TAMPER RESISTANT DOSAGE FORMS

1 - 169 . (canceled)

170 . A solid oral extended release dosage form, comprising:

a shaped extended release matrix comprising oxycodone or a pharmaceutically acceptable salt thereof, magnesium stearate and polyethylene oxide (PEO) having an approximate molecular weight of 4 million Da based on rheological measurements, wherein the PEO comprises at least about 65% (by weight) of the total weight of the dosage form;

wherein the extended release matrix is shaped to form a tablet and cured by subjecting a bed of free flowing tablets to a temperature from about 62° C. to about 90° C. for a time period from about 15 minutes to about 10 hours and thereafter cooling the bed;

wherein the extended release matrix is film coated;

wherein 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 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 ); and

wherein the dosage form comprising 10 mg is bioequivalent to a commercial reference tablet comprising 10 mg of oxycodone hydrochloride in a matrix formulation.

171 . The solid oral extended release dosage form of claim 170 , wherein the matrix formulation of the commercial reference tablet comprises

a) oxycodone hydrochloride in an amount of 10.0 mg per tablet;

b) lactose (spray-dried) in an amount of 69.25 mg per tablet;

c) povidone in an amount of 5.0 mg/tablet;

d) ammonio methacrylate copolymer in an amount of 10.0 mg per tablet;

e) triacetin in an amount of 2.0 mg per tablet;

f) stearyl alcohol in an amount of 25.0 mg per tablet;

g) talc in an amount of 2.5 mg per tablet; and

h) magnesium stearate in an amount of 1.25 mg per tablet.

172 . The solid oral extended release dosage form of claim 171 , wherein the reference tablet is prepared by the following steps:

i) ammonio methacrylate copolymer and triacetin are combined while passing through a 60 mesh screen, and mixed under low shear for approximately 5 minutes or until a uniform dispersion is observed;

ii) oxycodone HCl, lactose, and povidone are placed into a fluid bed granulator/dryer (FBD) bowl, and the suspension sprayed onto the powder in the fluid bed;

iii) after spraying, the granulation is passed through a #12 screen if necessary to reduce lumps;

iv) the dry granulation is placed in a mixer;

v) the required amount of stearyl alcohol is melted at a temperature of approximately 70° C.;

vi) the melted stearyl alcohol is incorporated into the granulation while mixing;

vii) the waxed granulation is transferred to a FBD or trays and allowed to cool to room temperature or below;

viii) the cooled granulation is then passed through a #12 screen;

ix) the waxed granulation is placed in a mixer/blender and lubricated with the required amounts of talc and magnesium stearate for approximately 3 minutes; and

x) the granulate is compressed into 125 mg tablets on a suitable tableting machine.

173 . The solid oral extended release dosage form of claim 170 , wherein the bed of free flowing tablets is cured in a coating pan.

174 . The solid oral extended release dosage form of claim 170 , wherein the bed of free flowing tablets is cured in a fluidized bed.

175 . The solid oral extended release dosage form of claim 170 , wherein the tablets are film coated prior to curing.

176 . The solid oral extended release dosage form of claim 170 , wherein the tablets are film coated after curing.

177 . The solid oral extended release dosage form of claim 170 , wherein the tablets are film coated prior to curing and after curing.

178 . The solid oral extended release dosage form of claim 170 , wherein the dosage form provides an in-vitro dissolution rate, which when measured in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37° C., is between 12.5 and 55% (by wt) oxycodone or pharmaceutically acceptable salt thereof released after 1 hour, between 25 and 65% (by wt) oxycodone or pharmaceutically acceptable salt thereof released after 2 hours, between 45 and 85% (by wt) oxycodone or pharmaceutically acceptable salt thereof released after 4 hours and between 55 and 95% (by wt) oxycodone or pharmaceutically acceptable salt thereof released after 6 hours.

179 . The solid oral extended release dosage form of claim 170 , wherein the 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 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.

180 . The solid oral extended release dosage form of claim 170 , when subjected to a maximum force of about 196 N or about 439 N in a tablet hardness test, does not break.

181 . The solid oral extended release dosage form of claim 170 , wherein the tablet when subjected to an indentation test resists a work of at least about 0.06 J without cracking.

182 . The solid oral extended release dosage form of claim 170 , wherein the total amount of PEO comprises at least about 80% (by wt) of the total weight of the dosage form.