Medicament delivery device for administration of opioid antagonists including formulations for naloxone
First Claim
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1. A method, comprising:
- removing a medicament delivery device from a case;
the medicament delivery device including a housing, a prefilled medicament container assembly disposed within the housing, a medicament delivery structure disposed within the housing, and a movable member configured to cause a force to be exerted on the prefilled medicament container assembly, the prefilled medicament container assembly including a container, a naloxone composition contained within the container, the naloxone composition including a tonicity-adjusting agent and a pH adjusting agent, the pH of the naloxone composition ranging from about 3 to about 5, and an elastomeric member disposed within the container to seal the naloxone composition within the container, the elastomeric member formulated to be compatible with the naloxone composition when in contact with the naloxone composition for a time period of at least one year;
an end portion of the medicament delivery structure being fluidically isolated from the naloxone composition when the prefilled medicament container assembly is in a first position within the housing;
placing a distal end portion of the medicament delivery device into a position relative to a target location of a patient; and
moving the movable member to transmit the force to be exerted on the prefilled medicament container assembly to move the prefilled medicament container assembly from the first position to a second position within the housing, bringing the end portion of the medicament delivery structure into fluid communication with the naloxone composition when the prefilled medicament container assembly is in the second position within the housing, and delivering the naloxone composition via the medicament delivery structure.
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Abstract
Medicament delivery devices for administration of opioid antagonists are described herein. In some embodiments, an apparatus includes a housing, a medicament container disposed within the housing and an energy storage member disposed within the housing. The medicament container is filled with a naloxone composition that includes naloxone or salts thereof, a tonicity-adjusting agent, and a pH-adjusting agent, whereby the osmolality of the naloxone composition ranges from about 250-350 mOsm and the pH ranges from about 3-5. The energy storage member is configured to produce a force to deliver the naloxone composition.
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Citations
26 Claims
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1. A method, comprising:
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removing a medicament delivery device from a case;
the medicament delivery device including a housing, a prefilled medicament container assembly disposed within the housing, a medicament delivery structure disposed within the housing, and a movable member configured to cause a force to be exerted on the prefilled medicament container assembly, the prefilled medicament container assembly including a container, a naloxone composition contained within the container, the naloxone composition including a tonicity-adjusting agent and a pH adjusting agent, the pH of the naloxone composition ranging from about 3 to about 5, and an elastomeric member disposed within the container to seal the naloxone composition within the container, the elastomeric member formulated to be compatible with the naloxone composition when in contact with the naloxone composition for a time period of at least one year;
an end portion of the medicament delivery structure being fluidically isolated from the naloxone composition when the prefilled medicament container assembly is in a first position within the housing;placing a distal end portion of the medicament delivery device into a position relative to a target location of a patient; and moving the movable member to transmit the force to be exerted on the prefilled medicament container assembly to move the prefilled medicament container assembly from the first position to a second position within the housing, bringing the end portion of the medicament delivery structure into fluid communication with the naloxone composition when the prefilled medicament container assembly is in the second position within the housing, and delivering the naloxone composition via the medicament delivery structure. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method, comprising:
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placing a distal end of a medicament delivery device into a delivery position, the medicament delivery device including a housing, a prefilled medicament container assembly disposed within the housing, a medicament delivery structure disposed within the housing, and a movable member configured to cause a force to be exerted on the prefilled medicament container assembly, the prefilled medicament container assembly including a container, a naloxone composition contained within the container, the naloxone composition including a tonicity-adjusting agent and a pH adjusting agent, the pH of the naloxone composition ranging from about 3 to about 5, and an elastomeric member disposed within the container to seal the naloxone composition within the container, the elastomeric member including a polymer and a curing agent, the elastomeric member formulated to minimize at least one of leaching or outgassing of compositions therein such that the elastomeric member is compatible with the naloxone composition when in contact with the naloxone composition for a time period of at least one year, an end portion of the medicament delivery structure being fluidically isolated from the naloxone composition when the prefilled medicament container assembly is in a first position within the housing; and actuating the medicament delivery device by moving the movable member to transmit the force to be exerted on the prefilled medicament container assembly to move the prefilled medicament container assembly from the first position to a second position within the housing, bringing the end portion of the medicament delivery structure into fluid communication with the naloxone composition when the prefilled medicament container assembly is in the second position within the housing, and delivering the naloxone composition via the medicament delivery, structure. - View Dependent Claims (9, 10, 11, 12, 13, 14)
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15. An apparatus, comprising:
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a housing; a prefilled syringe assembly disposed within the housing, the prefilled syringe assembly including a container, an elastomeric member disposed within the container, and a needle staked to a distal end portion of the container, the container containing a dose of a naloxone composition that includes a tonicity-adjusting agent and a pH adjusting agent, the pH of the naloxone composition ranging from about 3 to about 5, the elastomeric member disposed within the container to seal the naloxone composition within the container, the elastomeric member formulated to be compatible with the naloxone composition when in contact with the naloxone composition for a time period of at least one year; and a movable member coupled to the housing, the movable member configured to transmit a force to be exerted on the elastomeric member of the prefilled syringe assembly to deliver the naloxone composition via the needle. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
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Specification