Pharmaceutical formulation and its use

  • US 6,630,162 B1
  • Filed: 11/09/2000
  • Issued: 10/07/2003
  • Est. Priority Date: 11/11/1999
  • Status: Expired due to Term
First Claim
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1. An oral pharmaceutical formulation containing tolterodine or a tolterodine-related compound, or a pharmaceutically acceptable salt thereof, as active ingredient, wherein said formulation exhibits controlled in vitro release of the active ingredient in phosphate buffer at pH 6.8 of not less than about 80% after 18 hours, and after oral administration to a patient is capable of maintaining a substantially constant serum level of the active moiety or moieties for 24 hours, and wherein the controlled release formulation provides a mean fluctuation index of said serum level of active moiety or moieties that is not higher than about 2.0, said fluctuation index, FI, being defined as FI=(Cmax−

  • Cmin)/AUCτ

    , wherein Cmax and Cmin are the maximum and minimum concentrations, respectively, of active moiety or moieties, AUCτ

    is the area under the serum concentration profile, and τ

    is the length of the dosage interval.

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