FIELD: pharmaceutics.
SUBSTANCE: invention refers to pharmaceutical industry and concerns stable effervescent composition of bisphosphonate inhibitor of bone resorption in form of tablets, not containing filler, which can react with effervescent organic acid component. Tablet under the present invention includes an effective amount of micronized sodium trihydrate alendronate as bisphosphonate inhibitor of bone resorption, effervescent organic acid component containing citric acid and monosodium citrate, main effervescent component. Said tablet is tampered of granulate, produced during granulation in pseudo fluidized bed, has total weight of 3,500 mg to 6,000 mg and does not contain polyol binders, binders and lubricating substances used for tabletting; has drying loss of 0.25 % (m/m) or less; has complete disintegration time of not more than 180 seconds, if it is placed in 3–8 liquid ounces of water at 5–20 °C; and said alendronate is completely soluble in water in 2 minutes without stirring.
EFFECT: invention discloses a stable formulations of effervescent bisphosphonate with properties of fast solubilization.
14 cl, 3 dwg, 7 tbl, 1 ex
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Authors
Dates
2017-01-23—Published
2011-12-05—Filed