Packaging for drug administration

Abstract

A packaging for drug administration is provided. The packaging comprises a first tray having a first plurality of walls that define a first volume and a second tray having a second plurality of walls that define a second volume. The first volume houses a first set of drug delivery components, and the second volume houses a second set of drug delivery components. In a first configuration, the first tray is configured to be stacked on top of the second tray such that the second volume is covered by the first tray. In a second configuration, the first tray is configured to be separated from the second tray to allow access to the second volume.

Description

Docket No.10260-WO01-SEC PACKAGING FOR DRUG ADMINISTRATION CROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to U.S. Provisional Patent Application No. 63 / 580,822, filed September 6, 2023, the entire contents of which are hereby incorporated by reference herein. FIELD OF DISCLOSURE

[0002] The present disclosure generally relates to drug administration, and, more particularly, to packaging assemblies, kits, and / or configurations for drug administration. This invention was made with government support under Contract No.75A50119C00061 awarded by Administration for Strategic Preparedness & Response’s (ASPR’s) Biomedical Advanced Research and Development Authority (BARDA). The government has certain rights in the invention. BACKGROUND

[0003] Drug delivery devices, such as pre-filled syringes (PFS) or injectors, are used to administer liquid drugs to a patient. Upon activation, a drug delivery device will expel a drug stored within an internal reservoir through a needle, cannula, or other delivery member into the patient. In some instances, such drug delivery devices are delivered or given to patients in an end-user packaging so that the patients can self-administer the drug in the comfort of their home.

[0004] Conventional end-user packaging for such drug delivery devices, such as drug administration kits, however, generally lacks features that facilitate handling and manipulation of components within the packaging. For example, to self-administer certain drugs in their home, patients may need to perform certain procedures upon opening the packaging, including preparing a dose by mixing a drug contained in a vial with a diluent contained in a PFS, withdrawing an amount of the prepared drug using an injection syringe, and injecting the drug into the patient. These procedures may involve handling multiple drug containers, coupling multiple components within the packaging or the kit, which may be cumbersome and confusing for many patients without explicit instructions or demonstrations. Therefore, there is a need for improved packaging assemblies, kits, and / or configurations for drug administration that facilitate handling and manipulation of components therein and allow users to administer drugs with ease.

[0005] The present disclosure sets forth packaging for drug administration and corresponding approaches embodying advantageous alternatives to existing packaging and approaches, and that may address one or more of the challenges or needs mentioned herein. SUMMARY

[0006] In accordance with one aspect of the present disclosure, a packaging for drug administration is provided. The packaging may comprise a first tray having a first plurality of walls that define a first volume and a second tray having a second plurality of walls that define aDocket No.10260-WO01-SEC second volume. The first volume may house a first set of drug delivery components, and the second volume may house a second set of drug delivery components. In a first configuration, the first tray may be configured to be stacked on top of the second tray such that the second volume is covered by the first tray. In a second configuration, the first tray may be configured to be separated from the second tray to allow access to the second volume.

[0007] In some embodiments, in the first configuration, the first tray may be configured to be stacked on top of the second tray such that the second volume is completely covered by the first tray. In some embodiments, the first volume may include a first plurality of cavities dimensioned to house the first set of drug delivery components, and the second volume may include a second plurality of cavities dimensioned to house the second set of drug delivery components. The second plurality of cavities may include a cylindrical cavity dimensioned to accommodate a vial. In some embodiments, the first volume may further include a plurality of slots configured to facilitate removal of one or more components of the first set of drug delivery components and facilitate lifting of the first tray relative to the second tray. In some embodiments, the first set of drug delivery components may include at least one of a drug vial, a vial adapter, or a pre-filled syringe containing a diluent therein. In some embodiments, the second set of drug delivery components may include at least one of an injection syringe or an injection needle. In some embodiments, the first set of drug delivery components may include a drug vial, and the vial may be filled for treatment or prefilled with the drug. In some embodiments, the drug may comprise a therapeutic product, and the therapeutic product may comprise romiplostim.

[0008] In some embodiments, the packaging may further comprise a sleeve configured to be disposed about the first tray and the second tray when the first tray is stacked on top of the second tray. The sleeve may be configured to cover the first volume when the sleeve is disposed about the first tray and the second tray. In some embodiments, in the first configuration, the first plurality of walls of the first tray and the second plurality of walls of the second tray may be vertically aligned. In other embodiments, the packaging may further comprise a first manual configured to be disposed within the first volume. The first manual may include instructions for using the first set of drug delivery components. In other embodiments, the packaging may further comprise a second manual configured to be disposed within the second volume. The second volume may include instructions for using the second set of drug delivery components.

[0009] In some embodiments, the packaging may further comprise a lip portion formed around the second plurality of walls. The first plurality of walls may be configured to cover the lip portion when the first tray is stacked on top of the second tray. In some embodiments, the first tray and the second tray may be constructed from at least one of plastic, paperboard, or a combination of synthetic and natural materials.

[0010] In accordance with another aspect of the present disclosure, a packaging for drug administration is provided. The packaging may comprise a first tray having a first plurality ofDocket No.10260-WO01-SEC walls that define a first volume, a second tray having a second plurality of walls that define a second volume, and a sleeve configured to be disposed about the first tray and the second tray when the first tray is stacked on top of the second tray. The first volume may house a first set of drug delivery components, and the second volume may house a second set of drug delivery components. In a first configuration, the first tray may be configured to be stacked on top of the second tray such that the second volume is covered by the first tray, and the first plurality of walls and the second plurality of walls may be vertically aligned. In a second configuration, the first tray may be configured to be separated from the second tray to allow access to the second volume.

[0011] In some embodiments, in the first configuration, the first tray may be configured to be stacked on top of the second tray such that the second volume is completely covered by the first tray. In some embodiments, the first volume may include a first plurality of cavities dimensioned to house the first set of drug delivery components, and the second volume may include a second plurality of cavities dimensioned to house the second set of drug delivery components. In other embodiments, the second plurality of cavities may include a cylindrical cavity dimensioned to accommodate a vial. In yet another embodiment, the first volume may further include a plurality of slots configured to facilitate removal of one or more components of the first set of drug delivery components and facilitate lifting of the first tray relative to the second tray.

[0012] In some embodiments, the first set of drug delivery components may include at least one of a drug vial, a vial adapter, or a pre-filled syringe containing a diluent therein, and the second set of drug delivery components may include at least one of an injection syringe or an injection needle. In some embodiments, the packaging may further comprise a lip portion formed around the second plurality of walls. The first plurality of walls may be configured to cover the lip portion when the first tray is stacked on top of the second tray. In some embodiments, the first tray and the second tray may be constructed from at least one of plastic, paperboard, or a combination of synthetic and natural materials.

[0013] In accordance with yet another aspect of the present disclosure, a packaging for drug administration is provided. The packaging may comprise a first tray having a first plurality of walls that define a first volume and a second tray having a second plurality of walls that define a second volume. The first volume may include at least one cavity dimensioned to house at least one of a drug vial, a vial adapter, or a pre-filled syringe containing a diluent therein, and the second volume may include at least one cavity dimensioned to house at least one of an injection syringe or an injection needle. In a first configuration, the first tray may be configured to be stacked on top of the second tray such that the second volume is completely covered by the first tray, and the first plurality of walls and the second plurality of walls may be vertically aligned. In a second configuration, the first tray may be configured to be separated from the second tray to allow access to the second volume.Docket No.10260-WO01-SEC BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The above needs are at least partially met through provision of the packaging for drug administration described in the following detailed description, particularly when studied in conjunction with the drawings, wherein:

[0015] Fig.1A illustrates a perspective view of an exemplary packaging for drug administration, in accordance with various embodiments of the present disclosure;

[0016] Fig.1B illustrates a top view of the exemplary packaging of Fig.1A, in accordance with various embodiments of the present disclosure;

[0017] Fig.2 illustrates a top view of an exemplary top tray of the exemplary packaging of Fig. 1A, in accordance with various embodiments of the present disclosure; and

[0018] Fig.3 illustrates a top view of an exemplary bottom tray of the exemplary packaging of Fig.1A, in accordance with various embodiments of the present disclosure.

[0019] Skilled artisans will appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions and / or relative positioning of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of various embodiments of the present invention. Also, common but well-understood elements that are useful or necessary in a commercially feasible embodiment are often not depicted in order to facilitate a less obstructed view of these various embodiments. It will further be appreciated that certain actions and / or steps may be described or depicted in a particular order of occurrence while those skilled in the art will understand that such specificity with respect to sequence is not actually required. It will also be understood that the terms and expressions used herein have the ordinary technical meaning as is accorded to such terms and expressions by persons skilled in the technical field as set forth above except where different specific meanings have otherwise been set forth herein. DETAILED DESCRIPTION

[0020] Generally speaking, pursuant to these various embodiments, a packaging for drug administration is provided that facilitates user or patient handling and manipulation of components within the packaging. The packaging described herein advantageously includes a plurality of trays that are stackable in nature and that each include one or more cavities dimensioned to accommodate one or more drug delivery components. Further, such packaging may include slots that allow a user to quickly remove one or more drug delivery components therein and / or lift the stackable trays easily. Such packaging ensures that drug delivery components for different portions of the drug administration process are separated so that the user can focus on one portion of the drug administration process at a time, thereby making it easier for the user to understand the process, handle and manipulate different components throughout the drug administration process, and safely and easily administer the drug.

[0021] The drug delivery device delivers a drug, which may also be referred to herein as a medicament or drug product. The drug may be, but is not limited to, various biologicals such asDocket No.10260-WO01-SEC peptides, peptibodies, or antibodies. The drug may be in a fluid or liquid form, although the disclosure is not limited to a particular state. In some embodiments, a container, such as a vial, may be filled for treatment or prefilled with the drug. By way of example, the drug may comprise a therapeutic product, such as Nplate® (romiplostim). Various implementations and configurations of the drug delivery device are possible. For example, the present disclosure describes the drug delivery device as a pre-filled syringe (PFS). In other embodiments, the drug delivery device may be configured as a single-use, disposable injector or a multiple-use reusable injector. The drug delivery device may be operable for self-administration by a patient or for administration by a caregiver or a formally trained healthcare provider (e.g., a doctor or nurse).

[0022] As discussed above, end-user packaging is generally used to deliver and provide drug delivery devices to a user, such as a patient, a caregiver, or a formally trained healthcare provider, to allow the user to administer drugs. In some instances, such packaging is used to deliver drug delivery devices directly to a patient so as to allow the patient to self-administer drugs in the comfort of their home with little or no supervision. By way of example, such packaging may include a kit comprising various components for drug administration. However, conventional packaging generally lacks features that facilitate handling and manipulation of components within the packaging. For example, when the user receives conventional kits for drug administration, the user may not know where to begin the drug administration process or which components in the packaging to use for different portions of the drug administration process. Accordingly, the user may need to rely on explicit demonstrations or supervision to properly use the components within such packaging and may find the drug administration process cumbersome and confusing, particularly for self-administration. Therefore, there is a need for improved packaging assemblies and / or configurations for drug delivery devices that facilitate handling and manipulation of components therein and allow users to administer drugs with ease.

[0023] Figs.1A-1B, 2, and 3 illustrate an exemplary packaging 200 for drug administration, in accordance with various embodiments of the present disclosure. The packaging 200 may comprise a first tray 202 and a second tray 213. As shown in Figs.1A and 2, the first tray 202 may have a first plurality of sidewalls 204 that define a first volume 203 therein. Additionally, as shown in Figs.1B and 3, the second tray 213 may have a second plurality of sidewalls 216 that define a second volume 217 therein. In some embodiments, the first tray 202 and the second tray 213 may be constructed from plastic, paperboard, or a combination of synthetic and natural materials.

[0024] The first tray 202 may be configured to house a first set of drug delivery components that may be used for a first portion of a drug administration process, such as the preparation portion of the drug administration process. For example, the first tray 202 may be configured to house components that are needed to prepare the drug for administration, which may includeDocket No.10260-WO01-SEC mixing a predefined amount of drug contained in a vial with a predefined amount of diluent contained in a PFS. Accordingly, as shown in Figs.1A and 2, the first volume 203 of the first tray 202 may be configured to house a first set of drug delivery components needed for a first portion of the drug administration process, including a vial 207, a vial adapter 209, and / or a PFS 211. The PFS 211 may contain a predefined amount of diluent therein, and the vial 207 may contain a predefined amount of drug therein. During operation, the user may use the vial adapter 209 to couple the PFS 211 to the vial 207 and to thereby inject the diluent within the PFS 211 into the vial 207. Thus, the user may mix the diluent contained in the PFS 211 with the drug contained in the vial 207 and prepare the drug for subsequent administration in the vial 207.

[0025] The first tray 202 may be removably coupled to the second tray 213. For example, in a first, stacked configuration, the first tray 202 may be stacked on top of the second tray 213 such that the second volume 217 is completely covered by the first tray 202. Accordingly, in the first, stacked configuration, the user may not be able to access the second volume 217, nor the components housed within the second volume 217. In other embodiments, in a first, stacked configuration, the first tray 202 may be stacked on top of the second tray 213 such that the second volume 217 is at least partially covered by the first tray 202. Accordingly, the user may be able to partially access the second volume 217 in the first, stacked configuration. In a second, separated configuration (shown in Figs.1A and 1B), the first tray 202 may be physically separated from the second tray 213 such that the first tray 202 and the second tray 213 are physically segregated components of the packaging 200. In the second, separated configuration, the user may be able to access the second volume 217 and the components housed within the second volume 217. When the first tray 202 is stacked on top of the second tray 213 in the first, stacked configuration, the first plurality of sidewalls 204 and the second plurality of sidewalls 216 may be vertically aligned such that the first volume 203 sits directly on top of the second volume 217 and completely or at least partially covers the second volume 217. In some embodiments, as shown in Figs.1A and 3, the second tray 213 may comprise a lip portion 230 formed around the second plurality of sidewalls 216 to allow the first tray 202 to be stacked on top of the second tray 213 in the first, stacked configuration. The lip portion 230 may include a recess formed around the second plurality of sidewalls 216, and when the first tray 202 is stacked on top of the second tray 213, the first plurality of sidewalls 204 may be configured to cover the lip portion 230 of the second tray 213.

[0026] Fig.2 illustrates a top view of the first tray 202 of the packaging 200. As discussed above, the first tray 202 may be configured to house a first set of drug delivery components for, for example, the preparation portion of the drug administration process. Accordingly, as shown in Fig.2, for example, the first volume 203 of the first tray 202 may include a first plurality of cavities 206, 208, and 210 sized and dimensioned to accommodate or house the first set of drug delivery components, including the vial 207, the vial adapter 209, and the PFS 211, respectively. Additionally, in some embodiments, the first volume 203 may include a plurality of slots 205Docket No.10260-WO01-SEC configured to facilitate lifting of the first tray 202 relative to the second tray 213 when the first tray 202 is stacked on top of the second tray 213. For example, the user may place his or her fingers within the slots 205 to lift the first tray 202 off of the second tray 213. Additionally, or alternatively, the first volume 203 may include slots 226 within cavities 206, 208, and 210 to facilitate removal of the vial 207, the vial adapter 209, and the PFS 211, respectively. Similar to slots 205, the user may place his or her fingers within the slots 226 to remove one or more of the vial 207, the vial adapter 209, and the PFS 211 housed within the cavities 206, 208, and 210, respectively.

[0027] As discussed above, the first tray 202 may be configured to house a first set of drug delivery components that may be used for a first portion of a drug administration process, such as the preparation portion of the drug administration process. Similarly, the second tray 213 may be configured to house a second set of drug delivery components that may be used for a second, subsequent portion of the drug administration process, such as the injection portion of the drug administration process. For example, the second tray 213 may be configured to house components that are needed to inject the drug that was previously prepared using the components in the first tray 202. Accordingly, the second volume 217 of the second tray 213 may be configured to house an injection syringe 221 and / or an injection needle 224.

[0028] Fig.3 illustrates a top view of the second tray 213 of the packaging 200. As shown in Fig.3, for example, the second volume 217 of the second tray 213 may include a second plurality of cavities 219 and 222 sized and dimensioned to accommodate or house the second set of drug delivery components, including the injection syringe 221 and the injection needle 224, respectively. In some embodiments, the second volume 217 may also include one or more recesses 225 and slots 227 configured to facilitate removal of the injection syringe 221 and / or the injection needle 224 from the cavities 219 and 222, respectively. For example, the user may place his or her fingers within the recess 225 and / or slots 227 to remove the packaging 220 containing the injection syringe 221 and / or the packaging 223 containing the injection needle 224. Moreover, the second volume 217 may further comprise an additional cylindrical cavity 218 configured to accommodate the vial 207 from the first tray 202. By way of example, the user may place the vial 207 from the first tray 202 within the cylindrical cavity 218 while handling the second set of drug delivery components, such as the injection syringe 221 and the injection needle 224. The cylindrical cavity 218 may be sized and dimensioned to keep the vial 207 steady within the cavity 218.

[0029] As discussed above, during operation of the drug administration process, the user may first use the vial adapter 209 in the first tray 202 to couple the PFS 211 to the vial 207 and to thereby inject the diluent within the PFS 211 into the vial 207. Thus, the user may mix the diluent contained in the PFS 211 with the drug contained in the vial 207 and prepare the drug for subsequent administration in the vial 207. In some embodiments, the vial 207 may be filled for treatment or prefilled with the drug. In some embodiments, the drug contained in the vial 207Docket No.10260-WO01-SEC may comprise a therapeutic product, such as Nplate® (romiplostim). Once the user has completed this preparation portion of the drug administration process using the components housed within the first tray 202, the user may separate the first tray 202 from the second tray 213 to thereby expose access to the second volume 217 of the second tray 213 (as shown in Figs.1A and 1B). The user may then place the vial 207 with the mixed and prepared drug contained therein in the cavity 218 to keep the vial 207 steady while preparing the second set of drug delivery components for drug injection. The user may then dismount the empty PFS 211 from the vial adapter 209, remove the injection syringe 221 from its sterile packaging 220, and connect the injection syringe 221 to the vial adapter 209. Afterwards, the user may draw the mixed drug in the vial 207 into the injection syringe 221, discount the filled injection syringe 221 from the vial adapter 209, remove the injection needle 224 from its sterile packaging 223, and couple the injection needle 224 to the filled injection syringe 221. Subsequently, the user may administer the drug in the injection syringe 221 by piercing the skin with the injection needle 224 and delivering the drug.

[0030] Referring back to Figs.1A and 1B, in some embodiments, the packaging 200 may further comprise a sleeve 215 configured to be disposed about the first tray 202 and the second tray 213 initially when the first tray 202 is stacked on top of the second tray 213. When the packaging 200 is initially delivered to the user, the sleeve 215 may be disposed about the first tray 202 and the second tray 213 such that the first volume 203 is completely or at least partially covered by the sleeve 215. The user may remove the sleeve 215 to expose the first volume 203 and to access the first set of drug delivery components housed within the first volume 203 of the first tray 202. In some embodiments, the sleeve 215 may be constructed of recyclable material, such as paperboard. In some embodiments, the sleeve 215, the first plurality of sidewalls 204, and / or the second plurality of sidewalls 216 of the packaging 200 may be constructed of plastic, paperboard, or a combination of synthetic and natural materials to protect various drug delivery components housed within the packaging 200 against external disturbances, such as falling and vibration, as well as environmental impacts.

[0031] Additionally, the packaging 200 may further comprise a first manual 212 disposed within the first volume 203. The first manual 212 may include a set of instructions for using the first set of drug delivery components, such as the vial 207, the vial adapter 209, and the PFS 211. The first manual 212 may also include descriptions of the first set of drug delivery components, the drug contained within the vial 207, the diluent contained within the PFS 211, or the like. Similarly, the packaging 200 may further comprise a second manual 214 disposed within the second volume 217. The second manual 214 may include a set of instructions for using the second set of drug delivery components, such as the injection syringe 221 and the injection needle 224, and may also include descriptions of the second set of drug delivery components.Docket No.10260-WO01-SEC

[0032] As compared with some conventional end-user packaging, the packaging 200 advantageously comprises stacked trays that improve usability and reduces dose administration errors through progress disclosure of drug delivery components. In particular, the packaging 200 not only has a more compact form factor, but also separates the workflows for drug administration, such as the preparation workflow and the injection workflow, in physically segregated compartments (e.g., trays 202 and 213). When the trays 202, 213 are in the stacked configuration, the user may only be able to view the first tray 202 because the first tray 202 is stacked directly on top of the second tray 213 and, thus, the user’s attention and focus will be solely drawn to the first tray 202. As discussed above, the first tray 202 may include the drug delivery components and the manual to perform and complete the preparation portion of the drug administration process such that the user can easily focus on completing the preparation portion of the process. Once the user has completed the preparation portion and has successfully prepared the drug for subsequent administration, then the user can remove the first tray 202, which will then allow the user to access the second tray 213. The second tray 213 may include the drug delivery components and the manual to perform the subsequent injection portion of the drug administration process such that the user can focus on completing this subsequent portion. The stacked configuration of the packaging 200 may facilitate differentiation between the various stages or portions of the drug administration process, thereby making it easier for the user to handle and manipulate various drug delivery components and to understand the various stages of the drug administration process.

[0033] The packaging described herein may be shaped to be used with any number of different drug delivery components and devices having varying sizes, shapes, and / or configurations. Additionally, the packaging described herein may comprise more than two stackable trays, such as three, four, five, or six stackable trays. Moreover, the packaging described herein may comprise any number of cavities in each tray, and the cavities may be shaped and sized to accommodate any number of different drug delivery components having varying sizes, shapes, and / or configurations.

[0034] The above description describes various devices, packaging assemblies, components, subsystems and methods for use related to a drug delivery device. The devices, packaging assemblies, components, subsystems, methods or drug delivery devices can further comprise or be used with a drug including but not limited to those drugs identified below as well as their generic and biosimilar counterparts. The term drug, as used herein, can be used interchangeably with other similar terms and can be used to refer to any type of medicament or therapeutic material including traditional and non-traditional pharmaceuticals, nutraceuticals, supplements, biologics, biologically active agents and compositions, large molecules, biosimilars, bioequivalents, therapeutic antibodies, polypeptides, proteins, small molecules and generics. Non-therapeutic injectable materials are also encompassed. The drug may be in liquidDocket No.10260-WO01-SEC form, a lyophilized form, or in a reconstituted from lyophilized form. The following example list of drugs should not be considered as all-inclusive or limiting.

[0035] The drug will be contained in a reservoir. In some instances, the reservoir is a primary container that is either filled or pre-filled for treatment with the drug. The primary container can be a vial, a cartridge or a pre-filled syringe.

[0036] In some embodiments, the reservoir of the drug delivery device may be filled with or the device can be used with colony stimulating factors, such as granulocyte colony-stimulating factor (G-CSF). Such G-CSF agents include but are not limited to Neulasta® (pegfilgrastim, pegylated filgastrim, pegylated G-CSF, pegylated hu-Met-G-CSF) and Neupogen® (filgrastim, G-CSF, hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0037] In other embodiments, the drug delivery device may contain or be used 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, an ESA is an erythropoiesis stimulating protein. As used herein, “erythropoiesis stimulating protein” means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, by binding to and causing dimerization of the receptor. Erythropoiesis stimulating proteins include erythropoietin and variants, analogs, or derivatives thereof that bind to and activate erythropoietin receptor; antibodies that bind to erythropoietin receptor and activate the receptor; or peptides that bind to and activate erythropoietin receptor. Erythropoiesis stimulating proteins include, but are not limited to, Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin iota, epoetin omega, epoetin delta, epoetin zeta, epoetin theta, and epoetin delta, pegylated erythropoietin, carbamylated erythropoietin, as well as the molecules or variants or analogs thereof.

[0038] Among particular illustrative proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL specific antibodies, peptibodies, related proteins, and the like (also referred to as RANKL specific antibodies, peptibodies and the like), including fully humanized and human OPGL specific antibodies, particularly fully humanized monoclonal antibodies; Myostatin binding proteins, peptibodies, related proteins, and the like, including myostatin specific peptibodies; IL-4 receptor specific antibodies, peptibodies, related proteins, and the like, particularly those that inhibit activities mediated by binding of IL-4 and / or IL-13 to the receptor; Interleukin 1-receptor 1 (“IL1-R1”) specific antibodies, peptibodies, related proteins, and the like; Ang2 specific antibodies, peptibodies, related proteins, and the like; NGF specific antibodies, peptibodies, relatedDocket No.10260-WO01-SEC proteins, and the like; CD22 specific antibodies, peptibodies, related proteins, and the like, particularly human CD22 specific antibodies, such as but not limited to humanized and fully human 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, a dimer of a human-mouse monoclonal hLL2 gamma-chain disulfide linked to a human-mouse monoclonal hLL2 kappa-chain, for example, the human CD22 specific fully humanized antibody in Epratuzumab, CAS registry number 501423-23-0; IGF-1 receptor specific antibodies, peptibodies, and related proteins, and the like including but not limited to anti-IGF-1R antibodies; B-7 related protein 1 specific antibodies, peptibodies, related proteins and the like (“B7RP-1” and also referring to B7H2, ICOSL, B7h, and CD275), including but not limited to B7RP-specific fully human monoclonal IgG2 antibodies, including but not limited to fully human IgG2 monoclonal antibody that binds an epitope in the first immunoglobulin-like domain of B7RP-1, including but not limited to those that inhibit the interaction of B7RP-1 with its natural receptor, ICOS, on activated T cells; IL-15 specific antibodies, peptibodies, related proteins, and the like, such as, in particular, humanized monoclonal antibodies, including but not limited to HuMax IL- 15 antibodies and related proteins, such as, for instance, 145c7; IFN gamma specific antibodies, peptibodies, related proteins and the like, including but not limited to human IFN gamma specific antibodies, and including but not limited to fully human anti-IFN gamma antibodies; TALL-1 specific antibodies, peptibodies, related proteins, and the like, and 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;Hepatocyte growth factor (“HGF”) specific antibodies, peptibodies, related proteins, and the like, including those that target the HGF / SF:cMet axis (HGF / SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth factor / scatter (HGF / SF); TRAIL-R2 specific antibodies, peptibodies, related proteins and the like; Activin A specific antibodies, peptibodies, proteins, and the like; TGF-beta specific antibodies, peptibodies, related proteins, and the like; Amyloid-beta protein specific antibodies, peptibodies, related proteins, and the like; c-Kit specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind c-Kit and / or other stem cell factor receptors; OX40L specific antibodies, peptibodies, related proteins, and the like, including but not limited to proteins that bind 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, novel erythropoiesis stimulating protein (NESP); Epogen® (epoetin alfa, or erythropoietin); GLP-1, Avonex® (interferon beta-1a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti- α4ß7 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-Docket No.10260-WO01-SEC ErbB-1); Genotropin® (somatropin, Human Growth Hormone); Herceptin® (trastuzumab, anti- HER2 / neu (erbB2) receptor mAb); Kanjinti™ (trastuzumab-anns) anti-HER2 monoclonal antibody, biosimilar to Herceptin®, or another product containing trastuzumab for the treatment of breast or gastric cancers; Humatrope® (somatropin, Human Growth Hormone); Humira® (adalimumab); Vectibix® (panitumumab), Xgeva® (denosumab), Prolia® (denosumab), Immunoglobulin G2 Human Monoclonal Antibody to 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® (methoxy polyethylene glycol-epoetin beta); Mylotarg® (gemtuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870); Soliris™ (eculizumab); pexelizumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibizumab); Panorex® (17-1A, edrecolomab); Trabio® (lerdelimumab); TheraCim hR3 (nimotuzumab); Omnitarg (pertuzumab, 2C4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (visilizumab); 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 lIb / Ilia receptor monoclonal antibody); Actemra® (anti-IL6 Receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); MvasiTM (bevacizumab-awwb); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A®-(interferon alfa-2a); Simulect® (basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 145c7-CHO (anti-IL15 antibody, see U.S. Patent No.7,153,507); Tysabri® (natalizumab, anti-α4integrin 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 domains of both IL-1 receptor components (the Type I receptor and receptor accessory protein)); VEGF trap (Ig domains of VEGFR1 fused to IgG1 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 (mapatumumab; 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 mAb; anti-C. difficile Toxin A and Toxin B C 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 Phase IDocket No.10260-WO01-SEC Fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin1 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 receptors 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-PD1mAb (MDX-1106 (ONO-4538)); anti- PDGFRα antibody (IMC-3G3); anti-TGFß mAb (GC-1008); anti-TRAIL Receptor-2 human mAb (HGS-ETR2); anti-TWEAK mAb; anti-VEGFR / Flt-1 mAb; and anti-ZP3 mAb (HuMax-ZP3).

[0039] In some embodiments, the drug delivery device may contain or be used with a sclerostin antibody, such as but not limited to romosozumab, blosozumab, BPS 804 (Novartis), Evenity™ (romosozumab-aqqg), another product containing romosozumab for treatment of postmenopausal osteoporosis and / or fracture healing and in other embodiments, a monoclonal antibody (IgG) that binds 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 with rilotumumab, bixalomer, trebananib, ganitumab, conatumumab, motesanib diphosphate, brodalumab, vidupiprant or panitumumab. In some embodiments, the reservoir of the drug delivery device may be filled with or the device can be used with IMLYGIC® (talimogene laherparepvec) or another oncolytic HSV for the treatment of melanoma or other cancers including but are not limited to OncoVEXGALV / CD; OrienX010; G207, 1716; NV1020; NV12023; NV1034; and NV1042. In some embodiments, the drug delivery device may contain or be used with endogenous tissue inhibitors of metalloproteinases (TIMPs) such as but not limited to TIMP-3. In some embodiments, the drug delivery device may contain or be used with Aimovig® (erenumab-aooe), anti-human CGRP-R (calcitonin gene-related peptide type 1 receptor) or another product containing erenumab for the treatment of migraine headaches. Antagonistic antibodies for 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 with a drug delivery device 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 device of the present disclosure. In some embodiments, the drug delivery device may contain or be used with an APJ large molecule agonist such as but not limited to apelin or analogues thereof. In some embodiments, a therapeutically effective amount of an anti-thymic stromal lymphopoietin (TSLP) or 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 with AvsolaTM (infliximab-axxq), anti-TNF α monoclonal antibody, biosimilar to Remicade® (infliximab) (Janssen Biotech, Inc.) orDocket No.10260-WO01-SEC another product containing infliximab for the treatment of autoimmune diseases. In some embodiments, the drug delivery device may contain or be used 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 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 with ParsabivTM (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 with ABP 798 (rituximab), a biosimilar candidate to Rituxan® / MabThera™, or another product containing an anti-CD20 monoclonal antibody. In some embodiments, the drug delivery device may contain or be used with a VEGF antagonist such as a non-antibody VEGF antagonist and / or a VEGF-Trap such as aflibercept (Ig domain 2 from VEGFR1 and Ig domain 3 from VEGFR2, fused to Fc domain of IgG1). In some embodiments, the drug delivery device may contain or be used with ABP 959 (eculizumab), a biosimilar candidate to Soliris®, or another product containing a monoclonal antibody that specifically binds to the complement protein C5. In some embodiments, the drug delivery device may contain or be used with Rozibafusp alfa (formerly AMG 570) is 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 with Omecamtiv mecarbil, a small molecule selective cardiac myosin activator, or myotrope, which directly targets the contractile mechanisms of the heart, or another product containing a small molecule selective cardiac myosin activator. In some embodiments, the drug delivery device may contain or be used with Sotorasib (formerly known as AMG 510), a KRASG12C small molecule inhibitor, or another product containing a KRASG12C small molecule inhibitor. In some embodiments, the drug delivery device may contain or be used with Tezepelumab, a human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), or another product containing a human monoclonal antibody that inhibits the action of TSLP. In some embodiments, the drug delivery device may contain or be used with AMG 714, a human monoclonal antibody that binds to Interleukin-15 (IL-15) or another product containing a human monoclonal antibody that binds to Interleukin-15 (IL-15). In some embodiments, the drug delivery device may contain or be used with AMG 890, a small interfering RNA (siRNA) that lowers lipoprotein(a), also known as Lp(a), or another product containing a small interfering RNA (siRNA) that lowers lipoprotein(a). In some embodiments, the drug delivery device may contain or be used with ABP 654 (human IgG1 kappa antibody), a biosimilar candidate to Stelara®, or another product that contains human IgG1 kappa antibodyDocket No.10260-WO01-SEC and / or binds to the p40 subunit of human cytokines interleukin (IL)-12 and IL-23. In some embodiments, the drug delivery device may contain or be used with AmjevitaTM or AmgevitaTM (formerly ABP 501) (mab anti-TNF human IgG1), a biosimilar candidate to Humira®, or another product that contains human mab anti-TNF human IgG1. In some embodiments, the drug delivery device may contain or be used with AMG 160, or another product that contains 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 with AMG 119, or another product containing a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cellular therapy. In some embodiments, the drug delivery device may contain or be used with AMG 119, or another product containing a delta-like ligand 3 (DLL3) CAR T (chimeric antigen receptor T cell) cellular therapy. In some embodiments, the drug delivery device may contain or be used with AMG 133, or another product containing a gastric inhibitory polypeptide receptor (GIPR) antagonist and GLP-1R agonist. In some embodiments, the drug delivery device may contain or be used with AMG 171 or another product containing a Growth Differential Factor 15 (GDF15) analog. In some embodiments, the drug delivery device may contain or be used with AMG 176 or another product containing a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1). In some embodiments, the drug delivery device may contain or be used with AMG 199 or another product containing a half-life extended (HLE) bispecific T cell engager construct (BiTE®). In some embodiments, the drug delivery device may contain or be used with AMG 256 or another product containing an anti-PD-1 x IL21 mutein and / or an IL-21 receptor agonist designed to selectively turn on 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 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 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 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 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 with AMG 506 or another product containing a multi-specific FAP x 4-1BB-targeting DARPin® biologic under investigation as a treatment for solid tumors. In some embodiments, the drug delivery device may contain or be used with AMG 509 or another product containing a bivalent T-cell engager and is designed using XmAb® 2+1 technology. In some embodiments, the drug delivery device may contain or be used with AMG 562 or another product containing a half-life extended (HLE) CD19 x CD3 BiTE® (bispecific T cell engager) construct. In some embodiments, the drug delivery device mayDocket No.10260-WO01-SEC contain or be used with Efavaleukin alfa (formerly AMG 592) or another product containing an IL-2 mutein Fc fusion protein. In some embodiments, the drug delivery device may contain or be used with AMG 596 or another product containing 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 with AMG 673 or 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 with AMG 701 or another product containing 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 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 with AMG 910 or another product containing a half-life extended (HLE) epithelial cell tight junction protein claudin 18.2 x CD3 BiTE® (bispecific T cell engager) construct.

[0040] Although the drug delivery devices, packaging assemblies, components, subsystems and methods have been described in terms of exemplary embodiments, they are not limited thereto. The detailed description is to be construed as exemplary only and does not describe every possible embodiment of the present disclosure. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent that would still fall within the scope of the claims defining the invention(s) disclosed herein.

[0041] Those skilled in the art will recognize that a wide variety of modifications, alterations, and combinations can be made with respect to the above described embodiments without departing from the spirit and scope of the invention(s) disclosed herein, and that such modifications, alterations, and combinations are to be viewed as being within the ambit of the inventive concept(s).

Claims

Docket No.10260-WO01-SEC What is claimed is:

1. A packaging for drug administration, comprising: a first tray having a first plurality of walls that define a first volume, the first volume housing a first set of drug delivery components; and a second tray having a second plurality of walls that define a second volume, the second volume housing a second set of drug delivery components, wherein, in a first configuration, the first tray is configured to be stacked on top of the second tray such that the second volume is covered by the first tray, and wherein, in a second configuration, the first tray is configured to be separated from the second tray to allow access to the second volume.

2. The packaging of claim 1, wherein the first volume includes a first plurality of cavities dimensioned to house the first set of drug delivery components, and the second volume includes a second plurality of cavities dimensioned to house the second set of drug delivery components.

3. The packaging of claim 2, wherein the second plurality of cavities include a cylindrical cavity dimensioned to accommodate a vial.

4. The packaging of claim 2, wherein the first volume further includes a plurality of slots configured to facilitate removal of one or more components of the first set of drug delivery components and facilitate lifting of the first tray relative to the second tray.

5. The packaging of claim 1, wherein the first set of drug delivery components include at least one of a drug vial, a vial adapter, or a pre-filled syringe containing a diluent therein.

6. The packaging of claim 5, wherein the first set of drug delivery components includes a drug vial, and wherein the vial is filled for treatment or prefilled with the drug.

7. The packaging of claim 6, wherein the drug comprises a therapeutic product, and wherein the therapeutic product comprises romiplostim.

8. The packaging of claim 1, wherein the second set of drug delivery components include at least one of an injection syringe or an injection needle.

9. The packaging of claim 1, further comprising a sleeve configured to be disposed about the first tray and the second tray when the first tray is stacked on top of the second tray,Docket No.10260-WO01-SEC wherein the sleeve is configured to cover the first volume when the sleeve is disposed about the first tray and the second tray.

10. The packaging of claim 1, wherein, in the first configuration, the first plurality of walls of the first tray and the second plurality of walls of the second tray are vertically aligned.

11. The packaging of claim 1, further comprising a first manual configured to be disposed within the first volume, wherein the first manual includes instructions for using the first set of drug delivery components.

12. The packaging of claim 1, further comprising a second manual configured to be disposed within the second volume, wherein the second volume includes instructions for using the second set of drug delivery components.

13. The packaging of claim 1, further comprising a lip portion formed around the second plurality of walls, wherein the first plurality of walls are configured to cover the lip portion when the first tray is stacked on top of the second tray.

14. The packaging of claim 1, wherein the first tray and the second tray are constructed from at least one of plastic, paperboard, or a combination of synthetic and natural materials.

15. The packaging of claim 1, wherein, in the first configuration, the first tray is configured to be stacked on top of the second tray such that the second volume is completely covered by the first tray.

16. A packaging for drug administration, comprising: a first tray having a first plurality of walls that define a first volume, the first volume housing a first set of drug delivery components; a second tray having a second plurality of walls that define a second volume, the second volume housing a second set of drug delivery components; and a sleeve configured to be disposed about the first tray and the second tray when the first tray is stacked on top of the second tray, wherein, in a first configuration, the first tray is configured to be stacked on top of the second tray such that the second volume is covered by the first tray, and the first plurality of walls and the second plurality of walls are vertically aligned, and wherein, in a second configuration, the first tray is configured to be separated from the second tray to allow access to the second volume.Docket No.10260-WO01-SEC 17. The packaging of claim 16, wherein the first volume includes a first plurality of cavities dimensioned to house the first set of drug delivery components, and the second volume includes a second plurality of cavities dimensioned to house the second set of drug delivery components.

18. The packaging of claim 17, wherein the second plurality of cavities include a cylindrical cavity dimensioned to accommodate a vial.

19. The packaging of claim 17, wherein the first volume further includes a plurality of slots configured to facilitate removal of one or more components of the first set of drug delivery components and facilitate lifting of the first tray relative to the second tray.

20. The packaging of claim 16, wherein the first set of drug delivery components include at least one of a drug vial, a vial adapter, or a pre-filled syringe containing a diluent therein, and wherein the second set of drug delivery components include at least one of an injection syringe or an injection needle.

21. The packaging of claim 16, further comprising a lip portion formed around the second plurality of walls, wherein the first plurality of walls are configured to cover the lip portion when the first tray is stacked on top of the second tray.

22. The packaging of claim 16, wherein the first tray and the second tray are constructed from at least one of plastic, paperboard, or a combination of synthetic and natural materials.

23. The packaging of claim 16, wherein, in the first configuration, the first tray is configured to be stacked on top of the second tray such that the second volume is completely covered by the first tray.

24. A packaging for drug administration, comprising: a first tray having a first plurality of walls that define a first volume, the first volume including at least one cavity dimensioned to house at least one of a drug vial, a vial adapter, or a pre-filled syringe containing a diluent therein; and a second tray having a second plurality of walls that define a second volume, the second volume including at least one cavity dimensioned to house at least one of an injection syringe or an injection needle; wherein, in a first configuration, the first tray is configured to be stacked on top of the second tray such that the second volume is completely covered by the first tray, and the first plurality of walls and the second plurality of walls are vertically aligned, andDocket No.10260-WO01-SEC wherein, in a second configuration, the first tray is configured to be separated from the second tray to allow access to the second volume.

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