Tamper resistant dosage forms

A process of preparing a solid oral extended release pharmaceutical dosage form, comprising:

• (a) combining
• (1) at least one polyethylene oxide (PEO) having an approximate molecular weight of about 2 million Da to about 8 million Da based on rheological measurements, and
• (2) oxycodone or a pharmaceutically acceptable salt thereof, to form a mixture;
• (b) blending the mixture to form a blend;
• (c) compressing the blend in a press to form uncured dosage forms;
• and
• (d) curing the dosage forms in step (c) to form cured dosage forms, wherein the curing temperature is at least about 80° C.;
• wherein the uncured and cured dosage forms are both in a form of tablets;
• wherein the PEO comprises at least about 30% (by weight) of the total weight of the solid oral extended release pharmaceutical dosage form;
• wherein the solid oral extended release pharmaceutical 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 of the oxycodone or pharmaceutically acceptable salt thereof;
• wherein the solid oral extended release pharmaceutical dosage form provides a mean tmax of oxycodone at about 2 to about 6 hours after administration to a human subject;
• and wherein the solid oral extended release pharmaceutical dosage form provides an in-vitro dissolution rate, when measured in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) comprising 40% ethanol at 37° C., characterized by the percent amount of the oxycodone or pharmaceutically acceptable salt thereof released at 0.5 hours, that deviates no more than about 20% points 0.5 hours from the corresponding in-vitro dissolution rate measured in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37° C. without ethanol.