Patent ID: 8501226
Filing Date: 2013-08-06
Classification: A61K,A61P

Abstract:
1. A method for making a pharmaceutical product comprising mesalazine, comprising: coating an uncoated mesalazine composition with a coating mixture comprising ethyl cellulose and hydroxypropyl methylcellulose, thereby obtaining a mesalazine composition 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 composition 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 composition, wherein said mesalazine composition coated with a single coating layer exhibits 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 by stirring at 100 rpm in 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 mesalazine composition coated with a single coating layer.