FIELD: pharmacology.
SUBSTANCE: method for production of a vitamin complex in spheroid coated pills, which is implemented by the sequence of technological operations of spheroid pill-cores production, then coating with a protective layer with subsequent surface wax glazing, the difference is that the spherical pill-cores are obtained by direct pressing of the pill mass with a bulk density not less than 0.61 g/cm3, fluidity not less than 5.0 g/s, Hekkel coefficient from 0.00112 to 0.00075 cm2/N, with punches 7 to 9 mm in diameter with spherical working surface, with a ration of the spherical working surface radius (R) to the punch diameter (D) of 0.55 up to 0.70, working surface sphere radius offset from the bottom edge of the punch (N) 0.5-2.0 mm, weight from 0.24 to 0.86, at pressure from 250 to 700 N/cm2, with pressing speed of no more than 33 RPM of the pill press rotor and pressure of pill popping from the matrix of 20 to 50 N/cm2, the pill-cores are coated through excipients suspension, while the weight of the coating shall be less than that of the pill-core.
EFFECT: increased production efficiency, stability during finished product storage and pharmaceutical safety of the finished solid dosage form of mono-or multivitamin preparations while maintaining geometric and organoleptic indicators of pellets.
3 cl, 4 ex, 5 tbl
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Authors
Dates
2019-02-06—Published
2015-10-19—Filed