Classifications

• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
  • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
  • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
  • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
  • B65D75/325—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil
  • B65D75/326—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil and forming one compartment
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
  • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
  • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
  • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
  • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
  • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
  • B65D75/36—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed
  • B65D75/366—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed and forming one compartment

Definitions

• Packaging systems and kits are disclosed for drug delivery devices, particularly intranasal drug delivery devices.
• Blister packaging is one type of pharmaceutical packaging that is commonly used for packaging pills.
• blister packaging has been implemented in the packaging of drug delivery devices.
• the packaged drug delivery device(s) can rattle within the blister packs. This is because typical blister packs fail to sufficiently secure the drug delivery device(s) in a manner that prevents rattle. This rattle can have negative effects on the drug delivery devices, and ultimately, can cause the drug delivery devices to be defective for their intended use.
• some drug delivery devices that are packaged in blister packs can include a plunger that is used for dispensing a medicament disposed therein.
• a plunger that is used for dispensing a medicament disposed therein.
• movement of these drug delivery devices within typical blister packs can result in actuation of the plunger before it reaches the end-user, e.g., during shipping, handling, storage, sterilization, and the like.
• medicament can be prematurely expelled from the drug delivery device. This premature expulsion of drug can render the drug delivery device ineffective, and thus, can require the disposal thereof.
• a packaging system in one exemplary embodiment, includes a base extending from a first end to a second end and configured to receive a drug delivery device having a device body having an upper segment and a lower segment, and an actuator operatively coupled to the lower segment, in which the base is configured to house the received drug delivery device therein at a non- zero angle relative to a longitudinal axis of the base that extends between the first and second ends to thereby substantially prevent movement of the received drug delivery device while within the base.
• the base includes a retaining cavity and a gripping cavity adjacent the retaining cavity.
• the retaining cavity is configured to create an interference fit with at least a portion of an upper segment of a drug delivery device received within the base to thereby releasably retain the received drug delivery device within the base.
• the gripping cavity is configured to receive a lower segment of a device body and a portion of an actuator of a drug delivery device received within the base.
• the base can have a variety of configurations.
• the base can include an end cavity positioned between the first end of the base and the retaining cavity, in which the end cavity can be configured to receive at least a portion of an upper segment and an outer sleeve of a drug delivery device received within the base.
• the base can include an end cavity positioned between the gripping cavity and the second end of the base, in which the end cavity can be configured to receive a portion of an actuator of a drug delivery device received within the base.
• the base can be substantially transparent such that a drug delivery device received within the base is viewable through the base.
• the non- zero angle can be from about 1 degree to 5 degrees. In one embodiment, the non-zero angle can be about 4 degrees.
• the retaining cavity can have a variety of configurations.
• the retaining cavity can have a substantially c-shaped configuration.
• the packaging system includes a lid that can be releasably sealed to the base.
• the drug delivery device can have a variety of configurations.
• the drug delivery device can include an outer sleeve about a portion of the upper segment of the device body.
• the outer sleeve can have a first set of opposing flanges extending from a first end thereof.
• the gripping cavity can include a support element that can be configured to support a lower segment of a drug delivery device received within the base such that the first set of opposing flanges of the received drug delivery device is positioned between the retaining cavity and the support element to thereby substantially prevent actuation of an actuator of the received drug delivery while within the base.
• the support element can have a substantially c-shaped configuration.
• the gripping cavity can be configured to allow a device body of a drug delivery device received within the base to be gripped to remove the received drug delivery device from the base.
• a packaging kit in another exemplary embodiment, includes a drug delivery device and a packaging system having the drug delivery device disposed therein.
• the drug delivery device includes a device body having an upper segment and a lower segment, and an actuator operatively coupled to the lower segment.
• the packaging system includes a base extending from a first end to a second end and houses the drug delivery device therein at a non zero angle relative to a longitudinal axis of the base that extends between the first and second ends to thereby substantially prevent movement of the drug delivery device within the base.
• the base includes a retaining cavity that creates an interference fit with at least a portion of the upper segment of the drug delivery device to thereby releasably retain the drug delivery device within the base, and a gripping cavity adjacent to the retaining cavity and houses the lower segment of the device body and a portion of the actuator of the drug delivery device.
• the base can have a variety of configurations.
• the base can include an end cavity positioned between the first end of the base and the retaining cavity and receives at least a portion of the upper segment and the outer sleeve of the drug delivery device.
• the base can include an end cavity positioned between the gripping cavity and the second end of the base and receives a portion of the actuator of the drug delivery device.
• the packaging system can include a lid that can be releasably sealed to the base.
• the non-zero angle can be from about 1 degree to 5 degrees. In other embodiments, the non-zero angle can be about 4 degrees.
• the retaining cavity can have a variety of configurations.
• the retaining cavity can have a substantially c-shaped configuration.
• the drug delivery device can have a variety of configurations.
• the drug delivery device can include an outer sleeve positioned about a portion of the upper segment of the device body.
• the outer sleeve can have a first set of opposing flanges extending from a first end thereof.
• the gripping cavity can include a support element that supports the lower segment of the drug delivery device such that the first set of opposing flanges of the drug delivery device is positioned between the retaining cavity and the support element to thereby substantially prevent actuation of the actuator while the drug delivery device is within the base.
• the support element can have a substantially c- shaped configuration.
• the base can be substantially transparent such that the drug delivery device is viewable through the base.
• the gripping cavity can have a variety of configurations.
• the gripping cavity can allow the device body of the drug delivery device to be gripped to remove the drug delivery device from the base.
• FIG. 1 A is a front view of one embodiment of an intranasal drug delivery device
• FIG. IB is a side view of the intranasal drug delivery device of FIG. 1A;
• FIG. 1C is an exploded view of the intranasal drug delivery device of FIG. 1A;
• FIG. 2 is a partially exploded view of one embodiment of a packaging kit that includes a packaging system having a base and a lid, and the intranasal drug delivery device of FIG. 1A housed within the packaging system;
• FIG. 3 is a perspective view of the packaging kit of FIG. 2;
• FIG. 4 is a front magnified view of the lid of FIG. 3;
• FIG. 5 is a top view of the base of the packaging system of FIG. 2, showing the intranasal drug delivery device disposed therein;
• FIG. 6 is a cross-sectional side view of the base of the packaging system of FIG. 2 taken at line 6-6, showing the intranasal drug delivery device disposed therein;
• FIG. 7 is a perspective view of the base of the packaging system of FIG. 2 with the intranasal drug delivery device removed;
• FIG. 8 is a top view of the base of FIG. 7;
• FIG. 9 is a cross-sectional view of the base of FIG. 8 taken at line 9-9; and [0034] FIG. 10 is a cross-sectional view of the base of FIG. 7 taken at line 10-10.
• kits, and methods described herein can be applicable to a number of drug delivery devices, they are described herein in the context of an intranasal drug delivery device.
• the intranasal drug delivery devices can include a device body and an actuator that is operatively coupled to the device body and, upon actuation, is configured to expel one or more doses of medicament from the device.
• the actuator can have a variety of configurations such as, for example, a plunger, a button, a lever, and the like, the actuator described herein is in the context of a plunger.
• the intranasal drug delivery devices can be configured to expel one or more doses of a medicament disposed therein, they are described herein in the context of a bi-dose intranasal drug delivery device.
• an exemplary intranasal drug delivery device 100 includes a device body 102 having an upper segment 104a and a lower segment 104b, and a plunger 106 operatively coupled to the lower segment 104b.
• a user pushes the plunger 106 towards the upper segment 104a of the device body 102, thereby causing a dose of medicament (not shown) disposed within the device 100 to be expelled therefrom.
• the plunger 106 resets, the user can then subsequently push the plunger 106 again towards the upper segment 104a of the device body 102, thereby causing an additional dose of medicament (not shown) disposed within the device 100 to be expelled therefrom.
• a “medicament” as used herein refers to a therapeutic agent (a drug, a biologic, a biological material, etc.) that when administered to a subject will have the intended prophylactic effect, e.g., preventing or delaying the onset (or reoccurrence) of an injury, disease, pathology or condition, or reducing the likelihood of the onset (or reoccurrence) of an injury, disease, pathology, or condition, or their symptoms or the intended therapeutic effect, e.g., treatment or amelioration of an injury, disease, pathology or condition, or their symptoms including any objective or subjective parameter of treatment such as abatement; remission; diminishing of symptoms or making the injury, pathology or condition more tolerable to the patient; slowing in the rate of degeneration or decline; making the final point of degeneration less debilitating; or improving a patient’s physical or mental well-being.
• suitable medicaments include esketamine, ketamine, naloxone, and sumatriptan.
• the upper segment 104a of the device body 102 includes first and second indicator windows 108a, 108b.
• the first indicator window 108a is configured to indicate to a user or healthcare provider (HCP) that a first dose of the medicament has been expelled from the device 100
• the second indicator window 108b is configured to indicate to a user or HCP that a second dose of the medicament has been expelled from the device 100.
• HCP healthcare provider
• the indicator windows 108a, 108b can show a color such as green.
• the indicator window 108a can show a different color such as white.
• the indicator window 108b can likewise show the color white.
• the indicator windows 108a, 108b can each show a different color prior to and/or after corresponding actuation of the plunger 106.
• the intranasal drug delivery device 100 can include other elements.
• the intranasal drug delivery device 100 includes a tip 105 that extends from an end of the upper segment 104a, which is configured to be placed in a user’s nostril, a depth guide 110, and a finger rest 112.
• the depth guide 110 is conjoined to the finger rest 112 via an elongated tubular body 114, also referred to herein as an “outer sleeve.”
• the depth guide 110 includes a first set of opposing flanges 116a, 116b extending from a first end 114a of the elongated tubular body 114.
• the first set of opposing flanges 116a, 116b are configured to limit the insertion depth of the upper segment 104a of the device body 102 into a user’s nostril.
• the finger rest 112 includes a second set of two opposing flanges 118a, 118b extending from a second, opposing end 114b of the elongated tubular body 114.
• the finger rest 112 acts as a positioning guide for fingers of a user, e.g., the index and middle fingers of a user, such that a user can grasp and hold the device 100 while depressing the plunger 106 toward the upper segment 104a of the device body 102 using their thumb.
• the elongated tubular body 114 includes an oblong shaped hole 120 such that the first and second indicator windows 108a, 108b are visible therethrough.
• the packaging kits described herein include a packaging system and a drug delivery device, such as an intranasal drug delivery device, housed within the packaging system.
• the packaging systems described herein include a base that is designed to house an intranasal drug delivery device in a manner that substantially prevents movement of the device within the packaging system during transportation.
• the packaging system can house the device therein at a non-zero-angle with respect to the longitudinal axis of the base. As such, rattling of the device during transport, which commonly occurs when using conventional packaging systems, can therefore be substantially prevented.
• the present packaging systems can be configured to releasably retain the intranasal drug delivery device therein so as to prevent the device from being prematurely released from the packaging system, e.g., during opening of the packaging system.
• the intranasal drug delivery device can therefore be securely retained within the packaging system until the user or HCP decides to remove the device therefrom, e.g., at a point of use.
• the packaging systems can be designed to orient the intranasal drug delivery devices such that a first end of the devices, like first end 101a, is angled down and an opposing, second end of the devices, like second end 101b, is angled up.
• the packaging systems can be designed in which the first end of the devices is angled up and the second end of the devices is angled down.
• An exemplary packaging system can include a variety of features to facilitate secure positioning and orientation of an intranasal drug delivery device therein, as described herein and illustrated in the drawings.
• the packaging systems can include only some of these features and/or can include a variety of other features known in the art.
• the packaging systems described herein are merely intended to represent certain exemplary embodiments.
• FIGS. 2 and 3 illustrate an exemplary embodiment of a packaging kit 200 that includes a base 202 and a lid 204, which are collectively referred to herein as a packaging system, and the intranasal drug delivery device 100 as shown in FIGS. 1 A-1C.
• FIG. 2 illustrates the packaging kit 200 in a partially exploded view
• FIG. 3 illustrates the packaging kit 200 in an assembled view in which the intranasal drug delivery device 100 (obscured) is housed within the packaging system.
• the packaging system is configured to house and seal the intranasal drug delivery device 100 disposed therein.
• the packaging system is in a form of a blister pack, in which the lid 204 is releasably sealed to the base 202.
• the lid 204 can be sealed to at least a portion of the base 202 using any suitable sealing method, e.g., lamination, heat sealing, adhesive, heat and pressure sealing, and the like.
• the packaging system is designed such that the first end 101a of the device 100 is angled down and the second end 101b of the device 100 is angled up (see FIG. 6).
• the base 202 can be created via thermoforming, vacuum forming, or any other suitable process.
• thermoforming a plastic fdm or sheet is unwound from a reel and guided through a pre-heating station. The temperature of the pre-heating plates is such that the plastic will soften and become pliable. The warm plastic then arrives in a forming station where a large pressure forms a base into a negative mold. The mold is cooled such that the plastic becomes firm again and maintains its shape when removed from the mold.
• vacuum forming a plastic film or sheet is heated to a forming temperature, stretched onto a single surface mold, and forced against the mold by a vacuum.
• the base 202 can be formed of a variety of one or more base materials.
• the one or more base materials can be moldable material(s), e.g., thermoform material(s), and configured to retain a desired shape and to be crush resistant so prevent a device disposed within the base 202 from being damaged, e.g., during transport.
• the one or more base materials can impart specific characteristics to the base 202, e.g., a desired water vapor transmission rate, a desired oxygen transmission rate, a desired melting point, and the like.
• the one or more base materials can be opaque, transparent, or translucent. Further, compatibility of the one or more base materials with a device to be contained therein can also be a factor in the selection of the one or more base materials.
• Non-limiting examples of suitable base materials include a variety of polymeric materials such as polyvinyl chloride, polyethylene terephthalate (PET), a modified version of PET, e.g., a glycol modified version of PET (PETG), and the like.
• PET polyethylene terephthalate
• PET modified version of PET
• PETG glycol modified version of PET
• the indicator windows 108a and 108b can be visible to the user or HCP.
• the first indicator window 108a is configured to indicate to a user or HCP that a first dose of the medicament has been expelled from the device 100
• the second indicator window 108b is configured to indicate to a user or HCP that a second dose of the medicament has been expelled from the device 100.
• the user or HCP can verify that the device 100 has not been prematurely actuated by simply looking through the base 202 at the first and second indicator windows 108a, 108b of the assembled packaging kit 200 rather than having to open the packaging kit 200.
• the lid 204 can have a variety of configurations.
• the lid 204 can be formed of a single layer, whereas in other embodiments, the lid 204 can be formed of multiple layers.
• the lid 204 includes an adhesive layer 207, a printing layer 208, and a sealing layer 205 that is sealed to and interposed therebetween.
• the adhesive layer 207 is positioned between the sealing layer 205 and the base 202.
• the lid 204 as illustrated in FIGS.
• the lid 204 can have other suitable shapes and sizes. A person skilled in the art will appreciate that the size and shape of the lid depends at least upon the shape of the top surface 206 of the base 202.
• the packaging kit 200 when the packaging kit 200 is assembled, a portion of the lid 204 is unsealed to a portion of the top surface 206 of the base 202 such that the unsealed portion of the lid 204 can be grasped and used to open the packaging kit 200 to access the device 100 disposed within the base 202.
• the sealing layer 205 can be configured to be removed from the base 202 via a user or HCP grasping the unsealed position of the lid 204 and peeling the lid 204 in a direction away from the base 202.
• the sealing layer 205 can be sealed to at least a portion of the top surface 206 of the base 202 such that the resulting seal is air-tight, and the device 100 housed within the base 202 can be protected from the outside environment. Further, the resulting seal can function as a form of tamper evidence when compromised, e.g., by the resulting seal being at least partially removed from the base 202 prior to the device 100 reaching a desired point of use.
• the sealing layer 205 can formed of any one or more materials that are configured to suppress permeation of oxygen and/or water from the outside environment into the base 202.
• the sealing layer 205 can be a metal foil such as an aluminum foil, a silver film or a gold foil, a film on which a metal such as aluminum, silver or gold has been deposited, or a film on which an inorganic substance such as SiOx has been deposited.
• the sealing layer 205 is an aluminum foil.
• the sealing layer 205 can be sealed to at least a portion of the top surface 206 of the base 202 using any suitable processes. In this illustrated embodiment, the sealing layer 205 is sealed to at least a portion of the top surface 206 of the base 202 via the adhesive layer 207.
• the adhesive layer 207 can be applied to the entire outer surface 205a of the sealing layer 205, as shown in FIG.
• the adhesive layer 207 can be formed of one or more adhesives, such as hot melt laminate adhesive(s), or any other suitable adhesive(s) that can sufficiently seal the sealing layer 205 to at least a portion of the top surface 206 of the base 202.
• the adhesive layer 207 can be heat sealed to a portion of the top surface 206, whereas in other embodiments, the adhesive layer 207 can be sealed to the entire top surface 206 of the base 202.
• the sealing layer 206 can be sealed directly to at least a portion of the top surface 206 of the base 202.
• the printing layer 208 can be formed of any one or more materials that allows printing of indicia thereon, such as the name of a medicament filled in the device to be housed inside the base, a fill content of the medicament, a skew number, a lot number corresponding to the device itself and/or the medicament, an expiration date of the medicament, the company name associated with the device and/or medicament, instructions indicating where to open the packaging system to access the device disposed therein.
• the printing layer 208 can be formed of white paper that can allow for quick ink drying time and provide a visible contrast to a colored ink.
• the printing layer 208 can be omitted, and any desired indicia can be printed directly on the sealing layer 205.
• the base 202 can have a variety of configurations.
• the base 202 extends from a first end 210a to an opposing second end 210b.
• the base 202 is configured to house and position the intranasal drug delivery device 100 therein (see FIG. 5) such that the longitudinal axis (LD) of the device 100 extends at a non-zero angle (4D) relative to the longitudinal axis (LB) of the base 202 (see FIG. 6).
• the non-zero angle (4D) depends at least upon the height (HF) of the finger rest 112 and the end of the plunger 106 that would otherwise contact the lid 204 if the longitudinal axis (LD) of the device 100 extended at a zero angle relative to the longitudinal axis (LB) of the base 202.
• the non-zero angle (4D) can be from about 1 degree to 5 degrees. In one embodiment, the non-zero angle (4D) can be about 4 degrees.
• the base 202 is configured to substantially secure the device 100 thereto in a manner that substantially prevents movement of the device 100 within the base 202, e.g., during transport of the packaging kit 200. As a result, this resistance to movement can substantially hinder the device 100 from rattling within the base 202, which would otherwise occur within conventional packaging systems.
• the base 202 includes a retaining cavity 212 that is defined by two conjoined shoulder surfaces 214a, 214b.
• the retaining cavity 212 creates an interference fit with at least a portion of the upper segment 104a of the device body 102 (see FIG. 5). More specifically, as shown in FIG. 5 and partially shown in FIG. 6, a portion 115 of the outer sleeve 114, and thus the portion of the upper segment 104a of the device body 102 that extends through this portion 115 of the outer sleeve 114, is positioned within the retaining cavity 212.
• the interference fit is formed between the outer surface of this portion 115 of the outer sleeve 114 and the two conjoined shoulder surfaces 214a, 214b.
• the width (WR) of the retaining cavity 212 can be equal to or less than the outer diameter (Do) of the outer sleeve 114, excepting for dimensional tolerances in manufacturing.
• the width (WR) of the retaining cavity 212 refers to the largest distance between the two shoulder surfaces 214a, 214b (see e.g., FIG. 9).
• the width (WR) and depth (DR) of the retaining cavity 212 can vary and is dependent at least upon the structural configuration of the outer sleeve 114.
• the interference fit that is created between the outer sleeve 114 and the shoulder surfaces 214a, 214b can prevent movement, e.g., orthogonal movement, of the device 100 within the base 202, e.g., during transport of the packaging kit 200.
• This interference fit can releasably retain the device 100 within the base 202 such that the device 100 is secured to the base 202 during transport and opening of the packaging kit 200, while also allowing a user or HCP to remove the device 100 from the base 202 when desired.
• the device 100 can remain secured within the base 202. Further, by having the interference fit between the outer sleeve 114 and the shoulder surfaces 214a, 214b, the device 100 can be secured to the base 202 without the need to grip onto the plunger 106. This can reduce the chance of a user or HCP accidentally actuating the device 100 when removing it from the base 202.
• the retaining cavity 212 can have a variety of configurations, For example, in this illustrated embodiment, as shown in more detail in FIGS. 7 and 9, each of the two conjoined shoulder surfaces 214a, 214b have a curved configuration, and as a result, the retaining cavity 212 has a substantially c-shaped configuration.
• each of the two shoulder surfaces 214a, 214b, and thus the retaining cavity 212 defined thereby depends at least upon the structural configuration of the outer sleeve 114.
• each of the two shoulder surfaces 214a, 214b, and thus the retaining cavity 212 can have any other shaped configuration that can create an interference fit with the portion of a device that extends through the retaining cavity 212.
• the retaining cavity 212 can have a U-shaped configuration, a V-shaped configuration, a polygonal-shaped configuration (e.g., a square-shaped configuration, an octagon-shaped configuration, etc.), and the like.
• the base 202 is configured to house the device 100 therein at a non-zero angle. That is, the base 202 is configured to house and position the intranasal drug delivery device 100 therein (see FIG. 5) in which the longitudinal axis (LD) of the device 100 extends at a non-zero angle (4D) relative to the longitudinal axis (LB) of the base 202 (see FIG.
• the non-zero angle (4R) can be equal to the non-zero angle (4D), whereas in other embodiments, the non-zero angle (4R) can be less than or greater than the non-zero angle (4D).
• the base 202 includes a gripping cavity 218 that is adjacent to the retaining cavity 212.
• the gripping cavity 218 receives and houses the finger rest 112, the lower segment 104b, and a portion of the plunger 106 of the device body 102.
• the gripping cavity 218 includes a first portion 220, a second portion 222, and a support element 224 that separates the first portion 220 from the second portion 222.
• the first portion 220 can be configured to enable gripping, via digits of a hand of a user or HCP (e.g., a user’s or HCP’s finger and thumb), of a particular portion of the device 100 housed therein.
• the portion of the device 100 enabled for gripping may be isolated within the first portion 220 of the gripping cavity 218, such that the device 100 cannot be gripped, or would otherwise be difficult to grip, elsewhere.
• the first portion 220 is configured for insertion of the aforedescribed digits of a hand to engage with opposed sides of the lower segment 104b of the device body 102 housed within the gripping cavity 218.
• the first portion 220 can therefore be structurally dimensioned, i.e., having a length (LGP), a width (WGP), and a depth (DGP) as shown in FIGS. 8-10, so as to provide sufficient space for insertion of at least a single digit on either side of the lower segment 104b of the device body 102 in an opposed manner, whereby the lower segment 104b can be gripped by said digits (e.g., a user’s or HCP’s finger and thumb) with a pincer type action.
• LGP length
• WGP width
• DGP depth
• the user or HCP can grip and pull the lower segment 104b away from the base 202 with a sufficient amount of force that can overcome the frictional force of the interference fit between the outer sleeve 114 and the shoulder surfaces 214a, 214b, and thus, remove the device 100 from the base 202.
• the structural configuration of the first portion 220 can encourage a user or HCP to remove the device 100 from the base 202 via the lower segment 104b of the device body 102, which can keep their fingers away from the device tip 105, e.g., for hygiene purposes, and/or the plunger 106, e.g., to prevent accidental actuation of the device 100.
• the HCP removes the device 100 from the base 202
• the removal thereof via the lower segment 104b of the device body 102 can allow for a smooth transition or hand-over of the device 100 from the HCP to the user.
• the first portion 220 can be structurally dimensioned so as to provide a clearance from about 1 mm to 5 mm.
• the support element 224 is configured to support the lower segment 104b of the device body 102, and thus the device 100, such that the finger rest 112 is positioned between the retaining cavity 212 and the support element 224, and thus the finger rest 112 is positioned within the second portion 222 of the gripping cavity 218. That is, when the device 100 is inserted into and secured to the base 202, the finger rest 112 is confined between the retaining cavity 212 and the support element 224.
• the finger rest 112 is fixedly coupled to the device body 102 and the plunger 106 is operatively coupled to the device body 102, the position of the finger rest 112 within the second portion 222 of the gripping cavity 218, and the confinement of the finger rest 112 between the retaining cavity 212 and the support element 224, substantially prevents movement of the device 100 in a longitudinal direction (i.e., a direction that runs along the longitudinal axis (LB) of the base 202).
• a longitudinal direction i.e., a direction that runs along the longitudinal axis (LB) of the base 202).
• the plunger 106 can be maintained in its unactuated position, and thus premature actuation of the plunger 106 can be avoided, while the device 100 is housed within and secured to the base 202.
• the positioning and confinement of the finger rest 112 within the second portion 222 of the gripping cavity 218 can control the rotational orientation of device 100, and thus the orientation of the indicator windows 108a, 108b relative to the base 202.
• the interaction of the finger rest 112 with the second portion 222 of the gripping cavity 218 can position the indicators windows 108a, 108b at an orientation that is visible to a user or HCP through the base 202.
• the support element 224 can have a variety of configurations.
• the support element 224 as shown in FIGS. 5 and 7-9, has a substantially c-shaped configuration.
• the width (Ws) of the support element 224 can be configured to allow the support element 224 to receive and make contact with a portion of the lower segment 104b of the device body 102 (see FIGS. 5-6 and 9).
• the support element 224 can have any other suitable shape that can support the lower segment 104b of the device body 102 and can cooperate within the structural configuration of the retaining cavity 212 so as to confine the finger rest 112 therebetween.
• the structural configuration of the support element 224 can depend at least upon the structural configuration of the lower segment 104b of the device body 102 and the structural configuration of the retaining and gripping cavities 212, 218.
• the base 202 can include one or more additional cavities for housing other portions of the device 100.
• the base 202 includes a first end cavity 226 and a second, opposing end cavity 228.
• the first end cavity 226 is configured to receive and house at least a portion of the upper segment 104a and of the outer sleeve 114 (i.e., portions thereof that are not housed in any other cavity of the base 202).
• the first end cavity 226 can be configured to house the distal tip 105 and the depth guide 110 of the device 100 (see FIGS. 5-6).
• the first end cavity 226 is positioned between the retaining cavity 212 and the first end 210a of the base 202, and as a result, the retaining cavity 212 is positioned between the first end cavity 226 and the gripping cavity 218. In this illustrated embodiment, the retaining cavity 212 extends from the first end cavity 226 to the gripping cavity 218.
• the first end cavity 226 can have a variety of configurations.
• the first end cavity 226 has a substantially rectangle-shaped configuration.
• the structural configuration of the first end cavity 226 depends at least upon the structural configuration of the portions of a device that is to be housed therein, e.g., as shown in FIGS. 5-6, a portion of the upper segment 104a and of the outer sleeve 114, the distal tip 105, and/or the depth guide 110 of the device 100. Further, as shown in FIGS.
• the structural configuration of the first end cavity 226 also provides a clearance between the distal tip 105 and the base 202, which can help prevent accidental activation and/or breakage of the device 100.
• the first end cavity 226 can have any other suitable configuration that can house one or more portions of the device 100.
• the second end cavity 228 is configured to receive and house a portion of the plunger 106 (i.e., the portion of the plunger 106 that is not housed within the gripping cavity 218). As shown, the second end cavity 228 is positioned between the gripping cavity 218 and the second end 210b of the base 202, and as a result, the gripping cavity 218 is positioned between the retaining cavity 212 and the second end cavity 228.
• the second end cavity 228 can have a variety of configurations.
• the second end cavity 228 has a substantially rectangle-shaped configuration.
• the structural configuration of the second end cavity 228 depends at least upon the structural configuration of the portions of a device that is to be housed therein, e.g., as shown in FIGS. 5-6, a portion of the plunger 106 of the device 100.
• the structural configuration of the second end cavity 228 also provides a clearance between the plunger 106 and the base 202 which can help prevent accidental activation and/or breakage of the device 100.
• the second end cavity 228 can have any other suitable configuration that can house one or more portions of the device 100.
• the bottom surface 228a of the second end cavity 228 also extends at a non-zero angle (4-EI) relative to the longitudinal axis (LB) of the base 202 (see FIG. 10).
• 4-EI non-zero angle
• LB longitudinal axis
• 4D non-zero angle
• the non- zero angle (4-EI) can be equal to the non-zero angle (4D) and/or the non-zero angle (4R), whereas in other embodiments, the non-zero angle (4E2) can be less than or greater than the non-zero angle (4D) and/or the non-zero angle (4R).
• the bottom surface 212a of the retaining cavity 212 and the bottom surface 228a of the second end cavity 228 can each extend at a zero angle relative to the longitudinal axis (LB) of the base 202.
• the non-zero angle (4D) can be achieved and maintained by the relative heights between the bottom surface 212a of the retaining cavity 212 and the bottom surface 228a of the second end cavity 228 with respect to the top surface 206 of the base 202.
• the bottom surface 212a of the retaining cavity 212 can be positioned at a first height and the bottom surface 238 of the second end cavity 228 can be positioned at a second height that is greater than the first height.
• Values or ranges may be expressed herein as “about” and/or from/of “about” one particular value to another particular value. When such values or ranges are expressed, other embodiments disclosed include the specific value recited and/or from/of the one particular value to another particular value. Similarly, when values are expressed as approximations, by the use of antecedent “about,” it will be understood that here are a number of values disclosed therein, and that the particular value forms another embodiment. It will be further understood that there are a number of values disclosed therein, and that each value is also herein disclosed as “about” that particular value in addition to the value itself. In embodiments, “about” can be used to mean, for example, within 10% of the recited value, within 5% of the recited value or within 2% of the recited value.

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• Chemical & Material Sciences (AREA)
• Composite Materials (AREA)
• Engineering & Computer Science (AREA)
• Mechanical Engineering (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Packages (AREA)
• Coating Apparatus (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)

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• 2020
  • 2020-12-17 JP JP2022537304A patent/JP2023507401A/ja active Pending
  • 2020-12-17 CA CA3164799A patent/CA3164799A1/en active Pending
  • 2020-12-17 US US17/786,324 patent/US20230037529A1/en active Pending
  • 2020-12-17 AU AU2020404128A patent/AU2020404128A1/en active Pending
  • 2020-12-17 WO PCT/EP2020/086766 patent/WO2021122991A1/en unknown
  • 2020-12-17 IL IL294015A patent/IL294015A/en unknown
  • 2020-12-17 KR KR1020227024500A patent/KR20220113801A/ko unknown
  • 2020-12-17 EP EP20838416.4A patent/EP4077157A1/en active Pending
  • 2020-12-17 CN CN202080087696.XA patent/CN114829266A/zh active Pending
  • 2020-12-17 BR BR112022012025A patent/BR112022012025A2/pt unknown
  • 2020-12-17 MX MX2022007514A patent/MX2022007514A/es unknown

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