Delayed release tablet with defined core geometry
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.
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,
wherein the compression coating comprises at least one material chosen 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
and further provided that the compression coating contains substantially no natural or synthetic gum;
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
wherein the compression coating is sufficiently porous to permit the ingress of aqueous media to the core at a rate to ensure release of the glucocorticosteroid active substance after a period of time between 2 to 6 hours wherein said period of time is followed by rupture of the compression coating.
2. The method according to claim 1 , wherein the dosage form comprises 1 mg prednisone.
3. The method according to claim 1 , wherein the dosage form comprises 5 mg prednisone.
4. The method according to claim 1 , wherein the compression coating does not include a disintegrating agent.
5. The method according to claim 1 , wherein the dosage form releases at least 80% of the glucocorticosteroid active substance after 4.5 hours.
6. The method according to claim 1 , wherein the dosage form releases about 100% of the glucocorticosteroid active substance after 5 hours.
7. The method according to claim 2 , wherein the coating does not include a disintegrating agent.
8. The method according to claim 2 , wherein the dosage form releases at least 80% of the glucocorticosteroid active substance after 4.5 hours.
9. The method according to claim 2 , wherein the dosage form releases about 100% of the glucocorticosteroid active substance after 5 hours.
10. The method according to claim 3 , wherein the coating does not include a disintegrating agent.
11. The method according to claim 3 , wherein the dosage form releases at least 80% of the glucocorticosteroid active substance after 4.5 hours.
12. The method according to claim 3 , wherein the dosage form releases about 100% of the glucocorticosteroid active substance after 5 hours.
13. The method according to claim 1 , wherein the compression coating is coated with an aesthetic coating.
14. The method according to claim 1 , wherein the compression coating comprises 40 to 75% of a calcium phosphate salt, by weight of the coating.
15. The method according to claim 1 , wherein the compression coating comprises about 5 to 85% glyceryl behenate, by weight of the coating.
16. The method according to claim 1 , wherein the compression coating comprises from 30 to 50% glyceryl behenate, by weight of the coating.
17. The method according to claim 1 , wherein said compression coating ruptures to form two hemispheres of coating material that may remain conjoined.
18. The method according to claim 1 , wherein upon the ingress of aqueous media to the core, the core swells or effervesces.