Delayed release tablet with defined core geometry

  • US 8,168,218 B2
  • Filed: 04/23/2004
  • Issued: 05/01/2012
  • Est. Priority Date: 04/24/2003
  • Status: Active Grant
First Claim
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1. A press-coated tablet comprising a core containing 5 mg of prednisone and a coating around the core, said core being disposed within said coating such that the coating thickness about an axis (X-Y) is thicker than the coating about an axis (A-B) orthogonal to (X-Y),wherein the thickness of the coating about the axis (X-Y) is selected such that the coating ruptures upon immersion in an aqueous medium after a period of between about 2 to about 6 hours to release the drug,wherein coating material about the (X-Y) axis is relatively less dense than the coating material disposed about the (A-B) axis and the coating material about the (X-Y) axis is more permissive towards ingress of aqueous media than the coating material disposed about the axis (A-B),and wherein the axis (A-B) is the axis of the direction of movement of the punch used in the press-coating of the tablet:

  • said tablet comprising the following ingredientsCore of 5 mg prednisone tablet;

    Prednisone 8.33% as a percentage by weight in said core;

    Lactose monohydrate 64.47% as a percentage by weight in said core;

    Povidone 6.67% as a percentage by weight in said core;

    Croscarmellose sodium 18.33% as a percentage by weight in said core;

    Red ferric oxide 0.5% as a percentage by weight in said core;

    Magnesium stearate Vegetable origin 1.0% as a percentage by weight in said core;

    Colloidal silicon dioxide 0.5% as a percentage by weight in said core;

    Coating;

    Dibasic calcium phosphate dihydrate 50% as a percentage by weight in said coating;

    Glyceryl behenate 40% as a percentage by weight in said coating;

    Povidone 8.40% as a percentage by weight in said coating;

    Yellow ferric oxide 0.1% as a percentage by weight in said coating;

    Magnesium stearate Vegetable origin 1.0% as a percentage by weight in said coating;

    Colloidal silicon dioxide 0.5% as a percentage by weight in said coating.

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