Tamper resistant dosage forms

Abstract

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 method of treating pain comprising administering to a patient in need thereof a convection cured, shaped, extended release tablet comprising:
 (1) at least one high molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight selected from 4,000,000 and 7,000,000; and   (2) oxycodone 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 oxycodone or pharmaceutically acceptable salt thereof and said high molecular weight polyethylene oxide; 
 (b) convection 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 method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 170 , wherein said oxycodone or pharmaceutically acceptable salt thereof is oxycodone hydrochloride. 
     
     
         172 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 170 , wherein said time in said curing step is 30 minutes to 90 minutes. 
     
     
         173 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 170 , wherein said temperature in said curing step is from 62° C. to 90° C. 
     
     
         174 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 170 , wherein said tablet-shaped pharmaceutical preparation is coated before or after said curing step. 
     
     
         175 . A method of treating pain comprising administering to a patient in need thereof a convection cured, shaped, extended release tablet comprising:
 (1) at least one high molecular weight polyethylene oxide having, based on rheological 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) convection 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 method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 175 , wherein said temperature in said curing step is from 62° C. to 90° C. 
     
     
         177 . A method of treating pain comprising administering to a patient in need thereof 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 method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 175 , wherein said opioid analgesic or pharmaceutically acceptable salt thereof is selected form the group consisting of oxycodone, hydrocodone, hydromorphone, oxymorphone, morphine, or pharmaceutically acceptable salts of any of the foregoing. 
     
     
         179 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 175 , wherein said opioid analgesic or pharmaceutically acceptable salt thereof comprises oxycodone hydrochloride. 
     
     
         180 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 175 , wherein said opioid analgesic or pharmaceutically acceptable salt thereof comprises hydrocodone or a pharmaceutically acceptable salt thereof. 
     
     
         181 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 175 , wherein said opioid analgesic or pharmaceutically acceptable salt thereof comprises hydromorphone or a pharmaceutically acceptable salt thereof. 
     
     
         182 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 181 , wherein said hydromorphone or pharmaceutically acceptable salt thereof comprises hydromorphone hydrochloride. 
     
     
         183 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 175 , wherein said opioid analgesic or pharmaceutically acceptable salt thereof comprises oxymorphone or a pharmaceutically acceptable salt thereof. 
     
     
         184 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 183 , wherein said oxymorphone or pharmaceutically acceptable salt thereof comprises oxymorphone hydrochloride. 
     
     
         185 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 175 , wherein said opioid analgesic or pharmaceutically acceptable salt comprises morphine or a pharmaceutically acceptable salt thereof. 
     
     
         186 . A method of treating pain comprising administering to a patient in need thereof a convection cured, shaped, extended release tablet comprising:
 (1) at least one high molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight selected from 4,000,000 and 7,000,000; and   (2) oxycodone hydrochloride;   
       wherein said tablet is prepared by a process comprising the steps of:
 (a) forming a tablet-shaped pharmaceutical preparation comprising said oxycodone hydrochloride and said high molecular weight polyethylene oxide; 
 (b) convection curing said tablet-shaped pharmaceutical preparation by subjecting said preparation to a temperature from about 62° 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 hydrochloride, and at least 79% by weight of said high molecular weight polyethylene oxide; 
 (ii) 40 mg of said oxycodone hydrochloride, and at least 72% by weight of said high molecular weight polyethylene oxide; 
 (iii) 60 mg of said oxycodone hydrochloride, and at least 57% by weight of said high molecular weight polyethylene oxide; or 
 (iv) 80 mg of said oxycodone hydrochloride, 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. 
     
     
         187 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 186 , wherein said time in said curing step is 30 minutes to 90 minutes. 
     
     
         188 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 187 , wherein said tablet is coated before or after said curing step. 
     
     
         189 . A method of treating pain comprising administering to a patient in need thereof 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; and the percent by weight of said high molecular weight polyethylene oxide is at least 79%. 
     
     
         190 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 170 , wherein said tablet comprises 40 mg of said oxycodone or pharmaceutically acceptable salt thereof; and the percent by weight of said high molecular weight polyethylene oxide is at least 72%. 
     
     
         191 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 170 , wherein said tablet comprises 60 mg of said oxycodone or pharmaceutically acceptable salt thereof; and the percent by weight of said high molecular weight polyethylene oxide is at least 57%. 
     
     
         192 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 170 , wherein said tablet comprises 80 mg of said oxycodone or pharmaceutically acceptable salt thereof; and the percent by weight of said high molecular weight polyethylene oxide is at least 54%. 
     
     
         193 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 186 , 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%. 
     
     
         194 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 186 , 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%. 
     
     
         195 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 186 , 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%. 
     
     
         196 . A method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 186 , wherein said tablet comprises 80 mg of said oxycodone or pharmaceutically acceptable salt; 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%. 
     
     
         197 . A method of treating pain comprising administering to a patient in need thereof 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 method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 186 , 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 method of treating pain comprising administering to a patient in need thereof a tablet as defined in  claim 186 , 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.