Claims for Patent: 11,672,738

Summary for Patent: 11,672,738

Title:	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 distal end portions of the pusher and 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 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 towards the first position of the pusher after the tablet is expelled.
Inventor(s):	Casidy Domingo, Edmond Chiu, Bradley Blackwood
Assignee:	CITO MECHANICAL DESIGN Inc , Vertical Pharmaceuticals LLC
Application Number:	US15/965,285
Patent Claims:	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 actuation pathway being closed at the distal end portion of the housing when the pusher is in the first position, the pusher contacts a deformable portion of the distal end portion of the housing during movement of the pusher from the first position to the second position to deform the deformable portion of the distal end portion of the housing and produce an opening at the distal end portion of the housing such that the actuation pathway is open at the distal end portion of the housing when the pusher is in the second position, the housing including a cantilevered portion at least partially disposed within the deformable portion when the pusher is in the first position, the cantilevered portion configured to limit lift or rotation of the drug-containing tablet with respect to the housing when the drug-containing tablet is expelled from the volume, the deformable portion configured to deform away from the cantilevered portion when the pusher is moved in the distal direction relative to the housing to produce the opening. 2. The apparatus of claim 1, wherein the pusher includes an elongate body portion, the elongate body portion of the pusher includes a plurality of retaining members extended from a first side of the elongate body portion, the plurality of retaining members being disposed within the housing when the pusher is in the first position and when the pusher is in the second position, the plurality of retaining members being biased in a direction away from the elongate body portion of the pusher, the plurality of retaining members configured to engage or be at least partially received in a recess or opening defined by a sidewall of the housing defining the actuation pathway such that the plurality of retaining members and the housing collectively prevent movement of the pusher relative to the housing in a proximal direction. 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 the first position, the retaining member configured to inhibit movement of the pusher in the proximal direction with respect to the housing when the pusher is in the second position. 4. The apparatus of claim 1, wherein: the pusher includes a plurality of retaining members, 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 housing defines a third recess in communication with the actuation pathway, the second recess being distal to the first recess, the third recess being distal to the second recess, at least a portion of a first retaining member from the plurality of retaining members of the pusher being received in the first recess of the housing when the pusher is in the first position, at least a portion of the first retaining member being received in the second recess of the housing when the pusher is in the second position, at least a portion of a second retaining member from the plurality of retaining members of the pusher being received in the second recess of the housing when the pusher is in the first position, at least a portion of the second retaining member being received in the third recess of the housing when the pusher is in the second position, the plurality of retaining members of the pusher configured to limit movement of the pusher in a proximal direction with respect to the housing when the first retaining member is received in the second recess and when the second retaining member is received in the third recess so that the pusher cannot be returned to the first position after the pusher is moved to the second position. 5. The apparatus of claim 1, wherein the housing includes a first portion and a second portion, a distal end portion of the first portion of the housing and a distal end portion of the second portion of the housing collectively defining the opening when the opening is produced, the distal end portion of the first portion of the housing including the deformable portion, the distal end portion of the second portion of the housing being undeformed when the opening is produced. 6. The apparatus of claim 5, wherein the deformable portion includes a curved inner surface extended across the actuation pathway, the curved inner surface of the deformable portion positioned over the actuation pathway when the opening is produced to limit a height of the actuation pathway so that at least one of the rotation or the lift of the drug-containing tablet with respect to the housing is limited when the drug-containing tablet is expelled. 7. The apparatus of claim 1, wherein the cantilevered portion is defined by an aperture of the housing, at least a portion of the deformable portion is distal to the aperture with respect to the housing. 8. The apparatus of claim 7, wherein an outer surface of the cantilevered portion of the housing is co-planar with an outer surface of the deformable portion adjacent to the cantilevered portion before the deformable portion is deformed, the cantilevered portion is exposed when the opening is produced. 9. The apparatus of claim 1, wherein the housing defines a channel and includes a bridge disposed within the channel, the bridge configured to engage an elongate protrusion of the pusher slidably disposed within the channel, the bridge configured to be at least partially separated from the housing when the pusher is moved from the first position to the 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. 10. 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. 11. 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 including a deformable portion 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, the deformable portion including an inner surface extended from a first side of the deformable portion of the housing to a second side of the deformable portion of the housing across the actuation pathway, the inner surface of the deformable portion being contoured to extend into the actuation pathway to limit a height of the actuation pathway to less than a diameter of the drug-containing tablet when the deformable portion is deformed so that the inner surface of the deformable portion limits at least one of rotation or lift of the drug-containing tablet with respect to the housing when the drug-containing tablet is expelled, the housing including a cantilevered portion at least partially disposed within the deformable portion when the deformable portion is in an undeformed position, the cantilevered portion configured to limit at least one of the rotation or the lift of the drug-containing tablet with respect to the housing when the drug-containing tablet is expelled; and 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 pusher contacts the distal end portion of the first portion of the housing during movement of the pusher in the distal direction to deform the deformable portion away from the cantilevered portion and away from the distal end portion of the second portion of the housing to produce the opening. 12. The apparatus of claim 11, 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 such that a distal end portion of the actuation pathway is closed 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, the distal end portion of the second portion of the housing is undeformed in the second configuration. 13. The apparatus of claim 11, wherein a portion of the pusher is fixedly and irreversibly 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. 14. The apparatus of claim 11, 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. 15. The apparatus of claim 11, wherein: the distal end portion of the first portion of the housing includes non-deformable portions disposed on opposite sides of the actuation pathway, and the deformable portion of the distal end portion of the first portion of the housing is disposed between the non-deformable portions of the distal end portion of the first portion of the housing. 16. The apparatus of claim 11, wherein the inner surface of the deformable portion includes a convex inner surface geometry extended across the actuation pathway. 17. The apparatus of claim 11, wherein the housing defines a channel and includes a bridge disposed within the channel, the bridge configured to engage an elongate protrusion of the pusher slidably disposed within the channel, 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. 18. The apparatus of claim 11, wherein the pusher includes an elongate body portion and a plurality of retaining members extended from a first side of 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. 19. The apparatus of claim 11, wherein: the pusher includes a plurality of retaining members, 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 housing defines a third recess in communication with the actuation pathway, the second recess being distal to the first recess, the third recess being distal to the second recess, at least a portion of a first retaining member from the plurality of retaining members of the pusher being received in the first recess of the housing when the pusher is in a first position, at least a portion the first retaining member being received in the second recess of the housing when the pusher is in a second position, at least a portion of a second retaining member from the plurality of retaining members of the pusher being received in the second recess of the housing when the pusher is in the first position, at least a portion of the second retaining member being received in the third recess of the housing when the pusher is in the second position, the plurality of retaining members of the pusher configured to limit movement of the pusher in a proximal direction with respect to the housing when the first retaining member is received in the second recess and when the second retaining member is received in the third recess so that the pusher cannot be returned to the first position after the pusher is moved to the second position. 20. The apparatus of claim 11, further comprising: the drug-containing tablet, the drug-containing tablet being disposed in a volume collectively defined by a distal end portion of the pusher, the distal end portion of the first portion of the housing, and the distal end portion of the second portion of the housing, the drug-containing tablet including a dosage of sufentanil.