Storage and dispensing devices for administration of oral transmucosal dosage forms

• US 9,066,847 B2
• Filed: 07/03/2007
• Issued: 06/30/2015
• Est. Priority Date: 01/05/2007
• Status: Active Grant

• Current Assignee: AcelRx Pharmaceuticals Incorporated
• Original Assignee: AcelRx Pharmaceuticals Incorporated
• Inventors: Poutiatine, Andrew I., Rampersaud, Charles, Edwards, Bruce, Chiu, Edmond, Tzannis, Stelios, Palmer, Pamela, Kolosi, William, Retailleau, Sascha
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): KOO, BENJAMIN K
• Application Number:
  US11/825,212
• Publication Number:
  US 20080164275A1
• Time in Patent Office: 2,919 Days
• Field of Search: 604/57, 604 59- 64, 604/73, 604/77, 604/275, 604/514
• US Class Current: 1/1
• CPC Class Codes: A61J 2205/10 Bar codes
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61J 7/0023 Spoons
• CPC Class Codes: A61J 7/0046 Cups, bottles or bags
• CPC Class Codes: A61J 7/0053 Syringes, pipettes or oral dispensers
• CPC Class Codes: A61J 7/0076 Medicament distribution means with pill counting devices A61J7/02; with time indication A61J7/04; containers or packages with special means for dispensing contents B65D83/00
• 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: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 2205/3653 by Joule effect, i.e. electric resistance
• CPC Class Codes: A61M 2205/8268 Fuel storage cells
• CPC Class Codes: A61M 31/007 Injectors for solid bodies, e.g. suppositories
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: G07F 17/0092 for assembling and dispensing of pharmaceutical articles medical dispensers for private use, A61J7/00
• CPC Class Codes: G16H 20/13 delivered from dispensers

Abstract

Drug storage and dispensing devices for dispensing dosage forms to the oral mucosa of a patient are disclosed. The drug storage and dispensing device is a single dose applicator or a device which includes 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 for dispensing a drug-containing tablet to an oral mucosal membrane of a patient, comprising:

a proboscis defining a passage through which the tablet can be passed, the passage having an exit port adjacent a distal end of the proboscis;

a seal disposed over the exit port and configured to prevent the ingress of moisture into the exit port, the seal defining a slit configured to permit passage of the tablet therethrough; and

a shroud disposed at the distal end of the proboscis, the shroud being extended distally past the seal, the shroud being at least partially disposed about and spaced apart from the exit port of the proboscis such that the shroud inhibits contact by a tongue and an oral mucosal membrane with the exit port.

2. The apparatus of claim 1, wherein the shroud includes a top portion disposed above the exit port and configured to be engaged with the tongue of the patient, and a side portion extending downwardly from the top portion, the side portion having a lower rim disposed below the exit port and configured to engage the oral mucosal membrane.

3. The apparatus of claim 1, wherein the shroud defines a cavity and has a lower rim disposed about a perimeter of at least a portion of the cavity and spaced from the exit port, a portion of the lower rim defining a relief sized to allow the tablet to pass therethrough to avoid engaging the tablet when the tablet is dispensed onto the oral mucosal membrane and the shroud is withdrawn from between the tongue and the oral mucosal membrane.

4. The apparatus of claim 1, wherein the shroud includes a top portion and a side portion extending downwardly from the top portion, the top portion and side portion forming a cavity being open at a bottom portion of the shroud, at least one of the exit port or the seal disposed over the exit port being extended into the cavity of the shroud such that, when the tablet is dispensed via at least one of the exit port or the seal, the tablet can fall from the at least one exit port or seal through the open bottom portion of the shroud to the oral mucosal membrane.

5. The apparatus of claim 1, wherein the shroud is configured to maintain a space between the exit port and each of the tongue and the oral mucosal membrane.

6. The apparatus of claim 1, wherein an interior surface of the shroud is hydrophilic.

7. The apparatus of claim 1, wherein an interior surface of the shroud is constructed of a hydrophilic wicking material configured to wick away moisture from within a cavity defined by the shroud.

8. The apparatus of claim 1, wherein at least a portion of an interior surface of the shroud is rounded.

9. The apparatus of claim 1, wherein the seal is at least partially disposed in a cavity defined by the shroud.

10. The apparatus of claim 1, wherein the seal is configured to maintain a uniform seal around the tablet when the tablet is passed through the seal upon exiting the exit port.

11. The apparatus of claim 1, further comprising:

a push rod disposed in the passage for movement between a first position in which a distal end of the push rod extends from the exit port and a second position in which the distal end of the push rod is within the passage, the push rod configured to dispense a tablet from the exit port upon movement of the distal end of the push rod from the second position to the first position, and

wherein the seal is configured to maintain a uniform seal around the push rod when the push rod is passed through the seal.

12. The apparatus of claim 1, wherein the seal is configured to wipe moisture off of a surface of a push rod as the push rod is passed through the slit of the seal.

13. The apparatus of claim 1, wherein the proboscis defines an S-shape configured to facilitate placement of the shroud beneath the tongue of the patient.

14. The apparatus of claim 1, wherein at least a portion of the passage defined by the proboscis is arcuate;

the apparatus further comprising;

a push rod, at least a portion of the push rod being sufficiently flexible to accommodate curvature of the arcuate portion of the passage when the push rod is moved within the passage.

15. A delivery tip for a device to deliver a drug-containing tablet to the oral mucosal membrane of a patient, comprising:

a passage through which the tablet can be passed, the passage having an exit port;

a shroud configured to be disposed within the mouth of the patient between a tongue and an oral mucosal membrane, the shroud defining a cavity about the exit port; and

a seal disposed over the exit port and through which the tablet can be dispensed from the passage, the seal configured to prevent ingress of moisture into the exit port, the seal defining a slit configured to permit passage of the tablet therethrough during dispensation of the tablet, at least the portion of the seal defining the slit being extended into the cavity of the shroud, a portion of the shroud extending distally past the seal, the seal configured to maintain a seal about the drug-containing tablet as the tablet is passed through the slit of the seal.

16. The delivery tip of claim 15, wherein the shroud is configured to inhibit each of the tongue and the oral mucosal membrane from engaging the slit of the seal.

17. The delivery tip of claim 15, wherein the oral mucosal membrane is a sublingual membrane, the portion of the seal defining the slit is configured to be disposed in the mouth beneath the tongue and above the sublingual membrane when the shroud is disposed within the mouth beneath the tongue and above the sublingual membrane, the shroud is configured to maintain the slit of the seal spaced apart from each of the tongue and the sublingual membrane.

18. The delivery tip of claim 15, wherein at least a portion of an interior surface of the shroud is rounded.

19. The delivery tip of claim 15, wherein at least a portion of an interior surface of the shroud is hydrophilic, the hydrophilic portion configured to wick moisture away from at least the slit of the seal.

20. A delivery device for delivering a drug-containing tablet to the sublingual membrane of a patient, comprising:

a shroud configured to facilitate sublingual dispensation of a drug-containing tablet from a delivery device, at least a portion of the shroud configured to be disposed within a mouth of a patient beneath a tongue and above a sublingual membrane, the portion of the shroud defining a cavity, at least a portion of a surface of the shroud defining the cavity being hydrophilic such that the hydrophilic surface portion is configured to wick away moisture within the cavity;

a seal configured to seal an exit port through which the tablet can be dispensed from the delivery device to prevent the ingress of moisture into the exit port, the seal defining a slit configured to permit passage of the tablet therethrough during dispensation of the tablet, at least the portion of the seal defining the slit being extended into the cavity defined by the shroud, the shroud being extended distally past the seal, the seal configured to maintain a seal about at least one of the tablet or a push rod as the at least one tablet or push rod is passed through the slit of the seal, the seal configured to wipe moisture from a surface of the push rod as the push rod is passed through the slit of the seal;

a delivery passage through which the tablet can be passed, at least a portion of the delivery passage having an arcuate shape, the delivery passage including the exit port; and

a push rod at least partially disposed and movable within the delivery passage, at least a portion of the push rod being sufficiently flexible to assume the arcuate shape of the delivery passage as the push rod is moved within the delivery passage.