Medicament delivery device for administration of opioid antagonists including formulations for naloxone
First Claim
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1. An apparatus, comprising:
- a housing;
a medicament container assembly at least partially disposed within the housing, the medicament container assembly including a container body and an elastomeric member, the container body containing a naloxone composition, the naloxone composition including a tonicity-adjusting agent and a pH adjusting agent, the pH of the naloxone composition ranging from 3 to 5, the elastomeric member disposed within an internal volume of the container body, the elastomeric member including a silicone-based material;
a delivery member coupled to a coupling member disposed within the housing, the delivery member being fluidically isolated from the internal volume of the container body when the coupling member and the medicament container assembly are in a first configuration, the delivery member in fluid communication with the internal volume of the container body when the coupling member and the medicament container assembly are in a second configuration; and
an actuator coupled to the housing, the actuator configured to cause a force to be exerted to (1) transition the coupling member and the medicament container assembly from the first configuration to the second configuration and (2) deliver a single dose of the naloxone composition from the internal volume of the container body via the delivery member.
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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
42 Claims
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1. An apparatus, comprising:
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a housing; a medicament container assembly at least partially disposed within the housing, the medicament container assembly including a container body and an elastomeric member, the container body containing a naloxone composition, the naloxone composition including a tonicity-adjusting agent and a pH adjusting agent, the pH of the naloxone composition ranging from 3 to 5, the elastomeric member disposed within an internal volume of the container body, the elastomeric member including a silicone-based material; a delivery member coupled to a coupling member disposed within the housing, the delivery member being fluidically isolated from the internal volume of the container body when the coupling member and the medicament container assembly are in a first configuration, the delivery member in fluid communication with the internal volume of the container body when the coupling member and the medicament container assembly are in a second configuration; and an actuator coupled to the housing, the actuator configured to cause a force to be exerted to (1) transition the coupling member and the medicament container assembly from the first configuration to the second configuration and (2) deliver a single dose of the naloxone composition from the internal volume of the container body via the delivery member. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A method, comprising:
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removing a medicament delivery device from a case, the medicament delivery device including a medicament container assembly, a coupling member, and a delivery member, the medicament container assembly including a container body and an elastomeric member, the container body defining an internal volume containing a naloxone composition, the naloxone composition including a tonicity-adjusting agent and a pH adjusting agent, the pH of the naloxone composition ranging from 3 to 5, the elastomeric member disposed within the internal volume of the container body, the elastomeric member including a silicone-based material, the delivery member coupled to the coupling member such that the delivery member is fluidically isolated from the internal volume of the container body; placing a distal end portion of the medicament delivery device into a position relative to a target location of a patient; and actuating the medicament delivery device to (1) cause the medicament container assembly to move distally to place the delivery member in fluid communication with the internal volume of the container body and (2) convey a single dose of the naloxone composition from the internal volume via the delivery member. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
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27. A method, comprising:
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removing a medicament delivery device from a case, the medicament delivery device including a medicament container assembly, a coupling member and an atomizer, the medicament container assembly including a container body and an elastomeric member, the container body defining an internal volume containing a single dose of a naloxone composition, the naloxone composition including a tonicity-adjusting agent, the pH of the naloxone composition ranging from 3 to 5, the elastomeric member disposed within the internal volume of the container body, the elastomeric member including a silicone-based material, the atomizer coupled to the medicament container assembly via the coupling member; placing a distal end portion of the medicament delivery device into a delivery position relative to a nostril of a patient; and moving an actuator of the medicament delivery device to (1) cause the medicament container assembly to move relative to the coupling member to place the atomizer in fluid communication with the internal volume of the container body and (2) convey the single dose of the naloxone composition from the internal volume via the atomizer. - View Dependent Claims (28, 29, 30, 31, 32, 33, 34, 35, 36)
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37. An apparatus, comprising:
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a housing; a medicament container assembly at least partially disposed within the housing, the medicament container assembly including a container body and an elastomeric member, the container body containing a single dose of a naloxone composition, the naloxone composition including a tonicity-adjusting agent and a pH adjusting agent, the pH of the naloxone composition ranging from 3 to 5, the elastomeric member disposed within an internal volume of the container body, the elastomeric member including a silicone-based material; an atomizer coupled to the medicament container assembly via a coupling member, the atomizer being fluidically isolated from the internal volume of the container body when the coupling member and the medicament container assembly are in a first configuration, the atomizer in fluid communication with the internal volume of the container body when the coupling member and the medicament container assembly are in a second configuration; and an actuator coupled to the housing, the actuator configured to cause a force to be exerted to (1) transition the coupling member and the medicament container assembly from the first configuration to the second configuration and (2) deliver the single dose of the naloxone composition from the internal volume of the container body via the atomizer. - View Dependent Claims (38, 39, 40, 41, 42)
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Specification