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 320 mg oxycodone or a pharmaceutically acceptable salt thereof;
acetaminophen; 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 aqueous liquid is water.
3. 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 ml to about 3 ml of aqueous liquid.
4. The controlled release oral dosage form of claim 1 , wherein a viscosity of at least about 60 cP is imparted.
5. The controlled release oral dosage form of claim 1 , wherein the oxycodone or pharmaceutically acceptable salt thereof comprises oxycodone hydrochloride.
6. The controlled release oral dosage form of claim 5 , comprising from about 5 mg to about 10 mg oxycodone hydrochloride.
7. 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.
8. The controlled release oral dosage form of claim 1 , wherein the viscosity is obtained when the dosage form is subject to tampering by dissolution in the aqueous liquid with heating greater than 45° C.
9. The controlled release oral dosage form of claim 1 , wherein the dosage is in the form of a tablet.
10. The controlled release oral dosage form of claim 1 , wherein the dosage form further comprises microcrystalline cellulose.
11. The controlled release oral dosage form of claim 1 , wherein the dosage form further comprises hydroxypropyl cellulose.
12. The controlled release oral dosage form of claim 1 , wherein the dosage form further comprises magnesium stearate.
13. The controlled release oral dosage form of claim 1 , wherein the dosage form further comprises starch.