Packaging systems and packaging kits for drug delivery devices

Abstract

The present disclosure describes various packaging systems and packaging kits. In an exemplary embodiment, a packaging system is provided, and includes a base configured to receive a drug delivery device, the drug delivery device having a device body and an actuator, the device body having an upper section and a lower section. The base is configured to accommodate the received drug delivery device in the base at a non-zero angle relative to the longitudinal axis of the base. The base includes a holding cavity and a clamping cavity adjacent to the holding cavity. The holding cavity is configured to form an interference fit with at least a portion of the upper section of the drug delivery device received in the base, and the clamping cavity is configured to receive a lower section of the device body of the drug delivery device and a part of the actuator, the drug delivery device being received in the base.

Description

Technical Field

[0001] The present invention discloses packaging systems and kits for drug delivery devices, particularly intranasal drug delivery devices. Background Art

[0002] Pharmaceutical packaging protects the packaged product from damage and contamination during transportation. Blister packaging is a type of pharmaceutical packaging commonly used to package pills. Recently, blister packaging has been applied to the packaging of drug delivery devices. However, during transportation, the packaged drug delivery devices can rattle inside the blister packaging. This is because typical blister packaging does not adequately secure the drug delivery device in a manner that prevents the rattling. This rattling can negatively impact the drug delivery device and ultimately cause the drug delivery device to be defective for its intended use.

[0003] In addition, some drug delivery devices packaged in blister packs may include a plunger for dispensing the drug disposed therein. Unfortunately, the movement of these drug delivery devices within a typical blister pack may result in the actuation of the plunger prior to reaching the end user, such as during transportation, handling, storage, sterilization, etc. As a result, the drug may be prematurely discharged from the drug delivery device. This premature discharge of the drug may render the drug delivery device ineffective, and therefore may require disposal thereof.

[0004] Therefore, there remains a need for improved packaging systems for drug delivery devices. Summary of the invention

[0005] Various packaging systems and packaging kits for drug delivery devices are disclosed.

[0006] In an exemplary embodiment, a packaging system is provided, the packaging system comprising a base extending from a first end to a second end and configured to receive a drug delivery device, the drug delivery device having a device body and an actuator, the device body having an upper section and a lower section, the actuator being operably connected to the lower section, wherein the base is configured to accommodate the received drug delivery device in the base at a non-zero angle relative to the longitudinal axis of the base extending between the first end and the second end, thereby substantially preventing the movement of the received drug delivery device when in the base. The base includes a holding cavity and a clamping cavity adjacent to the holding cavity. The holding cavity is configured to form an interference fit with at least a portion of the upper section of the drug delivery device received in the base, thereby releasably retaining the received drug delivery device in the base. The clamping cavity is configured to receive a portion of the lower section of the device body of the drug delivery device received in the base and the actuator.

[0007] 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 holding cavity, wherein the end cavity can be configured to receive at least a portion of an upper section and an outer sleeve of a drug delivery device, and the drug delivery device is received in the base. In other embodiments, the base can include an end cavity positioned between the clamping cavity and the second end of the base, wherein the end cavity can be configured to receive a portion of an actuator of a drug delivery device, and the drug delivery device is received in the base.

[0008] In some embodiments, the base can be substantially transparent such that a drug delivery device received within the base can be seen through the base.

[0009] In some embodiments, the non-zero angle may be between about 1 and 5 degrees. In one embodiment, the non-zero angle may be about 4 degrees.

[0010] The holding cavity can have a variety of configurations. For example, in some embodiments, the holding cavity can have a substantially c-shaped configuration.

[0011] In some embodiments, the packaging system includes a lid that is releasably sealable to a base.

[0012] The drug delivery device can have a variety of configurations. For example, in some embodiments, the drug delivery device can include an outer sleeve around a portion of the upper section of the device body. The outer sleeve can have a first group of relative flanges extending from the first end of the outer sleeve. In such embodiments, the clamping cavity can include a support element, which can be configured to support the lower section of the drug delivery device received in the base, so that the first group of relative flanges of the received drug delivery device is positioned between the holding cavity and the support element, thereby substantially preventing the actuation of the actuator when the received drug is delivered in the base. In one embodiment, the support element can have a substantially c-shaped configuration.

[0013] In some embodiments, the clamping cavity can be configured to allow a device body of a drug delivery device received within the seat to be clamped to remove the received drug delivery device from the seat.

[0014] In another exemplary embodiment, a packaging kit is provided, the packaging kit comprising a drug delivery device and a packaging system, in which a drug delivery device is provided. The drug delivery device comprises a device body and an actuator, the device body having an upper section and a lower section, and the actuator is operably connected to the lower section. The packaging system comprises a base, the base extending from a first end to a second end, and the drug delivery device is contained in the base at a non-zero angle relative to the longitudinal axis of the base extending between the first end and the second end, thereby substantially preventing the movement of the drug delivery device in the base. The base comprises a holding cavity and a clamping cavity, the holding cavity forms an interference fit with at least a portion of the upper section of the drug delivery device, so that the drug delivery device is releasably held in the base, the clamping cavity is adjacent to the holding cavity and accommodates a portion of the lower section of the device body of the drug delivery device and the actuator.

[0015] 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 holding cavity, and receive at least a portion of the upper section and outer sleeve of the drug delivery device. In other embodiments, the base can include an end cavity positioned between the clamping cavity and the second end of the base, and receive a portion of the actuator of the drug delivery device.

[0016] In some embodiments, the packaging system can include a lid that can be releasably sealed to a base.

[0017] In some embodiments, the non-zero angle may be about 1 to 5 degrees. In other embodiments, the non-zero angle may be about 4 degrees.

[0018] The holding cavity can have a variety of configurations. For example, in some embodiments, the holding cavity can have a substantially c-shaped configuration.

[0019] 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 to surround a portion of the upper section of the device body. The outer sleeve can have a first group of relative flanges extending from the first end of the outer sleeve. In such embodiments, the clamping cavity can include a support element that supports the lower section of the drug delivery device so that the first group of relative flanges of the drug delivery device is positioned between the holding cavity and the support element, thereby substantially preventing the actuation of the actuator when the drug delivery device is in the base. In one embodiment, the support element can have a substantially c-shaped configuration.

[0020] In some embodiments, the base can be substantially transparent such that the drug delivery device can be seen through the base.

[0021] The clamping cavity can have a variety of configurations. For example, in some embodiments, the clamping cavity can allow the device body of the drug delivery device to be clamped to remove the drug delivery device from the base. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The present invention will be more fully understood through the following detailed description made in conjunction with the accompanying drawings, in which:

[0023] Figure 1A is a front view of one embodiment of an intranasal drug delivery device;

[0024] Figure 1B yes Figure 1A A side view of an intranasal drug delivery device;

[0025] Figure 1C yes Figure 1A An exploded view of an intranasal drug delivery device;

[0026] Figure 2 is a partially exploded view of one embodiment of a packaging kit including a packaging system having a base and a lid and a packaging device contained within the packaging system Figure 1A intranasal drug delivery device;

[0027] Figure 3 yes Figure 2 A perspective view of a packaging kit;

[0028] Figure 4 yes Figure 3 A front enlarged view of the cover;

[0029] Figure 5 yes Figure 2 A top view of a base of a packaging system of FIG. 1 , showing an intranasal drug delivery device disposed in the packaging system;

[0030] Figure 6 yes Figure 2 A cross-sectional side view of a base of a packaging system of taken at line 6-6, showing an intranasal drug delivery device disposed in the packaging system;

[0031] Figure 7 yes Figure 2 A perspective view of a base of a packaging system with an intranasal drug delivery device removed;

[0032] Figure 8 yes Figure 7 Top view of the base;

[0033] Fig. 9 yes Figure 8 A cross-sectional view of the base taken at line 9-9; and

[0034] Fig.10yes Figure 7 A cross-sectional view of the base taken at line 10-10. DETAILED DESCRIPTION

[0035] Certain exemplary embodiments will now be described to understand the principles of the structure, function, manufacture and use of the packaging system and kit disclosed herein as a whole. One or more examples of these embodiments are shown in the accompanying drawings. It will be appreciated by those skilled in the art that the devices, systems and methods specifically described herein and shown in the accompanying drawings are non-restrictive exemplary embodiments, and the scope of the present invention is limited only by the claims. The features shown or described in conjunction with an 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.

[0036] Although the packaging systems, kits, and methods described herein may be applicable to many drug delivery devices, they are described herein in the context of intranasal drug delivery devices.

[0037] Typically, an intranasal drug delivery device may include a device body and an actuator that is operably coupled to the device body and, when actuated, is configured to expel one or more doses of a drug from the device. Although the actuator may have a variety of configurations, such as a plunger, a button, a lever, etc., the actuators described herein are in the context of a plunger. In addition, although the intranasal drug delivery device may be configured to expel one or more doses of a drug disposed therein, they are described herein in the context of a dual-dose intranasal drug delivery device.

[0038] For example, Figures 1A to 1C As shown, the exemplary intranasal drug delivery device 100 includes a device body 102 having an upper section 104a and a lower section 104b, and a plunger 106 operably connected to the lower section 104b. In use, a user pushes the plunger 106 toward the upper section 104a of the device body 102, thereby causing a dose of a drug (not shown) disposed in the device 100 to be expelled therefrom. In addition, after the plunger 106 is reset, the user may then push the plunger 106 toward the upper section 104a of the device body 102 again, thereby causing another dose of a drug (not shown) disposed in the device 100 to be expelled therefrom.

[0039] As used herein, "drug" refers to a therapeutic agent (pharmaceutical, biologic, biological material, etc.) that, when administered to a subject, will have a desired preventive effect, such as preventing or delaying the onset (or recurrence) of an injury, disease, pathology, or condition, or reducing the likelihood of the onset (or recurrence) of an injury, disease, pathology, or condition, or symptoms thereof, or a desired therapeutic effect, such as treating or ameliorating an injury, disease, pathology, or condition, or symptoms thereof, including any objective or subjective therapeutic parameter, such as abating, alleviating, reducing symptoms, or making the injury, pathology, or condition more tolerable to the patient; slowing the rate of degeneration or decline; making the final point of degeneration less debilitating; or improving the patient's physical or psychological health. Non-limiting examples of suitable drugs include esketamine, ketamine, naloxone, and sumatriptan.

[0040] The upper section 104a of the device body 102 includes a first indication window 108a and a second indication window 108b. The first indication window 108a is configured to indicate to a user or a healthcare provider (HCP) that a first dose of medicine has been discharged from the device 100, and the second indication window 108b is configured to indicate to a user or a HCP that a second dose of medicine has been discharged from the device 100. For example, before the actuation of the piston 106, the indication windows 108a, 108b can show a color, such as green. After the first actuation of the plunger 106 and thus the first dose of medicine is discharged from the device 100, the indication window 108a can show a different color, such as white. In addition, after the second actuation of the plunger 106 and thus the second dose of medicine is discharged from the device 100, the indicator window 108b can also show white. In other embodiments, the indication windows 108a, 108b can each show different colors before and / or after the corresponding actuation of the plunger 106.

[0041] The intranasal drug delivery device 100 may include other elements. For example, in the illustrated embodiment, the intranasal drug delivery device 100 includes a tip 105 extending from the end of the upper section 104a and configured to be placed in the user's nostril, as well as a depth guide 110 and a finger rest 112. The depth guide 110 is coupled to the finger rest 112 via an elongated tubular body 114 (also referred to herein as an "outer cannula"). 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 depth of insertion of the upper section 104a of the device body 102 into the 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 the user's fingers (e.g., the user's index and middle fingers) so that the user can grasp and hold the device 100 while using their thumb to depress the plunger 106 toward the upper section 104a of the device body 102. The elongated tubular body 114 includes an oblong aperture 120 so that the first and second indicator windows 108a, 108b are visible therethrough.

[0042] Typically, the packaging kit described herein includes a packaging system and a drug delivery device, such as an intranasal drug delivery device contained in the packaging system. The packaging system described herein includes a base, which is designed to hold the intranasal drug delivery device in a manner that substantially prevents the device from moving during transportation. Specifically, the packaging system can hold the device therein at a non-zero angle relative to the longitudinal axis of the base. Therefore, the rattling of the device during transportation, which usually occurs when using a traditional packaging system, can be substantially prevented. In addition, the packaging system of the present invention can be configured to releasably hold the intranasal drug delivery device therein so as to prevent the device from being released prematurely from the packaging system, such as during the opening of the packaging system. Therefore, the intranasal drug delivery device can be securely held in the packaging system until the user or HCP decides to remove the device therefrom, such as when in use.

[0043] In some embodiments, the packaging system can be designed to orient the intranasal drug delivery device so that a first end of the device (e.g., first end 101a) is angled downward and an opposite second end of the device (e.g., second end 101b) is angled upward. In other embodiments, the packaging system can be designed wherein the first end of the device is angled upward and the second end of the device is angled downward.

[0044] As described herein and shown in the accompanying drawings, an exemplary packaging system may include a variety of features to facilitate safe positioning and orientation of an intranasal drug delivery device therein. However, those skilled in the art will appreciate that the packaging system may include only some of these features and / or may include a variety of other features known in the art. Therefore, the packaging system described herein is intended to represent only certain exemplary embodiments.

[0045] Figure 2 and Figure 3 An exemplary embodiment of a packaging kit 200 is shown, which includes a base 202 and a cover 204, collectively referred to herein as a packaging system, and Figures 1A to 1C The intranasal drug delivery device 100 shown in FIG. Figure 2 The packaging kit 200 is shown in a partially exploded view, and Figure 3 The packaging kit 200 is shown in an assembled view with the intranasal drug delivery device 100 (obscured) contained within the packaging system.

[0046] The packaging system is configured to contain and seal an intranasal drug delivery device 100 disposed therein. In the illustrated embodiment, the packaging system is in the form of a blister package in which a cover 204 is releasably sealed to a base 202. The cover 204 may be sealed to at least a portion of the base 202 using any suitable sealing method, such as lamination, heat sealing, bonding, heat compression sealing, etc. In addition, in the illustrated embodiment, the packaging system is designed such that a first end 101a of the device 100 is angled downward and a second end 101b of the device 100 is angled upward (see Figure 6 ).

[0047] The base 202 can be formed 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 directed through a preheating station. The temperature of the preheating plate is such that the plastic will soften and become pliable. The warm plastic then reaches a forming station where high pressure forms the base into a female mold. The mold is cooled so that the plastic hardens again and retains its shape when removed from the mold. In the case of vacuum forming, the plastic film or sheet is heated to the forming temperature, stretched onto a single-sided mold, and pressed against the mold by a vacuum.

[0048] Pedestal 202 can be formed by various one or more substrates.The one or more substrates can be moldable materials, such as thermoforming materials, and are configured to keep the desired shape and have resistance to compression, thereby preventing the device arranged in pedestal 202 from being damaged, such as during transportation.In some embodiments, the one or more substrates can give pedestal 202 specific characteristics, such as desired water vapor transmission rate, desired oxygen transmission rate, desired melting point, etc.The one or more substrates can be opaque, transparent or translucent.In addition, the compatibility of the one or more base materials and the device to be included therein can also be the factor of selecting one or more base materials.The non-limiting example of suitable base materials includes various polymer materials, such as polyvinyl chloride, polyethylene terephthalate (PET), the modified form of PET, for example the glycol modified form of PET (PETG), etc.

[0049] In an embodiment where the base 202 is transparent, the indicator windows 108a and 108b may be visible to the user or HCP. As described above, the first indicator window 108a is configured to indicate to the user or HCP that a first dose of the drug has been expelled from the device 100, and the second indicator window 108b is configured to indicate to the user or HCP that a second dose of the drug has been expelled from the device 100. Thus, the user or HCP is able to verify that the device 100 has not been prematurely actuated by simply looking through the base 202 at the first indicator window 108a and the second indicator window 108b of the assembled packaging kit 200 without having to open the packaging kit 200.

[0050] The cover 204 can have a variety of configurations. For example, in some embodiments, the cover 204 can be formed from a single layer, while in other embodiments, the cover 204 can be formed from multiple layers. In the illustrated embodiment, Figure 4 As shown in more detail in FIG. 2 , the cover 204 includes an adhesive layer 207, a printed layer 208, and a sealing layer 205 that is sealed and interposed between these layers. When the cover 204 is sealed to at least a portion of the top surface 206 of the base 202, the adhesive layer 207 is positioned between the sealing layer 205 and the base 202. In addition, as shown in FIG. Figures 2 to 3 As shown, the cover 204 is in the form of a rounded rectangle and defines a planar upper surface of the packaging system, and thus defines the packaging kit 200. In other embodiments, the cover 204 may have other suitable shapes and sizes. Those skilled in the art will understand that the size and shape of the cover depends at least on the shape of the top surface 206 of the base 202.

[0051] Although not shown, when the packaging kit 200 is assembled, a portion of the cover 204 is not sealed to a portion of the top surface 206 of the base 202, such that the unsealed portion of the cover 204 can be grasped and used to open the packaging kit 200 to access the device 100 disposed within the base 202. For example, in use, the sealing layer 205 can be configured to be removed from the base 202 via a user or HCP grasping the unsealed location of the cover 204 and peeling the cover 204 away from the base 202.

[0052] 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 airtight and can protect the device 100 housed within the base 202 from the external environment. In addition, the resulting seal can function as a form of anti-tampering portion when compromised, such as by at least partially removing the resulting seal from the base 202 before the device 100 reaches its intended point of use.

[0053] The sealing layer 205 may be formed of any one or more materials configured to inhibit oxygen and / or water from penetrating from the external environment into the base 202. For example, the sealing layer 205 may be a metal foil, such as an aluminum foil, a silver film, or a gold foil, on which a film of a metal such as aluminum, silver, or gold is deposited, or on which a film of an inorganic substance such as SiOx is deposited. In some embodiments, the sealing layer 205 is an aluminum foil.

[0054] The sealing layer 205 may be sealed to at least a portion of the top surface 206 of the base 202 using any suitable process. In the 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 may be applied to the entire outer surface 205a of the sealing layer 205, such as Figure 4 206 , or alternatively, applied to one or more portions of the outer surface 205a of the sealing layer 205. The adhesive layer 207 can be formed of one or more adhesives, such as a hot melt laminating adhesive, or any other suitable adhesive capable of adequately sealing the sealing layer 205 to at least a portion of the top surface 206 of the base 202. In some embodiments, the adhesive layer 207 can be heat sealed to a portion of the top surface 206, while 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 directly sealed to at least a portion of the top surface 206 of the base 202.

[0055] The printed layer 208 may be formed of any one or more materials that allow for indicia to be printed thereon, such as the name of the drug filled in the device to be contained in the base, the fill content of the drug, a deflection number, a batch number corresponding to the device itself and / or the drug, an expiration date of the drug, a company name associated with the device and / or the drug, instructions indicating where to open the packaging system to access the device disposed therein. In some embodiments, the printed layer 208 may be formed of white paper, which may allow for a fast ink drying time and provide a visible contrast to a colored ink. In other embodiments, the printed layer 208 may be omitted, and any desired indicia may be printed directly on the sealing layer 205.

[0056] The base 202 can have a variety of configurations. The base 202 extends from a first end 210a to an opposite second end 210b. As will be discussed in more detail below, the base 202 is configured to receive and position the intranasal drug delivery device 100 (see Figure 5 ), such that the longitudinal axis (L D ) relative to the longitudinal axis (L B ) at a non-zero angle Extension (see Figure 6 ). non-zero angle At least depends on the height (H) of the finger rest 112 F ) and the end of the plunger 106, if the longitudinal axis (L D ) relative to the longitudinal axis (L B ) extends at a zero angle, the end will contact the cover 204. In some embodiments, the non-zero angle It can be about 1 degree to 5 degrees. In one embodiment, the non-zero angle The angle of rotation of the packaging kit 200 may be about 4 degrees. In addition, the base 202 is configured to substantially secure the device 100 thereto in a manner that substantially prevents the device 100 from moving within the base 202 (e.g., during transportation of the packaging kit 200). Thus, this resistance to movement may substantially prevent the device 100 from rattling within the base 202, which would otherwise occur in conventional packaging systems.

[0057] like Figures 5 to 10 As shown, the base 202 includes a retaining cavity 212 defined by two joined shoulder surfaces 214a, 214b. The retaining cavity 212 forms an interference fit with at least a portion of the upper section 104a of the device body 102 (see Figure 5 ). More specifically, Figure 5 As shown Figure 6As shown partially, a portion 115 of the outer sleeve 114, and thus the portion of the upper section 104a of the device body 102 that extends through this portion 115 of the outer sleeve 114, is positioned within the retaining cavity 212. Thus, an interference fit is formed between the outer surface of this portion 115 of the outer sleeve 114 and the two joined shoulder surfaces 214a, 214b. Thus, in addition to dimensional tolerances in manufacturing, the width (W) of the retaining cavity 212 R ) may be equal to or less than the outer diameter (D O As used herein, the width (W) of the holding cavity 212 is R ) refers to the maximum distance between the two shoulder surfaces 214a, 214b (see e.g. Fig. 9 Those skilled in the art will appreciate that maintaining the width (W) of cavity 212 R ) and depth (D R ) can vary and depends at least on the structural configuration of the outer sleeve 114.

[0058] The interference fit formed between the outer sleeve 114 and the shoulder surfaces 214a, 214b can prevent movement of the device 100 within the base 202, for example, orthogonal movement during transportation of the packaging kit 200. This interference fit can releasably retain the device 100 within the base 202, so that the device 100 is fixed to the base 202 during transportation and opening of the packaging kit 200, while also allowing the user or HCP to remove the device 100 from the base 202 when necessary. For example, during opening of the packaging kit 200, for example, when the user or HCP separates the cover 204 from the base 202 (e.g., by pulling the cover 204 away from the base 202), the device 100 can remain fixed in the base 202. In addition, by making an interference fit between the outer sleeve 114 and the shoulder surfaces 214a, 214b, the device 100 can be fixed to the base 202 without clamping the plunger 106. This may reduce the chance of a user or HCP accidentally actuating the device 100 when removing the device 100 from the base 202 .

[0059] The holding chamber 212 can have a variety of configurations, for example, in the illustrated embodiment, Figure 7 and Fig. 9, each of the two combined shoulder surfaces 214a, 214b has a curved configuration, and thus the retention cavity 212 has a substantially c-shaped configuration. Those skilled in the art will appreciate that the configuration of each of the two shoulder surfaces 214a, 214b, and thus the retention cavity 212 defined, depends at least on the structural configuration of the outer sleeve 114. Therefore, in other embodiments, each of the two shoulder surfaces 214a, 214b, and thus the retention cavity 212, may have any other shape configuration that may form an interference fit with the portion of the device extending through the retention cavity 212. For example, in other embodiments, the retention cavity 212 may have a U-shaped configuration, a V-shaped configuration, a polygonal configuration (e.g., a square configuration, an octagonal configuration, etc.), etc.

[0060] As described above, the base 202 is configured to receive the device 100 therein at a non-zero angle. That is, the base 202 is configured to receive and position the intranasal drug delivery device 100 therein (see Figure 5 ), wherein the longitudinal axis (L D ) relative to the longitudinal axis (L B ) at a non-zero angle Extension (see Figure 6 ). For example, Fig.10 As shown in more detail in FIG. 2 , this can be accomplished by aligning at least the bottom surface 212a of the holding cavity 212 (i.e., the point where the two shoulder surfaces 214a, 214b join) relative to the longitudinal axis (L) of the base 202. B ) at a non-zero angle Thus, when the device 100 is inserted and fixed into the base 202 via the interference fit formed between the outer sleeve 114 and the two shoulder surfaces 214a, 214b defining the holding cavity 212, the longitudinal axis (L D ) relative to the longitudinal axis (L B ) at a non-zero angle Extension (see Figure 6 ). In some embodiments, the non-zero angle Can be equal to a non-zero angle In other embodiments, a non-zero angle Can be smaller or larger than a non-zero angle

[0061] like Figures 5 to 8 and Fig.10As shown, the base 202 includes a clamping cavity 218 adjacent to the holding cavity 212. The clamping cavity 218 receives and accommodates the finger rest 112, the lower section 104b, and a portion of the plunger 106 of the device body 102. The clamping 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 a specific portion of the device 100 contained therein to be clamped via the fingers of a user or HCP (e.g., the fingers and thumb of the user or HCP). In some embodiments, the portion of the device 100 that can be used for clamping may be isolated in the first portion 220 of the clamping cavity 218, so that the device 100 cannot be clamped, or otherwise it will be difficult to clamp elsewhere. In the illustrated embodiment, the first portion 220 is configured to be inserted into the aforementioned fingers of the hand to engage with the opposite side of the lower section 104b of the device body 102 contained in the clamping cavity 218.

[0062] Thus, the first portion 220 may be dimensioned structurally, i.e., have a Figures 8 to 10 The length shown (L GP )、Width(W GP ) and depth (D GP ) so as to provide sufficient space for inserting at least a single finger on either side of the lower section 104b of the device body 102 in an opposing manner, whereby the lower section 104b can be grasped by the fingers (e.g., the fingers and thumb of the user or HCP) in a clamp-like action. In this way, the user or HCP can grasp the lower section 104b and pull it away from the base 202 with a sufficient amount of force to overcome the friction of the interference fit between the outer sleeve 114 and the shoulder surfaces 214a, 214b, thereby removing the device 100 from the base 202. Therefore, the structural configuration of the first portion 220 can encourage The user or HCP is encouraged to remove the device 100 from the base 202 via the lower section 104b of the device body 102, which can keep their fingers away from the device tip 105 (e.g., for hygienic purposes) and / or the plunger 106 (e.g., to prevent accidental actuation of the device 100). In addition, in the event that the HCP removes the device 100 from the base 202, removing it via the lower section 104b of the device body 102 can allow for a smooth transition or handover of the device 100 from the HCP to the user. In some embodiments, the first portion 220 can be structurally dimensioned to provide a clearance of approximately 1 mm to 5 mm.

[0063] The support element 224 is configured to support the lower section 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 clamping cavity 218. That is, when the device 100 is inserted and secured into the base 202, the finger rest 112 is constrained between the retaining cavity 212 and the support element 224. Since the finger rest 112 is fixedly coupled to the device body 102 and the plunger 106 is operably coupled to the device body 102, the position of the finger rest 112 within the second portion 222 of the clamping cavity 218 and the constraining of the finger rest 112 between the retaining cavity 212 and the support element 224 substantially prevent the device 100 from being moved in the longitudinal direction (i.e., along the longitudinal axis (L) of the base 202). B ) in the direction of extension). Thus, 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 in the base 202 and fixed thereto.

[0064] Additionally, the positioning and restraint of the finger rest 112 within the second portion 222 of the clamp cavity 218 can control the rotational orientation of the device 100, thereby controlling the orientation of the indicator windows 108a, 108b relative to the base 202. Thus, in embodiments where the base is transparent, the interaction of the finger rest 112 with the second portion 222 of the clamp cavity 218 can position the indicator windows 108a, 108b in an orientation that is visible to the user or HCP through the base 202.

[0065] The support element 224 can have a variety of configurations. Figure 5 and Figures 7 to 9 As shown, the support element 224 has a substantially C-shaped configuration. In addition, the width (W S ) may be configured to allow the support element 224 to receive and contact a portion of the lower section 104b of the device body 102 (see Figures 5 and 6 and Fig. 9 ). In other embodiments, the support element 224 can have any other suitable shape that can support the lower section 104b of the device body 102 and can fit within the structural configuration of the holding cavity 212 to constrain the finger rest 112 therebetween. Those skilled in the art will appreciate that the structural configuration of the support element 224 can depend at least on the structural configuration of the lower section 104b of the device body 102 and the structural configurations of the holding cavity 212 and the clamping cavity 218.

[0066] In some embodiments, the base 202 may include one or more additional cavities for housing other portions of the device 100. For example, Figures 5 to 8 and Fig.10As shown, the base 202 includes a first end cavity 226 and a second opposite end cavity 228. The first end cavity 226 is configured to receive and accommodate at least a portion of the upper section 104a and the outer sleeve 114 (i.e., the portion thereof not accommodated in any other cavity of the base 202). In addition, the first end cavity 226 can be configured to accommodate the distal tip 105 and the depth guide 110 of the device 100 (see Figures 5 and 6 ). As shown, the first end cavity 226 is positioned between the holding cavity 212 and the first end 210a of the base 202, and therefore, the holding cavity 212 is positioned between the first end cavity 226 and the clamping cavity 218. In the illustrated embodiment, the holding cavity 212 extends from the first end cavity 226 to the clamping cavity 218.

[0067] The first end cavity 226 can have a variety of configurations. Figures 5 to 7 In the embodiment, the first end cavity 226 has a substantially rectangular configuration. It will be appreciated by those skilled in the art that the structural configuration of the first end cavity 226 depends at least on the structural configuration of the portion of the device to be housed therein, such as Figures 5 and 6 As shown, the upper section 104a and a portion of the outer sleeve 114, the distal tip 105 and / or the depth guide 110 of the device 100. In addition, as shown Figure 5 and Figure 6 As shown, the structural configuration of the first end cavity 226 also provides a gap between the distal tip 105 and the base 202, which can help prevent accidental activation and / or breakage of the device 100. In other embodiments, the first end cavity 226 can have any other suitable configuration capable of accommodating one or more parts of the device 100.

[0068] The second end cavity 228 is configured to receive and accommodate a portion of the plunger 106 (i.e., the portion of the plunger 106 not accommodated in the clamping cavity 218). As shown, the second end cavity 228 is positioned between the clamping cavity 218 and the second end 210b of the base 202, and therefore, the clamping cavity 218 is positioned between the holding cavity 212 and the second end cavity 228.

[0069] The second end cavity 228 can have a variety of configurations. Figures 5 to 7 In the embodiment, the second end cavity 228 has a substantially rectangular configuration. It will be appreciated by those skilled in the art that the structural configuration of the second end cavity 228 depends at least on the structural configuration of the portion of the device to be accommodated therein, for example, Figures 5 and 6 As shown, a portion of the plunger 106 of the device 100. In addition, as Figure 5 and Figure 6As shown, the structural configuration of the second end cavity 228 also provides a gap between the plunger 106 and the base 202, which can help prevent accidental activation and / or breakage of the device 100. In other embodiments, the second end cavity 228 can have any other suitable configuration capable of accommodating one or more parts of the device 100.

[0070] In addition, similar to the bottom surface 212a of the holding cavity 212, the bottom surface 228a of the second end cavity 228 is also oriented relative to the longitudinal axis (L) of the base 202. B ) at a non-zero angle Extension (see Fig.10 ). Thus, the longitudinal axis (L D ) at a non-zero angle Extension of (see Figure 6 ). In some embodiments, the non-zero angle Can be equal to a non-zero angle and / or non-zero angle In other embodiments, a non-zero angle Can be smaller or larger than a non-zero angle and / or non-zero angle

[0071] In other embodiments, the bottom surface 212a of the holding cavity 212 and the bottom surface 228a of the second end cavity 228 may each be oriented relative to the longitudinal axis (L) of the base 202. B ) extends at a zero angle. In this case, for example, the non-zero angle can be achieved and maintained by maintaining the relative height between the bottom surface 212a of the cavity 212 and the bottom surface 228a of the second end cavity 228 relative to the top surface 206 of the base 202. For example, the bottom surface 212a of the retaining cavity 212 may be positioned at a first height, and the bottom surface 238 of the second end cavity 228 may be positioned at a second height greater than the first height.

[0072] In this article, a value or range may be expressed as "about" and / or from "about" one specific value to another specific value. When such a value or range is expressed, other disclosed embodiments include the listed specific values ​​and / or from one specific value to another specific value. Similarly, when a value is expressed as an approximation by using the antecedent "about", it should be understood that many values ​​are disclosed herein, and the specific value forms another embodiment. It should also be understood that many values ​​are disclosed, and each value is also disclosed herein as "about" the specific value in addition to the value itself. In an embodiment, "about" can be used to represent, for example, within 10% of the listed value, within 5% of the listed value, or within 2% of the listed value.

[0073] For the purposes of describing and defining the present teachings, it is noted that unless otherwise indicated, the term "substantially" is used herein to represent the inherent degree of uncertainty that may characterize any quantitative comparison, value, measurement, or other representation. The term "substantially" may also be used herein to represent the degree to 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.

[0074] According to the above-mentioned embodiment, those skilled in the art will recognize the other features and advantages of the present invention. Therefore, the present invention should not be limited by the content specifically shown and described, unless the attached claims indicate otherwise. All publications and references cited herein are expressly incorporated herein by reference in their entirety. Any patent, publication or information incorporated herein in its entirety or in part by reference is incorporated herein only to the extent that the incorporated material does not conflict with the existing definition, statement or other public materials described in this document. Similarly, the disclosure explicitly set forth in this application replaces any conflicting materials incorporated into this application by reference.

Claims

1. A packaging system for a drug delivery device, the system comprising: A base extending from a first end to a second end and configured to receive a drug delivery device having a device body and an actuator, the device body having an upper section and a lower section, the actuator operably coupled to the lower section, the base configured to accommodate the received drug delivery device in the base at a non-zero angle relative to a longitudinal axis of the base extending between the first end and the second end, thereby substantially preventing movement of the received drug delivery device while within the base, the base comprising: a retaining cavity configured to form an interference fit with at least a portion of an upper section of a drug delivery device received within the base, thereby releasably retaining the received drug delivery device within the base, and A clamping cavity is adjacent to the retaining cavity, the clamping cavity being configured to receive a lower section of a device body and a portion of an actuator of a drug delivery device received within the base.

2. A system according to claim 1, wherein the drug delivery device includes an outer sleeve positioned around a portion of the upper section of the device body, and wherein the base also includes an end cavity, the end cavity is positioned between the first end of the base and the retaining cavity, the end cavity is configured to receive the upper section of the drug delivery device and at least a portion of the outer sleeve, the drug delivery device being received in the base.

3. The system of claim 1 , wherein the base further comprises an end cavity positioned between the clamping cavity and the second end of the base, the end cavity being configured to receive a portion of an actuator of a drug delivery device received within the base.

4. The system of claim 1 further comprising a cover releasably sealed to the base. The system of claim 1 , wherein the non-zero angle is approximately 1 to 5 degrees. The system of claim 1 , wherein the non-zero angle is approximately 4 degrees.

7. The system of claim 1, wherein the holding cavity has a substantially c-shaped configuration.

8. The system of claim 1 , wherein the drug delivery device comprises an outer sleeve positioned around a portion of the upper section of the device body, and wherein the drug delivery device has a set of opposing flanges extending from an end of the outer sleeve adjacent the lower section.

9. The system of claim 8, wherein the retaining cavity includes a support element configured to support a lower section of a drug delivery device received within the base such that the set of opposing flanges of the received drug delivery device are positioned between the retaining cavity and the support element, thereby substantially preventing actuation of the actuator when the received drug delivery device is within the base.

10. The system of claim 9, wherein the support element has a substantially c-shaped configuration.

11. The system of claim 1, wherein the base is substantially transparent such that a drug delivery device received within the base can be seen through the base.

12. The system of claim 1, wherein the clamping cavity is configurable to allow a device body of a drug delivery device received within the base to be clamped to remove the received drug delivery device from the base.

13. A packaging kit comprising: a drug delivery device having a device body having an upper section and a lower section and an actuator operably coupled to the lower section; and A packaging system, in which the drug delivery device is arranged, the packaging system comprising: a base extending from a first end to a second end and accommodating the drug delivery device in the base at a non-zero angle relative to a longitudinal axis of the base extending between the first end and the second end so as to substantially prevent movement of the drug delivery device within the base, the base comprising: a retaining cavity that forms an interference fit with at least a portion of the upper section of the drug delivery device to releasably retain the drug delivery device within the base, and A clamping cavity is adjacent to the retaining cavity and receives the lower section of the device body and a portion of the actuator of the drug delivery device.

14. A kit according to claim 13, wherein the drug delivery device includes an outer sleeve positioned around a portion of the upper section of the device body, and wherein the base also includes an end cavity positioned between the first end of the base and the retaining cavity and receiving the upper section of the drug delivery device and at least a portion of the outer sleeve.

15. The kit of claim 13, wherein the base further comprises an end cavity positioned between the clamp cavity and the second end of the base and receiving a portion of the actuator of the drug delivery device.

16. The kit of claim 13, wherein the packaging system comprises a lid releasably sealed to the base.

17. The kit of claim 13, wherein the non-zero angle is between about 1 degree and 5 degrees.

18. The kit of claim 13, wherein the non-zero angle is about 4 degrees.

19. The kit of claim 13, wherein the holding cavity has a substantially c-shaped configuration.

20. The kit of claim 13, wherein the drug delivery device comprises an outer sleeve positioned around a portion of the upper section of the device body, and wherein the drug delivery device has a set of opposing flanges extending from an end of the outer sleeve adjacent the lower section.

21. A kit according to claim 20, wherein the clamping cavity includes a support element, which supports the lower section of the drug delivery device so that the set of opposing flanges of the drug delivery device are positioned between the retaining cavity and the support element, thereby substantially preventing actuation of the actuator when the drug delivery device is in the base.

22. The kit of claim 21, wherein the support element has a substantially c-shaped configuration.

23. The kit of claim 13, wherein the base is substantially transparent such that the drug delivery device can be seen through the base.

24. The kit of claim 13, wherein the clamping cavity allows the device body of the drug delivery device to be clamped to remove the drug delivery device from the base.

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