Delayed release tablet with defined core geometry
AssigneeJagotec AG
InventorsGuy Vergnault, Pascal Grenier, Christophe Dragan
Life of this patent
Estimating the term…
Abstract
A tablet comprising a core containing an active agent, and a coating, the core being disposed within the coating such that the coating has a thickness about a longitudinal axis (X-Y) of about 4.85 to 4.95 mm. The position of the core within the coating dictating that the active agent is released rapidly after a lag time during which time no active agent is released.
Claims11
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
- fatty acids or their esters or salts;
- long chain fatty alcohols;
- polyoxyethylene alkyl ethers;
- polyoxyethylene stearates;
- sugar esters;
- lauroyl macrogol-32 glyceryl;
- and
- stearoyl macrogol-32 glyceryl,
- 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.
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 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
- fatty acids or their esters or salts;
- long chain fatty alcohols;
- polyoxyethylene alkyl ethers;
- polyoxyethylene stearates;
- sugar esters;
- lauroyl macrogol-32 glyceryl;
- and
- stearoyl macrogol-32 glyceryl,
- 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 or synthetic gum, and
- wherein the compression coating ruptures upon immersion in an aqueous medium after a period of time between about 2 to about 6 hours to release the glucocorticosteroid active substance.
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 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
- fatty acids or their esters or salts;
- long chain fatty alcohols;
- polyoxyethylene alkyl ethers;
- polyoxyethylene stearates;
- sugar esters;
- lauroyl macrogol-32 glyceryl;
- and
- stearoyl macrogol-32 glyceryl,
- 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 or synthetic gum, and
- wherein the oral dosage form releases not more than 10% of the active substance prior to expiry of a lag time;
- the oral dosage form releases substantially all of the active substance within about 1 hour after the expiry of the lag time;
- and the lag time is a time between 2 to 6 hours after administration of the oral dosage form to the patient.
Dependencies are inferred from the claim text.