Controlled release hydromorphone composition

Details Controlled release hydromorphone composition Controlled release hydromorphone composition

1987-10-26

1989-07-04

Dixon, Jr., William R.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

424484, 424488, 424493, 424494, 424495, 424498, A61K 936

Patent

active

048449091

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 100 rpm in 900 ml aqueous buffer (pH between 1.6 and 7.2) at 37.degree. C. is between 12.5% and 42.5% (by weight) hydromorphone released after 1 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% ad 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.

REFERENCES:
patent: 4320759 (1982-03-01), Theeuwes
patent: 4576604 (1986-03-01), Guittard et al.
patent: 4599342 (1986-07-01), LaHann
patent: 4622218 (1986-11-01), Bodor
Chemical Abstracts, 108(4): 26895u.

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