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 controlled release oral solid dosage form comprising:
(i) particles comprising methylphenidate or a pharmaceutically acceptable salt thereof and
(ii) particles comprising polyethylene oxide,
the dosage form providing a therapeutic effect for about 12 hours to about 24 hours when orally administered to a human patient, and when dissolved in from about 0.5 ml to about 10 ml of an aqueous liquid, forming a viscous gel,
wherein the particles comprising polyethylene oxide are free from said methylphenidate or pharmaceutically acceptable salt thereof.
42 . The controlled release oral solid dosage form of claim 41 , wherein the viscous gel is unsuitable for injection.
43 . The controlled release oral solid dosage form of claim 41 , wherein the particles comprising polyethylene oxide comprise a hydrophobic material.
44 . The controlled release oral solid dosage form of claim 43 , wherein the hydrophobic material is an ammonio methacrylate copolymer.
45 . The controlled release oral solid dosage form of claim 41 , wherein the viscous gel cannot be injected through an insulin syringe.
46 . The controlled release oral solid dosage form of claim 41 , wherein the particles comprising polyethylene oxide comprise polyvinylpyrrolidone.
47 . The controlled release oral solid dosage form of claim 44 , wherein the particles comprising methylphenidate and the particles comprising polyethylene oxide are contained in a pharmaceutically acceptable capsule.
48 . The controlled release oral solid dosage form of claim 47 , wherein the particles comprising said methylphenidate or pharmaceutically acceptable salt thereof and particles comprising polyethylene oxide are indistinguishable in appearance.
49 . The controlled release oral solid dosage form of claim 41 , wherein the viscous gel cannot be drawn into an insulin syringe.
50 . The controlled release oral solid dosage form of claim 41 , wherein the particles comprising said methylphenidate or pharmaceutically acceptable salt thereof have a diameter from about 0.5 mm to about 2.5 mm.
51 . The controlled release oral solid dosage form of claim 41 , wherein the polyethylene oxide is in an effective amount to impart a viscosity of at least about 10 cP to the dosage form when the dosage form is dissolved in from about 0.5 ml to about 10 ml of an aqueous liquid.
52 . The controlled release oral solid dosage form of claim 41 , wherein the polyethylene oxide is in an effective amount to impart a viscosity of at least about 60 cP to the dosage form when the dosage form is dissolved in from about 0.5 ml to about 10 ml of an aqueous liquid.
53 . The controlled release oral solid dosage form of claim 41 , wherein the polyethylene oxide is in an effective amount to impart a viscosity of from 120 cP to 5000 cP to the dosage form when the dosage form is dissolved in from about 0.5 to about 10 ml of an aqueous liquid.
54 . The controlled release oral solid dosage form of claim 41 , wherein the polyethylene oxide is in an effective amount to impart a viscosity of from 375 cP to 5000 cP to the dosage form when the dosage form is dissolved in from about 0.5 ml to about 10 ml of an aqueous liquid.
55 . The controlled release oral solid dosage form of claim 41 , wherein the polyethylene oxide is in an effective amount to impart a viscosity of from 2,000 cP to 5000 cP to the dosage form when the dosage form is dissolved in from about 0.5 ml to about 10 ml of an aqueous liquid.
56 . The controlled release oral solid dosage form of claim 41 , wherein the polyethylene oxide is in an effective amount to impart a viscosity of from 120 cP to 5,000 cP when the dosage form is dissolved in from about 0.5 ml to about 10 ml of an aqueous liquid.
57 . A controlled release oral solid dosage form comprising a capsule containing:
(i) particles comprising methylphenidate or a pharmaceutically acceptable salt thereof and
(ii) particles comprising polyethylene oxide,
the dosage form providing a therapeutic effect for about 12 hours when orally administered to a human patient, and having a viscosity unsuitable for injection when dissolved in from about 0.5 ml to about 10 ml of water, wherein
the particles comprising polyethylene oxide are free from said methylphenidate or pharmaceutically acceptable salt thereof.
58 . The controlled release oral solid dosage form of claim 57 , wherein the polyethylene oxide is in an effective amount to impart a viscosity of from 375 cP to 5000 cP when the dosage form is dissolved in from about 0.5 ml to about 10 ml of water.
59 . The controlled release oral solid dosage form of claim 57 , wherein the polyethylene oxide is in an effective amount to impart a viscosity of from 2000 cP to 5000 cP when the dosage form is dissolved.
60 . The controlled release oral solid dosage form of claim 57 , wherein the polyethylene oxide is in an effective amount to impart a viscosity of from 120 cP to 5,000 cP when the dosage form is dissolved in from about 0.5 ml to about 10 ml of water.
61 . A controlled release oral solid dosage form comprising a capsule containing:
(i) particles comprising methylphenidate or a pharmaceutically acceptable salt thereof and
(ii) particles comprising polyethylene oxide,
the dosage form providing a therapeutic effect for about 12 hours to about 24 hours when orally administered to a human patient, and when dissolved in from about 0.5 ml to about 10 ml of water, forming a viscous gel,
wherein the particles comprising polyethylene oxide are free from said methylphenidate or pharmaceutically acceptable salt thereof.
62 . The controlled release oral solid dosage form of claim 61 , wherein the particles comprising polyethylene oxide and the particles comprising said methylphenidate or pharmaceutically acceptable salt thereof are indistinguishable in appearance.
63 . The controlled release oral solid dosage form of claim 61 , wherein the polyethylene oxide is in an effective amount to impart a viscosity of from 10 cP to 60 cP when the dosage form is dissolved in from about 0.5 ml to about 10 ml of an aqueous liquid.
64 . The controlled release oral solid dosage form of claim 61 , wherein the polyethylene oxide is in an effective amount to impart a viscosity of from 120 cP to 5,000 cP when the dosage form is dissolved in from about 0.5 ml to about 10 ml of an aqueous liquid.