Pharmaceutical compositions
First Claim
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1. A solid pharmaceutical composition comprising two layers and containing a single analgesic for the treatment of pain, comprising:
- a) a first layer comprising an opioid analgesic effective to treat pain, wherein the opioid analgesic is oxycodone or a pharmaceutically acceptable salt thereof, wherein the oxycodone or the pharmaceutically acceptable salt thereof 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, and wherein about 90% to about 100% of the opioid analgesic is released in about 60 minutes following contact of the solid pharmaceutical composition with a dissolution fluid as measured with a USP Apparatus 2 (Paddle Apparatus); and
b) a second layer comprising an antiemetic effective to reduce nausea or vomiting associated with the opioid analgesic, wherein the antiemetic is promethazine or a pharmaceutically acceptable salt thereof, and wherein about 90% of the antiemetic is released in about 1 minute to about 20 minutes following contact of the solid pharmaceutical composition with a dissolution fluid as measured with the USP Apparatus 2 (Paddle Apparatus).
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Abstract
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.
275 Citations
36 Claims
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1. A solid pharmaceutical composition comprising two layers and containing a single analgesic for the treatment of pain, comprising:
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a) a first layer comprising an opioid analgesic effective to treat pain, wherein the opioid analgesic is oxycodone or a pharmaceutically acceptable salt thereof, wherein the oxycodone or the pharmaceutically acceptable salt thereof 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, and wherein about 90% to about 100% of the opioid analgesic is released in about 60 minutes following contact of the solid pharmaceutical composition with a dissolution fluid as measured with a USP Apparatus 2 (Paddle Apparatus); and b) a second layer comprising an antiemetic effective to reduce nausea or vomiting associated with the opioid analgesic, wherein the antiemetic is promethazine or a pharmaceutically acceptable salt thereof, and wherein about 90% of the antiemetic is released in about 1 minute to about 20 minutes following contact of the solid pharmaceutical composition with a dissolution fluid as measured with the USP Apparatus 2 (Paddle Apparatus). - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36)
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Specification