US 12,263,226 B1
Neratinib-cyclodextrin composition and method for preparing same
Qinghai Lai, Hangzhou (CN); Jing Xu, Hangzhou (CN); and Bingxu Zhang, Hangzhou (CN)
Assigned to Hangzhou Jitai Pharmaceutical Technology Co., Ltd., Zhejiang (CN)
Filed by Hangzhou Jitai Pharmaceutical Technology Co., Ltd, Hangzhou (CN)
Filed on Apr. 23, 2024, as Appl. No. 18/643,422.
Application 18/643,422 is a continuation of application No. PCT/CN2024/086956, filed on Apr. 10, 2024.
Int. Cl. A61K 47/69 (2017.01); A61K 47/10 (2017.01); A61P 1/12 (2006.01)
CPC A61K 47/6951 (2017.08) [A61K 47/10 (2013.01); A61P 1/12 (2018.01)] 20 Claims
 
1. A formulation of neratinib, comprising an active ingredient comprising a therapeutically effective amount of neratinib thereof, or a pharmaceutically acceptable salt thereof, or a hydrate thereof, and cyclodextrin, wherein the active ingredient and the cyclodextrin are in a ratio ranging from 1:2.5 to 1:4.0 by weight, wherein the active ingredient is neratinib maleate and the cyclodextrin is 2-hydroxypropyl-β-cyclodextrin (HP-β-cyclodextrin).