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 - 40 . (canceled)
41 . A method of treating pain comprising administering to a patient in need thereof an abuse deterrent controlled release oral dosage form comprising:
a matrix comprising oxycodone or a pharmaceutically acceptable salt thereof, a copolymer comprising trimethyl ammonioethyl methacrylate, and a gelling agent comprising polyethylene oxide and microcrystalline cellulose; and
a coating over the matrix, the coating comprising a mixture comprising an aminoalkyl methacrylate copolymer, sodium lauryl sulfate, talc and simethicone;
wherein the oxycodone or pharmaceutically acceptable salt thereof is the sole active agent in the dosage form,
the abuse deterrent dosage form forming a gel when 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 oxycodone or pharmaceutically acceptable salt thereof from about 8:1 to about 1:8; and
the dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient.
42 . The method of claim 41 , wherein the gelling agent is in an effective amount to impart a viscosity of about 10 cP or more to the gel.
43 . The method of claim 41 , wherein the gelling agent is in an effective amount to impart a viscosity of about 60 cP or more to the gel.
44 . The method of claim 41 , wherein the gelling agent is in an effective amount to impart a viscosity of about 120 cP or more to the gel.
45 . The method of claim 41 , wherein the gelling agent is in an effective amount to impart a viscosity of about 2,000 cP or more to the gel.
46 . The method of claim 41 , wherein the dosage form subjected to tampering is unsuitable for injection with an insulin syringe.
47 . The method of claim 41 , wherein the dosage form subjected to tampering is difficult to pull into an insulin syringe.
48 . The method of claim 41 , wherein the dosage form subjected to tampering cannot be filled into an insulin syringe without picking up pockets of air.
49 . The method of claim 41 , wherein the dosage form subjected to tampering has a milk like color.
50 . The method of claim 41 , wherein the aqueous liquid is water.
51 . The method of claim 41 , wherein the gel is formed when the dosage form is subjected to tampering comprising dissolution in about 1 ml to about 3 ml of aqueous liquid.
52 . The method of claim 43 , wherein the gel is formed when the dosage form is subjected to tampering comprising crushing and dissolution in the aqueous liquid.
53 . The method of claim 41 , wherein the gel is formed when the dosage form is subjected to tampering comprising dissolution in the aqueous liquid at ambient temperature.
54 . The method of claim 41 , wherein the gel is formed when the dosage form is subjected to tampering comprising dissolution in the aqueous liquid with heating greater than 45° C.
55 . The method of claim 41 , wherein the polyethylene oxide has a weight average molecular weight from about 100,000 daltons to about 1,000,000 daltons.
56 . The method of claim 41 , wherein the polyethylene oxide has a weight average molecular weight from about 1,000,000 daltons to about 10,000,000 daltons.
57 . The method of claim 41 , wherein the ratio of gelling agent to oxycodone or pharmaceutically acceptable salt thereof is from about 1:1 to about 8:1.
58 . A method of treating pain comprising administering to a patient in need thereof an abuse deterrent controlled release oral dosage form comprising:
a matrix comprising oxycodone or a pharmaceutically acceptable salt thereof, a copolymer comprising trimethyl ammonioethyl methacrylate, and a gelling agent comprising polyethylene oxide and microcrystalline cellulose; and
a coating over the matrix, the coating comprising a mixture comprising an aminoalkyl methacrylate copolymer, sodium lauryl sulfate, talc and simethicone;
wherein the oxycodone or pharmaceutically acceptable salt thereof is the sole active agent in the dosage form,
the abuse deterrent dosage form forming a gel when 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 oxycodone or pharmaceutically acceptable salt thereof from about 1:1 to about 1:8; and
the dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient.
59 . The method of claim 58 , wherein the polyethylene oxide has a weight average molecular weight from about 100,000 daltons to about 1,000,000 daltons.
60 . The method of claim 58 , wherein the polyethylene oxide has a weight average molecular weight from about 1,000,000 daltons to about 10,000,000 daltons.