Patent ID: 8778395
Filing Date: 2014-07-15
Classification: A61K

Abstract:
1. A controlled release oral pharmaceutical formulation comprising a tablet consisting of a mixture of (A) extended release diltiazem pellets, and (B) a gel-forming material, wherein (A) consists of: 45-75% of the total weight of the tablet and is a heterogeneous population of extended release diltiazem pellets wherein the extended release diltiazem pellets comprise: i) a pellet core comprising diltiazem; and ii) an extended release coating applied to the pellet core wherein the extended release coating controls the release of the drug from the pellet core so that the heterogeneous population of pellets exhibits a dissolution profile when tested in a USP Type 2 apparatus at 75 rpms, and 900 ml of simulated intestinal fluid (pH 7.5 phosphate buffer) at 37° C.: and (B) consists of: wherein the mixture of (A) and (B) is compressed into a tablet and the combination of the extended release coating on the extended release pellets and the polymer of the gel-forming material controls the release of the diltiazem from the tablet so the time of maximum blood plasma diltiazem concentration occurs about 10 to about 15 hours after administration of the tablet; and wherein the tablet exhibits a dissolution profile when tested in a USP Type 1 apparatus at 100 rpms, and 900 ml of simulated intestinal fluid (pH 7.5 phosphate buffer) at 37° C.: and wherein the polymer of the gel-forming material is 5-25% of the total weight of the tablet and the gel-forming material is free of flux enhancers selected from the group consisting of magnesium sulfate, magnesium chloride, sodium chloride, potassium chloride, lithium chloride, potassium sulfate, sodium carbonate, sodium sulfate, lithium sulfate, potassium acid phosphate, calcium lactate, tartaric acid, lactose, fructose, sucrose, mannitol, sorbitol and mixtures thereof and the tablet may optionally be coated with a water soluble seal coat, aesthetic coat, color coat or polishing coat.