Controlled release hydromorphone composition

Details Controlled release hydromorphone composition Controlled release hydromorphone composition

A - Human Necessities

61

K

167/227

A61K 31/485 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/22 (2006.01) A61K 9/50 (2006.01) A61K 9/52 (2006.01)

Patent

CA 1297025

ABSTRACT A solid controlled release, oral dosage form, the dosage form comprising a therapeutically effective amount of hydromorphone or a salt thereof in a matrix wherein the dissolution rate in vitro of the dosage form, when measured by the USP Paddle Method at 100rpm in 900ml aqueous buffer (pH between 1.6 and 7.2) at 37°C is between 12.5% and 42.5% (by weight) hydromorphone released after l hour, between 25% and 55% (by weight hydromorphone released after 2 hours, between 45% and 75% (by weight) hydromorphone released after 4 hours and between 55% and 85% by weight) hydromorphone released after 6 hours, the in vitro release rate being independent of pH between pH 1.6 and 7.2 and chosen such that the peak plasma level of hydromorphone obtained in vivo occurs between 2 and 4 hours after administration of the dosage form.

550717

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