FIELD: pharmacology.
SUBSTANCE: invention relates to a solid pharmaceutical form of zafirlukast having anti-inflammatory, anti-asthmatic, bronchospasm-warning action, which is a coated tablet containing zafirlukast and target additives at the following component ratio, %: core: zafirlukast - 7.8-10.2, calcium hydrophosphate dihydrate - 25.0-35.0, Prosolve - 22.0-40.0, hypromellose - 3.0-8.0, pregelatinized starch - 10.2-25.5, croscarmellose sodium - 1.0-3.0, aerosil - 0.5-3.0, stearic acid and/or its salts - 0.5-1.0; shell: hypromellose - 0.5-1.4, titanium dioxide - 0.3-0.6, macrogol - 0.1-0.6. The invention also relates to a process for preparation of a solid form of zafirlukast which includes a direct compression method.
EFFECT: invention allows to obtain solid forms of zafirlukast, in particular in the form of pills, characterized by good disintegration and strength, as well as rapid solubility.
10 cl, 3 tbl
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Authors
Dates
2017-05-12—Published
2016-01-25—Filed