	US 12,419,857 B2
	Oral topiramate suspension formulations with extended shelf stability and enhanced bioavailability
Tajamal Mustafa, Leeds (GB); Mark Kneale Foley, Leeds (GB); Hayley Louise Lonergan, Leeds (GB); and David Robert Thompson, Leeds (GB)
Assigned to Rosemont Pharmaceuticals Limited, Leeds (GB)
Appl. No. 17/295,933
Filed by Rosemont Pharmaceuticals Limited, Leeds (GB)
PCT Filed Nov. 21, 2018, PCT No. PCT/IB2018/059194 § 371(c)(1), (2) Date May 21, 2021, PCT Pub. No. WO2020/104837, PCT Pub. Date May 28, 2020.
Prior Publication US 2022/0016074 A1, Jan. 20, 2022
Int. Cl. A61K 31/36 (2006.01); A61K 9/00 (2006.01); A61K 47/02 (2006.01); A61K 47/10 (2017.01); A61K 47/12 (2006.01); A61K 47/26 (2006.01); A61K 47/34 (2017.01); A61K 47/36 (2006.01)

CPC A61K 31/36 (2013.01) [A61K 9/0053 (2013.01); A61K 47/02 (2013.01); A61K 47/10 (2013.01); A61K 47/12 (2013.01); A61K 47/26 (2013.01); A61K 47/34 (2013.01); A61K 47/36 (2013.01)]

5 Claims

1. A pharmaceutical composition comprising a pharmaceutically effective amount of topiramate particles dispersed in suspension, wherein the composition is suitable for oral delivery, characterised in that approximately ninety percent of topiramate starting material has a maximum particle diameter between 7 μm and 13 μm,

wherein the topiramate concentration is 10 mg/ml or 20 mg/ml,

wherein the D(0.9) value of the 20 mg/ml composition is approximately 26 μm to 35 μm and viscosity approximately 1177 to 2155 cP,

wherein the D(0.9) value of the 10 mg/ml composition is approximately 21 μm to 36 μm and viscosity approximately 1175 to 2000 cP.