Packaging assembly

Abstract

A packaging assembly, comprising: a housing configured to at least partially contain a plurality of injection devices for delivering a medicament, the housing being formed as a box having at least one open end face; a lid coupled to the housing and movable between an open position and a closed position, the lid being configured to be hinged on another face at an edge of the lid furthest from the open end face of the housing, and in the closed position being arranged to extend substantially above the open end face of the housing and at least partially above another face adjacent to the open end face; and a handle portion having an upper side and a lower side and being arranged to project from the lid such that pressure applied to the upper side when the lid is in the closed position causes the lid to move to the open position, and pressure applied to the lower side when the lid is in the open position causes the lid to move to the closed position.

Description

Technical Field

[0001] This application relates to a packaging assembly for a medicament and, in particular but not exclusively, to a packaging assembly configured to provide a reminder alarm at a scheduled administration time. Background Art

[0002] Patients suffering from chronic diseases need to be treated regularly with medicaments, for example, based on a predefined schedule. Certain medicaments need to be stored refrigerated and are typically stored refrigerated in a household freezer or refrigerator. In a home treatment environment, patients store the medicaments in their refrigerator and administer a predefined dose as needed. Thus, the medicaments are typically provided in a secondary packaging for ease of placement and storage in a household refrigerator. However, the medicaments are surely stored together with other items (such as food and beverages) that need to be continuously refrigerated.

[0003] Depending on the dosage form of the medicament, the secondary packaging containing the medicament can store the medicament itself in a primary packaging or can store one or more different types of drug delivery devices. For example, the medicament can be provided in a prefilled syringe or a pen injector.

[0004] The chronic diseases that patients suffer from may cause loss of mobility, strength, and dexterity in the hands and fingers. For example, rheumatoid arthritis is an inflammatory systemic disease of connective tissue that mainly affects joints. Patients with rheumatoid arthritis may experience swelling of the joints in the fingers and hands, morning stiffness in the fingers and wrists, and pressure pain when the joints at the back of the fingers or toes are laterally compressed. Patients may be unable to make a fist or pinch, and the strength of the hands and fingers may also be weakened. Summary of the Invention

[0005] Embodiments of the present disclosure provide a packaging assembly comprising: a housing configured to at least partially contain a plurality of injection devices for delivering a medicament, the housing being formed as a box having at least one open end face; a lid coupled to the housing and movable between an open position and a closed position, the lid being configured to be hinged on another face at an edge of the lid furthest from the open end face of the housing and being arranged in the closed position to extend substantially above the open end face of the housing and at least partially above another face adjacent to the open end face; and a handle portion having an upper side and a lower side and being arranged to project from the lid such that pressure applied to the upper side causes the lid to move to the open position when the lid is in the closed position, and pressure applied to the lower side causes the lid to move to the closed position when the lid is in the open position.

[0006] The handle portion may be formed to extend longitudinally along the cover parallel to a boundary formed between a first portion of the cover and a second portion of the cover, the first portion extending above the open end face of the housing and the second portion extending partially above the other face of the housing.

[0007] The packaging assembly may include one or more spring ejectors configured to at least partially eject at least one of the plurality of injection devices out of the housing when the cover is in the open position.

[0008] The housing may be configured to contain the plurality of injection devices in an arrangement where each injection device is placed perpendicular to the open end face of the housing.

[0009] The housing may include a spring ejector for each of the plurality of injection devices, each spring ejector being configured to push at least a portion of a corresponding injection device through the open end face of the housing.

[0010] The housing may be configured to contain the plurality of injection devices in an arrangement where each injection device is placed parallel to the open end face of the housing.

[0011] The housing may include a spring ejector configured to push the plurality of injection devices towards the open end face of the housing.

[0012] The packaging assembly may include a retaining lip and a release opening.

[0013] The plurality of injection devices are pushed by the spring ejector against the retaining lip, and the retaining lip is arranged to hold the plurality of injection devices within the housing.

[0014] The release slot may be arranged such that one of the plurality of injection devices can be lifted above the retaining lip through the release opening.

[0015] The cover may include a dispensing slot configured to contain one injection device.

[0016] The spring ejector may be configured to push the plurality of injection devices towards the cover such that when the cover is moved from the closed position to the open position, one of the plurality of injection devices is contained in the dispensing slot.

[0017] The housing may be configured to contain the plurality of injection devices in an arrangement where each injection device is placed perpendicular to the open end face of the housing.

[0018] The housing may include a plurality of flexible bands, each flexible band being arranged to extend around the end of the respective injection device that is furthest from the open end face of the housing, such that when the flexible band is tightened, the respective injection device is pulled by the flexible band towards the open end face of the housing.

[0019] The packaging assembly may include the plurality of injection devices.

[0020] Each of the plurality of injection devices may include an annular element formed at one end of the injection device, and the housing is configured to contain the plurality of injection devices in an arrangement in which the annular element of each injection device is adjacent to the open end face of the housing.

[0021] Other aspects of the present disclosure provide a packaging assembly including: a housing configured to at least partially contain a plurality of injection devices for delivering a medicament, the housing being formed as a box having at least one opening; and at least one tray configured to contain at least one of the plurality of injection devices and arranged to slide out of the housing through the opening.

[0022] The packaging assembly may include a tray for each of the plurality of injection devices.

[0023] Each of the plurality of trays may be configured to rotate about its length such that the injection device contained in the tray falls out of the tray.

[0024] The packaging assembly may include a tray configured to contain all of the plurality of injection devices.

[0025] The tray may be configured to hinge about an edge adjacent to the housing when fully pulled out of the housing.

[0026] The tray may be configured to contain the plurality of injection devices in an arrangement in which each injection device is placed perpendicular to the direction in which the tray is configured to slide, and the side panels of the tray may include at least one opening for pushing one or more of the injection devices out of the tray.

[0027] The tray may be formed with at least one inclined portion arranged to push one or more of the injection devices out of the tray when pushed through the at least one opening in the side panel.

[0028] The tray can be configured to contain the plurality of injection devices in an arrangement where each injection device is placed parallel to the direction along which the tray is configured to slide, and the bottom panel of the tray can include at least one opening for pushing one or more of the injection devices upward out of the tray. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0030] FIG. 1 is an isometric view of a packaging assembly according to a first exemplary embodiment;

[0031] FIG. 2 is an isometric view of the package of FIG. 1;

[0032] FIG. 3 is an exploded view of the packaging assembly of FIG. 1;

[0033] FIG. 4 is a block diagram of an electronic system of a packaging assembly according to an exemplary embodiment;

[0034] FIGS. 5A and 5B are isometric views of a packaging assembly according to an exemplary embodiment;

[0035] FIGS. 6A and 6B are isometric views of a packaging assembly according to an exemplary embodiment;

[0036] FIGS. 7A and 7B are isometric views of a packaging assembly according to an exemplary embodiment;

[0037] FIGS. 8A and 8B are isometric views of a packaging assembly according to an exemplary embodiment;

[0038] FIGS. 9A and 9B are isometric views of a packaging assembly according to an exemplary embodiment;

[0039] FIGS. 10A and 10B are isometric views of a packaging assembly according to an exemplary embodiment;

[0040] FIGS. 11A and 11B are side views of an auto-injector device for use with a packaging assembly according to an exemplary embodiment. DETAILED DESCRIPTION

[0041] Embodiments of the present invention provide a packaging assembly configured to contain and store a plurality of injection devices for delivering a medicament. The injection devices are examples of drug delivery devices and can be pen injectors or auto-injectors. The packaging assembly is configured to provide access to the plurality of injection devices to patients with diminished mobility, strength, and / or dexterity. The packaging assembly can further allow a patient to easily remove or insert an injection device. The packaging assembly provides a predictable, convenient, and independent experience for the patient.

[0042] The packaging assembly may include a cap for safe and discreet storage of the injection device. The cap may be configured such that it can be opened by the patient and multiple injection devices can be removed without the need to make a fist or pinch.

[0043] As described herein, a drug delivery device may be configured to inject a medicament into a patient. For example, the delivery may be subcutaneous, intramuscular, or intravenous. Such an injection device may be operated by a patient or a caregiver (such as a nurse or a physician) and may include various types of safety syringes, pen injectors, or auto-injectors. The injection device may include a cartridge-based system that requires penetration of a sealed ampoule prior to use. The volume of medicament delivered with these different injection devices may range from about 0.2 ml to about 3 ml.

[0044] In combination with a particular medicament, the injection devices described herein may also be customized to operate within required specifications. For example, the device may be customized to inject the medicament within a certain time period (such as about 3 seconds to about 20 seconds). Other specifications may include a low or minimum level of discomfort, or certain conditions related to human factors, shelf life, expiration date, biocompatibility, environmental factors, etc. Such variations may arise due to various factors (such as, the viscosity of the drug ranges from about 3 cP to about 50 cP). Accordingly, the injection device will generally include a hollow needle sized from about 25 to about 31 Gauge. Common sizes are 27 Gauge and 29 Gauge.

[0045] The injection devices described herein may also include one or more automated functions. For example, one or more of needle insertion, medicament injection, and needle retraction may be automated. The energy for one or more of the automated steps may be provided by one or more energy sources. The energy sources may include, for example, mechanical energy, pneumatic energy, chemical energy, or electrical energy. For example, a mechanical energy source may include a spring, a lever, an elastomer, or other mechanical mechanisms that store or release energy. One or more energy sources may be combined into a single device. The device may further include gears, valves, or other mechanisms that convert the energy into the movement of one or more components of the device.

[0046] One or more automated functions of an auto-injector may be activated via an activation mechanism. Such an activation mechanism may include one or more of a button, a lever, a needle sleeve, or other activation components. The activation may be a one-step or multi-step process. That is, the user may need to activate one or more activation mechanisms in order to effect the automated function. For example, the user may press the needle sleeve against their body to cause injection of the medicament. In other devices, it may be required that the user press a button and retract the needle shield in order to cause injection.

[0047] Additionally, such activation can activate one or more mechanisms. For example, the activation sequence can activate at least two of needle insertion, medicament injection, and needle retraction. Some devices may also require a specific sequence of steps to cause the one or more automated functions to occur. Other devices may operate in a series of independent steps.

[0048] Some delivery devices can include one or more functions of a safety syringe barrel, a pen injector, or an autoinjector. For example, the delivery device can include a mechanical energy source configured to automatically inject a medicament (such as typically found in an autoinjector) and a dose setting mechanism (such as typically found in a pen injector).

[0049] Referring to FIGS. 1 and 2, a package assembly 100 according to an exemplary embodiment is shown. The package assembly 100 includes a housing 110 having a lid 120. The housing 110 includes a bottom surface 131, a top surface 141, and two side walls 142. The bottom surface 131 is curved so as to meet the top surface 141 at the rear of the device. At the front end of the housing 110, an opening is formed between the bottom surface 131, the top surface 141, and the two side walls 142.

[0050] The lid 120 of the housing 110 is arranged to cover the opening of the housing 110. The lid 120 is attached in a hinged manner between the two side walls 142 of the housing 110. The lid 120 can move freely between a closed position and an open position in a hinged manner. In the closed position, the lid 120 is arranged to cover the opening of the housing 110. In the open position, the opening of the housing 110 is not covered, and the interior of the housing 110 is accessible.

[0051] As shown in FIG. 1, the bottom surface 131 of the housing 110 is shorter than the top surface 141. The lid 120 extends from the front edge of the bottom surface 131 to the front edge of the top surface 141. The lid 120 covers the entire extent of the front side of the package assembly 100 and a partial extent of the lower side of the package assembly 100. The lid 120 can be curved. This curvature allows the lid 120 to form the entire front portion of the housing 110 and a part of the bottom in the closed position. Other lid configurations can also be considered.

[0052] The lid 120 can include a latching mechanism to hold the lid 120 in the closed position. The latching mechanism can include a protruding portion arranged at the edge of the lid 120. The protruding portion can be configured to engage a corresponding feature in the housing 110 when the lid is in the closed position. The protruding portion can be flexible or retractable to disengage from the housing 110 and allow the lid 120 to move to the open position.

[0053] The lid 120 further includes a handle 121. The handle 121 is formed to protrude from the outer surface of the lid 120. The handle 121 protrudes from the front of the housing 110 when the lid 120 is in the closed position. The handle 121 is formed to extend laterally along the width of the housing 110, parallel to the top surface 141 and the bottom surface 131. The handle 121 is formed to extend over at least a portion of the width of the housing 110 and may be formed to extend over the entire width between the two side walls 142.

[0054] The housing 110 is configured to hold and store a plurality of injection devices 10. The depth of the housing 110 measured between the rear portion and the lid 120 is sufficient to accommodate the length of each injection device 10. The depth of the housing 110 may be between 160 mm and 180 mm. The height of the housing 110 measured between the bottom surface 131 and the top surface 141 is sufficient to accommodate the width of each injection device 10. The height of the housing may be between 30 mm and 40 mm. The width of the housing 110 measured between the two side walls 142 is sufficient to accommodate six injection devices 10. The width of the housing may be between 180 mm and 200 mm. In some examples, the housing may be 188.7 mm wide, 174.7 mm high and 34 mm deep.

[0055] The length of the top surface 141 may be the entire depth of the housing 110. The length of the top surface 141 may be between 160 mm and 180 mm. The length of the bottom surface 131 may be less than the entire depth of the housing 110. The length of the bottom surface 131 may be between 130 mm and 150 mm. The overhang depth of the top surface 141 beyond the front of the bottom surface 131 may be between 30 mm and 40 mm. A portion of the length of each injection device 10 (corresponding to the overhang depth) may be exposed.

[0056] The bottom surface 131, the top surface 141 and the two side walls 142 are formed of an opaque material, such as an opaque plastic material. The lid 120 is formed of a translucent or frosted material, such as a transparent plastic material with a frosted coating or a treated surface. A portion of the lid 120 may be clear and transparent to form an observation window through the lid 120.

[0057] The housing 110 further includes an internal structure 150 disposed within the opening. The internal structure 150 is only visible when the lid 120 of the housing 110 is in the open position. When the lid 120 is in the closed position, the lid obscures the view of the internal structure 150. The internal structure 150 includes a plurality of openings 151. The openings 151 are configured to hold the corresponding plurality of injection devices 10. The internal structure 150 includes a row of six openings 151 for holding six injection devices 10 arranged in a row along the width of the housing 110. The injection devices 10 are held longitudinally arranged, extending along the depth of the housing 110. The packaging assembly 100 may be configured to hold more than six or less than six injection devices 10 in the housing 110.

[0058] The outline of the opening 151 is generally rectangular. The opening 151 can be square or circular to accommodate injection devices 10 of other sizes. The width of each opening is sufficient to accommodate the width of each injection device 10. Each opening 151 leads to an internal space (not shown) for holding the injection device 10. The internal structure 150 is formed such that each opening 151 exposes a portion of the injection device held within the opening 151. The opening 151 is formed to expose the end of each injection device 10 at the lower side of the housing 110.

[0059] The lid 120 can be configured to hold the plurality of injection devices 10 in place within the housing 110 when in the closed position. The lid 120 can be arranged in the closed position to prevent the injection devices 10 from falling out or slipping out of the housing 110. Each injection device 10 can be held in place within the respective opening 151 by a friction fit with the opening 151.

[0060] A retention mechanism can hold the plurality of injection devices 10 in place within the opening 151. The retention mechanism can include a mechanical gripper configured to engage each injection device 10, for example, a spring-loaded push-grip push-release mechanism. The injection device 10 is pushed into the opening 151 and pushed against the spring of the retention mechanism to engage the gripper. A second push on the injection device 10 releases the gripper. A release button or switch can be provided for each opening 151, which is configured to release the gripper of the retention mechanism when pressed.

[0061] An ejection mechanism can be configured to eject one or more injection devices 10 out of the housing 110. The ejection mechanism can include one or more springs arranged to eject each injection device 10 out of the housing 110. Alternatively, a flexible band can be provided for each injection device 10 to pull the injection device out of the housing 110. The ejection mechanism will be described in more detail below with reference to FIGS. 5 and 6.

[0062] FIG. 2 shows the packaging assembly 100 with the lid 120 in the closed position. The handle 121 extends laterally along the width of the housing 110. The handle 121 extends over a portion of the width of the housing 110, which is less than the entire width of the housing 110. The width of the handle 121 can be between 80 mm and 110 mm. The handle 121 protrudes from the front of the housing 110 when the lid 120 is in the closed position. The depth of the handle 121 can be between 5 mm and 20 mm. The thickness of the handle 121 can be between 2 mm and 10 mm. When the lid 120 is in the closed position, the handle 121 can be formed to extend at an angle below the horizontal line. When the lid 120 is in the closed position, the angle of the handle 121 can be between 10° and 20°.

[0063] The handle 121 is formed to have an upper surface and a lower surface. The handle 121 is formed to move the cover 120 between an open position and a closed position by applying pressure. When the cover 120 is in the closed position, a downward pressure on the upper surface will cause the cover to move to the open position. When the cover 120 is in the open position, an upward pressure on the lower surface will cause the cover to move to the closed position. In this case, the interior of the housing 110 can be accessed and closed by simply applying direct pressure, without the need for pinching or other fine motor skills.

[0064] The user can receive the packaging assembly 100 in an empty condition. When a plurality of injection devices 10 are provided to the user, the plurality of injection devices can be loaded into the packaging assembly 100. The cover 120 is moved to the open position, and each injection device 10 is inserted into a respective one of the openings 151. The cover 120 is moved to the closed position. The packaging assembly 100 is placed in a refrigerator until the scheduled administration time expires.

[0065] For example, depending on the form of the medicament provided in the plurality of injection devices 10, the administration time can be scheduled every 14 days or 28 days. In some embodiments, depending on the requirements of the medicament, the time period between scheduled administration times can be between 2 days and 60 days.

[0066] The packaging assembly 100 can be configured to provide a visual and / or reminder to the user when the scheduled administration time expires. The packaging assembly 100 can be further configured to determine whether the cover 120 is in the open position or the closed position, and can deactivate the reminder when it detects that the cover 120 has moved to the open position. When the reminder is active, the user can push the handle 121 to move the cover to the open position, and the reminder will also be deactivated. In this way, the reminder can be easily deactivated with less input and without fine motor skills, such as moving a switch or pressing a button.

[0067] The functions of the packaging assembly 100 are provided by the following electronics:

[0068] The packaging assembly 100 includes an electronic system 160 (not visible in FIG. 1 but visible in FIG. 3). The electronic system includes a plurality of components connected together to provide a set of specific functions, as described below. The components of the electronic system 160 are mounted on a printed circuit board (PCB), but alternatively, the components can be interconnected by some other medium.

[0069] The electronic system 160 is attached to the internal structure 150. Some of the electronic components of the electronic system 160 are user interface hardware components, and together they provide a user interface. The components providing the user interface are located at one end of a row of openings 151 in the internal structure 150.

[0070] The electronic system 160 is schematically shown in FIG. 4. The electronic system 160 includes a processor component 101, which is shown in FIG. 4. The processor component 101 controls the operation of other hardware components of the electronic system 160. The processor component 101 is configured to control the hardware components forming the user interface. The processor component 101 is configured to process one or more input signals from at least one input sensor.

[0071] The electronic system 160 includes a display 161. The display 161 is an example of an optical transducer. The display 161 includes two seven-segment light-emitting diode (LED) arrays. The display 161 may be visible to the user through a transparent or translucent cover 120 or, in some embodiments, through a transparent viewing window in the cover 120. The electronic system 160 includes a light-emitting diode (LED) 162. The LED 162 is an example of an optical transducer. The color of the LED 162 is different from the color of the seven-segment LED arrays in the display 161. For example, the color of the LED 162 is red, while the color of the display 161 is blue. The electronic system 160 includes a reset button 164. The reset button 164 is an example of an input device. The reset button 164 is a spring-loaded user plunger button that can be pressed. The electronic system 160 includes a speaker 163 (not shown in this figure). The speaker 163 is an example of an audio transducer.

[0072] Further referring to FIG. 3, an exploded view of a packaging assembly 100 according to a first embodiment is shown. The housing 110 of the packaging assembly 100 includes a first part 130 and a second part 140.

[0073] The first part 130 of the housing 110 is formed as a single piece. The first part 130 of the housing 110 includes a bottom surface 131 and the rear portion of the packaging assembly 100. A plurality of openings 133 are formed along each side edge of the bottom surface 131 for engagement with the second part 140 of the housing 110. Three openings 133 are formed along each edge of the first part 130. The first part 130 further includes a plurality of separators 134 for holding the plurality of injection devices 10 (not shown in FIG. 2) in place within the housing 110. Each side of the first part 130 includes a first hinge portion 136. Each side of the first part 130 includes a first latch portion 137.

[0074] An internal structure 150 is formed in the first part 130 of the housing 110. The internal structure 150 includes a plurality of openings 151. The openings 151 are configured to hold the corresponding plurality of injection devices 10. The internal structure 150 further includes one or more openings 152 for the hardware components of the user interface. The openings 152 are arranged in a flat panel 153 of the internal structure 150. The flat panel 153 is arranged adjacent to the openings 151.

[0075] The second part 140 includes the top surface 141 of the housing 110, a first side wall 142a and a second side wall 142b. The lengths of the first side wall 142a and the second side wall 142b may be less than the overall depth of the housing 110. The lengths of the first side wall 142a and the second side wall 142b may be between 130 mm and 150 mm. The second part 140 is formed as a single piece. The second part 140 further includes a plurality of dividers 144 for holding and storing the plurality of injection devices 10 in place within the housing 110. The dividers 144 of the second part 140 are aligned with the dividers 134 of the first part 130.

[0076] The housing 110 of the packaging assembly 100 includes a plurality of magnets 148. The magnets 148 are fixed in place on the inner side of the top surface 141. The housing includes four magnets 148 fixed in a square arrangement. The plurality of magnets 148 allow the top surface 141 of the housing 110 to be releasably attached to a magnetic surface, such as a steel surface. The magnets 148 may be neodymium magnets.

[0077] The packaging assembly 100 further includes a mounting plate 190. The mounting plate 190 includes a plurality of adhesive tapes 191. The mounting plate 190 can be fixed to a surface, such as the wall inside a refrigerator or under a shelf, using the adhesive tapes 191. The mounting plate 190 is formed of a magnetic material, such as steel. The housing 110 can be releasably attached to the surface by being magnetically attached to the mounting plate 190.

[0078] The mounting plate 190 includes three adhesive tapes 191. The adhesive tapes 191 are arranged parallel to each other across the width of the mounting plate 190, and each adhesive tape 191 extends substantially along the entire length of the mounting plate. Alternatively, the mounting plate 190 may include only two adhesive tapes 191 spaced apart on the mounting plate 190, or may include more than three adhesive tapes 191 extending in parallel. Further alternatively, the mounting plate 190 may include four adhesive tapes 191 positioned in a rectangular arrangement (e.g., at each corner of the mounting plate 190). The mounting plate may include any number of adhesive tapes 191 arranged in a regular array.

[0079] Alternatively, the mounting plate 190 can be placed on the upper side of a shelf without an adhesive. The housing 110 can be magnetically held under the shelf by the magnetic attraction to the mounting plate 190.

[0080] The packaging assembly 100 further includes a plurality of batteries 170. The batteries 170 are arranged to supply power to components of the user interface. The second portion 140 of the housing 110 includes a battery opening 145 formed in the top surface 141. The battery opening 145 is configured to receive the plurality of batteries 170. A battery cover member 180 is configured to slidably engage with the battery opening 145 of the second portion 140 and cover the battery opening 145 when using the packaging assembly 100. The battery cover member 180 includes a plurality of latches 181 arranged to engage with the second portion 140 of the housing 110.

[0081] Each of the first side wall 142a and the second side wall 142b of the housing 110 includes a plurality of engagement hooks 143. The engagement hooks 143 are arranged on the inner surface of the corresponding side wall. Each side wall 142 includes three engagement hooks 143. Each of the engagement hooks 143 is configured to engage with a corresponding opening 133 in the first portion 130 of the housing 110.

[0082] The cover 120 of the housing 110 includes a second hinge portion 126 configured to engage with a first hinge portion 136 of the first portion 130 of the housing 110. The first hinge portion 136 and the second hinge portion 126 together form a hinge 106 for attaching the cover 120 to the first portion 130 of the housing 110. For example, the second hinge portion 126 includes an opening, and the first hinge portion 136 includes a protrusion arranged to fit within the opening of the second hinge portion 126. The first hinge portion 136 is configured to rotate within the opening of the second hinge portion 126.

[0083] The cover 120 of the housing 110 includes a second latch portion (not shown) configured to engage with a first latch portion 137 of the first portion 130 of the housing 110. The second latch portion is configured to releasably engage with the first latch portion 137 to maintain the cover 120 in the closed position. For example, the first latch portion 137 includes a protrusion, and the second latch portion includes an opening configured to releasably engage with the protrusion of the first latch portion 137.

[0084] The cover 120 is formed of a translucent plastic material. A portion of the cover 120 may be clear and transparent to form an observation window through the cover 120. A handle 121 is formed as a part of the cover 120 and extends outward from the body of the housing 110.

[0085] The packaging assembly 100 includes an electronic system 160. The electronic system 160 includes hardware components of the user interface, namely a display 161, an LED 162, a speaker 163, and a reset button 164. The display 161 of the user interface can be seen through the translucent cover 120. The electronic system 160 is coupled to battery contacts 169. The battery contacts 169 are mounted with a plurality of batteries 170 to supply power to the electronic system 160.

[0086] The electronic system 160 includes a reset switch 165. The reset button 164 is a spring-loaded plunger button arranged to be pressed by a user. The reset switch 165 is a mechanical switch mounted on the electronic system 160. The reset switch 165 is positioned below the reset button 164. The reset switch 165 is arranged to be actuated by the reset button 164. The reset button 164 may be coupled to the reset switch 165.

[0087] The electronic system 160 includes a hinge switch (167). The hinge switch may be an electromechanical switch, such as a microswitch or other micro snap-action switch. The hinge switch is an example of a lid-open sensor.

[0088] The hinge switch is arranged to engage with the lid 120 of the housing 110 when the lid 120 is in the closed position. The actuating portion of the lid 120 may be shaped to press the hinge switch 167 when the lid 120 is in the closed position. The hinge switch may be mounted at the edge of the PCB of the electronic system 160. The actuating portion of the lid 120 may be arranged to pass over the edge of the PCB of the electronic system 160 when the lid 120 is in the closed position.

[0089] The electronic system 160 further includes a processor assembly 101 (not shown in this figure). The processor assembly 101 is configured to process input signals from one or more sensors and switches on the electronic system 160. The processor assembly 101 is configured to control the output of user interface elements on the electronic system 160.

[0090] Regarding FIG. 4, a schematic representation of the electronic system 160 of the packaging assembly 100 according to the first embodiment is shown. The electronic system 160 includes a processor assembly 101. The processor assembly 101 and other hardware components may be connected via a system bus (not shown). Each hardware component may be directly or via an interface connected to the system bus. The battery 170 is arranged to supply power to the electronic system 160.

[0091] The processor assembly 101 controls the operation of other hardware components of the electronic system 160. The processor assembly 101 may be any type of integrated circuit. The processor assembly 101 may be, for example, a general-purpose processor. The general-purpose processor may be a single-core device or a multi-core device. The processor assembly 101 may be a central processing unit (CPU) or a general-purpose processing unit (GPU). Alternatively, it may be a more specialized unit, such as a RISC processor or programmable hardware with embedded firmware. Multiple processors may be included. The processor assembly 101 may be referred to as a processing device.

[0092] The processor component 101 has a clock speed of 2 Hz. The clock speed is selected to provide a balance between power usage and availability. A greater clock speed provides improved availability by reducing the time required for the processor component 101 to respond to an input. However, a greater clock speed will increase the power usage of the processor component 101. The clock speed can be selected between 0.5 Hz and 100 Hz.

[0093] The electronic system 160 includes a working or volatile memory 102. The processor component 101 can access the volatile memory 102 to process data and can control the storage of data in the memory. The volatile memory 102 can be any type of RAM, e.g., static RAM (SRAM), dynamic RAM (DRAM), or it can be flash memory. Multiple volatile memories can be included, but are omitted in the figure.

[0094] The electronic system 160 includes a non-volatile memory 103. The non-volatile memory 103 stores a set of operating instructions for controlling the normal operation of the processor component 101. The non-volatile memory 103 can be any type of memory, such as read-only memory (ROM), flash memory, or magnetic drive memory. Other non-volatile memories can be included, but are omitted in the figure.

[0095] The processor component 101 operates under the control of the operating instructions. The operating instructions can include code related to the hardware components of the electronic system 160 (i.e., drivers), as well as code related to the basic operation of the packaging device. The operating instructions can also cause the activation of one or more software modules stored in the non-volatile memory 103. Generally, the processor component 101 executes one or more of the operating instructions permanently or semi-permanently stored in the non-volatile memory 103, using the volatile memory 102 to temporarily store data generated during the execution of the operating instructions.

[0096] The processor component 101, the volatile memory 102, and the non-volatile memory 103 can be provided as separate integrated circuit chips connected by an off-chip bus, or they can be provided on a single integrated circuit chip. The processor component 101, the volatile memory 102, and the non-volatile memory 103 can be provided as a microcontroller.

[0097] The electronic system 160 includes a clock 104. The clock 104 can be a clock crystal, e.g., a quartz crystal oscillator. The clock 104 can be a component separate from the processor component 101 that is configured to provide a clock signal to the processor component 101. The processor component 101 can be configured to provide a real-time clock based on the signal from the clock 104. Alternatively, the clock 104 can be a clock crystal that is provided on a single integrated circuit chip together with the processor component 101.

[0098] The processor component 101 is configured to perform a countdown operation. The countdown operation monitors the remaining days until the scheduled administration time. The countdown operation is set and activated in response to an input from the reset switch 165. The predetermined period for counting down to the next scheduled administration time is stored in the non-volatile memory together with the operation instructions of the processor component 101. The processor component 101 records the number of days to the volatile memory 102 and reduces the recorded number of days by one day every 24 hours.

[0099] For example, if the predetermined period until the next scheduled administration time expires is 14 days, the countdown operation starts from 14 days.

[0100] The electronic system 160 may include a timer duration switch. The timer duration switch may be configured to select the period until the next scheduled administration time. The timer duration switch may be a slide switch having a first position and a second position. The processor component 101 may be configured to set the period for counting down to the next scheduled administration time based on the position of the timer duration switch. If the slide switch is in the first position, the processor component 101 may set the period to 14 days. If the slide switch is in the second position, the processor component 101 may set the period to 28 days.

[0101] The position of the timer duration switch may be preset as part of the manufacturing process and may not be adjustable by the user. Alternatively, the user may access the timer duration switch to set the timer period to the next scheduled administration time. The timer duration switch may be mounted on the top surface of the PCB of the electronic system. The timer duration switch may be accessed through the battery opening 145.

[0102] Every 24 hours, the number of days recorded to the volatile memory 102 is reduced by one day. After 13 days, when there is 1 day remaining until the scheduled administration time, the processor component 101 may control the electronic system 160 to generate an output to indicate that the scheduled administration time is approaching. After 14 days, on the day of the scheduled administration time, the processor component 101 may control the electronic system 160 to generate an output to indicate that the scheduled administration time has expired. The hardware components of the electronic system 160 forming the user interface may be controlled to indicate that the scheduled administration time has expired.

[0103] On a certain day, such as the first day, a reduction in the number of days can be provided in less than 24 hours. For example, this can be achieved in 20 hours or 22 hours. This can help prevent the alarm time from creeping later and later in the day after multiple resets of the countdown timer. Alternatively, when the remaining number of days recorded in the volatile memory equals one, the processor component 101 can be configured to reduce the time remaining until the next scheduled dosing time expires. For example, the processor component 101 can be configured to wait only 23 hours before reducing the number of days to zero. In this way, the time of day when the scheduled dosing time expires is one hour earlier than the time when the reset button 164 is pressed.

[0104] The processor component 101 can be configured to perform one or more timing operations. The processor component 101 can start a timing operation from zero and monitor the increasing amount of time. Alternatively, the processor component 101 can start a timing operation from a predetermined time and count down until the timer expires.

[0105] The processor component 101 can be configured to verify the charge state of one or more batteries 170 included in the package assembly 100. If the charge state is below a threshold (which can be built into the design of the package assembly), the charge state is determined to be low. The charge state can be determined by measuring the voltage provided by the battery 170, by monitoring the energy usage starting from a fully charged state, or a combination of these two techniques.

[0106] The electronic system 160 includes a lid open sensor. The lid open sensor 167 is configured to provide a signal to the processor component 101 when the lid 120 of the housing 110 is in the closed position.

[0107] The lid open sensor 167 can be a hinge switch, such as an electromechanical switch, such as a microswitch or other micro snap switch. The lid open sensor 167 can be arranged to mechanically engage with the lid 120 when the lid 120 is in the closed position. The actuating portion 128 of the lid 120 can be shaped to engage with the lid open sensor 167 when the lid 120 is in the closed position. The lid open sensor 167 can be a normally open switch having an open state and a closed state. When pressed, the switch can be operated to move from the open state to the closed state. The switch can be configured to conduct current only in the closed state.

[0108] The lid open sensor 167 can be configured to provide a signal to the processor component 101 when the lid 120 presses the switch to the closed state. The processor component 101 can be configured to set a variable to indicate whether the lid 120 has been opened.

[0109] The electronic system 160 includes a reset switch 165. The reset switch 165 is configured to provide a signal to the processor assembly 101 when actuated by a reset button 164. The user presses the reset button 164 to indicate that a scheduled dose has occurred and to reset the time period for the next scheduled administration time.

[0110] The reset switch 165 can be a mechanical switch mounted on the electronic system 160. The reset switch 165 is arranged to be actuated by the reset button 164. The reset switch 165 can be a normally open switch having an open state and a closed state. When pressed, the reset switch 165 can be operated to move from the open state to the closed state. The reset switch 165 can be configured to conduct current only in the closed state. The reset switch 165 can be configured to provide a signal to the processor assembly 101 when moving to the closed state.

[0111] The reset button 164 can be coupled to the reset switch 165. The reset switch 165 can be positioned below the reset button 164. If the reset button 164 is pressed, the reset switch 165 can be moved to the closed state by the reset button 164. The reset switch 165 is configured to provide a signal to the processor assembly 101 when actuated by the reset button 164. The processor assembly 101 is configured to reset the countdown operation in response to a signal from the reset switch 165. The processor assembly 101 resets the remaining time until the scheduled administration time expires to 14 days. In some embodiments, the user must hold the reset button 164 for 2 seconds to reset the time period for the next scheduled administration time. The packaging assembly 11 can filter out short presses of the reset button 164 to reduce the occurrence of accidentally triggering the reset operation.

[0112] The electronic system 160 includes a display 161 of the user interface. The display 161 can be operated to provide a notification. The display 161 can be operated to provide an indication of the status of the packaging assembly 100. The display 161 is an example of a status indicator. The display 161 can be operated to show information related to the status of the packaging assembly 100. By illuminating some or all of the LED segments, the display 161 can be operated to show any number from 00 to 99. The display 161 can also show certain letters.

[0113] The electronic system 106 can include a display driver 105. The display driver 105 can be provided as a separate integrated circuit chip to the processor assembly 101 connected via an off-chip bus. Alternatively, the display driver 105 can be provided on the same integrated circuit chip as the processor assembly 101. The display driver 105 can be a port expander for individually controlling the segments of a seven-segment LED display.

[0114] The processor component 101 can operate the display 161 to show the number of days remaining until the scheduled administration time expires. The display 161 can be operated to provide a visual reminder output that the scheduled administration time has expired. The display 161 can also be operated to provide a visual reminder output that the scheduled administration time is approaching.

[0115] If the countdown operation of the processor component 101 is reset, the countdown operation starts from 14 days. The display 161 is operated to show the number "14" to indicate that 14 days remain. Each day, the number of days shown on the display 161 decreases by one day. After 13 days, when there is 1 day remaining until the scheduled administration time, the display 161 is operated to show "01". The display 161 is operated to flash or blink to indicate that the scheduled administration time is approaching. The display 161 is operated to blink by intermittently showing "01".

[0116] After 14 days, on the day of the scheduled administration time, the display 161 is operated to show "00". The display 161 is operated to blink to indicate that the scheduled administration time has expired. The display 161 is operated to blink by intermittently showing "00". The blinking period of the display 161 can be on the order of 0.25 seconds to 2 seconds.

[0117] The processor component 101 can verify the charge state of one or more batteries 170 included in the packaging assembly 100. If it is determined that the charge state is low, the display 161 can be operated to show a low battery warning.

[0118] The low battery warning shown on the display 161 can be a message including a capital letter L on a first seven-segment array and a lowercase letter o on a second seven-segment array. That is, the display 161 can show the message "Lo". Under the control of the processor component 101, the display 161 can intermittently show the low battery warning. The display 161 can be operated to alternately show the low battery warning and the number of days remaining until the scheduled administration time. The periodicity of the intermittent or alternate operation of the display 161 can be on the order of 0.25 seconds to 2 seconds.

[0119] The electronic system 160 includes an LED 162 of the user interface. The LED 162 can be operated to provide a notification. The LED 162 can be operated to provide an indication of the status of the packaging assembly 100. The LED 162 is an example of a status indicator.

[0120] The processor component 101 can operate the LED 162 to provide a visual reminder that the scheduled administration time has expired. After 14 days, on the day of the scheduled administration time, the LED 162 is operated to generate intermittent output light. The LED 162 is operated to flash or blink red to provide a visual reminder that the scheduled administration time has expired. The blinking period of the LED 162 can be on the order of 0.25 seconds to 2 seconds.

[0121] The electronic system 160 includes a speaker 163 of the user interface. The speaker 163 can be operated to output a notification signal. The speaker 162 can be operated to provide an indication of the status of the packaging assembly 100. The speaker 162 is an example of a status indicator.

[0122] The processor component 101 operates the speaker 163 to provide an audio reminder that the scheduled administration time has expired. After 14 days, on the day of the scheduled administration time, the speaker 163 is operated to output an audio reminder that the scheduled administration time has expired. The speaker 163 can be operated to output intermittent tones. The period of the output of the speaker 163 can be on the order of 0.25 seconds to 2 seconds.

[0123] The processor component 101 controls the operation of the speaker 163 according to the signal input by the lid open sensor 167. When the scheduled administration time expires, the processor component 101 operates the speaker 163 to output an audio indication that the scheduled administration time has expired, as described above. When the lid open sensor 167 provides a signal to the processor component 101 to indicate that the lid 120 of the housing 110 is open, the processor component 101 controls the speaker 163 to deactivate the reminder.

[0124] The processor component 101 can control the operation of the speaker 163 according to the stored value of the lid flag. When the lid open sensor 167 provides a signal to the processor component 101 to indicate that the lid 120 is open, the processor component 101 can set the lid flag to have a value of 1. When the stored value of the lid flag is equal to 1, the processor component 101 controls the speaker 163 to deactivate the reminder. When the reset button 164 is pressed, the processor component 101 can set the lid flag to have a value of 0.

[0125] In this way, the audio reminder output by the speaker 163 is deactivated only when the user opens the lid. The speaker 163 is deactivated only when the user opens the lid 120 of the housing 110 to retrieve the injection device 10 for a scheduled administration. Thus, the packaging assembly 100 improves compliance with the scheduled dosing regimen.

[0126] Regarding FIGS. 5A and 5B, a packaging assembly 200 according to a second embodiment is shown. Elements not described below are substantially the same as those of the first embodiment.

[0127] The housing 210 of the packaging assembly 200 includes a flat panel 250 that forms the internal structure of the housing 210. The flat panel 250 extends across the entire width of the housing 210. An opening 251 for the injection device 10 and an opening 252 for the user interface are formed in the flat panel 150.

[0128] Regarding Figure 5C, a ejection mechanism 254 according to a second embodiment is shown. The packaging assembly 200 may include one or more ejection mechanisms 254, and may include an ejection mechanism 254 for each injection device 10. The ejection mechanism 254 includes at least one ejection spring 255 that is arranged to push the injection device 10 out of the housing 210.

[0129] The ejection mechanism 254 may be configured to push a portion of each injection device 10 out of the corresponding opening 251. The ejection mechanism 254 may be biased against a retention mechanism to push the injection device when each injection device is released by the retention mechanism. The retention mechanism and the ejection mechanism may be combined into a push engagement and push disengagement mechanism. A spring that pushes the injection device 10 into the opening 251 and pushes it against the retention mechanism engages a gripper. The injection device 10 is pushed a second time to release the gripper, and the ejection spring 255 of the ejection mechanism 254 pushes the injection device 10 at least partially out of the housing 110. The spring of the retention mechanism and the ejection spring 255 of the ejection mechanism 254 may be a single spring. The ejection mechanism 254 includes a cam mechanism 256 to adjust the push engagement and push disengagement mechanism.

[0130] Regarding Figures 6A and 6B, a packaging assembly 300 according to a third embodiment is shown. Elements not described below are substantially the same as the elements of the first embodiment.

[0131] The housing 310 of the packaging assembly 300 includes a flat panel 350, substantially as described with respect to the second embodiment.

[0132] Regarding Figure 6C, an ejection mechanism 354 according to the third embodiment is shown. The ejection mechanism 354 includes a flexible band 355 for each of the plurality of injection devices 10. Each band 355 is arranged such that when the band 355 is pulled, the corresponding injection device 10 is pulled out of the housing 310. The first end of the band 355 is fixed in place within the housing 310. The second end of the band 355 is not attached. The second end passes through the corresponding opening 151 and remains outside the housing 310. The middle portion of the band 355 bypasses the end of the injection device 10 within the housing 310. In this way, pulling the band 355 will pull the injection device 10 out of the housing 310.

[0133] The width of the strip 355 is less than the width of each opening 151 such that the strip 355 can pass through the opening 351. The width of the strip 355 is the same as or substantially the same as the width of each injection device 10 such that when the injection device 10 is inserted into the housing 310, the injection device 10 pushes the strip 353 into place.

[0134] The second end of the strip 355 includes a loop 356 for pulling the strip 355. The inner diameter of the loop 356 is large enough to allow a finger to pass through the loop 356 and pull the strip 355. In this way, the strip 355 can be pulled without forming a pinch grip. The outer diameter of the loop 356 can be greater than the opening 351 such that the second end of the strip 355 cannot pass through the interior of the housing 310. Alternatively, the second end of the strip 355 can be formed with a hook or a T-shaped handle for pulling the strip 355.

[0135] With reference to FIGS. 7A and 7B, a packaging assembly 400 according to a fourth embodiment is shown. Elements not described below are substantially the same as the elements of the first embodiment.

[0136] The housing 410 includes a flat panel 450, substantially as described with respect to the second embodiment.

[0137] The housing 410 includes a plurality of trays 453 corresponding to the plurality of injection devices. Each of the trays 453 is configured to hold one of the injection devices 10. The trays 453 are cylindrical and open on one side such that the injection device 10 can fall into the tray 453 from the side. The housing 410 includes six trays 453 corresponding to each opening 451. Each tray 453 is arranged to slide into and out of the corresponding opening 451. A retaining lip at one end of the tray 453 can prevent the tray 453 from being completely removed from the housing 410. The tray 453 can be rotated within the opening to cause the injection device 10 to fall out of the tray 453. The user can rotate the tray 453 until the open side is facing down and the injection device 10 falls out of the tray 453. The tray 453 can include one or more retaining grooves or tracks to maintain the tray in an upright orientation when sliding into and out of the opening 451. The retaining grooves or tracks can be configured such that the tray 453 can be rotated once it is completely withdrawn from the housing 410.

[0138] The outer end of the tray 453 includes a loop 454 for pulling the strip. The inner diameter of the loop 454 is large enough to allow a finger to pass through the loop 454 and pull the tray 453. In this way, the tray 453 can be pulled without forming a pinch grip. Alternatively, the outer end of the tray 453 can be formed with a hook or a T-shaped handle for pulling the tray 453.

[0139] When fully inserted into the housing 410, the retention mechanism can lock one or more trays 453 in place. According to an embodiment, the housing 410 is formed without a lid. Alternatively, the plurality of trays 453 can be provided in combination with a lid.

[0140] With reference to FIGS. 8A and 8B, a packaging assembly 500 according to a fourth embodiment is shown. Elements not described below are substantially the same as those of the first embodiment.

[0141] The internal structure 550 of the housing 510 is formed with a single opening 551. The opening 551 is generally rectangular. The opening 551 extends throughout the height of the housing 510 and across most of the width of the housing 510 up to the flat panel that holds the user interface.

[0142] The housing 510 includes a tray 553 configured to hold a plurality of injection devices 10. The tray 553 is shaped generally rectangular. The tray 553 includes a base, two side walls, and a rear wall (not shown). The tray 553 is open at the upper side and the front end such that the plurality of injection devices 10 can fall into or be withdrawn from the tray 553. A plurality of partition walls are arranged to hold the injection devices 10 in place within the tray 553. The injection devices 10 are held longitudinally arranged, extending along the depth of the housing 510.

[0143] The tray 553 is configured to slide into and out of the opening 551. Retaining elements at the rear end of the tray 553 can prevent the tray 553 from being completely removed from the housing 510. The tray 553 can be configured to pivot downward when fully withdrawn from the housing 510. The tray 553 can pivot downward between 10° and 20° to present the injection devices 10 to the user.

[0144] The base of the tray 553 is formed with a handle 554 at the front end to pull the tray 553 out of the housing 510. The handle 554 can be formed by an opening or alternatively by a protrusion to be grasped. The base further includes a plurality of openings 555 corresponding to the plurality of injection devices 10. The openings 555 are arranged between the partition walls, at the front end of the base. The diameter of each opening 555 is large enough for a user to insert a finger to withdraw the injection device 10 from the tray 553. In this way, the injection device 10 can be easily removed from the tray 553 without the need to form a pinch grip.

[0145] With reference to FIGS. 9A and 9B, a packaging assembly 600 according to a fourth embodiment is shown. Elements not described below are substantially the same as those of the first embodiment.

[0146] The internal structure 650 of the housing 610 is formed with a single opening 651. The opening 651 is formed such that the injection device 10 can pass through the opening 651 from the side. The width of the opening 651 is greater than the length of the injection device 10. The height of the opening 651 is greater than the width of the injection device 10. The opening 651 includes a cut-out section 653 to enable the injection device 10 to be removed through the opening 651.

[0147] The packaging assembly 600 is configured to hold the injection device 10 in a lateral arrangement, extending along the width of the housing 610. The ejection mechanism is configured to push the injection device 10 towards the opening 651. When the injection device 10 is removed through the opening 651, the ejection mechanism pushes the remaining injection devices 10 towards the opening 651. The spring of the ejection mechanism is arranged to push the injection device 10 towards the opening 651. Alternatively, a flexible band may be provided, substantially as described with respect to the third embodiment.

[0148] The opening 651 forms a retaining lip to hold the injection device 10 within the housing 610. The lip is arranged along the lower side of the opening 651. The lip is arranged such that the ejection mechanism pushes the foremost injection device 10 against the lip. By lifting the injection device 10 above the retaining lip, the injection device 10 can be removed from the housing 610. The cut-out section 653 is arranged such that a user can push the lower side of the injection device 10 and lift the injection device 10 above the retaining lip. In this way, when the user pushes the injection device 10 upwards with their fingertip, the ejection mechanism pushes the injection device 10 out of the housing 610 into the user's palm. The injection device 10 can be easily removed from the housing 610 without having to close the fist or form a pinch.

[0149] With reference to FIGS. 10A and 10B, a packaging assembly 700 according to a fourth embodiment is shown. Elements not described below are substantially the same as the elements of the first embodiment.

[0150] The internal structure 750 of the housing 710 is formed with a single opening 751. The opening 751 is generally rectangular. The opening 751 extends throughout the height of the housing 710 and across most of the width of the housing 710 up to a flat panel 753 that holds the user interface.

[0151] The housing 710 includes a tray 753 configured to hold a plurality of injection devices 10. The tray 753 is generally rectangular in shape. The tray 753 includes a base, a front wall, and a rear wall. The tray 753 is configured to slide into and out of the opening 751. Retaining elements at the rear end of the tray 753 can prevent the tray 753 from being completely removed from the housing 710. The front wall of the tray 753 is formed to have a handle 754 on the outer-facing surface to pull the tray 753 out of the housing 710. The handle 754 is formed by an opening or cut-out section in the outer-facing surface and has a hanging lip or protrusion to be grasped.

[0152] The tray 753 is open at the upper side such that a plurality of injection devices 10 can fall into or be withdrawn from the tray 753. The injection devices 10 are held in a lateral arrangement, extending along the width of the housing 710. The base is formed with a certain inclination, descending from the rear end of the tray to the front end of the tray 753. In this way, the plurality of injection devices 10 can slide towards the front end of the tray 753. As shown in the figure, when the tray 753 is withdrawn from the housing 710, the injection devices 10 can be laterally pushed out of the tray 753. The injection devices 10 can be pushed with one hand until they fall into the user's other hand. In this way, the injection devices 10 can be easily removed from the tray 753 without the need to make a pinching or a fist.

[0153] Regarding FIGS. 11A and 11B, an exemplary injection device 10 is shown. As described above, the injection device 10 is configured to inject a medicament into a user's body. The injection device 10 includes a housing 11, which typically contains a reservoir (e.g., a syringe barrel) containing the medicament to be injected and components required for one or more steps of facilitating the delivery process. As shown, the housing 11 is formed in an ergonomic shape. The shape of the housing 11 is generally rectangular, with one side enlarged to form a curved outer surface 13. The curved outer surface 13 improves the fit of the housing in the user's hand and allows the injection device 10 to be held without making a fist or a pinch. The edges of the housing 11 are generally circular so that the user feels comfortable when holding the injection device 10.

[0154] The injection device 10 may further include a cap assembly 12 that can be removably mounted to the housing 11. Typically, before operating the injection device 10, the user must remove the cap 12 from the housing 11. The cap 12 includes a ring to pull the cap 12 out of the housing 11. The inner diameter of the ring is large enough to allow a finger to pass through the ring and pull the cap 12. In this way, the cap 12 can be pulled without forming a pinch. The enlarged curved outer surface 13 of the housing 11 can prevent the injection device 10 from slipping out of the user's hand when pulling the cap 12, even with a merely loose grip.

[0155] The housing 11 has a distal region 20 and a proximal region 21. The term "distal" refers to a position relatively closer to the injection site, and the term "proximal" refers to a position relatively farther from the injection site.

[0156] The insertion of the needle 17 can occur via several mechanisms. For example, the needle 17 can be fixedly positioned relative to the housing 11 and initially located within a protruding needle sleeve. By placing the distal end of the sleeve against the user's body and moving the housing 11 in the distal direction to move the sleeve proximally, the distal end of the needle 17 will be exposed. Such relative movement allows the distal end of the needle 17 to extend into the user's body. This insertion is referred to as "manual" insertion because the needle 17 is manually inserted by the user moving the housing 11 relative to the sleeve manually.

[0157] Another form of insertion is "automatic", whereby the needle 17 moves relative to the housing 11. This insertion can be triggered by movement of the sleeve or by another form of activation such as, for example, a button. The button can be located at the proximal end of the housing 11, or in other embodiments, the button can be located on one side of the housing 11.

[0158] Other manual or automated features can include drug injection or needle retraction or both. Injection is the process by which a plug or piston moves from a proximal position within a syringe barrel (not shown) to a more distal position within the syringe barrel in order to force a medicament from the syringe barrel through the needle 17. In some embodiments, prior to activation of the device 10, a drive spring (not shown) is in a compressed state. The proximal end of the drive spring can be fixed within the proximal region 21 of the housing 11, and the distal end of the drive spring can be configured to apply a compressive force to the proximal surface of the piston. After activation, at least a portion of the energy stored in the drive spring can be applied to the proximal surface of the piston. This compressive force can act on the piston to move it in the distal direction. This distal movement is used to compress the liquid medicament within the syringe barrel, thereby forcing it out through the needle 17.

[0159] After injection, the needle 17 can be retracted into the sleeve or the housing 11. As the user removes the device 10 from the user's body, retraction can occur as the sleeve moves distally. This can occur while the needle 17 remains fixedly positioned relative to the housing 11. Once the distal end of the sleeve has moved past the distal end of the needle 17 and the needle 17 is covered, the sleeve can be locked. This locking can include locking any proximal movement of the sleeve relative to the housing 11.

[0160] Another form of needle retraction can occur if the needle 17 moves relative to the housing 11. This can occur if the syringe barrel within the housing 11 moves in the proximal direction relative to the housing 11. This proximal movement can be achieved by using a retraction spring (not shown) located in the distal region 20. The compressed retraction spring can provide sufficient force to the syringe barrel when activated to move it in the proximal direction. After sufficient retraction, any relative movement between the needle 17 and the housing 11 can be locked with a locking mechanism. Additionally, the button or other components of the device 10 can be locked as needed.

[0161] It should be understood that the above embodiments are purely illustrative and do not limit the scope of the claims. After reading this application, other changes and modifications will be obvious to those skilled in the art, and some changes and modifications will now be described.

[0162] The housing of the packaging assembly can be generally rectangular in shape, or it can be any other shape suitable for containing the plurality of syringes. The housing can be of a suitable shape and size for easy placement in a household freezer.

[0163] The housing can be formed to surround the syringe and can be sealed. Alternatively, the housing can be formed as a structure for externally supporting a plurality of injection devices. The syringes can be arranged in one or more rows (e.g., six in a row or three in two rows) or in a circular arrangement. The syringes can be arranged to hang below the support structure.

[0164] The housing can be configured to store any number of injection devices according to the dosage requirements of the medicament. For example, the housing can store 5 to 15 injection devices. The size of the housing can be designed to store a sufficient number of injection devices for a quarter or a 6-month period. In the case of more regular administration of the medicament, the housing can store a sufficient number of syringes for a week.

[0165] The housing can be formed of an opaque material. One or more components of the housing can be at least formed with transparent portions. The transparent portions of the housing can allow the user to view the number of injection devices or to view the user interface. One or more components of the housing can be translucent to improve the visibility of the visual reminder output.

[0166] The housing can be formed of a plastic material such as polyethylene, polystyrene, polycarbonate, etc., or it can be made of any other suitable material. Desirable properties of the housing material include temperature stability, medium impact strength, resistance to cleaning fluids, a wipe-clean finish, and rigidity.

[0167] Each part of the housing can be formed as a single piece, such as a molded plastic part. Alternatively, multiple parts can be machined. The body of the housing can be formed of two parts joined or attached together, or it can be formed as a single part. The interior of the housing can be formed as a single large cavity (a cavity divided into multiple regions for holding each syringe), or it can be formed as multiple cavities for holding each syringe individually.

[0168] The housing can include any number of magnets sufficient to support the weight of the packaging assembly and the injection devices. For example, the housing can include an arrangement of 2 larger magnets or 6 smaller magnets. The magnets can be any permanent magnets, or they can be rare earth magnets. The magnets can be formed of neodymium or they can be formed of samarium cobalt.

[0169] The housing may also include one or more ventilation holes to allow air to flow into the housing. Alternatively, when the lid is in the closed position, the housing may be sealed. The lid may also include a rubber seal to prevent air from entering the housing between the lid and the housing. If removed from the refrigerator for a short period of time, the housing may be insulated to maintain the low temperature of the syringe.

[0170] The lid may be hinged to the housing. The mechanism for connecting the lid to the housing and allowing the lid to open and close may take any suitable form. Instead of the above hinge mechanism, the hinge may be a butt hinge, a living hinge, or some other type. The lid may be connected to the housing with a flexible and / or elastic material. The hinge may allow some translational movement as well as pure rotational movement to allow better viewing or access to the interior portion of the housing when the lid is open.

[0171] The hinge may allow the user to remove the lid. For example, the protrusion of each second hinge portion may be pushed inward to disengage from the corresponding first hinge portion and separate the lid from the housing. One or more alternative lids that may be of different designs (e.g., different colors) may be provided to the user. The alternative lid may have a larger transparent portion or may be completely opaque.

[0172] Alternatively, the lid may be slidably engaged with the housing. The lid may include runners at the edges, each runner being configured to engage with a corresponding groove on the housing. The lid may slide out of the groove and separate from the housing. The lid may be arranged to slide to the limit of the groove and pivot freely in the open position. Further alternatively, the lid may be separated from the housing and fixedly attached thereto by a friction fit. The lid may fit tightly within the opening at the front end of the housing or may fit over the front portion of the housing.

[0173] The lid may include a latch to maintain the lid in the closed position. The latch may include a sliding catch arranged to slidably move between a first position and a second position. The catch may be arranged to protrude from the edge of the lid in the first position. The catch may be configured to retract slidably in the second position so as not to protrude. The latch may include a spring to push the catch to the first position. The catch may be configured to engage with an opening in the housing when the lid is in the closed position. The catch may engage with the opening to maintain the lid in the closed position.

[0174] The latch can be a spring-loaded push-to-grip push-to-release mechanism. The latch can be configured to engage to a closed position by a first push and maintain the lid in the closed position. The latch can be configured to disengage by a second push and allow the lid to open. The latch can be configured to engage when the lid is closed to hold the lid in the closed position. The latch can also include a release switch to disengage the latch and allow the lid to open. The release switch can be a mechanical switch or an electrical switch. The release switch can be an electrical switch coupled to a code input, the electrical switch being configured to disengage the lid gripper when the correct code is entered.

[0175] Although the lid open sensor is described as an electromechanical switch, it can alternatively be an optical sensor assembly, a magnetic sensor assembly, or any other suitable assembly configured to detect whether the lid is open or closed or whether the lid has transitioned from a closed position to an open position.

[0176] The packaging assembly can include a housing without a lid. The packaging assembly can not include a lid open sensor. The speaker can alternatively be deactivated by the processor assembly according to an alarm timer. The processor assembly can be configured to operate the alarm timer. The processor assembly can activate the alarm timer when the speaker is controlled to output an audio reminder alarm for a scheduled dosing time. The processor assembly can activate the alarm timer when the scheduled dosing time expires, provided that the refrigerator door is open. The processor assembly can deactivate the speaker when the alarm timer reaches 30 seconds. Alternatively, the processor assembly can activate the alarm timer at 20 seconds and count down until the timer expires. The processor assembly can be configured to deactivate the speaker when the alarm timer expires. The expiration period of the alarm timer can be from 5 seconds to 60 seconds.

[0177] The electronic system can include a syringe sensor to determine whether a syringe is positioned in one of the plurality of openings. The syringe sensor can determine whether a syringe is positioned within each opening. The processor assembly can be configured to deactivate the speaker when the syringe sensor indicates that the syringe has been removed from the opening.

[0178] The syringe sensor can include one or more syringe switches. The syringe switches can be respectively arranged within the openings. Each syringe switch can be a mechanical switch. The syringe switch can be a normally open switch, and the syringe pen presses the syringe switch to a closed position when in place within the opening. The syringe switch can be a membrane switch. The syringe switch can be actuated by a lever located within the opening.

[0179] Each syringe switch can be configured to send a signal to the processor assembly when the syringe is within the corresponding opening. The processor assembly can be configured to deactivate the speaker when no longer receiving a signal from the syringe switch. The processor assembly can be further configured to reset the countdown to the scheduled administration time when the syringe is removed from the opening. Alternatively, in the case of replacing the syringe within the housing after administering the medicament, the processor assembly can be configured to reset the countdown when the syringe is replaced. The processor assembly can be configured to monitor the number of syringes in place in the packaging assembly. The processor assembly can control the display to show the number of syringes in the packaging assembly. When the packaging assembly is empty, the processor assembly can control the electronic system to provide a notification output.

[0180] The retention mechanism can be disposed at the lower end of the housing. The retention mechanism can be arranged to engage the end of each syringe passing through the opening. The retention mechanism can include additional plural openings at the lower end of the housing. The additional openings can be sized to hold the syringe in place by friction fit. Alternatively, the retention mechanism can include a lever clamp assembly arranged to clamp the side of the syringe when the syringe is longitudinally pushed into the assembly and release the syringe when the syringe is longitudinally pulled out of the assembly.

[0181] The retention mechanism can include a release switch configured to disengage the retention mechanism. The release switch can be configured to release one or all of the syringes. Multiple release switches can be provided for the corresponding plural syringes. The release switch can be a mechanical switch or lever coupled to the retention mechanism. The release switch can be further coupled to an ejection mechanism. The release switch can be an electromechanical switch. The release switch can be controlled by the processor assembly. The processor assembly can control the release switch to disengage the retention mechanism if the scheduled administration time has expired. When the scheduled administration time has expired, the processor assembly can control the release switch to disengage the retention mechanism for one syringe. The retention mechanism can be controlled to release one syringe that is partially ejected from the opening by the ejection mechanism. Such an assembly can provide a visual reminder alert in the form of a portion of the syringe being ejected from the opening.

[0182] The strap of the ejection mechanism can be formed of any suitable flexible material. For example, the strap can be made of fabric, rubber, silicone, or any other suitable material. The loop at the second end of the strap can be made of plastic or, alternatively, metal, rubber, wood, or any other suitable material. The loop can be attached to or integrated with the strap.

[0183] The ejection mechanism can include a motorized actuator. For example, a roller arranged perpendicular to the plurality of syringes can be driven to eject the syringes out of the opening. The roller can push all the syringes equally, where the retention mechanism is configured to hold all but one of the syringes in place. Further alternatively, the actuator can include a portion protruding from the rear of the housing, and the protruding portion is driven laterally across the width of the housing. The protruding portion can be driven along a track or can protrude from a conveyor belt extending along the width of the housing. The protruding portion is configured to engage each syringe in sequence and eject the syringe out of the opening.

[0184] The time period for reminder can be any suitable dosing time period, depending on the medicament stored in the packaging assembly. The set time period until the next scheduled dosing time can be any number of days, which can be, for example, between 2 and 60 days. The time period can be several weeks, such as a time period of 7 days, 14 days, 21 days or 28 days. The time period can be 28 days, i.e., 4 weeks, or the time period can be 1 month.

[0185] Alternatively, the time period can be 1 day or 2 days, and the display can be configured to show the number of hours until the scheduled dosing time expires. Similarly, for a time period of approximately several hours, the display can show the number of minutes.

[0186] The timer duration switch can be configured to select between any two time periods. For example, the first switch position can correspond to a 7-day time period, and the second switch position can correspond to a 14-day time period. Alternatively, the timer duration switch can be a multi-position switch, such as a rotary switch or a dial. The time period can be set in combination with the display, where a first user input causes the display to show the current time period, and a second input is used to adjust the time period.

[0187] The reset timer can act on any suitable time frame. For example, the reset button can be configured to reset the countdown timer if pressed for 1 second or up to 5 seconds.

[0188] The display can include more than 2 LED arrays to accommodate larger numbers and messages, or can be just a single LED array. Alternatively, the display can include any form of electronic display suitable for displaying numbers and / or messages. For example, the display can be an LED pixel array, an LCD or an electronic paper screen, or a flip card display. The display can be arranged in a peripheral module separated from the housing. The display module can be connected to the electronic system by a wired or wireless connection. The electronic system can include any display driver suitable for the selected display.

[0189] The display can be configured to provide further status information or more details in the form of a text message on the display. For example, by showing a reminder message in addition to or instead of the flashing digits 00, the display can provide a visual reminder that the scheduled administration time has expired. The output of the digits 00 is an example of a reminder message. The display can be controlled to show the number of syringes remaining in the packaging assembly. The processor assembly can be configured to determine the number of syringes based on an input from a syringe sensor. Alternatively, the processor assembly can be configured to monitor the number of times the scheduled administration time has passed. When the packaging assembly is empty, the display can be controlled to show a notification message.

[0190] The processor assembly can be configured to deactivate the display of the user interface if the lid of the housing is closed. The processor assembly can activate an LED based on a refrigerator open sensor to indicate to the user that the status of the packaging assembly is normal when the number of remaining days is greater than one, regardless of whether the lid is closed. If desired, the user can open the lid to activate the display and show the number of days. When the scheduled administration time expires, the processor assembly can activate both the LED and the display to flash to provide a visual reminder, regardless of whether the lid is open.

[0191] More than one LED can be included in the user interface to indicate the status of the packaging assembly in more detail. For example, a status LED with a first color can be activated when the number of days to the scheduled administration time is greater than one; the status LED can flash when the number of remaining days is one; and a second LED with a second color can be activated when the scheduled administration time expires. Alternatively, a single two-color LED can be used. Alternatively, any other form of notification light or visual output transducer can be used instead of the LED.

[0192] A plurality of LEDs corresponding to the plurality of openings can be provided in the packaging assembly of any embodiment. The LEDs can be controlled as described with respect to the fourth embodiment. Alternatively, the processor assembly can cause one of the plurality of LEDs to flash or blink while the remaining LEDs are off or continuously illuminated. Different LEDs can be controlled to flash each time to guide the user to the next syringe for use. One LED can blink in different colors. The processor assembly can control the plurality of LEDs based on the number of injection devices remaining in the packaging assembly.

[0193] The speaker can be any suitable form of audio output transducer, such as an electroacoustic transducer, a piezoelectric buzzer, a moving diaphragm speaker, or a mechanical bell. Instead of or in addition to the audio output transducer, a vibration alarm can be used.

[0194] The refrigerator door open sensor may include a phototransistor, or alternatively, a photoresistor or a photodiode. Alternatively, the refrigerator door open sensor may include a mechanical switch. The refrigerator door open sensor may be located outside the housing and may be positioned at the hinge or the frame of the refrigerator door. The refrigerator door open sensor may be a mechanical switch arranged to be pressed by the refrigerator door in the closed position.

[0195] An open door timer may be operable such that, for example, if the refrigerator door is open for 10 minutes or 15 minutes, the user interface may enter a partial sleep mode.

[0196] Alternative implementations of the countdown timer include off-chip and on-chip state-based logic circuits having clock means, and other forms will be apparent to the person skilled in the art.

[0197] The PCB and the components of the electronic system may be sealed for protection. For example, the PCB may be coated on each side with a waterproof paint or another suitable coating. The electronic system may be coated to prevent moisture or humidity inside the household refrigerator.

[0198] Depending on the power requirements of the electronic system, the packaging assembly may include a greater or lesser number of batteries. For example, the packaging assembly may include a single battery power pack. The (multiple) batteries may be removable and replaceable, or may be fixed within the housing of the packaging assembly. Alternatively, the packaging assembly may be adapted for mains power or any alternative power source.

[0199] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical preparation that contains one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof and optionally a pharmaceutically acceptable carrier. The term active pharmaceutical ingredient ("API") in its broadest sense is a chemical structure that has a biological effect on a human or an animal. In pharmacology, a drug or a medicament is used to treat, cure, prevent or diagnose a disease or to otherwise enhance physical or mental health. A drug or a medicament may be used for a limited duration or regularly for a chronic disorder.

[0200] As described below, a drug or medicament may include at least one API or a combination thereof in various types of formulations for treating one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, i.e., double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0201] The term "drug delivery device" shall cover any type of device or system that is configured to dispense a drug or medicament into the human or animal body. Non-limiting examples of drug delivery devices can be injection devices (e.g., syringes, pen injectors, autoinjectors, or other devices configured for intravitreal, subcutaneous, intramuscular, or intravascular delivery), skin patches (e.g., permeation, chemical, microneedle), inhalers (e.g., nasal or pulmonary). The drugs described herein may be particularly useful for injection devices that include needles (e.g., subcutaneous injection needles, e.g., having a gauge number of 24 or higher).

[0202] A drug or medicament can be included in a primary packaging or "drug container" suitable for use with a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel that is configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber can be designed to store the drug for about 1 month to about 2 years. Storage can be carried out at room temperature (e.g., about 20 °C) or refrigerated temperature (e.g., from about -4 °C to about 4 °C). In some cases, the drug container can be or can include a dual-chamber cartridge that is configured to separately store two or more components of a drug formulation to be administered (e.g., an API and a diluent, or two different drugs), with one component stored in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components before and / or during dispensing into the human or animal body. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., via a conduit between the two chambers) and allow the user to mix the two components when needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing when the components are being dispensed into the human or animal body.

[0203] The drugs or medicaments contained in a drug delivery device as described herein can be used for treating and / or preventing many different types of medical disorders. Examples of disorders include, for example, diabetes or diabetes-related complications such as diabetic retinopathy, thromboembolic disorders such as deep vein or pulmonary thromboembolism. Further examples of diseases are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following compendia: such as Rote Liste 2014 (e.g., but not limited to, main group 12 (antidiabetic drugs) or 86 (oncological drugs)) and Merck Index, 15th Edition.

[0204] Examples of APIs for treating and / or preventing type 1 or type 2 diabetes or diabetes-related complications of type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or their analogs or derivatives; dipeptidyl peptidase-4 (DPP4) inhibitors, or their pharmaceutically acceptable salts or solvates; or any mixture thereof. As used herein, the terms “analog” and “derivative” refer to any substance that is structurally similar enough to the original substance to have substantially similar functions or activities (e.g., therapeutic efficacy). In particular, the term “analog” refers to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues can be encoded amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. In particular, the term “derivative” refers to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, e.g., the structure of human insulin, where one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may have been deleted and / or replaced by other amino acids (including non-encoded amino acids), or amino acids (including non-encoded amino acids) have been added to the naturally occurring peptide.

[0205] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0206] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, ); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (insulin degludec, ); B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0207] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are, for example, lixisenatide exenatide (Exendin-4, a 39-amino acid peptide produced by the salivary gland of the Gila monster), liraglutide semaglutide, taspoglutide, albiglutide dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C, CM-3, GLP-1 Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Exenatide-XTEN, and Glucagon-Xten.

[0208] Examples of oligonucleotides are, for example, mipomersen sodium It is a cholesterol-reducing antisense therapeutic agent for the treatment of familial hypercholesterolemia.

[0209] Examples of DPP4 inhibitors are vildagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0210] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, gonadotropic hormone), somatropine (growth hormone), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0211] Examples of polysaccharides include glucosaminoglycane, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., the polysulfated forms of the above polysaccharides), and / or their pharmaceutically acceptable salts. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 It is a sodium hyaluronate.

[0212] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized antibodies or humanized antibodies, fully human antibodies, non-human (e.g., murine) antibodies, or single-chain antibodies. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has a reduced or no ability to bind to Fc receptors. For example, the antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., it has a mutagenized or deleted Fc receptor-binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable domain antibody-like binding proteins with cross-over binding domain orientation (CODV).

[0213] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not contain the full-length antibody polypeptide but still contains at least a portion of the full-length antibody polypeptide capable of binding antigen. Antibody fragments can include cleaved portions of the full-length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (such as bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies)), monovalent or multivalent antibody fragments (such as divalent, trivalent, tetravalent, and multivalent antibodies), minibodies, chelating recombinant antibodies, triabodies or diabodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and antibodies containing VHHs. Additional examples of antigen-binding antibody fragments are known in the art.

[0214] The term "complementary determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both the heavy chain polypeptide and the light chain polypeptide that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to the amino acid sequences within the variable regions of both the heavy chain polypeptide and the light chain polypeptide that are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequences to allow antigen binding. Although the framework regions themselves generally do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDRs to interact with the antigen.

[0215] Examples of antibodies are anti-PCSK-9 mAb (e.g., Alirocumab), anti-IL-6 mAb (e.g., Sarilumab), and anti-IL-4 mAb (e.g., Dupilumab).

[0216] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or agent in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0217] Those skilled in the art will understand that various components of the APIs, formulations, devices, methods, systems, and embodiments described herein can be modified (added and / or removed) without departing from the full scope and spirit of the invention, and the invention encompasses such modifications and any and all equivalents thereof.

Claims

1. A packaging assembly, which comprises: a housing configured to at least partially contain a plurality of injection devices for delivering a medicament, the housing being formed as a box having at least one open end face, wherein the housing is configured to contain the plurality of injection devices in such an arrangement that each injection device is placed parallel to the open end face of the housing; a lid coupled to the housing and movable between an open position and a closed position, wherein the lid includes a dispensing slot configured to contain one injection device; and a spring ejector configured to push the plurality of injection devices towards the open end face of the housing, wherein the spring ejector is configured to push the plurality of injection devices towards the lid such that when the lid moves from the closed position to the open position, one of the plurality of injection devices is contained in the dispensing slot.

2. The packaging assembly according to claim 1, further comprising a handle portion having an upper side and a lower side and arranged to project from the lid such that pressure applied to the upper side when the lid is in the closed position causes the lid to move to the open position, and pressure applied to the lower side when the lid is in the open position causes the lid to move to the closed position.

3. The packaging assembly according to claim 2, wherein the handle portion is formed to extend longitudinally along the lid parallel to a boundary formed between a first portion of the lid and a second portion of the lid, the first portion extending above the open end face of the housing and the second portion partially extending above another face of the housing.

4. The packaging assembly according to claim 1, wherein the lid is arranged in the closed position to extend above the open end face of the housing and at least partially above another face adjacent to the open end face, and wherein the lid is configured to be hinged on the another face adjacent to the open end face at an edge of the lid furthest from the open end face of the housing.

5. The packaging assembly according to claim 1 or 2, further comprising the plurality of injection devices.

6. The packaging assembly according to claim 5, wherein each of the plurality of injection devices includes an annular element formed at one end of the injection device, and the housing is configured to contain the plurality of injection devices in such an arrangement that the annular element of each injection device is adjacent to the open end face of the housing.

7. A packaging assembly, which comprises: a housing configured to at least partially contain a plurality of injection devices for delivering a medicament, the housing being formed as a box having at least one opening; and a tray configured to contain all of the plurality of injection devices and arranged to slide out of the housing through the opening, wherein the tray is configured to contain the plurality of injection devices in such an arrangement that each injection device is placed perpendicular to the direction along which the tray is configured to slide. wherein a side panel of the tray includes at least one opening for ejecting one or more of the injection devices from the tray, and wherein the tray is formed to have at least one inclined portion, the at least one inclined portion being arranged to eject one or more of the injection devices from the tray when pushed through the at least one opening in the side panel.

8. The packaging assembly according to claim 7, wherein the tray is configured to hinge about an edge of the tray adjacent to the housing when fully pulled out of the housing.

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