KR20220113801A - Packaging Systems and Packaging Kits for Drug Delivery Devices - Google Patents

Abstract

Various packaging systems and packaging kits are described. In one exemplary embodiment, a packaging system is provided, the packaging system comprising a device body having an upper segment and a lower segment, and a base configured to receive a drug delivery device having an actuator. The base is configured to house the received drug delivery device therein at a non-zero angle with respect to the longitudinal axis of the base. The base includes a retaining cavity and a gripping cavity adjacent the retaining cavity. The retention cavity is configured to create an interference fit with at least a portion of an upper segment of the drug delivery device received within the base, the gripping cavity receiving a lower segment of the device body and a portion of an actuator of the drug delivery device received within the base configured to do

Description

Packaging Systems and Packaging Kits for Drug Delivery Devices

Packaging systems and kits for drug delivery devices, particularly intranasal drug delivery devices, are disclosed.

Pharmaceutical packaging protects the packaged product from damage and contamination during transportation. Blister packaging is one type of pharmaceutical packaging commonly used to package pills. Recently, blister packaging has been implemented in the packaging of drug delivery devices. However, during transport, the packaged drug delivery device(s) may rattle within the blister pack. This is because typical blister packs do not sufficiently secure the drug delivery device(s) in a manner that prevents rattling. This rattling can have a negative effect on the drug delivery device and, ultimately, cause the drug delivery device to become defective for its intended use.

Additionally, some drug delivery devices packaged within blister packs may include a plunger used to dispense a medicament disposed therein. Unfortunately, movement of such a drug delivery device within a typical blister pack can result in actuation of the plunger before it reaches the end user, for example during transportation, handling, storage, sterilization, etc. As a result, the medicament can be discharged prematurely from the drug delivery device. Early release of such drugs may make the drug delivery device inefficient and thus require its disposal.

Accordingly, there remains a need for improved packaging systems for drug delivery devices.

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

In one exemplary embodiment, a packaging system is provided, the packaging system extending from a first end to a second end and having a device body having an upper segment and a lower segment, and an actuator operatively coupled to the lower segment. a base configured to receive a drug delivery device, the base housing therein a drug delivery device received at a non-zero angle with respect to a longitudinal axis of the base extending between the first and second ends, thereby and substantially prevent movement of the contained drug delivery device during operation. The base includes a retaining cavity and a gripping cavity adjacent the retaining cavity. The retention cavity is configured to create an interference fit with at least a portion of an upper segment of the medicament delivery device received within the base, thereby releasably retaining the medicament delivery device received within the base. The gripping cavity is configured to receive a lower segment of the device body and a portion of the actuator of the drug delivery device received within the base.

The base may have various configurations. For example, in some embodiments, the base may include an end cavity positioned between the first end of the base and the retention cavity, wherein the end cavity includes at least a portion of the upper segment and an outer sleeve of the drug delivery device received within the base. can be configured to accommodate In another embodiment, the base may include an end cavity positioned between the gripping cavity and a second end of the base, wherein the end cavity may 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 contained within the base can be seen through the base.

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

The holding cavity may have a variety of configurations. For example, in some embodiments, the retention cavity may 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 may have various configurations. For example, in some embodiments, the drug delivery device may include an outer sleeve around a portion of the upper segment of the device body. The outer sleeve may have a first set of opposed flanges extending from a first end thereof. In this embodiment, the gripping cavity includes a support element configured to support a lower segment of the drug delivery device received within the base, such that the opposing flanges of the first set of received drug delivery devices are positioned between the retention cavity and the support element, This may substantially prevent actuation of the actuator of the contained drug delivery device while in the base. In one embodiment, the support element may have a substantially c-shaped configuration.

In some embodiments, the gripping cavity may be configured to enable the device body of a drug delivery device received within the base to be gripped to remove the drug delivery device received from the base.

In another exemplary embodiment, a packaging kit is provided, the packaging kit comprising a drug delivery device and a packaging system having the drug delivery device disposed therein. A 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, the base housing the drug delivery device therein at a non-zero angle relative to a longitudinal axis of the base extending between the first end and the second end; This substantially prevents movement of the drug delivery device within the base. The base is adjacent to the retention cavity and creates an interference fit with at least a portion of the upper segment of the drug delivery device, thereby releasably holding the drug delivery device within the base, and the lower segment of the device body and the drug delivery device. and a gripping cavity housing a portion of the actuator.

The base may have various configurations. For example, in some embodiments, the base may include an end cavity positioned between the first end of the base and the retention cavity and receiving at least a portion of the upper segment and an outer sleeve of the drug delivery device. In another embodiment, the base may include an end cavity positioned between the gripping cavity and the second end of the base and receiving a portion of an actuator of the drug delivery device.

In some embodiments, the packaging system may include a lid that may be releasably sealed to the base.

In some embodiments, the non-zero angle may be between about 1 degree and 5 degrees. In another embodiment, the non-zero angle may be about 4 degrees.

The holding cavity may have a variety of configurations. For example, in some embodiments, the retention cavity may have a substantially c-shaped configuration.

The drug delivery device may have various configurations. For example, in some embodiments, the drug delivery device may include an outer sleeve positioned around a portion of the upper segment of the device body. The outer sleeve may have a first set of opposed flanges extending from a first end thereof. In such an embodiment, the gripping cavity includes a support element for supporting the lower segment of the drug delivery device, such that the opposing flanges of the first set of the drug delivery device are positioned between the retention cavity and the support element, whereby the drug delivery device may substantially prevent actuation of the actuator while in the base. In one embodiment, the support element may have a substantially c-shaped configuration.

In some embodiments, the base may be substantially transparent so that the drug delivery device can see through the base.

The gripping cavity can have a variety of configurations. For example, in some embodiments, the gripping cavity may enable the device body of the drug delivery device to be gripped to remove the drug delivery device from the base.

BRIEF DESCRIPTION OF THE DRAWINGS The present invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings.
1A is a front view of one embodiment of an intranasal drug delivery device.
1B is a side view of the intranasal drug delivery device of FIG. 1A .
1C is an exploded view of the intranasal drug delivery device of FIG. 1A .
FIG. 2 is a partially exploded view of one embodiment of a packaging kit comprising a packaging system having a base and a lid, and the intranasal drug delivery device of FIG. 1A housed within the packaging system.
3 is a perspective view of the packaging kit of FIG. 2 .
Figure 4 is a front enlarged view of the lid of Figure 3;
FIG. 5 is a plan view of the base of the packaging system of FIG. 2 showing an intranasal drug delivery device disposed therein;
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.
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 plan view of the base of Fig. 7;
9 is a cross-sectional view of the base of FIG. 8 taken along line 9-9;
FIG. 10 is a cross-sectional view of the base of FIG. 7 taken along line 10-10;

Certain illustrative embodiments will now be described in order to provide a general understanding of the principles of structure, function, manufacture, and use of the packaging systems and kits disclosed herein. Examples of one or more of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the apparatus, systems and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the invention is limited only by the claims. Features illustrated or described in connection with one exemplary embodiment may be combined with features of another embodiment. Such modifications and variations are intended to be included within the scope of the present invention.

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

Alternatively, an intranasal drug delivery device may include a device body and an actuator operatively coupled to the device body, wherein, upon actuation, the intranasal drug delivery device is configured to eject one or more doses of the medicament from the device. An actuator may have a variety of configurations, such as, for example, plungers, buttons, levers, and the like, although the actuators described herein are in the context of a plunger. Additionally, an intranasal drug delivery device may be configured to release one or more doses of a medicament disposed therein, although this is described herein in the context of a dual-dose intranasal drug delivery device.

For example, as shown in FIGS. 1A-1C , the exemplary intranasal drug delivery device 100 includes a device body 102 having an upper segment 104a and a lower segment 104b, and a lower segment 104b. ) and a plunger 106 operatively coupled to the In use, the user pushes the plunger 106 towards the upper segment 104a of the device body 102 , thereby causing a dose of a medicament (not shown) disposed within the device 100 to be expelled therefrom. Also, after the plunger 106 is reset, the user subsequently pushes the plunger 106 back towards the upper segment 104a of the device body 102 , thereby causing a medicament (not shown) disposed within the device 100 . not) can be expelled from it.

As used herein, a “agent,” when administered to a subject, has an intended prophylactic effect, such as preventing or delaying the onset (or recurrence) of an injury, disease, pathology or disease, or injury. , reducing the likelihood of onset (or recurrence) of a disease, lesion or condition or symptoms thereof, or an intended therapeutic effect, such as abatement; remission; weakening of symptoms or making the injury, lesion or disease more tolerable to the patient; slowing the rate of regression or decline; making the endpoint of regression less debilitating; or a therapeutic agent (drug, biologic) that will have the treatment or amelioration of an injury, disease, lesion or condition or symptom thereof, including any objective or subjective parameter of treatment, such as improving the physical or mental well-being of a patient , biological substances, etc.). Non-limiting examples of suitable agents include esketamine, ketamine, naloxone, and sumatriptan.

The upper segment 104a of the device body 102 includes first and second indicator windows 108a, 108b. The first indicator window 108a is configured to indicate to a user or a healthcare provider (HCP) that a first dose of the medicament has been expelled from the device 100 , and the second indicator window 108b is configured to indicate to a user or a healthcare provider (HCP) of the medicament. and indicate to the user or HCP that the second dose has been expelled from the device 100 . For example, prior to actuation of the plunger 106, the indicator windows 108a, 108b may exhibit a color such as green. After the first actuation of the plunger 106 , and thus after ejection of the first dose of medicament from the device 100 , the indicator window 108a may exhibit a different color, such as white. Further, after the second actuation of the plunger 106 , and thus after ejection of the second dose of medicament from the device 100 , the indicator window 108b may likewise appear white. In another embodiment, the indicator windows 108a and 108b may each exhibit a different color before and/or after a corresponding actuation of the plunger 106 .

The intranasal drug delivery device 100 may include other elements. For example, in this illustrated embodiment, the intranasal drug delivery device 100 includes a tip 105 extending from an end of an upper segment 104a configured to be placed in a user's nasal cavity, a depth guide 110 , and a finger and a finger rest 112 . The depth guide 110 is conjoined to the finger seat 112 via an elongate tubular body 114 , also referred to herein as an “outer sleeve”. The depth guide 110 includes a first set of opposing flanges 116a , 116b extending from a first end 114a of the elongate tubular body 114 . The first set of opposed flanges 116a , 116b are configured to limit the depth of insertion of the upper segment 104a of the device body 102 into a user's nasal cavity. The finger rest 112 includes a second set of two opposing flanges 118a , 118b extending from a second opposing end 114b of the elongate tubular body 114 . The finger seat 112 serves as a positioning guide for the user's fingers, for example for the user's index and middle fingers, so that the user can use their thumb to the upper segment 104a of the device body 102 . ) to hold the device 100 while pressing the plunger 106 towards it. The elongate tubular body 114 includes a rectangular shaped aperture 120 such that the first and second indicator windows 108a, 108b are visible through the apertures.

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 system described herein includes a base designed to house the 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 may house the device therein at a non-zero-angle with respect to the longitudinal axis of the base. Thus, as such, rattling of the device during transportation that normally occurs when using conventional packaging systems can be substantially avoided. Additionally, the present packaging system may be configured to releasably retain the intranasal drug delivery device therein, for example, to prevent premature release of the device from the packaging system during opening of the packaging system. Thus, the intranasal drug delivery device may remain rigidly within the packaging system until the user or HCP decides to remove the device therefrom, for example, at the point of use.

In some embodiments, the packaging system orients the intranasal drug delivery device such that a first end of the device, such as first end 101a, is inclined downward and an opposite second end of the device, such as second end 101b, is inclined upward. can be designed to In another embodiment, the packaging system may be designed such that the first end of the device slopes up and the second end of the device slopes down.

Exemplary packaging systems, as described herein and illustrated in the figures, may include various features therein to facilitate rigid positioning and orientation of the intranasal drug delivery device. However, those skilled in the art will appreciate that the packaging system may include only some of these features and/or may include various other features known in the art. Accordingly, the packaging systems described herein are intended to represent only certain exemplary embodiments.

2 and 3 include a base 202 and a lid 204, collectively referred to herein as a packaging system, and an intranasal drug delivery device 100 as shown in FIGS. 1A-1C . An exemplary embodiment of a packaging kit 200 is illustrated. 2 illustrates the packaging kit 200 in a partially exploded view, and FIG. 3 illustrates the packaging kit 200 in an assembled view in which the intranasal drug delivery device 100 (shown blurred) is housed within a 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 the form of a blister pack in which a lid 204 is releasably sealed to a base 202 . The lid 204 may be sealed to at least a portion of the base 202 using any suitable sealing method, such as lamination, heat sealing, adhesives, heat and pressure sealing, and the like. Also, in this illustrated embodiment, the packaging system is designed such that the first end 101a of the device 100 slopes down and the second end 101b of the device 100 slopes upward (see FIG. 6 ). .

The base 202 may be created via thermoforming, vacuum forming, or any other suitable process. In the case of thermoforming, the plastic film or sheet is unwound from a reel and guided through a preheat station. The temperature of the preheat plate causes the plastic to soften and become flexible. The warmed plastic then reaches a forming station where great pressure forms the base into a negative mold. The mold is cooled so that the plastic hardens again and retains its shape when removed from the mold. For 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 vacuum.

Base 202 may be formed from one or more of a variety of base materials. The one or more base materials may be formable material(s), eg, thermoformable material(s), to maintain a desired shape, and be crush resistant so that a device disposed within base 202 can, for example, For example, it may be configured to prevent damage during transport. In some embodiments, one or more base materials may impart certain properties to the base 202 , such as a desired water vapor transmission rate, a desired oxygen transmission rate, a desired melting point, and the like. The one or more base materials may be opaque, transparent, or translucent. In addition, the compatibility of the one or more base materials with the device to be incorporated therein may also be a factor in the selection of the one or more base materials. Non-limiting examples of suitable base materials include various polymeric materials such as polyvinyl chloride, polyethylene terephthalate (PET), a modified PET version, for example a glycol modified version of PET (PETG), and the like.

In embodiments 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 medicament has been expelled from the device 100 , and the second indicator window 108b is a second dose of the medicament It is configured to indicate to the user or HCP that it has been ejected from the device 100 . As such, the user or HCP does not have to open the packaging kit 200 , but rather by simply viewing the device through the base 202 in the first and second indicator windows 108a , 108b of the assembled packaging kit 200 . It can be verified that (100) did not act prematurely.

Lid 204 may have a variety of configurations. For example, in some embodiments, lid 204 may be formed of a single layer, while in other embodiments, lid 204 may be formed of multiple layers. In this illustrated embodiment, as shown in greater detail in FIG. 4 , the lid 204 includes an adhesive layer 207 , a printed layer 208 , and a sealing layer 205 sealed thereto and interposed therebetween. include When the lid 204 is sealed to at least a portion of the top surface 206 of the base 202 , an adhesive layer 207 is positioned between the sealing layer 205 and the base 202 . Also, as illustrated in FIGS. 2 and 3 , the lid 204 is in the form of a rounded rectangle and defines a planar top surface of the packaging system, and thus the packaging kit 200 . In other embodiments, the lid 204 may have other suitable shapes and sizes. Those skilled in the art will understand that the size and shape of the lid is at least dependent on the shape of the upper surface 206 of the base 202 .

Although not illustrated, when the packaging kit 200 is assembled, a portion of the lid 204 is not sealed to a portion of the upper surface 206 of the base 202 , such that the unsealed portion of the lid 204 is gripped. Allows it to be 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 grips the unsealed position of the lid 204 and peels the lid 204 away from the base 202 by a user or HCP. may be configured to be removed from

The sealing layer 205 may seal to at least a portion of the upper surface 206 of the base 202 such that the resulting seal is hermetically sealed, and the device 100 housed within the base 202 may be protected from the external environment. . Further, the resulting seal may serve as a form of tamper evidence when damaged, for example, by at least partially removing the resulting seal from the base 202 before the device 100 reaches the desired point of use. .

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

The sealing layer 205 may be sealed to at least a portion of the upper surface 206 of the base 202 using any suitable process. In this illustrated embodiment, the sealing layer 205 may be sealed to at least a portion of the upper 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 , or alternatively to one or more portions of the outer surface 205a of the sealing layer 205 , as shown in FIG. 4 . can The adhesive layer 207 may be one or more adhesives, such as hot melt laminate adhesive(s), or any other suitable adhesive capable of sufficiently sealing the sealing layer 205 to at least a portion of the upper surface 206 of the base 202 . (s) may be formed. In some embodiments, the adhesive layer 207 may be heat sealed to a portion of the top surface 206 , while in other embodiments, the adhesive layer 207 seals to the entire top surface 206 of the base 202 . can be In other embodiments, the sealing layer 206 may seal directly to at least a portion of the upper surface 206 of the base 202 .

The printed layer 208 is the name of the medicament filled into the device to be housed inside the base, the fill content of the medicament, the skew number, the device itself and/or the lot number corresponding to the medicament, the expiration date of the medicament, the device and/or the or a company name associated with the medicament, instructions indicating where to open the packaging system to access a device disposed therein, may be formed of any one or more materials that permit printing thereon. In some embodiments, the print layer 208 may be formed of white paper that may allow for fast ink drying times and provide a visible contrast to 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 .

_D)로 연장되도록(도 6 참조) 비강내 약물 전달 장치(100)를 내부에 하우징 및 위치시키도록 구성된다(도 5 참조). 0이 아닌 각도(

_D)는 적어도 손가락 안착부(112)의 높이(H_F)에 의존하고, 그리고 장치(100)의 종축(L_D)이 베이스(202)의 종축(L_B)에 대해 0의 각도로 연장되는 경우 달리 뚜껑(204)에 접촉할 플런저(106)의 단부에 의존한다. 일부 실시예에서, 0이 아닌 각도(

_D)는 약 1도 내지 5도일 수 있다. 일 실시예에서, 0이 아닌 각도(

_D)는 약 4도일 수 있다. 또한, 베이스(202)는, 예를 들어, 패키징 키트(200)의 운송 동안, 베이스(202) 내에서 장치(100)의 움직임을 실질적으로 방지하는 방식으로 장치(100)를 그에 실질적으로 고정하도록 구성된다. 그 결과, 움직임에 대한 이러한 저항은, 그렇지 않으면 종래의 패키징 시스템 내에서 발생할 베이스(202) 내에서의 덜컹거림으로부터 장치(100)를 실질적으로 방해할 수 있다.The base 202 may have a variety of configurations. The base 202 extends from a first end 210a to an opposite second end 210b. As discussed in greater detail below, the base 202 is positioned at a non-zero angle at which the longitudinal axis L _D of the device 100 is relative to the longitudinal axis L _B of the base 202 .

_D ) (see FIG. 6 ) and configured to housing and position the intranasal drug delivery device 100 therein (see FIG. 5 ). non-zero angle (

_D ) depends at least on the height H _F of the finger rest 112 , and at which the longitudinal axis L _D of the device 100 extends at an angle of zero relative to the longitudinal axis L _B of the base 202 . It otherwise relies on the end of the plunger 106 to contact the lid 204 . In some embodiments, a non-zero angle (

_D ) may be about 1 degree to 5 degrees. In one embodiment, a non-zero angle (

_D ) 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 movement of the device 100 within the base 202, for example, during transportation of the packaging kit 200 . is composed As a result, this resistance to movement can substantially prevent the device 100 from rattling within the base 202 that would otherwise occur in conventional packaging systems.

5-10, the base 202 includes a retention cavity 212 defined by two joined shoulder surfaces 214a, 214b. The retention cavity 212 creates an interference fit with at least a portion of the upper segment 104a of the device body 102 (see FIG. 5 ). More specifically, as shown in FIG. 5 and partially shown in FIG. 6 , a portion 115 of the outer sleeve 114 , and thus a device body extending through this portion 115 of the outer sleeve 114 ( A portion of the upper segment 104a of 102 is located within the holding cavity 212 . As a result, an interference fit is formed between the outer surface of this portion 115 of the outer sleeve 114 and the two mated shoulder surfaces 214a, 214b. As such, the width W _R of the retaining cavity 212 may be equal to or smaller than the outer diameter Do of the outer sleeve 114 , except for dimensional tolerances during manufacture. As used herein, the width W _R of the retention cavity 212 refers to the longest distance between the two shoulder surfaces 214a , 214b (see, eg, FIG. 9 ). Those skilled in the art will understand that the width W _R and depth D _R of the retaining cavity 212 can vary and depend at least on the structural configuration of the outer sleeve 114 .

The interference fit created between the outer sleeve 114 and the shoulder surfaces 214a , 214b can result in movement of the device 100 within the base 202 , for example during transportation of the packaging kit 200 , for example. It is possible to prevent movement in the orthogonal direction. This interference fit can releasably retain the device 100 within the base 202 so that the device 100 is secured to the base 202 during transport and opening of the packaging kit 200 , while also allowing the user, if desired, to or allow the HCP to remove the device 100 from the base 202 . For example, while opening the packaging kit 200 , eg, a user or HCP separates the lid 204 from the base 202 (eg, by pulling the lid 204 away from the base 202 ). In this case, the device 100 may remain fixed within the base 202 . Also, by having an interference fit between the outer sleeve 114 and the shoulder surfaces 214a , 214b , the device 100 can be secured to the base 202 without the need to grip the plunger 106 . This may reduce the likelihood that a user or HCP will accidentally activate the device when the device 100 is removed from the base 202 .

The retention cavity 212 may have a variety of configurations. For example, in this illustrated embodiment, as shown in greater detail in FIGS. 7 and 9 , each of the two joined shoulder surfaces 214a , 214b has a curved configuration, resulting in a retention cavity ( 212) has a substantially c-shaped configuration. A person skilled in the art will understand that the configuration of each of the two shoulder surfaces 214a , 214b and thus the retention cavity 212 defined thereby depends at least on the structural configuration of the outer sleeve 114 . As such, in another embodiment, each of the two shoulder surfaces 214a , 214b and thus the retaining cavity 212 is any that can create an interference fit with the portion of the device extending through the retaining cavity 212 . may have a different shape configuration. For example, in other embodiments, the retention cavity 212 may have a U-shaped configuration, a V-shaped configuration, a polygonal configuration (eg, a square-shaped configuration, an octagonal-shaped configuration, etc.), and the like.

_D)로 연장되는(도 6 참조) 비강내 약물 전달 장치(100)를 내부에 하우징 및 위치시키도록 구성된다(도 5 참조). 이것은, 예를 들어, 도 10에 더 상세히 도시된 바와 같이, 적어도 베이스(202)의 종축(L_B)에 대해 0이 아닌 각도(

_R)로 연장되는 유지 공동(212)의 하부 표면(212a)(즉, 2개의 견부 표면(214a, 214b)이 결합되는 지점)을 갖는 것에 의해 달성될 수 있다. 결과적으로, 장치(100)가 유지 공동(212)을 한정하는 2개의 견부 표면(214a, 214b)과 외부 슬리브(114) 사이에 생성된 간섭 끼워맞춤을 통해 베이스(202) 내로 삽입되어 그에 고정될 때, 장치(100)의 종축(L_D)은 베이스(202)의 종축(L_B)에 대해 0이 아닌 각도(

_D)로 연장된다(도 6 참조). 일부 실시예에서, 0이 아닌 각도(

_R)는 0이 아닌 각도(

_D)와 동일할 수 있는 반면, 다른 실시예에서, 0이 아닌 각도(

_R)는 0이 아닌 각도(

_D)보다 더 작거나 더 클 수 있다.As noted above, the base 202 is configured to house the device 100 therein at a non-zero angle. That is, the base 202 is positioned at a non-zero angle at which the longitudinal axis L _D of the device 100 is relative to the longitudinal axis _LB of the base 202 .

_D ) (see FIG. 6 ) and configured to housing and position the intranasal drug delivery device 100 therein (see FIG. 5 ). This is, for example, as shown in more detail in FIG. 10 , at least at a non-zero angle ( L _B ) with respect to the longitudinal axis LB of the base 202 .

_R ) may be achieved by having the lower surface 212a of the retention cavity 212 (ie, the point at which the two shoulder surfaces 214a , 214b join). As a result, the device 100 can be inserted into and secured to the base 202 via an interference fit created between the outer sleeve 114 and the two shoulder surfaces 214a , 214b defining the retention cavity 212 . when the longitudinal axis L _D of the device 100 is at a non-zero angle with respect to the longitudinal axis L _B of the base 202

_D ) (see FIG. 6 ). In some embodiments, a non-zero angle (

_R ) is a non-zero angle (

_D ), while in other embodiments a non-zero angle (

_R ) is a non-zero angle (

_D ) may be smaller or larger than

5-8 and 10 , the base 202 includes a gripping cavity 218 adjacent the retaining cavity 212 . The gripping cavity 218 receives and houses the finger seat 112 , the lower segment 104b , and a portion of the plunger 106 of the device body 102 . The gripping cavity 218 includes a first portion 220 , a second portion 222 , and a support element 224 separating the first portion 220 from the second portion 222 . The first portion 220 holds the fingers of the user's or HCP's hand (eg, the user's or HCP's finger and thumb) of a particular portion of the device 100 housed therein. and may be configured to enable gripping through. In some embodiments, the portion of the device 100 that enables gripping is isolated within the first portion 220 of the gripping cavity 218 such that the device 100 cannot be gripped or otherwise difficult to grip elsewhere. can be In the illustrated embodiment, the first portion 220 is configured for insertion of the aforementioned fingers of the hand to engage opposite sides of the lower segment 104b of the device body 102 housed within the gripping cavity 218 . .

Accordingly, the first portion 220 may be structurally dimensioned to provide sufficient space for inserting at least one finger in an opposing manner on either side of the lower segment 104b of the device body 102 , i.e., It may have a length (L _GP ), a width (W _GP ), and a depth (D _GP ) as shown in FIGS. 8-10 , whereby the lower segment 104b is of a pincer type action It may be gripped by the fingers (eg, the user's or HCP's finger and thumb). In this way, the user or HCP grips the lower segment 104b and the base 202 with a sufficient amount of force to overcome the frictional force of the interference fit between the outer sleeve 114 and the shoulder surfaces 214a, 214b. ) may pull the lower segment 104b away, thus removing the device 100 from the base 202 . Accordingly, the structural configuration of the first portion 220 may encourage a user or HCP to remove the device 100 from the base 202 through the lower segment 104b of the device body 102, which may , eg, may be kept away from the device tip 105 for hygiene purposes and/or may be kept away from the plunger 106, eg, to prevent accidental actuation of the device 100 . Further, when the HCP removes the device 100 from the base 202 , its removal through the lower segment 104b of the device body 102 facilitates the smooth transition or handover of the device 100 from the HCP to the user. can allow In some embodiments, first portion 220 may be structurally dimensioned to provide a gap of about 1 mm to 5 mm.

The support element 224 is configured to support the lower segment 104b of the device body 102 , and thus the device 100 , such that the finger seat 112 is between the retention cavity 212 and the support element 224 . , thus allowing the finger seat 112 to be 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 seat 112 is constrained between the retention cavity 212 and the support element 224 . Since the finger seat 112 is fixedly coupled to the device body 102 and the plunger 106 is operatively coupled to the device body 102 , the finger rests in the second portion 222 of the gripping cavity 218 . The position of the portion 112 and the restraint of the finger seat 112 between the retaining cavity 212 and the support element 224 are substantially dependent on the longitudinal direction of the device 100 (ie, the longitudinal axis L of the base 202 ). _B ) to prevent movement in the following direction). As a result, the plunger 106 can be held in its non-actuated 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 .

Additionally, positioning and constraining the finger seat 112 within the second portion 222 of the gripping cavity 218 may control the rotational orientation of the device 100 , and thus the indicator window relative to the base 202 . The orientation of (108a, 108b) can be controlled. As a result, in embodiments in which the base is transparent, the interaction of the finger seat 112 with the second portion 222 of the gripping cavity 218 is an indicator window in an orientation visible to the user or HCP through the base 202 . (108a, 108b) can be positioned.

The support element 224 may have a variety of configurations. For example, as shown in FIGS. 5 and 7-9 , the support element 224 has a substantially c-shaped configuration. Further, the width W _S of the support element 224 may be configured to allow the support element 224 to receive and contact a portion of the lower segment 104b of the device body 102 ( FIGS. 5 and 6 ). and FIG. 9). In other embodiments, the support element 224 may have any other suitable shape capable of supporting the lower segment 104b of the device body 102 and cooperate within the structural configuration of the retaining cavity 212 . The finger seating part 112 may be constrained therebetween. Those skilled in the art will appreciate that the structural configuration of the support element 224 may depend at least on the structural configuration of the lower segment 104b of the device body 102 , and the structural configuration of the retaining and gripping cavities 212 , 218 .

In some embodiments, base 202 may include one or more additional cavities for housing other parts of device 100 . For example, as shown in FIGS. 5-8 and 10 , the base 202 includes a first end cavity 226 and an opposing second end cavity 228 . The first end cavity 226 is configured to receive and house at least a portion of the upper segment 104a and a portion of the outer sleeve 114 (ie, portions thereof that are not housed in any other cavity of the base 202 ). do. Further, the first end cavity 226 may be configured to house the distal tip 105 and the depth guide 110 of the device 100 (see FIGS. 5 and 6 ). As shown, the first end cavity 226 is positioned between the retaining cavity 212 and the first end 210a of the base 202 , as a result of which the retaining cavity 212 becomes the first end cavity 226 . ) and the gripping cavity 218 . In this illustrated embodiment, the retention cavity 212 extends from the first end cavity 226 to the gripping cavity 218 .

The first end cavity 226 may have a variety of configurations. For example, in FIGS. 5-7 , the first end cavity 226 has a substantially rectangular-shaped configuration. One of ordinary skill in the art is skilled in the art that the structural configuration of the first end cavity 226 is at least part of the device to be housed therein, for example a portion of the upper segment 104a and the outer sleeve 114 as shown in FIGS. 5 and 6 . It will be appreciated that it will depend on the structural configuration of the portion of the , the distal tip 105 , and/or the depth guide 110 of the device 100 . 5 and 6 , the structural configuration of the first end cavity 226 may also help prevent accidental activation and/or breakage of the device 100 , the distal tip. A gap is provided between 105 and base 202 . In other embodiments, the first end cavity 226 may have any other suitable configuration capable of housing 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 (ie, a portion of the plunger 106 that is not housed within the gripping cavity 218 ). As shown, the second end cavity 228 is positioned between the gripping cavity 218 and the second end 210b of the base 202 , as a result of which the gripping cavity 218 engages with the retaining cavity 212 . located between the second end cavities 228 .

The second end cavity 228 may have a variety of configurations. For example, in FIGS. 5-7 , the second end cavity 228 has a substantially rectangular-shaped configuration. One of ordinary skill in the art would know that the structural configuration of the second end cavity 228 is at least the portion of the device to be housed therein, for example the structural configuration of the portion of the plunger 106 of the device 100, as shown in FIGS. 5 and 6 . You will understand that it depends on the configuration. 5 and 6 , the structural configuration of the second end cavity 228 may also help prevent accidental activation and/or breakage of the device 100, the plunger ( A gap is provided between 106 and base 202 . In other embodiments, the second end cavity 228 may have any other suitable configuration capable of housing one or more portions of the device 100 .

_E2)로 연장된다(도 10 참조). 결과적으로, 0이 아닌 각도(

_D)로의 장치(100)의 종축(L_D)의 연장부가 유지될 수 있다(도 6 참조). 일부 실시예에서, 0이 아닌 각도(

_E2)는 0이 아닌 각도(

_D) 및/또는 0이 아닌 각도(

_R)와 동일할 수 있는 반면, 다른 실시예에서, 0이 아닌 각도(

_E2)는 0이 아닌 각도(

_D) 및/또는 0이 아닌 각도(

_R)보다 더 작거나 더 클 수 있다.Further, similar to the lower surface 212a of the retaining cavity 212 , the lower surface 228a of the second end cavity 228 also has a non-zero angle with respect to the longitudinal axis _LB of the base 202 .

_E2 ) (see FIG. 10 ). As a result, a non-zero angle (

An extension of the longitudinal axis L _D of the device 100 to _D ) can be maintained (see FIG. 6 ). In some embodiments, a non-zero angle (

_E2 ) is a non-zero angle (

_D ) and/or non-zero angle (

_R ), while in other embodiments, a non-zero angle (

_E2 ) is a non-zero angle (

_D ) and/or non-zero angle (

_R ) may be smaller or larger than

_D)는 베이스(202)의 상부 표면(206)에 대한, 유지 공동(212)의 하부 표면(212a)과 제2 단부 공동(228)의 하부 표면(228a) 사이의 상대 높이에 의해 달성되고 유지될 수 있다. 예를 들어, 유지 공동(212)의 하부 표면(212a)은 제1 높이에 위치될 수 있고, 제2 단부 공동(228)의 하부 표면(238)은 제1 높이보다 큰 제2 높이에 위치될 수 있다.In another embodiment, the lower surface 212a of the retaining cavity 212 and the lower surface 228a of the second end cavity 228 may each extend at a zero angle with respect to the longitudinal axis _LB of the base 202 . can In such a case, for example, a non-zero angle (

_D ) is achieved and retained by the relative height between the lower surface 212a of the retaining cavity 212 and the lower surface 228a of the second end cavity 228 relative to the upper surface 206 of the base 202 . can be For example, the lower surface 212a of the retaining cavity 212 may be located at a first height, and the lower surface 238 of the second end cavity 228 may be located at a second height greater than the first height. can

A value or range may be expressed herein as “about” and/or as “about” one particular value to another particular value. When such values or ranges are expressed, other disclosed embodiments include the recited specific value and/or from one specific value to another specific value. Similarly, when values are expressed as approximations, by use of the antecedent of "about," it will be understood that there are multiple values disclosed therein and that the particular value forms another embodiment. Moreover, it will also be understood that there are multiple values disclosed therein, and that each value is disclosed herein "about" that particular value in addition to that particular value itself. In the examples, "about" may be used to mean within 10% of a recited value, within 5% of a recited value, or within 2% of a recited value, for example.

For purposes of describing and defining the present teachings, unless otherwise indicated, the term "substantially" is used herein to denote the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. Note that used The term "substantially" is also used herein to denote the extent to which a quantitative expression may differ from a specified reference without causing a change in the basic function of the subject matter in question.

Those skilled in the art will understand further features and advantages of the present invention based on the above-described embodiments. Accordingly, the invention is not limited by what has been shown and described in detail, 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 incorporated herein by reference, in whole or in part, is incorporated herein by reference only to the extent that the material incorporated by reference does not conflict with an existing definition, description, or other disclosure material set forth herein. is included As such, the disclosure as expressly set forth herein supersedes any conflicting material incorporated herein by reference.

Claims (24)

A packaging system for a drug delivery device, comprising:
a base configured to receive a drug delivery device extending from a first end to a second end, the device body having an upper segment and a lower segment, and an actuator operatively coupled to the lower segment, the base comprising: housing the received drug delivery device therein at a non-zero angle to the longitudinal axis of the base extending between the first end and the second end, thereby substantially controlling movement of the received drug delivery device while in the base is configured to prevent, the base,
a retention cavity configured to create an interference fit with at least a portion of an upper segment of the drug delivery device received within the base, thereby releasably retaining the drug delivery device received within the base; and
and a gripping cavity adjacent the retention cavity and configured to receive a lower segment of the device body and a portion of an actuator of a drug delivery device received within the base. The medicament delivery device of claim 1 , wherein the base further comprises an end cavity located between the first end of the base and the retention cavity, the end cavity being at least a portion of the upper segment and external to the drug delivery device received within the base. A system configured to receive a sleeve. The base of claim 1 , wherein the base further comprises an end cavity positioned between the gripping cavity and a second end of the base, the end cavity configured to receive a portion of an actuator of a drug delivery device received within the base. becoming a system. The system of claim 1 , further comprising a lid releasably sealed to the base. The system of claim 1 , wherein the non-zero angle is between about 1 degree and 5 degrees. The system of claim 1 , wherein the non-zero angle is about 4 degrees. The system of claim 1 , wherein the retention cavity has a substantially c-shaped configuration. The device of claim 1 , wherein the drug delivery device comprises an outer sleeve positioned around a portion of the upper segment of the device body, the outer sleeve having a first set of opposing flanges extending from a first end thereof. system. 9. The holding cavity of claim 8, wherein the gripping cavity includes a support element configured to support a lower segment of a drug delivery device received within the base, such that opposing flanges of the first set of received drug delivery devices are configured to support the retention cavity and the support. positioned between the elements, thereby substantially preventing actuation of the actuator of the housed medicament delivery device while in the base. 10. The system of claim 9, wherein the support element has a substantially c-shaped configuration. The system of claim 1 , wherein the base is substantially transparent such that a drug delivery device contained within the base can be seen through the base. The system of claim 1 , wherein the gripping cavity can be configured to enable 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 comprising:
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; and
The drug delivery device includes a packaging system disposed therein, the packaging system comprising:
a base extending from a first end to a second end, the base housing the drug delivery device therein at a non-zero angle with respect to a longitudinal axis of the base extending between the first end and the second end thereby substantially preventing movement of the drug delivery device within the base, wherein the base comprises:
a retention cavity for creating an interference fit with at least a portion of the upper segment of the drug delivery device, thereby releasably retaining the drug delivery device in the base; and
and a gripping cavity adjacent the retention cavity and housing a lower segment of the device body and a portion of an actuator of the drug delivery device. 14. The method of claim 13, wherein the base is positioned between the first end of the base and the retention cavity, and further comprising an end cavity for receiving at least a portion of the upper segment and the outer sleeve of the drug delivery device. kit. The kit of claim 13 , wherein the base is positioned between the gripping cavity and the second end of the base, and further comprising an end cavity for receiving a portion of the actuator of the drug delivery device. The kit of claim 13 , wherein the packaging system includes a lid releasably sealed to the base. The kit of claim 13 , wherein the non-zero angle is between about 1 degree and 5 degrees. The kit of claim 13 , wherein the non-zero angle is about 4 degrees. The kit of claim 13 , wherein the retention cavity has a substantially c-shaped configuration. 14. The device of claim 13, wherein the drug delivery device comprises an outer sleeve positioned around a portion of the upper segment of the device body, the outer sleeve having a first set of opposing flanges extending from a first end thereof. kit. 21. The method of claim 20, wherein the gripping cavity comprises a support element for supporting a lower segment of the drug delivery device, such that the opposing flanges of the first set of the drug delivery device are positioned between the retention cavity and the support element. thereby substantially preventing actuation of the actuator while the drug delivery device is in the base. 22. The kit of claim 21, wherein the support element has a substantially c-shaped configuration. The kit of claim 13 , wherein the base is substantially transparent such that the drug delivery device can see through the base. The kit of claim 13 , wherein the gripping cavity allows the device body of the drug delivery device to be gripped to remove the drug delivery device from the base.

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