Patent ID: 7022342

Claim:
A controlled release pharmaceutical dosage form comprising a plurality of pellets wherein the pellets consists essentially of: (a) a core consisting essentially of: (i) propranolol or a pharmaceutically acceptable derivative thereof; (ii) sugar spheres; (iii) microcrystalline cellulose; and (iv) ethylcellulose; and (b) a coating applied directly to the core consisting essentially of a mixture of: (i) ethylcellulose; (ii) hydroxypropyl methylcellulose; (iii) acetyl tributyl citrate; and (iv) talc, wherein the viscosity of the core ethylcellulose is 8–12 cps and the viscosity of the coating ethylcellulose is above 8 cps wherein the dosage form exhibits the following dissolution profile when tested in a USP type 1 apparatus at 100 rpm in 900 ml of simulated intestinal fluid (pH 6.8 phosphate buffer) at 37° C.: after 2 hours 15–40% of the propranolol or a pharmaceutically acceptable derivative thereof is released; after 4 hours 35–65% of the propranolol or a pharmaceutically acceptable derivative thereof is released; after 8 hours 40–80% of the propranolol or a pharmaceutically acceptable derivative thereof is released; not less than 70% of the propranolol or a pharmaceutically acceptable derivative thereof is released after 12 hours; and not less than 80% of the propranolol or a pharmaceutically acceptable derivative thereof is released after 16 hours.