Patent ID: 6599529
Filing Date: 2003-07-29
Classification: A61K,A61P

Abstract:
An oral pharmaceutical modified release multiple-units composition in unit dosage form for administration of a therapeutically and/or prophylactically effective amount of a non-steroid anti-inflammatory drug substance, an NSAID substance, said unit dosage form comprising at least two NSAID-containing fractions,i) a first NSAID-containing fraction of multiple-units for quick release of the NSAID substance, wherein said fraction comprises an antacid or an alkaline agent and wherein the quick in vitro release is such that, when subjecting the first NSAID-containing fraction to dissolution method II employing 0.07 N HCl as dissolution medium, at least 50% w/w of the NSAID substance is released within the first 20 min of the test; and ii) a second NSAID-containing fraction of multiple-units in the form of coated delayed release multiple units for extended release of the NSAID substance, said units coated with a coating substantially water-insoluble, but water-diffusible and substantially pH-independent, wherein said second NSAID-containing fraction of multiple-units releases from about 6% to 30% of said NSAID substance within 0.5 hours upon dissolution testing by dissolution method III, and wherein the release of said second NSAID-containing fraction is independent of the release of said first NSAID-containing fraction.