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 .- 22 . (canceled)
23 . A composition comprising a controlled release opioid analgesic, an immediate release agent that reduces or eliminates an adverse effect of the controlled release opioid analgesic, and optionally a controlled release non-opioid analgesic.
24 . The composition of claim 23 , comprising a single oral dosage form.
25 . The composition of claim 24 , wherein the single oral dosage form is a liquid composition.
26 . The composition of claim 25 , wherein the liquid composition is a liquid tannate, a suspension, a solution, or a syrup.
27 . The composition of claim 24 , wherein the single oral dosage form is a solid composition.
28 . The composition of claim 27 , wherein the solid composition is a tablet, a capsule, a bead, or a powder.
29 . The composition of claim 28 , wherein the tablet is a tannate tablet.
30 . The composition of claim 28 , wherein the tablet is oral disintegrating.
31 . The composition of claim 28 , wherein the tablet is a multi-layer tablet.
32 . The composition of claim 28 , wherein the tablet is a bi-layer tablet.
33 . The composition of claim 28 , wherein the capsule is a soft capsule or hard capsule.
34 . The composition of claim 33 , wherein the capsule comprises gelatin.
35 . The composition of claim 27 , wherein the solid composition is soft and chewable.
36 . The composition of claim 27 , wherein the solid composition is hard and oral disintegrating.
37 . The composition of claim 23 , wherein the immediate release agent is an antiemetic or an antihistamine.
38 . The composition of claim 23 , wherein the immediate release agent is a 5-HT 3 receptor antagonist, a dopamine antagonist, a cannabinoid, a benzodiazepine, or an anticholinergic.
39 . The composition of claim 37 , wherein the antiemetic or antihistamine is promethazine, dolasetron, granisetron, ondansetron, tropisetron, palonosetron, domperidone, droperidol, haloperidol, chlorpromazine, prochloperazine, metoclopramide, alizapride, cyclizine, diphenhydramine, dimenhydrinate, meclizine, hydroxyzine, cannabis, dronabinol, nabilone, midazolam, lorazepam, hyoscine, dexamethasone, trimethobenzamide, emetrol, propofol, or a pharmaceutically acceptable salt thereof.
40 . The composition of claim 23 , wherein the controlled release opioid analgesic is hydrocodone, oxycodone, morphine, diamorphine, codeine, pethidine, alfentanil, buprenorphine, butorphanol, codeine, dezocine, fentanyl, hydromorphone, levomethadyl acetate, levorphanol, meperidine, methadone, morphine sulfate, nalbuphine, oxycodone, oxymorphone, pentazocine, propoxyphene, remifentanil, sufentanil, tramadol or a pharmaceutically acceptable salt thereof.
41 . The composition of claim 23 , wherein the controlled release non-opioid analgesic is a non-steroidal anti-inflammatory drug (NSAID), an arylalkanoic acid, a profen, a fenamic acid, an oxicam, a pyrazolidine, or a synthetic drug having narcotic properties.
42 . The composition of claim 23 , wherein the controlled release 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.
43 . The composition of claim 23 , further comprising an agent for reducing abuse and/or diversion.
44 . The composition of claim 43 , wherein the agent for reducing abuse and/or diversion is an opioid antagonist.
45 . The composition of claim 44 , wherein the opioid antagonist is formulated for immediate release, quick release, controlled release, sustained release, or extended release.
46 . The composition of claim 44 , wherein the opioid antagonist is nalmefene, naloxone, naltrexone, or a pharmaceutically acceptable salt thereof.
47 . The composition of claim 23 , wherein about 90% of the immediate release agent is released in about 1 minute to about 20 minutes following administration and about 100% of the immediate release agent is released within about 1 hour following administration.
48 . The composition of claim 23 , wherein the controlled release opioid analgesic is released within about 20 minutes to about 180 minutes following administration.
49 . The composition of claim 23 , comprising the immediate release agent, the controlled release non-opioid analgesic, and the controlled release opioid analgesic in a mass ratio of about (1 to 2):(40 to 45):(1 to 2).
50 . The composition of claim 23 , comprising the immediate release agent, the controlled release non-opioid analgesic, and the controlled release opioid analgesic in a mass ratio of about (1.67):(43.33):(1).
51 . A method of treating pain in a subject, comprising administering to the subject the composition of claim 23 .
52 . A method of alleviating an adverse effect associated with administration of an opioid analgesic to a subject, the method comprising administering to the subject the composition of claim 23 .
53 . The method of claim 52 , wherein the adverse effect is nausea or vomiting.
54 . The method of claim 52 , wherein the adverse effect is constipation, gastric upset, skin rash, swelling, unusual bleeding or bruising, or abdominal pain.