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

• US 10,143,792 B2
• Filed: 10/21/2016
• Issued: 12/04/2018
• 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.
• Primary Examiner(s): HAYMAN, IMANI N
• Application Number:
  US15/331,073
• Publication Number:
  US 20170035957A1
• Time in Patent Office: 774 Days
• 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 see also A61M19/00
• 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 housing, a medicament container, and a delivery member, the medicament container disposed within the housing and defining an internal volume containing the naloxone composition, the naloxone composition including a tonicity-adjusting agent, the pH of the naloxone composition ranging from 3 to 5, the delivery member coupled to the medicament container before the removing;

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

actuating the medicament delivery device to (1) cause the medicament container to move distally within the housing to place the delivery member in fluid communication with the internal volume of the medicament container and (2) convey a single dose of the naloxone composition from the internal volume via the 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 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. The method of claim 1, wherein:

the medicament delivery device is stored within the case for at least six months before the removing; and

the actuating the medicament delivery device causes movement of an elastomeric member within the medicament container to convey the single dose of the naloxone composition from the internal volume, the elastomeric member including a silicone-based material.

9. The method of claim 1, wherein:

the tonicity-adjusting agent includes sodium chloride in an amount such that a concentration of sodium chloride is between 0.1 mg/mL and 20 ng/mL.

10. The method of claim 1, wherein the medicament delivery device is a medical injector and the delivery member is a needle covered by a needle sheath, the method further comprising:

removing, before the actuating, a safety lock coupled to a distal end portion of the housing, the safety lock including an engagement portion that engages the needle sheath and removes the needle sheath from about the needle in response to the removing the safety lock.

11. The method of claim 1, wherein:

the actuating the medicament delivery device includes placing, by a first person, a distal end portion of the housing against a target location of a second person,

the instructions received by the first person,

the single dose of the naloxone composition conveyed to the target location of the second person.

12. The method of claim 1, wherein the naloxone composition includes 4,5-epoxy-3,14-di hydroxy-17-(2-propenyl)morphinan-6-one in a concentration of between about 0.01 mg/mL and about 60 mg/mL.

13. The method of claim 12, wherein the concentration of the 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)morphinan-6-one is about 10 mg/mL.

14. The method of claim 12, wherein the single dose of the naloxone composition conveyed from the internal volume contains between 3 mg and 24 mg of the naloxone composition.

15. The method of claim 14, wherein the single dose of the naloxone composition conveyed from the internal volume contains between 4 mg and 18 mg of the naloxone composition.

16. A method of delivering a single dose of a naloxone composition to a patient, comprising:

removing a medical injector containing the naloxone composition from a case, the medical injector including a housing, a prefilled medicament container assembly, and a needle, the prefilled medicament container assembly disposed within the housing and including a container body, the naloxone composition contained within the container body, and an elastomeric member that seals the naloxone composition within the container body, 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 needle coupled to the prefilled medicament container assembly before the removing;

receiving an instruction associated with a use of the medical injector;

placing a portion of the medical injector into contact with the patient; and

actuating the medical injector to cause the elastomeric member to move within the container body to convey the single dose of the naloxone composition from the container body via the needle.

17. The method of claim 16, wherein the actuating includes moving an actuator coupled to an end portion of the housing to cause a force to be applied to a rod that moves the elastomeric member within the container body.

18. The method of claim 16, wherein the prefilled medicament container assembly is a prefilled syringe.

19. The method of claim 16, wherein:

the medical injector is stored within the case for at least six months before the removing; and

the elastomeric member includes a silicone-based material.

20. The method of claim 16, wherein the elastomeric member is formulated to be compatible with the naloxone composition when in contact with the naloxone composition for a time period of at least two years.

21. The method of claim 20, wherein the elastomeric member is formulated to include a polymer and a curing agent, the polymer including at least one of bromobutyl or chlorobutyl, the curing agent including at least one of sulfur or a metal oxide.

22. The method of claim 16, wherein:

the pH of the naloxone composition ranges from about 3.2-3.6;

the tonicity-adjusting agent includes at least one of dextrose, glycerin, mannitol, potassium chloride or sodium chloride; and

the elastomeric member includes a polymer and a curing agent, the elastomeric member is formulated to be compatible with the naloxone composition when in contact with the naloxone composition for a time period of at least two years.

23. The method of claim 16, wherein the naloxone composition includes 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)morphinan-6-one in a concentration of between about 0.01 mg/mL and about 60 mg/mL.

24. The method of claim 23, wherein the concentration of the 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)morphinan-6-one is about 10 mg/mL.

25. The method of claim 23, wherein the single dose of the naloxone composition conveyed from the internal volume contains between 3 mg and 24 rig of the naloxone composition.

26. The method of claim 25, wherein the single dose of the naloxone composition conveyed from the internal volume contains between mg and 18 mg of the naloxone composition.