Patent ID: 8389008
Filing Date: 2013-03-05
Classification: A61K,A61P

Abstract:
1. A delayed release oral solid dosage form comprising: i) an immediate release core comprising a therapeutically effective amount of a drug which can be absorbed in the colon; from about 5% to about 50% of at least two surfactants by weight of the core, wherein one of the surfactants is polyethylene glycol; and ii) a delayed release material compression coated onto the surface of said core, said delayed release material consisting of a mixture of a heteropolysaccharide gum and a homopolysaccharide gum and iii) a material selected from the group consisting of a monosaccharide selected from the group consisting of dextrose and fructose, a disaccharide selected from the group consisting of sucrose and lactose, a polyhydric alcohol selected from the group consisting of xylitol, sorbitol, and mannitol, microcrystalline cellulose, starches, and any combinations or mixtures thereof; said mixture being compression coated in an amount effective to impart a desired delayed release such that said dosage form provides no release of drug until at least about 2 hours after oral administration of the dosage form, and the inclusion of the surfactant in the core facilitates the release of the drug from the dosage form in less than about 4 hours after initial release; said dosage form providing an in-vitro dissolution rate of the dosage form, when measured by the USP apparatus type III with 250 mL solution (pH 1.5) at 15 dpm that is 0% by weight drug released at about 3 hours, from about 5% to about 40% by weight drug release at about 4 hours, from about 30% to about 90% by weight drug released at 5 hours and greater than about 60% by weight drug released after 6 hours.