US 12,303,499 B2
Aqueous based pharmaceutical formulations of 1,2-dihydropyridine compounds
Geoffrey S. Hird, Chapel Hill, NC (US); Ganesh S. P. Bommareddy, Durham, NC (US); Anjali Joshi, Cary, NC (US); and James McShane, Raleigh, NC (US)
Assigned to Eisai R&D Management Co., Ltd., Tokyo (JP)
Appl. No. 17/312,077
Filed by Eisai R&D Management Co., Ltd., Tokyo (JP)
PCT Filed Dec. 16, 2019, PCT No. PCT/US2019/066622
§ 371(c)(1), (2) Date Jun. 9, 2021,
PCT Pub. No. WO2020/124090, PCT Pub. Date Jun. 18, 2020.
Claims priority of provisional application 62/779,620, filed on Dec. 14, 2018.
Prior Publication US 2022/0023275 A1, Jan. 27, 2022
Int. Cl. A61K 9/08 (2006.01); A61K 9/19 (2006.01); A61K 31/444 (2006.01); A61K 47/40 (2006.01)
CPC A61K 31/444 (2013.01) [A61K 9/08 (2013.01); A61K 9/19 (2013.01); A61K 47/40 (2013.01)] 15 Claims
OG exemplary drawing
 
1. A pharmaceutical formulation comprising a solubilizing agent and a therapeutically effective amount of perampanel or a hydrate thereof;
wherein said solubilizing agent is a sulfobutyl ether β-cyclodextrin;
wherein said sulfobutyl ether β-cyclodextrin is present in a molar ratio of between 28 to 108 moles per 1 mole perampanel;
wherein the pharmaceutical formulation is in an aqueous solution;
wherein the pharmaceutical formulation has 0.6 mg/mL to 0.8 mg/mL perampanel solution in 30% to 40% sulfobutyl ether β-cyclodextrin by weight;
and a pH in a range of 6 to 8.