US 12,403,117 B2
Stable pharmaceutical composition containing non-steroidal anti-inflammatory drug derivative
Jing Zhang, Shanghai (CN)
Assigned to ZHEJIANG YUEJIA PHARMACEUTICALS CO., LTD, Deqing County (CN)
Filed by ZHEJIANG YUEJIA PHARMACEUTICALS CO., LTD, Deqing County (CN)
Filed on May 20, 2024, as Appl. No. 18/668,653.
Application 18/668,653 is a continuation of application No. 18/312,466, filed on May 4, 2023, granted, now 11,986,453.
Application 18/312,466 is a continuation of application No. 16/758,880, abandoned, previously published as PCT/CN2018/108622, filed on Sep. 29, 2018.
Claims priority of application No. 201711014218.2 (CN), filed on Oct. 26, 2017.
Prior Publication US 2024/0299332 A1, Sep. 12, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/245 (2006.01); A61K 9/08 (2006.01); A61K 31/216 (2006.01)
CPC A61K 31/245 (2013.01) [A61K 9/08 (2013.01); A61K 31/216 (2013.01)] 20 Claims
 
1. A stable pharmaceutical composition containing a non-steroidal anti-inflammatory drug derivative, including at least a separated solid portion and a separated liquid portion,
wherein the solid portion includes a therapeutically effective amount of a salt, and the liquid portion includes a pharmaceutically acceptable solvent,
the salt is selected from the group consisting of 2-(diethylamino)-ethyl-2-acetoxybenzoate hydrochloride, salicylic acid-(2-diethylaminoethyl ester) hydrochloride, and 2-(diethylamino)-ethyl-2-(4-isobutylphenyl) propionate hydrochloride,
the solid portion is in a dosage form selected from the group consisting of powders, tablets and granules comprising a pharmaceutically acceptable binder,
wherein the pharmaceutically acceptable binder is selected from the group consisting of hypromellose, carbomer, ethyl cellulose, hydroxypropyl cellulose, vinyl cellulose, starch, pregelatinized starch, and polyvinylpyrrolidone,
the mass ratio of said salt to the pharmaceutically acceptable binder is from 100:0.05 to 100:10,
the solid portion and the liquid portion are configured to be mixed when the pharmaceutical composition is used so as to form a solution dosage form for external administration, and
the solid portion is stored in a hermetic, pharmaceutically acceptable packaging material,
wherein the solid portion is stable after storing at 25° C.±2° C. for 12 months.