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Claims for Patent: 8,627,816

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Claims for Patent: 8,627,816

Title:Medicament delivery device for administration of opioid antagonists including formulations for naloxone
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.
Inventor(s): Edwards; Eric S. (Midlothian, VA), Edwards; Evan T. (Gordonsville, VA), Licata; Mark J. (Doswell, VA), Blondino; Frank E. (Henrico, VA)
Assignee: Intelliject, Inc. (Richmond, VA)
Application Number:13/036,720
Patent Claims: 1. An apparatus, comprising: a housing; a medicament container disposed within the housing, the medicament container containing a naloxone composition; an elastomeric member movably disposed within the medicament container, the elastomeric member formulated to be compatible with the naloxone composition, at least a portion of the elastomeric member being coated with a silicone-based material; and an energy storage member disposed within the housing, the energy storage member configured to produce a force that is exerted on the elastomeric member to deliver the naloxone composition, wherein the naloxone composition 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.

2. The apparatus of claim 1, wherein the pH adjusting agent is present in the naloxone composition in an amount sufficient to cause the pH of the naloxone composition to be within the range from 3-5.

3. The apparatus of claim 2, wherein the naloxone composition has a concentration of 4,5-epoxy-3,14-dihydroxy-17-(2-propeny)morphinan-6-one between approximately 0.01 mg/mL and approximately 10 mg/mL.

4. The apparatus of claim 2, wherein the naloxone composition has a concentration of 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)morphinan-6-one between approximately 0.05 mg/mL and approximately 2 mg/mL.

5. The apparatus of claim 1, wherein the naloxone composition includes 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)morphinan-6-one.

6. The apparatus of claim 1, wherein the tonicity-adjusting agent includes at least one of dextrose, glycerin, mannitol, potassium chloride or sodium chloride.

7. The apparatus of claim 1, wherein the tonicity-adjusting agent includes sodium chloride in an amount such that a concentration of sodium chloride is between approximately 0.1 mg/mL and approximately 20 mg/mL.

8. The apparatus of claim 1, wherein the pH adjusting agent includes at least one of hydrochloric acid, citric acid, citrate salts, acetic acid, acetate salts, phosphoric acid or phosphate salts.

9. The apparatus of claim 1, wherein the pH adjusting agent includes a dilute hydrochloric acid.

10. The apparatus of claim 1, wherein the medicament container is configured to contain an amount of the naloxone composition, the amount being any one of approximately 0.4 mg, 0.8 mg, 1 mg, 1.6 mg or 2 mg.

11. The apparatus of claim 1, 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.

12. The apparatus of claim 1, wherein at least a portion of the elastomeric member is coated with polydimethylsiloxane.

13. The apparatus of claim 1, wherein at least the portion of the elastomeric member is coated with polydimethylsiloxane in an amount of between approximately 0.02 mg/cm.sup.2 and approximately 0.80 mg/cm.sup.2.

14. The apparatus of claim 1, further comprising: an electronic circuit system coupled to the housing, the electronic circuit system configured to produce an output when the electronic circuit system is actuated.

15. The apparatus of claim 14, wherein the output is associated with the naloxone composition, the apparatus further comprising: a cover configured to receive at least a portion of the housing, the cover blocking an optical pathway between the medicament container and a region outside of the housing when the portion of the housing is within the cover, the electronic circuit system configured to be actuated when the portion of the housing is at least partially removed from the cover.

16. The apparatus of claim 1, further comprising: a delivery member coupled to the medicament container, the naloxone composition configured to be delivered from the medicament container via the delivery member.

17. The apparatus of claim 16, wherein the delivery member is a needle defining a lumen therein having a size of between 19 gauge and 31 gauge.

18. The apparatus of claim 16, wherein the delivery member is an atomizer configured to atomize the naloxone composition.

19. The apparatus of claim 1, wherein the pH adjusting agent is present in the naloxone composition in an amount sufficient to cause the pH of the naloxone composition to be about 3.2.

20. The apparatus of claim 1, wherein the pH adjusting agent is present in the naloxone composition in an amount sufficient to cause the pH of the naloxone composition to be about 3.3.

21. The apparatus of claim 1, wherein the pH adjusting agent is present in the naloxone composition in an amount sufficient to cause the pH of the naloxone composition to be about 3.4.

22. The apparatus of claim 1, wherein the pH adjusting agent is present in the naloxone composition in an amount sufficient to cause the pH of the naloxone composition to be about 3.5.

23. The apparatus of claim 1, wherein the pH adjusting agent is present in the naloxone composition in an amount sufficient to cause the pH of the naloxone composition to be about 3.6.

24. An apparatus, comprising: a housing; a medicament container disposed within the housing, the medicament container containing a naloxone composition; an elastomeric member disposed within the medicament container, at least a portion of the elastomeric member coated with a silicone-based material; and an energy storage member disposed within the housing, the energy storage member configured to produce a force that is exerted on the elastomeric member to deliver the naloxone composition, wherein the naloxone composition includes naloxone or salts thereof, a tonicity-adjusting agent, and a pH adjusting agent, whereby at least one of the osmolality of the naloxone composition ranges from about 250-350 mOsm or the pH of the naloxone composition ranges from about 3-5.

25. The apparatus of claim 24, wherein: the elastomeric member is formulated to include a curing agent including at least one of sulfur or a metal oxide; and at least the portion of the elastomeric member is coated with polydimethylsiloxane.

26. The apparatus of claim 24, further comprising: an electronic circuit system coupled to the housing, the electronic circuit system configured to produce an output when the electronic circuit system is actuated.

27. The apparatus of claim 24, wherein at least the portion of the elastomeric member is coated with polydimethylsiloxane in an amount of between approximately 0.02 mg/cm.sup.2 and approximately 0.80 mg/cm.sup.2.

28. The apparatus of claim 24, further comprising: a delivery member coupled to the medicament container, the naloxone composition delivered from the medicament container via the delivery member when the force is exerted on the elastomeric member.

29. The apparatus of claim 28, wherein the delivery member is a needle defining a lumen therein having a size of between 19 gauge and 31 gauge.

30. The apparatus of claim 28, wherein the delivery member is an atomizer configured to atomize the naloxone composition.

31. The apparatus of claim 24, further comprising: a needle coupled to the medicament container, the energy storage member configured to produce the force to move the needle between a first position and a second position, the needle disposed within the housing when the needle is in the first position, at least a portion of the needle disposed outside of the housing when the needle is in the second position.

32. The apparatus of claim 24, further comprising: a needle coupled to the medicament container, the needle having a length of at least 1 inch.
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