Programmable multi-dose intranasal drug delivery device

• US 6,948,492 B2
• Filed: 08/15/2001
• Issued: 09/27/2005
• Est. Priority Date: 08/15/2000
• Status: Expired due to Fees

• Current Assignee: University Of Kentucky Research Foundation (University of Kentucky)
• Original Assignee: University Of Kentucky Research Foundation (University of Kentucky)
• Inventors: Wermeling, Daniel P., Main, John Alan, Vallance, Ryan, Walcott, Bruce Lanier, Balasubramaniam, Aravind, Lumpp, James E. Jr.
• Primary Examiner(s): Dawson, Glenn K.
• Assistant Examiner(s): Erezo, Darwin P.
• Application Number:
  US10/129,578
• Publication Number:
  US 20030163099A1
• Time in Patent Office: 1,504 Days
• Field of Search: 128/200.14, 128/200.17, 128/200.23, 128/203.15, 128/203.23, 128/203.21
• US Class Current: 128/200.14
• CPC Class Codes: A61M 11/06 of the injector type
• CPC Class Codes: A61M 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0081 Locking means
• CPC Class Codes: A61M 15/0083 Timers
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/073 Syringe, piston type
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: B05B 11/02 Membranes or pistons acting on the contents inside the container, e.g. follower pistons

Abstract

An apparatus and method for the self-administration of a plurality of doses of an intranasal liquid pharmaceutical composition, including opioid analgesics, that includes a drug delivery device containing a plurality of sealed vials, each vial containing a predetermined volume of the pharmaceutical composition, a pump assembly for conveying the liquid pharmaceutical composition from the interior of the vial and discharging it as a nasal spray in response to manual activation by the patient, and programmable means for sequentially advancing a vial to the ready position after passage of a prescribed time interval following the last activation of the delivery device.

Claims

1. A method for controlling the minimum time interval between the self-administration of a plurality of prescribed unit doses of an intranasal pharmaceutical composition intranasally by a patient capable of self-administering the composition, the method comprising:

a) providing a plurality of sealed vials, each vial having an access orifice and containing the prescribed unit dose of the pharmaceutical composition;

b) providing a drug delivery device having a microprocessor, a power source, and means for securing a plurality of the sealed vials containing the pharmaceutical composition in a predetermined array and dispensing means for recovering the pharmaceutical composition from each of the vials and dispensing the pharmaceutical composition in the form of a spray for intranasal administration in response to a manual activation force applied to the drug delivery device by the patient;

c) securing a plurality of the sealed vials to a supporting member rotatably mounted in the drug delivery device in the predetermined array;

d) programming the microprocessor to generate a signal at the end of a prescribed period of time following the dispensing of a dose of pharmaceutical composition from a vial;

e) generating a signal to initiate sequential movement of the vials relative to the dispensing means; and

f) sequentially moving each of the vials containing the pharmaceutical composition relative to the dispensing means at the end of a prescribed time interval following activation of the dispensing means to intranasally administer a dose of the liquid composition.

2. The method of claim 1, wherein the prescribed time interval between each sequential movement is the same.

3. The method of claim 1, wherein each of the sequential movements occur in the range of from 2 to 4 hours.

4. The method of claim 1 which includes generating an audible or visual signal at the end of the prescribed time interval.

5. The method of claim 1, wherein a motive force for moving the vials is applied continuously to the rotatably mounted support member and the rotation of the support member is restrained by control means.

6. The method of claim 5 which includes the step of periodically moving the control means in response to the microprocessor signal, whereby the vials are rotationally moved in response to the motive force.

7. The method of claim 5, wherein the control means moves between first and second restraining positions with respect to said support member, and the method includes sequentially moving the control member between the first and second restraining positions to control the sequential movement of the vials.

8. The method of claim 5 which includes the steps of charging and then discharging a capacitor to thereby generate a current in response to signals received from the microprocessor.

9. The method of claim 8, wherein the current discharged from the capacitor is passed through a shape memory actuated wire operatively joined to said control means.

10. The method of claim 1, wherein each of the sequential movements is performed by a patient after the signal is generated.

11. The method of claim 1, wherein each of the sequential movements is performed by a motive force generated from the device after the signal is generated.

12. An apparatus for the intranasal administration of a plurality of doses of a liquid pharmaceutical composition, the apparatus comprising:

a) a plurality of sealed vials, each vial having an access orifice and containing a predetermined volume of the pharmaceutical composition;

b) a vial supporting member having supports for receiving the plurality of sealed vials;

c) a pump assembly including a liquid delivery channel for conveying the liquid pharmaceutical composition from the interior of the vial to a discharge outlet;

d) a pump activator cooperating with said pump assembly;

e) means for sequentially aligning the pump assembly with the access orifice of each of the vials to permit discharge of the liquid pharmaceutical composition from the aligned vial upon actuation of the pump;

f) an ergonomic intranasal cap affixed to said pump assembly and in communication with said pump assembly discharge outlet;

g) motive means for moving the vial support member relative to the pump assembly;

h) release means for restricting the movement of the vial support member relative to the pump assembly; and

i) a programmable control means for controlling the release means, whereby the support member advances a vial containing pharmaceutical composition into alignment with the pump assembly for discharging the pharmaceutical composition upon activation of the pump actuator.

13. The apparatus of claim 12 where the release means comprises an escapement assembly.

14. The apparatus of claim 13 where the release means include a nitinol wire and an electrical discharge circuit, whereby an electric current is passed through said nitinol wire in response to a signal generated by said programmable control means.

15. The apparatus of claim 12 where the means for moving the vial support member is selected from the group consisting of springs, electric motors, elastic members and manually applied forces.

16. The apparatus of claim 12 where the intranasal cap includes an atomizing chamber, whereby a liquid discharged from the cap is in the form of a spray.

17. The apparatus of claim 12 where the vial support member is generally circular and each of the plurality of supports is positioned to receive a vial radially with the vial access orifice facing outwardly.

18. The apparatus of claim 17 where the vial support member includes at least one central chamber and the programmable control means is contained in the at least one central chamber.

19. The apparatus of claim 18 which further includes a power source.

20. The apparatus of claim 19 where the power source is at least one battery.

21. The apparatus of claim 12 which contains at least twelve vials.

22. The apparatus of claim 12 where each of the plurality of vials contains a unit dose of the pharmaceutical composition.

23. The apparatus of claim 12 where the release means further includes a ratchet assembly, whereby the vial support member is movable in only one direction relative to the pump assembly.

24. The apparatus of claim 23 where a pawl of the ratchet assembly is fixed relative to the vial support member.

25. An apparatus for the intranasal administration of a plurality of predetermined unit doses of a liquid pharmaceutical composition, each of said unit doses being contained in a plurality of sealed vials of uniform dimension, said apparatus comprising:

a) a vial supporting member for receiving the plurality of sealed vials each of said vials having an access orifice;

b) a pump assembly including a liquid delivery channel for conveying the liquid pharmaceutical composition from the interior of a vial to a discharge outlet;

c) a pump activator cooperating with said pump assembly

d) means for aligning the pump assembly and the access orifice of each of the vials to permit discharge of the liquid pharmaceutical composition from the aligned vial upon activation of the pump;

e) an ergonomic intranasal cap affixed to said pump assembly and in communication with said pump assembly discharge outlet;

f) motive means for moving the vial support member relative to the pump assembly;

g) release means for restricting the movement of the vial support member relative to the pump assembly; and

h) a preprogrammed microprocessor for controlling the release means, whereby the support member advances a vial containing pharmaceutical composition into alignment for discharging the pharmaceutical composition upon activation of the pump actuator in response to a signal from the microprocessor.

26. The apparatus of claim 25, wherein both of the timing means and the control means are elements of a programmable microprocessor.

27. The apparatus of claim 25 that includes a plurality of button cell batteries.

28. The apparatus of claim 25, wherein the release means includes a solenoid.

29. The apparatus of claim 25 that includes at least one housing member that engages the supporting member;

whereby the plurality of vials is contained between the housing and support member.

30. The apparatus of claim 29 comprising a pair of mating housing members that enclose the support member.

31. The apparatus of claim 30 that includes an aperture in said mated housing, whereby a manual force can be applied to the periphery of the enclosed support member.

32. The apparatus of claim 29, wherein the pump assembly extends from and is joined to at least one housing member.

33. The apparatus of claim 25, wherein the microprocessor has at least one pin voltage and wherein the control means includes an actuator for actuating the rotating means, the actuator being powered by the at least one pin voltage.

34. The apparatus of claim 33, wherein the actuator is a nitinol wire.

35. The apparatus of claim 34, wherein the control—

means includes a capacitor charging circuit chargeable by the at least one pin voltage, the actuator being powered by discharge of the capacitor charging circuit.

36. The apparatus of claim 33, wherein, the control means includes a manually actuated input means, the control means actuating the rotating means in response to manual actuation of the input means at one of the prescribed times for delivery of a drug dosage determined by the timing means.

37. The apparatus of claim 36, wherein the actuator is a nitinol wire.

38. The apparatus of claim 37, wherein the control means includes a capacitor charging circuit chargeable by the at least one pin voltage, the actuator being powered by discharge of the capacitor charging circuit in response to manual actuation of the input means.

39. The apparatus of claim 25, that includes a button cell battery for providing power for actuating the rotating means.

40. The apparatus of claim 39, wherein the programmable microprocessor is powered by the battery, the microprocessor having at least one pin voltage in response to power from the battery.

41. The apparatus of claim 40, wherein the actuator is a nitinol wire.

42. The apparatus of claim 41, wherein the control means includes a capacitor charging circuit chargeable by the at least one pin voltage, the actuator being powered by discharge of the capacitor charging circuit.

43. The apparatus of claim 40, wherein the control means includes a manually actuated input means, the control means actuating the rotating means in response to manual actuation of the input means at one of the prescribed times for delivery of a drug dosage determined by the timing means.

44. The apparatus of claim 43, wherein the actuator is a nitinol wire.

45. The apparatus of claim 44, wherein the control means includes a capacitor charging circuit chargeable by the at least one pin voltage, the actuation being powered by discharge of the capacitor charging circuit in response to manual actuation of the input means.

46. The apparatus of claim 25, wherein each of the plurality of vials is independently supported.

47. The apparatus of claim 46, wherein each vial is generally cylindrical and is received in a supporting snap-fit.