Claims
- 1. A multilayer dosage form for oral administration comprising:
at least one layer comprising an opioid analgesic, a non-opioid analgesic, and a sustained release mechanism; and at least another layer comprising an opioid analgesic and a non-opioid analgesic.
- 2. The dosage form of claim 1, wherein the dissolution profile for each of the opioid analgesic and non-opioid analgesic is between about 30% and about 65% released in about 1 hour and between about 55% and about 85% released in about 4 hours.
- 3. The dosage form of claim 2, wherein said dosage form is suitable for twice a day or three times a day administration.
- 4. The dosage form of claim 1, wherein the dissolution profile for each of the opioid analgesic and non-opioid analgesic is between about 15% and about 45% released in about 1 hour and between about 35% and about 65% released in about 4 hours.
- 5. The dosage form of claim 4, wherein said dosage from is suitable for once a day administration.
- 6. The dosage form of any of claims 1-3, wherein the at least one layer comprises oxycodone, APAP, and a sustained release mechanism, and the at least one additional layer comprises oxycodone and APAP.
- 7. The dosage form of any of claims 1-3, wherein the at least one layer comprises hydrocodone, APAP, and a sustained release mechanism, and the at least one additional layer comprises hydrocodone and APAP.
- 8. A dosage form of any of claims 1-3, wherein the at least one layer comprises oxymorphone, APAP, and a sustained release mechanism, and the at least one additional layer comprises oxymorphone and APAP.
- 9. The dosage form of claims 1, 4, or 5, wherein the at least one layer comprises oxycodone, APAP, and a sustained release mechanism, and the at least one additional layer comprises oxycodone and APAP.
- 10. The dosage form of claims 1, 4, or 5, wherein the at least one layer comprises hydrocodone, APAP, and a sustained release mechanism, and the at least one additional layer comprises hydrocodone and APAP.
- 11. A dosage form of claims 1, 4, or 5, wherein the at least one layer comprises oxymorphone, APAP, and a sustained release mechanism, and the at least one additional layer comprises oxymorphone and APAP.
- 12. A method of making a multilayer oral dosage form comprising:
forming at least one layer comprising an opioid analgesic, a non-opioid analgesic, and a sustained release mechanism and compressing it; and, forming at least one additional layer comprising an opioid analgesic and a non-opioid analgesic and compressing it over the compressed first layer, or vice versa.
- 13. The method of claim 12, wherein the opioid analgesic is selected from the group consisting of oxycodone, hydrocodone and oxymorphone.
- 14. The method of claim 12 or 13, wherein the non-opioid analgesic is APAP.
- 15. A dosage form for oral administration comprising:
a sustained release core layer comprising an opioid analgesic, a non-opioid analgesic, and a sustained release mechanism; and, a coating layer comprising an opioid analgesic and a non-opioid analgesic.
- 16. The dosage form of claim 15, wherein the dissolution profile for each of the opioid analgesic and non-opioid analgesic is between about 30% and about 65% released in about 1 hour and between about 55% and about 85% released in about 4 hours.
- 17. The dosage form of claim 15, wherein said dosage form is suitable for twice a day or three times a day administration.
- 18. The dosage form of claim 15, wherein the dissolution profile for each of the opioid analgesic and non-opioid analgesic is between about 15% and about 45% released in about 1 hour and between about 35% and about 65% released in about 4 hours.
- 19. The dosage form of claim 18, wherein said dosage from is suitable for once a day administration.
- 20. The dosage form of any of claims 15-17, wherein the sustained release core comprises oxycodone, APAP, and a sustained release mechanism, and the IR coating layer comprises oxycodone and APAP.
- 21. The dosage form of any of claims 15-17, wherein the sustained release core comprises hydrocodone, APAP, and a sustained release mechanism, and the IR coating layer comprises hydrocodone and APAP.
- 22. The dosage form of any of claims 15-17, wherein the sustained release core comprises oxymorphone, APAP, and a sustained release mechanism, and the IR coating layer comprises oxymorphone and APAP.
- 23. The dosage form of claims 15, 18, or 19, wherein the sustained release core comprises oxycodone, APAP, and a sustained release mechanism, and the IR coating layer comprises oxycodone and APAP.
- 24. The dosage form of claims 15, 18, or 19, wherein the sustained release core comprises hydrocodone, APAP, and a sustained release mechanism, and the IR coating layer comprises hydrocodone and APAP.
- 25. The dosage form of claims 15, 18, or 19, wherein the sustained release core comprises oxymorphone, APAP, and a sustained release mechanism, and the IR coating layer comprises oxymorphone and APAP.
- 26. A method of making an oral dosage form comprising:
forming a core tablet comprising an opioid analgesic, a non-opioid analgesic, and a sustained release mechanism and compressing it; and, forming a coating over the core tablet comprising an opioid analgesic and a non opioid analgesic with an immediate release mechanism.
- 27. The method of claim 26, wherein the opioid analgesic is selected from the group consisting of oxycodone, hydromorphone and oxymorphone.
- 28. The method of claim 26 or 27, wherein the non-opioid analgesic comprises APAP.
- 29. A method of treating pain comprising administering the dosage form of any of claims 1-11 and 15-25 to a human or animal.
Parent Case Info
[0001] This application claims priority to U.S. Provisional Application Serial No. 60/322,667, filed Sep. 17, 2001 and U.S. Provisional Application Serial No. 60/323,546, filed Sep. 19, 2001, the specifications of which are incorporated by reference into this application in their entirety.
Provisional Applications (2)
|
Number |
Date |
Country |
|
60322667 |
|
US |
|
60323546 |
Sep 2001 |
US |