FIELD: medicine; pharmaceuticals.
SUBSTANCE: present invention relates to a tablet pharmaceutical composition comprising a therapeutically effective dose of cinacalcet hydrochloride having a particle size distribution D90 equal to or less than 30 mcm in an amount of from 45% to 55% by weight. As pharmaceutically acceptable excipients, the composition comprises pregelatinized starch to be added intragranularly, microcrystalline cellulose to be added extragranularly, as well as a binder, a disintegrant, a lubricant and a glidant. Pregelatinized starch and microcrystalline cellulose are included in the composition in an amount of 30 to 50% by weight. Pharmaceutical composition of the invention releases at least 75% of the cinacalcet hydrochloride at thirty minutes.
EFFECT: tablet composition of the invention is characterized by a high amount of cinacalcet hydrochloride, a reduced size and is bioequivalent as compared to the commercially available tablets.
16 cl, 2 dwg, 2 tbl, 2 ex
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