Pharmaceutical formulation containing gelling agent
Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.
1. A controlled release oral dosage form comprising:
from about 2.5 mg to about 800 mg morphine or a pharmaceutically acceptable salt thereof; and
a gelling agent comprising polyethylene oxide in an effective amount to impart a viscosity of at least about 10 cP when the dosage form is subjected to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid;
the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.
2. The controlled release oral dosage form of claim 1 , wherein the ratio of polyethylene oxide to morphine or pharmaceutically acceptable salt thereof is from about 1:40 to about 40:1.
3. The controlled release oral dosage form of claim 1 , wherein the ratio of polyethylene oxide to morphine or pharmaceutically acceptable salt thereof is from about 1:1 to about 30:1.
4. The controlled release oral dosage form of claim 1 , wherein the ratio of polyethylene oxide to morphine or pharmaceutically acceptable salt thereof is from about 2:1 to about 10:1.
5. The controlled release oral dosage form of claim 1 , wherein the aqueous liquid is water.
6. The controlled release oral dosage form of claim 1 , wherein the viscosity is imparted when the dosage form is subjected to tampering by dissolution in about 1 to about 3 ml of aqueous liquid.
7. The controlled release oral dosage form of claim 1 , wherein a viscosity of at least about 60 cP is imparted.
8. The controlled release oral dosage form of claim 1 , wherein the polyethylene oxide possesses a weight-average molecular weight of from about 1,000,000 to about 10,000,000.
9. The controlled release oral dosage form of claim 8 , wherein the polyethylene oxide possesses a weight-average molecular weight of from about 1,000,000 to about 7,000,000.
10. The controlled release oral dosage form of claim 8 , wherein the polyethylene oxide possesses a weight-average molecular weight of about 5,000,000.
11. The controlled release oral dosage form of claim 1 , wherein the morphine or pharmaceutically acceptable salt thereof comprises morphine sulfate.
12. The controlled release oral dosage form of claim 11 , comprising from about 2.5 mg to about 30 mg morphine sulfate.
13. The controlled release oral dosage form of claim 11 , comprising about 2.5 mg morphine sulfate.
14. The controlled release oral dosage form of claim 11 , comprising about 30 mg morphine sulfate.
15. The controlled release oral dosage form of claim 11 , wherein the polyethylene oxide:morphine sulfate ratio is from about 1:40 to about 40:1 by weight.
16. The controlled release oral dosage form of claim 11 , wherein the polyethylene oxide:morphine sulfate ratio is from about 1:1 to about 30:1 by weight.
17. The controlled release oral dosage form of claim 11 , wherein the polyethylene oxide:morphine sulfate ratio is from about 2:1 to about 10:1 by weight.
18. The controlled release oral dosage form of claim 11 , wherein the polyethylene oxide:morphine sulfate ratio is from about 1:15 to about 15:1 by weight.
19. The controlled release oral dosage form of claim 11 , wherein the polyethylene oxide:morphine sulfate ratio is from about 1:8 to about 8:1 by weight.
20. The controlled release oral dosage form of claim 11 , wherein the polyethylene oxide:morphine sulfate ratio is from about 1:3 to about 3:1 by weight.
21. The controlled release oral dosage form of claim 1 , wherein the viscosity is obtained when the dosage form is subjected to tampering by crushing and dissolution in the aqueous liquid.
22. The controlled release oral dosage form of claim 1 , wherein the viscosity is obtained when the dosage form is subjected to tampering by dissolution in the aqueous liquid with heating greater than 45° C.