US 11,911,512 B2
Encased tamper resistant controlled release dosage forms
Haiyong Hugh Huang, Princeton, NJ (US)
Assigned to Purdue Pharma L.P., Stamford, CT (US)
Filed by Purdue Pharma L.P., Stamford, CT (US)
Filed on Jan. 13, 2023, as Appl. No. 18/096,686.
Application 14/024,360 is a division of application No. 13/333,560, filed on Dec. 21, 2011, granted, now 8,808,740, issued on Aug. 19, 2014.
Application 18/096,686 is a continuation of application No. 17/185,221, filed on Feb. 25, 2021, granted, now 11,590,082.
Application 17/185,221 is a continuation of application No. 16/662,745, filed on Oct. 24, 2019, granted, now 10,966,932, issued on Apr. 6, 2021.
Application 16/662,745 is a continuation of application No. 15/681,906, filed on Aug. 21, 2017, abandoned.
Application 15/681,906 is a continuation of application No. 15/045,975, filed on Feb. 17, 2016, granted, now 9,750,703, issued on Sep. 5, 2017.
Application 15/045,975 is a continuation of application No. 14/024,360, filed on Sep. 11, 2013, granted, now 9,744,136, issued on Aug. 29, 2017.
Claims priority of provisional application 61/426,306, filed on Dec. 22, 2010.
Prior Publication US 2023/0301921 A1, Sep. 28, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 9/20 (2006.01); A61K 9/24 (2006.01); A61K 31/485 (2006.01); A61K 9/00 (2006.01); A61K 9/28 (2006.01)
CPC A61K 9/2077 (2013.01) [A61K 9/0053 (2013.01); A61K 9/209 (2013.01); A61K 9/2031 (2013.01); A61K 9/2054 (2013.01); A61K 9/2086 (2013.01); A61K 9/28 (2013.01); A61K 31/485 (2013.01)] 20 Claims
 
1. A method of treating pain in a subject, comprising:
administering to the subject a solid controlled release dosage form, the solid controlled release dosage form comprising:
a core comprising a first portion of an opioid analgesic dispersed in a first matrix material, wherein the opioid analgesic comprises oxycodone, a pharmaceutically acceptable salt thereof or combinations thereof; and
a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material,
wherein the dosage form further comprises acetaminophen;
wherein the amount of opioid analgesic released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in-vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37° C.