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 cured shaped extended release tablet comprising:
(1) an opioid or a pharmaceutically acceptable salt thereof,
(2) at least one low molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight of less than 1,000,000,
(3) at least one high molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 7,000,000, and
(4) at least one additive;
wherein said tablet is prepared by a process comprising the steps of:
(a) forming a shaped pharmaceutical preparation comprising said opioid or pharmaceutically acceptable salt thereof, said low molecular weight polyethylene oxide, said high molecular weight polyethylene oxide, and said at least one additive; and
(b) curing said shaped pharmaceutical preparation by subjecting said preparation to a temperature from about 60° C. to about 90° C. for a time of from about 15 minutes to about 10 hours; and
(c) optionally applying one or more coatings to said shaped pharmaceutical preparation;
wherein the total combined weight of said high and low molecular weight polyethylene oxides is at least 79% by weight, and said percent by weight is based upon the total weight of said pharmaceutical preparation, not including the combined weight of said coatings.
171 . A cured shaped tablet as defined in claim 170 , wherein the percent by weight of said opioid or pharmaceutically acceptable salt is at least 2.4%.
172 . A cured shaped tablet as defined in claim 170 , wherein said time in said curing step is 15 minutes to 60 minutes.
173 . A cured shaped tablet as defined in claim 170 , wherein said temperature in said curing step is from about 70° C. to about 78° C.
174 . A cured shaped tablet as defined in claim 170 , wherein said opioid or pharmaceutically acceptable salt is hydrocodone or a pharmaceutically acceptable salt thereof and said at least one additive is selected from microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, and combinations thereof.
175 . A cured shaped tablet as defined in claim 174 , wherein said time in said curing step is 15 minutes to 60 minutes and said temperature in said curing step is from about 70° C. to about 78° C.
176 . A cured shaped tablet as defined in claim 174 , wherein said curing comprises convection curing in a convection curing device and said curing temperature is measured as a mean exhaust temperature of said convection curing device during said curing time.
177 . A cured shaped tablet as defined in claim 175 , wherein said curing comprises convection curing in a convection curing device and said curing temperature is measured as a mean exhaust temperature of said convection curing device during said curing time.
178 . A cured shaped tablet as defined in claim 174 , wherein the total combined weight of said high and low molecular weight polyethylene oxides is at least 80% by weight.
179 . A cured shaped tablet as defined in claim 174 , wherein the total combined weight of said high and low molecular weight polyethylene oxides is at least 85% by weight.
180 . A cured shaped tablet as defined in claim 174 , wherein the total combined weight of said high and low molecular weight polyethylene oxides is at least 90% by weight.
181 . A cured shaped tablet as defined in claim 174 , wherein the percent by weight of said hydrocodone or pharmaceutically acceptable salt thereof is at least 2.4%.
182 . A cured shaped tablet as defined in claim 174 , wherein said time in said curing step is 15 minutes to 60 minutes, said temperature in said curing step is from about 70° C. to about 78° C., said curing comprises convection curing in a convection curing device, and said curing temperature is measured as a mean exhaust temperature of said convection curing device during said curing time.
183 . A cured shaped tablet as defined in claim 181 , wherein said time in said curing step is 15 minutes to 60 minutes, said temperature in said curing step is from about 70° C. to about 78° C., said curing comprises convection curing in a convection curing device, and said curing temperature is measured as a mean exhaust temperature of said convection curing device during said curing time.
184 . A cured shaped tablet as defined in claim 178 , wherein said time in said curing step is 15 minutes to 60 minutes, said temperature in said curing step is from about 70° C. to about 78° C., said curing comprises convection curing in a convection curing device, and said curing temperature is measured as a mean exhaust temperature of said convection curing device during said curing time.
185 . A cured shaped tablet as defined in claim 179 , wherein said time in said curing step is 15 minutes to 60 minutes, said temperature in said curing step is from about 70° C. to about 78° C., said curing comprises convection curing in a convection curing device, and said curing temperature is measured as a mean exhaust temperature of said convection curing device during said curing time.
186 . A cured shaped tablet as defined in claim 180 , wherein said time in said curing step is 15 minutes to 60 minutes, said temperature in said curing step is from about 70° C. to about 78° C., said curing comprises convection curing in a convection curing device, and said curing temperature is measured as a mean exhaust temperature of said convection curing device during said curing time.
187 . A cured shaped tablet as defined in claim 181 , wherein the percent by weight of said high molecular weight polyethylene oxide is at least 54%.
188 . A cured shaped tablet as defined in claim 174 , wherein the percent by weight of said hydrocodone or pharmaceutically acceptable salt thereof is at least 5%.
189 . A cured shaped tablet as defined in claim 174 , wherein the percent by weight of said hydrocodone or pharmaceutically acceptable salt thereof is at least 10%.
190 . A cured shaped tablet as defined in claim 174 , wherein said shaped pharmaceutical preparation is coated before or after said curing step.
191 . A cured shaped tablet as defined in claim 179 , wherein said shaped pharmaceutical preparation is coated before or after said curing step.
192 . A cured shaped tablet as defined in claim 191 , wherein said time in said curing step is 15 minutes to 60 minutes, said temperature in said curing step is from about 70° C. to about 78° C., said curing comprises convection curing in a convection curing device, and said curing temperature is measured as a mean exhaust temperature of said convection curing device during said curing time.
193 . A cured shaped tablet as defined in claim 177 , wherein said cured shaped pharmaceutical preparation has a density that is at least about 1% lower than the density of said shaped pharmaceutical preparation prior to curing.
194 . A cured shaped tablet as defined in claim 181 , wherein said cured shaped pharmaceutical preparation has a density that is at least about 1% lower than the density of said shaped pharmaceutical preparation prior to curing.
195 . A cured shaped tablet as defined in claim 192 wherein said cured shaped pharmaceutical preparation has a density that is at least about 1% lower than the density of said shaped pharmaceutical preparation prior to curing.