METHODS FOR ADMINISTERING SMALL VOLUME ORAL TRANSMUCOSAL DOSAGE FORMS USING A DISPENSING DEVICE
First Claim
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1. An apparatus, comprising:
- a delivery member defining a non-linear delivery passage, a distal end portion of the delivery member defining an exit port;
a push rod, at least a portion of the push rod being movably disposed in the delivery passage, a distal end portion the push rod being within the delivery passage when the push rod is in a first position, the distal end portion of the push rod configured to deliver a drug-containing tablet through the exit port when the push rod is moved from its first position to a second position;
a shroud coupled to the distal end portion of the delivery member, at least a portion of the shroud configured to be disposed within a mouth of a patient between a tongue and a sublingual membrane and to inhibit contact by at least one of the tongue or the sublingual membrane with the exit port, the shroud including a hydrophilic material; and
a seal disposed about the exit port, the seal configured to prevent the ingress of moisture into the exit port, a portion of the seal defining a slit configured to permit passage of the tablet and the distal end portion of the push rod therethrough during delivery of the tablet, the portion of the seal configured to maintain a seal about at least one of the tablet or the push rod when the push rod is moved from its first position to its second position to deliver the tablet.
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Abstract
Systems and methods for administration of small volume sufentanil drug dosage forms to the sublingual mucosa of a subject using a device are disclosed. The dispensing device includes a lock-out feature and a means to retard or prevent saliva and/or moisture ingress such that the drug dosage forms in the device remain dry prior to administration.
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Citations
18 Claims
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1. An apparatus, comprising:
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a delivery member defining a non-linear delivery passage, a distal end portion of the delivery member defining an exit port; a push rod, at least a portion of the push rod being movably disposed in the delivery passage, a distal end portion the push rod being within the delivery passage when the push rod is in a first position, the distal end portion of the push rod configured to deliver a drug-containing tablet through the exit port when the push rod is moved from its first position to a second position; a shroud coupled to the distal end portion of the delivery member, at least a portion of the shroud configured to be disposed within a mouth of a patient between a tongue and a sublingual membrane and to inhibit contact by at least one of the tongue or the sublingual membrane with the exit port, the shroud including a hydrophilic material; and a seal disposed about the exit port, the seal configured to prevent the ingress of moisture into the exit port, a portion of the seal defining a slit configured to permit passage of the tablet and the distal end portion of the push rod therethrough during delivery of the tablet, the portion of the seal configured to maintain a seal about at least one of the tablet or the push rod when the push rod is moved from its first position to its second position to deliver the tablet. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. An apparatus, comprising:
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a delivery member defining a curved delivery passage, a distal end portion of the delivery member defining an exit port; a push rod, at least a portion of the push rod being movably disposed in the delivery passage, a distal end portion the push rod being within the delivery passage when the push rod is in a first position, the distal end portion of the push rod configured to deliver a drug-containing tablet through the exit port when the push rod is moved from its first position to a second position; a shroud coupled to the distal end portion of the delivery member, the shroud at least partially disposed about and spaced apart from the exit port such that the shroud inhibits contact by at least one of a tongue or a sublingual membrane with the exit port when the distal end portion of the delivery member is disposed within a mouth, at least a portion of the shroud being constructed from a hydrophilic material; and a seal disposed about the exit port, a portion of the seal defining a slit configured to permit passage of the tablet and the distal end portion of the push rod therethrough during delivery of the tablet, the portion of the seal configured to maintain sealing contact with at least one of the tablet or the push rod when the push rod is moved from its first position to its second position to deliver the tablet. - View Dependent Claims (12, 13, 14, 15, 16, 17)
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18. An apparatus, comprising:
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a delivery member defining a delivery passage, a distal end portion of the delivery member defining an exit port; a push rod, at least a portion of the push rod being movable within in the delivery passage from a first position to a second position, the push rod configured to deliver a drug-containing tablet through the exit port when the push rod is moved to its second position; a lockout mechanism configured to prevent movement of the push rod from its first position to its second position during a predetermined lockout period, the lockout mechanism including an actuator and a locking portion, the actuator configured to move the locking portion when the actuator is actuated such that the locking portion is at least one of engaged with the push rod or disengaged with the push rod thereby preventing movement of the push rod from its first position to its second position.
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Specification