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) at least one high molecular weight polyethylene oxide having, based on theological measurements, an approximate molecular weight selected from 4,000,000 and 7,000,000; and
(2) oxycodone or a pharmaceutically acceptable salt;
wherein said tablet is prepared by a process comprising the steps of:
(a) forming a tablet-shaped pharmaceutical preparation comprising said oxycodone or pharmaceutically acceptable salt thereof and said high molecular weight polyethylene oxide;
(b) curing said tablet-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 at least one coating to said tablet-shaped pharmaceutical preparation, before, during or after curing;
wherein said tablet comprises:
(i) 5, 7.5, 10, 15, 20, or 30 mg of said oxycodone or pharmaceutically acceptable salt thereof, and at least 79% by weight of said high molecular weight polyethylene oxide;
(ii) 40 mg of said oxycodone or pharmaceutically acceptable salt thereof, and at least 72% by weight of said high molecular weight polyethylene oxide;
(iii) 60 mg of said oxycodone or pharmaceutically acceptable salt thereof, and at least 57% by weight of said high molecular weight polyethylene oxide; or
(iv) 80 mg of said oxycodone or pharmaceutically acceptable salt thereof, and at least 54% by weight of said high molecular weight polyethylene oxide; and
wherein percent by weight is based upon the total weight of said tablet-shaped pharmaceutical preparation, not including the combined weight of said applied coatings.
171 . A tablet as defined in claim 170 , wherein said oxycodone or pharmaceutically acceptable salt thereof is oxycodone hydrochloride.
172 . A tablet as defined in claim 170 , wherein said time in said curing step is 30 minutes to 90 minutes.
173 . A tablet as defined in claim 170 , wherein said temperature in said curing step is from 62° C. to 90° C.
174 . A tablet as defined in claim 170 , wherein at least one coating is applied to said tablet-shaped pharmaceutical preparation, before, during or after said curing step.
175 . A cured shaped extended release tablet comprising:
(1) at least one high molecular weight polyethylene oxide having, based on theological measurements, an approximate molecular weight selected from 4,000,000 and 7,000,000; and
(2) an opioid analgesic or a pharmaceutically acceptable salt thereof;
wherein said tablet is prepared by a process comprising the steps of:
(a) forming a tablet-shaped pharmaceutical preparation comprising said opioid or pharmaceutically acceptable salt thereof and said high molecular weight polyethylene oxide;
(b) curing said tablet-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 at least one coating to said tablet-shaped pharmaceutical preparation, before, during or after curing;
wherein said high molecular weight polyethylene oxide is in an amount of at least 54%, by weight, based upon the total weight of said tablet-shaped pharmaceutical preparation, not including the combined weight of said applied coatings.
176 . A tablet as defined in claim 175 , wherein, said temperature in said curing step is from 62° C. to 90° C.
177 . A tablet as defined in claim 175 , wherein at least one coating is applied to said tablet-shaped pharmaceutical preparation, before, during or after said curing step.
178 . A tablet as defined in claim 175 , wherein the percent by weight of said high molecular weight polyethylene oxide is at least 80%, and said opioid analgesic or pharmaceutically acceptable salt comprises hydrocodone or a pharmaceutically acceptable salt thereof.
179 . A tablet as defined in claim 175 , wherein the percent by weight of said high molecular weight polyethylene oxide is at least 80%, and said opioid analgesic or pharmaceutically acceptable salt thereof comprises hydromorphone or a pharmaceutically acceptable salt thereof.
180 . A tablet as defined in claim 179 , wherein said hydromorphone or pharmaceutically acceptable salt thereof comprises hydromorphone hydrochloride.
181 . A tablet as defined in claim 175 , wherein the percent by weight of said high molecular weight polyethylene oxide is at least 80%, and said opioid analgesic or pharmaceutically acceptable salt comprises oxymorphone or a pharmaceutically acceptable salt thereof.
182 . A tablet as defined in claim 181 , wherein the percent by weight of said high molecular weight polyethylene oxide is at least 80%, and said oxymorphone or pharmaceutically acceptable salt thereof comprises oxymorphone hydrochloride.
183 . A tablet as defined in claim 175 , wherein the percent by weight of said high molecular weight polyethylene oxide is at least 80%, and said opioid analgesic or pharmaceutically acceptable salt comprises morphine or a pharmaceutically acceptable salt thereof.
184 . A tablet as defined in claim 170 , wherein said tablet comprises 5, 7.5, 10, 15, 20, or 30 mg of said oxycodone or pharmaceutically acceptable salt thereof; said high molecular weight polyethylene oxide has an approximate molecular weight of 4,000,000; and the percent by weight of said high molecular weight polyethylene oxide is at least 79%.
185 . A tablet as defined in claim 170 , wherein said tablet comprises 40 mg of said oxycodone or pharmaceutically acceptable salt thereof; said high molecular weight polyethylene oxide has an approximate molecular weight of 4,000,000; and the percent by weight of said high molecular weight polyethylene oxide is at least 72%.
186 . A tablet as defined in claim 170 , wherein said tablet comprises 60 mg of said oxycodone or pharmaceutically acceptable salt thereof; said high molecular weight polyethylene oxide has an approximate molecular weight of 4,000,000; and the percent by weight of said high molecular weight polyethylene oxide is at least 57%.
187 . A tablet as defined in claim 170 , wherein said tablet comprises 80 mg of said oxycodone or pharmaceutically acceptable salt thereof; said high molecular weight polyethylene oxide has an approximate molecular weight of 4,000,000; and the percent by weight of said high molecular weight polyethylene oxide is at least 54%.
188 . A tablet as defined in claim 170 , wherein said tablet-shaped pharmaceutical preparation is formed by direct compression.
189 . A tablet as defined in claim 188 , wherein said tablet comprises 5, 7.5, 10, 15, 20, or 30 mg of said oxycodone or pharmaceutically acceptable salt thereof; said high molecular weight polyethylene oxide has an approximate molecular weight of 4,000,000; and the percent by weight of said high molecular weight polyethylene oxide is at least 79%.
190 . A tablet as defined in claim 188 , wherein said tablet comprises 40 mg of said oxycodone or pharmaceutically acceptable salt thereof; said high molecular weight polyethylene oxide has an approximate molecular weight of 4,000,000; and the percent by weight of said high molecular weight polyethylene oxide is at least 72%.
191 . A tablet as defined in claim 188 , wherein said tablet comprises 60 mg of said oxycodone or pharmaceutically acceptable salt thereof; said high molecular weight polyethylene oxide has an approximate molecular weight of 4,000,000; and the percent by weight of said high molecular weight polyethylene oxide is at least 57%.
192 . A tablet as defined in claim 188 , wherein said tablet comprises 80 mg of said oxycodone or pharmaceutically acceptable salt thereof; said high molecular weight polyethylene oxide has an approximate molecular weight of 4,000,000; and the percent by weight of said high molecular weight polyethylene oxide is at least 54%.
193 . A tablet as defined in claim 170 , wherein said curing comprises convection curing in a convection curing device.
194 . A tablet as defined in claim 175 , wherein said curing comprises convection curing in a convection curing device.
195 . A tablet as defined in claim 188 , wherein said curing comprises curing in a convection curing device.
196 . A tablet as defined in claim 170 , wherein said cured tablet-shaped pharmaceutical preparation has a density that is at least about 1% lower than the density of said preparation prior to curing.
197 . A tablet as defined in claim 175 , wherein said cured tablet-shaped pharmaceutical preparation has a density that is at least about 1% lower than the density of said preparation prior to curing.
198 . A tablet as defined in claim 188 , wherein said cured tablet-shaped pharmaceutical preparation has a density that is at least about 1% lower than the density of said preparation prior to curing.
199 . A tablet as defined in claim 188 , wherein said cured tablet-shaped pharmaceutical preparation has a density that is at least about 2% lower than the density of said preparation prior to curing.