Pharmaceutical compositions
Methods and compositions are provided which comprise effective amounts of analgesic to treat a subject, including reducing or eliminating an adverse effect associated with the analgesic.
1. A solid oral pharmaceutical composition for treating pain, and reducing or preventing opioid-induced nausea or vomiting in a subject in need thereof, wherein the solid oral pharmaceutical composition comprises:
a first matrix that comprises an antiemetic, wherein the antiemetic is promethazine or a pharmaceutically acceptable salt thereof; and
a second matrix that comprises an opioid analgesic and a non-opioid analgesic, wherein the opioid analgesic is hydrocodone or a pharmaceutically acceptable salt thereof and is present in an amount of about 5 mg, about 7.5 mg, about 10 mg, about 15 mg, about 20 mg, or about 30 mg, wherein the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof and is present in an amount of about 200-600 mg,
wherein about 90% of the antiemetic is released in about 1 minute to about 20 minutes following contact of the solid oral pharmaceutical composition with a dissolution fluid as measured by a USP Apparatus 2 (Paddle Apparatus), wherein about 100% of the opioid analgesic is released in about 60 minutes following contact of the solid oral pharmaceutical composition with a dissolution fluid as measured by a USP Apparatus 2 (Paddle Apparatus),
wherein the solid oral pharmaceutical composition contains an effective amount of the opioid analgesic and the non-opioid analgesic to treat pain, wherein the solid oral pharmaceutical composition contains an effective amount of the antiemetic to reduce or prevent nausea associated with the opioid analgesic or vomiting associated with the opioid analgesic, and wherein the solid oral pharmaceutical composition is for administration at about every 4, 5, or 6 hours.
2. The solid oral pharmaceutical composition of claim 1 , wherein the pharmaceutically acceptable salt of the hydrocodone is hydrocodone bitartrate.
3. The solid oral pharmaceutical composition of claim 1 , wherein the hydrocodone or the pharmaceutically acceptable salt thereof is present in an amount of about 7.5 mg.
4. The solid oral pharmaceutical composition of claim 3 , wherein the pharmaceutically acceptable salt of the hydrocodone is hydrocodone bitartrate, and is present in an amount of about 7.5 mg.
5. The solid oral pharmaceutical composition of claim 1 , wherein the hydrocodone or the pharmaceutically acceptable salt thereof is present in an amount of about 5 mg or about 10 mg.
6. The solid oral pharmaceutical composition of claim 1 , wherein the promethazine or the pharmaceutically acceptable salt thereof is present in an amount of about 11-14 mg.
7. The solid oral pharmaceutical composition of claim 6 , wherein the promethazine or the pharmaceutically acceptable salt thereof is present in an amount of about 12.5 mg.
8. The solid oral pharmaceutical composition of claim 7 , wherein the pharmaceutically acceptable salt of the promethazine is promethazine hydrochloride, and is present in an amount of about 12.5 mg.
9. The solid oral pharmaceutical composition of claim 6 , wherein the promethazine or the pharmaceutically acceptable salt thereof is present in an amount of about11 mg.
10. The solid oral pharmaceutical composition of claim 1 , wherein the pharmaceutically acceptable salt of the promethazine is promethazine hydrochloride.
11. The solid oral pharmaceutical composition of claim 1 , wherein the acetaminophen or the pharmaceutically acceptable salt thereof is present in an amount of about 290-360 mg.
12. The solid oral pharmaceutical composition of claim 11 , wherein the acetaminophen or the pharmaceutically acceptable salt thereof is present in an amount of about 325 mg.
13. The solid oral pharmaceutical composition of claim 1 , wherein the promethazine or the pharmaceutically acceptable salt thereof is present in an amount of about 0.5 mg to about 60 mg.
14. The solid oral pharmaceutical composition of claim 13 , wherein the promethazine or a pharmaceutically acceptable salt thereof, and is present in an amount of about 25 mg or about 50 mg.
15. The solid oral pharmaceutical composition of claim 1 , wherein the first matrix is a layer and the second matrix is a layer.
16. The solid oral pharmaceutical composition of any one of claim 1 , 2 - 5 , 6 - 10 , 11 , 12 , 13 , 14 , or 15 , wherein the solid oral pharmaceutical composition is a tablet.
17. The solid oral pharmaceutical composition of claim 16 , wherein the tablet is a bi-layer tablet.
18. The solid oral pharmaceutical composition of claim 5 , wherein the pharmaceutically acceptable salt of the hydrocodone is hydrocodone bitartrate, and is present in an amount of about 5 mg or about 10 mg.
19. The solid oral pharmaceutical composition of claim 1 , wherein the solid oral pharmaceutical composition further comprises an opioid antagonist or an abuse deterrent agent.
20. The solid oral pharmaceutical composition of claim 1 , wherein about 30% to about 60% of the opioid analgesic is released in about 5 to 10 minutes following contact of the solid oral pharmaceutical composition with a dissolution fluid as measured by a USP Apparatus 2 (Paddle Apparatus).