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 0.34 ml;
a needle configured to be placed in fluid communication with the medicament container when an end portion of the needle is extended outside of the housing; and
an actuation assembly including an energy storage member configured to produce a force on an elastomeric member within the medicament container to 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 0.5 seconds such that a 90% confidence interval of at least one of a relative mean maximum naloxone plasma concentration after the dose is delivered into the body (Cmax), a time to reach a maximum naloxone plasma concentration (Tmax), an area under a plasma concentration-time curve from pre-dose (time
0) extrapolated to infinity (AUC0-∞
), or an area under the plasma concentration-time curve from pre-dose (time
0) to a time of a last quantifiable concentration (Tlast) (AUC0-t) of the delivered dose to a delivered dose of a corresponding naloxone composition 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
21 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 0.34 ml; a needle configured to be placed in fluid communication with the medicament container when an end portion of the needle is extended outside of the housing; and an actuation assembly including an energy storage member configured to produce a force on an elastomeric member within the medicament container to 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 0.5 seconds such that a 90% confidence interval of at least one of a relative mean maximum naloxone plasma concentration after the dose is delivered into the body (Cmax), a time to reach a maximum naloxone plasma concentration (Tmax), an area under a plasma concentration-time curve from pre-dose (time
0) extrapolated to infinity (AUC0-∞
), or an area under the plasma concentration-time curve from pre-dose (time
0) to a time of a last quantifiable concentration (Tlast) (AUC0-t) of the delivered dose to a delivered dose of a corresponding naloxone composition via a manually-actuated syringe is within 80% to 125%. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method of delivering a dose of a naloxone composition, 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 the dose of the naloxone composition, the dose having a delivered volume of at least 0.34 ml; a needle coupled to the medicament container; and an actuation assembly including an energy storage member; and actuating the medicament injector such that the energy storage member produces a force to move an elastomeric member within the medicament container to deliver the dose of the naloxone composition from the medicament container via the needle into the body in less than 0.5 seconds and in a manner such that a 90% confidence interval of at least one of a relative mean maximum naloxone plasma concentration after the dose is delivered into the body (Cmax), a time to reach a maximum naloxone plasma concentration (Tmax), an area under a plasma concentration-time curve from pre-dose (time
0) extrapolated to infinity (AUC0-∞
), or an area under the plasma concentration-time curve from pre-dose (time
0) to a time of a 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 (13, 14, 15, 16, 17, 18, 19, 20, 21)
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Specification