Claims for Patent: 9,572,779

Summary for Patent: 9,572,779

Title:	Encased tamper resistant controlled release dosage forms
Abstract:	In certain embodiments, the present invention is directed to a solid controlled release dosage form comprising: a core comprising a first portion of an opioid analgesic dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material; 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.
Inventor(s):	Huang; Haiyong Hugh (Princeton, NJ)
Assignee:	Purdue Pharma L.P. (Stamford, CT)
Application Number:	15/045,962
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,572,779
Patent Claims:	1. A solid controlled release dosage form comprising: a core comprising a first portion of hydrocodone or a pharmaceutically acceptable salt thereof dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the hydrocodone or pharmaceutically acceptable salt thereof dispersed in a second matrix material; wherein the amount of hydrocodone or pharmaceutically acceptable salt thereof released from the dosage form, 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.degree. C., at 2 hours, is less than about 25%; at 4 hours, is from about 10% to about 30%; at 8 hours, is from about 20% to about 60%; at 12 hours, is from about 40% to about 90%; and at 18 hours, is greater than about 70%; and wherein the amount of hydrocodone or pharmaceutically acceptable salt thereof 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.degree. C. 2. The solid controlled release dosage form of claim 1, wherein the first matrix material, the second matrix material, or both the first and second matrix material comprises polyethylene oxide. 3. The solid controlled release dosage form of claim 2, wherein the polyethylene oxide has an average molecular weight from about 300,000 to about 10,000,000. 4. The solid controlled release dosage form of claim 2, wherein the polyethylene oxide has an average molecular weight from about 1,000,000 to about 10,000,000. 5. The solid controlled release dosage form of claim 2, wherein the first matrix material, the second matrix material, or both the first and second matrix material comprises a cellulose ether. 6. The solid controlled release dosage form of claim 5, wherein the first matrix material, the second matrix material, or both the first and second matrix material comprises a hydroxyalkylcellulose. 7. The solid controlled release dosage form of claim 6, wherein the hydroxyalkylcellulose is hydroxypropylcellulose. 8. The solid controlled release dosage form of claim 5, wherein the first matrix material, the second matrix material, or both the first and second matrix material comprises microcrystalline cellulose. 9. The solid controlled release dosage form of claim 8, comprising a compressed dispersion of the hydrocodone or pharmaceutically acceptable salt thereof and the matrix material. 10. The solid controlled release dosage form of claim 8, comprising granules comprising the hydrocodone or pharmaceutically acceptable salt thereof and the first matrix material. 11. The solid controlled release dosage form of claim 10, wherein the granules are compressed into a tablet. 12. The solid controlled release dosage form of claim 8, wherein the hydrocodone or pharmaceutically acceptable salt thereof is hydrocodone bitartrate. 13. The solid controlled release dosage form of claim 12, wherein the total amount of hydrocodone bitartrate in the dosage form is from about 0.5 mg to about 1250 mg. 14. The solid controlled release dosage form of claim 8, which provides a C.sub.24/C.sub.max ratio of hydrocodone of about 0.55 to about 1.0 after oral administration to a subject. 15. The solid controlled release dosage form of claim 8, which provides a T.sub.max (h) of hydrocodone from about 4 to about 20 hours after oral administration to a subject. 16. The solid controlled release dosage form of claim 14, wherein the administration is a first administration to a population of subjects. 17. The solid controlled release dosage form of claim 14, wherein the administration is steady state administration to a subject. 18. The solid controlled release dosage form of claim 8, which contains about 20 mg hydrocodone or pharmaceutically acceptable salt thereof. 19. The solid controlled release dosage form of claim 8, which contains about 120 mg hydrocodone or pharmaceutically acceptable salt thereof. 20. The solid controlled release dosage form of claim 8, which provides a mean AUC (ng*h/mL) after oral administration to a subject of about 250 to 400 per each 20 mg hydrocodone or pharmaceutically acceptable salt thereof included in the dosage form. 21. The solid controlled release dosage form of claim 8, which provides a mean C.sub.max (ng/mL) after oral administration to a subject of about 10 to about 30 per each 20 mg hydrocodone or pharmaceutically acceptable salt thereof included in the dosage form. 22. The solid controlled release dosage form of claim 8, which provides a mean T.sub.max (h) after oral administration to a subject of about 10 to about 20. 23. The solid controlled release dosage form of claim 8, which provides a mean T.sub.1/2 (h) after oral administration to a subject of about 5 to about 10. 24. The solid controlled release dosage form of claim 8, which provides a mean T.sub.lag (h) after oral administration to a subject of about 0.01 to about 0.2. 25. The solid controlled release dosage form of claim 8, wherein the mean C.sub.24/C.sub.max ratio is about 0.2 to about 0.8 after oral administration to a subject. 26. The solid controlled release dosage form of claim 25, wherein the administration is in the fasted state. 27. The solid controlled release dosage form of claim 8, wherein the mean AUC (ng*h/mL) after oral administration to a subject in the fed state is less than 20% higher than the AUC (ng*h/mL) after oral administration to a subject in the fasted state. 28. The solid controlled release dosage form of claim 8, wherein the mean C.sub.max (ng/mL) after oral administration to a subject in the fed state is less than 80% higher than the C.sub.max after oral administration to a subject in the fasted state. 29. The solid controlled release dosage form of claim 8, wherein the mean T.sub.max (h) after oral administration to a subject in the fed state is within 25% of the T.sub.max (h) after oral administration to a subject in the fasted state. 30. The solid controlled release dosage form of claim 8, wherein the mean T.sub.1/2 (h) after oral administration to a subject in the fed state is within 8% of the T.sub.1/2 after oral administration to a subject in the fasted state.