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Claims for Patent: 9,040,085

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Claims for Patent: 9,040,085

Title:Delayed release tablet with defined core geometry
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.
Inventor(s): Vergnault; Guy (Kembs, FR), Grenier; Pascal (Kappelen, FR), Dragan; Christophe (Geispitzen, FR)
Assignee: Jagotec AG (Muttenz, CH)
Application Number:14/329,631
Patent Claims: 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 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.

2. The method according to claim 1, wherein the compression coating further comprises at least one excipient selected from cellulosic derivatives and polymers and polymethacrylic polymers.

3. The method according to claim 1, wherein the compression coating further comprises alkylcellulose.

4. The method according to claim 1, wherein the dosage form comprises 1 mg prednisone.

5. The method according to claim 1, wherein the dosage form comprises 5 mg prednisone.

6. 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.

7. The method according to claim 6, wherein the dosage form comprises 1 mg prednisone.

8. The method according to claim 6, wherein the dosage form comprises 5 mg prednisone.

9. 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.

10. The method according to claim 9, wherein the dosage form comprises 1 mg prednisone.

11. The method according to claim 9, wherein the dosage form comprises 5 mg prednisone.
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