Long-term drug storage device and method

Abstract

An apparatus for storing a drug delivery device, the apparatus comprising: a container defining a storage cavity having an opening, the storage cavity configured to accommodate a syringe pre-filled with a drug; an absorbent disposed within the cavity, the absorbent being at least partially hydrated with a liquid solution; and a sealing member at least selectively connected to the cavity to form a seal that is at least substantially gas-impermeable.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 63 / 090,500, filed October 12, 2020, the entire contents of which are expressly incorporated herein by reference.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to medication storage devices, and more particularly to long-term humidity-controlled medication storage devices and related methods. [Background technology]

[0003] Pre-filled medication treatments can be used for home use because the treatment is prepared with the required dosage for a single use of the medication. For example, some pre-filled medication treatments may include pre-filled hypodermic syringes or auto-injector products. These pre-filled medication treatments are designed to be easily used by patients.

[0004] Such pre-filled drug products can often be stored for extended periods of time, sometimes for more than two years. Although the pre-filled drug products include various shields and seals both on the back of the primary container and at the open needle tip, in certain circumstances the drug can sometimes dry out and clog the needle of the pre-filled drug product. A clogged needle can make it more difficult to use the pre-filled drug product. Summary of the Invention [Means for solving the problem]

[0005] Disclosed herein is an apparatus for long-term storage of a medication delivery device. The apparatus includes a container defining a storage cavity having an opening, the storage cavity configured to receive a syringe prefilled with a medication. Additionally, the container includes an absorbent disposed within the cavity, the absorbent being at least partially hydrated with a liquid solution. The apparatus further includes a seal member at least selectively connected to the cavity to form an at least substantially gas-tight seal.

[0006] Additionally, a method of packaging a medication delivery device for storage is disclosed herein. The method includes providing a container having a cavity and an opening and disposing a syringe prefilled with a medication within the cavity of the container. Additionally, the method includes disposing an absorbent within the cavity of the container, the absorbent being at least partially hydrated. The method further describes sealing the cavity of the container with a seal member by at least selectively connecting the seal member to the cavity to form a seal that is substantially at least gas impermeable.

[0007] Additionally, disclosed herein is an apparatus for storing drug delivery devices. The apparatus includes a rigid storage container configured to accommodate at least one pre-filled drug delivery device or at least one container containing a pre-filled drug delivery device. The apparatus also includes an absorbent carrier disposed within the rigid storage container, the absorbent carrier including an absorbent at least partially hydrated with a liquid solution.

[0008] The present disclosure will be more fully understood when the following description is taken in conjunction with the accompanying drawings. Some of the drawings may be simplified by selectively omitting elements to more clearly show other elements. The omission of such elements in some of the drawings does not necessarily represent the presence or absence of the particular element in any of the illustrative embodiments, unless expressly described in the corresponding written description. Additionally, none of the drawings are necessarily drawn to scale. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a side view of a pre-filled hypodermic syringe including a needle shield. [Figure 2] 2 is a perspective view of a container for storing a drug delivery device according to the present disclosure, such as the pre-filled hypodermic needle of FIG. 1. [Figure 3] 3 is a perspective view of a container for storing the medication delivery device of FIG. 2, further comprising a gas-permeable sealing member disposed over the first sub-cavity. [Figure 4] 4 is a perspective view of a container for storing the medication delivery device of FIG. 3, further including a member disposed on the container. [Figure 5] FIG. 10 is a perspective view of an alternative apparatus for storing a medication delivery device according to the present disclosure. [Figure 6] 1 is an exemplary graph of relative humidity within an enclosed container based on hydration time for an absorbent. [Figure 7] 1 is an exemplary graph of relative humidity within an enclosed container based on hydration of an absorbent with water and alcohol solutions. [Figure 8a] FIG. 1 is a perspective view of a rigid storage container according to the present disclosure. [Figure 8b] 8b is an additional view of a graphic display disposed on the rigid storage container of FIG. 8a. [Figure 8c] 8b is an additional view of a graphic display disposed on the rigid storage container of FIG. 8a. [Figure 8d] 8b is a fingerprint lock interface disposed on the rigid storage container of FIG. 8a. [Figure 9] 8b is a perspective view of the rigid storage container of FIG. 8a in an open state for storing at least one container for storing a medication delivery device; FIG. [Figure 10] 1 is a perspective view of a container for storing one container having a medication delivery device according to the present disclosure. FIG. [Figure 11a] FIG. 1 is a perspective view of a rigid travel container in an open position for storing at least one medication delivery device according to the present disclosure. [Figure 11b] FIG. 1 is a perspective view of a rigid travel container in a closed state for storing at least one medication delivery device. DETAILED DESCRIPTION OF THE INVENTION

[0010] Those skilled in the art will understand that elements in the figures are drawn for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions and / or relative positions of some of the elements in the figures may be exaggerated relative to other elements to improve understanding of various embodiments of the present invention. Also, common but well-understood elements that are useful or necessary in commercially feasible embodiments are often not shown in order to unduly distract from the illustrations of these various embodiments. Furthermore, it will be appreciated that certain acts and / or steps may be described or shown in a particular chronological order, although those skilled in the art will understand that such specificity with respect to order is not actually required. It will also be understood that the terms and phrases used herein have the ordinary technical meaning, as set forth above, that would be ascribed to such terms and phrases by those skilled in the art, unless a different specific meaning is explained herein.

[0011] For example, pre-filled drug delivery devices are provided to patients for personal administration at home. Pre-filled drug delivery devices can dry out and clog, even when stored under ideal conditions. If the drug in the pre-filled drug delivery device dries out or clogs, it can be difficult or painful to administer the drug in the pre-filled drug delivery device.

[0012] The apparatus for storing the drug delivery device of the present disclosure prevents the drug from drying out during long-term storage. For example, the apparatus may include an absorbent designed to maintain a high relative humidity within an enclosed container. The absorbent is any material that can be hydrated, retain moisture, and release moisture to maintain a moist environment within the enclosed area. In addition, the absorbent can be optimally designed based on the size of the container, the desired relative humidity level, the length of storage, etc.

[0013] Additionally, the apparatus and method of using the apparatus may include sterilizing the apparatus for storing the drug delivery device, including the container, the drug delivery device, and the absorbent. For example, the apparatus can be sterilized using a sterilant such as a vapor pressure hydrogen peroxide (VPHP, also called hydrogen peroxide vapor (VHP)) process and / or the absorbent can be hydrated in a water sterilant solution such as ethanol, isopropanol, or benzyl alcohol solution. As a result, when a patient opens the apparatus for storing the drug delivery device to self-administer the drug, the apparatus for storing the drug delivery device can be sterile and safe for personal use.

[0014] FIG. 1 is a side view of a pre-filled hypodermic syringe 100 including a needle shield 102. The pre-filled hypodermic syringe 100 includes a reservoir 110 in fluid communication with a needle 112. The needle shield 102 covers the needle 112 and protects it from the external environment. The sealed reservoir 110 is filled with a dose of medication 116. The reservoir 110 is filled with a predetermined amount of medication 116 suitable for convenient personal use by a patient, for example. As shown in FIG. 1, the pre-filled hypodermic syringe 100 and needle shield 102 are transparent; however, in other embodiments, the pre-filled hypodermic syringe 100 and / or needle shield 102 are opaque.

[0015] The needle 112 is in fluid communication with the container 110 and the external environment. The needle 112 is disposed within a needle shield 102. The needle shield 102 may be constructed of plastic, rubber, silicone, or a similar material that can protect the needle 112 during shipping and storage and cover the needle 112 from the ambient environment to ensure that the needle 112 is sterile. In some embodiments, the needle shield 102 can be a non-porous material to completely seal the needle 112 from the ambient environment, or the needle shield 102 can be a porous material that partially seals the needle 112 from the ambient environment because the needle shield 102 is gas permeable.

[0016] The medication 116 may be prone to drying out and may be more difficult to use. For example, the needle shield 102 is sufficiently porous to allow moisture from the medication to evaporate. As a result, any medication 116 that may be present in the needle 112 may at least partially solidify, potentially partially or completely clogging the needle. When the needle becomes partially clogged in a hypodermic syringe, actuating the syringe plunger may be difficult and painful. For example, if more than about 40 Newtons (N) of force is required to actuate the plunger, the syringe plunger may be difficult to use.

[0017] Similarly, medication 116 may be stored and dried within an autoinjector product, such as an autoinjector cartridge. As a result, medication 116 may still dry out and clog the needle supported by the autoinjector cartridge. Thus, the needle of the autoinjector may become partially or completely clogged. If the needle becomes partially or completely clogged, the autoinjector may provide an error message when initiating medication delivery that the force required to deliver the medication 116 exceeded a preset threshold. For example, the autoinjector may be designed to deliver a force of 20 to 120 Newtons (N).

[0018] Figure 2 illustrates one embodiment of a medication storage device 200. Figure 2 provides a perspective view of the device 200 including a container 202 for storing a medication delivery device 204, such as the pre-filled hypodermic needle 100 of Figure 1. As shown in Figure 2, the device additionally includes an absorbent material 206 within the container 202. The container 202 provides long-term protection and storage for the medication delivery device 204.

[0019] Container 202 includes a container rim 208 that surrounds opening 210 and a storage cavity 212. Storage cavity 212 is configured to accommodate a medication delivery device 204, such as a syringe 214 that is pre-filled with a medication. Syringe 214 additionally includes a needle shield 216 and a syringe plunger 218, similar to pre-filled hypodermic syringe 100 of FIG. 1. As shown in FIG. 2, container 202 is transparent; however, container 202 may also be translucent, opaque, or opaque. For long-term storage, container 202 is preferably made of a rigid, gas-impermeable material, such as plastic, to seal the environment within container 202 and protect syringe 214 from damage during shipping and storage.

[0020] The absorbent 206 is also disposed within the storage cavity 212 of the container 202. The absorbent 206 is at least partially hydrated with a liquid solution, such as an aqueous solution. Alternatively, the liquid solution may be a water and alcohol solution to maintain the sterility of the container 202 during long-term storage. The absorbent 206 may be a humidification pouch, a moisturizing bag, a sponge, a fabric article, a liquid gel, or a similar liquid-absorbing material that also allows the liquid to evaporate over time. Depending on the desired humidity within the container 202 and the material of the absorbent 206, the absorbent may be immersed in the liquid solution for a predetermined period of time (e.g., 1 second, 5 seconds, 10 seconds, 20 seconds, etc.). Alternatively, the absorbent may be provided with a specific volume of the liquid solution (e.g., 0.5 milliliters (mL), 1 mL, 2 mL, 5 mL) or a specific weight of the liquid solution (e.g., 0.5 grams (g), 1 g, 2 g, 5 g). Furthermore, in some embodiments, the absorbent may be provided with a liquid solution proportional to the dry weight of the absorbent (e.g., 50 percent (%), 100%, 150% dry weight of the liquid solution). Accordingly, any method of measuring the amount of liquid absorbed by the absorbent may be considered within the scope of the present disclosure.

[0021] The storage cavity 212 and its contents, including the absorbent 206 and the syringe 214, are sterile. The storage cavity 212 may additionally undergo a sterilization process prior to and / or after disposing the syringe 214 and absorbent 206 within the container 202. Sterilizing the storage cavity 212 and the syringe 214 may include exposing the storage cavity 212 and the syringe 214 to a sterilant. For example, the container and its contents may undergo a vaporized hydrogen peroxide (VPHP) sterilization process, although other medical storage sterilization methods are considered within the scope of the present disclosure.

[0022] The storage cavity 212 of the container 202 is divided into a first sub-cavity 220 and a second sub-cavity 222 separated by a container wall 224, with the first sub-cavity 220 housing the syringe 214 and the second sub-cavity 222 housing the absorbent 206. In other embodiments, the storage cavity 212 can include additional container walls to divide the storage cavity 212 into two or more sub-cavities. While the absorbent 206 is shown in the second sub-cavity 222, the absorbent can be disposed in the first sub-cavity 220 along with the syringe 214. The first sub-cavity includes a first retainer 226 and a second retainer 228 for housing the syringe 214. The first retainer 226 and the second retainer 228 can additionally secure the syringe 214 and prevent or reduce movement of the syringe 214 within the first sub-cavity 220.

[0023] 3 is a perspective view of the container 202 for storing the medication delivery device 204 of FIG. 2 , further including a gas-permeable seal member 302 disposed over the first sub-cavity 220. Gases and vapors can pass through the gas-permeable seal member 302. However, the gas-permeable seal member 302 prevents larger particles and materials, including bacteria and fungal spores, from passing into or out of the first sub-cavity 220. The gas-permeable seal member 302 can include any of a variety of gas-permeable seal members known in the art of sterile medical packaging.

[0024] 3 , gas-permeable seal member 302 is positioned on container 202 over at least a portion of opening 210 and encloses at least a portion of first sub-cavity 220, which houses syringe 214. Gas-permeable seal member 302 allows the passage of gases and vapors, but protects syringe 214 from bacteria, mold, and other particulate matter. Thus, gas-permeable seal member 302 maintains the sterility of syringe 214 for long-term storage. In some embodiments, gas-permeable seal member 302 can additionally cover second sub-cavity 222.

[0025] 3, the absorbent 206 is disposed in the second sub-cavity 222 outside the gas-permeable seal member 302. Even though the first sub-cavity 220 is covered by the gas-permeable seal member 302, moisture evaporated from the absorbent 206 can fill the entire container. Because the gas-permeable seal member is permeable to water vapor, moisture from the absorbent 206 fills the entire cavity, including the first sub-cavity 220.

[0026] 2 and 3 , further comprising a package 402 and a sealing member 404 disposed on the container 202, which in some variations may be a gas-impermeable member. The package 402 including the container 202 is configured for long-term storage, sometimes greater than two years. Additionally, the package 402 may include instructions for use 410 or other information useful to the end user or patient.

[0027] Seal member 404 is positioned adjacent container 202 and over opening 210, enclosing the entire storage cavity 212. Gas-permeable seal member 302 is therefore between seal member 404 and container 202. Seal member 404 forms a gas-impermeable seal between seal member 404 and container 202. As a result, container 202 is in an enclosed environment, and the sterility of container 202 is maintained as long as the seal is maintained.

[0028] The absorbent 206 is hydrated and placed in the second sub-cavity 222 before the seal member 404 is placed on the container. The absorbent 206 releases moisture to maintain a desired humidity level within the sealed container 202. As a result, if the container is maintained at a high relative humidity, the drug in the drug delivery device 204 will not dry out or clog. The absorbent 206 placed in the second sub-cavity maintains a high relative humidity (e.g., greater than 60%) throughout the container 202. For example, the relative humidity can be maintained at above 75% for an extended period of time (e.g., one month, six months, one year, three years). Thus, the absorbent 206 releasing and maintaining humidity in the container can prevent clogging of the drug delivery device 204 for months or years.

[0029] Figure 5 shows an additional embodiment of a medication storage apparatus. Figure 5 provides a perspective view of an alternative apparatus 500 for storing a medication delivery device 204. In contrast to the apparatus 200 of Figures 2, 3, and 4, the apparatus 500 of Figure 5 includes a container 510 disposed within a sealed gas-impermeable bag 512. The gas-impermeable seal is the sealed gas-impermeable bag 512 within which the container 510, syringe 514, and absorbent material 516 are disposed.

[0030] The container 510 is made of a rigid material that can protect the medication delivery device 204, such as the syringe 514, during storage and transportation. Additionally, the container 510 includes a first retainer 520 and a second retainer 522. The first retainer 520 and the second retainer 522 accommodate the syringe 514 and, in some embodiments, secure it against movement within the container 510. Additionally, the container 510 can include a sealing member 534, which can be either gas permeable or gas impermeable. As a result, the absorbent 516 can maintain the humidity of the gas impermeable bag 512 or simply the container 510.

[0031] Additionally, the container is placed within a gas-tight bag 512. The gas-tight bag 512 is sealed to maintain a sterile environment, including the container 510. While the container 510 is placed within the gas-tight bag 512, the gas-tight bag 512 may undergo a sterilization procedure (e.g., a VPHP process). After being sealed, the gas-tight bag 512 must be cut or torn open to remove the container 510. In some preferred embodiments, the gas-tight bag 512 is designed to be cut for arthritic patients who may not prefer to tear open the gas-tight bag 512.

[0032] 5, the absorbent 516 is positioned near the needle shield 530 of the syringe 514, but can be positioned anywhere within the container 510. The absorbent 516 positioned within the container 510 maintains a high relative humidity (e.g., a relative humidity of greater than 60%) throughout the container 510. Thus, the absorbent 516 positioned within the container 510 can prevent clogging of a drug delivery device, such as the syringe 514.

[0033] 6 is an exemplary graph 600 of relative humidity within an enclosed container based on hydration time for an absorbent. The horizontal axis relates to time from 0 hours to 625 hours (approximately 26 days). Additionally, the vertical axis relates to 40% to 100% relative humidity measurements within the enclosed container. Graph 600 includes a first data set 610, a second data set 620, and a third data set 630 measuring relative humidity within the enclosed container over time.

[0034] As shown in Figure 6, a first data set 610 corresponds to the relative humidity of the absorbent hydrated over a 5-second period. The first data set 610 shows humidity fluctuating between 70% and 80%. In contrast, a second data set 620 (corresponding to 10 seconds of hydration) and a third data set 630 (corresponding to 15 seconds of hydration) both maintain the container at a relative humidity of 95% to 100%. Thus, the hydration time can be used to control the relative humidity within the container over time.

[0035] Although each data set in graph 600 is measured in hydration time, the data sets may be measured in weight, volume, or other measurements of the stored liquid. For example, for some absorbents, 5 seconds of hydration (corresponding to first data set 610) may equate to approximately 6 grams (g) of water or approximately 6 milliliters (mL) of water, while 15 seconds of hydration (corresponding to third data set 630) may equate to approximately 9 g of water or 9 mL of water. Additionally, 10 minutes of hydration may only absorb 16 g (or 16 mL) of water. Other absorbents may absorb water weight or volume more quickly or more slowly.

[0036] The absorbent may be hydrated for a predetermined period of time based on design considerations, including the size of the container, the desired relative humidity, and the permeability of the needle shield covering the needle. Typically, the absorbent is hydrated for a period of about 5 seconds to about 10 seconds to maintain a relative humidity of 75% to 95%. As shown by the first data set 610, the absorbent maintained a relative humidity of 70% to 80% for the duration of the experiment. Therefore, a longer hydration time results in a higher relative humidity being maintained within the container.

[0037] Absorbents of different designs may require more or less hydration time to maintain the same relative humidity. Additionally, an absorbent placed in a larger container may require more hydration agent than a similar absorbent placed in a smaller container. Furthermore, if the drug delivery device includes a non-porous needle shield, the relative humidity does not need to be as high as if the needle shield were more porous, because the non-porous needle shield prevents the drug from drying out. Each of the above factors can be considered when designing the apparatus of the present disclosure.

[0038] 7 is an exemplary graph 700 of relative humidity within an enclosed container based on hydration of an absorbent with water and an alcohol solution (i.e., ethanol alcohol). The horizontal axis relates to the time from 0 hours to 520 hours (approximately 21 days) over which the relative humidity within the container is measured. Additionally, the vertical axis relates to 40% to 100% relative humidity of the relative humidity measurements within the enclosed container. The absorbent can be hydrated with water or other liquid solutions besides water and ethanol alcohol, such as benzyl alcohol or other sterilants.

[0039] As shown in Figure 7, the absorbent is hydrated in an ethanol-water solution (EtOH) for 15 seconds. Ethanol is often used in antimicrobial applications and can be added to the hydration solution to further maintain a sterile environment for the container during long-term storage. Similar chemicals, such as isopropanol or benzyl alcohol solutions, can be added to the hydration solution to maintain a desired relative humidity and sterile environment within the container. The percentage of ethanol in the ethanol-water solution appears to have minimal effect on the relative humidity maintained within the container.

[0040] As shown in FIG. 7 , a first data set 710 corresponds to an absorbent immersed in a 20% EtOH solution for 15 seconds. A second data set 720 corresponds to an absorbent immersed in a 50% EtOH solution for 15 seconds. And a third data set 730 corresponds to an absorbent immersed in a 70% EtOH solution for 15 seconds. As shown in FIG. 7 , each of the first data set 710, the second data set 720, and the third data set 730 indicates that the humidity within the container is maintained at greater than 95%. Thus, graph 700 indicates that the percentage of ethanol in the EtOH solution has little effect on the humidity maintained within the container.

[0041] Although each data set in graph 700 is measured in hydration time, the data sets may be measured in weight, volume, or other measurements of stored liquid. For example, for some absorbents, 15 seconds of hydration may be equivalent to about 1.5 grams (g) of EtOH, or about 1.6 milliliters (mL) of EtOH solution. Similarly, 10 minutes of hydration may only be equivalent to about 2 g of EtOH, or 2.2 mL of EtOH. Other absorbents may absorb water weight or volume more quickly or slowly.

[0042] 8a is a perspective view of a rigid storage container 800 manufactured in accordance with the present disclosure. The rigid storage container 800 is a container made of a rigid material and includes a storage cavity. The rigid container 800 includes a bottom 802 and a top 804. Both the bottom 802 and the top 804 completely enclose the rigid storage container 800. The rigid storage container 800 may be made of a rigid plastic, metal, or similar material capable of supporting the weight of the rigid storage container 800 and protecting the contents of the rigid storage container 800. In some embodiments, the rigid storage container 800 may additionally include a handle to make it easier to carry the rigid storage container 800.

[0043] Rigid storage container 800 is preferably designed with a sleek, slim, space-saving design so that it minimizes the amount of space it uses in the patient's refrigerator. Additionally, the outer casing of rigid storage container 800 is made of durable plastic or stainless steel, which may have antibacterial properties. Other materials are possible. The casing may also be double-walled to improve the insulating properties of rigid storage container 800. However, in the event of a power outage or for extended storage outside of a refrigerator, rigid storage container 800 may include a coolant- or alcohol-filled compartment (not shown). The coolant- or alcohol-filled compartment passively cools rigid storage container 800 via the coolant- or alcohol-filled compartment. Thus, if the temperature within the rigid storage container rises above a preset threshold, rigid storage container 800 may be cooled for a short duration. Alternatively, rigid storage container 800 may include a battery-powered device that includes the coolant- or alcohol-filled compartment to enable battery-powered cooling of rigid storage container 800.

[0044] Rigid storage container 800 includes a locking mechanism 806 and a graphic display 808. Both locking mechanism 806 and graphic display 808 are powered by a battery (not shown) housed within rigid storage container 800. In other embodiments, rigid storage container 800 may be powered via an alternative power source, including being plugged into an electrical outlet or having a photovoltaic cell in addition to a battery. As shown in FIG. 8 a, locking mechanism 806 and graphic display 808 are located on a sidewall of bottom 802. In other embodiments, locking mechanism 806 and / or graphic display 808 are located on top 804 or elsewhere on bottom 802. Graphic display 808 displays a temperature value corresponding to the temperature inside rigid storage container 800, as shown. Alternatively, graphic display 808 can display a humidity value corresponding to the relative humidity inside rigid storage container 800. As such, container 800 may include a temperature sensor and / or humidity sensor (not shown) disposed inside the container and communicatively coupled to graphic display 808. Other sensors may also be included.

[0045] FIG. 8b is an additional view of a graphic display 808 disposed on the rigid storage container 800 of FIG. 8a. The graphic display 808 includes a first display 810. As shown in FIG. 8b, the first display 810 additionally includes a graphic indicating the temperature within the rigid storage container 800 of FIG. 8a. The exemplary first display 810 indicates that the internal temperature of the rigid storage container 800 is currently 44 degrees Fahrenheit (°F). The graphic display 808 additionally includes a color indicator 812. The color indicator 812 corresponds to the information provided on the first display 810. For example, the color indicator 812 may display a color indicating good health, such as green, to indicate that the temperature is within the appropriate or target temperature range. Additionally, the graphic display 808 includes a display toggle 814. The display toggle 814 may be pressed to activate the graphic display 808 or to alternate between the graphic display of temperature, humidity, remaining battery life, or time until temperature excursion. Medications and agents are designed to be stored within a set range of storage temperatures. A temperature excursion occurs when a medication or agent within a drug delivery device is exposed to a temperature outside the storage temperature range for that medication or agent. In some embodiments, the graphic display 808 can include more or fewer display toggles 814 than shown in FIG. 8b.

[0046] FIG. 8c is an additional view of the graphic display 808 disposed on the rigid storage container 800 of FIG. 8a. The graphic display 808 of FIG. 8c includes a second display 812 that is different from the first display 810 of FIG. 8b. As shown in FIG. 8c, the internal temperature of the rigid storage container 800 is currently 47 degrees Fahrenheit (°F), and the color indicator 812 has changed to a second color. For example, the color indicator 812 can transition from a green color associated with an appropriate or target range (i.e., 44°F) to a red color associated with a higher 47°F, which is outside the appropriate or target range. In other examples, the color indicator 812 can change based on the internal relative humidity, the amount of battery life remaining, or the time until a temperature excursion.

[0047] FIG. 8d illustrates a fingerprint lock interface 806 disposed on the rigid storage container 800 of FIG. 8a. The fingerprint lock interface 806 prevents tampering with the contents of the rigid storage container 800. The fingerprint lock interface 806 recognizes the fingerprint of a patient or other authorized user to unlock the rigid storage container 800. The fingerprint lock interface 806 includes a fingerprint reader 820 and first and second toggles 822 and 824. The fingerprint reader 820 scans a fingerprint placed on the fingerprint reader 820 and verifies whether the fingerprint matches that of the patient or other authorized user. Additionally, the first and second toggles 822 and 824 can be used to control the fingerprint lock interface 806, if desired.

[0048] In other embodiments, fingerprint lock interface 806 may be a number pad for entering a numeric PIN, or a keyhole for use with a key or any similar locking mechanism. Additionally, rigid storage container 800 may include more than one locking mechanism. For example, if the battery within rigid storage container 800 cannot effectively power fingerprint lock interface 806, a mechanical locking mechanism may be used.

[0049] Figure 9 is a perspective view of the rigid storage container 800 of Figure 8a in an open position. As shown in Figure 9, the rigid storage container 800 is open along hinge 902, revealing the storage cavity of the rigid storage container 800. The top 804 of the rigid storage container 800 additionally includes a latch 904. The latch 904 engages with a fingerprint lock interface 806 to secure the top 804 in a closed position. When the top 804 is in the closed position and the latch 904 engages with the fingerprint lock interface 806, the rigid storage container 800 forms a sealed interior container.

[0050] Rigid storage container 800 additionally includes an absorbent carrier 910. Absorbent carrier 910 includes a base 912 and a gas permeable lid 914. Gas permeable lid 914 allows moisture stored in absorbent 916 to pass through it. Absorbent 916 is similar to absorbent 206. For example, absorbent 916 can absorb the same aqueous solution as absorbent 206 and can be made of the same material as absorbent 206. Gas permeable lid 914 is openable so that absorbent 916 can be removed, rehydrated, or replaced, for example, by a patient or other end user. In some embodiments, absorbent 916 is an antimicrobial substance that inhibits microbial growth during storage. Rigid storage container 800 further includes a rim 918 for enclosing the inner container of rigid storage container 800 from the external environment. In some embodiments, rim 918 closes against the inside surface of top 804 or against rim 919 of top 804. Additionally, rim 918 and / or rim 919 may comprise a resilient material that seals container 800 from the outside environment.

[0051] The rigid storage container 800 is designed to store at least one container 920 for storing medication delivery devices. As shown in FIG. 9 , the rigid storage container 800 includes a first container 920a, a second container 920b, a third container 920c, and a fourth container 920d. In other embodiments, the rigid storage container 800 includes more or less than four containers. Each of the containers 920a, 920b, 920c, and 920d is substantially identical to the container 920. The container 920 is a blister pack having a tray 922 and a gas permeable film 924 surrounding the container 920. Contained within the container 920 is a pre-filled medication delivery device 926. In some embodiments, the film 924 is peeled from the tray 922 to access the pre-filled medication delivery device 926. Alternatively, the pre-filled medication delivery device 926 can be pushed through the film 924 and the tray 922. In some embodiments, pre-filled medication delivery device 926 is a pre-filled syringe, and the reservoir additionally includes a syringe plunger 928. Each of reservoirs 920a, 920b, 920c, and 920d contains substantially identical contents.

[0052] 10 is a perspective view of a prescription package 1000 including one container 1004 and a container 1002 for storing an absorbent 1006. The container 1002 of the prescription package 1000 is sealable with a seal 1012. In some embodiments, the container 1002 is a gas-impermeable bag, and the seal 1012 is resealable. The container 1002 additionally includes a label 1014 and instructions for use 1016 (IFU). The container 1002 can include an absorbent 1006 similar to absorbent 206 and absorbent 916. As a result, the absorbent 1006 maintains a desired relative humidity within the container 1002 when the container 1002 is sealed.

[0053] The prescription package additionally includes a container 1004, which is substantially similar to container 920 of FIG. 9 . The container 1004 includes a tray 1022 and a film 1024 for sealing the container 1004. The container 1004 additionally includes a pre-filled drug delivery device 1026. In some embodiments, the pre-filled drug delivery device 1026 is a pre-filled syringe, and the container 1004 additionally includes a plunger 1028 for actuating the pre-filled syringe. In some embodiments, the film 1024 is a gas permeable film that allows moisture to pass through the film 1024. In other embodiments, the film 1024 is not gas permeable, and moisture cannot pass through the film 1024. In such embodiments, an absorbent 1006 is disposed within the container 1004.

[0054] FIG. 11 a is a perspective view of a rigid travel container 1100 in an open position for storing at least one medication delivery device. The travel container 1100 includes a base container 1102 and a lid 1104. The lid 1104 includes a latch 1106 for closing the travel container 1100. The travel container 1100 is designed to store an absorbent carrier 1108 and at least one pre-filled medication delivery device. As shown in FIG. 11 a, the travel container 1100 includes a washable foam insert 1110 configured to accommodate a first pre-filled medication delivery device 1112a and a second pre-filled medication delivery device 1112b. In other embodiments, the travel container 1100 is designed to accommodate more or fewer pre-filled medication delivery devices.

[0055] The travel container 1100 is designed to store and transport medication delivery devices for short-term or long-term travel. Accordingly, the travel container 1100 is designed to maintain a moist environment within the travel container for extended periods of time (e.g., days, weeks, or months). As a result, the travel container creates a sealed environment, and the absorbent carrier 1108 contains an absorbent material to maintain humidity within the travel container when sealed. The absorbent carrier 1108 is similar to the absorbent carrier 910 in FIG. 9 . For example, the absorbent carrier 1108 can be opened and rehydrated by the patient or other end user. Additionally, the absorbent carrier 1108 preferably contains antimicrobial properties to maintain the sterility of the travel container 1100.

[0056] FIG. 11b is a perspective view of a rigid travel container 1100 in a closed state for storing at least one medication delivery device. The travel container 1100 includes a prescription label 1120. The prescription label 1120 is substantially similar to the prescription label 1014. As shown in FIG. 11b, a latch 1106 can be used to seal the container 1100 and can be pulled to open the container 1100. The rigid travel container 1100 is designed to be compact and sleek for convenience in packing and short-term storage during travel.

[0057] While the apparatus and methods of this disclosure have been described in connection with various embodiments, it will be understood that the apparatus and methods of this disclosure are capable of further modifications. This disclosure is intended to cover any variations, uses, or adaptations of the apparatus and methods that generally follow the principles of the disclosure, including departures from the disclosure as come within known and customary practice in the art to which the disclosure pertains.

[0058] Furthermore, it should be noted that the construction and arrangement of the disclosed long-term medication storage devices, and their various components and assemblies, as shown in various exemplary embodiments, are merely exemplary. While this disclosure has described in detail only a few embodiments of the subject matter at issue, those skilled in the art who review this disclosure will readily appreciate that many modifications (e.g., variations in the size, dimensions, structure, shape, and proportions of various elements, parameter values, mounting configurations, use of materials, color, orientation, etc.) are possible without substantially departing from the novel teachings and advantages of the subject matter disclosed herein. For example, elements shown as integrally formed may be composed of multiple parts or elements, and vice versa. Also, the positions of elements may be reversed or changed, and the nature or number of individual elements or positions may be altered or changed. Accordingly, all such modifications are intended to be included within the scope of the present disclosure, as defined by the appended claims. Furthermore, the order or sequence of any process or method steps may be changed or re-arranged in accordance with alternative embodiments. Other substitutions, modifications, changes, and omissions may be made in the design, operating conditions, and arrangement of the various exemplary embodiments without departing from the scope of the present disclosure.

[0059] It will be understood that the systems and techniques described herein may be used to store and transport drugs in a variety of states, including, but not limited to, drug products that have completed blending and / or other finishing steps, drug substances that are intended to be blended and / or finished after delivery, ingredients or raw materials used in drugs, or other drug-related states or components.

[0060] The above description describes various devices, assemblies, components, subsystems, and methods of use related to drug delivery devices. The devices, assemblies, components, subsystems, methods, or drug delivery devices may further include or be used in conjunction with drugs, including, but not limited to, the drugs identified below and their generic and biosimilar equivalents. As used herein, the term drug may be used interchangeably with other similar terms and may be used to refer to any type of drug or therapeutic material, including traditional and non-traditional medicines, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules, and generic drugs. Non-therapeutic injectable materials are also encompassed. Drugs may be in liquid form, lyophilized form, or reconstituted from lyophilized form. The following list of exemplary drugs should not be considered exhaustive or limiting.

[0061] The medication will be contained within a reservoir. In some cases, the reservoir is a primary container that is either filled or pre-filled with medication for treatment. The primary container may be a vial, cartridge, or pre-filled syringe.

[0062] In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used in conjunction with, a colony-stimulating factor, such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF agents include, but are not limited to, Neulasta® (pegfilgrastim, PEGylated filgastim, PEGylated G-CSF, PEGylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-Met-G-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0063] In other embodiments, the drug delivery device may contain or be used in conjunction with an erythropoiesis-stimulating agent (ESA), which may be in liquid or lyophilized form. An ESA is any molecule that stimulates erythropoiesis. In some embodiments, the ESA is an erythropoiesis-stimulating protein. As used herein, "erythropoiesis-stimulating protein" refers to any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to the receptor and causing receptor dimerization. Erythropoiesis-stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate the erythropoietin receptor; antibodies that bind to and activate the erythropoietin receptor; or peptides that bind to and activate the erythropoietin receptor. Erythropoiesis-stimulating proteins include Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methoxypolyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), and Binocrit® (epoetin alfa). Epoetin alpha, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, PEGylated erythropoietin, carbamylated erythropoietin, and molecules or variants or analogs thereof.

[0064] Among certain exemplary proteins are the specific proteins described below, including fusions, fragments, analogs, variants, or derivatives thereof: OPGL-specific antibodies (also referred to as RANKL-specific antibodies, peptibodies, etc.), peptibodies, related proteins, etc., including fully humanized and human OPGL-specific antibodies, particularly fully humanized monoclonal antibodies; myostatin-binding proteins, peptibodies, related proteins, etc., including myostatin-specific peptibodies; and antibodies that bind to receptors for IL-4 and / or IL-13, among others. IL-4 receptor-specific antibodies, peptibodies, related proteins, etc., which inhibit activity mediated by the binding of IL-4 receptor; interleukin 1-receptor 1 ("IL1-R1")-specific antibodies, peptibodies, related proteins, etc.; Ang2-specific antibodies, peptibodies, related proteins, etc.; NGF-specific antibodies, peptibodies, related proteins, etc.; CD22-specific antibodies, peptibodies, related proteins, etc., particularly a dimer of human-mouse monoclonal hLL2 gamma chain disulfide bound to human-mouse monoclonal hLL2 kappa chain. human CD22-specific antibodies, including, but not limited to, humanized and fully human monoclonal antibodies, particularly including, but not limited to, human CD22-specific IgG antibodies, such as, for example, the human CD22-specific fully humanized antibody epratuzumab (CAS Registry Number 501423-23-0); IGF-1 receptor-specific antibodies, peptibodies, and related proteins, including, but not limited to, anti-IGF-1R antibodies; B7RP-specific fully human monoclonal IgG2 B-7 related protein 1 specific antibodies, peptibodies, related proteins, etc. (also referred to as "B7RP-1" and B7H2, ICOSL, B7h, and CD275), including but not limited to, antibodies that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells, including but not limited to, fully human IgG2 monoclonal antibodies that bind to an epitope in the first immunoglobulin-like domain of B7RP-1; IL-15 specific antibodies, peptibodies, related proteins, etc., particularly humanized monoclonal antibodies, including but not limited to, HuMax IL-15 antibodies and related proteins, such as 145c7;IFN gamma-specific antibodies, peptibodies, related proteins, and the like, including but not limited to, human IFN gamma-specific antibodies, and fully human anti-IFN gamma antibodies; TALL-1-specific antibodies, peptibodies, related proteins, and the like, as well as other TALL-specific binding proteins; parathyroid hormone ("PTH")-specific antibodies, peptibodies, related proteins, and the like; thrombopoietin receptor ("TPO-R")-specific antibodies, peptibodies, related proteins, and the like; fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter factor (HGF / SF) Hepatocyte growth factor ("HGF")-specific antibodies, peptibodies, related proteins, etc., including those that target the HGF / SF:c-Met axis (HGF / SF:c-Met), such as clonal antibodies; TRAIL-R2-specific antibodies, peptibodies, related proteins, etc.; activin A-specific antibodies, peptibodies, proteins, etc.; TGF-beta-specific antibodies, peptibodies, related proteins, etc.; amyloid-beta protein-specific antibodies, peptibodies, related proteins, etc.; proteins that bind to c-Kit and / or other stem cell factor receptors, including, but not limited to, those c-Kit-specific antibodies, peptibodies, related proteins, etc., including but not limited to; OX40L-specific antibodies, peptibodies, related proteins, etc., including but not limited to proteins that bind to OX40L and / or other ligands of the OX40 receptor; Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa), erythropoietin [30-asparagine, 32-threonine, 87-valine, 88-asparagine, 90-threonine], darbepoetin alfa, de novo hematopoietic stimulating protein Protein (NESP); Epogen® (epoetin alfa, or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, an anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, an anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb);Enbrel® (etanercept, TNF receptor / Fc fusion protein, TNF blocker); Eprex® (epoetin alfa); Erbitux® (cetuximab, anti-EGFR / HER1 / c-ErbB-1); Genotropin® (somatropin, human growth hormone); Herceptin® (trastuzumab, anti-HER2 / neu(erbB2) receptor mAb); Kanjinti™ (trastuzumab-anns) anti-HER2 monoclonal antibody, a biosimilar of Herceptin®, or another product containing trastuzumab for the treatment of breast or gastric cancer; Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); Vectibix (registered trademark) (Panitumumab), Xgeva® (Denosumab), Prolia® (Denosumab), immunoglobulin G2 human monoclonal antibody against RANK ligand, Enbrel® (Etanercept, TNF receptor / Fc fusion protein, TNF blocker), Nplate® (Romiplostim), Rilotumumab, Ganitumab, Conatumumab, Brodalumab, Insulin in solution; Infergen® (Interferon alfacon-1); Natrecor® (Nesiritide; recombinant human B-type natriuretic peptide (hBNP); Kineret® (Anakinra); Leukine® (Sargamostim, rhuGM-CSF); LymphoCide® (Epratuzumab, anti-CD22 mAb); Benlysta™ (lymphostat B, belimumab, anti-BlyS mAb); Metalyse® (tenecteplase, t-PA analog); Mircera® (methoxypolyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-complement C5); Numax® (MEDI-524); Lucentis® (ranibizumab);Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (vigilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® (oprelvekin, human interleukin-11); Orthoclone OKT3® (muromonab-CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alfa); Remicade® (infliximab, anti-TNFα monoclonal antibody); Reopro® (abciximab, anti-GP IL6 / IL6 receptor monoclonal antibody; Actemra® (anti-IL6 receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); Mvasi™ (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A® (interferon alpha-2a); Simulect® (basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Pat. No. 7,153,507); Tysabri® (natalizumab, anti-α4 integrin mAb); Valortim® (MDX-1303, anti-B. anthracis protective antigen mAb); ABthrax™; Xolair® (omalizumab); ETI211 (anti-MRSA mAb); IL-1 trap (the Fc portion of human IgG1 and the extracellular domain of both IL-1 receptor components (type I receptor and receptor accessory protein)); VEGF trap (IgG1 Ig domain of VEGFR1 fused to Fc; Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Rα mAb);Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); HGS-ETR1 (mapatuzumab; human anti-TRAIL receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb, and VEGFR-1 (IMC-18F1); anti-BR3 mAbs; anti-C. difficile toxin A and toxin BC mAbs MDX-066 (CDA-1) and MDX-1388; anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Cripto mAb; anti-CTGF idiopathic pulmonary fibrosis stage 1 fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin 1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb;Anti-ganglioside GM2 mAb;Anti-GDF-8 human mAb (MYO-029);Anti-GM-CSF receptor mAb (CAM-3001);Anti-HepC mAb (HuMax HepC);Anti-IFNα mAb (MEDI-545, MDX-198);Anti-IGF1R mAb;Anti-IGF-1R mAb (HuMax-Inflam);Anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95);Anti-IP10 ulcerative colitis mAb (MDX-1100);BMS-66513;Anti-mannose receptor / hCGβ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1 mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC-3G3); anti-TGFβ mAb (GC-1008); anti-TRAIL receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-V; EGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0065] In some embodiments, the drug delivery device may contain or be used in conjunction with a sclerostin antibody, such as, but not limited to, romosozumab, brosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), or another product containing romosozumab for the treatment of postmenopausal osteoporosis and / or fracture healing, and in other embodiments, a monoclonal antibody (IgG) that binds to human proprotein convertase subtilisin / kexin type 9 (PCSK9). Such PCSK9-specific antibodies include, but are not limited to, Repatha® (evolocumab) and Praluent® (alirocumab). In other embodiments, the drug delivery device may contain or be used in conjunction with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib niphosphate, brodalumab, vidupiprant, or panitumumab. In some embodiments, the reservoir of the drug delivery device may be loaded with, or the device may be used in conjunction with, IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers, including, but not limited to, OncoVEX GALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain, or be used in conjunction with, an endogenous tissue inhibitor of metalloproteinases (TIMP), such as, but not limited to, TIMP-3. In some embodiments, the drug delivery device may house, or be used in conjunction with, Aimovig® (erenumab-aooe), an anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor), or another product containing erenumab for the treatment of migraines. Antagonistic antibodies of the human calcitonin gene-related peptide (CGRP) receptor, such as, but not limited to, erenumab, and bispecific antibody molecules that target the CGRP receptor and other headache targets, may also be delivered using the drug delivery devices of the present disclosure.Additionally, bispecific T cell engager (BiTE®) molecules, such as, but not limited to, BLINCYTO® (blinatumomab), can be used in or with the drug delivery devices of the present disclosure. In some embodiments, the drug delivery device may contain or be used in conjunction with an APJ large molecule agonist, such as, but not limited to, apelin or an analog thereof. In some embodiments, a therapeutically effective amount of anti-thymic stromal lymphopoietin (TSLP) or a TSLP receptor antibody is used in or with the drug delivery device of the present disclosure. In some embodiments, the drug delivery device may contain or be used in conjunction with Avsola™ (infliximab-axxq), an anti-TNF-α monoclonal antibody, a biosimilar of Remicade® (infliximab) (Janssen Biotech, Inc.), or another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used in conjunction with Kyprolis® (carfilzomib), (2S)—N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma. In some embodiments, the drug delivery device may contain or be used in conjunction with Otezla® (apremilast), N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide, or another product containing apremilast for the treatment of various inflammatory diseases.In some embodiments, the drug delivery device may contain or be used in conjunction with Parsabiv™ (etelcalcetide HCl, KAI-4169) or another product containing etelcalcetide HCl for the treatment of secondary hyperparathyroidism (sHPT), such as in patients with chronic kidney disease (KD) on hemodialysis. In some embodiments, the drug delivery device may contain or be used in conjunction with ABP 798 (rituximab), a biosimilar candidate for Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used in conjunction with a VEGF antagonist, such as a non-antibody VEGF antagonist, and / or a VEGF trap (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2 fused to the Fc domain of IgG1), such as aflibercept. In some embodiments, the drug delivery device may contain or be used in conjunction with ABP 959 (eculizumab), a biosimilar candidate for Soliris®, or another product containing a monoclonal antibody that specifically binds to complement protein C5. In some embodiments, the drug delivery device may contain or be used in conjunction with rozivacsp alfa (formerly AMG 570), a novel bispecific antibody-peptide conjugate that simultaneously blocks ICOSL and BAFF activity. In some embodiments, the drug delivery device may contain or be used in conjunction with omecamtib mecarbil, a small molecule selective cardiac myosin activator or myotrope that directly targets the cardiac contractile machinery, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain sotorasib (formerly known as AMG 510), a KRAS inhibitor. G12C Small molecule inhibitors, or KRAS G12CThe drug delivery device may contain or be used in conjunction with another product containing a small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 714, a human monoclonal antibody that binds to interleukin-15 (IL-15), or a human monoclonal antibody that binds to interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 890, a small interfering RNA (siRNA) that reduces lipoprotein(a), also known as Lp(a), or a small interfering RNA (siRNA) that reduces lipoprotein(a). In some embodiments, the drug delivery device may contain or be used in conjunction with ABP 654 (a human IgG1 kappa antibody), a biosimilar candidate for Stelara®, or another product containing a human IgG1 kappa antibody and / or binding to the p40 subunit of the human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used in conjunction with Amjevita™ or Amgevita™ (formerly ABP 501) (a mab anti-TNF human IgG1), a biosimilar candidate for Humira®, or another product containing a human mab anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 160, or another product containing a half-life extended (HLE) anti-prostate specific membrane antigen (PSMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 119 or a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy.In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 119, or a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cell therapy. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 133, or a gastric inhibitory polypeptide receptor (GIPR) antagonist and GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 171, or a growth differentiation factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 176, or a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 199, or a half-life extended (HLE) bispecific T-cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 256, or another product containing an anti-PD-1 x IL21 mutein and / or IL-21 receptor agonist designed to selectively activate the interleukin-21 (IL-21) pathway in programmed cell death-1 (PD-1)-positive cells. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 330, or another product containing an anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 404, or another product containing a human anti-programmed cell death-1 (PD-1) monoclonal antibody being investigated as a treatment for patients with solid tumors.In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 427, or another product containing a half-life extended (HLE) anti-fms-like tyrosine kinase 3 (FLT3) x anti-CD3 BiTE® (bispecific T-cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 430, or another product containing an anti-Jagged-1 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 506, or another product containing a multispecific FAP x 4-1BB-targeted DARPin® biologic being investigated as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 509, or another product containing a bivalent T-cell engager and designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device contains AMG 562, or half-life extended (HLE) CD19xCD3 BiTE® (bispecific T cell engager). In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing a half-life extended (HLE) anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing efavalukin alfa (formerly AMG 592) or an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 596 or a CD3 x epidermal growth factor receptor vIII (EGFRvIII) BiTE® (bispecific T cell engager) molecule. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 673 or a half-life extended (HLE) anti-CD33 x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with another product containing AMG 701 or a half-life extended (HLE) anti-B cell maturation antigen (BCMA) x anti-CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 757 or another product containing a half-life extended (HLE) anti-delta-like ligand 3 (DLL3) x anti-CD3 BiTE® (bispecific T-cell engager) construct. In some embodiments, the drug delivery device may contain or be used in conjunction with AMG 910 or another product containing a half-life extended (HLE) epithelial cell tight junction component protein claudin 18.2 x CD3 BiTE® (bispecific T-cell engager) construct.

[0066] Drug delivery devices, assemblies, components, subsystems, and methods have been described in terms of exemplary, but not limited to, embodiments. The detailed description should be construed as merely exemplary and does not describe every possible embodiment of the present disclosure. Many alternative embodiments can be implemented using either current technology or technology developed after the filing date of this patent, and such embodiments will still fall within the scope of the claims that define the invention disclosed herein.

[0067] Those skilled in the art will appreciate that numerous modifications, variations, and combinations can be made to the above-described embodiments without departing from the spirit and scope of the invention disclosed herein, and that such modifications, variations, and combinations are to be construed as being within the scope of the inventive concept.

Claims

1. 1. An apparatus for storing a medication delivery device, the apparatus comprising: a container defining a storage cavity having an opening, the storage cavity configured to receive a syringe pre-filled with a medicament; an absorbent disposed within the cavity, the absorbent being at least partially hydrated with a liquid solution; and a seal member at least selectively connected to said cavity to form a seal that is at least substantially gas impermeable.

2. The device of claim 1 , wherein the cavity of the container and contents within the cavity are sterile.

3. 10. The device of claim 1, further comprising a gas-permeable seal member disposed on the container over at least a portion of the opening and surrounding at least a portion of the cavity that contains the syringe, the gas-permeable seal member being disposed between the seal member and the container.

4. 4. The device of claim 3, wherein the cavity comprises a first sub-cavity and a second sub-cavity separated by a container wall, the first sub-cavity housing the syringe and the second sub-cavity housing the absorbent.

5. 5. The apparatus of claim 4, wherein the gas permeable seal member is disposed over the first sub-cavity but not over the second sub-cavity, and the seal member is disposed over the first sub-cavity and the second sub-cavity.

6. The device of claim 1 , wherein the absorbent is at least partially hydrated with an aqueous solution.

7. The device of claim 1 , wherein the sealing member is a sealed gas impermeable bag in which the container, the syringe, and the absorbent are disposed.

8. 1. A method of packaging a medication delivery device for storage, the method comprising: providing a container defining a storage cavity and an opening; placing a syringe pre-filled with a medication within the storage cavity of the container; placing an absorbent material within the storage cavity of the container, the absorbent material being at least partially hydrated; and sealing the storage cavity of the container with a sealing member by at least selectively connecting the sealing member to the cavity to form a seal that is at least substantially gas impermeable.

9. The method of claim 8 , wherein sealing the storage cavity of the container comprises sealing the seal member to the container adjacent the opening to enclose the storage cavity.

10. The method of claim 8 , further comprising sterilizing the storage cavity and the syringe prior to sealing the storage cavity of the container with the sealing member.

11. 11. The method of claim 10, wherein sterilizing the storage cavity and the syringe comprises exposing the storage cavity and the syringe to a vaporized hydrogen peroxide (VPHP) sterilization process.

12. 11. The method of claim 10, further comprising sealing at least a portion of the storage cavity housing the syringe with a gas permeable sealing member prior to sealing the storage cavity of the container with the sealing member.

13. The method of claim 8 , wherein sealing the storage cavity of the container comprises sealing the container in a sealed gas impermeable bag.

14. 9. The method of claim 8, wherein placing the syringe in the storage cavity of the container comprises placing the syringe in a first sub-cavity of the container, and placing the absorbent in the storage cavity comprises placing the absorbent in a second sub-cavity of the container, the first sub-cavity and the second sub-cavity being separated by a container wall.

15. The method of claim 8 , further comprising hydrating the absorbent in an aqueous solution for a predetermined period of time prior to disposing the absorbent in the cavity.

16. 1. An apparatus for storing a medication delivery device, the apparatus comprising: a rigid storage container configured to accommodate at least one pre-filled medication delivery device or at least one container containing a pre-filled medication delivery device; an absorbent carrier disposed within the rigid storage container, the absorbent carrier comprising an absorbent at least partially hydrated with a liquid solution.

17. 17. The apparatus of claim 16, further comprising a locking mechanism disposed on the rigid storage container to lock the rigid storage container.

18. 17. The apparatus of claim 16, wherein the absorbent carrier includes a lid for accessing the absorbent stored within the absorbent carrier.

19. 20. The device of claim 18, wherein the absorbent is at least partially hydrated with an aqueous solution.

20. 17. The apparatus of claim 16, further comprising a coolant reservoir containing either a coolant or alcohol.

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