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 method of preparing an abuse deterrent controlled release oral dosage form comprising:
preparing a mixture comprising an active agent comprising hydrocodone or a pharmaceutically acceptable salt thereof, and a gelling agent comprising polyethylene oxide and a poloxamer; and
formulating the mixture into an abuse deterrent dosage form comprising a cellulosic polymer coating,
wherein the hydrocodone or pharmaceutically acceptable salt thereof is the sole active agent in the dosage form,
the abuse deterrent dosage form forming a gel when the dosage form is subjected to tampering comprising dissolution in from about 0.5 ml to about 10 ml of an aqueous liquid;
the dosage form having a ratio of gelling agent to hydrocodone or pharmaceutically acceptable salt thereof from about 2:1 to about 15:1; and
the dosage form providing a therapeutic effect for about 24 hours or longer when orally administered to a human patient.
2. The method of claim 1 , wherein the gelling agent is in an effective amount to impart a viscosity of about 10 cP or more to the gel.
3. The method of claim 1 , wherein the gelling agent is in an effective amount to impart a viscosity of about 60 cP or more to the gel.
4. The method of claim 1 , wherein the gelling agent is in an effective amount to impart a viscosity of about 120 cP or more to the gel.
5. The method of claim 1 , wherein the gelling agent is in an effective amount to impart a viscosity of about 2,000 cP or more to the gel.
6. The method 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 to the gel.
7. The method of claim 1 , wherein the hydrocodone or pharmaceutically acceptable salt thereof comprises hydrocodone bitartrate.
8. The method of claim 1 , wherein the imparted viscosity makes the dosage form subjected to tampering unsuitable for injection with an insulin syringe.
9. The method of claim 1 , wherein the imparted viscosity makes the dosage form subjected to tampering difficult to pull into an insulin syringe.
10. The method of claim 1 , wherein the dosage form subjected to tampering cannot be filled into an insulin syringe without picking up pockets of air.
11. The method of claim 1 , wherein the dosage form subjected to tampering has a milk like color.
12. The method of claim 1 , wherein the aqueous liquid is water.
13. The method of claim 1 , wherein the viscosity is imparted when the dosage form is subjected to tampering comprising dissolution in about 1 ml to about 3 ml of aqueous liquid.
14. The method of claim 1 , wherein the viscosity is imparted when the dosage form is subjected to tampering comprising crushing and dissolution in the aqueous liquid.
15. The method of claim 1 , wherein the viscosity is imparted when the dosage form is subjected to tampering comprising dissolution in the aqueous liquid at ambient temperature.
16. The method of claim 1 , wherein the viscosity is imparted when the dosage form is subjected to tampering comprising dissolution in the aqueous liquid with heating greater than 45° C.
17. The method of claim 7 , wherein the gelling agent is in an effective amount to impart a viscosity of about 10 cP or more to the gel.
18. The method of claim 7 , wherein the gelling agent is in an effective amount to impart a viscosity of about 60 cP or more to the gel.
19. The method of claim 7 , wherein the gelling agent is in an effective amount to impart a viscosity of about 120 cP or more to the gel.
20. The method of claim 7 , wherein the gelling agent is in an effective amount to impart a viscosity from about 120 cP to about 5,000 cP to the gel.
21. The method of 1 , wherein the gelling agent further comprises a cellulosic polymer.
22. The method of claim 1 , wherein the mixture comprises from about 75 ng to about 750 mg hydrocodone bitartrate.
23. The method of claim 1 , wherein the polyethylene oxide has a weight average molecular weight of from about 100,000 daltons to about 1,000,000 daltons.
24. The method of claim 1 , wherein the polyethylene oxide has a weight average molecular weight of from about 1,000,000 daltons to about 10,000,000 daltons.
25. The method of claim 7 , wherein the polyethylene oxide has a weight average molecular weight of from about 100,000 daltons to about 1,000,000 daltons.
26. The method of claim 7 , wherein the polyethylene oxide has a weight average molecular weight of from about 1,000,000 daltons to about 10,000,000 daltons.