US 12,133,847 B2
Pharmaceutical composition and preparation method therefor
Zeren Wang, Yunnan (CN); Yulan Zhao, Yunnan (CN); Lijiang Wang, Yunnan (CN); Xiao Zhang, Yunnan (CN); Jun Xu, Shenzhen (CN); Shunqin Chen, Shenzhen (CN); Meili Sun, Shenzhen (CN); and Guisheng Jiang, Shenzhen (CN)
Assigned to Shenzhen Pharmacin, Co., Ltd., Shenzhen (CN)
Filed by Shenzhen Pharmacin Co., Ltd., Guangdong (CN)
Filed on Jul. 7, 2021, as Appl. No. 17/369,531.
Application 16/727,469 is a division of application No. 16/156,983, filed on Oct. 10, 2018, granted, now 10,864,204, issued on Dec. 15, 2020.
Application 17/369,531 is a continuation of application No. 16/727,469, filed on Dec. 26, 2019, granted, now 11,083,721.
Application 16/156,983 is a continuation of application No. 15/636,353, filed on Jun. 28, 2017, granted, now 10,159,664, issued on Dec. 25, 2018.
Application 15/636,353 is a continuation of application No. PCT/CN2015/100263, filed on Dec. 31, 2015.
Claims priority of application No. 201410853865.2 (CN), filed on Dec. 31, 2014; and application No. 201510988362.0 (CN), filed on Dec. 25, 2015.
Prior Publication US 2021/0401819 A1, Dec. 30, 2021
Int. Cl. A61K 31/4439 (2006.01); A61K 9/48 (2006.01); A61K 47/02 (2006.01); A61K 47/12 (2006.01); A61K 47/18 (2017.01)
CPC A61K 31/4439 (2013.01) [A61K 9/4858 (2013.01); A61K 47/02 (2013.01); A61K 47/12 (2013.01); A61K 47/183 (2013.01)] 21 Claims
 
1. A solid oral pharmaceutical composition, comprising:
(i) a first component, wherein the first component comprises an active pharmaceutical ingredient or a pharmaceutically acceptable salt or hydrate thereof, wherein the active pharmaceutical ingredient or the pharmaceutically acceptable salt or hydrate thereof is labile to acids or alkalis in the pharmaceutical composition and is substantially insoluble in physiological conditions;
(ii) a second component, wherein the second component comprises:
(a) a pharmaceutically acceptable surface-modified acidic auxiliary material, wherein the surface of the pharmaceutically acceptable surface-modified acidic auxiliary material comprises a neutral salt layer that comprises: 1) an anion of an acidic medicinal auxiliary material in a powdered form; and 2) a cation of a pharmaceutically acceptable alkaline substance for surface modification, and wherein a weight ratio of the pharmaceutically acceptable alkaline substance for surface modification to the acidic medicinal auxiliary material is 0.1% to 10%; or
(b) a pharmaceutically acceptable surface-modified alkaline auxiliary material, wherein the surface of the pharmaceutically acceptable surface-modified alkaline auxiliary material comprises a neutral salt layer that comprises: 1) a cation of an alkaline medicinal auxiliary material in a powdered form; and 2) an anion of a pharmaceutically acceptable acidic substance for surface modification, and wherein a weight ratio of the pharmaceutically acceptable acidic substance for surface modification to the alkaline medicinal auxiliary material is 0.1% to 10%; and
wherein the pharmaceutical composition is in a solid dosage form.