FIELD: pharmaceuticals.
SUBSTANCE: group of inventions relates to variants of a stable oral liquid pharmaceutical composition of celecoxib and methods for their use. The proposed liquid pharmaceutical composition contains celecoxib in an amount of 1% to 8% by weight based on the total weight of the composition, at least one medium chain glyceride, which is or is glyceryl tricaprylate/tricaprate and/or glyceryl monocaprylate, and at least one solubilizer, which is or is polyethoxylated castor oil and/or lauryl macrogol glyceride. In one embodiment, the composition contains at least one solubilizer in an amount of from 10% to 70% by weight based on the total weight of the composition and has a D50 oil droplet size of not more than about 125 nm after exposure to stability evaluation conditions at a temperature of 40 °C/RH 75% for 3 months. In another embodiment, the composition contains at least one medium chain glyceride in an amount of 5% to 75% by weight and has a D90 oil droplet size of not more than about 250 nm after exposure to stability evaluation conditions at 40°C/75% relative humidity within 3 months. Also the methods of treating or reduction of pain, comprising administering any of the variations of the above composition to a human are provided.
EFFECT: composition variants remain stable during storage, have a favorable profile of pharmacokinetic parameters, are easily dissolved/dispersed in the gastrointestinal tract for rapid absorption from it, providing rapid pain relief.
22 cl, 5 tbl, 8 ex, 5 dwg
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Authors
Dates
2023-05-15—Published
2016-05-27—Filed