Tamper resistant dosage forms

A solid oral extended release dosage form, comprising:

• a tablet comprising a compressed extended release matrix comprising oxycodone or a pharmaceutically acceptable salt thereof
• wherein the extended release dosage form is prepared by a process comprising
• step (a) combining oxycodone or pharmaceutically acceptable salt thereof and polyethylene oxide (PEO), wherein the PEO comprises a high molecular weight PEO having an approximate molecular weight of 2 million Da to 15 million Da based on rheological measurements;
• step (b) curing the tablet at a temperature which is at least the softening temperature of the PEO and thereafter cooling the tablet;
• wherein the dosage form comprises at least about 30% (by weight) of the PEO, and the dosage form comprises about 10 mg, about 15 mg, about 20 mg, about 30 mg, about 40 mg, about 60 mg or about 80 mg oxycodone or a pharmaceutically acceptable salt thereof;
• wherein the extended release dosage form provides a mean tmax of oxycodone at about 2 to about 6 hours after administration at steady state or of a single dose to human subjects;
• wherein the dosage form provides a mean maximum plasma concentration (Cmax) of oxycodone from about 6 ng/mL to about 240 ng/mL after administration at steady state or of a single dose to human subjects;
• wherein the solid oral extended release pharmaceutical dosage form is resistant to alcohol extraction;
• wherein the density of the cured tablet in comparison to the density of the uncured tablet decreases by at least about 0.5%;
• and
• wherein the solid oral extended release pharmaceutical dosage form when subjected to a maximum force of about 196 N in a tablet hardness test, does not break.

A solid oral extended release dosage form, comprising:

• a tablet comprising a compressed extended release matrix comprising oxycodone or a pharmaceutically acceptable salt thereof
• wherein the extended release dosage form is prepared by a process comprising
• step (a) combining oxycodone or pharmaceutically acceptable salt thereof and polyethylene oxide (PEO), wherein the PEO comprises a high molecular weight PEO having an approximate molecular weight of 2 million Da to 15 million Da based on rheological measurements;
• step (b) curing the tablet at a temperature which is at least the softening temperature of the PEO and thereafter cooling the tablet;
• wherein the dosage form comprises at least about 30% (by weight) of the PEO, and the dosage form comprises about 10 mg, about 15 mg, about 20 mg, about 30 mg, about 40 mg, about 60 mg or about 80 mg oxycodone or a pharmaceutically acceptable salt thereof;
• wherein the extended release dosage form provides a mean tmax of oxycodone at about 2 to about 6 hours after administration at steady state or of a single dose to human subjects;
• wherein the dosage form provides a mean maximum plasma concentration (Cmax) of oxycodone from about 6 ng/ml to about 240 ng/ml after administration at steady state or of a single dose to human subjects;
• wherein the solid oral extended release pharmaceutical dosage form is resistant to alcohol extraction;
• wherein the density of the cured tablet in comparison to the density of the uncured tablet decreases by at least about 0.5%;
• and
• wherein the hardness of the cured tablet is increased in comparison to the hardness of the uncured tablet.