Pharmaceutical formulation containing gelling agent
First Claim
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1. A controlled release oral solid dosage form comprising:
- a first population of particles comprising hydrocodone bitartrate and an ammonio methacrylate copolymer and a second population of particles comprising polyethylene oxide and coated with a coating, whereinthe particles of the first population are free from polyethylene oxide;
the particles of the second population have a diameter from about 0.5 mm to about 2 mm and are free from hydrocodone bitartrate;
polyethylene oxide is releasable from the particles of the second population in an effective amount to impart a viscosity from 10 cP to 5000 cP when the dosage form is crushed and dissolved in from about 0.5 ml to about 10 ml of an aqueous liquid; and
hydrocodone bitartrate is the only drug in the dosage form;
the dosage form is a capsule.
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Abstract
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.
328 Citations
22 Claims
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1. A controlled release oral solid dosage form comprising:
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a first population of particles comprising hydrocodone bitartrate and an ammonio methacrylate copolymer and a second population of particles comprising polyethylene oxide and coated with a coating, wherein the particles of the first population are free from polyethylene oxide; the particles of the second population have a diameter from about 0.5 mm to about 2 mm and are free from hydrocodone bitartrate; polyethylene oxide is releasable from the particles of the second population in an effective amount to impart a viscosity from 10 cP to 5000 cP when the dosage form is crushed and dissolved in from about 0.5 ml to about 10 ml of an aqueous liquid; and hydrocodone bitartrate is the only drug in the dosage form; the dosage form is a capsule. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A controlled release oral solid dosage form comprising a capsule containing:
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a first population of particles comprising hydrocodone bitartrate and an ammonio methacrylate copolymer and a second population of particles comprising polyethylene oxide and coated with a coating, wherein hydrocodone bitartrate is the only drug in the dosage form; the particles of the first population are free from polyethylene oxide; the particles of the second population have a diameter from about 0.5 mm to about 2 mm and are free from hydrocodone bitartrate; polyethylene oxide is releasable from the particles of the second population in an effective amount to impart a viscosity of at least 10 cP when the dosage form is crushed and dissolved in from about 0.5 ml to about 10 ml of water. - View Dependent Claims (13, 14)
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15. A controlled release oral solid dosage form comprising a capsule containing:
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a first population of particles comprising hydrocodone bitartrate and an ammonio methacrylate copolymer and a second population of particles comprising polyethylene oxide and coated with a coating, wherein hydrocodone bitartrate is the only drug in the dosage form; the particles of the first population are free from polyethylene oxide; the particles of the second population have a diameter from about 0.5 mm to about 2 mm and are free from hydrocodone bitartrate; polyethylene oxide is releasable from the particles of the second population in an effective amount to impart a viscosity from 10 cP to 2000 cP when the dosage form is crushed and dissolved in from about 0.5 ml to about 10 ml of water. - View Dependent Claims (16, 17)
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18. A controlled release oral solid dosage form comprising:
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a first population of particles comprising hydrocodone bitartrate and a controlled release material comprising an acrylic resin, and a second population of particles comprising a gelling agent and one or more pharmaceutically acceptable hydrophobic materials, wherein hydrocodone bitartrate is the only drug in the dosage form; the particles of the first population are free from gelling agent; the particles of the second population have a diameter from about 0.5 mm to about 2 mm and are free from hydrocodone bitartrate; the gelling agent is releasable from the particles of the second population in an effective amount to impart a viscosity from 10 cP to 5000 cP when the dosage form is crushed and dissolved in from about 0.5 ml to about 10 ml of an aqueous liquid; and the gelling agent is polyethylene oxide. - View Dependent Claims (19, 20, 21, 22)
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Specification