➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Moodys
Boehringer Ingelheim
McKesson
McKinsey
Mallinckrodt
Colorcon

Last Updated: October 31, 2020

DrugPatentWatch Database Preview

Claims for Patent: 9,872,837

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

Summary for Patent: 9,872,837
Title: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:15/045,977
Patent Claims: 1. A solid tamper resistant controlled release dosage form comprising: hydrocodone or a pharmaceutically acceptable salt thereof dispersed in a matrix material comprising polyethylene oxide having an average molecular weight from about 300,000 to about 10,000,000 as measured by correlation to viscosity, wherein the dosage form is cured at a temperature of at least 60.degree. C. for at least 1 minute; 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 dosage form can be flattened without breaking, wherein the thickness of the dosage form after flattening corresponds to no more than about 20% of the thickness of the dosage form before flattening; and the amount of hydrocodone or pharmaceutically acceptable salt thereof released at 0.5 hour from a flattened dosage form deviates no more than about 20% points from a non-flattened 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.

2. The solid controlled release tamper resistant dosage form of claim 1, wherein the polyethylene oxide has an average molecular weight from about 1,000,000 to about 10,000,000 as measured by correlation to viscosity.

3. The solid controlled release tamper resistant dosage form of claim 1, wherein the matrix material further comprises a cellulose ether.

4. The solid controlled release tamper resistant dosage form of claim 3, wherein the cellulose ether comprises a hydroxyalkylcellulose.

5. The solid controlled release tamper resistant dosage form of claim 4, wherein the hydroxyalkylcellulose is hydroxypropylcellulose.

6. The solid controlled release tamper resistant dosage form of claim 3, wherein the matrix material further comprises microcrystalline cellulose.

7. The solid controlled release tamper resistant dosage form of claim 6, comprising a compressed dispersion of the hydrocodone or pharmaceutically acceptable salt thereof and the matrix material.

8. The solid controlled release tamper resistant dosage form of claim 6, comprising granules comprising the hydrocodone or pharmaceutically acceptable salt thereof and the matrix material.

9. The solid controlled release tamper resistant dosage form of claim 8, wherein the granules are compressed into a tablet.

10. The solid controlled release tamper resistant dosage form of claim 6, wherein the hydrocodone or pharmaceutically acceptable salt thereof is hydrocodone bitartrate.

11. The solid controlled release tamper resistant dosage form of claim 10, wherein the amount of hydrocodone bitartrate in the dosage form is from about 0.5 mg to about 1250 mg.

12. The solid controlled release tamper resistant dosage form of claim 6, 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.

13. The solid controlled release tamper resistant dosage form of claim 6, which provides a T.sub.max(h) of hydrocodone from about 4 to about 20 hours after oral administration to a subject.

14. The solid controlled release tamper resistant dosage form of claim 12, wherein the administration is a first administration to a population of subjects.

15. The solid controlled release tamper resistant dosage form of claim 12, wherein the administration is steady state administration to a subject.

16. The solid controlled release tamper resistant dosage form of claim 6, which contains about 20 mg hydrocodone or pharmaceutically acceptable salt thereof.

17. The solid controlled release tamper resistant dosage form of claim 6, which contains about 120 mg hydrocodone or pharmaceutically acceptable salt thereof.

18. The solid controlled release tamper resistant dosage form of claim 6, 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.

19. The solid controlled release tamper resistant dosage form of claim 6, 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.

20. The solid controlled release tamper resistant dosage form of claim 6, which provides a mean T.sub.max (h) after oral administration to a subject of about 10 to about 20.

21. The solid controlled release tamper resistant dosage form of claim 6, which provides a mean T.sub.1/2 (h) after oral administration to a subject of about 5 to about 10.

22. The solid controlled release tamper resistant dosage form of claim 6, which provides a mean T.sub.lag (h) after oral administration to a subject of about 0.01 to about 0.2.

23. The solid controlled release tamper resistant dosage form of claim 6, wherein the mean C.sub.24/C.sub.max ratio is about 0.2 to about 0.8 after oral administration to a subject.

24. The solid controlled release tamper resistant dosage form of claim 1, comprising a core comprising a first portion of the hydrocodone or pharmaceutically acceptable salt thereof dispersed in a first portion of the matrix material; and a layer encasing the core and comprising a second portion of the hydrocodone or pharmaceutically acceptable salt thereof dispersed in a second portion of the matrix material.

25. The solid controlled release tamper resistant dosage form of claim 23, wherein the layer is a compression coating.

26. The solid controlled release tamper resistant dosage form of claim 23, further comprising a hydrophilic coating over the layer encasing the core.

27. The solid controlled release tamper resistant dosage form of claim 26, wherein the hydrophilic coating is a cosmetic coat.

28. The solid controlled release tamper resistant dosage form of claim 23, wherein the first portion of the matrix material comprises polyethylene oxide having an average molecular weight from about 1,000,000 to about 10,000,000 and the second portion of the matrix material comprises polyethylene oxide having an average molecular weight from about 1,000,000 to about 10,000,000, all as measured by correlation to viscosity.

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Baxter
Harvard Business School
Colorcon
Medtronic
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.