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Sustained-release pharmaceutical tablet and process for preparation thereof

  • US 4,415,547 A
  • Filed: 06/14/1982
  • Issued: 11/15/1983
  • Est. Priority Date: 06/14/1982
  • Status: Expired due to Fees
First Claim
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1. A sustained-release pharmaceutical tablet consisting essentially of(A) from about 35% to about 85% by weight of a plurality of encapsulated pellets each consisting essentially of(a) from about 30% to about 98% by weight of a sugar-starch bead which is coated with(b) from about 1% to about 70% by weight of a first coat consisting of from about 75% to about 99% by weight of theophylline an orally administrable drug and from about 1% to about 25% by weight of a water-soluble drug-binding substance selected from the group consisting of polyvinylpyrrolidone, polyvinyl alcohol, methylcellulose and hydroxypropyl methycellulose and(c) from about 1% to about 15% by weight of a second coat consisting essentially of from about 1% to about 10% by weight of a water-soluble film-forming substance selected from the group consisting of polyvinylpyrrolidone, polyvinyl alcohol, methylcellulose and hydroxypropyl methylcellulose, from about 1% to about 60% by weight of a water-insoluble film-forming substance consisting of ethylcellulose and from about 30% to about 98% by weight of a dusting powder selected from the group consisting of talc, silicon dioxide and titanium dioxide, which encapsulated pellets are blended and compressed into tablet form with(B) from about 15% to about 65% by weight of a compressible tableting mixture consisting essentially of from about 20% to about 40% by weight of a diluent selected from the group consisting of the monosaccharides and the disaccharides, from about 30% to about 50% by weight of a diluent-binder consisting of microcrystalline cellulose, from about 10% to about 30% by weight of a binder consisting of ethyl cellulose, and from about 5% to about 20% by weight of a hydrophobic lubricant selected from the group consisting of hydrogenated vegetable oil, stearic acid, magnesium stearate and calcium sterate.

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