A61K 31/7008 (2013.01); A61K 38/005 (2013.01); A61K 47/10 (2013.01); A61K 47/20 (2013.01); A61K 47/26 (2013.01); A61K 47/34 (2013.01); A61K 47/36 (2013.01); A61K 47/42 (2013.01); A61K 47/6939 (2017.08); A61P 25/00 (2018.01)] 20 Claims
OG exemplary drawing
 
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 comprises:
(i) 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
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 liquid pharmaceutical composition is administered directly to the patient without adding water, and
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.