IP Library › Granted Patent US 8,574,189

Granted Patent B2

US 8,574,189 · App. 13/416,236 · Granted Nov 5, 2013

Storage and dispensing devices for administration of oral transmucosal dosage forms

Inventors: Andrew Poutiatine (Mill Valley, CA); Bruce Edwards (Menlo Park, CA); Charles Rampersaud (Castro Valley, CA); Pamela Palmer (San Francisco, CA); Bradley Blackwood (San Jose, CA); Benjamin K. Yaffe (San Francisco, CA)

Assignee: AcelRx Pharmaceuticals, Inc.

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Quick Facts

Patent No.: US 8,574,189
App. No.: 13/416,236
Granted: Nov 5, 2013
Kind: B2

External Links

USPTO Patent Center↗ Full Patent PDF↗

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 (51)

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:

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.

Assignments (6)

SECURITY INTEREST Recorded Jun 30, 2023

From: VERTICAL PHARMACEUTICALS, LLC

To: CIBC BANK USA

Reel/Frame 064133/0094 →

ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 25, 2023

From: ACELRX PHARMACEUTICALS, INC.