Medicament delivery device for administration of opioid antagonists including formulations for naloxone

• US 8,939,943 B2
• Filed: 10/24/2013
• Issued: 01/27/2015
• Est. Priority Date: 01/26/2011
• Status: Active Grant

• Current Assignee: Kaleo, Inc.
• Original Assignee: Kaleo, Inc.
• Inventors: Edwards, Eric S., Edwards, Evan T., Licata, Mark J., Meyers, Paul F., Blondino, Frank E.
• Primary Examiner(s): Bosworth, Kami A
• Assistant Examiner(s): HAYMAN, IMANI N
• Application Number:
  US14/062,516
• Publication Number:
  US 20140052069A1
• Time in Patent Office: 460 Days
• Field of Search: 604/131, 604140-147, 604/187, 604/196, 604/218, 206/571, 128/200.14
• US Class Current: 604/198
• 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 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 2202/048 Anaesthetics
• 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 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/3204 Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
• 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

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. An apparatus, comprising:

a housing;

a medicament container disposed within the housing;

a movable member coupled to the medicament container and a needle, the movable member configured to move within the housing in a first direction between a first position and a second position in response to a force produced by an energy storage member, the needle disposed within the housing when the movable member is in the first position, a portion of the needle disposed outside of the housing when the movable member is in the second position;

a lock portion configured to engage a portion of the housing when the movable member is in the first position to limit movement of the movable member in a second direction, the lock portion and the movable member monolithically formed; and

a biasing member configured to move the movable member in the second direction when the movable member is in the second position.

2. The apparatus of claim 1, wherein:

the housing defines an opening; and

the lock portion of the movable member includes a protrusion configured to be disposed within the opening when the movable member is in the first position.

3. The apparatus of claim 1, wherein the lock portion of the movable member is configured to deform when the movable member moves from the first position towards the second position.

4. The apparatus of claim 1, wherein:

the housing defines an opening; and

the lock portion of the movable member includes a protrusion configured to be disposed within the opening when the movable member is in the first position, the lock portion configured to deform to disengage the protrusion from within the opening when the movable member moves from the first position towards the second position.

5. The apparatus of claim 1, wherein the movable member includes a release portion, the release portion configured to interface with a release member when the movable member is in the second position to release the force from the movable member.

6. The apparatus of claim 1, wherein the movable member is a first movable member, the apparatus further comprising:

a second movable member configured to move relative to the first movable member when the first movable member is in the second position to convey a medicament from the medicament container via the needle.

7. The apparatus of claim 1, wherein the medicament container contains a naloxone composition.

8. The apparatus of claim 1, wherein:

the medicament container contains a naloxone composition and an elastomeric member disposed within the medicament container, at least a portion of the elastomeric member being coated with a silicone-based material; and

at least a portion of the force produced by the energy storage member is exerted on the elastomeric member when the movable member is in the second position to deliver the naloxone composition via the needle.

9. The apparatus of claim 1, wherein:

the housing defines a first opening and a second opening;

the lock portion of the movable member includes a protrusion configured to be disposed within the first opening when the movable member is in the first position; and

a portion of the medicament container configured to be aligned with the second opening when the movable member is in the second position such that a contents of the medicament container are visible via the second opening.

10. An apparatus, comprising:

a housing defining a first opening and a second opening;

a medicament container disposed within the housing, the medicament container containing a medicament and configured to be coupled to a needle; and

a movable assembly coupled to the medicament container, the movable assembly including a first movable member, a second movable member and an elastomeric member, the first movable member configured to move within the housing between a first position and a second position in response to a force produced by an energy storage member, the needle disposed within the housing when the first movable member is in the first position, a portion of the needle disposed outside of the housing when the first movable member is in the second position, the second movable member configured to move the elastomeric member within the medicament container when the first movable member is in the second position to convey a medicament from the medicament container via the needle,

a lock portion of the first movable member configured to be disposed within the first opening of the housing when the first movable member is in the first position, a portion of the movable assembly configured to be aligned with the second opening to produce a visual indication that the medicament has been conveyed.

11. The apparatus of claim 10, wherein the lock portion of the first movable member is configured to limit movement of the first movable member within the housing.

12. The apparatus of claim 10, wherein the first movable member moves in a first direction from the first position to the second position, the lock portion of the first movable member configured to limit movement of the first movable member in a second direction when the first movable member is in the first position.

13. The apparatus of claim 12, further comprising:

a biasing member configured to move the first movable member in the second direction when the first movable member is in the second position.

14. The apparatus of claim 12, wherein the lock portion of the first movable member is configured to deform when the first movable member moves from the first position towards the second position.

15. The apparatus of claim 10, wherein the housing defines a third opening through which the portion of the needle is disposed when the first movable member is in the second position, the apparatus further comprising:

a cover configured to be removably coupled to the housing, the cover configured to cover the third opening of the housing when the cover is coupled to the housing, the cover defining a cover opening configured to be aligned with the second opening of the housing when the cover is coupled to the housing.

16. The apparatus of claim 10, wherein the medicament is a naloxone composition.

17. The apparatus of claim 10, wherein:

the medicament is a naloxone composition;

at least a portion of the elastomeric member is coated with a silicone-based material; and

at least a portion of the force produced by the energy storage member is exerted on the elastomeric member when the first movable member is in the second position to deliver the naloxone composition via the needle.

18. The apparatus of claim 10, wherein the first movable member includes a release portion configured to interface with the second movable member to release the force from the first movable member.

19. An apparatus, comprising:

a housing defining a first opening, a second opening and a third opening;

a medicament container disposed within the housing, the medicament container including a medicament and configured to be coupled to a needle;

a movable assembly coupled to the medicament container, the movable assembly configured to move within the housing in response to a force produced by an energy storage member to move the needle from a first needle position to a second needle position, the needle disposed within the housing when the needle is in the first needle position, a portion of the needle disposed outside of the housing via the third opening when the needle is in the second needle position, a portion of the movable assembly configured to move within the medicament container when the needle is in the second needle position to convey the medicament from the medicament container via the needle, the portion of the movable assembly configured to be aligned with the second opening to produce a visual indication that the medicament has been conveyed, a lock portion of the movable assembly configured to be disposed within the first opening of the housing to limit movement of the movable assembly; and

a cover configured to be removably coupled to the housing, the cover configured to cover the third opening of the housing when the cover is coupled to the housing, the cover defining a cover opening configured to correspond with the second opening of the housing when the cover is coupled to the housing.

20. The apparatus of claim 19, wherein the movable assembly includes a carrier configured to move in a first direction from a first position to a second position to move the needle from the first needle position to the second needle position, the lock portion configured to limit movement of the carrier in a second direction when the carrier is in the first position.

21. The apparatus of claim 20, further comprising:

a biasing member configured to move the carrier in the second direction when the carrier is in the second position.

22. The apparatus of claim 19, wherein the lock portion is configured to deform when the needle moves from the first needle position towards the second needle position.

23. The apparatus of claim 19, wherein the movable includes a carrier configured to move the medicament container within the housing, the portion of the movable assembly configured to move relative to the carrier to convey a medicament from the medicament container via the needle.

24. The apparatus of claim 19, wherein the medicament is a naloxone composition.

25. The apparatus of claim 19, wherein:

the medicament is a naloxone composition;

the portion of the movable assembly includes an elastomeric member is coated with a silicone-based material; and

at least a portion of the force produced by the energy storage member is exerted on the elastomeric member to deliver the naloxone composition via the needle.