FIELD: pharmacy.
SUBSTANCE: group of inventions relates to a pharmaceutical formulation of clozapine with sustained release in the form of tablets, film coated, containing 30.0-50.0 wt % of clozapine, 20.0-30.0 wt % of microcrystalline cellulose, 4.0-6.0 wt % of lactose monohydrate, 15.0-25.0 wt % of hydroxypropyl methylcellulose HPMC K15M, 1.0-3.0 wt % of hydroxypropyl methylcellulose HPMC 2910, 1.0-3.0 wt % of colloidal silicon dioxide, 0.05-1.5 wt % of pharmaceutically acceptable salts of stearic acid and 2.0-4.0 wt % of film coating which comprises polyvinyl alcohol, titanium dioxide, macrogol and acceptable dyes or a mixture Opadry II yellow; as well as to a process for preparing such a pharmaceutical composition.
EFFECT: obtaining a stable pharmaceutical composition of clozapine in the form of tablets with sustained release and stable technological properties, as well as reproducible release kinetics of the active substance.
9 cl, 5 ex, 1 tbl, 2 dwg
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Authors
Dates
2017-03-15—Published
2016-02-18—Filed