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. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet comprising an extended release matrix comprising a composition, wherein said tablet comprises:
(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, and
wherein said tablet is prepared by a process comprising the steps of:
(a) combining at least (1) and (2) 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
wherein said convection cured shaped tablet comprises:
(i) 5, 7.5, 10, 15, 20, or 30 mg of said oxycodone or pharmaceutically acceptable salt and at least 79% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000;
(ii) 40 mg of said oxycodone or pharmaceutically acceptable salt and at least 72% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000;
(iii) 60 mg of said oxycodone or pharmaceutically acceptable salt and at least 57% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000; or
(iv) 80 mg of said oxycodone or pharmaceutically acceptable salt and at least 54% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000.
2. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 1 , wherein said oxycodone or pharmaceutically acceptable salt is oxycodone hydrochloride.
3. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 1 , wherein said time in said convection curing step is 30 minutes to 90 minutes.
4. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 1 , wherein said temperature in said convection curing step is from 62 to 90° C.
5. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 1 , wherein said shaped tablet is coated before or after said convection curing step.
6. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet comprising an extended release matrix comprising a composition, wherein said tablet comprises:
(1) at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000, and
(2) an opioid analgesic or a pharmaceutically acceptable salt;
wherein said tablet is prepared by a process comprising the steps of:
(a) combining at least (1) and (2) 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 having, based on rheological measurements, an approximate molecular weight of 4,000,000, in said blend is in an amount of at least 79% by weight, based upon the total weight of said composition.
7. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 6 , wherein, said temperature in said convection curing step is from 62 to 90° C.
8. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 6 , wherein said shaped tablet is coated before or after said convection curing step.
9. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet 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 method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 9 , wherein said opioid analgesic or pharmaceutically acceptable salt comprises oxycodone hydrochloride.
11. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 6 , wherein said opioid analgesic or pharmaceutically acceptable salt comprises hydrocodone or a pharmaceutically acceptable salt thereof.
12. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 6 , wherein said opioid analgesic or pharmaceutically acceptable salt comprises hydromorphone or a pharmaceutically acceptable salt thereof.
13. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 12 , wherein said hydromorphone or a pharmaceutically acceptable salt thereof comprises hydromorphone hydrochloride.
14. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 6 , wherein said opioid analgesic or pharmaceutically acceptable salt comprises oxymorphone or a pharmaceutically acceptable salt thereof.
15. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 14 , wherein said oxymorphone or a pharmaceutically acceptable salt thereof comprises oxymorphone hydrochloride.
16. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 6 , wherein said opioid analgesic or pharmaceutically acceptable salt comprises morphine or a pharmaceutically acceptable salt thereof.
17. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet comprising an extended release matrix comprising a composition, wherein said tablet comprises:
(1) at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000, and
(2) oxycodone hydrochloride;
wherein said tablet is prepared by a process comprising the steps of:
(a) combining at least (1) and (2) 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, 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 having, based on rheological measurements, an approximate molecular weight of 4,000,000;
(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 having, based on rheological measurements, an approximate molecular weight of 4,000,000;
(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 having, based on rheological measurements, an approximate molecular weight of 4,000,000; or
(iv) 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 having, based on rheological measurements, an approximate molecular weight of 4,000,000.
18. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 17 , wherein said time in said convection curing step is 30 minutes to 90 minutes.
19. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 18 , wherein said shaped tablet is coated before or after said convection curing step.
20. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet 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 and at least 79% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000.
21. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 1 , wherein said convection cured shaped tablet comprises 40 mg of said oxycodone or pharmaceutically acceptable salt and at least 72% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000.
22. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 1 , wherein said convection cured shaped tablet comprises 60 mg of said oxycodone or pharmaceutically acceptable salt and at least 57% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000.
23. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 1 , wherein said convection cured shaped tablet comprises 80 mg of said oxycodone or pharmaceutically acceptable salt and at least 54% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000.
24. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 17 , 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 having, based on rheological measurements, an approximate molecular weight of 4,000,000.
25. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 17 , 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 having, based on rheological measurements, an approximate molecular weight of 4,000,000.
26. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 17 , wherein said convection cured shaped tablet comprises 60 mg of said oxycodone hydrochloride salt and at least 57% by weight, based upon the total weight of said composition, of said at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 4,000,000.
27. A method of treating pain comprising administering to a patient in need thereof a convection cured shaped tablet as defined in claim 17 , 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 having, based on rheological measurements, an approximate molecular weight of 4,000,000.