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

• US 9,289,583 B2
• Filed: 10/30/2007
• Issued: 03/22/2016
• Est. Priority Date: 01/06/2006
• Status: Active Grant

• Current Assignee: AcelRx Pharmaceuticals Incorporated
• Original Assignee: AcelRx Pharmaceuticals Incorporated
• Inventors: Palmer, Pamela, Poutiatine, Andrew I, Rampersaud, Charles, Edwards, Bruce, Chiu, Edmond, Schreck, Thomas, Tzannis, Stelios, Hamel, Larry
• Primary Examiner(s): Bosworth, Kami A
• Assistant Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US11/980,216
• Publication Number:
  US 20080147044A1
• Time in Patent Office: 3,066 Days
• Field of Search: 604/77, 424/45
• US Class Current: 1/1
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

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. A method, comprising:

moving a shipping tablet from a first position in which the shipping tablet is adjacent a cartridge containing a plurality of drug-containing tablets to a second position in which the shipping tablet is within a delivery pathway of a delivery device and proximate to a sensor of the delivery device, the shipping tablet including a detection feature configured to differentiate the shipping tablet from a drug-containing tablet of the plurality of drug-containing tablets;

detecting the shipping tablet with the sensor of the delivery device when the shipping tablet is in its second position, the detecting including sensing the detection feature of the shipping tablet; and

inhibiting the delivery device from dispensing the drug-containing tablet of the plurality of drug-containing tablets until the shipping tablet is detected by the delivery device.

2. The method of claim 1, further comprising:

dispensing the drug-containing tablet of the plurality of drug-containing tablets following detection of the shipping tablet by the delivery device.

3. The method of claim 1, wherein the detecting the shipping tablet by the delivery device facilitates calibration of the delivery device.

4. The method of claim 1, wherein the detection feature of the shipping tablet is based on at least one of a physical, optical, radiofrequency, electronic, or magnetic property.

5. The method of claim 1, wherein the moving includes engaging the shipping tablet with a dispensing mechanism of the delivery device, the dispensing mechanism configured to move the shipping tablet from its second position to a third position in which the shipping tablet is dispensed from the delivery device via an exit port in communication with the delivery pathway.

6. The method of claim 5, wherein the dispensing mechanism is configured to move the shipping tablet from its first position to its third position by way of its second position in a continuous movement.

7. The method of claim 1, further comprising:

transmitting an electronic signal from the delivery device, the electronic signal including at least one of a confirmation that the shipping tablet was detected and a confirmation that the shipping tablet was dispensed from the delivery device.

8. The method of claim 1, further comprising:

transmitting a signal indicating that the cartridge containing the plurality of drug-containing tablets is unused in response to the detecting.

9. The method of claim 1, wherein the drug-containing tablet of the plurality of drug-containing tablets includes a dosage of sufentanil and a bioadhesive material.

10. A method, comprising:

removably coupling a cartridge to a delivery device, the cartridge containing a shipping tablet and a plurality of drug-containing tablets, the shipping tablet being positioned within the cartridge with respect to the plurality of drug-containing tablets so that the shipping tablet is dispensed from the cartridge before a drug-containing tablet of the plurality of drug-containing tablets can be dispensed from the cartridge by the delivery device;

initiating a calibration of the delivery device, the calibration performed by moving the shipping tablet within a delivery pathway of the delivery device to a position proximate a sensor of the delivery device, the sensor of the delivery device configured to detect the shipping tablet and the drug-containing tablet from the plurality of drug-containing tablets, the delivery device configured to differentiate the shipping tablet from the drug-containing tablet of the plurality of drug-containing tablets; and

initiating the dispensing of the drug-containing tablet of the plurality of drug-containing tablets after the calibration, the delivery device configured to prevent the dispensing of the drug-containing tablet of the plurality of drug-containing tablets before the calibrating.

11. The method of claim 10, wherein the delivery device is configured to differentiate the shipping tablet from the drug-containing tablet of the plurality of drug-containing tablets based on at least one of a physical, optical, radiofrequency, electronic, or magnetic property of the shipping tablet.

12. The method of claim 10, wherein each of the plurality of drug-containing tablets contains sufentanil.

13. The method of claim 10, wherein the cartridge is in electrical communication with the delivery device.

14. The method of claim 10, further comprising:

inserting, before the dispensing, at least a portion of a proboscis of the delivery device within a mouth of a patient such that a shroud of the proboscis is disposed beneath a tongue of the patient, the shroud being configured to prevent a bodily tissue within the mouth from engaging an exit port defined by the portion of the proboscis, the proboscis having an S-shaped curved to facilitate the positioning, the dispensing including delivering the drug-containing tablet of the plurality to a sublingual mucosa of the patient.

15. The method of claim 10, further comprising:

inserting a dispensing end of the delivery device into a mouth of a patient, each drug-containing tablet of the plurality of drug-containing tablets including a dose of about 2.5 mcg to about 200 mcg of sufentanil; and

positioning the dispensing end of the delivery device beneath a tongue of the subject such that a shroud of the dispensing end is disposed between the tongue and a sublingual membrane of the patient, the dispensing end of the device including a seal extended into a cavity formed by the shroud, the shroud forming a barrier about at least a portion of the seal to prevent engagement of at least one of the tongue and the sublingual membrane with the seal,

the dispensing including moving the drug-containing tablet of the plurality of drug-containing tablets from the cartridge through the delivery pathway and through the seal of the dispensing end of the device such that the drug-containing tablet is placed on the sublingual membrane of the patient, the seal configured to prevent moisture ingress into the dispensing end of the device during the dispensing, the seal configured to maintain a uniform seal about the drug-containing tablet when the drug-containing tablet is passed through the seal, the seal configured to wipe moisture from a delivery mechanism of the delivery device as the delivery mechanism is retracted into the delivery pathway after dispensing the drug-containing tablet through the seal of the dispensing end of the device.

16. A method, comprising:

removably coupling a cartridge to a delivery device, the cartridge containing a shipping tablet and a plurality of drug-containing tablets, the shipping tablet including a detection feature configured to differentiate the shipping tablet from a drug-containing tablet of the plurality of drug-containing tablets;

moving the shipping tablet within a delivery pathway of the delivery device to a position proximate a sensor of the delivery device by advancing a delivery member within the delivery pathway;

calibrating a position of the delivery member within the delivery pathway based on an input from the sensor produced in response to the moving the shipping tablet;

inserting a distal end portion the delivery device within a mouth; and

dispensing the drug-containing tablet of the plurality of drug-containing tablets into the mouth via the distal end portion of the delivery device, the delivery device configured to prevent the dispensing the drug-containing tablet of the plurality of drug-containing tablets before the calibrating.

17. The method of claim 16, wherein the detection feature of the shipping tablet is based on at least one of a physical, optical, radiofrequency, electronic, or magnetic property.

18. The method of claim 16, wherein the moving includes moving the shipping tablet from the position proximate the sensor to a dispensing position in which the shipping tablet is dispensed via the distal end portion of the delivery device.

19. The method of claim 16, further comprising:

transmitting an electronic signal from the delivery device in response to the input from the sensor.

20. The method of claim 16, further comprising:

transmitting a signal indicating that the cartridge containing the plurality of drug-containing tablets is unused in response to the calibrating.

21. The method of claim 16, wherein the drug-containing tablet of the plurality of drug-containing tablets includes a dosage of sufentanil and a bioadhesive material.