Bazedoxifene acetate formulations and preparation method

Bazedoxifene acetate formulations and preparation method

  • CN 101,304,731 B
  • Filed: 08/23/2006
  • Issued: 06/20/2012
  • Est. Priority Date: 08/24/2005
  • Status: Active Grant
First Claim
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1. comprise the bazedoxifene acetate of medicine effective quantity and the pharmaceutical composition of carrier or excipient systems, described carrier or excipient systems comprise:

  • A) first kind of filler/thinner composition accounts for 5% to 85% of pharmaceutical preparation weight;

    Wherein said first kind of filler/thinner composition is selected from one or more in sugar, Powderd cellulose, microcrystalline Cellulose, maltodextrin, starch, carboxymethyl cellulose, NATROSOL 250, hydroxyethyl-cellulose, calcium phosphate dibasic anhydrous, primojel and the metallic silicon aluminate, and wherein said sugar is monosaccharide, disaccharide or sugar alcohol;

    B) second kind of filler/thinner composition choosing wantonly accounts for 5% to 85% of pharmaceutical preparation weight;

    Wherein said second kind of optional filler/thinner composition be selected from sugar, Powderd cellulose, microcrystalline Cellulose, maltodextrin, starch, carboxymethyl cellulose, NATROSOL 250, hydroxyethyl-cellulose, calcium phosphate dibasic anhydrous, primojel and the metallic silicon aluminate other one or more, wherein said sugar is monosaccharide, disaccharide or sugar alcohol;

    C) antioxidant ingredients of choosing wantonly accounts for maximum 15% of pharmaceutical preparation weight;

    D) fluidizer/disintegrating agent component accounts for 0.01% to 10% of pharmaceutical preparation weight;

    WithE) lubricant composition accounts for 0.01% to 10% of pharmaceutical preparation weight;

    Wherein said bazedoxifene acetate exists with A polymorph form, and wherein the X-ray powder diffraction data of A polymorph form (2 θ

    ) comprise 12.7 °

    , and 16.0 °

    , 18.5 °

    , 20.7 °

    , 22.3 °

    .

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