Pharmaceutical compositions for treating or preventing pain
Methods and compositions are provided which comprise effective amounts of one or more analgesics, such as hydrocodone or acetaminophen, and an antiemetic, such as promethazine, to treat or prevent pain in a subject, and to reduce or prevent an adverse effect associated with the analgesics.
1. A solid oral pharmaceutical composition, wherein the solid oral pharmaceutical composition comprises:
(1) a first layer that comprises:
(a) 0.5 mg to 30 mg of an antiemetic;
(b) 75 mg to 150 mg of silicified microcrystalline cellulose;
(c) 5 mg to 20 mg of croscarmellose sodium; and
(d) 0.2 mg to 5 mg of magnesium stearate; and
(2) a second layer that comprises:
(a) 1 mg to 100 mg of an opioid analgesic;
(b) 100 mg to 250 mg of silicified microcrystalline cellulose;
(c) 5 mg to 30 mg of hydroxy methyl propyl cellulose;
(d) 0.5 mg to 5 mg of magnesium stearate; and
(e) 0.5 mg to 10 mg of stearic acid.
2. The solid oral pharmaceutical composition of claim 1 , wherein the opioid analgesic is present in an amount of about 1.5 mg, about 2.5 mg, about 5 mg, about 7.5 mg, about 10 mg, about 12.5 mg, about 15 mg, about 17.5 mg, about 20 mg, about 25 mg, about 30 mg, about 40 mg, or about 50 mg.
3. The solid oral pharmaceutical composition of claim 1 , wherein at least two antiemetics are present in the first layer.
4. The solid oral pharmaceutical composition of claim 1 , wherein the antiemetic comprises promethazine or a pharmaceutically acceptable salt thereof, ondansetron or a pharmaceutically acceptable salt thereof, or a combination thereof.
5. The solid oral pharmaceutical composition of claim 4 , wherein the antiemetic comprises the promethazine or the pharmaceutically acceptable salt thereof.
6. The solid oral pharmaceutical composition of claim 4 , wherein the antiemetic comprises the pharmaceutically acceptable salt of promethazine that is promethazine hydrochloride.
7. The solid oral pharmaceutical composition of claim 4 , wherein the antiemetic comprises 5 mg to 20 mg of the promethazine or the pharmaceutically acceptable salt thereof.
8. The solid oral pharmaceutical composition of claim 4 , wherein the antiemetic comprises 10 mg to 15 mg of the promethazine or the pharmaceutically acceptable salt thereof.
9. The solid oral pharmaceutical composition of claim 4 , wherein the antiemetic comprises about 12.5 mg of the promethazine or the pharmaceutically acceptable salt thereof.
10. The solid oral pharmaceutical composition of claim 4 , wherein the antiemetic comprises about 11 mg of the promethazine.
11. The solid oral pharmaceutical composition of claim 1 , wherein the opioid analgesic comprises oxycodone or a pharmaceutically acceptable salt thereof.
12. The solid oral pharmaceutical composition of claim 1 , wherein the opioid analgesic comprises hydrocodone or a pharmaceutically acceptable salt thereof.
13. The solid oral pharmaceutical composition of claim 12 , wherein the hydrocodone or the pharmaceutically acceptable salt thereof is present in an amount from 2 mg to 15 mg.
14. The solid oral pharmaceutical composition of claim 1 , wherein: the antiemetic is promethazine or a pharmaceutically acceptable salt thereof; and the opioid analgesic is oxycodone or a pharmaceutically acceptable salt thereof.
15. The solid oral pharmaceutical composition of claim 14 , wherein: the antiemetic is the pharmaceutically acceptable salt of promethazine that is promethazine hydrochloride present in an amount of about 12.5 mg; and the opioid analgesic is the pharmaceutically acceptable salt of oxycodone that is oxycodone hydrochloride present in an amount of about 5 mg.
16. The solid oral pharmaceutical composition of claim 1 , wherein the second layer further comprises 200 mg to 1000 mg of a non-opioid analgesic.
17. The solid oral pharmaceutical composition of claim 16 , wherein the non-opioid analgesic comprises acetaminophen or a pharmaceutically acceptable salt thereof.
18. The solid oral pharmaceutical composition of claim 1 , wherein the solid oral pharmaceutical composition further comprises an effective amount of an abuse deterrent agent.
19. A method for treating or preventing pain, and reducing or preventing an adverse effect associated with an opioid analgesic, comprising administering to a subject in need thereof the solid oral pharmaceutical composition of claim 1 , wherein the solid oral pharmaceutical composition provides an effective amount of the opioid analgesic to treat or prevent pain in the subject in need thereof, and an effective amount of the antiemetic to reduce or prevent an adverse effect associated with the opioid analgesic in the subject in need thereof.
20. The method of claim 19 , wherein the administration to the subject in need thereof occurs at every 4 to 6 hours.
21. The method of claim 19 , wherein the pain is moderate to severe pain.