Storage and dispensing devices for administration of oral transmucosal dosage forms

Abstract

Dispensing devices and systems for oral transmucosal administration of small volume drug dosage forms to the oral mucosa are provided. The dispensing device may be a single dose applicator (SDA), or an electromechanical device comprising a means for patient identification such as a wrist worn RFID tag and annular bidirectional antenna together with a lock-out feature.

It is claimed: 
     
         1 . A radio frequency identification (RFID) system for patient identification, comprising:
 (a) a handheld device having an RFID reader antenna; and   (b) a matching wrist worn RFID tag or inlay consisting essentially of a die or chip, a circuit and an antenna, wherein the antenna comprises annular conductors that circumvent the wrist and the antenna field has an axis directed at the patient's hand, and said patient identification occurs when a handheld device comprising the reader antenna is held in the patient's hand, whereby the reader antenna is activated.   
     
     
         2 . The RFID system according to  claim 1 , wherein said wrist worn RFID tag is a bracelet. 
     
     
         3 . The RFID system according to  claim 1 , wherein said RFID signal is directional and symmetrical. 
     
     
         4 . The RFID system according to  claim 1 , wherein the distance between said handheld device and said wrist worn RFID tag or inlay, is selected from the group of distances consisting of between 0 inches and 12 inches, between 0 and 8 inches, and between 0 and 6 inches. 
     
     
         5 . The RFID system according to  claim 1 , wherein said RFID antenna is bidirectional but not symmetrical. 
     
     
         6 . A drug dispensing system comprising an RFID system component according to  claim 1 . 
     
     
         7 . The drug dispensing system according to  claim 6 , wherein said RFID antenna axis orientation is directional and symmetrical. 
     
     
         8 . The drug dispensing system according to  claim 6 , wherein the distance between said handheld device and said wrist worn RFID tag or inlay, is selected from the group of distances consisting of between 0 inches and 12 inches, between 0 and 8 inches, and between 0 and 6 inches. 
     
     
         9 . The drug dispensing system according to  claim 6 , further comprising a sufentanil-containing drug dosage form. 
     
     
         10 . The drug dispensing system according to  claim 6 , wherein when the wrist worn RFID tag is removed, the RFID tag or inlay is damaged or destroyed and the drug dispensing system becomes non-functional. 
     
     
         11 . A method for controlled access to a drug by a patient, comprising:
 providing a drug dispensing device comprising the RFID system for patient identification according to  claim 1 , said dispensing device further comprising small volume drug dosage forms and a timed lock-out feature, said timed lock-out feature providing for a set lock-out time, wherein said dispensing device is activated and dispenses a drug dosage form following patient identification when said set lock-out time has passed.   
     
     
         12 . The method according to  claim 11 , wherein said dispensing device cannot be activated during said lock-out time. 
     
     
         13 . The method according to  claim 11 , for use in the inpatient or hospital setting. 
     
     
         14 . The method according to  claim 13 , for use in the treatment of acute inpatient pain. 
     
     
         15 . The method according to  claim 14 , wherein said acute inpatient pain is post-operative pain. 
     
     
         16 . The method according to  claim 11 , for use in the outpatient setting. 
     
     
         17 . The method according to  claim 11 , wherein said drug is an opioid. 
     
     
         18 . The method according to  claim 11 , wherein said opioid is sufentanil. 
     
     
         19 . The method according to  claim 11 , wherein the axis orientation of said RFID antenna is directional and symmetrical. 
     
     
         20 . The method according to  claim 11 , wherein the distance between said handheld device and said wrist worn RFID tag or inlay is selected from the group of distances consisting of between 0 inches and 12 inches, between 0 and 8 inches, and between 0 and 6 inches.