DEVICES AND METHODS FOR DELIVERING OPIOID ANTAGONISTS INCLUDING FORMULATIONS FOR NALOXONE
First Claim
1. An apparatus, comprising:
- a housing;
a medicament container disposed within the housing, the medicament container containing a dose of a naloxone composition, the dose having a delivered volume of at least about 0.34 ml;
a needle configured to move between a first needle position, in which the needle is disposed within the housing, and a second needle position, in which a portion of the needle extends from the housing, the needle configured to be placed in fluid communication with the medicament container when the needle is in the second needle position; and
an actuation assembly including an energy storage member and a movable member, the energy storage member configured to produce a force on the movable member to move the needle from the first needle position to the second needle position and deliver the dose of the naloxone composition from the medicament container via the needle,when actuated, the actuation assembly delivers the dose of the naloxone composition into a body in less than about 0.5 seconds and such that the 90% confidence interval of at least one of the relative mean maximum naloxone plasma concentration after the dose is delivered into the body (Cmax), time to reach the maximum naloxone plasma concentration (Tmax), area under the plasma concentration-time curve from pre-dose (time
0) extrapolated to infinity (AUC0-∞
), or area under the plasma concentration-time curve from pre-dose (time
0) to the time of the last quantifiable concentration (Tlast) (AUC0-t) of the delivered dose to a delivered dose of a corresponding naloxone composition delivered via a manually-actuated syringe is within 80% to 125%.
2 Assignments
0 Petitions
Accused Products
Abstract
An apparatus includes a container, a needle, and an actuation assembly. The container contains a dose of a naloxone composition having a delivered volume of at least about 0.34 mL. The actuation assembly includes an energy storage member that produces a force on a movable member to move the needle and to deliver the dose of the naloxone composition. The 90% confidence interval of at least one of the relative mean maximum naloxone plasma concentration after dose delivery into the body (Cmax), time to reach the maximum naloxone plasma concentration (Tmax), area under the plasma concentration-time curve from pre-dose (time 0) extrapolated to infinity (AUC0-∞), or area under the plasma concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (Tlast) (AUC0-t) of the delivered dose to a delivered dose of a corresponding naloxone composition delivered via a manually-actuated syringe is within 80% to 125%.
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Citations
32 Claims
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1. An apparatus, comprising:
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a housing; a medicament container disposed within the housing, the medicament container containing a dose of a naloxone composition, the dose having a delivered volume of at least about 0.34 ml; a needle configured to move between a first needle position, in which the needle is disposed within the housing, and a second needle position, in which a portion of the needle extends from the housing, the needle configured to be placed in fluid communication with the medicament container when the needle is in the second needle position; and an actuation assembly including an energy storage member and a movable member, the energy storage member configured to produce a force on the movable member to move the needle from the first needle position to the second needle position and deliver the dose of the naloxone composition from the medicament container via the needle, when actuated, the actuation assembly delivers the dose of the naloxone composition into a body in less than about 0.5 seconds and such that the 90% confidence interval of at least one of the relative mean maximum naloxone plasma concentration after the dose is delivered into the body (Cmax), time to reach the maximum naloxone plasma concentration (Tmax), area under the plasma concentration-time curve from pre-dose (time
0) extrapolated to infinity (AUC0-∞
), or area under the plasma concentration-time curve from pre-dose (time
0) to the time of the last quantifiable concentration (Tlast) (AUC0-t) of the delivered dose to a delivered dose of a corresponding naloxone composition delivered via a manually-actuated syringe is within 80% to 125%. - View Dependent Claims (3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 26, 31)
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2. (canceled)
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17-22. -22. (canceled)
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23. A method, comprising:
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placing a medicament injector against a body, the medicament injector including; a housing; a medicament container disposed within the housing, the medicament container containing a dose of a naloxone composition, the dose having a delivered volume of at least about 0.34 ml; a needle configured to move between a first needle position and a second needle position, a portion of the needle extending from the housing when the needle is in the second needle position, the needle configured to be placed in fluid communication with the medicament container when the needle is in the second needle position; and an actuation assembly including an energy storage member and a movable member; and actuating the medicament injector such that the energy storage member produces a force on the movable member to move the needle from the first needle position to the second needle position and deliver the dose of the naloxone composition from the medicament container via the needle into the body in less than about 0.5 seconds and in a manner such that the 90% confidence interval of at least one of the relative mean maximum naloxone plasma concentration after the dose is delivered into the body (Cmax), time to reach the maximum naloxone plasma concentration (Tmax), area under the plasma concentration-time curve from pre-dose (time
0) extrapolated to infinity (AUC0-∞
), or area under the plasma concentration-time curve from pre-dose (time
0) to the time of the last quantifiable concentration (Tlast) (AUC0-t) of the delivered dose to a delivered dose of a corresponding naloxone composition delivered via a manually-actuated syringe is within 80% to 125%. - View Dependent Claims (24, 32)
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25. (canceled)
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27-30. -30. (canceled)
Specification