	US 11,701,352 B2
	Process for preparing aripiprazole oral soluble film
Rongbin Ling, Xiamen (CN); Lingyu Cai, Xiamen (CN); Fuxiang Lin, Xiamen (CN); Yong Yu, Xiamen (CN); and Xiaojin Xiao, Xiamen (CN)
Assigned to XIAMEN LP PHARMACEUTICAL CO., LTD., Xiamen (CN)
Filed by Xiamen LP Pharmaceutical Co., Ltd., Xiamen (CN)
Filed on Dec. 15, 2021, as Appl. No. 17/552,333.
Application 17/552,333 is a division of application No. 17/087,949, filed on Nov. 3, 2020, granted, now 11,331,315.
Claims priority of application No. 202010995622.8 (CN), filed on Sep. 21, 2020.
Prior Publication US 2022/0105089 A1, Apr. 7, 2022
Int. Cl. A61K 31/496 (2006.01); A61K 9/00 (2006.01); A61K 9/70 (2006.01)

CPC A61K 31/496 (2013.01) [A61K 9/0056 (2013.01); A61K 9/7007 (2013.01)]

8 Claims

1. A process for preparing an aripiprazole oral soluble film comprising aripiprazole in a crystalline state, comprising the steps of:

(a) grinding a starting material of aripiprazole by a milling process until 90% of the aripiprazole particles have a size of <14.3 μm, wherein the aripiprazole maintains a crystalline state;

(b) blending the aripiprazole particles of (a) and one or more film-forming materials in an aqueous solution by homogenization blending at a speed of at least 1500 rpm followed by plate-and-frame blending to prepare a uniform suspension,

(d) coating the defoamed suspension on a substrate and drying the suspension to form the film.