Devices and methods for delivering opioid antagonists including formulations for naloxone

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 a...

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Bibliographische Detailangaben
Hauptverfasser:	Edwards, Evan T, Kelley, Glen L, Edwards, Eric S, Blondino, Frank E, Meyers, Paul F
Format:	Patent
Sprache:	eng
Schlagworte:	DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROMTHE BODY GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS HUMAN NECESSITIES HYGIENE MEDICAL OR VETERINARY SCIENCE PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINSTCLIMATE CHANGE
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Beschreibung
Zusammenfassung:	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%.