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 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,
(2) oxycodone or a pharmaceutically acceptable salt, and
(3) at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of less than 1,000,000;
wherein said tablet is prepared by a process comprising the steps of:
(a) combining at least (1), (2), and (3) to form a blend;
(b) shaping said blend to form a shaped tablet; and
(c) 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 cured shaped tablet comprises:
(i) 5, 7.5, 10, 15, 20, or 30mg 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 cured shaped tablet as defined in claim 1 , wherein said oxycodone or pharmaceutically acceptable salt is oxycodone hydrochloride.
3. A cured shaped tablet as defined in claim 1 , wherein said time in said curing step is 30 minutes to 90 minutes.
4. A cured shaped tablet as defined in claim 1 , wherein said temperature in said curing step is from 62 to 90° C.
5. A cured shaped tablet as defined in claim 1 , wherein said shaped tablet is coated before or after said curing step.
6. A 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,
(2) an opioid analgesic or a pharmaceutically acceptable salt, and
(3) at least one polyethylene oxide having, based on rheological measurements, an approximate molecular weight of less than 1,000,000;
wherein said tablet is prepared by a process comprising the steps of: (a) combining at least (1), (2), and (3) to form a blend; (b) shaping said blend to form a shaped tablet; and
(c) 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 10hours, 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 cured shaped tablet as defined in claim 6 , wherein, said temperature in said curing step is from 62 to 90° C.
8. A cured shaped tablet as defined in claim 6 , wherein said shaped tablet is coated before or after said curing step.
9. A cured shaped tablet as defined in claim 6 , wherein said opioid analgesic or pharmaceutically acceptable salt comprises hydrocodone or a pharmaceutically acceptable salt thereof.
10. A cured shaped tablet as defined in claim 6 , wherein said opioid analgesic or pharmaceutically acceptable salt comprises hydromorphone or a pharmaceutically acceptable salt thereof.
11. A cured shaped tablet as defined in claim 10 , wherein said hydromorphone or a pharmaceutically acceptable salt thereof comprises hydromorphone hydrochloride.
12. A cured shaped tablet as defined in claim 6 , wherein said opioid analgesic or pharmaceutically acceptable salt comprises oxymorphone or a pharmaceutically acceptable salt thereof.
13. A cured shaped tablet as defined in claim 12 , wherein said oxymorphone or a pharmaceutically acceptable salt thereof comprises oxymorphone hydrochloride.
14. A cured shaped tablet as defined in claim 6 , wherein said opioid analgesic or pharmaceutically acceptable salt comprises morphine or a pharmaceutically acceptable salt thereof.
15. A cured shaped tablet as defined in claim 1 , wherein said 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.
16. A cured shaped tablet as defined in claim 1 , wherein said 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.
17. A cured shaped tablet as defined in claim 1 , wherein said 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.
18. A cured shaped tablet as defined in claim 1 , wherein said 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.
19. A cured shaped tablet as defined in claim 1 , wherein said tablet is prepared by a process comprising the steps of:
(a) combining at least (1), (2) and (3) to form a blend;
(b) shaping said blend by compression to form a shaped tablet; and
(c) curing said shaped tablet by subjecting the shaped tablet to a temperature from about 60to about 90° C. for a time of from about 15 minutes to about 10hours.
20. A cured shaped tablet as defined in claim 19 , wherein said 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 polyethylene oxides.
21. A cured shaped tablet as defined in claim 19 , wherein said 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 polyethylene oxides.
22. A cured shaped tablet as defined in claim 19 , wherein said 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 polyethylene oxides.
23. A cured shaped tablet as defined in claim 19 , wherein said 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 polyethylene oxides.
24. A cured shaped tablet as defined in claim 1 , wherein said curing comprises convection curing in a convection curing device.
25. A cured shaped tablet as defined in claim 6 , wherein said curing comprises convection curing in a convection curing device.
26. A cured shaped tablet as defined in claim 19 , wherein said curing comprises curing in a convection curing device.
27. A cured shaped tablet as defined in claim 1 , wherein said cured shaped tablet has a density that is at least about 1% lower than the density of said shaped tablet prior to curing.
28. A cured shaped tablet as defined in claim 6 , wherein said cured shaped tablet has a density that is at least about 1% lower than the density of said shaped tablet prior to curing.
29. A cured shaped tablet as defined in claim 19 , wherein said cured shaped tablet has a density that is at least about 1% lower than the density of said shaped tablet prior to curing.
30. A cured shaped tablet as defined in claim 19 , wherein said cured shaped tablet has a density that is at least about 2% lower than the density of said shaped tablet prior to curing.