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 mixture of (i) morphine or a pharmaceutically acceptable thereof; and
(ii) a gelling agent comprising polyethylene oxide having a weight average molecular weight of about 1,000,000 Da to about 10,000,000 Da, 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;
the dosage form having a ratio of gelling agent to morphine or pharmaceutically acceptable salt thereof from about 40:1 to about 1:40;
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 , wherein the gelling agent is in an effective amount to impart a viscosity of about 60 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.
3. The controlled release oral dosage form of claim 1 , wherein the gelling agent is in an effective amount to impart a viscosity of about 120 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.
4. The controlled release oral dosage form of claim 1 , wherein the gelling agent is in an effective amount to impart a viscosity of about 2,000 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.
5. The controlled 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 ml to about 10 ml of an aqueous liquid.
6. The controlled release oral dosage form of claim 1 , comprising from about 750 ng to about 750 mg of morphine or a pharmaceutically acceptable salt thereof.
7. The controlled release oral dosage form of claim 1 , comprising from about 2.5 mg to about 800 mg of morphine or a pharmaceutically acceptable salt thereof.
8. The controlled release oral dosage form of claim 1 , wherein the aqueous liquid is water.
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 about 1 ml to about 3 ml of aqueous liquid.
10. The controlled release oral dosage form of claim 2 , wherein the viscosity is imparted when the dosage form is subjected to tampering by crushing and dissolution in the aqueous liquid.
11. 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.
12. 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.
13. The controlled release oral dosage form of 1 , wherein the gelling agent further comprises a cellulosic polymer.
14. The controlled release oral dosage form of claim 1 , comprising morphine sulfate.
15. The controlled release dosage form of claim 1 , wherein the ratio of gelling agent to morphine or pharmaceutically acceptable salt thereof is from about 1:1 to about 30:1.
16. The controlled release dosage form of claim 1 , wherein the ratio of gelling agent to morphine or pharmaceutically acceptable salt thereof is from about 2:1 to about 15:1.
17. A controlled release oral dosage form comprising:
a mixture of (i) from about 2.5 mg to about 800 mg morphine or a pharmaceutically acceptable salt thereof; and
(ii) a gelling agent comprising polyethylene oxide, having a weight average molecular weight of about 1,000,000 Da to about 10,000,000 Da, 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 morphine or pharmaceutically acceptable salt thereof from about 30:1 to about 1:30;
the dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient.
18. The controlled release oral dosage form of claim 17 , wherein the gelling agent is in an effective amount to impart a viscosity of about 60 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.