Opioid formulations having extended controlled released

Details Opioid formulations having extended controlled released Opioid formulations having extended controlled released

1995-11-27

1999-09-28

Harrison, Robert H.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

424458, 424461, 424462, 424480, 424482, 424495, 424497, 514282, A61K 914, A61K 916, A61K 936, A61K 962

Patent

active

059584599

ABSTRACT:
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.degree. 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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