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:
a matrix comprising a mixture of (i) hydrocodone or a pharmaceutically acceptable salt thereof; and
(ii) a gelling agent comprising polyethylene oxide, the gelling agent is in an effective amount to impart a viscosity of about 10 cP or more when the dosage form is subjected to tampering by dissolution in from about 0.5 ml to about 10 ml of an aqueous liquid;
a coating comprising a hydrophobic material, the coating applied on the matrix and comprising one or more passageways through the coating;
the dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient.
2. The controlled release oral dosage form of claim 1 , comprising from about 750 ng to about 750 mg hydrocodone or a pharmaceutically acceptable salt thereof.
3. The controlled release oral dosage form of claim 1 , comprising from about 2 mg to about 50 mg hydrocodone or a pharmaceutically acceptable salt thereof.
4. The controlled release oral dosage form of claim 1 , wherein the hydrocodone or pharmaceutically acceptable salt thereof is hydrocodone bitartrate.
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 ml to about 3 ml of aqueous liquid.
7. The controlled release oral dosage form of claim 1 , wherein the viscosity is imparted 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 imparted when the dosage form is subjected to tampering by dissolution in the aqueous liquid at ambient temperature.
9. 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 the aqueous liquid with heating greater than 45° C.
10. The controlled release oral dosage form of 1 , wherein the hydrophobic material comprises a cellulosic polymer.
11. The controlled release oral dosage form of claim 1 , wherein the cellulosic polymer comprises ethylcellulose.
12. The controlled release 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.
13. The controlled release 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.
14. The controlled release dosage form of claim 1 , wherein the ratio of gelling agent to hydrocodone or pharmaceutically acceptable salt thereof is from about 40:1 to about 1:40.
15. The controlled release dosage form of claim 1 , wherein the ratio of gelling agent to hydrocodone or pharmaceutically acceptable salt thereof is from about 1:1 to about 30:1.
16. A controlled release oral dosage form comprising:
a matrix comprising a mixture of (i) from about 750 ng to about 750 mg hydrocodone or a pharmaceutically acceptable salt thereof; and
(ii) a gelling agent comprising polyethylene oxide, the gelling agent is in an effective amount to impart a viscosity of at least 10 cP when the dosage form is subjected to tampering by 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 40:1 to about 1:40;
a coating comprising ethylcellulose, the coating applied on the matrix and comprising one or more passageways through the coating;
the dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient.