Compositions for the oral delivery of corticosteroids
An oral drug delivery composition includes a sustained release component which includes a corticosteroid drug and which is contained within a capsule that has been treated so that the sustained release component is predominately released from the capsule in the intestine following oral administration. A drug delivery composition for delivering a corticosteroid drug to the intestine also includes: (a) a sustained release component comprising a corticosteroid drug, an alkali-containing ethylcellulose material and an acid; and (b) a delayed release component which substantially prevents release of the sustained release component until the composition reaches the intestine following oral administration. The compositions of the invention are useful for treating inflammatory diseases of the gastrointestinal tract, such as Crohn's disease and ulcerative colitis, and for treating glomerulonephritis.
1. An oral drug delivery composition for providing sustained release of budesonide to a subject's intestine comprising:
(a) a sustained release component comprising a core comprising budesonide, wherein the core is coated with a layer comprising an acid, and the acid-containing layer is coated with a layer comprising an alkali-containing ethylcellulose; and
(b) a delayed release component which substantially prevents release of the sustained release component until the composition reaches the intestine following oral administration to the subject.
2. A composition according to claim 1 , wherein the alkali-containing ethylcellulose material is an ammonia-containing ethylcellulose material.
3. A composition according to claim 1 , wherein the layer comprising the alkali-containing ethylcellulose further comprises a water soluble material selected from mannitol, dextrose, sucrose, polyethylene glycol, hydroxypropyl methylcellulose, hydroxypropyl cellulose, methylcellulose, triacetin and polyvinyl alcohol.
4. A composition according to claim 1 , wherein the acid is an organic acid.
5. A composition according to claim 1 , wherein the sustained release component comprises coated drug particles, coated pellets, coated granules or coated tablets.
6. A composition according to claim 1 , wherein the sustained release component is contained within a capsule.
7. A composition according to claim 6 , wherein the capsule is a starch capsule.
8. A composition according to claim 6 , wherein the capsule is coated with the delayed release component (b).
9. A method for treating an inflammatory disease of a subject's gastrointestinal tract, the method comprising orally administering to the subject the composition of claim 1 .
10. A method for treating Crohn's disease of a subject, the method comprising orally administering to the subject the composition of claim 1 .
11. A method for treating ulcerative colitis of a subject, the method comprising orally administering to the subject the composition of claim 1 .
12. A method for treating glomerulonephritis of a subject, the method comprising orally administering to the subject the composition of claim 1 .
13. A method for sustained release of a corticosteroid drug administered to a subject, the method comprising orally administering to the subject a composition according to claim 1 .
14. A composition according to claim 1 in which the alkali-containing ethylcellulose is present in the sustained release component in an amount of from about 1% to about 10% by weight of the sustained release component.
15. A method according to claim 12 for the treatment of glomerulonephritis, which provides a duration of drug release of from about 2 to about 6 hours.