US20230037529A1 - Packaging systems for drug delivery devices and packaging kits - Google Patents
Packaging systems for drug delivery devices and packaging kits Download PDFInfo
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- US20230037529A1 US20230037529A1 US17/786,324 US202017786324A US2023037529A1 US 20230037529 A1 US20230037529 A1 US 20230037529A1 US 202017786324 A US202017786324 A US 202017786324A US 2023037529 A1 US2023037529 A1 US 2023037529A1
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- drug delivery
- delivery device
- cavity
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Images
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. 1 B is a side view of the intranasal drug delivery device of FIG. 1 A ;
- FIG. 1 C is an exploded view of the intranasal drug delivery device of FIG. 1 A ;
- 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. 1 A 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 ;
- FIG. 10 is a cross-sectional view of the base of FIG. 7 taken at line 10 - 10 .
- packaging systems, 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 104 a and a lower segment 104 b, and a plunger 106 operatively coupled to the lower segment 104 b.
- a user pushes the plunger 106 towards the upper segment 104 a of the device body 102 , thereby causing a dose of medicament (not shown) disposed within the device 100 to be expelled therefrom.
- the user can then subsequently push the plunger 106 again towards the upper segment 104 a 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 104 a of the device body 102 includes first and second indicator windows 108 a, 108 b.
- the first indicator window 108 a 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 108 b 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 108 a, 108 b can show a color such as green.
- the indicator window 108 a can show a different color such as white.
- the indicator window 108 b can likewise show the color white.
- the indicator windows 108 a, 108 b 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 104 a, 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 116 a, 116 b extending from a first end 114 a of the elongated tubular body 114 .
- the first set of opposing flanges 116 a, 116 b are configured to limit the insertion depth of the upper segment 104 a of the device body 102 into a user's nostril.
- the finger rest 112 includes a second set of two opposing flanges 118 a, 118 b extending from a second, opposing end 114 b 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 104 a 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 108 a, 108 b 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 101 a, is angled down and an opposing, second end of the devices, like second end 101 b, 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- 1 C .
- 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 101 a of the device 100 is angled down and the second end 101 b 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 film 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 108 a and 108 b can be visible to the user or HCP.
- the first indicator window 108 a 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 108 b 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 108 a, 108 b 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 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 205 a of the sealing layer 205 , as shown in FIG. 4 , or alternatively, to one or more portions of the outer surface 205 a of the sealing layer 205 .
- 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 . In other embodiments, 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 210 a to an opposing second end 210 b.
- the base 202 is configured to house and position the intranasal drug delivery device 100 therein (see FIG. 5 ) such that the longitudinal axis (L D ) of the device 100 extends at a non-zero angle ( D ) relative to the longitudinal axis (L B ) of the base 202 (see FIG. 6 ).
- the non-zero angle ( D ) depends at least upon the height (H F ) of the finger rest 112 and the end of the plunger 106 that would otherwise contact the lid 204 if the longitudinal axis (L D ) of the device 100 extended at a zero angle relative to the longitudinal axis (L B ) of the base 202 .
- the non-zero angle ( D ) can be from about 1 degree to 5 degrees. In one embodiment, the non-zero angle ( D ) 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 214 a, 214 b.
- the retaining cavity 212 creates an interference fit with at least a portion of the upper segment 104 a 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 104 a 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 214 a, 214 b.
- the width (W R ) of the retaining cavity 212 can be equal to or less than the outer diameter (D O ) of the outer sleeve 114 , excepting for dimensional tolerances in manufacturing.
- the width (W R ) of the retaining cavity 212 refers to the largest distance between the two shoulder surfaces 214 a, 214 b (see e.g., FIG. 9 ).
- the width (W R ) and depth (D R ) 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 214 a, 214 b 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 214 a, 214 b, 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 214 a, 214 b have a curved configuration, and as a result, the retaining cavity 212 has a substantially c-shaped configuration.
- a person skilled in the art will appreciate that the configuration of each of the two shoulder surfaces 214 a, 214 b, 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 214 a, 214 b, 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 (L D ) of the device 100 extends at a non-zero angle ( D ) relative to the longitudinal axis (L B ) of the base 202 (see FIG. 6 ). This can be achieved for example, as shown in more detail in FIG.
- the non-zero angle ( R ) can be equal to the non-zero angle ( D ), whereas in other embodiments, the non-zero angle ( R ) can be less than or greater than the non-zero angle ( D ).
- 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 104 b, 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.
- HCP e.g., a user's or HCP's finger and thumb
- 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 104 b 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 (L GP ), a width (W GP ), and a depth (D GP ) 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 104 b of the device body 102 in an opposed manner, whereby the lower segment 104 b can be gripped by said digits (e.g., a user's or HCP's finger and thumb) with a pincer type action.
- digits e.g., a user's or HCP's finger and thumb
- the user or HCP can grip and pull the lower segment 104 b 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 214 a, 214 b, 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 104 b 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 104 b 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 104 b 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 (L B ) of the base 202 ). As a result, 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 .
- a longitudinal direction i.e., a direction that runs along the longitudinal axis (L B ) of 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 108 a, 108 b 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 108 a, 108 b 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 (W S ) 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 104 b 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 104 b 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 104 b 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 104 a 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 210 a 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 .
- 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 104 a 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 210 b 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 228 a of the second end cavity 228 also extends at a non-zero angle ( E2 ) relative to the longitudinal axis (L B ) of the base 202 (see FIG. 10 ).
- E2 the longitudinal axis relative to the longitudinal axis relative to the longitudinal axis (L B ) of the base 202
- the extension of the longitudinal axis (L D ) of the device 100 at the non-zero angle ( D ) can be maintained (see FIG. 6 ).
- the non-zero angle ( E2 ) can be equal to the non-zero angle ( D ) and/or the non-zero angle ( R ), whereas in other embodiments, the non-zero angle ( E2 ) can be less than or greater than the non-zero angle ( D ) and/or the non-zero angle ( R ).
- the bottom surface 212 a of the retaining cavity 212 and the bottom surface 228 a of the second end cavity 228 can each extend at a zero angle relative to the longitudinal axis (L B ) of the base 202 .
- the non-zero angle ( D ) can be achieved and maintained by the relative heights between the bottom surface 212 a of the retaining cavity 212 and the bottom surface 228 a of the second end cavity 228 with respect to the top surface 206 of the base 202 .
- the bottom surface 212 a 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.
- the term “substantially” is utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation.
- the term “substantially” is also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.
Abstract
Description
- Packaging systems and kits are disclosed for drug delivery devices, particularly intranasal drug delivery devices.
- Pharmaceutical packaging protects the packaged product from damage and contamination during shipping. Blister packaging is one type of pharmaceutical packaging that is commonly used for packaging pills. Recently, blister packaging has been implemented in the packaging of drug delivery devices. However, while being transported, 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.
- Further, some drug delivery devices that are packaged in blister packs can include a plunger that is used for dispensing a medicament disposed therein. Unfortunately, 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. As a result, 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.
- Accordingly, there remains a need for improved packaging systems for drug delivery devices.
- Various packaging systems for drug delivery devices and packaging kits are disclosed.
- In one exemplary embodiment, a packaging system is provided and 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. For example, in some embodiments, 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. In other embodiments, 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.
- In some embodiments, the base can be substantially transparent such that a drug delivery device received within the base is viewable through the base.
- In some embodiments, 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. For example, in some embodiments, the retaining cavity can have a substantially c-shaped configuration.
- In some embodiments, the packaging system includes a lid that can be releasably sealed to the base.
- The drug delivery device can have a variety of configurations. For example, in some embodiments, 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. In such embodiments, 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. In one embodiment, the support element can have a substantially c-shaped configuration.
- In some embodiments, 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.
- In another exemplary embodiment, a packaging kit is provided and 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. For example, in some embodiments, 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. In other embodiments, 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.
- In some embodiments, the packaging system can include a lid that can be releasably sealed to the base.
- In some embodiments, 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. For example, in some embodiments, the retaining cavity can have a substantially c-shaped configuration.
- The drug delivery device can have a variety of configurations. For example, in some embodiments, 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. In such embodiments, 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. In one embodiment, the support element can have a substantially c-shaped configuration.
- In some embodiments, 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. For example, in some embodiments, 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.
- This invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
-
FIG. 1A is a front view of one embodiment of an intranasal drug delivery device; -
FIG. 1B is a side view of the intranasal drug delivery device ofFIG. 1A ; -
FIG. 1C is an exploded view of the intranasal drug delivery device ofFIG. 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 ofFIG. 1A housed within the packaging system; -
FIG. 3 is a perspective view of the packaging kit ofFIG. 2 ; -
FIG. 4 is a front magnified view of the lid ofFIG. 3 ; -
FIG. 5 is a top view of the base of the packaging system ofFIG. 2 , showing the intranasal drug delivery device disposed therein; -
FIG. 6 is a cross-sectional side view of the base of the packaging system ofFIG. 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 ofFIG. 2 with the intranasal drug delivery device removed; -
FIG. 8 is a top view of the base ofFIG. 7 ; -
FIG. 9 is a cross-sectional view of the base ofFIG. 8 taken at line 9-9; and -
FIG. 10 is a cross-sectional view of the base ofFIG. 7 taken at line 10-10. - Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the packaging systems and kits disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices, systems, and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
- While the packaging systems, 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.
- In general, 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. While 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. Further, while 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.
- For example, as shown in
FIGS. 1A-1C , an exemplary intranasaldrug delivery device 100 includes adevice body 102 having anupper segment 104 a and alower segment 104 b, and aplunger 106 operatively coupled to thelower segment 104 b. In use, a user pushes theplunger 106 towards theupper segment 104 a of thedevice body 102, thereby causing a dose of medicament (not shown) disposed within thedevice 100 to be expelled therefrom. Further, after theplunger 106 resets, the user can then subsequently push theplunger 106 again towards theupper segment 104 a of thedevice body 102, thereby causing an additional dose of medicament (not shown) disposed within thedevice 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. Non-limiting examples of suitable medicaments include esketamine, ketamine, naloxone, and sumatriptan.
- The
upper segment 104 a of thedevice body 102 includes first andsecond indicator windows first indicator window 108 a is configured to indicate to a user or healthcare provider (HCP) that a first dose of the medicament has been expelled from thedevice 100, and thesecond indicator window 108 b is configured to indicate to a user or HCP that a second dose of the medicament has been expelled from thedevice 100. For example, prior to actuation of theplunger 106, theindicator windows plunger 106, and thus the expulsion of the first dose of medicament from thedevice 100, theindicator window 108 a can show a different color such as white. Further, after the second actuation of theplunger 106, and thus the expulsion of the second dose of medicament from thedevice 100, theindicator window 108 b can likewise show the color white. In other embodiments, theindicator windows plunger 106. - The intranasal
drug delivery device 100 can include other elements. For example, in this illustrated embodiment, the intranasaldrug delivery device 100 includes atip 105 that extends from an end of theupper segment 104 a, which is configured to be placed in a user's nostril, adepth guide 110, and afinger rest 112. Thedepth guide 110 is conjoined to thefinger rest 112 via an elongatedtubular body 114, also referred to herein as an “outer sleeve.” Thedepth guide 110 includes a first set of opposingflanges first end 114 a of the elongatedtubular body 114. The first set of opposingflanges upper segment 104 a of thedevice body 102 into a user's nostril. Thefinger rest 112 includes a second set of two opposingflanges 118 a, 118 b extending from a second, opposingend 114 b of the elongatedtubular body 114. Thefinger 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 thedevice 100 while depressing theplunger 106 toward theupper segment 104 a of thedevice body 102 using their thumb. The elongatedtubular body 114 includes an oblong shapedhole 120 such that the first andsecond indicator windows - In general, 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. In particular, 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. Further, 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.
- In some embodiments, the packaging systems can be designed to orient the intranasal drug delivery devices such that a first end of the devices, like
first end 101 a, is angled down and an opposing, second end of the devices, likesecond end 101 b, is angled up. In other embodiments, 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. However, a person skilled in the art will appreciate that the packaging systems can include only some of these features and/or can include a variety of other features known in the art. Thus, the packaging systems described herein are merely intended to represent certain exemplary embodiments.
-
FIGS. 2 and 3 illustrate an exemplary embodiment of apackaging kit 200 that includes abase 202 and alid 204, which are collectively referred to herein as a packaging system, and the intranasaldrug delivery device 100 as shown inFIGS. 1A-1C .FIG. 2 illustrates thepackaging kit 200 in a partially exploded view, andFIG. 3 illustrates thepackaging 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. In this illustrated embodiment, the packaging system is in a form of a blister pack, in which thelid 204 is releasably sealed to thebase 202. Thelid 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. Further, in this illustrated embodiment, the packaging system is designed such that thefirst end 101 a of thedevice 100 is angled down and thesecond end 101 b of thedevice 100 is angled up (seeFIG. 6 ). - The base 202 can be created via thermoforming, vacuum forming, or any other suitable process. In the case of thermoforming, a plastic film 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. In instances of 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. In some embodiments, 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. - In embodiments where the
base 202 is transparent, theindicator windows first indicator window 108 a is configured to indicate to a user or HCP that a first dose of the medicament has been expelled from thedevice 100, and thesecond indicator window 108 b is configured to indicate to a user or HCP that a second dose of the medicament has been expelled from thedevice 100. As such, the user or HCP can verify that thedevice 100 has not been prematurely actuated by simply looking through the base 202 at the first andsecond indicator windows packaging kit 200 rather than having to open thepackaging kit 200. - The
lid 204 can have a variety of configurations. For example, in some embodiments, thelid 204 can be formed of a single layer, whereas in other embodiments, thelid 204 can be formed of multiple layers. In this illustrated embodiment, as shown in more detail inFIG. 4 , thelid 204 includes anadhesive layer 207, aprinting layer 208, and asealing layer 205 that is sealed to and interposed therebetween. When thelid 204 is sealed to at least a portion of thetop surface 206 of thebase 202, theadhesive layer 207 is positioned between thesealing layer 205 and thebase 202. Further, thelid 204, as illustrated inFIGS. 2-3 , is in the form of a rounded rectangle and defines a planar upper surface of the packaging system, and thus thepackaging kit 200. In other embodiments, thelid 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 thetop surface 206 of thebase 202. - While not illustrated, when the
packaging kit 200 is assembled, a portion of thelid 204 is unsealed to a portion of thetop surface 206 of the base 202 such that the unsealed portion of thelid 204 can be grasped and used to open thepackaging kit 200 to access thedevice 100 disposed within thebase 202. For example, in use, thesealing layer 205 can be configured to be removed from thebase 202 via a user or HCP grasping the unsealed position of thelid 204 and peeling thelid 204 in a direction away from thebase 202. - The
sealing layer 205 can be sealed to at least a portion of thetop surface 206 of the base 202 such that the resulting seal is air-tight, and thedevice 100 housed within thebase 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 thebase 202 prior to thedevice 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 thebase 202. For example, thesealing 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. In some embodiments, thesealing layer 205 is an aluminum foil. - The
sealing layer 205 can be sealed to at least a portion of thetop surface 206 of the base 202 using any suitable processes. In this illustrated embodiment, thesealing layer 205 is sealed to at least a portion of thetop surface 206 of thebase 202 via theadhesive layer 207. Theadhesive layer 207 can be applied to the entire outer surface 205 a of thesealing layer 205, as shown inFIG. 4 , or alternatively, to one or more portions of the outer surface 205 a of thesealing layer 205. Theadhesive 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 thesealing layer 205 to at least a portion of thetop surface 206 of thebase 202. In some embodiments, theadhesive layer 207 can be heat sealed to a portion of thetop surface 206, whereas in other embodiments, theadhesive layer 207 can be sealed to the entiretop surface 206 of thebase 202. In other embodiments, thesealing layer 206 can be sealed directly to at least a portion of thetop surface 206 of thebase 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. In some embodiments, theprinting 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. In other embodiments, theprinting layer 208 can be omitted, and any desired indicia can be printed directly on thesealing layer 205. - The base 202 can have a variety of configurations. The
base 202 extends from afirst end 210 a to an opposingsecond end 210 b. As will be discussed in more detail below, thebase 202 is configured to house and position the intranasaldrug delivery device 100 therein (seeFIG. 5 ) such that the longitudinal axis (LD) of thedevice 100 extends at a non-zero angle ( D) relative to the longitudinal axis (LB) of the base 202 (seeFIG. 6 ). The non-zero angle ( D) depends at least upon the height (HF) of thefinger rest 112 and the end of theplunger 106 that would otherwise contact thelid 204 if the longitudinal axis (LD) of thedevice 100 extended at a zero angle relative to the longitudinal axis (LB) of thebase 202. In some embodiments, the non-zero angle ( D) can be from about 1 degree to 5 degrees. In one embodiment, the non-zero angle ( D) can be about 4 degrees. Further, thebase 202 is configured to substantially secure thedevice 100 thereto in a manner that substantially prevents movement of thedevice 100 within thebase 202, e.g., during transport of thepackaging kit 200. As a result, this resistance to movement can substantially hinder thedevice 100 from rattling within thebase 202, which would otherwise occur within conventional packaging systems. - As shown in
FIGS. 5-10 , thebase 202 includes a retainingcavity 212 that is defined by two conjoined shoulder surfaces 214 a, 214 b. The retainingcavity 212 creates an interference fit with at least a portion of theupper segment 104 a of the device body 102 (seeFIG. 5 ). More specifically, as shown inFIG. 5 and partially shown inFIG. 6 , aportion 115 of theouter sleeve 114, and thus the portion of theupper segment 104 a of thedevice body 102 that extends through thisportion 115 of theouter sleeve 114, is positioned within the retainingcavity 212. As a result, the interference fit is formed between the outer surface of thisportion 115 of theouter sleeve 114 and the two conjoined shoulder surfaces 214 a, 214 b. As such, the width (WR) of the retainingcavity 212 can be equal to or less than the outer diameter (DO) of theouter sleeve 114, excepting for dimensional tolerances in manufacturing. As used herein, the width (WR) of the retainingcavity 212 refers to the largest distance between the twoshoulder surfaces FIG. 9 ). A person skilled in the art will appreciate that the width (WR) and depth (DR) of the retainingcavity 212 can vary and is dependent at least upon the structural configuration of theouter sleeve 114. - The interference fit that is created between the
outer sleeve 114 and the shoulder surfaces 214 a, 214 b can prevent movement, e.g., orthogonal movement, of thedevice 100 within thebase 202, e.g., during transport of thepackaging kit 200. This interference fit can releasably retain thedevice 100 within thebase 202 such that thedevice 100 is secured to the base 202 during transport and opening of thepackaging kit 200, while also allowing a user or HCP to remove thedevice 100 from the base 202 when desired. For example, during the opening thepackaging kit 200, e.g., when a user or HCP separates thelid 204 from the base 202 (e.g., by pulling thelid 204 away from the base 202), thedevice 100 can remain secured within thebase 202. Further, by having the interference fit between theouter sleeve 114 and the shoulder surfaces 214 a, 214 b, thedevice 100 can be secured to thebase 202 without the need to grip onto theplunger 106. This can reduce the chance of a user or HCP accidentally actuating thedevice 100 when removing it from thebase 202. - The retaining
cavity 212 can have a variety of configurations, For example, in this illustrated embodiment, as shown in more detail inFIGS. 7 and 9 , each of the two conjoined shoulder surfaces 214 a, 214 b have a curved configuration, and as a result, the retainingcavity 212 has a substantially c-shaped configuration. A person skilled in the art will appreciate that the configuration of each of the twoshoulder surfaces cavity 212 defined thereby, depends at least upon the structural configuration of theouter sleeve 114. As such, in other embodiments, each of the twoshoulder surfaces cavity 212, can have any other shaped configuration that can create an interference fit with the portion of a device that extends through the retainingcavity 212. For example, in other embodiments, the retainingcavity 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. - As mentioned above, the
base 202 is configured to house thedevice 100 therein at a non-zero angle. That is, thebase 202 is configured to house and position the intranasaldrug delivery device 100 therein (seeFIG. 5 ) in which the longitudinal axis (LD) of thedevice 100 extends at a non-zero angle ( D) relative to the longitudinal axis (LB) of the base 202 (seeFIG. 6 ). This can be achieved for example, as shown in more detail inFIG. 10 , by having at least thebottom surface 212 a of the retaining cavity 212 (i.e., the point at which the twoshoulder surfaces base 202. As result, when thedevice 100 is inserted into and secured to thebase 202 via the interference fit created between theouter sleeve 114 and the twoshoulder surfaces cavity 212, the longitudinal axis (LD) of thedevice 100 extends at a non-zero angle ( D) relative to the longitudinal axis (LB) of the base 202 (seeFIG. 6 ). In some embodiments, the non-zero angle ( R) can be equal to the non-zero angle ( D), whereas in other embodiments, the non-zero angle ( R) can be less than or greater than the non-zero angle ( D). - As shown in
FIGS. 5-8 and 10 , thebase 202 includes agripping cavity 218 that is adjacent to the retainingcavity 212. Thegripping cavity 218 receives and houses thefinger rest 112, thelower segment 104 b, and a portion of theplunger 106 of thedevice body 102. Thegripping cavity 218 includes a first portion 220, asecond portion 222, and asupport element 224 that separates the first portion 220 from thesecond 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 thedevice 100 housed therein. In some embodiments, the portion of thedevice 100 enabled for gripping may be isolated within the first portion 220 of thegripping cavity 218, such that thedevice 100 cannot be gripped, or would otherwise be difficult to grip, elsewhere. In the illustrated embodiment, the first portion 220 is configured for insertion of the aforedescribed digits of a hand to engage with opposed sides of thelower segment 104 b of thedevice body 102 housed within thegripping 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 thelower segment 104 b of thedevice body 102 in an opposed manner, whereby thelower segment 104 b can be gripped by said digits (e.g., a user's or HCP's finger and thumb) with a pincer type action. In this way, the user or HCP can grip and pull thelower segment 104 b away from the base 202 with a sufficient amount of force that can overcome the frictional force of the interference fit between theouter sleeve 114 and the shoulder surfaces 214 a, 214 b, and thus, remove thedevice 100 from thebase 202. Thus, the structural configuration of the first portion 220 can encourage a user or HCP to remove thedevice 100 from thebase 202 via thelower segment 104 b of thedevice body 102, which can keep their fingers away from thedevice tip 105, e.g., for hygiene purposes, and/or theplunger 106, e.g., to prevent accidental actuation of thedevice 100. Further, in instances where the HCP removes thedevice 100 from thebase 202, the removal thereof via thelower segment 104 b of thedevice body 102 can allow for a smooth transition or hand-over of thedevice 100 from the HCP to the user. In some embodiments, 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 thelower segment 104 b of thedevice body 102, and thus thedevice 100, such that thefinger rest 112 is positioned between the retainingcavity 212 and thesupport element 224, and thus thefinger rest 112 is positioned within thesecond portion 222 of thegripping cavity 218. That is, when thedevice 100 is inserted into and secured to thebase 202, thefinger rest 112 is confined between the retainingcavity 212 and thesupport element 224. Since thefinger rest 112 is fixedly coupled to thedevice body 102 and theplunger 106 is operatively coupled to thedevice body 102, the position of thefinger rest 112 within thesecond portion 222 of thegripping cavity 218, and the confinement of thefinger rest 112 between the retainingcavity 212 and thesupport element 224, substantially prevents movement of thedevice 100 in a longitudinal direction (i.e., a direction that runs along the longitudinal axis (LB) of the base 202). As a result, theplunger 106 can be maintained in its unactuated position, and thus premature actuation of theplunger 106 can be avoided, while thedevice 100 is housed within and secured to thebase 202. - Further, the positioning and confinement of the
finger rest 112 within thesecond portion 222 of thegripping cavity 218 can control the rotational orientation ofdevice 100, and thus the orientation of theindicator windows base 202. As a result, in embodiments where the base is transparent, the interaction of thefinger rest 112 with thesecond portion 222 of thegripping cavity 218 can position theindicators windows base 202. - The
support element 224 can have a variety of configurations. For example, thesupport element 224, as shown inFIGS. 5 and 7-9 , has a substantially c-shaped configuration. Further, the width (WS) of thesupport element 224 can be configured to allow thesupport element 224 to receive and make contact with a portion of thelower segment 104 b of the device body 102 (seeFIGS. 5-6 and 9 ). In other embodiments, thesupport element 224 can have any other suitable shape that can support thelower segment 104 b of thedevice body 102 and can cooperate within the structural configuration of the retainingcavity 212 so as to confine thefinger rest 112 therebetween. A person skilled in the art will appreciate that the structural configuration of thesupport element 224 can depend at least upon the structural configuration of thelower segment 104 b of thedevice body 102 and the structural configuration of the retaining andgripping cavities - In some embodiments, the base 202 can include one or more additional cavities for housing other portions of the
device 100. For example, as shown inFIGS. 5-8 and 10 , thebase 202 includes afirst end cavity 226 and a second, opposingend cavity 228. Thefirst end cavity 226 is configured to receive and house at least a portion of theupper segment 104 a and of the outer sleeve 114 (i.e., portions thereof that are not housed in any other cavity of the base 202). Further, thefirst end cavity 226 can be configured to house thedistal tip 105 and thedepth guide 110 of the device 100 (seeFIGS. 5-6 ). As shown, thefirst end cavity 226 is positioned between the retainingcavity 212 and thefirst end 210 a of thebase 202, and as a result, the retainingcavity 212 is positioned between thefirst end cavity 226 and thegripping cavity 218. In this illustrated embodiment, the retainingcavity 212 extends from thefirst end cavity 226 to thegripping cavity 218. - The
first end cavity 226 can have a variety of configurations. For example, inFIGS. 5-7 , thefirst end cavity 226 has a substantially rectangle-shaped configuration. A person skilled in the art will appreciate that the structural configuration of thefirst 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 inFIGS. 5-6 , a portion of theupper segment 104 a and of theouter sleeve 114, thedistal tip 105, and/or thedepth guide 110 of thedevice 100. Further, as shown inFIGS. 5 and 6 , the structural configuration of thefirst end cavity 226 also provides a clearance between thedistal tip 105 and thebase 202, which can help prevent accidental activation and/or breakage of thedevice 100. In other embodiments, thefirst end cavity 226 can have any other suitable configuration that can house one or more portions of thedevice 100. - The
second end cavity 228 is configured to receive and house a portion of the plunger 106 (i.e., the portion of theplunger 106 that is not housed within the gripping cavity 218). As shown, thesecond end cavity 228 is positioned between thegripping cavity 218 and thesecond end 210 b of thebase 202, and as a result, thegripping cavity 218 is positioned between the retainingcavity 212 and thesecond end cavity 228. - The
second end cavity 228 can have a variety of configurations. For example, inFIGS. 5-7 , thesecond end cavity 228 has a substantially rectangle-shaped configuration. A person skilled in the art will appreciate that the structural configuration of thesecond 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 inFIGS. 5-6 , a portion of theplunger 106 of thedevice 100. Further, as shown inFIGS. 5 and 6 , the structural configuration of thesecond end cavity 228 also provides a clearance between theplunger 106 and the base 202 which can help prevent accidental activation and/or breakage of thedevice 100. In other embodiments, thesecond end cavity 228 can have any other suitable configuration that can house one or more portions of thedevice 100. - Further, similar to the
bottom surface 212 a of the retainingcavity 212, thebottom surface 228 a of thesecond end cavity 228 also extends at a non-zero angle ( E2) relative to the longitudinal axis (LB) of the base 202 (seeFIG. 10 ). As a result, the extension of the longitudinal axis (LD) of thedevice 100 at the non-zero angle ( D) can be maintained (seeFIG. 6 ). In some embodiments, the non-zero angle ( E2) can be equal to the non-zero angle ( D) and/or the non-zero angle ( R), whereas in other embodiments, the non-zero angle ( E2) can be less than or greater than the non-zero angle ( D) and/or the non-zero angle ( R). - In other embodiments, the
bottom surface 212 a of the retainingcavity 212 and thebottom surface 228 a of thesecond end cavity 228 can each extend at a zero angle relative to the longitudinal axis (LB) of thebase 202. In such instances, for example, the non-zero angle ( D) can be achieved and maintained by the relative heights between thebottom surface 212 a of the retainingcavity 212 and thebottom surface 228 a of thesecond end cavity 228 with respect to thetop surface 206 of thebase 202. For example, thebottom surface 212 a of the retainingcavity 212 can be positioned at a first height and the bottom surface 238 of thesecond 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.
- For purposes of describing and defining the present teachings, it is noted that unless indicated otherwise, the term “substantially” is utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. The term “substantially” is also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.
- One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety. Any patent, publication, or information, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this document. As such, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference.
Claims (24)
Priority Applications (1)
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US17/786,324 US20230037529A1 (en) | 2019-12-18 | 2020-12-17 | Packaging systems for drug delivery devices and packaging kits |
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US201962949744P | 2019-12-18 | 2019-12-18 | |
PCT/EP2020/086766 WO2021122991A1 (en) | 2019-12-18 | 2020-12-17 | Packaging systems for drug delivery devices and packaging kits |
US17/786,324 US20230037529A1 (en) | 2019-12-18 | 2020-12-17 | Packaging systems for drug delivery devices and packaging kits |
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EP (1) | EP4077157A1 (en) |
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CN (1) | CN114829266A (en) |
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USD1015139S1 (en) * | 2019-12-18 | 2024-02-20 | Janssen Pharmaceutica Nv | Package |
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CN110913938B (en) * | 2017-04-13 | 2022-06-28 | C·R·巴德股份有限公司 | Catheterization tray with integrated instructions |
ES2831362T3 (en) * | 2018-02-07 | 2021-06-08 | Becton Dickinson France | Packaging for a prefilled drug delivery device |
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2020
- 2020-12-17 MX MX2022007514A patent/MX2022007514A/en unknown
- 2020-12-17 KR KR1020227024500A patent/KR20220113801A/en unknown
- 2020-12-17 WO PCT/EP2020/086766 patent/WO2021122991A1/en unknown
- 2020-12-17 CN CN202080087696.XA patent/CN114829266A/en active Pending
- 2020-12-17 US US17/786,324 patent/US20230037529A1/en active Pending
- 2020-12-17 EP EP20838416.4A patent/EP4077157A1/en active Pending
- 2020-12-17 AU AU2020404128A patent/AU2020404128A1/en active Pending
- 2020-12-17 BR BR112022012025A patent/BR112022012025A2/en unknown
- 2020-12-17 IL IL294015A patent/IL294015A/en unknown
- 2020-12-17 JP JP2022537304A patent/JP2023507401A/en active Pending
- 2020-12-17 CA CA3164799A patent/CA3164799A1/en active Pending
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US5772031A (en) * | 1996-02-15 | 1998-06-30 | Zimmer, Inc. | Package for an elongated medical product |
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WO2021122991A1 (en) | 2021-06-24 |
EP4077157A1 (en) | 2022-10-26 |
JP2023507401A (en) | 2023-02-22 |
KR20220113801A (en) | 2022-08-16 |
IL294015A (en) | 2022-08-01 |
CA3164799A1 (en) | 2021-06-24 |
AU2020404128A1 (en) | 2022-08-11 |
CN114829266A (en) | 2022-07-29 |
BR112022012025A2 (en) | 2022-09-06 |
MX2022007514A (en) | 2022-09-19 |
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