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 cured shaped tablet comprising an extended release matrix comprising a composition, wherein said tablet comprises:
(1) an opioid or a pharmaceutically acceptable salt thereof,
(2) at least one low molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight of less than 1,000,000, and
(3) at least one high molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 7,000,000;
wherein said tablet is prepared by a process comprising the steps of:
(a) combining said opioid or pharmaceutically acceptable salt thereof with each of said low molecular weight polyethylene oxide and said high molecular weight polyethylene oxide to form at least one blend;
(b) applying each 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 a once-a-day dosage form having at least 79% by weight, based upon the total weight of said composition, of the total combined weight of said high and low molecular weight polyethylene oxides.
2. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 1 , wherein said opioid or pharmaceutically acceptable salt comprises at least 2.4% by weight, based upon the total weight of said composition.
3. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 1 , wherein said time in said curing step is 15 minutes to 60 minutes.
4. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 1 , wherein said temperature in said curing step is from 70 to 78° C.
5. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 1 , wherein said shaped tablet is coated before or after said curing step.
6. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet comprising an extended release matrix comprising a composition, wherein said tablet comprises:
(1) hydrocodone or a pharmaceutically acceptable salt thereof,
(2) at least one low molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight of less than 1,000,000, and
(3) at least one high molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 7,000,000;
wherein said tablet is prepared by a process comprising the steps of:
(a) combining said hydrocodone or pharmaceutically acceptable salt thereof with each of said low molecular weight polyethylene oxide and said high molecular weight polyethylene oxide to form at least one blend;
(b) applying each 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 a once-a-day dosage form having at least 79% by weight, based upon the total weight of said composition, of the total combined weight of said high and low molecular weight polyethylene oxides, and wherein said low molecular weight polyethylene oxide comprises at least 20% 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 cured shaped tablet as defined in claim 6 , wherein, said temperature in said curing step is from 70 to 78° C.
8. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 6 , wherein said at least one blend further comprises at least one additive.
9. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 6 , wherein said low molecular weight polyethylene oxide is at least 22% by weight and said high molecular weight polyethylene oxide is at least 50% by weight, based upon the total weight of said composition.
10. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 6 , wherein said hydrocodone or pharmaceutically acceptable salt thereof comprises at least 2.4% by weight, based upon the total weight of said composition.
11. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 6 , wherein said hydrocodone or pharmaceutically acceptable salt thereof comprises at least 5% by weight, based upon the total weight of said composition.
12. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 6 , wherein said hydrocodone or pharmaceutically acceptable salt thereof comprises at least 10% by weight, based upon the total weight of said composition.
13. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 9 , wherein said cured shaped tablet comprises at least 80% by weight, based upon the total weight of said composition, of said high and low molecular weight polyethylene oxides.
14. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 10 , wherein, said temperature in said curing step is from 70 to 78° C.
15. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 6 , wherein said time in said curing step is 15 minutes to 60 minutes.
16. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 10 , wherein said time in said curing step is 15 minutes to 60 minutes.
17. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 6 , wherein said temperature in said curing step is from 70 to 78° C. and said time in said curing step is 15 minutes to 60 minutes.
18. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 10 , wherein said temperature in said curing step is from 70 to 78° C. and said time in said curing step is 15 minutes to 60 minutes.
19. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 10 , wherein said cured shaped tablet comprises at least 54% high molecular weight polyethylene oxide.
20. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 6 , wherein said cured shaped tablet comprises at least 85% by weight, based upon the total weight of said composition, of said high and low molecular weight polyethylene oxides.
21. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 6 , wherein said cured shaped tablet comprises at least 90% by weight, based upon the total weight of said composition, of said high and low molecular weight polyethylene oxides.
22. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 10 , wherein said cured shaped tablet comprises at least about 80% by weight, based upon the total weight of said composition, of said high and low molecular weight polyethylene oxides.
23. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 10 , wherein said cured shaped tablet comprises at least about 85% by weight, based upon the total weight of said composition, of said high and low molecular weight polyethylene oxides.
24. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 10 , wherein said cured shaped tablet comprises at least about 90% by weight, based upon the total weight of said composition, of said high and low molecular weight polyethylene oxides.
25. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 1 , wherein said curing comprises convection curing in a convection curing device.
26. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 8 , wherein said at least one additive is selected from microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, and combinations thereof, and said curing comprises convection curing in a convection curing device.
27. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 17 , wherein said curing comprises convection curing in a convection curing device.
28. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 26 , wherein said curing temperature is measured as a mean exhaust temperature of said convection curing device during said curing time.
29. A method of treating pain comprising administering to a patient in need thereof 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.
30. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet as defined in claim 9 , 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.