Apparatus and methods for dispensing oral transmucosal dosage forms

Abstract

Single dose drug dosage form dispensing devices, and methods for operating such devices are disclosed herein. In one embodiment, an apparatus includes a housing defining an actuation pathway and a pusher. At least a portion of the pusher is disposed within the actuation pathway such that a distal end portion of the pusher and a distal end portion of the housing define a volume configured to contain a drug-containing tablet. The pusher is configured to move relative to the housing in a distal direction from a first position to a second position to expel the drug-containing tablet from the volume. The distal end portion of the pusher is extended from an opening in the housing when the pusher is in its second position. The housing is configured to limit movement of the pusher relative to the housing in a proximal direction from the second position of the pusher towards the first position of the pusher after the drug-containing tablet is expelled from the volume.

What is claimed is: 
     
         1 . An apparatus, comprising:
 a housing defining an actuation pathway; and   a pusher, at least a portion of the pusher disposed within the actuation pathway such that a distal end portion of the pusher and a distal end portion of the housing define a volume configured to contain a drug-containing tablet, the pusher configured to move relative to the housing in a distal direction from a first position to a second position to expel the drug-containing tablet from the volume, the distal end portion of the pusher being extended from an opening in the housing when the pusher is in its second position,   the housing being configured to limit movement of the pusher relative to the housing in a proximal direction from the second position of the pusher towards the first position of the pusher after the drug-containing tablet is expelled from the volume.   
     
     
         2 . The apparatus of  claim 1 , wherein the pusher includes an elongate body portion, the elongate body portion of the pusher includes plurality of retaining members extended from the elongate body portion, a retaining member from the plurality of retaining members being biased in a direction away from the elongate body portion of the pusher. 
     
     
         3 . The apparatus of  claim 1 , wherein:
 the pusher includes a retaining member, the retaining member configured to inhibit movement of the pusher in a proximal direction with respect to the housing when the pusher is in its first position, the retaining member configured to inhibit movement of the pusher in a proximal direction with respect to the housing when the pusher is in its second position.   
     
     
         4 . The apparatus of  claim 1 , wherein:
 the pusher includes a retaining member,   the housing defines a first recess in communication with the actuation pathway, the housing defines a second recess in communication with the actuation pathway, the second recess being distal to the first recess, at least a portion of the retaining member of the pusher being received in the first recess of the housing when the pusher is in its first position, at least a portion of the retaining member of the pusher being received in the second recess of the housing when the pusher is in its second position,   the retaining member of the pusher configured to limit movement of the pusher in a proximal direction with respect to the housing when the retaining member is received in the first recess and when the retaining member is received in the second recess.   
     
     
         5 . The apparatus of  claim 1 , wherein the distal end portion of the housing is configured to deform when the pusher is moved in the distal direction relative to the housing to produce an opening through which the drug-containing tablet can be expelled. 
     
     
         6 . The apparatus of  claim 1 , wherein the housing includes a first portion and a second portion, the first portion and the second portion of the housing collectively defining the actuation pathway, a distal end portion of the first portion of the housing configured to move away from the actuation pathway when the pusher is moved from its first position to its second position to produce an opening through which the drug-containing tablet can be expelled. 
     
     
         7 . The apparatus of  claim 6 , wherein the distal end portion of the first portion of the housing has a curved inner surface configured to limit rotation of the drug-containing tablet with respect to the housing when the drug-containing tablet is expelled. 
     
     
         8 . The apparatus of  claim 1 , wherein the housing includes a cantilevered portion defined by an aperture of the housing, the distal end portion of the housing is configured to deform away from the cantilevered portion of the housing when the pusher is moved in the distal direction relative to the housing to produce an opening through which the drug-containing tablet can be expelled. 
     
     
         9 . The apparatus of  claim 8 , wherein the cantilevered portion of the housing is configured to limit rotation of the drug-containing tablet with respect to the housing when the drug-containing tablet is expelled. 
     
     
         10 . The apparatus of  claim 1 , wherein the housing includes a bridge configured to engage the pusher, the bridge configured to be at least partially separated from the housing when the pusher is moved from its first position to its second position, the housing defining a recess configured to receive at least a portion of the bridge when the bridge is at least partially separated from the housing. 
     
     
         11 . The apparatus of  claim 1 , further comprising:
 the drug-containing tablet, the drug-containing tablet being disposed in the volume when the pusher is in the first position, the drug-containing tablet including a dosage of sufentanil.   
     
     
         12 . An apparatus, comprising:
 a housing having a first portion and a second portion and defining an actuation pathway between the first portion and the second portion, a distal end portion of the first portion of the housing configured to deform away from a distal end portion of the second portion of the housing to produce an opening for delivery of a drug-containing tablet from the housing;   a pusher, at least a portion of the pusher disposed within the actuation pathway and moveable in a distal direction with respect to the housing;   the housing and the pusher being collectively configured to limit movement of the distal end portion of the first portion of the housing towards the distal end portion of the second portion of the housing after delivery of the drug-containing tablet from the housing.   
     
     
         13 . The apparatus of  claim 12 , wherein the housing has a first configuration in which the distal end portion of the first portion of the housing is in contact with the distal end portion of the second portion of the housing and a second configuration in which the distal end portion of the first portion of the housing is spaced apart from the distal end portion of the second portion of the housing. 
     
     
         14 . The apparatus of  claim 12 , wherein a portion of the pusher is fixedly disposed between the distal end portion of the first portion of the housing and the distal end portion of the second portion of the housing after delivery of the drug containing tablet from the housing. 
     
     
         15 . The apparatus of  claim 12 , wherein the housing includes an elongate housing body and a protrusion extended from the elongate housing body, a portion of the pusher configured to engage the protrusion of the housing when the pusher is moved in the distal direction with respect to the housing to inhibit further movement of the pusher in the distal direction with respect to the housing. 
     
     
         16 . The apparatus of  claim 12 , wherein the distal end portion of the first portion of the housing has a curved inner surface configured to limit rotation of the drug-containing tablet with respect to the housing during delivery of the drug-containing tablet from the housing. 
     
     
         17 . The apparatus of  claim 12 , wherein the distal end portion of the first portion of the housing includes a convex inner surface geometry configured to limit at least one of rotation or lift of the drug-containing tablet with respect to the housing during delivery of the drug-containing tablet from the housing. 
     
     
         18 . The apparatus of  claim 12 , wherein the housing includes a bridge configured to engage the pusher, the bridge configured to be at least partially separated from the housing when the pusher is moved in the distal direction with respect to the housing, the housing defining a recess configured to receive at least a portion of the bridge when the bridge is at least partially separated from the housing. 
     
     
         19 . The apparatus of  claim 12 , wherein the pusher includes a plurality of retaining members extended from the elongate body portion, the plurality of retaining members configured to limit movement of the pusher in a proximal direction with respect to the housing. 
     
     
         20 . The apparatus of  claim 12 , wherein:
 the pusher includes a retaining member,   the housing defines a first recess in communication with the actuation pathway, the housing defines a second recess in communication with the actuation pathway, the second recess being distal to the first recess, at least a portion of the retaining member of the pusher being received in the first recess of the housing when the pusher is in a first position, at least a portion of the retaining member of the pusher being received in the second recess of the housing when the pusher is in a second position,   the retaining member of the pusher configured to limit movement of the pusher in a proximal direction with respect to the housing when the retaining member is received in the first recess and when the retaining member is received in the second recess.   
     
     
         21 . The apparatus of  claim 12 , further comprising:
 the drug-containing tablet, the drug-containing tablet being disposed in the volume, the drug-containing tablet including a dosage of sufentanil.