IP Library › Granted Patent US 9,492,390

Granted Patent B2

US 9,492,390 · App. 14/729,601 · Granted Nov 15, 2016

Tamper resistant dosage forms

Inventors: William H. McKenna (Yonkers, NY); Richard O. Mannion (Furlong, PA); Edward P. O'Donnell (Basking Ridge, NJ); Haiyong H. Huang (Princeton, NJ)

Assignees: PURDUE PHARMA L.P.; PURDUE PHARMACEUTICALS L.P.

A61K9/28 A61J3/06 A61J3/10 A61K9/0002 A61K9/1641 A61K9/209 A61K9/2013 A61K9/2018 A61K9/2031 A61K9/2054 A61K9/2077 A61K9/2095 A61K9/2853 A61K9/2866 A61K9/2893 A61K31/485 A61K45/06 A61K47/10 A61K47/34 B29C43/003 A61K9/2072

View Patent ↗

Loading inventors, assignments & file history…

Monitor This Case

Get email alerts when status or documents change.

Order Certified Copies

Most orders are placed with the USPTO same day — all within 24 business hours.

Order via The Patent Place →

Pre-filled with this patent's details

Quick Facts

Patent No.: US 9,492,390
App. No.: 14/729,601
Granted: Nov 15, 2016
Kind: B2

External Links

USPTO Patent Center↗ Full Patent PDF↗

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.

Claims (58)

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;

(d) curing said shaped tablet by subjecting the shaped tablet to an air temperature from about 60 to about 90° C. for a duration about 15 minutes to about 10 hours,

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° 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;

(d) curing said shaped tablet by subjecting the shaped tablet to an air temperature from about 60 to about 90° 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° C.

8. A method according to claim 6 , wherein

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° 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

17. A method according to claim 10 , wherein said air temperature in said curing step is from 70 to 78° 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° 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 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.

Assignments (3)

ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 6, 2026

From: PURDUE PHARMA L.P

To: KNOA PHARMA LLC

Reel/Frame 075645/0702 →

ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 31, 2017

From: MCKENNA, WILLIAM H.; MANNION, RICHARD O.; O'DONNELL, EDWARD P.; HUANG, HAIYONG H.

To: PURDUE PHARMA L.P.

Reel/Frame 043148/0589 →

ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 10, 2015

From: PURDUE PHARMA L.P.

To: PURDUE PHARMA L.P.; PURDUE PHARMACEUTICALS L.P.