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US 9,433,625 B2Granted
Pharmaceutical compositions for treating or preventing pain
AssigneeLocl Pharma, Inc.
InventorsPaul Bosse, John Ameling, Bernard Schachtel, Ray Takigiku
Life of this patent
Estimating the term…
Abstract
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.
Claims75
A pharmaceutical composition in the form of a tablet comprising two layers, wherein the tablet comprises
- (1) a layer formulated for immediate release comprising:
- (a) 5 mgs to 30 mgs of an antiemetic;
- (b) about 75 mgs to about 150 mgs of silicified microcrystalline cellulose;
- (c) about 10 mgs to about 20 mgs of croscarmellose sodium;
- and
- (d) about 0.5 mgs to about 2 mgs of magnesium stearate;
- and
- (2) a layer formulated for controlled release comprising:
- (a) about 200 mgs to about 1000 mgs of a non-opioid analgesic;
- (b) about 0.5 mgs to about 20 mgs of an opioid analgesic;
- (c) about 75 mgs to about 250 mgs of silicified microcrystalline cellulose;
- (d) about 10 mgs to about 40 mgs of hydroxypropyl methylcellulose;
- (e) about 0.5 mgs to 5 mgs of magnesium stearate;
- and
- (f) about 0.5 mgs to about 5 mgs of stearic acid.
12 more elements
A method of treating or preventing pain in a subject in need thereof, comprising:
- orally administering to a subject in need thereof in a dosing interval of 4 to 6 hours, as needed, a pharmaceutical composition in the form of a tablet comprising two layers, wherein the tablet comprises:
- (1) a layer formulated for immediate release comprising:
- (a) 5 mgs to 30 mgs of an antiemetic;
- (b) about 75 mgs to about 150 mgs of silicified microcrystalline cellulose;
- (c) about 10 mgs to about 20 mgs of croscarmellose sodium;
- and
- (d) about 0.5 mgs to about 2 mgs of magnesium stearate;
- and
- (2) a layer formulated for controlled release comprising:
- (a) about 200 mgs to about 1000 mgs of a non-opioid analgesic;
- (b) about 0.5 mgs to about 20 mgs of an opioid analgesic;
- (c) about 75 mgs to about 250 mgs of silicified microcrystalline cellulose;
- (d) about 10 mgs to about 40 mgs of hydroxypropyl methylcellulose;
- (e) about 0.50 mgs to 5 mgs of magnesium stearate;
- and
- (f) about 0.5 mgs to about 5 mgs of stearic acid,
- wherein the pharmaceutical composition provides an effective amount of the opioid analgesic and the non-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.
14 more elements
Dependencies are inferred from the claim text.