FIELD: pharmaceuticals.
SUBSTANCE: invention relates to pharmaceutical compositions and dosage forms containing cinacalcet hydrochloride (CCH). Proposed is a tablet core containing, as an active principle, a complex of cinacalcet hydrochloride with hydroxypropyl cellulose, obtained by introducing cinacalcet hydrochloride with vigorous stirring into a saturated aqueous methanol solution of hydroxypropyl cellulose at a temperature of 40-60°C with a cinacalcet hydrochloride content of 46-63 wt %, with the following ratio of ingredients in the final product (wt %): silicon dioxide 0.5-2; magnesium stearate 0.5-2; complex of cinacalcet hydrochloride with hydroxypropyl cellulose - the rest.
EFFECT: claimed composition of the tablet core ensures the solubility of CCH more than 90% at acidic and neutral pH.
2 cl, 1 tbl, 3 ex
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Authors
Dates
2021-07-02—Published
2019-09-17—Filed