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. An immediate release oral dosage form comprising:
a compressed mixture, comprising:
a therapeutically effective amount of oxycodone hydrochloride;
a gelling agent comprising polyethylene oxide, the polyethylene oxide in a ratio to oxycodone hydrochloride from about 1:1 to about 8:1 by weight;
a disintegrant;
sodium lauryl sulfate; and
magnesium stearate,
the dosage form providing an immediate release of the oxycodone hydrochloride when orally administered to a human patient.
2. The immediate release oral dosage form of claim 1 , wherein the ratio of the polyethylene oxide to the oxycodone hydrochloride is from about 2:1 to about 8:1.
3. The immediate release oral dosage form of claim 1 , wherein the gelling agent is in an effective amount to form a gel when the dosage form is subjected to tampering by dissolution in about 0.5 ml to about 10 ml of an aqueous liquid.
4. The immediate release oral dosage form of claim 3 , wherein the aqueous liquid is water.
5. The immediate release oral dosage form of claim 3 , wherein the gel has a viscosity of at least 10 cP.
6. The immediate release oral dosage form of claim 3 , wherein the gel has a viscosity of at least 60 cP.
7. The immediate release oral dosage form of claim 1 , further comprising an additional drug selected from the group consisting of an NSAID, a COX-2 inhibitor, acetaminophen, aspirin, an NMDA receptor antanalgesic, a drug that blocks a major intracellular consequence of NMDA-receptor activation, an antitussive, an expectorant, a decongestant, an antihistamine and mixtures thereof.
8. The immediate release oral dosage form of claim 1 , wherein the ratio of the polyethylene oxide to the oxycodone hydrochloride is from about 1:1 to about 3:1.
9. The immediate release oral dosage form of claim 1 , further comprising microcrystalline cellulose.
10. The immediate release oral dosage form of claim 1 , further comprising silicon dioxide.
11. The immediate release oral dosage form of claim 1 , wherein the dosage form is a tablet.
12. The immediate release oral dosage form of claim 1 , wherein the gelling agent is in an effective amount to impart a viscosity of at least 120 cP when the dosage form is subjected to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid.
13. The immediate release oral dosage form of claim 1 , wherein the gelling agent is in an effective amount to impart a viscosity from about 120 cP to about 5,000 cP when the dosage form is subjected to tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid.
14. The immediate release oral dosage form of claim 3 , wherein the imparted viscosity makes the tampered dosage form difficult to pull into an insulin syringe.
15. The immediate release oral dosage form of claim 3 , wherein the imparted viscosity makes the tampered dosage form difficult to pull into an insulin syringe as compared to the same dosage form having an inert pharmaceutically acceptable excipient in place of the gelling agent.
16. The immediate release oral dosage form of claim 3 , wherein the tampered dosage form cannot be filled into an insulin syringe without picking up pockets of air.
17. The immediate release oral dosage form of claim 3 , wherein the tampered dosage form has a milk like color.
18. The immediate release oral dosage form of claim 3 , wherein the viscosity is imparted when the dosage form is subjected to tampering by crushing and dissolution in the aqueous liquid.
19. The immediate release oral dosage form of claim 3 , wherein the viscosity is imparted when the dosage form is subjected to tampering by dissolution in the aqueous liquid at ambient temperature.
20. The immediate release oral dosage form of claim 3 , wherein the viscosity is imparted when the dosage form is subjected to tampering by dissolution in the aqueous liquid with heating greater than 45° C.
21. The immediate release oral dosage form of claim 1 , wherein the polyethylene oxide has a weight average molecular weight from about 100,000 daltons to about 1,000,000 daltons.
22. The immediate release oral dosage form of claim 1 , wherein the polyethylene oxide has a weight average molecular weight from about 1,000,000 daltons to about 10,000,000 daltons.
23. The immediate release oral dosage form of claim 1 , comprising about 2.5 mg to about 10 mg of the oxycodone hydrochloride.
24. The immediate release oral dosage form of claim 1 , comprising about 5 mg of the oxycodone hydrochloride.