US 12,290,503 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 Jan. 11, 2024, as Appl. No. 18/409,952.
Application 17/308,910 is a division of application No. 16/999,772, filed on Aug. 21, 2020, abandoned.
Application 18/409,952 is a continuation of application No. 18/222,061, filed on Jul. 14, 2023, granted, now 11,911,362.
Application 18/222,061 is a continuation of application No. 18/126,551, filed on Mar. 27, 2023, granted, now 11,826,343, issued on Nov. 28, 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 2024/0277656 A1, Aug. 22, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/25 (2006.01); A61J 1/06 (2006.01); A61J 7/00 (2006.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 9/14 (2006.01); A61K 9/48 (2006.01); A61K 31/047 (2006.01); A61K 31/235 (2006.01); A61K 31/357 (2006.01); A61K 31/7008 (2006.01); A61K 38/00 (2006.01); A61K 47/10 (2017.01); A61K 47/20 (2006.01); A61K 47/26 (2006.01); A61K 47/34 (2017.01); A61K 47/36 (2006.01); A61K 47/42 (2017.01); A61K 47/69 (2017.01); A61P 25/00 (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)] 19 Claims
OG exemplary drawing
 
1. A method for treating a disease or disorder, or a symptom thereof, comprising orally administering a pharmaceutical composition directly without dilution to a patient in need thereof, wherein the pharmaceutical composition comprises:
(a) topiramate, or a pharmaceutically acceptable addition salt thereof, in an amount of about 25 mg/ml;
(b) polyethylene glycol in an amount of about 40% w/v to about 60% w/v;
(c) glycerin in an amount of about 40% w/v to about 70% w/v;
(d) one or more preservatives; and
(e) optionally, one or more sweeteners, a flavor component comprising one or more flavor compounds, or a combination thereof;
wherein the pharmaceutical composition is administered to the patient at 25 mg/ml of topiramate, or a pharmaceutically acceptable addition salt thereof, and
wherein 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.