Patent ID: 9040085
Filing Date: 2015-05-26
Classification: A61J,A61K,A61P

Abstract:
1. A method of administering a glucocorticosteroid active substance selected from prednisone, prednisolone, and methylprednisolone to a patient in need thereof comprising administering to the patient an oral dosage form comprising a defined core and a compression coating completely covering the core, wherein the core comprises the glucocorticosteroid active substance and further comprises at least one disintegrating agent that, upon exposure to aqueous media, provides a force to rupture the coating, wherein the compression coating comprises at least one excipient selected from wherein the compression coating lacks ingredients that swell and gel to such an extent that the compression coating acts as a diffusion barrier to the release of the active substance, and further provided that the compression coating contains substantially no natural synthetic gum, and wherein the oral dosage form has an in vitro dissolution profile, as determined using purified water, with a volume of 500 mL in a USP dissolution apparatus No. 2 (paddles) with stationary baskets and a stirring rate of 100 rpm, such that after 4 hours, no active substance is released from the oral dosage form; and by 5 hours, 100% of the active substance is released from the oral dosage form.