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Immediate release tablet cores of insoluble drugs having sustained-release coating

  • US 6,024,982 A
  • Filed: 06/06/1995
  • Issued: 02/15/2000
  • Est. Priority Date: 11/23/1993
  • Status: Expired due to Term
First Claim
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1. A method for preparing an oral, sustained release formulation of an insoluble, therapeutically active agent, comprisingcoating an immediate release tablet core including acetaminophen in an amount sufficient to render a therapeutic effect with a controlled release coating on the tablet core comprising a hydrophobic material such that said formulation reproducibly provides a dissolution rate in-vitro of the dosage form, when measured by the USP Paddle Method at 100 rpm in 900 ml aqueous buffer, pH between 1.6 and about 7.2, at 37°

  • C. between 12.5 and 42.5 (by wt) released after 1 hour, between 25 and 56% (by wt) released after 2 hours, between 45 and 75% (by wt) released after 4 hours, and between 55 and 85% (by wt) released after 6 hours.

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