Storage and dispensing devices for administration of oral transmucosal dosage forms

• US 8,548,623 B2
• Filed: 03/16/2010
• Issued: 10/01/2013
• Est. Priority Date: 03/18/2009
• Status: Active Grant

• Current Assignee: Vertical Pharmaceuticals LLC (Vertical/Trigen Holdings LLC)
• Original Assignee: AcelRx Pharmaceuticals Incorporated
• Inventors: Poutiatine, Andrew, Edwards, Bruce, Rampersaud, Charles, Palmer, Pamela, Blackwood, Bradley, Yaffe, Benjamin K.
• Primary Examiner(s): WAGGONER, TIMOTHY R
• Application Number:
  US12/724,634
• Publication Number:
  US 20100253476A1
• Time in Patent Office: 1,295 Days
• Field of Search: 700/236, 700/240, 700/242, 221/268, 221/270
• US Class Current: 700/236
• CPC Class Codes: A61J 2200/30 Compliance analysis for taking medication
• CPC Class Codes: A61J 2205/50 using icons or symbolic figures, e.g. by a graphical representation symbolising the type of pathology or the organ by an image
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61J 7/0053 Syringes, pipettes or oral dispensers
• CPC Class Codes: A61J 7/0418 with electronic history memory
• CPC Class Codes: A61J 7/0436 resulting from removing a drug from, or opening, a container
• CPC Class Codes: A61J 7/0445 for preventing drug dispensing during a predetermined time period
• CPC Class Codes: A61J 7/0463 for multiple patients
• CPC Class Codes: G06K 19/07762 the adhering arrangement making the record carrier wearable, e.g. having the form of a ring, watch, glove or bracelet record carriers for insertion in the human body for medical purposes A61B90/00; record carriers adapted for attachment to animals A01K11/00
• CPC Class Codes: G06K 19/07783 the coil being planar
• CPC Class Codes: G16H 10/65 stored on portable record carriers, e.g. on smartcards, RFID tags or CD
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass
• CPC Class Codes: H04B 5/77 for interrogation

Abstract

Dispensing devices and systems for oral transmucosal administration of small volume drug dosage forms to the oral mucosa are provided. The dispensing device may be a single dose applicator (SDA), or an electromechanical device comprising a means for patient identification such as a wrist worn RFID tag and annular bidirectional antenna together with a lock-out feature.

Claims

1. An apparatus, comprising:

a container defining an interior volume configured to at least partially contain a plurality of single dose dispensers, each single dose dispenser of the plurality of single dose dispensers being configured for delivery of a drug-containing tablet to an oral mucosal membrane; and

an ejector being moveable from a first position with respect to the container to a second position with respect to the container, the ejector configured to eject at least a portion of a first single dose dispenser of the plurality of single dose dispensers from the interior volume of the container when the ejector is moved from its first position to its second position.

2. The apparatus of claim 1, wherein said oral mucosal membrane is a sublingual membrane.

3. The apparatus of claim 1, further comprising:

a lock-out feature adapted for inhibiting ejection of a single dose dispenser from the interior volume of the container during a lock-out period.

4. The apparatus of claim 1, further comprising:

a dose counting mechanism configured to determine a number of single dose dispensers of the plurality of single dose dispensers that have been removed from the container.

5. The apparatus of claim 1, further comprising a patient identification feature.

6. The apparatus of claim 5, wherein said patient identification feature is RFID.

7. The apparatus of claim 1, further comprising a child resistant feature.

8. The apparatus of claim 1, wherein each single dose dispenser of the plurality of single dose dispensers includes:

a housing defining an actuation pathway;

a delivery member, at least a portion of the delivery member being disposed within the actuation pathway, the delivery member configured to move relative to the housing in a distal direction to expel a drug-containing tablet from a volume defined at least in part by the housing and the deliver member, the deliver member including a protrusion configured to engage a portion of the housing to limit movement of the deliver member relative to the housing in a proximal direction.

9. The apparatus of claim 1, wherein each single dose dispenser includes a drug dosage form with an amount of sufentanil selected from the group consisting of 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, 40 mcg, 50 mcg, 60 mcg, 70 mcg, 80 mcg and 100 mcg, the drug dosage form having a volume of less than 30 microliters or a mass of less than 30 mg.

10. The apparatus of claim 1, further comprising:

a sensor configured to detect when the first single dose dispenser is removed from the container.

11. The apparatus of claim 1, further comprising a sensor disposed within a pathway along which the ejector is moved from its first position to its second position when the portion of the first single dose dispenser is ejected from the container.

12. The apparatus of claim 1, wherein the ejector is configured to move the first single dose dispenser in a first direction with respect to the housing, the container including a retainer configured to limit movement of a second single dose dispenser of the plurality of single dose dispensers.

13. The apparatus of claim 1, further comprising:

a memory configured to store data associated with the removal of each single dose dispenser of the plurality of single dose dispensers from the container.

14. The apparatus of claim 13, further comprising:

a port configured to operatively couple the memory to a computer.

15. An apparatus, comprising:

a container configured to contain a plurality of single dose dispensers, each single dose dispenser of the plurality of single dose dispensers including a housing, a delivery member and a drug-containing tablet, at least a portion of the delivery member being disposed within the housing such that a distal end portion of the delivery member and a distal end portion of the housing define a volume configured to contain the drug-containing tablet, the delivery member configured to move relative to the housing in a distal direction to expel the drug-containing tablet from the volume, the delivery member including a protrusion configured to engage a portion of the housing to limit movement of the delivery member relative to the housing in a proximal direction, the container having a first configuration in which the plurality of single dose dispensers is contained within the container, the container having a second configuration in which a proximal end portion of the delivery member of a single dose dispenser of the plurality of single dose dispensers is disposed exterior to the container; and

an ejector configured to move the container from its first configuration to its second configuration.

16. The apparatus of claim 15, wherein the ejector is slideably moveable from a first position to a second position, movement of the ejector from its first position to its second position corresponds to movement of the container from its first configuration to its second configuration.

17. The apparatus of claim 15, further comprising:

a lock-out feature configured to inhibit movement of the container from its first configuration to its second configuration during a lock-out period.

18. The apparatus of claim 15, further comprising:

a dose counting mechanism configured to determine a number of times the container has been moved from its first configuration to its second configuration.

19. The apparatus of claim 15, further comprising:

a sensor configured to detect at least one of movement of the container to its second configuration or removal of the single dose dispenser of the plurality of single dose dispensers from the container.

20. The apparatus of claim 15, wherein each single dose dispenser of the plurality of single dose dispensers includes a safety member removably coupled to the housing, the safety member configured to limit movement of the delivery member relative to the housing in the distal direction.

21. The apparatus of claim 15, wherein the ejector is configured to move the first single dose dispenser in the proximal direction with respect to the housing when the container is moved from its first configuration to its second configuration, the container including a retainer configured to limit movement of a second single dose dispenser of the plurality of single dose dispensers in the proximal direction.

22. The apparatus of claim 15, further comprising:

a memory configured to store data associated with removal of each single dose dispenser of the plurality of single dose dispensers from the container.

23. The apparatus of claim 22, further comprising:

a port configured to operatively couple the memory to a computer.

24. An apparatus, comprising:

a container configured to at least partially contain a plurality of single dose dispensers, each single dose dispenser of the plurality of single dose dispensers configured to deliver a drug-containing tablet to an oral mucosa;

an ejector moveable with respect to the container, the ejector configured to move a first single dose dispenser of the plurality of single dose dispensers from a first position in which the first single dose dispenser is disposed within the container to a second position in which at least a portion of the first single dose dispenser is disposed outside of the container; and

a sensor configured to detect movement of the first single dose dispenser from its first position to its second position.

25. The apparatus of claim 24, further comprising:

a memory configured to store data associated with movement of the first single dose dispenser from its first position to its second position; and

a port configured to be operatively coupled to a computer to convey the data from the memory to the computer.

26. The apparatus of claim 24, further comprising:

a dose counting mechanism configured to determine a number of single dose dispensers of the plurality of single dose dispensers that have been moved by the ejector.

27. The apparatus of claim 24, further comprising:

a lock-out feature configured to inhibit movement of the first single dose dispenser from its first position to its second position during a lock-out time period.

28. The apparatus of claim 24, wherein the drug-containing tablet includes a dosage of sufentanil.

29. The apparatus of claim 24, wherein the sensor is disposed within a pathway along which the ejector is moved relative to the container.

30. The apparatus of claim 24, wherein the first single dose dispenser of the plurality of single dose dispensers including a housing, a delivery member and the drug-containing tablet, at least a portion of the delivery member being disposed within the housing such that a distal end portion of the delivery member and a distal end portion of the housing define a volume configured to contain the drug-containing tablet, the delivery member configured to move relative to the housing in a distal direction to expel the drug-containing tablet from the volume, the delivery member including a protrusion configured to engage a portion of the housing to limit movement of the delivery member relative to the housing in a proximal direction,

a proximal end portion of the delivery member of the first single dose dispenser disposed outside of the container when the first single dose dispenser is in the second position.