Claims for Patent: 9,044,402

Summary for Patent: 9,044,402

Title:	Abuse-deterrent pharmaceutical compositions for controlled release
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.
Inventor(s):	Tygesen; Peter Holm (Vaerlose, DK), Lindhardt; Karsten (Haslev, DK), Olsen; Martin Rex (Holbaek, DK), Fischer; Gina Engslev (Vaerlose, DK), Overgard; Jan Martin (Frederikssund, DK), Boye; Georg (Hedehusene, DK), Skak; Nikolaj (Virum, DK), Elhauge; Torben (Copenhagen K, DK)
Assignee:	EGALET LTD. (London, GB)
Application Number:	14/249,965
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,044,402
Patent Claims:	1. 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: about 1-30% w/w of the opioid; and about 70-98% w/w of a polyethylene oxide (PEO) having an average molecular weight of from about 400,000 daltons to about 600,000 daltons; and the cosmetic coat, when present, covers at least a portion of the tablet composition, and dissolves within 30 minutes after contact with an aqueous media, wherein the tablet composition does not provide immediate release of the opioid even after the abuse-deterrent tablet is subjected to physical tampering selected from crushing, grinding, grating, cutting, or crisping, and 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. 2. The abuse deterrent tablet of claim 1, 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. 3. The abuse deterrent tablet of claim 1, wherein the opioid is selected from the group consisting of morphine and pharmaceutically acceptable salts thereof. 4. The abuse deterrent tablet of claim 1, wherein the tablet composition exhibits a release rate of opioid in ethanol that is equal to or lower than the release rate of opioid in water. 5. The abuse deterrent tablet of claim 1, wherein the tablet yields a non-snortable composition when subjected to physical tampering selected from crushing, hammering, grinding, grating, and cutting. 6. An abuse-deterrent tablet formulated for oral administration of an opioid, consisting of a tablet composition and, optionally, a cosmetic coat, wherein: the tablet composition comprises: about 1-30% w/w of the opioid; and about 70-98% w/w of a polyethylene oxide (PEO) blend comprising two or more PEOs, wherein each of the two or more PEOs has a different average molecular weight and the average molecular weight of the blend of the two or more PEOs included in the tablet composition is from about 400,000 daltons to about 600,000 daltons; and the cosmetic coat, when present, covers at least a portion of the tablet composition, and dissolves within 30 minutes after contact with an aqueous media, wherein the tablet composition does not provide immediate release of the opioid even after the abuse-deterrent tablet is subjected to physical tampering selected from crushing, grinding, grating, cutting, or crisping, and 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. 7. The abuse deterrent tablet of claim 6, 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. 8. The abuse deterrent tablet of claim 6, wherein the opioid is selected from the group consisting of morphine and pharmaceutically acceptable salts thereof. 9. The abuse deterrent tablet of claim 6, wherein the PEO blend includes 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 average molecular weight of the PEO blend included in the tablet composition is about 400,000 daltons. 10. The abuse deterrent tablet of claim 6, wherein the tablet composition exhibits a release rate of opioid in ethanol that is equal to or lower than the release rate of opioid in water. 11. The abuse deterrent tablet of claim 6, wherein the tablet yields a non-snortable composition when subjected to physical tampering selected from crushing, hammering, grinding, grating, and cutting. 12. An abuse-deterrent tablet formulated for oral administration of an opioid, consisting of a tablet composition and, optionally, a cosmetic coat, wherein: the tablet composition comprises: about 1-30% w/w of the opioid; about 70-98% w/w of a polyethylene oxide (PEO) selected from a single PEO having an average molecular weight of from about 400,000 daltons to about 600,000 daltons and a PEO blend comprising two or more PEOs, wherein each of the two or more PEOs has a different average molecular weight and the average molecular weight of the blend of the two or more PEOs included in the tablet composition is from about 400,000 daltons to about 600,000 daltons; and at least 1% w/w of a plasticizer; and the cosmetic coat, when present, covers at least a portion of the tablet composition, and dissolves within 30 minutes after contact with an aqueous media, wherein the tablet composition does not provide immediate release of the opioid even after the abuse-deterrent tablet is subjected to physical tampering selected from crushing, grinding, grating, cutting, or crisping, and 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. 13. The abuse deterrent tablet of claim 12, 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. 14. The abuse deterrent tablet of claim 12, wherein the opioid is selected from the group consisting of morphine and pharmaceutically acceptable salts thereof. 15. The abuse deterrent tablet of claim 12, wherein the tablet composition exhibits a release rate of opioid in ethanol that is equal to or lower than the release rate of opioid in water. 16. The abuse deterrent tablet of claim 12, 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. 17. The abuse deterrent tablet of claim 12, wherein the tablet yields a non-snortable composition when subjected to physical tampering selected from crushing, hammering, grinding, grating, and cutting. 18. 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 12. 19. 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 1. 20. 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 6. 21. The abuse deterrent tablet of claim 1, wherein the average molecular weight of the PEO included in the tablet composition is about 400,000 daltons. 22. The abuse deterrent tablet of claim 6, wherein the average molecular weight of the PEO blend included in the tablet composition is about 400,000 daltons. 23. The abuse deterrent tablet of claim 12, wherein the average molecular weight of the PEO or PEO blend included in the tablet composition is about 400,000 daltons.