MEDICAMENT DELIVERY DEVICE FOR ADMINISTRATION OF OPIOID ANTAGONISTS INCLUDING FORMULATIONS FOR NALOXONE

• US 20170035957A1
• Filed: 10/21/2016
• Published: 02/09/2017
• Est. Priority Date: 02/28/2011
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: EDWARDS, Eric S., EDWARDS, Evan T., LICATA, Mark J., BLONDINO, Frank E.
• Granted Patent: US 10,143,792 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 11/007 Syringe-type or piston-type sprayers or atomisers
• CPC Class Codes: A61M 15/0001 Details of inhalators; Constructional features thereof
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 2202/048 Anaesthetics
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/80 voice-operated command
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2209/06 Packaging for specific medical equipment
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/2046 Media being expelled from injector by gas generation, e.g. explosive charge
• CPC Class Codes: A61M 5/2459 upon internal pressure increase, e.g. pierced or burst A61M5/2429 takes precedence
• CPC Class Codes: A61M 5/3232 Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: G09B 19/24 : Use of tools
• CPC Class Codes: G09B 5/04 : with audible presentation of the material to be studied sound recording or reproducing G11B

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.

Claims

1. A method, comprising:

removing a medicament delivery device containing a naloxone composition from a case, the medicament delivery device including a medicament container 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;

receiving an instruction associated with a use of the medicament delivery device; 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 a delivery member.

2. The method of claim 1, wherein:

the medicament delivery device is an auto-injector; and

the delivery member is a needle, the needle being coupled to the medicament container via a coupling member, the needle being fluidically isolated from the internal volume when the coupling member and the medicament container are in a first configuration, the needle in fluid communication with the internal volume when the coupling member and the medicament container are in a second configuration.

3. The method of claim 1, wherein:

the medicament delivery device is an intranasal spray device; and

the delivery member is associated with an atomizer defining an orifice through which the naloxone composition is delivered, the atomizer being coupled to the medicament container via a coupling member, the coupling member including a needle, the coupling member and the medicament container being in a first configuration prior to the medicament delivery device being removed from the case, an end portion of the needle being disposed outside of the internal volume when the coupling member and the medicament container assembly are in the first configuration, the end portion of the needle disposed within the internal volume when the coupling member and the medicament container are in a second configuration.

4. The method of claim 1, further comprising:

storing, before the removing, the medicament delivery device within the case for at least six months.

5. The method of claim 1, further comprising:

sending a wireless signal in response to the removing the medicament delivery device from the case.

6. The method of claim 1, wherein the instruction is a written instruction coupled to at least one of the case or the medicament delivery device.

7. The method of claim 1, wherein the instruction is a recorded speech output produced by at least one of the case or the medicament delivery device.

8. An apparatus, comprising:

a housing;

a medicament container within the housing, the medicament container 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;

a delivery member coupled to the medicament container via a coupling member, the delivery member being fluidically isolated from the internal volume when the coupling member and the medicament container assembly are in a first configuration, the delivery member in fluid communication with the internal volume 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 via the delivery member.

9. The apparatus of claim 8, wherein a longitudinal axis of the actuator is non-coaxial with a longitudinal axis of the delivery member.

10. An apparatus, comprising:

a housing;

a medicament container disposed within the housing, the medicament container containing a single dose of a naloxone composition; and

an electronic circuit system coupled to the housing, the electronic circuit system configured to produce an output when the electronic circuit system is actuated.