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 dosage form, comprising,
a first matrix, wherein the first matrix comprises effective amounts of an opioid analgesic and a non-opioid analgesic to treat pain, and wherein the opioid analgesic is hydrocodone or a pharmaceutically acceptable salt thereof, and
a second matrix, wherein the second matrix comprises an effective amount of an antiemetic to reduce or prevent nausea or vomiting associated with the opioid analgesic, and wherein the antiemetic is promethazine or a pharmaceutically acceptable salt thereof.
2 - 22 . (canceled)
23 . The solid oral pharmaceutical dosage form of claim 1 , wherein following administration of the solid oral pharmaceutical dosage form to a subject in need thereof: (i) the antiemetic is released at a faster rate than the opioid analgesic within about 1 hour, and (ii) the opioid analgesic and the antiemetic are released within about 1 hour.
24 . The solid oral pharmaceutical dosage form of claim 1 , wherein the solid oral pharmaceutical dosage form is a tablet, a bead, or a powder.
25 . The solid oral pharmaceutical dosage form of claim 1 , wherein the solid oral pharmaceutical dosage form is oral disintegrating.
26 . The solid oral pharmaceutical dosage form of claim 1 , wherein the solid oral pharmaceutical dosage form is chewable.
27 . The solid oral pharmaceutical dosage form of claim 1 , wherein the first matrix or the second matrix is encapsulated by a capsule.
28 . The solid oral pharmaceutical dosage form of claim 1 , wherein the non-opioid analgesic is a non-steroidal anti-inflammatory drug (NSAID), an arylalkanoic acid, a profen, a fenamic acid, an oxicam, or a pyrazolidine.
29 . The solid oral pharmaceutical dosage form of claim 1 , wherein the non-opioid analgesic is aspirin, amoxiprin, benorilate, choline magnesium salicylate, diflunisal, faislamine, methyl salicylate, magnesium salicylate, diclofenac, aceclofenac, acemetacin, bromfenac, etodolac, indometacin, nabumetone, sulindac, tolmetin, ibuprofen, carprofen, fenbuprofen, flubiprofen, ketaprofen, ketorolac, loxoprofen, naproxen, suprofen, mefenamic acid, meclofenamic acid, piroxicam, lomoxicam, meloxicam, tenoxicam, phenylbutazone, azapropazone, metamizole, oxyphenbutazone, sulfinprazone, tramadol, or a pharmaceutically acceptable salt thereof.
30 . The solid oral pharmaceutical dosage form of claim 1 , wherein the solid oral pharmaceutical dosage form further comprises an agent for reducing abuse and/or diversion.
31 . The solid oral pharmaceutical dosage form of claim 30 , wherein the agent for reducing abuse and/or diversion is an opioid antagonist.
32 . The solid oral pharmaceutical dosage form of claim 31 , wherein the opioid antagonist is in a matrix formulated for immediate release, quick release, controlled release, sustained release, or extended release.
33 . The solid oral pharmaceutical dosage form of claim 31 , wherein the opioid antagonist is nalmefene, naloxone, naltrexone, or a pharmaceutically acceptable salt thereof.
34 . The solid oral pharmaceutical dosage form of claim 1 , wherein the opioid analgesic is hydrocodone bitartrate.
35 . The solid oral pharmaceutical dosage form of claim 1 , wherein the antiemetic is promethazine hydrochloride.
36 . The solid oral pharmaceutical dosage form of claim 1 , wherein the non-opioid analgesic is acetaminophen, ibuprofen, ketaprofen, naproxen, aspirin, or a pharmaceutically acceptable salt thereof.
37 . The solid oral pharmaceutical dosage form of claim 1 , wherein the non-opioid analgesic is acetaminophen or a pharmaceutically acceptable salt thereof.
38 . The solid oral pharmaceutical dosage form of claim 1 , wherein the solid oral pharmaceutical dosage form is formulated for administration about every 4, 5, or 6 hours.
39 . The solid oral pharmaceutical dosage form of claim 1 , wherein the opioid analgesic, the non-opioid analgesic, and the antiemetic are the only three active agents in the solid oral pharmaceutical dosage form.
40 . A method for treating pain in a subject, comprising administering to the subject the solid oral pharmaceutical dosage form of claim 1 .
41 . A method for alleviating or reducing nausea or vomiting associated with administration of an opioid analgesic to a subject, comprising administering to the subject the solid oral pharmaceutical dosage form of claim 1 .