Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations

  • US 6,419,960 B1
  • Filed: 12/16/1999
  • Issued: 07/16/2002
  • Est. Priority Date: 12/17/1998
  • Status: Expired due to Term
First Claim
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1. An oral controlled release formulation which provides a rapid onset of therapeutic effect and a rapid drop in plasma concentration after a prolonged period of therapeutic effect, comprisinga plurality of substrates comprising a portion of the effective dose of a drug in immediate release form, a hydrophobic material coated onto the surface of said substrates in an amount sufficient to retard the release of said drug, an enteric coating applied over said hydrophobic coating in an amount sufficient to substantially delay the release of said drug from said substrate until after said formulation passes through the stomach, the formulation further comprising the remaining portion of said drug in immediate release form;

  • wherein the oral dosage form provides a time to maximum plasma concentration at about 0.5 to about 4 hours after oral administration and wherein the duration of effect provided by the drug contained in the formulation falls below effective plasma concentrations at about 8 to about 12 hours after oral administration.

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