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Last Updated: April 15, 2024

Claims for Patent: 9,545,380


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Summary for Patent: 9,545,380
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) PURDUE PHARMACEUTICALS L.P. (Wilson, NC)
Application Number:14/729,688
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,545,380
Patent Claims: 1. A method of treating pain comprising administering to a patient in need thereof a pharmaceutical tablet comprising: (1) at least a first compression shaped and then air cured matrix, wherein said curing is without compression, by heated air having a temperature of at least about 62.degree. C. for a duration of at least about 5 minutes, said matrix comprising hydrocodone or a pharmaceutically acceptable salt thereof in combination with at least one high molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight selected from the group consisting of 4,000,000, 7,000,000, and a combination thereof, and optionally further comprising at least one low molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight of less than 1,000,000; (2) optionally a second air cured matrix comprising hydrocodone or a pharmaceutically acceptable salt thereof in combination with 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) optionally a coating, wherein in said tablet: said high molecular weight polyethylene oxide is at least 54% by weight of the total weight of said uncoated tablet; said low molecular weight polyethylene oxide, if present, is at least 10% by weight of the total weight of said uncoated tablet; and said tablet provides a once-daily extended release of said hydrocodone or pharmaceutically acceptable salt thereof.

2. A method as defined in claim 1, wherein said hydrocodone or pharmaceutical salt thereof comprises at least 2.4% by weight, based upon the total weight of said uncoated tablet.

3. A method as defined in claim 1, wherein each shaped and cured matrix has been cured by heated air having a temperature of about 62.degree. C. to about 90.degree. C. for a duration of about 15 minutes to about 10 hours, and then is subsequently cooled.

4. A method as defined in claim 3, wherein said heated air temperature is from about 65.degree. C. to about 90.degree. C., said duration is about 15 minutes to about 8 hours, and said cooling comprises exposure to an air temperature of less than about 62.degree. C.

5. A method as defined in claim 1, wherein said shaped tablet is coated at least one of before or after being cured.

6. A method as defined in claim 4, wherein one or both of said first matrix and second matrix further comprise a coating.

7. A method as defined in claim 1, wherein, said second matrix is present and said low molecular weight polyethylene oxide comprises at least about 20% by weight of the total weight of said uncoated tablet.

8. A method as defined in claim 6, wherein, said second matrix is present and said low molecular weight polyethylene oxide comprises at least about 20% by weight of the total weight of said uncoated tablet.

9. A method as defined in claim 7, wherein said low molecular weight polyethylene oxide is at least 22% by weight based upon the total weight of said uncoated tablet and said hydrocodone or pharmaceutically acceptable salt is at least 2.4% by weight based upon the total weight of said uncoated tablet.

10. A method as defined in claim 6, wherein the total combined weight of said high and low molecular weight polyethylene oxide is at least 60% by weight, based upon the total weight of said uncoated tablet.

11. A method as defined in claim 6, wherein the total combined weight of said high and low molecular weight polyethylene oxide is at least 65% by weight, based upon the total weight of said uncoated tablet.

12. A method as defined in claim 6, wherein the total combined weight of said high and low molecular weight polyethylene oxide is at least 80% by weight, based upon the total weight of said uncoated tablet.

13. A method as defined in claim 6, wherein the total combined weight of said high and low molecular weight polyethylene oxide is at least 85% by weight, based upon the total weight of said uncoated tablet.

14. A method as defined in claim 6, wherein the total combined weight of said high and low molecular weight polyethylene oxide is at least 90% by weight, based upon the total weight of said uncoated tablet.

15. A method as defined in claim 6, wherein said tablet further comprises magnesium stearate.

16. A method as defined in claim 15, wherein said tablet further comprises butylated hydroxytoluene.

17. A method as defined in claim 15, wherein said tablet further comprises at least one of lactose, microcrystalline cellulose and hydroxypropyl cellulose.

18. A method as defined in claim 1, wherein said tablet, when subjected to an indentation test, has at least one of (i) a cracking force of at least 110 N; and (ii) a penetration depth to crack distance of at least 1.0 mm.

19. A method as defined in claim 1, wherein said tablet can be flattened to a thickness that is no more than about 60% of the initial tablet thickness without breaking; and said flattened tablet swells upon exposure to water or ethanol.

20. A method according to claim 1, wherein, after a plurality of at least 100 of the same tablets are stored at 40.degree. C. and 75% relative humidity for at least 3 months, a set of at least ten of said stored tablets, on average, when measured in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37.degree. C., in the absence of an added stabilizer, release an amount of said hydrocodone or pharmaceutical salt thereof, after 1 hour, 4 hours, and 12 hours, that deviates from an initial dosage amount of said hydrocodone or pharmaceutically acceptable salt thereof by no more than about 10% points.

21. A method as defined in claim 3, wherein said air temperature during curing exhibits a plateau profile.

22. A method as defined in claim 4, wherein said air temperature during curing exhibits a plateau profile.

23. A method as defined in claim 3, wherein said air temperature during curing exhibits a parabolic or triangular profile.

24. A method as defined in claim 4, wherein said air temperature during curing exhibits a parabolic or triangular profile.

25. A method as defined in claim 3, wherein curing is by convection and said air temperature is measured as a mean exhaust temperature of a convection curing device.

26. A method as defined in claim 3, wherein curing is by convection at atmospheric pressure and said air temperature is measured as a mean exhaust temperature of a convection curing device.

27. A method as defined in claim 4, wherein curing is by convection at atmospheric pressure and said air temperature is measured as a mean exhaust temperature of a convection curing device.

28. A method as defined in claim 19, wherein said tablet, when subjected to an indentation test, has at least one of (i) a cracking force of at least 110 N; and (ii) a penetration depth to crack distance of at least 1.0 mm.

29. A method 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.

30. A method as defined in claim 4 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.

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