Patent ID: 6197347
Filing Date: 2001-03-06
Classification: A61K,Y10S

Abstract:
A controlled release pharmaceutical dosage form consisting essentially of:(a) a core consisting essentially of:(i) 50-90% of ketoprofen;(ii) 10-35% of an inert pellet starting material; and(ii) 0.5-7.5% of ethylcellulose; and(b) a coating consisting essentially of:(i) 20-70% of shellac;(ii) 15-40% of ethylcellulose; and(iii) 25-75% of a lubricant,wherein the viscosity of the core ethylcellulose is 9-11 cps, the viscosity for the coating ethylcellulose is 5.6-8.4 cps and that exhibits the following dissolution profile when tested in a USP type 2 apparatus at 75 rpm in 900 ml of simulated intestinal fluid, pH 7.5 phosphate buffer and at 37.degree. C.:after 2 hours 20-60% of the ketoprofen is released;after 4 hours 30-90% of the ketoprofen is released;not less than 50% of the ketoprofen is released after 8 hours;not less than 60% of the ketoprofen is released after 12 hours; and not less than 70% of the ketoprofen is released after 18 hours.