Patent ID: 8956662
Filing Date: 2015-02-17
Classification: A61K,A61P

Abstract:
1. A pharmaceutical composition comprising phenylephrine and having two portions, wherein a first portion comprises phenylephrine in an immediate release form, which releases phenylephrine in a human's upper gastrointestinal system, and a second portion comprises phenylephrine in a sustained release form, which releases at least a portion of phenylephrine in a human's colon, wherein the composition contains 30 mg of phenylephrine and provides a mean C max and at least one of a mean AUC inf and the mean AUC 0-12 for phenylephrine under fasted conditions based on a single-dose administration that are from 80% to 125% of the mean C max and at least one of the mean AUC inf and the mean AUC 0-12 for phenylephrine provided by an extended release tablet containing 30 mg of phenylephrine and having an extended release core consisting essentially of about 22.5 mg of phenylephrine hydrochloride, about 25 mg of hydroxypropyl cellulose 300-600 cPs at 10%, about 25 mg of hydroxylpropyl cellulose 150-300 cPs at 2%, about 90 mg of carboxymethylcellulose sodium, about 332.5 mg of microcrystalline cellulose, and about 5 mg of magnesium stearate, and an immediate release coating layer consisting essentially of about 7.5 mg phenylephrine hydrochloride and about 36 mg polyvinylalcohol-based polymer.