You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for Patent: 9,492,390


✉ Email this page to a colleague

« Back to Dashboard


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)
Filing Date:Jun 03, 2015
Application Number:14/729,601
Claims:1. A method of treating pain comprising administering to a patient in need thereof a cured shaped pharmaceutical tablet comprising: (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; and (4) at least one component selected from an additive and a coating; 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, and optionally said additive to form at least one blend; (b) applying each said blend to form a shaped tablet; (c) optionally applying said coating to the shaped tablet; and (d) curing said shaped tablet by subjecting the shaped tablet to an air temperature from about 60 to about 90.degree. C. for a duration about 15 minutes to about 10 hours, wherein said cured shaped tablet comprises an extended release once-a-day tablet having at least 79% by weight, based upon the total weight of said uncoated tablet, of the total combined weight of said high and low molecular weight polyethylene oxides.

2. A method according to claim 1, wherein said opioid or pharmaceutically acceptable salt comprises at least 2.4% by weight, based upon the total weight of said uncoated tablet.

3. A method according to claim 1, wherein said duration in said curing step is 15 minutes to 90 minutes.

4. A method according to claim 1, wherein said air temperature in said curing step is from 70 to 78.degree. C.

5. A method according to claim 1, wherein said coating, when present, is applied at least one of before or after said curing step and said coating comprises a film coating, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, talc, silica, fumed silica, colloidal silica dioxide, calcium stearate, carnauba wax, stearic acid, stearyl alcohol, mineral oil, paraffin, glycerin, propylene glycol, polyethylene glycol, lactose, povidone, and combinations thereof, and said additive, when present, comprises microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, talc, silica, fumed silica, colloidal silica dioxide, calcium stearate, carnauba wax, stearic acid, stearyl alcohol, mineral oil, paraffin, glycerin, propylene glycol, polyethylene glycol, lactose, povidone, and combinations thereof.

6. A method of treating pain comprising administering to a patient in need thereof a cured shaped tablet comprising: (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, (3) at least one high molecular weight polyethylene oxide having, based on rheological measurements, an approximate molecular weight of 7,000,000; and (4) at least one component selected from an additive and a coating; 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, and optionally said additive, to form at least one blend; (b) applying each said blend to form a shaped tablet; (c) optionally applying said coating to the shaped tablet; and (d) curing said shaped tablet by subjecting the shaped tablet to an air temperature from about 60 to about 90.degree. C. for a duration about 15 minutes to about 10 hours, wherein said cured shaped tablet comprises an extended release once-a-day tablet having at least 79% by weight, based upon the total weight of said uncoated tablet, 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 uncoated tablet.

7. A method according to claim 6, wherein, said air temperature in said curing step is from 70 to 78.degree. C.

8. A method according to claim 6, wherein said coating, when present, is applied at least one of before or after said curing step and said coating comprises a film coating, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, talc, silica, fumed silica, colloidal silica dioxide, calcium stearate, carnauba wax, stearic acid, stearyl alcohol, mineral oil, paraffin, glycerin, propylene glycol, polyethylene glycol, lactose, povidone, and combinations thereof, and said additive, when present, comprises microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, talc, silica, fumed silica, colloidal silica dioxide, calcium stearate, carnauba wax, stearic acid, stearyl alcohol, mineral oil, paraffin, glycerin, propylene glycol, polyethylene glycol, lactose, povidone, and combinations thereof.

9. A method according to 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 uncoated tablet.

10. A method according to claim 6, wherein said tablet comprises at least one coating, and at least 2.4% by weight of hydrocodone or pharmaceutically acceptable salt thereof, based upon the total weight of said uncoated tablet.

11. A method according to claim 6, wherein said tablet comprises at least one coating, and at least 5% by weight of hydrocodone or pharmaceutically acceptable salt thereof, based upon the total weight of said uncoated tablet.

12. A method according to claim 6, wherein said tablet comprises at least one coating, and at least 10% by weight of hydrocodone or pharmaceutically acceptable salt thereof, based upon the total weight of said uncoated tablet.

13. A method according to claim 10, wherein said cured shaped tablet comprises at least 80% by weight, based upon the total weight of said uncoated tablet, of said high and low molecular weight polyethylene oxides.

14. A method according to claim 10, wherein, said air temperature in said curing step is from 70 to 78.degree. C.

15. A method according to claim 10, wherein said duration in said curing step is 15 minutes to 90 minutes.

16. A method according to claim 10, wherein said coating, when present, is applied at least one of before or after said curing step and said coating comprises a film coating, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, talc, silica, fumed silica, colloidal silica dioxide, calcium stearate, carnauba wax, stearic acid, stearyl alcohol, mineral oil, paraffin, glycerin, propylene glycol, polyethylene glycol, lactose, povidone, and combinations thereof, and said additive, when present, comprises microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, talc, silica, fumed silica, colloidal silica dioxide, calcium stearate, carnauba wax, stearic acid, stearyl alcohol, mineral oil, paraffin, glycerin, propylene glycol, polyethylene glycol, lactose, povidone, and combinations thereof.

17. A method according to claim 10, wherein said air temperature in said curing step is from 70 to 78.degree. C. and said duration in said curing step is 15 minutes to 90 minutes.

18. A method according to claim 11, wherein said air temperature in said curing step is from 70 to 78.degree. C. and said duration in said curing step is 15 minutes to 90 minutes.

19. A method according to claim 10, wherein said cured shaped tablet comprises at least 54% by weight, based upon the total weight of said uncoated tablet, of said high molecular weight polyethylene oxide.

20. A method according to claim 6, wherein said cured shaped tablet comprises at least 85% by weight, based upon the total weight of said uncoated tablet, of said high and low molecular weight polyethylene oxides.

21. A method according to claim 6, wherein said cured shaped tablet comprises at least 90% by weight, based upon the total weight of said uncoated tablet, of said high and low molecular weight polyethylene oxides.

22. A method according to claim 10, wherein said cured shaped tablet comprises at least about 80% by weight, based upon the total weight of said uncoated tablet, of said high and low molecular weight polyethylene oxides and said shaped tablet comprises at least one of a coating, an additive, and combinations thereof, wherein said coating, when present, is applied at least one of before or after said curing step and said coating comprises a film coating, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, and combinations thereof, and said additive, when present, comprises microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, and combinations thereof.

23. A method according to claim 10, wherein said cured shaped tablet comprises at least about 85% by weight, based upon the total weight of said uncoated tablet, of said high and low molecular weight polyethylene oxides.

24. A method according to claim 10, wherein said cured shaped tablet comprises at least about 90% by weight, based upon the total weight of said uncoated tablet, of said high and low molecular weight polyethylene oxides.

25. A method according to claim 22, wherein tablet comprises said additive selected from microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, and combinations thereof.

26. A method according to claim 25, wherein said curing comprises convection curing in a convection curing device.

27. A method according to claim 10, wherein said curing comprises convection curing in a convection curing device and said air temperature is measured as a mean exhaust temperature of said convection curing device during said curing duration.

28. A method according to claim 26, wherein said air temperature is measured as a mean exhaust temperature of said convection curing device during said curing duration.

29. A method according to claim 6 wherein said cured shaped tablet, when measured without said optional coating, has a density that is at least about 1% lower than the density of said shaped tablet prior to curing, based upon an uncoated tablet.

30. A method according to claim 26 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.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.