Details for Patent: 8,821,929

Title:	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.
Inventor(s):	McKenna; William H. (Yonkers, NY), Mannion; Richard O. (Furlong, PA), O'Donnell; Edward P. (Basking Ridge, NJ), Huang; Haiyong H. (Princeton, NJ)
Assignee:	Purdue Pharma L.P. (Stamford, CT)
Filing Date:	May 23, 2013
Application Number:	13/900,873
Claims:	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.degree. 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.degree. 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.degree. 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.degree. 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.degree. 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.