Patent ID: 8282958

Claim:
A method for making a pharmaceutical product comprising non-spherical granules comprising mesalazine wherein said non-spherical granules are coated with a single coating layer, which method comprises: coating uncoated extruded non-spherical granules having an elongated or cylindrical shape and comprising mesalazine with a coating mixture comprising ethyl cellulose and hydroxypropyl methylcellulose, thereby obtaining granules coated with a single coating layer; wherein a) the amount of ethyl cellulose in said coating mixture is an amount that would be effective to provide a closing membrane around said granules in the absence of said hydroxypropyl methylcellulose, and b) the amount of hydroxypropyl methylcellulose in said coating mixture is 50-250 mg per g uncoated granules, wherein said coated granules exhibit controlled release of mesalazine and in vitro dissolution characteristics of mesalazine of between 5% and 25% at 1 hour; between 30% and 50% at 2 hours; between 60% and 90% at 4 hours; and not less than 85% dissolved at 8 hours; as measured according to the standard conditions defined by stirring at 100 rpm in an apparatus 2 according to USP 24, in a 0.05 M pH 7.5 phosphate buffer prepared by dissolving 6.8 g monobasic potassium phosphate and 1 g sodium hydroxide in water to make 1000 mL of solution, and adjusting with 10 N sodium hydroxide to a pH of 7.50±0.05; and preparing a pharmaceutical product comprising said granules coated with a single coating layer.