Storage and dispensing devices for administration of oral transmucosal dosage forms

• US 8,574,189 B2
• Filed: 03/09/2012
• Issued: 11/05/2013
• 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): SHUMATE, VICTORIA PEARL
• Application Number:
  US13/416,236
• Publication Number:
  US 20120232473A1
• Time in Patent Office: 606 Days
• Field of Search: 604/11, 604/14, 604/15, 604/57, 604/59
• US Class Current: 604/59
• 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 housing defining an actuation pathway and a channel in communication with the actuation pathway;

a delivery member, at least a portion of the delivery member being disposed within the actuation pathway such that a distal end portion of the delivery member and a distal end portion of the housing define a volume configured to contain a 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 delivery member including an elongate protrusion slidably disposed within the channel, an edge of the elongate protrusion configured to limit movement of the delivery member relative to the housing in the distal direction; and

a safety member removably coupled the housing, the safety member configured to limit movement of the delivery member relative to the housing in the distal direction.

2. The apparatus of claim 1, wherein the safety member is a label coupled to the distal end portion of the housing.

3. The apparatus of claim 1, wherein

the elongate protrusion is configured to contact an edge of the safety member to limit movement of the delivery member relative to the housing in the distal direction.

4. The apparatus of claim 1, wherein the distal end portion of the housing is configured to deform when the delivery member is moved in the distal direction relative to the housing to produce an opening through which the drug-containing tablet can be expelled.

5. The apparatus of claim 1, wherein:

the distal end portion of the housing is configured to deform when the delivery member is moved in the distal direction relative to the housing to produce an opening through which the drug-containing tablet can be expelled; and

the safety member is configured to inhibit deformation of the distal end portion of the housing.

6. The apparatus of claim 1, wherein:

the housing includes a bridge configured to engage the delivery member, at least a portion of the bridge configured to be separated from the housing when the delivery member is moved relative to the housing in the distal direction.

7. The apparatus of claim 1, further comprising:

a drug-containing tablet disposed in the volume, the drug-containing tablet including a dosage of sufentanil.

8. The apparatus of claim 7, wherein the drug-containing tablet includes 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, and wherein said drug-containing tablet has a volume of less than 30 microliters or a mass less than 30 mg.

9. The apparatus of claim 1, wherein the housing and delivery member are configured to enable a user to deliver a drug-containing tablet to a sub-lingual mucosal membrane.

10. The apparatus of claim 1, wherein:

the distal end portion of the delivery member includes a geometric surface configured to engage the distal end portion of the housing when the delivery member is moved in the distal direction relative to the housing to deform the distal end portion of the housing to produce an opening through which the drug-containing tablet can be expelled.

11. An apparatus, comprising:

a housing defining an actuation pathway;

a delivery member, at least a portion of the delivery member being disposed within the actuation pathway such that a distal end portion of the delivery member and a distal end portion of the housing define a volume configured to contain a 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 distal end portion of the housing is configured to deform when the delivery member is moved in the distal direction to produce an opening through which the drug-containing tablet can be expelled; and

a safety member removably coupled to the distal end portion of the housing, a first portion of the safety member configured to limit deformation of the distal end portion of the housing, a second portion of the safety member configured to contact a portion of the delivery member to limit movement of the delivery member relative to the housing in the distal direction.

12. The apparatus of claim 11, wherein the safety member is a label, the first portion of the label is disposed about the distal end portion of the housing.

13. The apparatus of claim 11, wherein:

the delivery member includes a protrusion, the portion of the delivery member being disposed within the actuation pathway such that the protrusion limits movement of the delivery member relative to the housing in the distal direction.

14. The apparatus of claim 11, wherein,

the housing defines a channel in communication with the actuation pathway;

and

the delivery member includes a protrusion slidably disposed within the channel, the protrusion configured to limit movement of the delivery member relative to the housing in the distal direction.

15. The apparatus of claim 11, wherein:

the housing includes a bridge member configured to engage the delivery member, the bridge member configured to resist movement of the delivery member relative to the housing in the distal direction, the bridge member configured to deform when a force applied by the delivery member in the distal direction exceeds a predetermined threshold.

16. The apparatus of claim 11, wherein the delivery member includes 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.

17. The apparatus of claim 11, further comprising:

a drug-containing tablet disposed in the volume, the drug-containing tablet including a dosage of sufentanil.

18. An apparatus, comprising:

a housing defining an actuation pathway, a proximal end portion of the housing including a bridge member;

a delivery member, at least a portion of the delivery member being disposed within the actuation pathway such that a distal end portion of the delivery member and a distal end portion of the housing define a volume configured to contain a 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 through an opening defined by the distal end portion of the housing, the delivery member including a first 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 delivery member configured to engage the bridge member such that the bridge member deforms when a force applied by the delivery member in the distal direction exceeds a predetermined threshold; and

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.

19. The apparatus of claim 18, wherein the distal end portion of the housing is configured to deform when the delivery member is moved in the distal direction to expand the opening.

20. The apparatus of claim 18, wherein:

the distal end portion of the delivery member includes a geometric surface configured to engage the distal end portion of the housing when the delivery member is moved in the distal direction relative to the housing to deform the distal end portion of the housing to produce the opening.

21. The apparatus of claim 18, wherein:

the distal end portion of the housing is configured to deform when the delivery member is moved in the distal direction to expand the opening; and

a portion of the safety member is configured to limit deformation of the distal end portion of the housing.

22. The apparatus of claim 18, further comprising:

a container configured to at least partially contain the housing, the container including a sensor configured to detect when the housing is removed from the container.

23. The apparatus of claim 22, wherein:

the housing is a first housing from a plurality of housings, the container is configured to contain the plurality of housings.

24. The apparatus of claim 22, wherein the container includes:

a memory configured to store data associated with the removal of the housing; and

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