Pharmaceutical formulation containing gelling agent
First Claim
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1. A controlled release oral solid dosage form comprising:
- (i) a first population of particles comprising hydrocodone bitartrate; and
(ii) a second population of particles comprising polyethylene oxide;
whereinthe particles of the first population are free from polyethylene oxide;
the particles of the second population are free from hydrocodone bitartrate;
hydrocodone bitartrate is the only drug in the dosage form; and
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 3 ml of water.
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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.
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Citations
22 Claims
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1. A controlled release oral solid dosage form comprising:
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(i) a first population of particles comprising hydrocodone bitartrate; and (ii) a second population of particles comprising polyethylene oxide;
whereinthe particles of the first population are free from polyethylene oxide; the particles of the second population are free from hydrocodone bitartrate; hydrocodone bitartrate is the only drug in the dosage form; and 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 3 ml of water. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A controlled release oral solid dosage form comprising a capsule containing:
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(i) a first population of particles comprising hydrocodone bitartrate; and (ii) a second population of particles comprising polyethylene oxide;
whereinthe particles of the first population are free from polyethylene oxide; the particles of the second population are free from hydrocodone bitartrate; hydrocodone bitartrate is the only drug in the dosage form; and 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 (14, 15, 16, 17, 18)
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19. A controlled release oral solid dosage form comprising a capsule containing:
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(i) a first population of particles comprising hydrocodone bitartrate; and (ii) a second population of particles comprising polyethylene oxide;
whereinthe particles of the first population are free from polyethylene oxide; the particles of the second population are free from hydrocodone bitartrate; hydrocodone bitartrate is the only drug in the dosage form; and 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 an aqueous liquid. - View Dependent Claims (20, 21, 22)
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Specification