Pharmaceutical formulation comprising lanthanum compounds

  • US 7,465,465 B2
  • Filed: 08/26/2004
  • Issued: 12/16/2008
  • Est. Priority Date: 08/26/2003
  • Status: Active Grant
First Claim
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1. A lanthanum carbonate pharmaceutical formulation in a chewable tablet, comprising lanthanum carbonate in an amount of from about 200 mg to about 1000 mg elemental lanthanum in the proportion of about 10 to about 40 wt % of the formulation as elemental lanthanum and pharmaceutically acceptable excipients comprising a diluent in an amount from about 40 to about 80 wt % of the formulation and a flow agent in an amount from about 0.1 to about 5.0 wt % of the formulation, produced by a process which comprises the steps of:

  • a. blending the lanthanum carbonate and the pharmaceutically acceptable excipients to form a mixture;

    orb. blending the lanthanum carbonate and the pharmaceutically acceptable excipients, compressing the resulting combination into a slug material or roller compacting the resulting combination into a strand material, and milling the prepared material into a free flowing mixture; and

    c. compressing the mixture formed in steps a or b into a tablet,wherein the process is performed without wet granulation or drying, the diluent is dextrates, corn syrup, oligosaccharide, isomaltooligosaccharide, glucose, lycasin, xylitol, lactitol, erythritol, mannitol, isomaltose, polydextrose, dextrin, starch, fructose, xylitol, maltodextrin, maltitol, isomalt, lactose, sorbitol, microcrystalline cellulose, sucrose based diluent-binders, confectioner'"'"'s sugar, calcium sulfate dihydrate, calcium lactate trihydrate, hydrolysed starches, dextrose, inositol, hydrolyzed cereal solids, amylase, or glycine, and the flow agent is magnesium stearate, talc, polyethylene glycol, silica, colloidal anhydrous silica, hydrogenated vegetable oils, glyceryl behenate, or glyceryl monostearate.

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