US2017333354A9PendingUtilityA9

Abuse deterrent pharmaceutical compositions for controlled release

47
Assignee: EGALET LTDPriority: Jul 6, 2012Filed: Dec 8, 2016Published: Nov 23, 2017
Est. expiryJul 6, 2032(~6 yrs left)· nominal 20-yr term from priority
Inventors:Peter Holm TygesenKarsten LindhardtMartin Rex OlsenGina FischerJan Martin OvergardGeorg BoyeNikolaj SkakTorben Elhauge
A61P 25/20A61P 25/26A61P 25/04A61K 31/46A61K 9/28A61K 45/06A61K 31/485A61K 9/0053A61K 9/146A61K 9/2031
47
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Claims

Abstract

The present disclosure relates to pharmaceutical compositions that are abuse resistant and may also provide controlled release. The present disclosure also relates to the use of pharmaceutical compositions in the treatment of pain.

Claims

exact text as granted — not AI-modified
1 - 21 . (canceled) 
     
     
         22 . An abuse-deterrent tablet formulated for oral administration of an opioid, the tablet consisting of a tablet composition and, optionally, a cosmetic coat, wherein:
 the tablet composition comprises:   (a) about 1-60% w/w of the opioid; and   (b) about 40-98% w/w of a polyethylene oxide (PEO) selected from the group consisting of (i) a single PEO having an average molecular weight of from about 400,000 daltons to about 900,000 daltons and (ii) two or more PEOs having a combined average molecular weight of from about 400,000 daltons to about 900,000 daltons,   wherein the cosmetic coat, when present, covers at least a portion of the tablet composition, and dissolves within 30 minutes after contact with aqueous media,   wherein the tablet composition exhibits a viscosity of at least 170 mPas when measured by Viscosity Test #2, or a viscosity of at least 46 Pas when measured by Viscosity Test #1, such that the tablet composition, when subjected to a liquid environment, forms a viscous hydrogel that resists passage through a hypodermic needle.   
     
     
         23 . The abuse deterrent tablet of  claim 22 , wherein the opioid is selected from the group consisting of buprenorphine, codeine, dextromoramide, dihydrocodeine, fentanyl, hydrocodone, hydromorphone, morphine, pentazocine, oxycodeine, oxycodone, oxymorphone, norhydrocodone, noroxycodone, morphine-6-glucuronode, tramadol, tapentadol, dihydromorphine, and pharmaceutically acceptable salts thereof. 
     
     
         24 . The abuse deterrent tablet of  claim 22 , wherein the opioid is selected from the group consisting of morphine and pharmaceutically acceptable salts thereof. 
     
     
         25 . The abuse deterrent tablet of  claim 22 , wherein the opioid comprises morphine sulfate. 
     
     
         26 . The abuse deterrent tablet of  claim 22 , wherein the opioid is selected from the group consisting of oxycodone and pharmaceutically acceptable salts thereof. 
     
     
         27 . The abuse deterrent tablet of  claim 22 , wherein the opioid comprises oxycodone hydrochloride. 
     
     
         28 . The abuse deterrent tablet of  claim 22 , wherein the opioid is selected from the group consisting of hydrocodone and pharmaceutically acceptable salts thereof. 
     
     
         29 . The abuse deterrent tablet of  claim 22 , wherein the opioid comprises hydrocodone bitartrate. 
     
     
         30 . The abuse deterrent tablet of  claim 22 , wherein the tablet composition exhibits a release rate of opioid in phosphate buffered saline with 40% v/v ethanol that is equal to or lower than the release rate of opioid in phosphate buffered saline. 
     
     
         31 . The abuse deterrent tablet of  claim 22 , wherein the tablet yields a non-snortable composition when subjected to physical tampering selected from crushing, hammering, grinding, grating, and cutting. 
     
     
         32 . The abuse deterrent tablet of  claim 22 , wherein the tablet composition comprises a single PEO having an average molecular weight of from about 400,000 daltons to about 600,000 daltons. 
     
     
         33 . The abuse deterrent tablet of  claim 22 , wherein the tablet composition comprises a single PEO having an average molecular weight of about 400,000 daltons. 
     
     
         34 . The abuse deterrent tablet of  claim 22 , wherein the tablet composition comprises a single PEO having an average molecular weight of about 600,000 daltons. 
     
     
         35 . The abuse deterrent tablet of  claim 22 , wherein the tablet composition comprises two or more PEOs having a combined average molecular weight of from about 400,000 daltons to about 600,000 daltons. 
     
     
         36 . The abuse deterrent tablet of  claim 22 , wherein the tablet composition comprises two or more PEOs having a combined average molecular weight of about 400,000 daltons. 
     
     
         37 . The abuse deterrent tablet of  claim 22 , wherein the tablet composition comprises two or more PEOs having a combined average molecular weight of about 600,000 daltons. 
     
     
         38 . The abuse deterrent tablet of  claim 22 , wherein the tablet composition comprises a first PEO having an average molecular weight of about 200,000 daltons and a second PEO having an average molecular weight of about 600,000 daltons, wherein the combined average molecular weight of the PEO present in the tablet composition is about 400,000 daltons. 
     
     
         39 . The abuse deterrent tablet of  claim 22 , further comprising at least 1% w/w of a plasticizer. 
     
     
         40 . The abuse deterrent tablet of  claim 39 , wherein the plasticizer is selected from the group consisting of poloxamers having an average molecular weight from about 3,000 to about 30,000 daltons. 
     
     
         41 . A method for treating an individual suffering from moderate to severe pain, the method comprising administering to the individual an abuse-deterrent tablet according to  claim 22 , wherein the tablet composition, when subjected to a liquid environment, forms a viscous hydrogel that resists passage through a hypodermic needle. 
     
     
         42 . The method of  claim 41 , wherein the opioid is selected from morphine and pharmaceutically acceptable salts thereof. 
     
     
         43 . The method of  claim 41 , wherein the opioid comprises morphine sulfate. 
     
     
         44 . The method of  claim 41 , wherein the opioid is selected from oxycodone and pharmaceutically acceptable salts thereof. 
     
     
         45 . The method of  claim 41 , wherein the opioid comprises oxycodone hydrochloride. 
     
     
         46 . The method of  claim 41 , wherein the opioid is selected from hydrocodone and pharmaceutically acceptable salts thereof. 
     
     
         47 . The method of  claim 41 , wherein the opioid comprises hydrocodone bitartrate. 
     
     
         48 . The method of  claim 41 , wherein the method comprises twice daily administration. 
     
     
         49 . The method of  claim 41 , wherein the method comprises once daily administration.

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