US 12,433,887 B2
Aripiprazole injectable suspension formulation having prolonged shelf life
Yunzhe Sun, Jiangsu Province Nanjing (CN); Qi Peng, Jiangsu Province Nanjing (CN); Cheng-Gang Lin, Jiangsu Province Nanjing (CN); Li Gui, Jiangsu Province Nanjing (CN); Zhihui Liu, Jiangsu Province Nanjing (CN); and Fei Liu, Jiangsu Province Nanjing (CN)
Assigned to Nanjing Noratech Pharmaceuticals Co., LTD, Nanjing (CN)
Filed by NANJING NORATECH PHARMACEUTICALS CO., LTD., Nanjing (CN)
Filed on Apr. 24, 2023, as Appl. No. 18/305,825.
Application 18/305,825 is a continuation of application No. 15/755,801, granted, now 11,786,522, previously published as PCT/CN2016/076454, filed on Mar. 16, 2016.
Claims priority of application No. 201510546844.0 (CN), filed on Aug. 31, 2015.
Prior Publication US 2023/0255960 A1, Aug. 17, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/496 (2006.01); A61K 9/00 (2006.01); A61K 9/10 (2006.01); A61K 47/26 (2006.01); A61K 47/38 (2006.01); A61P 25/18 (2006.01)
CPC A61K 31/496 (2013.01) [A61K 9/0019 (2013.01); A61K 9/10 (2013.01); A61K 47/26 (2013.01); A61K 47/38 (2013.01); A61P 25/18 (2018.01)] 19 Claims
 
1. An aripiprazole injectable suspension formulation having prolonged shelf life, comprising: aripiprazole in an amount of 200 mg/mL; sodium carboxymethyl cellulose in an amount of 2 mg to 10 mg/mL; polyoxyethylene (20) sorbitan monooleate in an amount of 4 mg to 24 mg/mL; mannitol in an amount of 20 mg to 50 mg/mL; and sodium dihydrogen phosphate in an amount of 0.4 mg to 4 mg/mL, wherein the prolonged shelf life is at least 6 months, and the ratio by weight of the sodium carboxymethyl cellulose to the polyoxyethylene (20) sorbitan monooleate is 1:2 to 1:3.