ABUSE RESISTANT PHARMACEUTICAL COMPOSITIONS
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Accused Products
Abstract
The present invention relates to a composition comprising pharmaceutical active ingredients which are susceptible to, or have potential for, abuse. The invention provides an oral pharmaceutical composition comprising a first population of beads and a second population of beads. The first bead population comprises a pharmaceutically active ingredient susceptible to, or having the potential for, abuse. The second bead population comprises a gelling agent and a coating substantially surrounding the gelling agent, but containing no pharmaceutically active ingredient. The first bead population and the second bead population are physically separable, but visually indistinguishable to the naked eye. Upon ingress of water into the second population of beads, the gelling agent is caused to swell forming a viscous mass inhibiting or preventing the extraction of the active ingredient.
1 Citation
40 Claims
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1-15. -15. (canceled)
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16. An oral pharmaceutical composition comprising:
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a first population of beads comprising hydrocodone or a pharmaceutically acceptable salt thereof, wherein the first population of beads is substantially free of polyethylene oxide; and a second population of beads comprising polyethylene oxide and a permeable or semi-permeable coating, wherein the second population of beads is substantially free of any pharmaceutically active ingredient. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 29, 30, 31, 32, 33, 34)
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24. An oral pharmaceutical composition comprising:
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a population of immediate release beads comprising hydrocodone bitartrate that is substantially free of polyethylene oxide; a population of controlled release beads comprising hydrocodone bitartrate that is substantially free of polyethylene oxide; and a population of beads comprising polyethylene oxide and a permeable or semi-permeable coating that is substantially free of any pharmaceutically active ingredient. - View Dependent Claims (25, 26, 27, 28)
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35. A method for the treatment of pain comprising administering to a subject in need thereof an oral pharmaceutical composition comprising a first population of beads comprising hydrocodone or a pharmaceutically acceptable salt thereof, wherein the first population of beads is substantially free of polyethylene oxide;
- and a second population of beads comprising polyethylene oxide and a permeable or semi-permeable coating, wherein the second population of beads is substantially free of any pharmaceutically active ingredient.
- View Dependent Claims (36, 37)
- 38. A method for the treatment of pain comprising administering to a subject in need thereof an oral pharmaceutical composition comprising a population of immediate release beads comprising hydrocodone bitartrate that is substantially free of polyethylene oxide, a population of controlled release beads comprising hydrocodone bitartrate that is substantially free of polyethylene oxide, and a population of beads comprising polyethylene oxide and a permeable or semi-permeable coating that is substantially free of any pharmaceutically active ingredient.
Specification