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PRODUCTION OF SOLID ORAL DOSAGE FORM OF METFORMIN AND GLYBURIDE BY HOMOGENIZING GLYBURIDE IN ORGANIC SOLUTION, SPRAYING SLURRY ONTO PHARMACEUTICAL EXCIPIENTS AND THEN MIXING WITH METFORMIN GRANULES HAVING EFFECT OF EXHIBITING BIOAVAILABILITY AND SOLUBILITY EQUAL TO CONVENTIONAL GLUCOVANCE AND BEING USED IN TREATMENT OF NON-INSULIN DEPENDENT DIABETES
PRODUCTION OF SOLID ORAL DOSAGE FORM OF METFORMIN AND GLYBURIDE BY HOMOGENIZING GLYBURIDE IN ORGANIC SOLUTION, SPRAYING SLURRY ONTO PHARMACEUTICAL EXCIPIENTS AND THEN MIXING WITH METFORMIN GRANULES HAVING EFFECT OF EXHIBITING BIOAVAILABILITY AND SOLUBILITY EQUAL TO CONVENTIONAL GLUCOVANCE AND BEING USED IN TREATMENT OF NON-INSULIN DEPENDENT DIABETES
PURPOSE: A simple and easy method for the preparation of solid oral dosages of the combination of metformin and glyburide by homogenizing glyburide in an organic solution, spraying resulted slurry onto pharmaceutical excipients and then mixing with metformin granules is provided. The product exhibits bioavailability and solubility equal to conventional Glucovance and is used in treatment of non-insulin dependent diabetes by administering to a patient in need thereof. CONSTITUTION: The solid oral dosages are prepared by the steps of: obtaining a slurry by homogenizing glyburide in an organic solution at 5,000 to 50,000rpm; spraying the resulted slurry onto pharmaceutical excipients; mixing the resulted product with metformin granules; forming the solid oral dosage of metformin and glyburide; and additionally screening the slurry with a sieve of 45m in diameter. The slurry contains about 8 to 15% by weight of glyburide in soluble form and remaining glyburide in particle form with a diameter of 45m or less. The organic solution is selected from the group consisting of methanol, ethanol or lower alkanol having 1-6C and mixtures thereof. The weight ratio of glyburide and organic solution is 1/10 to 1/40.
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