Opiod formulations having extended controlled release

Details Opiod formulations having extended controlled release Opiod formulations having extended controlled release

A - Human Necessities

61

K

A61K 31/485 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/22 (2006.01) A61K 9/28 (2006.01) A61K 9/50 (2006.01) A61K 9/56 (2006.01) A61K 31/522 (2006.01)

Patent

CA 2126611

Solid controlled-release oral dosage forms comprising a therapeutically effective amount of an opioid analgesic or a salt thereof which provide an extended duration of pain relief of about 24 hours, have a dissolution rate in-vitro of the dosage form, when measured by the USP Paddle Method of 100 rpm in 900 ml aqueous buffer at 37°C from about 12.5% to about 42.5% (by weight) active agent released after 1 hour, from about 25% to about 55% (by weight) active agent released after 2 hours, from about 45% to about 75% (by weight) opioid analgesic released after 4 hours and greater than about 60% (by weight) opioid analgesic released after 8 hours, the in-vitro release rate being substantially independent of pH and chosen such that the peak plasma level of active agent obtained in-vivo between about 2 and about 8 hours after administration of the dosage form.

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