Pharmaceutical composition 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 tamper-resistant immediate release pharmaceutical tablet comprising a compressed mixture comprising:
(a) oxycodone hydrochloride;
(b) polyethylene oxide in a ratio to oxycodone hydrochloride from about 1:1 to about 40:1 by weight;
(c) polyvinylpyrrolidone; and
(d) a surfactant;
wherein the polyethylene oxide forms a gel upon tampering with the tablet by solvent extraction such that when the tampered tablet is dissolved in about 1 ml to about 5 ml of an aqueous liquid the resultant mixture has a viscosity of at least 10 cP.
2. A tamper-resistant immediate release pharmaceutical tablet according to claim 1 , comprising from about 5 mg to about 20 mg oxycodone hydrochloride.
3. A tamper-resistant immediate release pharmaceutical tablet according to claim 1 , wherein the surfactant is sodium lauryl sulfate.
4. A tamper-resistant immediate release pharmaceutical tablet according to any one of claims 1 to 3 , wherein the polyethylene oxide possesses a weight-average molecular weight of about 1,000,000 to about 10,000,000.
5. A tamper-resistant immediate release pharmaceutical tablet according to claim 4 , wherein the polyethylene oxide possesses a weight-average molecular weight of about 1,000,000 to about 7,000,000.
6. A tamper-resistant immediate release pharmaceutical tablet according to claim 4 , wherein the polyethylene oxide possesses a weight-average molecular weight of about 5,000,000.
7. A tamper-resistant immediate release pharmaceutical tablet according to any one of claims 1 to 3 comprising about 5 mg oxycodone hydrochloride.
8. A tamper-resistant immediate release pharmaceutical tablet of any one of claims 1 to 3 , wherein the resultant mixture has a viscosity of at least 60 cP.
9. A tamper-resistant immediate release pharmaceutical tablet according to any one of claims 1 to 3 , further comprising a film coating overcoated on the compressed mixture.
10. A tamper-resistant immediate release pharmaceutical tablet according to any one of claims 1 - 3 , wherein the tablet does not comprise an opioid antagonist.
11. The tamper-resistant immediate release pharmaceutical tablet according to any one of claims 1 - 3 , wherein the tablet imparts an irritating sensation to an abuser upon nasal administration of the tablet after tampering.
12. A tamper-resistant immediate release pharmaceutical tablet of claim 1 , consisting of a compressed mixture consisting of:
(a) oxycodone hydrochloride;
(b) polyethylene oxide having a weight-average molecular weight of about 1,000,000 to about 10,000,000 in a ratio to oxycodone hydrochloride from about 1:1 to about 40:1 by weight;
(c) polyvinylpyrrolidone; and
(d) sodium lauryl sulfate.
13. A tamper-resistant immediate release pharmaceutical tablet of claim 9 , consisting of
(I) a compressed mixture consisting of:
(a) oxycodone hydrochloride;
(b) polyethylene oxide having a weight-average molecular weight of about 1,000,000 to about 10,000,000 in a ratio to oxycodone hydrochloride from about 1:1 to about 40:1 by weight;
(c) polyvinylpyrrolidone;
(d) sodium lauryl sulfate; and
(II) a film coating overcoated on the compressed mixture.
14. The tamper-resistant immediate release pharmaceutical tablet according to any one of claims 1 - 3 , wherein the polyethylene oxide: oxycodone hydrochloride ratio is from about 1:1 to about 30:1 by weight.
15. The tamper-resistant immediate release pharmaceutical tablet according to claim 14 , wherein the polyethylene oxide: oxycodone hydrochloride ratio is from about 2:1 to about 10:1 by weight.
16. The tamper-resistant immediate release pharmaceutical tablet according to claim 14 , wherein the polyethylene oxide: oxycodone hydrochloride ratio is from about 1:15 to about 15:1 by weight.
17. The tamper-resistant immediate release pharmaceutical tablet according to claim 14 , wherein the polyethylene oxide: oxycodone hydrochloride ratio is from about 1:8 to about 8:1 by weight.
18. The tamper-resistant immediate release pharmaceutical tablet according to claim 14 , wherein the polyethylene oxide: oxycodone hydrochloride ratio is from about 1:3 to about 3:1 by weight.
19. The tamper-resistant immediate release pharmaceutical tablet according to claim 14 , wherein the polyethylene oxide: oxycodone hydrochloride ratio is from about 2:1 to about 30:1 by weight.
20. The tamper-resistant immediate release pharmaceutical tablet according to claim 14 , wherein the polyethylene oxide: oxycodone hydrochloride ratio is from about 3:1 to about 15:1 by weight.