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 an abuse deterrent controlled release dosage form comprising:
preparing a mixture of hydrocodone or a pharmaceutically acceptable salt thereof and a gelling agent comprising polyethylene oxide and a cellulosic polymer; and
formulating the mixture into an abuse deterrent dosage form that forms 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 polyethylene oxide to hydrocodone or pharmaceutically acceptable salt thereof from about 40:1 to about 1:40; 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 cellulosic polymer is selected from the group consisting of microcrystalline cellulose, sodium carboxymethylcellulose, methylcellulose, ethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose and combinations thereof.
43 . The method of claim 42 , wherein the cellulosic polymer is selected from the group consisting of hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose and combinations thereof.
44 . The method of claim 41 , wherein the cellulosic polymer comprises microcrystalline cellulose.
45 . The method of claim 41 , wherein the cellulosic polymer comprises hydroxypropylcellulose.
46 . The method of claim 41 , wherein the cellulosic polymer comprises hydroxypropylcellulose and microcrystalline cellulose.
47 . The method of claim 41 , wherein the dosage form does not comprise a semi-permeable coating.
48 . The method of claim 47 , wherein the dosage form comprises a film coating.
49 . The method of claim 41 , wherein the hydrocodone or pharmaceutically acceptable salt thereof and the gelling agent are granulated and compressed into a tablet.
50 . The method of claim 41 , wherein the gel is unsuitable for injection with an insulin syringe.
51 . The method of claim 41 , wherein the gel is difficult to pull into an insulin syringe.
52 . The method of claim 41 , wherein the gel cannot be filled into an insulin syringe without picking up pockets of air.
53 . The method of claim 41 , wherein the gel has a milk like color.
54 . The method of claim 41 , wherein the aqueous liquid is water.
55 . The method of claim 41 , wherein the dosage form forms the gel when subjected to tampering comprising dissolution in about 1 ml to about 3 ml of aqueous liquid.
56 . The method of claim 41 , wherein the dosage form forms the gel when subjected to tampering comprising crushing and dissolution in the aqueous liquid.
57 . The method of claim 41 , wherein the dosage form forms the gel when subjected to tampering comprising dissolution in the aqueous liquid at ambient temperature.
58 . The method of claim 41 , wherein the dosage form forms the gel when subjected to tampering comprising dissolution in the aqueous liquid with heating greater than 45° C.
59 . The method of claim 41 , wherein the gel has a viscosity of about 10 cP or more.
60 . The method of claim 41 , wherein the gel has a viscosity of about 60 cP or more.
61 . The method of claim 41 , wherein the gel has a viscosity of about 120 cP or more.
62 . The method of claim 41 , wherein the gel has a viscosity from about 120 cP to about 5,000 cP.
63 . The method of 41 , wherein the hydrocodone or pharmaceutically acceptable salt thereof comprises hydrocodone bitartrate.
64 . The method of claim 63 , comprising from about 75 ng to about 750 mg hydrocodone bitartrate.
65 . The controlled release dosage form of claim 41 , wherein the polyethylene oxide has a weight average molecular weight from about 100,000 daltons to about 1,000,000 daltons.
66 . The controlled release dosage form 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.
67 . The controlled release dosage form of claim 41 , wherein the ratio of polyethylene oxide to hydrocodone or pharmaceutically acceptable salt thereof is from about 1:8 to about 8:1.
68 . The controlled release dosage form of claim 41 , wherein the ratio of polyethylene oxide to hydrocodone or pharmaceutically acceptable salt thereof is from about 1:1 to about 30:1.
69 . A method of preparing an abuse deterrent controlled release dosage form comprising:
preparing a mixture of hydrocodone bitartrate, polyethylene oxide and hydroxypropylcellulose; and
formulating the mixture into an abuse deterrent dosage form that forms a gel having a viscosity of at least 10 cP 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 polyethylene oxide to hydrocodone bitartrate from about 30:1 to about 1:30; and
the dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient.
70 . The method of claim 69 , wherein the dosage form has a ratio of polyethylene oxide to hydrocodone bitartrate from about 30:1 to about 1:1.