Methods for administering small volume oral transmucosal dosage forms using a dispensing device

• US 8,753,308 B2
• Filed: 11/15/2012
• Issued: 06/17/2014
• Est. Priority Date: 01/06/2006
• Status: Active Grant

• Current Assignee: AcelRx Pharmaceuticals Incorporated
• Original Assignee: AcelRx Pharmaceuticals Incorporated
• Inventors: Palmer, Pamela, Poutiatine, Andrew, Rampersaud, Charles, Edwards, Bruce, Chiu, Edmond, Schreck, Thomas, Tzannis, Stelios, Hamel, Lawrence, Kolosi, William, Retailleau, Sascha
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US13/678,141
• Publication Number:
  US 20130090594A1
• Time in Patent Office: 579 Days
• Field of Search: 604/514, 604/77, 604 57- 62
• US Class Current: 604/59
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61J 2205/70 Audible labels, e.g. for pre-recorded info or messages
• 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: A61M 31/007 Injectors for solid bodies, e.g. suppositories

Abstract

Systems and methods for administration of small volume sufentanil drug dosage forms to the sublingual mucosa of a subject using a device are disclosed. The dispensing device includes a lock-out feature and a means to retard or prevent saliva and/or moisture ingress such that the drug dosage forms in the device remain dry prior to administration.

Claims

1. An apparatus, comprising:

a delivery tip defining a non-linear delivery passage, a distal end portion of the delivery tip defining an exit port;

a push rod, at least a portion of the push rod being movably disposed in the delivery passage, a distal end portion of the push rod being within the delivery passage when the push rod is in a first position, the distal end portion of the push rod configured to deliver a drug-containing tablet through the exit port when the push rod is moved from its first position to a second position;

a shroud coupled to the distal end portion of the delivery tip, at least a portion of the shroud configured to be disposed within a mouth of a patient between a tongue and a sublingual membrane and to inhibit contact by at least one of the tongue or the sublingual membrane with the exit port, the shroud including a hydrophilic material; and

a seal disposed about the exit port, the seal configured to prevent the ingress of moisture into the exit port, a portion of the seal defining a slit configured to permit passage of the tablet and the distal end portion of the push rod therethrough during delivery of the tablet, the portion of the seal configured to maintain a seal about at least one of the tablet or the push rod when the push rod is moved from its first position to its second position to deliver the tablet.

2. The apparatus of claim 1, wherein the push rod is flexible.

3. The apparatus of claim 1, wherein the distal end portion of the push rod defines an opening therethrough, the apparatus further comprising:

a sensor configured to detect the passing of the opening when the push rod is moved within the delivery passage.

4. The apparatus of claim 1, wherein the distal end portion of the push rod defines an opening therethrough, the apparatus further comprising:

an optical sensor assembly having a first portion and a second portion, the optical sensor assembly configured to detect the passing of the opening when the push rod is moved within the delivery passage between the first portion and the second portion.

5. The apparatus of claim 1, further comprising:

a sensor configured to detect a position of the push rod when the push rod is moved within the delivery passage.

6. The apparatus of claim 1, further comprising:

a sensor configured to distinguish the passing of a shipping tablet within the delivery passage from the drug-containing tablet within the delivery passage.

7. The apparatus of claim 1, wherein the shroud substantially surrounds the exit port.

8. The apparatus of claim 1, wherein the seal is configured to maintain contact with at least one of the tablet or the push rod when the push rod is moved from its first position to its second position to deliver the tablet.

9. The apparatus of claim 1, wherein a shape of the slit defined by the seal substantially corresponds to a shape of at least one of the tablet or the push rod.

10. The apparatus of claim 1, further comprising:

the tablet, the tablet formulated to include sufentanil.

11. An apparatus, comprising:

a delivery tip defining a curved delivery passage, a distal end portion of the delivery tip defining an exit port;

a push rod, at least a portion of the push rod being movably disposed in the delivery passage, a distal end portion of the push rod being within the delivery passage when the push rod is in a first position, the distal end portion of the push rod configured to deliver a drug-containing tablet through the exit port when the push rod is moved from its first position to a second position;

a shroud coupled to the distal end portion of the delivery tip, the shroud at least partially disposed about and spaced apart from the exit port such that the shroud inhibits contact by at least one of a tongue or a sublingual membrane with the exit port when the distal end portion of the delivery tip is disposed within a mouth, at least a portion of the shroud being constructed from a hydrophilic material; and

a seal disposed about the exit port, a portion of the seal defining a slit configured to permit passage of the tablet and the distal end portion of the push rod therethrough during delivery of the tablet, the portion of the seal configured to maintain sealing contact with at least one of the tablet or the push rod when the push rod is moved from its first position to its second position to deliver the tablet.

12. The apparatus of claim 11, wherein the push rod is flexible.

13. The apparatus of claim 11, wherein the distal end portion of the push rod defines an opening therethrough, the apparatus further comprising:

a sensor configured to detect the passing of the opening when the push rod is moved within the delivery passage.

14. The apparatus of claim 11, wherein the distal end portion of the push rod defines an opening therethrough, the apparatus further comprising:

an optical sensor assembly having a first portion and a second portion, the optical sensor assembly configured to detect the passing of the opening when the push rod is moved within the delivery passage between the first portion and the second portion.

15. The apparatus of claim 11, further comprising:

a sensor assembly configured to detect a position of the push rod when the push rod is moved within the delivery passage.

16. The apparatus of claim 11, further comprising:

a sensor configured to distinguish the passing of a shipping tablet within the delivery passage from the drug-containing tablet within the delivery passage.

17. The apparatus of claim 11, wherein the seal is configured to maintain contact with at least one of the tablet or the push rod when the push rod is moved from its first position to its second position to deliver the tablet.

18. An apparatus, comprising:

a delivery tip defining a curved delivery passage, a distal end portion of the delivery tip defining an exit port;

a push rod, at least a portion of the push rod being movably disposed in the delivery passage, a distal end portion of the push rod being within the delivery passage when the push rod is in a first position, the distal end portion of the push rod configured to deliver a drug-containing tablet through the exit port when the push rod is moved from its first position to a second position, the distal end portion of the push rod including a sensor portion configured to allow light to pass therethrough to allow detection of a position of the push rod within the delivery passage;

a shroud coupled to the distal end portion of the delivery tip the shroud at least partially disposed about and spaced apart from the exit port such that the shroud inhibits contact by at least one of a tongue or a sublingual membrane with the exit port when the distal end portion of the delivery tip is disposed within a mouth, at least a portion of the shroud being constructed from a hydrophilic material; and

a seal disposed about the exit port, a portion of the seal defining a slit configured to permit passage of the tablet and the distal end portion of the push rod therethrough during delivery of the tablet, the portion of the seal configured to maintain sealing contact with at least one of the tablet or the push rod when the push rod is moved from its first position to its second position to deliver the tablet.

19. The apparatus of claim 18, wherein the sensor portion of the push rod defines an opening therethrough, the apparatus further comprising:

a sensor configured to detect the passing of the opening when the push rod is moved within the delivery passage.

20. The apparatus of claim 18, wherein the sensor portion of the push rod defines an opening therethrough, the apparatus further comprising:

an optical sensor assembly having a first portion and a second portion, the optical sensor assembly configured to detect the passing of the opening when the push rod is moved within the delivery passage between the first portion and the second portion.

21. The apparatus of claim 18, further comprising:

a sensor configured to distinguish the passing of a shipping tablet within the delivery passage from the drug-containing tablet within the delivery passage.