Method of moving a delivery member of a dispensing device for administration of oral transmucosal dosage forms

• US 8,499,966 B2
• Filed: 12/28/2007
• Issued: 08/06/2013
• 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): Sirmons, Kevin C
• Assistant Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US12/521,983
• Publication Number:
  US 20100137836A1
• Time in Patent Office: 2,048 Days
• Field of Search: 604/59, 221/15, 221/232
• US Class Current: 221/232
• CPC Class Codes: A61J 2200/30 Compliance analysis for taking medication
• CPC Class Codes: A61J 7/0038 Straws
• 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 7/0445 for preventing drug dispensing during a predetermined time period
• CPC Class Codes: A61J 7/0481 working on a schedule basis
• CPC Class Codes: A61K 31/4535 containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/20 Pills, tablets, discs, rods A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095
• CPC Class Codes: A61K 9/2009 Inorganic compounds
• CPC Class Codes: A61K 9/2018 Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
• CPC Class Codes: A61K 9/2031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0081 Locking means
• CPC Class Codes: A61M 15/0083 Timers
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/583 : by visual feedback
• CPC Class Codes: A61M 2205/6054 : Magnetic identification systems
• CPC Class Codes: A61M 2205/609 : Biometric patient identification means
• CPC Class Codes: A61M 2209/086 : Docking stations
• CPC Class Codes: A61P 25/00 : Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/04 : Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: G07C 9/22 : in combination with an identity check of the pass holder
• CPC Class Codes: G07F 17/0092 : for assembling and dispensing of pharmaceutical articles medical dispensers for private use, A61J7/00
• CPC Class Codes: H01Q 1/2208 : associated with components used in interrogation type services, i.e. in systems for information exchange between an interrogator/reader and a tag/transponder, e.g. in Radio Frequency Identification [RFID] systems methods or arrangements for sensing record carriers, e.g. for reading patterns G06K7/00; record carrier for use with machines and with at least a part designed to carry digital markings G06K19/00

Abstract

A method of administering small, bioadhesive drug tablets includes moving an end portion of a delivery member. A surface of the delivery member can be positioned to prevent movement of the drug tablet from a tablet cartridge channel to a delivery passage of a delivery device when the end portion of the delivery member is in a first stopped position. The end portion of the delivery member can be moved to a second position within the delivery passage such that the tablet cartridge channel is in communication with the delivery passage. The drug tablet can be conveyed into the delivery passage via the tablet cartridge channel. The end portion of the delivery member can be moved to a third position within the delivery passage to convey the drug tablet through an exit opening of the delivery device.

Claims

1. A method, comprising:

inserting a distal end portion of a housing of a device into a mouth, the device configured to deliver a bioadhesive, small-volume, solid drug tablet containing a dosage of sufentanil;

moving an end portion of a delivery member to a first stopped position within a delivery passage defined by the housing, a distal end portion of the housing defining an exit opening and a tablet cartridge channel, a surface of the delivery member positioned to prevent movement of the drug tablet from the tablet cartridge channel to the delivery passage when the end portion of the delivery member is in the first stopped position;

moving the end portion of the delivery member in a proximal direction to a second position within the delivery passage such that the tablet cartridge channel is in communication with the delivery passage;

conveying the drug tablet into the delivery passage via the tablet cartridge channel; and

moving the end portion of the delivery member in a distal direction to a third position within the delivery passage to convey the drug tablet through the exit opening.

2. The method of claim 1, wherein the moving the end portion of the delivery member to the first stopped position includes moving the end portion of the delivery member in the proximal direction.

3. The method of claim 1, further comprising:

moving the end portion of the delivery member in the distal direction, before the moving the end portion of the delivery member to the first stopped position, to convey a shipping tablet through the exit opening, the shipping tablet different than the drug tablet.

4. The method of claim 1, wherein at least one of the moving the end portion of the delivery member to the first stopped position, the moving the end portion of the delivery member in the proximal direction or the moving the end portion of the delivery member in the distal direction includes bending the delivery member.

5. The method of claim 1, wherein:

the end portion of the delivery member is a first end portion; and

at least one of the moving the first end portion of the delivery member to the first stopped position, the moving the first end portion of the delivery member in the proximal direction or the moving the first end portion of the delivery member in the distal direction includes rotating a second end portion of the delivery member about a hub.

6. The method of claim 1, wherein the moving the end portion of the delivery member in the distal direction includes moving the end portion of the delivery member within a nonlinear portion of the delivery passage.

7. The method of claim 1, wherein the moving the end portion of the delivery member in the distal direction includes conveying the drug tablet through a seal disposed about the exit opening.

8. The method of claim 1, wherein the conveying the drug tablet includes conveying the drug tablet from a tablet cartridge at least partially disposed within the tablet cartridge channel.

9. The method of claim 1, wherein the conveying the drug tablet includes conveying the drug tablet from a tablet cartridge in response to a force produced by a spring disposed within the tablet cartridge.

10. The method of claim 1, further comprising:

sensing the presence of the drug tablet during the moving the end portion of the delivery member in the distal direction.

11. The method of claim 1, further comprising:

sensing, before the moving the end portion of the delivery member to the first stopped position, the presence of the end portion of the delivery member at a predetermined location within the delivery passage.

12. The method of claim 1, wherein the drug tablet contains 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.

13. A method, comprising:

inserting a distal end portion of a housing of a device into a mouth, the device configured to deliver a bioadhesive, small-volume, solid drug tablet containing a dosage of sufentanil from a tablet cartridge;

moving a first end portion of a delivery member to a first stopped position within a delivery passage defined by the housing of the device, the housing further defining an exit opening;

moving the first end portion of the delivery member in a proximal direction to a second position within the delivery passage to receive the drug tablet from the tablet cartridge; and

rotating a second end portion of the delivery member to move the first end portion of the delivery member in a distal direction to a third position within the delivery passage to convey the drug tablet through the exit opening.

14. The method of claim 13, wherein a surface of the delivery member is positioned to prevent movement of the drug tablet from the tablet cartridge into the delivery passage when the first end portion of the delivery member is in the first stopped position.

15. The method of claim 13, wherein the moving the first end portion of the delivery member in the proximal direction includes placing a tablet cartridge channel in communication with the delivery passage.

16. The method of claim 13, wherein at least one of the moving the first end portion of the delivery member to the first stopped position, the moving the first end portion of the delivery member in the proximal direction or the rotating the second end portion of the delivery member includes bending the delivery member.

17. The method of claim 13, wherein the moving the first end portion of the delivery member in the distal direction includes moving the first end portion of the delivery member within a curved portion of the delivery passage.

18. The method of claim 13, further comprising:

moving the first end portion of the delivery member in the distal direction, before the moving the first end portion of the delivery member to the first stopped position, to convey a shipping tablet through the exit opening, the shipping tablet different than the drug tablet.

19. The method of claim 13, further comprising:

conveying the drug tablet from the tablet cartridge into the delivery passage in response to a force produced by a spring disposed within the tablet cartridge.

20. The method of claim 13, further comprising:

sensing the presence of the drug tablet when the first end portion of the delivery member is being moved to the third position.

21. A method, comprising:

inserting a distal end portion of a housing of a device into a mouth, the device configured to deliver a bioadhesive, small-volume, solid drug dosage tablet containing a dosage of sufentanil from a tablet cartridge;

moving, at a first time, an end portion of a delivery member in a distal direction to a stopped position within a delivery passage defined by the housing to convey a shipping tablet through an exit opening defined by the housing;

producing a signal uniquely associated with the shipping tablet during the moving;

moving, at a second time, the end portion of the delivery member in a proximal direction within the delivery passage to receive the drug dosage tablet from the tablet cartridge; and

moving, at a third time, the end portion of the delivery member in the distal direction within the delivery passage to convey the drug dosage tablet through the exit opening.

22. The method of claim 21, further comprising:

moving, after the first time and before the second time, the end portion of the delivery member in the proximal direction such that a surface of the delivery member is positioned to prevent movement of the drug dosage tablet from the tablet cartridge.

23. The method of claim 21, wherein at least one of the moving at the first time, the moving at the second time or the moving at the third time includes bending the delivery member.

24. The method of claim 21, wherein:

the end portion of the delivery member is a first end portion; and

at least one of the moving the first end portion of the delivery member at the first time, the moving the first end portion of the delivery member at the second time or the moving the first end portion of the delivery member at the third time includes rotating a second end portion of the delivery member.

25. The method of claim 21, wherein at least one of the moving the end portion of the delivery member at the first time or the moving the end portion of the delivery member at the third time includes moving the end portion of the delivery member within a nonlinear portion of the delivery passage.

26. The method of claim 21, wherein the producing the signal includes sensing the presence of the shipping tablet at a predetermined location within the delivery passage.

27. The method of claim 21, wherein the producing the signal includes sensing the presence of the shipping tablet at a predetermined location within the delivery passage via an optical sensor coupled to the device.

28. The method of claim 21, wherein the drug dosage tablet contains 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.