FIELD: medicine; pharmaceuticals.
SUBSTANCE: present invention relates to a pharmaceutical complex granular composition comprising a first granular portion comprising levocetirizine or a pharmaceutically acceptable salt thereof, a cyclodextrin or a derivative thereof, and an alkalinizing agent; and a second granular portion comprising monteleukast or a pharmaceutically acceptable salt thereof, a cyclodextrin or a derivative thereof, and an alkalinizing agent. Cyclodextrin or derivative thereof is β-cyclodextrin or hydroxypropyl β-cyclodextrin in an amount of 3 to 7 % by weight. Alkalizing agent is selected from the group consisting of meglumine, sodium bicarbonate, sodium carbonate monohydrate, aqueous ammonia solution, sodium citrate, dry sodium carbonate, and a mixture thereof.
EFFECT: composition according to the invention is characterized by good stability of levocetirizine and monteleukast during storage, pleasant taste, high bioavailability of levocetirizine and monteleukast, and also improves adherence of patients to treatment because of effective masking of bitter taste.
6 cl, 11 dwg, 13 tbl, 8 ex
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Authors
Dates
2018-11-01—Published
2014-06-16—Filed