Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Inventors
Edwards, Eric S. • Edwards, Evan T. • Licata, Mark J. • Meyers, Paul F. • Blondino, Frank E.
Assignees
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Publication Number
US-10322239-B2
Publication Date
2019-06-18
Expiration Date
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.
Core Innovation
The document describes a medicament delivery device and methods that deliver a naloxone composition from a prefilled medicament container assembly. The container includes a naloxone composition containing a tonicity-adjusting agent and a pH adjusting agent, with a pH ranging from about 3 to about 5. The naloxone composition is sealed within the container by an elastomeric member, where the elastomeric member is formulated to be compatible with the naloxone composition when in contact for a time period of at least one year.
An end portion of a medicament delivery structure is fluidically isolated from the naloxone composition in a first position, and fluid communication is established when the container assembly moves to a second position. A movable member causes a force to be exerted on the prefilled medicament container assembly to move it from the first position to the second position within the housing, and the naloxone composition is then delivered via the medicament delivery structure.
In particular embodiments, the medicament delivery structure is a needle or an atomizer with an orifice for intranasal delivery. The document also describes elastomeric member formulations intended to minimize at least one of leaching or outgassing of compositions therein such that compatibility with the naloxone composition is maintained for at least one year.
Claims Coverage
The partial content includes three independent claims. Across these claims, the inventive coverage centers on a naloxone composition with specified formulation and seal compatibility, and on movement of a prefilled medicament container assembly from a first fluid-isolated position to a second position that establishes fluid communication for delivery.
Fluidic isolation and fluid communication by moving the prefilled container assembly
The end portion of the medicament delivery structure is fluidically isolated from the naloxone composition when the prefilled medicament container assembly is in a first position within the housing, and moving the prefilled medicament container assembly to a second position brings the end portion into fluid communication with the naloxone composition.
Naloxone composition with tonicity and pH adjusting agents within pH 3 to 5
The naloxone composition includes a tonicity-adjusting agent and a pH adjusting agent, with the pH of the naloxone composition ranging from about 3 to about 5.
Elastomeric seal compatible with naloxone composition for at least one year
The elastomeric member disposed within the container seals the naloxone composition within the container and is formulated to be compatible with the naloxone composition when in contact for a time period of at least one year.
Force-exerting movable member to transfer the container assembly and deliver naloxone
A movable member is configured to cause a force to be exerted on the prefilled medicament container assembly to move it from the first position to the second position and deliver the naloxone composition via the medicament delivery structure.
Prefilled syringe apparatus with a housing, elastomeric seal, needle, and force-transmitting movable member
The apparatus includes a housing with a prefilled syringe assembly containing a dose of a naloxone composition sealed by an elastomeric member compatible for at least one year, and a movable member coupled to the housing configured to transmit a force to deliver the naloxone composition via the needle.
Overall, the independent claims protect the naloxone composition formulation, the elastomeric member compatibility for at least one year, and the delivery mechanism in which a movable member moves a prefilled container assembly from a first fluid-isolated position to a second position that establishes fluid communication for delivery via a medicament delivery structure, including needle or atomizer embodiments.
Stated Advantages
Compatibility with the naloxone composition is maintained for at least one year.
At least one of leaching or outgassing of compositions therein is minimized.
Documented Applications
Intranasal delivery.
Delivery via an atomizer with an orifice.
Delivery via a needle.
Auto-injectors.
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