FIELD: medicine.
SUBSTANCE: composition contains celecoxib in an amount of less than 400 mg, preferably 240 mg, or 180 mg, or 120 mg, medium-chain glyceride in amount of 5 to 75 wt. %, a solubilising agent in amount of 10 to 70 wt. %, a polar solvent in amount of 20 to 80 wt. % and a pharmaceutically acceptable excipient. Celecoxib composition has average size of oil drops of not more than 500 nm. According to the invention, the liquid composition of celecoxib shows no precipitation when exposed to gastric juice obtained by simulating starvation (FaSSGF), at pH 2.0, temperature 37 ± 0.5 °C and while stirring with frequency of 50 rpm for at least 60 minutes. Liquid composition of celecoxib under the invention a) releases at least 70 % celecoxib for a period of time of 10 min or b) releases at least 80 % celecoxib for period of 15 minutes, in 900 ml 0.01 n. solution of HCl with 0.5 % sodium lauryl sulphate, when tested in apparatus USP type 2 with weights at 50 rpm and temperature of 37 °C.
EFFECT: present invention relates to an oral liquid pharmaceutical composition of celecoxib for treating human pain.
31 cl, 5 dwg, 5 tbl, 8 ex
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Authors
Dates
2019-12-05—Published
2016-05-27—Filed