TAMPER RESISTANT DOSAGE FORMS
The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.
1 - 169 . (canceled)
170 . A solid oral extended release dosage form, comprising:
a shaped extended release matrix comprising oxycodone hydrochloride and polyethylene oxide (PEO) having an approximate molecular weight of 2 million Da to 15 million Da based on rheological measurements, wherein the PEO comprises at least about 30% (by weight) of the total weight of the dosage form, wherein the oxycodone hydrochloride has a 14-hydroxycodeinone level of less than about 25 ppm,
wherein the extended release matrix is shaped to form a tablet and convection heated in a coating pan for a time period of at least about 5 minutes at a temperature of at least about 60° C. and thereafter cooled, and
wherein the density of the shaped extended release matrix is equal to or less than about 1.20 g/cm 3 as determined by Archimedes Principle using a liquid of known density (ρ 0 ).