Pharmaceutical compositions
Pharmaceutical compositions are provided which comprise effective amounts of analgesic to treat a subject, including to reduce or eliminate an adverse effect associated with the analgesic.
1. A solid oral pharmaceutical composition for treatment of pain, and reduction or prevention of nausea or vomiting associated with an opioid analgesic, comprising:
a layer formulated for immediate-release that comprises an antiemetic; and
a layer formulated for controlled-release that comprises an opioid analgesic and a non-opioid analgesic,
wherein the opioid analgesic, the non-opioid analgesic, and the antiemetic are present in a ratio by weight of (1 to 2):(40 to 45):(1 to 2), respectively, and
wherein the solid oral pharmaceutical composition provides an effective amount of the antiemetic to reduce or prevent nausea associated with the opioid analgesic or vomiting associated with the opioid analgesic in a subject in need thereof, and an effective amount of the opioid analgesic and the non-opioid analgesic to treat pain in the subject in need thereof.
2. The solid oral pharmaceutical composition of claim 1 , wherein the opioid analgesic is hydrocodone or a pharmaceutically acceptable salt thereof, or oxycodone or a pharmaceutically acceptable salt thereof.
3. The solid oral pharmaceutical composition of claim 2 , wherein the hydrocodone or the pharmaceutically acceptable salt thereof, or the oxycodone or the pharmaceutically acceptable salt thereof is present in an amount of 1-20 mg.
4. The solid oral pharmaceutical composition of claim 2 , wherein the opioid analgesic is hydrocodone or the pharmaceutically acceptable salt thereof, and is present in an amount of about 1-15 mg.
5. The solid oral pharmaceutical composition of claim 1 , wherein the opioid analgesic is hydrocodone or a pharmaceutically acceptable salt thereof, and is present in an amount of about 7.5 mg.
6. The solid oral pharmaceutical composition of claim 1 , wherein the opioid analgesic is hydrocodone or the pharmaceutically acceptable salt thereof, and is present in an amount of 5 mg.
7. The solid oral pharmaceutical composition of claim 1 , wherein the opioid analgesic is hydrocodone bitartrate and is present in an amount of about 7.5 mg.
8. The solid oral pharmaceutical composition of claim 1 , wherein the opioid analgesic is oxycodone or a pharmaceutically acceptable salt thereof, and is present in an amount of about 7.5 mg.
9. The solid oral pharmaceutical composition of claim 1 , wherein the opioid analgesic is oxycodone or a pharmaceutically acceptable salt thereof, and is present in an amount of 10 mg.
10. The solid oral pharmaceutical composition of any one of claims 1 , 2 , 3 , 4 , or 6 , wherein the opioid analgesic is hydrocodone bitartrate.
11. The solid oral pharmaceutical composition of any one of claims 1 , 2 , 3 , 8 or 9 , wherein the opioid analgesic is oxycodone hydrochloride.
12. The solid oral pharmaceutical composition of any one of claims 1 or 3 - 9 , wherein the antiemetic is promethazine or a pharmaceutically acceptable salt thereof.
13. The solid oral pharmaceutical composition of any one of claims 1 , or 3 - 9 , wherein the antiemetic is promethazine hydrochloride.
14. The solid oral pharmaceutical composition of any one of claims 1 or 2 , wherein the antiemetic is promethazine or a pharmaceutically acceptable salt thereof, and is present in an amount of about 0.5-60 mg.
15. The solid oral pharmaceutical composition of any one of claims 1 - 5 , 7 or 8 , wherein the antiemetic is promethazine or a pharmaceutically acceptable salt thereof, and is present in an amount of about 12.5 mg.
16. The solid oral pharmaceutical composition of claim 1 , wherein the antiemetic is promethazine and is present in an amount of 11 mg.
17. The solid oral pharmaceutical composition of claim 15 , wherein the antiemetic is promethazine hydrochloride and is present in an amount of about 12.5 mg.
18. The solid oral pharmaceutical composition of any one of claims 1 - 9 , wherein the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof.
19. The solid oral pharmaceutical composition of any one of claims 1 - 9 , wherein the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof and is present in an amount of about 200-600 mg.
20. The solid oral pharmaceutical composition of any one of claims 1 - 5 , 7 or 8 , wherein the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof, and is present in an amount of about 325 mg.
21. The solid oral pharmaceutical composition of claim 1 , wherein the opioid analgesic is hydrocodone or a pharmaceutically acceptable salt thereof, the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof, and the antiemetic is promethazine or a pharmaceutically acceptable salt thereof, which are present in a ratio by weight of about 1:43:1.7, respectively.
22. The solid oral pharmaceutical composition of claim 1 , wherein the opioid analgesic is hydrocodone or a pharmaceutically acceptable salt thereof, the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof, and the antiemetic is promethazine or a pharmaceutically acceptable salt thereof, which are present in a ratio by weight of 1:43.33:1.67, respectively.
23. The solid oral pharmaceutical composition of claim 1 , wherein the opioid analgesic is hydrocodone or a pharmaceutically acceptable salt thereof, the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof, and the antiemetic is promethazine or a pharmaceutically acceptable salt thereof, which are present in an amount of 6-8 mg, 200-350 mg, and 5-13 mg, respectively.
24. The solid oral pharmaceutical composition of claim 1 , wherein the opioid analgesic is hydrocodone or a pharmaceutically acceptable salt thereof, the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof, and the antiemetic is promethazine or a pharmaceutically acceptable salt thereof, which are present in an amount of about 7.5 mg, about 325 mg, and about 12.5 mg, respectively.
25. The solid oral pharmaceutical composition of claim 1 , wherein the opioid analgesic oxycodone or a pharmaceutically acceptable salt thereof, the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof, and the antiemetic is promethazine or a pharmaceutically acceptable salt thereof, which are present in an amount of about 7.5 mg, about 325 mg, and about 12.5 mg, respectively.
26. The solid oral pharmaceutical composition of any one of claims 1 - 9 , 21 - 24 or 25 , wherein the solid oral pharmaceutical composition is a tablet.
27. The solid oral pharmaceutical composition of claim 26 , wherein the tablet is a bi-layer tablet.
28. The solid oral pharmaceutical composition of claim 1 , wherein the solid oral pharmaceutical composition further comprises an opioid antagonist or an additional agent for reducing abuse and/or diversion.