FIELD: pharmaceutics.
SUBSTANCE: invention relates to production of tablets of mesalazine with enteric coating. Above method involves (i) stage of granulation of composition, (ii) stage of pelletization of obtained granulate with microcrystalline cellulose, structured polyvinyl pyrrolidone and magnesium stearate and stage (iii) of coating of tablet core with intermediate and enteric layers, wherein hardness of tablet core is adjusted so, that it is within 80N and 105N. Said granulate contains mesalazine, microcrystalline cellulose, silicon dioxide and polyvinyl pyrrolidone. Said intermediate layer contains methylhydroxypropylcellulose and PEG6000, wherein said layer is less than 2 % of total weight of tablet. Said enteric layer contains Eudragit® mixture 100L/100S, talc, magnesium stearate, triethylacetate and dyes.
EFFECT: invention provides reduced variability in characteristics of active substance release.
12 cl, 1 dwg, 1 tbl, 1 ex
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