Storage and dispensing devices for administration of oral transmucosal dosage forms

• US 20080164275A1
• Filed: 07/03/2007
• Published: 07/10/2008
• Est. Priority Date: 01/05/2007
• Status: Active Grant

• Current Assignee: AcelRx Pharmaceuticals Incorporated
• Original Assignee: AcelRx Pharmaceuticals Incorporated
• Inventors: Edwards, Bruce, Tzannis, Stelios, Palmer, Pamela, Rampersaud, Charles, Chiu, Edmond, Poutiatine, Andrew I., Retailleau, Sascha, Kolosi, William
• Granted Patent: US 9,066,847 B2
• Time in Patent Office: Days
• US Class Current: 221/15
• 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

1-84. -84. (canceled)

85. A dispensing device for oral transmucosal administration of a drug dosage form to a patient, comprising:

(a) a housing with a dispensing end for dispensing into the mouth of said patient; and

(b) a lock-out feature.

86. The dispensing device of claim 85, wherein said lock-out feature is a programmable lock-out feature.

87. The dispensing device of claim 86, wherein said lock-out feature includes a set lock-out interval between dosings.

88. The dispensing device of claim 86, wherein the lock-out interval is a fixed time interval, a predetermined time interval, a predetermined variable time interval, a time interval determined by an algorithm or a variable time interval communicated to the device from a remote computer or docking station.

89. The dispensing device of claim 85, wherein said oral transmucosal administration is sublingual administration.

90. The dispensing device of claim 85, wherein said oral transmucosal administration is buccal administration.

91. The dispensing device of claim 85, wherein said dosage form comprises sulfentanil.

92. The dispensing device of claim 85, wherein said dosage form has a mass of less than 100 mg.

93. The dispensing device of claim 85, wherein said device includes a dispensing cartridge configured to hold one or more drug dosage forms.

94. The cartridge assembly of claim 93, wherein said cartridge includes a smart cartridge recognition system.

95. The dispensing device of claim 91, wherein said device includes a dispensing cartridge configured to hold one or more drug dosage forms.

96. The cartridge assembly of claim 95, wherein said cartridge includes a smart cartridge recognition system.

97. The cartridge assembly of claim 96, wherein said cartridge recognition system comprises a physical keyed feature on the cartridge, a bar code on the cartridge, a magnetic tag on the cartridge, an RFID tag on the cartridge, an electronic microchip on the cartridge, or a combination thereof.

98. The dispensing device of claim 85, further comprising a patient identification means.

99. The dispensing device of claim 98, wherein said patient identification means is a fingerprint reader, an optical retinal reader, voice recognition, RFID, Wi-Fi or a combination thereof.

100. The dispensing device of claim 99, wherein the patient identification means is a radio frequency identification (RFID) reader configured to couple with a matching RFID tag on a patient to be identified.

101. The dispensing device of claim 100, wherein said dispensing device is unlocked when the RFID reader on said dispensing device detects a matching RFID tag on a patient.

102. The dispensing device of claim 85, wherein said dispensing end comprises a means to prevent or retard saliva ingress into said dispensing device.

103. The dispensing device of claim 102, wherein said means to prevent or retard saliva ingress includes seals, wipers, absorbents, adsorbents, desiccants, air gaps, or a combination thereof.

104. A dispensing device system for oral transmucosal administration of a drug dosage form to a specific patient, comprising:

(a) a drug dispensing device according to claim 86;

(b) a patient; and

(c) a means for bidirectional communication with a computer system.

105. The system of claim 104, further comprising a memory means and a user interface.

106. The system of claim 104, wherein said device further comprises a dispensing cartridge configured to hold one or more drug dosage forms.

107. The system according to claim 104, wherein said oral mucosal membrane is a sublingual membrane.

108. A dispensing device system for oral transmucosal administration of a drug dosage form to a specific patient, comprising:

(a) a drug dispensing device according to claim 91;

(b) a patient; and

(c) a means for bidirectional communication with a computer system.

109. The system of claim 108, wherein said device further comprises a dispensing cartridge configured to hold one or more drug dosage forms.