摘要:
A solid, controlled release, oral dosage form, the dosage form comprising an analgesically effective amount of an opioid analgesic or a salt thereof, coated with a controlled-release coating or in a controlled-release matrix, wherein the dissolution rate in-vitro of the dosage form, when measured by the USP Paddle Method at 100 rpm at 900 ml aqueous buffer (pH between 1.6 and 7.2) at 37° C is from about 12.5% to about 42.5% (by wt) opioid released after 1 hour, from about 25% to about 65% (by wt) opioid released after 2 hours, from about 45% to about 85% (by wt) opioid released after 4 hours and greater than 60% (by wt) opioid released after 8 hours, the in-vitro release rate being substantially independent of pH and chosen such that the peak plasma level of said opioid obtained in-vivo occurs from about 2 to about 6 hours after administration of the dosage form.
摘要:
Disclosed in certain embodiments is a dosage form comprising a plurality of extruded particles comprising an adverse agent or antagonist and a layer disposed about the particles.
摘要:
The invention concerns controlled release oxycodone dosage forms comprising a multiparticulate system substrate comprising an effective amount of oxycodone salt, the substrate being coated with an aqueous dispersion of at least one hydrophobic polymer, whereby the coating provides controlled release and the release is further influenced by the addition of at least one release-modifying agent, whereby the dosage forms comprise the cured, coated substrate and provide a therapeutic effect for at least 12 hours when administered to a patient.
摘要:
Bioavailable sustained release oral opioid analgesic dosage forms, comprising a plurality of multiparticulates produced via melt extrusion techniques are disclosed.
摘要:
A sustained release oral analgesic dosage form, comprising a combination of a pharmaceutical extrudate in the form of multiparticulates including 5 mg to 400 mg oxycodone or a salt thereof dispersed in a matrix and a pharmaceutical extrudate in the form of multiparticulates including a mu-antagonist dispersed in a matrix.
摘要:
Disclosed in certain embodiments is a dosage form comprising a plurality of extruded particles comprising an adverse agent or antagonist and a layer disposed about the particles.
摘要:
sustained release oral solid dosage forms of opioid analgesics are provided as multiparticulate systems which are bioavailable and which provide effective blood levels of the opioid analgesic for at least about 24 hours. A unit dose of the opioid analgesic contains a plurality of substrates including the opioid analgesic in sustained release form. The substrates have a diameter from about 0.1 mm to about 3 mm.
摘要:
The invention concerns controlled release oxycodone dosage forms comprising a multiparticulate system substrate comprising an amount of an oxycodone salt, the substrate being coated with an aqueous dispersion of at least one hydrophobic polymer, whereby the coating provides controlled release, the substrate including an additional dose of an oxycodone salt included in either the controlled release coating or in an additional overcoating coated on the outer surface of the controlled release coating, whereby the dosage forms, comprising the cured, coated substrate, comprise an effective amount of an oxycodone salt and provide a therapeutic effect for at least 12 hours when administered to a patient.
摘要:
Bioavailable sustained release oral opioid analgesic dosage forms, comprising a plurality of multiparticulates produced via melt extrusion techniques are disclosed.