Sublingual fentanyl spray
First Claim
Patent Images
1. A sublingual fentanyl formulation comprising discrete liquid droplets of an effective amount of fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof;
- in a pharmaceutically acceptable liquid carrier;
said droplets having a mean diameter of at least about 10 microns.
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Accused Products
Abstract
The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
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Citations
138 Claims
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1. A sublingual fentanyl formulation comprising discrete liquid droplets of an effective amount of fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof;
- in a pharmaceutically acceptable liquid carrier;
said droplets having a mean diameter of at least about 10 microns. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 127, 128, 129)
- in a pharmaceutically acceptable liquid carrier;
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20. A unit dose of a sublingual fentanyl formulation comprising discrete liquid droplets of an effective amount of fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof;
- in a pharmaceutically acceptable liquid carrier suitable for sublingual spray administration;
said droplets having a mean diameter of at least about 10 microns. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34)
- in a pharmaceutically acceptable liquid carrier suitable for sublingual spray administration;
- 35. A method of treating pain comprising sublingually administering a liquid spray formulation in the form of discrete liquid droplets having a mean diameter of at least about 10 microns to a human patient experiencing pain, said liquid spray formulation comprising an effective amount of fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, dispersed in a pharmaceutically acceptable liquid carrier.
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37. A method of treating pain comprising sublingually administering a liquid spray formulation in the form of discrete liquid droplets having a size distribution of from about 5 microns to about 500 microns to a human patient experiencing pain;
- said liquid spray formulation comprising an effective amount of fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, dispersed in a pharmaceutically acceptable liquid carrier.
- View Dependent Claims (38)
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51. The method of claim 51, wherein said organic solvent is ethanol.
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59. A method of treating breakthrough pain comprising:
sublingually administering a liquid spray formulation comprising an effective amount of fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, dispersed in a pharmaceutically acceptable carrier to a human patient who is receiving chronic pain treatment, and is experiencing breakthrough pain. - View Dependent Claims (60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78)
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79. A unit dose or bi-dose device for sublingual administration of a drug comprising:
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a reservoir containing a unit dose or a bi-dose of a liquid formulation comprising an effective amount of fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof in a pharmaceutically acceptable liquid carrier; and
the device having an actuator which when actuated delivers the unit dose of the liquid formulation in the form of liquid droplets having a mean diameter of at least about 10 microns. - View Dependent Claims (80, 81, 82, 83, 84, 85, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 133, 134, 135)
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86. A multi-dose device for sublingual administration of a drug comprising:
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a reservoir containing a liquid formulation comprising fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof in a pharmaceutically acceptable liquid carrier; and
the device having an actuator which when actuated delivers a therapeutically effective dose of the liquid formulation in the form of liquid droplets having a mean diameter of at least about 10 microns. - View Dependent Claims (87, 88, 89, 90, 91, 102, 103, 104, 105, 136, 137, 138)
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106. A method of treating pain comprising:
utilizing a sublingual spray device comprising a reservoir containing a liquid formulation comprising fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof in a pharmaceutically acceptable liquid carrier; and
the device having an actuator which upon actuation delivers a therapeutically effective amount of liquid droplets to be sprayed from the device having a mean diameter of at least about 10 microns.- View Dependent Claims (107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118)
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119. A method of preparing a pharmaceutical composition for sublingual administration comprising:
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preparing a mixture of a therapeutically active agent in a pharmaceutically acceptable carrier, incorporating a sufficient amount of said mixture into a unit dose device to provide at least one therapeutic dose, said device being capable of being actuated to deliver liquid droplets of said at least one therapeutic dose having a mean diameter of at least about 10 microns to the sublingual region of a human.
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120. A sublingual pharmaceutical formulation comprising discrete liquid droplets of an effective amount of a therapeutically active agent in a pharmaceutically acceptable liquid carrier;
- said droplets having a mean diameter of at least about 10 microns.
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121. A unit dose of a sublingual pharmaceutical formulation comprising discrete liquid droplets of an effective amount of a therapeutically active agent, in a pharmaceutically acceptable liquid carrier suitable for sublingual spray administration;
- said droplets having a mean diameter of at least about 10 microns.
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122. A method of treating a human patient comprising sublingually administering a liquid spray formulation in the form of discrete liquid droplets having a mean diameter of at least about 10 microns to a human patient, said liquid spray formulation comprising an effective amount of therapeutically active agent, dispersed in a pharmaceutically acceptable liquid carrier.
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123. A method of treating a human patient comprising sublingually administering a liquid spray formulation in the form of discrete liquid droplets having a size distribution of from about 5 microns to about 500 microns to a human patient;
- said liquid spray formulation comprising an effective amount of therapeutically active agent, dispersed in a pharmaceutically acceptable liquid carrier.
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124. A unit dose or bi-dose device for sublingual administration of a drug comprising:
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a reservoir containing a unit dose or a bi-dose of a liquid formulation comprising an effective amount of a therapeutically active agent in a pharmaceutically acceptable liquid carrier; and
the device having an actuator which when actuated delivers the unit dose of the liquid formulation in the form of liquid droplets having a mean diameter of at least about 10 microns.
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125. A multi-dose device for sublingual administration of a drug comprising:
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a reservoir containing a liquid formulation comprising a therapeutically active agent; and
the device having an actuator which when actuated delivers a therapeutically effective dose of the liquid formulation in the form of liquid droplets having a mean diameter of at least about 10 microns.
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126. A method of treating a human patient comprising:
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utilizing a sublingual spray device comprising a reservoir containing a liquid formulation comprising a therapeutically active agent in a pharmaceutically acceptable liquid carrier; and
the device having an actuator which upon actuation delivers a therapeutically effective amount of liquid droplets to be sprayed from the device having a mean diameter of at least about 10 microns.
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Specification