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 preparing a pharmaceutical dosage form comprising:
preparing a mixture comprising buprenorphine hydrochloride and a gelling agent comprising polyethylene oxide and hydroxypropylmethylcellulose; and
formulating the mixture into a dosage form that provides an immediate release of the buprenorphine hydrochloride upon oral administration 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 when the dosage form is subjected to tampering comprising dissolution in from about 0.5 to about 10 ml of an aqueous liquid.
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 when the dosage form is subjected to tampering comprising dissolution in from about 0.5 to about 10 ml of an aqueous liquid.
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 when the dosage form is subjected to tampering comprising dissolution in from about 0.5 to about 10 ml of an aqueous liquid.
45 . The method of claim 41 , wherein the gelling agent is in an effective amount to impart a viscosity of about 375 cP or more when the dosage form is subjected to tampering comprising dissolution in from about 0.5 to about 10 ml of an aqueous liquid.
46 . 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 when the dosage form is subjected to tampering comprising dissolution in from about 0.5 to about 10 ml of an aqueous liquid.
47 . The method of claim 41 , 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 comprising tampering by dissolution in from about 0.5 to about 10 ml of an aqueous liquid.
48 . The method of claim 41 , wherein the gelling agent further comprises a sugar derived alcohol.
49 . The method of claim 41 , wherein the ratio of polyethylene oxide to buprenorphine hydrochloride is from about 1:40 to about 40:1.
50 . The method of claim 41 , wherein the ratio of polyethylene oxide to buprenorphine hydrochloride is from about 1:30 to about 30:1.
51 . The method of claim 41 , wherein the ratio of polyethylene oxide to buprenorphine hydrochloride is from about 1:8 to about 8:1.
52 . The method of claim 41 , wherein the ratio of polyethylene oxide to buprenorphine hydrochloride is from about 1:1 to about 40:1.
53 . The method of claim 41 , wherein the ratio of polyethylene oxide to buprenorphine hydrochloride is from about 1:1 to about 30:1.
54 . The method of claim 41 , wherein the ratio of polyethylene oxide to buprenorphine hydrochloride is from about 1:1 to about 8:1.
55 . The method of claim 41 , wherein the aqueous liquid is water.
56 . The method of claim 41 , wherein the dosage form forms a gel when the dosage form is subjected to tampering comprising dissolution in about 0.5 to about 10 ml of aqueous liquid.
57 . The method of claim 41 , wherein the dosage form forms a gel when the dosage form is subjected to tampering comprising dissolution in about 1 to about 3 ml of aqueous liquid.
58 . The method of claim 41 , wherein the dosage form forms a gel when the dosage form is subjected to tampering comprising dissolution in the aqueous liquid with heating greater than 45° C.
59 . The method of claim 41 , wherein the polyethylene oxide has a weight average molecular weight of about 50,000 daltons to about 1,000,000 daltons.
60 . The method of claim 41 , wherein the polyethylene oxide has a weight average molecular weight of about 100,000 daltons.
61 . The method of claim 41 , wherein the polyethylene oxide has a weight average molecular weight of about 200,000 daltons.
62 . A method of preparing a pharmaceutical dosage form comprising:
preparing a mixture comprising buprenorphine hydrochloride, polyethylene oxide, hydroxypropylmethylcellulose, a sugar derived alcohol and lime flavor;
formulating the mixture into a dosage form that provides an immediate release of the buprenorphine hydrochloride upon administration to a human patient,
wherein the polyethylene oxide is in an effective amount to impart a viscosity of about 10 cP or more when the dosage form is subjected to tampering comprising dissolution in from about 0.5 to about 10 ml of an aqueous liquid, and
wherein the ratio of polyethylene oxide to buprenorphine hydrochloride is from about 1:40 to about 40:1.
63 . A method of preparing a pharmaceutical dosage form comprising:
preparing a mixture comprising buprenorphine hydrochloride, polyethylene oxide, hydroxypropylmethylcellulose, a sugar derived alcohol and lime flavor;
formulating the mixture into a dosage form that provides an immediate release of the buprenorphine hydrochloride upon administration to a human patient,
wherein the polyethylene oxide has a weight average molecular weight of about 50,000 daltons to about 1,000,000 daltons, and
wherein the ratio of polyethylene oxide to buprenorphine hydrochloride is from about 1:30 to about 30:1.