US 12,280,152 B2
Tamper resistant dosage forms
William H. McKenna, Yonkers, NY (US); Richard O. Mannion, Furlong, PA (US); Edward P. O'Donnell, Basking Ridge, NJ (US); and Haiyong H. Huang, Princeton, NJ (US)
Assigned to PURDUE PHARMA L.P., Stamford, CT (US); and PURDUE PHARMACEUTICALS L.P., Wilson, NC (US)
Filed by PURDUE PHARMA L.P., Stamford, CT (US); and PURDUE PHARMACEUTICALS L.P., Wilson, NC (US)
Filed on Nov. 20, 2024, as Appl. No. 18/953,603.
Application 13/803,132 is a division of application No. 11/844,872, filed on Aug. 24, 2007, granted, now 8,894,987, issued on Nov. 25, 2014.
Application 18/953,603 is a continuation of application No. 18/603,884, filed on Mar. 13, 2024.
Application 18/603,884 is a continuation of application No. 18/475,755, filed on Sep. 27, 2023, granted, now 11,964,056, issued on Apr. 23, 2024.
Application 18/475,755 is a continuation of application No. 18/205,786, filed on Jun. 5, 2023, granted, now 11,938,225, issued on Mar. 26, 2024.
Application 18/205,786 is a continuation of application No. 18/143,927, filed on May 5, 2023, granted, now 11,826,472, issued on Nov. 28, 2023.
Application 18/143,927 is a continuation of application No. 17/892,553, filed on Aug. 22, 2022, granted, now 11,904,055, issued on Feb. 20, 2024.
Application 17/892,553 is a continuation of application No. 16/931,803, filed on Jul. 17, 2020, abandoned.
Application 16/931,803 is a continuation of application No. 16/697,855, filed on Nov. 27, 2019, abandoned.
Application 16/697,855 is a continuation of application No. 16/386,963, filed on Apr. 17, 2019, abandoned.
Application 16/386,963 is a continuation of application No. 15/885,074, filed on Jan. 31, 2018, abandoned.
Application 15/885,074 is a continuation of application No. 15/597,885, filed on May 17, 2017, abandoned.
Application 15/597,885 is a continuation of application No. 15/263,932, filed on Sep. 13, 2016, granted, now 9,775,812, issued on Oct. 3, 2017.
Application 15/263,932 is a continuation of application No. 14/729,593, filed on Jun. 3, 2015, granted, now 9,486,412, issued on Nov. 8, 2016.
Application 14/729,593 is a continuation of application No. 14/515,924, filed on Oct. 16, 2014, granted, now 9,084,816, issued on Jul. 21, 2015.
Application 14/515,924 is a continuation of application No. 13/803,132, filed on Mar. 14, 2013, abandoned.
Claims priority of provisional application 60/840,244, filed on Aug. 25, 2006.
Prior Publication US 2025/0082581 A1, Mar. 13, 2025
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/14 (2006.01); A61J 3/00 (2006.01); A61J 3/06 (2006.01); A61J 3/10 (2006.01); A61K 9/00 (2006.01); A61K 9/16 (2006.01); A61K 9/20 (2006.01); A61K 9/24 (2006.01); A61K 9/28 (2006.01); A61K 31/485 (2006.01); A61K 45/06 (2006.01); A61K 47/10 (2017.01); A61K 47/34 (2017.01); B29B 7/02 (2006.01); B29B 7/88 (2006.01); B29C 35/04 (2006.01); B29C 35/16 (2006.01); B29C 37/00 (2006.01); B29C 43/00 (2006.01); B29C 43/02 (2006.01); B29C 43/52 (2006.01); B29C 71/00 (2006.01); B29K 71/00 (2006.01); B29K 105/00 (2006.01); B29L 31/00 (2006.01)
CPC A61K 9/28 (2013.01) [A61J 3/005 (2013.01); A61J 3/06 (2013.01); A61J 3/10 (2013.01); A61K 9/0002 (2013.01); A61K 9/0053 (2013.01); A61K 9/1641 (2013.01); A61K 9/2013 (2013.01); A61K 9/2018 (2013.01); A61K 9/2027 (2013.01); A61K 9/2031 (2013.01); A61K 9/2054 (2013.01); A61K 9/2077 (2013.01); A61K 9/209 (2013.01); A61K 9/2095 (2013.01); A61K 9/284 (2013.01); A61K 9/2853 (2013.01); A61K 9/2866 (2013.01); A61K 9/2893 (2013.01); A61K 31/485 (2013.01); A61K 45/06 (2013.01); A61K 47/10 (2013.01); A61K 47/34 (2013.01); B29B 7/02 (2013.01); B29B 7/88 (2013.01); B29C 35/045 (2013.01); B29C 35/16 (2013.01); B29C 37/0025 (2013.01); B29C 43/003 (2013.01); B29C 43/02 (2013.01); B29C 43/52 (2013.01); B29C 71/00 (2013.01); B29C 71/009 (2013.01); A61K 9/2072 (2013.01); B29C 2035/046 (2013.01); B29C 2035/1658 (2013.01); B29K 2071/02 (2013.01); B29K 2105/0035 (2013.01); B29K 2105/251 (2013.01); B29K 2995/0088 (2013.01); B29L 2031/753 (2013.01)] 24 Claims
 
1. A solid oral extended release dosage form, comprising:
a shaped extended release matrix comprising oxycodone or a pharmaceutically acceptable salt thereof, magnesium stearate and polyethylene oxide (PEO) having an approximate molecular weight of 2 million Da to 15 million Da based on rheological measurements, wherein the PEO comprises at least about 30% (by weight) of the total weight of the dosage form;
wherein the extended release matrix is shaped to form a tablet and cured by subjecting a bed of free flowing tablets to a temperature of at least about 60° C. for a time period of at least about 5 minutes and thereafter cooling the bed;
wherein the extended release matrix is film coated;
wherein the dosage form comprises about 10 mg, about 15 mg, about 20 mg, about 30 mg, about 40 mg, about 60 mg or about 80 mg oxycodone or a pharmaceutically acceptable salt thereof;
wherein the density of the shaped extended release matrix is equal to or less than about 1.20 g/cm3 as determined by Archimedes Principle using a liquid of known density (ρ0); and
wherein the extended release dosage form provides a mean tmax of oxycodone at about 2 to about 6 hours.