GB2399015A — Process for the preparation of oral dosage forms comprising metformin and glyburide

USPTO Abstract

A method for the preparation of solid oral dosage forms of the combination of metformin and glyburide (glibenclamide) with increased biavailability/dissolvability wherein the glyburide need not be micronised. Glyburide is homogenised in an organic solvent, preferably methanol or ethanol, to create a slurry in which 8-15 % w/w of glyburide is in solution. The resulting slurry is then sprayed onto pharmaceutical excipients and then mixed with metformin granules, or alternatively sprayed directly onto metformin granules, to afford the solid oral dosage form. The invention further relates to solid oral dosage forms formed by such a process and those wherein 8-15 % w/w of glyburide has no detectable size value and the remainder is in the form of particles with diameters of less than 45 žm. A wetting agent such as polysorbate-80 or polyethylene 40 hydrogenated castor oil may be added during the slurry formation. The spraying process may comprise a spray-drying process.