Tamper resistant dosage forms

1. A process of preparing a solid oral extended release pharmaceutical dosage form comprising an extended release matrix comprising a composition, said process comprising the steps of:

(a) combining at least (1) at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000, and (2) oxycodone or a pharmaceutically acceptable salt thereof to form a blend;

(b) shaping said blend to form a shaped tablet; and

(c) convection curing said shaped tablet by subjecting the shaped tablet to a temperature from about 60 to about 90° C. for a time of from about 15 minutes to about 10 hours,

wherein said convection cured shaped 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, based upon the total weight of said composition, of said at least one polyethylene oxide;

(ii) 40 mg of said oxycodone or pharmaceutically acceptable salt thereof and at least 72% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide;

(iii) 60 mg of said oxycodone or pharmaceutically acceptable salt thereof and at least 57% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide; or

(iv) 80 mg of said oxycodone or pharmaceutically acceptable salt thereof and at least 54% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide.

2. A process as defined in claim 1 , wherein said oxycodone or pharmaceutically acceptable salt thereof is oxycodone hydrochloride.

3. A process as defined in claim 1 , wherein said time in said convection curing step is 30 minutes to 90 minutes.

4. A process as defined in claim 1 , wherein, said temperature in said convection curing step is from 62 to 90° C.

5. A process as defined in claim 1 , wherein said shaped tablet is coated before or after said convection curing step.

6. A process of preparing a solid oral extended release pharmaceutical dosage form comprising an extended release matrix comprising a composition, said process comprising the steps of:

(a) combining at least (1) at least one polyethylene oxide having, based on rheological measurements, an appropriate molecular weight of 4,000,000, and (2) an opioid analgesic or a pharmaceutically acceptable salt thereof to form a blend;

(b) shaping said blend to form a shaped tablet; and

(c) convection curing said shaped tablet by subjecting the shaped tablet to a temperature from about 60 to about 90° C. for a time of from about 15 minutes to about 10 hours, wherein said polyethylene oxide in said blend is in an amount of at least 79% by weight, based upon the total weight of said composition.

7. A process as defined in claim 6 , wherein, said temperature in said convection curing step is from 62 to 90° C.

8. A process as defined in claim 6 , wherein said shaped tablet is coated before or after said convection curing step.

9. A process as defined in claim 6 , wherein said opioid analgesic or pharmaceutically acceptable salt is selected form the group consisting of oxycodone, hydrocodone, hydromorphone, oxymorphone, morphine, or pharmaceutically acceptable salts of any of the foregoing.

10. A process as defined in claim 9 , wherein said opioid analgesic or pharmaceutically acceptable salt comprises hydrocodone or a pharmaceutically acceptable salt thereof.

11. A process as defined in claim 9 , wherein said opioid analgesic or pharmaceutically acceptable salt comprises hydromorphone or a pharmaceutically acceptable salt thereof.

12. A process as defined in claim 11 , wherein said hydromorphone or a pharmaceutically acceptable salt thereof comprises hydromorphone hydrochloride.

13. A process as defined in claim 9 , wherein said opioid analgesic or pharmaceutically acceptable salt comprises oxymorphone or a pharmaceutically acceptable salt thereof.

14. A process as defined in claim 13 , wherein said oxymorphone or a pharmaceutically acceptable salt thereof comprises oxymorphone hydrochloride.

15. A process as defined in claim 9 , wherein said opioid analgesic or pharmaceutically acceptable salt comprises morphine or a pharmaceutically acceptable salt thereof.

16. A process of preparing a solid oral extended release pharmaceutical dosage form comprising an extended release matrix comprising a composition, said process comprising the steps of:

(a) combining at least (1) at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000, and (2) oxycodone hydrochloride to form a blend;

(b) shaping said blend to form a shaped tablet; and

(c) convection curing said shaped tablet by subjecting the shaped tablet to a temperature from 62 to 90° C. for a time of from about 15 minutes to about 10 hours,

wherein said convection cured shaped tablet comprises:

(i) 5, 7.5, 10, 15, 20, 30, or 40 mg of said oxycodone hydrochloride and at least 79% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide;

(ii) 40 mg of said oxycodone hydrochloride and at least 72% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide;

(iii) 60 mg of said oxycodone hydrochloride and at least 57% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide; or

(iii) 80 mg of said oxycodone hydrochloride and at least 54% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide.

17. A process as defined in claim 16 , wherein said time in said convection curing step is 30 minutes to 90 minutes.

18. A process as defined in claim 16 , wherein said shaped tablet is coated before or after said convection curing step.

19. A process as defined in claim 1 , wherein said convection cured shaped tablet comprises 5, 7.5, 10, 15, 20, or 30 mg of said oxycodone or pharmaceutically acceptable salt thereof and at least 79% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide.

20. A process as defined in claim 1 , wherein said convection cured shaped tablet comprises 40 mg of said oxycodone or pharmaceutically acceptable salt thereof and at least 72% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide.

21. A process as defined in claim 1 , wherein said convection cured shaped tablet comprises 60 mg of said oxycodone or pharmaceutically acceptable salt thereof and at least 57% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide.

22. A process as defined in claim 1 , wherein said convection cured shaped tablet comprises 80 mg of said oxycodone or pharmaceutically acceptable salt thereof and at least 54% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide.

23. A process as defined in claim 16 , wherein said convection cured shaped tablet comprises 5, 7.5, 10, 15, 20, or 30 mg of said oxycodone hydrochloride and at least 79% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide.

24. A process as defined in claim 16 , wherein said convection cured shaped tablet comprises 40 mg of said oxycodone hydrochloride and at least 72% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide.

25. A process as defined in claim 16 , wherein said convection cured shaped tablet comprises 60 mg of said oxycodone hydrochloride and at least 57% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide.

26. A process as defined in claim 16 , wherein said convection cured shaped tablet comprises 80 mg of said oxycodone hydrochloride and at least 54% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide.