Optic labels for drug storage containers

Abstract

Devices for storing a drug, placebo, and / or other substance(s) and related assemblies are disclosed. The device may include a container having a wall with an inner surface and an outer surface. The inner surface may at least partially define a reservoir for storing the drug, placebo, and / or other substance(s). The device may further include a film which is at least partially transparent. The film may include an adhesive layer configured to couple the film with the outer surface of the wall of the container. The film may further include a tinted layer configured to prevent or substantially inhibit a viewer from visually distinguishing whether at least one substance disposed in the reservoir corresponds to the drug or placebo. Additionally, the device may include a label coupled with the film and comprising readable information and / or instructions relating to the drug, placebo, and / or other substance(s).

Description

10989-W001-SECOPTIC LABELS FOR DRUG STORAGE CONTAINERS CROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] Priority is claimed to United States Provisional Patent Application No. 63 / 745,595, filed January 15, 2025, the entire contents of which are hereby incorporated by reference herein.FIELD OF DISCLOSURE

[0002] The present disclosure generally relates to containers for storing drugs and other substances, and, more particularly, labeling for such containers.BACKGROUND

[0003] Clinical trials, including those evaluating the efficacy and safety of new drugs, often rely on blinding strategies to reduce bias and ensure the integrity of a study. One common approach is the double-blind method, where neither the participants nor the researchers administering the presumed drug know if a given participant is receiving the actual drug or a placebo.Conventional blinding measures, however, can be insufficient in certain cases, including, for example, if the drug or placebo can be visually distinguished by its color, turbidity, and / or other visible characteristic(s).

[0004] Furthermore, for injectable and other liquid drugs and placebos which are stored in a container such as a syringe or vial, it may be necessary for a user to inspect the fill level, stopper position, potential bubbles and / or particulates, and / or other aspects of the interior of the container prior to administration. Accordingly, completely blocking the user’s view of the interior of the container may not be desirable or safe in at least some instances.

[0005] Moreover, the appearance of certain fluids when viewed in a container may vary depending on the color of a background environment. For instance, certain fluids may appear clear when viewed against a white background but appear slightly colored when viewed against a black or dark background. This phenomenon may in certain instances provide the viewer with a hint as to whether the container holds the drug or placebo, which may be undesirable in the context of a clinical trial.

[0006] To address one or more of the needs and / or challenges mentioned herein and / or other related needs and / or challenges, the present disclosure sets forth advantageous devices and assemblies for altering the visual appearance of a substance stored in a container.SUMMARY

[0007] One aspect of the present disclosure provides a device for storing a drug, placebo, and / or other substance(s). The device may include a container having a wall with an inner surface and an outer surface. The inner surface may at least partially define a reservoir for storing the drug, placebo, and / or other substance(s). The device may further include a film which is at least partially transparent. The film may include an adhesive layer configured to couple the film with the outer surface of the wall of the container. The film may further include a tinted layer configured to prevent or substantially inhibit a viewer from visually distinguishing whether at least one substance disposed in the reservoir corresponds to the drug or placebo. Additionally, the device may include a label coupled with the film and comprising readable information and / or instructions relating to the drug, placebo, and / or other substance(s).

[0008] Another aspect of the present disclosure provides an assembly for a container configured to store a drug, placebo, and / or other substance(s). The assembly may include a film and a label. The film may be at least partially transparent.Furthermore, the film may include an adhesive layer configured to couple the film with an outer surface of the container. The film may additionally include a tinted layer configured to prevent or substantially inhibit a viewer from visually distinguishing whether at least one substance disposed in a reservoir of the container corresponds to the drug or placebo. The label may be coupled with the film and include readable information and / or instructions relating to the drug, placebo, and / or other substance(s).BRIEF DESCRIPTION OF THE DRAWINGS10989-W001-SEC

[0009] It is believed that the disclosure will be more fully understood from the following description taken in conjunction with the accompanying drawings. Some of the drawings may have been simplified by the omission of selected elements for the purpose of more clearly showing other elements. Such omissions of elements in some drawings are not necessarily indicative of the presence or absence of particular elements in any of the exemplary embodiments, except as may be explicitly delineated in the corresponding written description. Also, none of the drawings are necessarily drawn to scale.

[0010] Fig. 1 is a perspective view of a device in a first or stage state in accordance with various embodiments of the present disclosure.

[0011] Fig. 2 is a perspective view of the device in Fig. 1, in a second state.

[0012] Fig. 3 is a top view of a sheet including a film and labels in accordance with various embodiments of the present disclosure, including the embodiment in Figs. 1 and 2.

[0013] Fig. 4 is a cross-sectional view taken along line Z-Z in Fig. 3, where a second panel of one of the labels has been folded on top of a first panel of the label.

[0014] Fig. 5 is a perspective view of a device in accordance with another embodiment of the present disclosure.

[0015] Fig. 6 is another perspective view of the device in Fig. 5.

[0016] Fig. 7 is a top view of a sheet including a film and labels in accordance with various embodiments of the present disclosure, including the embodiment in Figs. 5 and 6.

[0017] Fig. 8 is a cross-sectional view taken along line Y-Y in Fig. 7.DETAILED DESCRIPTION

[0018] The present disclosure generally pertains to devices and assemblies for altering the visual appearance of a substance stored in a container, including, for example, masking or substantially masking a color, turbidity, and / or other visual characteristic of the substance. In some embodiments, the substance stored in the container may be a drug or a placebo and / or may be in liquid, solid, powdered, gaseous, and / or any other suitable form. Furthermore, in certain embodiments, multiple substances may be stored in the container. The container can take various forms including, for example, a syringe (for example, a prefilled syringe, a sterile syringe, a disposable syringe, a safety syringe, a Luer lock syringe, a Luer slip syringe, etc.), a cartridge, an ampoule, a vial, a bottle, an autoinjector, an on-body injector, and / or any other suitable container for storing a substance and / or delivering it to a patient.

[0019] In clinical trials and other settings, it may be necessary or beneficial to prevent or inhibit a viewer (for example, a user, a patient, a participant, a researcher, a healthcare provider, a doctor, a nurse, and / or a machine) from identifying a substance stored in a transparent or semi-transparent container based on a visual appearance of the substance. As an example, in a clinical trial evaluating the efficacy and / or safety of a particular drug, it may be necessary to blind or substantially blind the participant(s) and / or researcher(s) as to whether a container contains the drug or a placebo.

[0020] Moreover, the inventors have found that the visual appearance of certain drugs when stored in a container may vary depending on a color of a background environment, including, for example, appearing clear and / or colorless when viewed against a white or light background but appearing colored and / or opalescent when viewed against a black or dark background. As a result, if the drug container is packaged along with the placebo container inside of, for example, of a black or dark colored box, the viewer may be able to visually distinguish the drug from the placebo (particularly if the placebo is clear and / or colorless when viewed against most or all background colors). Accordingly, it may be important to ensure that the intended blinding effect remains consistent across different background environments and / or lighting conditions.

[0021] The presently disclosed devices and assemblies advantageously allow one to prevent or substantially inhibit a viewer from visually distinguishing whether one or more substances disposed in, for example, a container correspond(s) to, for example, a drug or placebo. Additionally, according to some embodiments, the devices and assemblies may include one or more films having one or more tinted layers which cover at least a portion of the container and / or has / have one or more colors selected (for10989-W001-SEC example, preselected, predetermined, predefined, and / or chosen) to prevent or substantially inhibit a viewer from visually distinguishing whether the substance(s) disposed in the container correspond(s) to the drug or placebo. In certain such embodiments, the color(s) of the tinted layer(s) may be selected to match or substantially match, and / or be a darker shade of, the color of the drug. Accordingly, when viewing the drug or placebo through the tinted layer(s), a viewer may see the same color or substantially the same color regardless of whether the drug or placebo is present in the container. Furthermore, in some embodiments, the film(s) may be configured such that it / they can couple with (for example, directly couple with) a label including readable information and / or instructions relating to the drug. This configuration may facilitate integrating the blinding functionality into existing drug container and / or label designs, without, for example, interfering with regulatory and / or other requirements for conveying information on dosing, active pharmaceutical ingredient (API), branding, and / or other identifying, informational, and / or instructional details pertaining to the drug.

[0022] In certain instances, an inspection of an interior of a container which contains a drug, placebo, and / or other substance may be necessary to determine, for example, a fill level of the container, a position of a stopper disposed in the container, the presence of particulates and / or bubbles, and / or other aspects of the interior of the container including, for example, prior to, during, and / or after administration of the drug or placebo. This inspection may require, in certain stances, a substantially unaltered and / or unobstructed view of the substance in the container. To accommodate such an inspection, the devices and assemblies according to the present disclosure may be configured to alter the visual appearance of the substance stored in the container only when the container is viewed from certain perspectives (for example, specific directions, angles, elevations, and / or lighting conditions). Accordingly, the substance and / or other element(s) disposed in the container may be inspected by some individuals (for example, an authorized individual, a manufacturer, a safety technician, and / or a researcher) without compromising the blinding effect intended for certain other individuals (for example, a participant and / or a researcher in a clinical trial).

[0023] Moreover, covering at least a portion of a container with a film according to certain of the disclosed embodiments may create an opportunity or platform to add, or provide flexibility with respect to adding, other beneficial optical features, in addition to or as an alternative to the mentioned blinding functionality. In some embodiments, the film, including, for example, the tinted layer and / or another layer of the film, may be configured to block or substantially block the transmission of certain wavelengths of light, including, for example, ultraviolet (UV) light, which may have the potential to, for example, degrade a drug or other substance stored in the container.

[0024] These and other advantages will be apparent to one of ordinary skill in the art reviewing the present disclosure.

[0025] Figs. 1 and 2 illustrate a device 10 for storing a substance 12 which, in some embodiments, may be a drug or a placebo. In some embodiments, the device 10 may be configured to deliver the substance 12 to a patient or other individual including, for example, by injecting the substance 12 into tissue of the patient or other individual via a needle and / or other delivery member. The substance 12 may be in a fluid or liquid form, gelatin form, powdered form, and / or any other suitable form. In any of the embodiments described herein where the substance 12 is a drug, the drug may be: a biologic (including, for example, peptide(s), peptibodie(s), and / or antibodie(s)), a small molecule drug, an antibiotic, an antiviral, a vaccine, a hormone, an immunosuppressant, and / or any other suitable drug. Furthermore, in any of the embodiments described herein where the substance 12 is a drug, the drug may include bispecific molecule(s) including, for example, a bispecific molecule which is an agonist of an GLP-1 receptor (GLP-1R) and / or an antagonist of a glucose-dependent insulinotropic polypeptide receptor (GIPR).

[0026] In some embodiments, the device 10 may include any one or combination of: a container 14, a film 16, a label 18, and other component(s). The film 16, label 18, and / or other component(s) may form an assembly which, in some embodiments, may be manufactured separately from the container 14 and / or coupled with the container 14 as part of, for example, a labeling process. In some embodiments, the film 16, label 18, and / or other component(s) may be integrally formed with at least a portion of the container 14 so as to define a one-piece structure.10989-W001-SEC

[0027] Fig. 1 illustrates the device 10 in a first or storage state, where an entirety of the label 18 is flush or substantially flush with the film 16 and / or container 14; whereas Fig. 2 illustrates the device 10 in a second state, where a portion of the label 18 has been peeled away from the film 16 and / or container 14 to reveal, for example, information and / or instructions on an underside and / or inner surfaces(s) of the label 18.

[0028]

[0029] In some embodiments, the container 14 may be configured as a syringe such as a prefilled syringe. In certain such embodiments and other embodiments, the container 14 may include anyone or combination of: a barrel 20, a stopper 22, a removable needle shield 24, a needle (obstructed from view by the removable needle shield 24 in Fig. 1), and other component(s). The barrel 20 may have a longitudinal axis A1 and a proximal end 20a and a distal end 20b arranged along the longitudinal axis A1. The proximal end 20a may include an opening 21 for inserting, for example, a plunger rod into the barrel 20 to couple it with the stopper 22 and / or filling the barrel 20 with the substance 12 prior to arranging the stopper 22 within the barrel 20. At least a portion of, or the entirety of, the barrel 12 may have cross-section (for example, a cross-section in a plane perpendicular or substantially perpendicular to the longitudinal axis A1) which is circular, substantially circular, or any other suitable shape.

[0030] The barrel 20 may include a wall 26 having an inner surface 26a and an outer surface 26b. In some embodiments, the inner surface 26a of the wall 26, the stopper 22, and / or other component(s) of the container 14 may define a reservoir 28 for storing the substance 12. In some embodiments, a portion or the entirety of the wall 26 may be cylindrical or substantially cylindrical. The wall 26 of the barrel 20 may be made of a rigid or semi-rigid material including, for example, glass, plastic (for example, polypropylene), and / or any other suitable material or combination of materials. In some embodiments, the wall 26 may be made of a material that is transparent or semi- transparent.

[0031] In some embodiments, a volume of the substance 12 in the reservoir 28 of the container 14 may be: equal to or equal to approximately (for example, ±10%) 1 mL, or equal to 2.25 mL, or equal to approximately (for example, ±10%) 2.25 mL, or equal to 3 mL, or equal to approximately (for example, ±10%) 3 mL, or less than or equal to approximately (for example, ±10%) 1 mL, or less than or equal to approximately (for example, ±10%) 2 mL, or less than or equal to approximately (for example, ±10%) 3 mL, or less than or equal to approximately (for example, ±10%) 4 mL, or less than approximately (for example, ±10%) 5 mL, or less than or equal to approximately (for example, ±10%) 10 mL, or within a range between approximately (for example, ±10%) 1.0 - 10 mL, or within a range between approximately (for example, ±10%) 1.0 - 5 mL, or within a range between approximately (for example, ±10%) 1.0- 4 mL, or within a range between approximately (for example, ±10%) 1.0 -3 mL, or within a range between approximately (for example, ±10%) 1.0 - 2.25 mL, or any other suitable volume.

[0032] In some embodiments, the barrel 20 may include a body portion 30, a shoulder portion 32, and a neck portion 34. The shoulder portion 32 may be disposed axially between the body portion 30 and the neck portion 34 and / or couple the body portion 30 with the neck portion 34. In some embodiments, prior to its removal from the container 14, the removable needle shield 24 may partially or entirely cover and / or couple with the neck portion 34 of the barrel 20. In some embodiments, an outer diameter OD1 of the body portion 30 may be larger than an outer diameter OD3 of the neck portion 34. In certain such embodiments, an outer diameter OD2 of the shoulder portion 32 may gradually decrease when traveling in an axial direction (for example, the distal direction) from the body portion 30 toward the neck portion 34. In other embodiments, the outer diameter OD2 of the shoulder portion 32 may be constant or substantially container along an axial length of the shoulder portion 32.

[0033] The stopper 22, which may be referred to as a plunger-stopper or a plunger in certain contexts, may be movably disposed in the barrel 20 such that when a distally directed force is applied to the stopper 22, for example, by a plunger rod (not illustrated in Figs. 1 and 2), the stopper 22 moves in the distal direction along the longitudinal axis A1 to expel the substance 12 in the reservoir 28 out through the needle. Proximal movement of the stopper 22 along the longitudinal axis A1 may also be possible in at least some configurations, for example, to draw fluid into the reservoir 28. The stopper 22 may slidably and / or10989-W001-SEC sealingly contact the inner surface 26a of wall 26 of the barrel 20 such that, for example, the substance 12 in the reservoir 28 is prevented or inhibited from leaking past the stopper 22 when the stopper 22 moves in the distal direction, as well as prior to and / or after such movement. As an example, the stopper 22 may form a fluid-tight seal with the inner surface 26a of wall 26 of the barrel 20. In some embodiments, the stopper 22 may include one or more radially outwardly extending protrusions or ribs configured to sealingly and / or slidably engage the interior surface of the barrel 20. The stopper 22 may be constructed of any suitable material or combination of materials which facilitate the sealing, sliding, and / or other function(s) of the stopper 22. In some embodiments, the stopper 22 may be made, partially or entirely, of an elastomeric material such as rubber, including, for example, butyl rubber, chlorobutyl rubber, bromobutyl rubber, and / or silicone rubber. In alternative embodiments, including, for example, certain embodiments where the device 10 is a vial, the stopper 22 may be omitted.

[0034] In some embodiments, the needle of the container 14 may be fixedly coupled with the distal end 20b of the barrel 20 and / or in fluid communication with the reservoir 28. A proximal end of the needle may be adhered, staked, or otherwise rigidly mechanically connected to, or integrally formed with, the wall 26 of the barrel 20 such that the needle cannot move with respect to (i.e., relative to) the wall 26 of the barrel 20. A distal end of the needle may include a sharpened tip or other pointed geometry allowing the distal end of the needle to pierce and / or penetrate through a patient’s skin, subcutaneous tissue, and / or other tissue of the patient. The needle may be hollow and / or include an axial passage that is parallel to and / or coaxial with the longitudinal axis A1 of the container 14. One or more openings may be formed in the distal end of the needle to allow drug to flow out of the needle into the patient during operation of the device 10. The needle may be made of metal, plastic, and / or any other suitably rigid material. In alternative embodiments, the needle may be omitted or at least not initially coupled with the barrel 20. In certain such alternative embodiments, the distal end 20b of the barrel 20 may be coupled with and / or form a nozzle or other fluid path member including, for example, a male or female Luer Lock fitting.

[0035] In some embodiments, prior to use, the distal end of the needle may be covered with the removable needle shield 24, as seen in Figs. 1 and 2. The removable needle shield 24 may be configured as a removable sterile barrier and / or configured to protect the needle from contaminants in an external or ambient environment prior to operation of the device 10. The patient or user may be required to remove the removable needle shield 24 from the device 10 prior to operating the device 10 to perform a drug injection. In some embodiments, the removable needle shield 24 may be configured as a rigid needle shield (RNS) and / or a non-rigid needle shield (nRNS).

[0036] In some embodiments, the film 16 may be formed of one or more layers, anyone or combination of which may wrap around at least a portion of the container 14, including, for example, the barrel 20 of the container 14. In some embodiments, the film 16 may wrap completely or substantially completely around at least a portion of the container 14, circumscribing or substantially circumscribing the at least a portion of the container 14. In some embodiments, the film 16 may wrap completely around the container 14 one or more times. In some embodiments, anyone or combination of the layer(s) forming the film 16 may be made partially or entirely of one or more flexible materials to facilitate, for example, wrapping the film 14 around the container 14. Furthermore, in some embodiments, any one or combination of the layer(s) forming the film 16 may be at least partially transparent (for example, semi-transparent and / or translucent) to facilitate, for example, viewing the substance 12, stopper 22, and / or other component(s) in the container 14 and / or information and / or instructions on an inner surface of the label 18. The transparency of the film 16 may also facilitate determining, by a person and / or machine viewing the container 14, a fill level of the reservoir 28, a position of the stopper 22 in the reservoir 28, the presence of particulates and / or bubbles in the substance 12 in the reservoir 28, and / or other aspects of the interior of the container 14.

[0037] As illustrated in Fig. 4, in some embodiments, the film 16 may include a first adhesive layer 40 and a tinted layer 42. The first adhesive layer 40 may be configured to couple (for example, adhere) the film 16 with the outer surface 26b of wall 26 of the barrel 20 of the container 14. In some embodiments, the first adhesive layer 40 may be transparent and / or colorless or substantially transparent and / or substantially colorless. In some embodiments, the first adhesive layer 40 may be made, partially10989-W001-SEC or entirely, of the Fasson® S3000 adhesive and / or any other suitable adhesive. In alternative embodiments, the first adhesive layer 40 may be omitted and instead the film 16 may be coupled with the container 14 via one or more fasteners and / or an adhesive which is applied to the outer surface 26b of the wall 26 of the container 14 prior to applying the film 14 to the outer surface 26b of the wall 26 of the container 14.

[0038] The tinted layer 42 of the film 16 may be configured to prevent or substantially inhibit a viewer from visually distinguishing whether the substance 12 disposed in the reservoir 28 of the container 14 corresponds to the drug or placebo. In some embodiments, this aspect of the tinted layer 42 may be provided, at least in part, by constructing the tinted layer 42 of one or more materials having one or more optical characteristics selected to prevent or substantially inhibit a viewer from visually distinguishing whether the substance 12 disposed in the reservoir 28 of the container 14 corresponds to the drug or placebo. Such optical characteristic(s) of the tinted layer 42 may include, for example, any one or combination of its: color, opacity, thickness, reflectivity, surface finish, light diffusivity, and other optical characteristic(s). In some embodiments, a color of the tinted layer 42 may be selected to match or substantially match, or be a darker shade of, the color of a particular drug stored in the container 14. Accordingly, when viewing the drug or placebo through the tinted layer 42, a viewer may see the same color, or substantially the same color, regardless of whether the drug or placebo is present in the container 14.

[0039] In some embodiments, the color of the tinted layer 42 may be blue, including, for example, a light shade of blue and / or any other shade of blue. Any other color and / or shade of color is / are also possible for the tinted layer 42 depending on, for example, what a particular application may require or benefit from. In some embodiments, a wavelength of the color of the tinted layer 42 may be within a range between approximately (for example, ±10%) 400 - 500 nanometers, or within a range between approximately (for example, ±10%) 425 - 500 nanometers, or within a range between approximately (for example, ±10%) 450 -500 nanometers, or within a range between approximately (for example, ±10%) 450 - 495 nanometers, or within a range between approximately (for example, ±10%) 460 - 495 nanometers, or within a range between approximately (for example, ±10%) 470 - 495 nanometers, or within a range between approximately (for example, ±10%) 480 - 495 nanometers, or within a range between approximately (for example, ±10%) 480 - 490 nanometers, or any other suitable wavelength range. In some embodiments, the color of the tinted layer 42 may correspond to Pantone Matching System ® (PMS) color 277.

[0040] In any of the embodiments described herein, the placebo may appear clear and / or colorless when viewed under at least certain conditions (including, for example, when viewed against a black and / or dark background) and / or the drug may appear opalescent and / or light blue when viewed under at least certain conditions (including, for example, when viewed against a black and / or dark background).

[0041] In some embodiments, the film 16, or at least the tinted layer 42 of the film 16, may cover only a limited portion of the outer surface 26b of the wall 26 of the barrel 20 of the container 14. In certain such embodiments, the film 16, or at least the tinted layer 42 of the film 16, may cover a portion, or the entirety, of the outer surface 26b of the wall 26 of the body portion 30 of the barrel 20, without also covering the outer surface 26b of the wall 26 of the shoulder portion 32 of the barrel 20 and / or the outer surface 26b of the wall 26 of the neck portion 34 of the barrel 20. By leaving the shoulder portion 32 and / or neck portion 34 of the barrel 20 uncovered, the film 16, or at least the tinted layer 42 of the film 16, may be configured to facilitate visual inspection of the substance 12 in the reservoir 28, because the film 16, or at least the tinted layer 42 of the film 16, may not visually obscure the substance 12 when the substance 12 is viewed through the shoulder portion 32 and / or the neck portion 34 of the barrel 20. Such a configuration may be beneficial or essential for a visual inspection to determine whether particulates, bubbles, and / or other defects are present in the substance 12 in the reservoir 28. Furthermore, such a configuration may require an individual and / or machine to look through the shoulder portion 32 and / or neck portion 34 of the barrel 20 (which may be relatively small as compared to the body portion 30 of the barrel 20) in order to have a view of the substance 12 in the reservoir 28 which is unaltered by the film 16. This relatively small viewing window may prevent or inhibit individuals who do not regularly handle and / or have the ability to closely inspect the device 10 (including, for example, participants in a clinical trial) from viewing10989-W001-SEC the substance 12 in the reservoir 28 without visual modification, as their view is obscured by the film 16, or at least the tinted layer 42 of the film 16, covering the body portion 30 of the barrel 20. In alternative embodiments, the film 16, or at least the tinted layer 42 of the film 16, may cover the entirety, or substantially the entirety, of the outer surface 26b of the wall 26 of the entire barrel 20.

[0042] In some embodiments, in addition to or as an alternative to its visual obscuring function, the film 16 may be configured to shield or substantially shield the substance 12 from UV light potentially present in the external environment. In certain such embodiments, the tinted layer 42 may be configured to shield or substantially shield the substance 12 from UV light. Additionally or alternatively, the film 16 may include one or more other layers configured to shield or substantially shield the substance 12 from UV light. By shielding or substantially shield a drug from UV light, the film 16 may facilitate long term storage of the drug in the container 14, including, for example, in cases where the container 14 is intended for commercial use.

[0043] In some embodiments, the tinted layer 42 may be made, partially or entirely, of any one or combination of: polyethylene terephthalate (PET), biaxially oriented polypropylene (BOPP), and any other suitable material. In some embodiments, a thickness of the film 16 and / or a thickness of the tinted layer 42 may be: equal to approximately (for example, ±10%) 2.0 mil, or equal to approximately (for example, ±10%) 1.5 mil, or equal to approximately (for example, ±10%) 3.5 mil, or within a range between approximately (for example, ±10%) 1.5 - 10.0 mil, or within a range between approximately (for example, ±10%) 1.5 -5.0 mil, or within a range between approximately (for example, ±10%) 1.5 - 3.5 mil, or any other suitable thickness.

[0044] In some embodiments, the tinted layer 42 may be made, partially or entirely, of one or more inks which is / are printed on a substrate. In certain such embodiments, the ink(s) may be thermally printed on the substrate and / or cured using UV light (for example, utilizing a UV Flexo printing process). Furthermore, in certain such embodiments, the substrate may be made, partially or entirely, of any one or combination of: polyethylene terephthalate (PET), biaxially oriented polypropylene (BOPP), and any other suitable material.

[0045] In some embodiments, the film 16 or the tinted layer 42 of the film 16 may have length LF which is parallel or substantially parallel to the longitudinal axis A1 of the container 14 when the film 16 is coupled with the container 14. In certain such embodiments, the length LF of the film 16 or the tinted layer of the film 16 may be: within a range between approximately (for example, ±10%) 1.0 - 10.0 in, or within a range between approximately (for example, ±10%) 1.0 -5.0 in, or within a range between approximately (for example, ±10%) 1.0 - 2.5 in, or within a range between approximately (for example, ±10%) 1.0 - 2.0 in, or less than or equal to approximately (for example, ±10%) 10.0 in, or less than or equal to approximately (for example, ±10%) 5.0 in, or less than or equal to approximately (for example, ±10%) 2.5 in, or less than or equal to approximately (for example, ±10%) 2.0 in, or equal to approximately (for example, ±10%) 1.875 in, or any other suitable dimension.

[0046] In some embodiments, the film 16 or the tinted layer 42 of the film 16 may have a width WF which is perpendicular or substantially perpendicular to the length LF of the film 16 or the tinted layer 42 of the film 16 when the film 16 or the tinted layer 42 of the film 16 lays flat (for example, prior to being coupled with the container 14), as seen in Fig. 4. In certain such embodiments, the width WF of the film 16 or the tinted layer of the film 16 may be: equal to or substantially equal to a circumference of the body portion 30 of the barrel 20 of the container 14, or less than the circumference of the body portion 30 of the barrel 20 of the container 14, or larger than the circumference of the body portion 30 of the barrel 20 of the container 14, or any other suitable dimension.

[0047] In some embodiments, the label 18 may be formed of one or more layers, anyone or combination of which may wrap around at least a portion of the container 14, including, for example, the barrel 20 of the container 14. In some embodiments, the label 18 may wrap completely or substantially completely around at least a portion of the container 14, circumscribing or substantially circumscribing the at least a portion of the container 14. In some embodiments, the label 18 may wrap around: less than or equal to approximately (for example, ±10%) 90% of the circumference of the circumference of the body portion 30 of the barrel 20 of the container 14, or less than or equal to approximately (for example, ±10%) 75% of the circumference of the10989-W001-SEC circumference of the body portion 30 of the barrel 20 of the container 14, or less than or equal to approximately (for example, ±10%) 60% of the circumference of the circumference of the body portion 30 of the barrel 20 of the container 14, or less than or equal to approximately (for example, ±10%) 50% of the circumference of the circumference of the body portion 30 of the barrel 20 of the container 14, or with a range between approximately (for example, ±10%) 25 - 75% of the circumference of the body portion 30 of the barrel 20 of the container 14, or any other suitable percentage of the circumference of the body portion 30 of the barrel 20 of the container 14. In some embodiments, anyone or combination of the layer(s) forming the label 18 may be made partially or entirely of one or more flexible materials to facilitate, for example, wrapping the label 18 around the container 14.

[0048] As depicted in Fig. 4, in some embodiments, the label 18 may include a display portion 44, a window 46, a second adhesive layer 48, and a third adhesive layer 50. Additional or fewer elements are also possible in alternative embodiments. The second adhesive layer 48 may be configured to couple (for example, adhere) the display portion 44 of the label 18 with, for example: the tinted layer 42 and / or another portion of the film 16 and / or the outer surface 26b of wall 26 of the barrel 20 and / or another portion of the container 14. The third adhesive layer 50 may be configured to couple (for example, adhere) the window 46 with, for example: the tinted layer 42 and / or another portion of the film 16, the outer surface 26b of wall 26 of the barrel 20 and / or another portion of the container 14, and / or the display portion 44 and / or another portion of the label 18. In some embodiments, the second adhesive layer 48 and / or the third adhesive layer 50 may be transparent and / or colorless or substantially transparent and / or substantially colorless. In some embodiments, the second adhesive layer 48 and / or the third adhesive layer 50 may be made, partially or entirely, of the Fasson® S3000 adhesive and / or any other suitable adhesive. In alternative embodiments, the second adhesive layer 48 and / or the third adhesive layer 50 may be omitted.

[0049] In some embodiments, such as the one illustrated in Fig. 4, the second adhesive layer 48 may cover a limited portion of a first panel 52 of the display portion 44 of the label 18; whereas, in other embodiments, the second adhesive layer 48 may cover the entire, or substantially the entire, first panel 52 of the display portion 44 of the label 18 and / or the second panel 54 of the display portion 44 of the label 18.

[0050] In some embodiments, such as the one illustrated in Fig. 4, the third adhesive layer 50 may cover only the window 46; whereas, in other embodiments, the third adhesive layer 50 may additionally or alternatively cover an underside of the second panel 54 of the display portion 44 of the label 18.

[0051] In some embodiments, the window 46 may be disposed adjacent to and / or coupled with an end of the second panel 54 of the display portion 44 of the label 18. In some embodiments, the window 46 may include: an opening (for example, a cut-out) formed in the second panel 54 of the display portion 44 of the label 18, and / or a layer of transparent or substantially transparent material. In some embodiments, the window 46 may be omitted.

[0052] In some embodiments, including the embodiment shown in Fig. 1, when the label 18 is wrapped around the container 14, the window 46 may overlap, couple with, and / or directly contact the tinted layer 42 of the film 16, such that, for example, a viewer can see through the window 46 and / or the tinted layer 42 of the film 16 to view the substance 12 in the reservoir 28 of the container 14. In embodiments where the film 16 does not wrap entirely around the container 14, the window 46 may couple with and / or directly contact the outer surface 26b of the wall 26 of the barrel 20 of the container 14.

[0053] In some embodiments, readable information and / or instructions relating to the substance 12 in the reservoir 28 of the container 14 may be disposed on (for example, printed on and / or adhered to) the display portion 44 of the label 18. In embodiments where the substance 12 is a drug or placebo, the readable information and / or instructions may include any one or combination of: drug identification information (for example, a name of the drug in the container, active pharmaceutical ingredient (API), a volume of the drug in the container, a concentration of the drug in the container, an amount of API per unit volume, branding information, etc.); dosage information (for example, a volume or weight of the drug in the container which should be administered per dose, frequency of dosing, etc.); expiration and lot information; manufacturer information; regulatory information; storage instructions; preparation instructions (for example, detailed steps on how to dilute or reconstitute drug in the10989-W001-SEC container); instructions for use (IFU); and other types of information and / or instructions relating the drug or placebo. In some embodiments, the readable information and / or instructions may be printed and / or adhered to the display portion 44, including, for example, the bottom and / or top surfaces of the first panel 52 and / or the bottom and / or top surfaces of the second panel 54.

[0054] In some embodiments, including the embodiment shown in Figs. 1-4, the label 18 may be configured as a booklet which can be, for example, unfolded by a user to reveal a portion of, or all of, the mentioned readable information and / or instructions. In certain such embodiments, one or more portions of the label 18 may be folded along a lengthwise direction of the label 18 (for example, a direction which is parallel or substantially parallel to the longitudinal axis A1 of the container 14 when the label 18 is coupled with the container 14) to define one or more panels. In the illustrated embodiment, the label 18 is folded at least once to define the first panel 52 and the second panel 54. In the first or storage state, the second panel 54 may lay on top of the first panel 52 and / or be flush or substantially flush with the first panel 52, as seen in Fig. 1. Later, a user may pull the second panel 54 away from the first panel 52 to reveal some or all of the readable information and / or instructions, which may printed or other disposed on the bottom surface of the panel 54 and / or the top surface of the first panel 52. This action may result in the second state shown in Fig. 2.

[0055] In some embodiments, the label 18 may include a pull tab 56 configured to allow a user to peel or otherwise pull at least a portion of the label 18 away from the container 14 in order to, for example, view readable information and / or instructions included on an inner surface or other inner portion of the label 18. In certain such embodiments, the pull tab 56 may not be adhered to another component, such that, for example, a user can easily grip and pull the pull tab 56 with his or her finger(s) and / or thumb. In some embodiments, the pull tab 56 may be adjacent to and / or integrally formed with an end of the second panel 54 of the display portion 44 of the label 18, as seen in Figs. 1-3. In other embodiments, the pull tab 56 may be omitted.

[0056] In some embodiments, the display portion 44 and / or the window 46 of the label 18 may be made, partially or entirely, of any one or combination of: polyethylene terephthalate (PET), bi axi ally oriented polypropylene (BOPP), and any other suitable material. In some embodiments, a thickness of the label 18, the display portion 44 of the label 18, and / or the window 46 of the label may be: equal to approximately (for example, ±10%) 2.0 mil, or equal to approximately (for example, ±10%) 1.5 mil, or equal to approximately (for example, ±10%) 3.5 mil, or within a range between approximately (for example, ±10%) 1.5 - 10.0 mil, or within a range between approximately (for example, ±10%) 1.5 - 5.0 mil, or within a range between approximately (for example, ±10%) 1.5 -3.5 mil, or any other suitable thickness.

[0057] In some embodiments, the display portion 44 of the label 18 may be made, partially or entirely, of one or more inks which is / are printed on a substrate. In certain such embodiments, the ink(s) may be thermally printed on the substrate and / or cured using UV light (for example, utilizing a UV Flexo printing process). Furthermore, in certain such embodiments, the substrate may be made, partially or entirely, of any one or combination of: polyethylene terephthalate (PET), biaxially oriented polypropylene (BOPP), and any other suitable material. Furthermore, in certain such embodiments, the mentioned ink(s) and / or substrate material(s) may render the display portion 44 of the label 18 opaque and / or substantially opaque. Furthermore, in certain such embodiments, the mentioned ink(s) may include: an opaque white ink (for example, Solaris Platinum white, UV Flexo ultra opaque white, a PW-100 ink, and / or a high opacity white), an opaque black ink, and / or any other suitable color and / or opacity.

[0058] In some embodiments, the display portion 44 of the label 18 may be white and / or opaque, and / or the readable information and / or instructions may be black and / or opaque.

[0059] In some embodiments, the label 18 or the display portion 44 of the label 18 may have length LL which is parallel or substantially parallel to the longitudinal axis A1 of the container 14 when the label 18 is coupled with the container 14. In certain such embodiments, the length LL of the label 18 or the display portion 44 of the label 18 may be: within a range between approximately (for example, ±10%) 1.0 - 10.0 in, or within a range between approximately (for example, ±10%) 1.0 - 5.0 in, or within a range between approximately (for example, ±10%) 1.0 -2.5 in, or within a range between approximately (for example,10989-W001-SEC ±10%) 1.0 -2.0 in, or less than or equal to approximately (for example, ±10%) 10.0 in, or less than or equal to approximately (for example, ±10%) 5.0 in, or less than or equal to approximately (for example, ±10%) 2.5 in, or less than or equal to approximately (for example, ±10%) 2.0 in, or equal to approximately (for example, ±10%) 1.875 in, or any other suitable dimension. In some embodiments, the length LL of the label 18 may be less than or equal to the length LF of the film 16.

[0060] In some embodiments, the first panel 52 of the display portion 44 of the label 18 may have a width WL1 which is perpendicular or substantially perpendicular to the length LL of the label 18 or the display portion 44 of the label 18 when the label 18 is laid flat, as seen in Fig. 4.

[0061] In some embodiments, the second panel 54 of the display portion 44 of the label 18 may have a width WL2 which is perpendicular or substantially perpendicular to the length LL of the label 18 or the display portion 44 of the label 18 when the label 18 is laid flat, as seen in Fig. 4.

[0062] In some embodiments, the second adhesive layer 48 of the label 18 may have a width WL3 which is perpendicular or substantially perpendicular to the length LL of the label 18 or the display portion 44 of the label 18 when the label 18 is laid flat, as seen in Fig. 4.

[0063] In some embodiments, the third adhesive layer 50 of the label 18 and / or the window 46 of the label 18 may have a width WL4 which is perpendicular or substantially perpendicular to the length LL of the label 18 or the display portion 44 of the label 18 when the label 18 is laid flat, as seen in Fig. 4.

[0064] In some embodiments, the width WF of the film 16 or the tinted layer 42 of the film 16 may be larger than or equal to, or substantially equal to: the width WL1 of the first panel 52 of the display portion 44 of the label 18, the width WL2 of the second panel 54 of the display portion 44 of the label 18, and / or a combination of the widths WL1 and WL2.

[0065] In some embodiments, the width WL2 of the second panel 54 of the display portion 44 of the label 18 may be equal or larger than: the width WL1 of the first panel 52 of the display portion 44 of the label 18, and / or the circumference of the body portion 30 of the barrel 20 of the container 14.

[0066] In some embodiments, the width WL3 of the second adhesive layer 48 of the label 18 may be less than or equal to, or substantially equal to, the width WL1 of the first panel 52 of the display portion 44 of the label 18.

[0067] In some embodiments, the width WL4 of the third adhesive layer 50 of the label 18 and / or the window 46 of the label 18 may be less than or equal to, or substantially equal to, the width WL2 of the second panel 54 of the display portion 44 of the label 18.

[0068] In some embodiments, the film 16 and / or label 18 may be cut from a sheet during manufacturing and / or at another time prior to being coupled with the container 14. Fig. 3 illustrates an example of such a sheet. Prior to the configuration shown in Fig. 3, the sheet may be wound into a roll, in some embodiments. A user and / or machine may unwind the roll and cut away one or more sections of the sheet to form the assembly including the film 16 and the label 18. Subsequently, this assembly may be coupled with the container 14 to form the configuration shown in Fig. 1. In Fig. 3, two labels, denoted with reference numerals 18 and 18a are disposed on the film 16, though additional labels disposed on the film are also possible. Elements of the label 18a which are similar or identical in structure, configuration, and / or function as corresponding elements of the label 18 are denoted with the same reference numerals, except appended with an “a” in Fig. 3.

[0069] Turning to Figs. 5-8, illustrated is another embodiment of a device 110 for storing a substance 112 which, in some embodiments, may be a drug or placebo. Various elements of the device 110 illustrated in Figs. 5-8 may be similar or identical in structure, configuration, and / or function to elements of the device 10 described above in conjunction with Figs. 1-4. Such elements are assigned with the same reference numeral as used in Figs. 1-4, except incremented by 100. A description of at least some of these elements is abbreviated or eliminated in the interest of conciseness. Details of the structure, configuration, and / or function which differentiate the embodiment of the device 110 illustrated in Figs. 5-8 from the embodiment of the device 10 in Figs. 1-4 are the primary focus of the discussion below.10989-WC01-SEC

[0070] Unlike the label 18, the label 118, or at least the display portion 114 of the label 118, may not be folded. As seen in Fig.8, the display portion 144 of the label 118 may include a single planar (for example flat) or substantially planar panel coupled with and / or directly contacting the film 116. In some embodiments, the display portion 144 may include one or more layers of material. In some embodiments, an adhesive layer 148 may be disposed between and / or couple the display portion 144 and the tinted layer 142. In other embodiments, the adhesive layer 148 may be omitted and instead, for example, the display portion 114 may be printed directly on the tinted layer 142.

[0071] In some embodiments, the dimensioning of the film 116 may be similar or identical to the dimensioning of the film 16 described above. Furthermore, in some embodiments, the dimensioning of the label 118 may be similar or identical to the dimensioning of the label 118 described above, except, in certain embodiments, for the differences described below.

[0072] In some embodiments, the film 116, or at least the tinted layer 142 of the film 116, may have a width WF which is perpendicular or substantially perpendicular to the length LL of the label 118 when the label 118 is laid flat, as seen in Fig. 8. Furthermore, in some embodiments, the display portion 144 of the label may have a width WL1 which is perpendicular or substantially perpendicular to the length LL of the label 118 when the label 118 is laid flat, as seen in Fig. 8. Furthermore, in some embodiments, the window 146 of the label 118 may have a width WL1 which is perpendicular or substantially perpendicular to the length LL of the label 118 when the label 118 is laid flat, as seen in Fig. 8.

[0073] In some embodiments, width WF of the film 116 or the tinted layer 142 of the film 116 may be larger than or equal to, or substantially equal to: the width WL1 of the display portion 144 of the label 118, the width WL2 of the window 146 of the label 118, and / or a combination of the widths WL1 and WL2.

[0074] Furthermore, in some embodiments, the width WL2 of the window 146 of the label 118 may be less than the width WL1 of the display portion 114 of the label 118.

[0075] All features described herein, including in the specification, claims, abstract, and drawings, and all the steps in any method or process described herein, may be combined in any combination, except combinations where one or more of the features and / or steps are mutually exclusive.

[0076] As will be recognized, the systems and methods according to the present disclosure may have one or more advantages relative to conventional technology, any one or more of which may be present in a particular embodiment in accordance with the features of the present disclosure included in that embodiment. Other advantages not specifically listed herein may also be recognized as well.

[0077] The above description describes various devices, assemblies, components, subsystems and methods for use related to a drug delivery device. The devices, 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, biologies, 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 liquid 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.

[0078] 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.

[0079] 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,10989-W001-SEC hu-MetG-CSF), UDENYCA® (pegfilgrastim-cbqv), Ziextenzo® (LA-EP2006; pegfilgrastim-bmez), or FULPHILA (pegfilgrastim-bmez).

[0080] 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.

[0081] 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, related 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 h LL2 gamma-chain disulfide linked to a human-mouse monoclonal h LL2 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 I gG2 antibodies, including but not limited to fully human I gG2 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,10989-W001-SEC 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 0X40 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-1 a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta);Campath® (alemtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-a4B7 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, 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, GDP 870); Soliris™ (eculizumab); pexelizumab (anti-C5 complement); Numax® (MEDI-524); Lucentis® (ranibizumab); Panorex® (17-1 A, 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-TNFa monoclonal antibody); Reopro® (abciximab, anti-GP llb / llia receptor monoclonal antibody); Actemra® (anti-l L6 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-a4integrin 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 IgG 1 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 IgG 1 Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-l L-2Ra mAb); Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-lg); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); BR2-Fc (huBR3 / huFc fusion protein, soluble BAFF antagonist); ONTO 148 (golimumab, anti-TNFa mAb); HGS-ETR1 (mapatumumab; human anti-TRAIL Receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-CD20 human mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-a5 1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 mAb and VEGFR-1 (IMC-18F1); anti-BR3 mAb; antiCD. 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 I Fibrogen (FG-3019); anti-CTLA4 mAb; anti-eotaxin1 mAb (CAT-213); anti-FGF8 mAb; anti-ganglioside GD2 mAb; antiganglioside GM2 mAb; anti-GDF-8 human mAb (MYO-029); anti-GM-CSF Receptor mAb (CAM-3001); anti-HepC mAb (HuMax HepC); anti-l FNa mAb (MEDI-545, MDX-198); anti-IGF1R mAb; anti-IGF-1 R mAb (HuMax-Inflam); anti-IL12 mAb (ABT-874); anti-IL12 / IL23 mAb (CNTO 1275); anti-l L13 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 / hCGfJ mAb (MDX-1307); anti-mesothelin dsFv-PE38 conjugate (CAT-5001); anti-PD1mAb (MDX-1106 (ONO-4538)); anti-PDGFRa10989-W001-SEC antibody (IMC-3G3); anti-TGFB 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).

[0082] 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; OrienXOW; 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 a monoclonal antibody, biosimilar to 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 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-[(1 S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1 ,3-dioxo- 1 H-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 HCI, KAI-4169) or another product containing etelcalcetide HCI 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 I gG 1 ) . 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 Sotorasib10989-W001-SEC (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 I gG 1 kappa antibody), a biosimilar candidate to Stelara®, or another product that contains human I gG 1 kappa antibody and / or binds to the p40 subunit of human cytokines interleukin (I L)- 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 IgG 1 ), a biosimilar candidate to Humira®, or another product that contains human mab anti-TNF human lgG1. 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 4-1 BB-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 may 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 vl 11 (EGFRvlll) 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 with10989-W001-SEC 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.

[0083] Although the drug delivery devices, 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.

[0084] 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

10989-W001-SEC What is claimed is:

1. A device for storing a drug or placebo, the device comprising:a container comprising a wall having an inner surface and an outer surface, the inner surface at least partially defining a reservoir for storing the drug or placebo;a film which is at least partially transparent and comprises:an adhesive layer configured to couple the film with the outer surface of the wall of the container, and a tinted layer configured to prevent or substantially inhibit a viewer from visually distinguishing whether at least one substance disposed in the reservoir corresponds to the drug or placebo; anda label coupled with the film and comprising readable information and / or instructions relating to the drug or placebo.

2. The device of claim 1, wherein at least a color of the tinted layer is selected to prevent or substantially inhibit the viewer from visually distinguishing whether at least one substance disposed in the reservoir corresponds to the drug or placebo.

3. The device of claim 2, wherein the color of the tinted layer is blue or substantially blue.

4. The device of any one of claims 2 or 3, wherein a wavelength of the color of the tinted layer is within a range between approximately 450 - 500 nanometers.

5. The device of any one of claims 1 to 4, wherein the tinted layer wraps around at least a portion of the container, circumscribing or substantially circumscribing the at least a portion of the container.

6. The device of any one of claims 1 to 4, wherein the label wraps around the container without completely circumscribing the container.

7. The device of any one of claims 1 to 6, wherein the label covers less than an entirety of the film such that the at least one substance disposed in the reservoir is visible through an uncovered portion of the film.

8. The device of any one of claims 1 to 7, wherein at least at a first portion of the label is opaque or substantially opaque and comprises the readable information and / or instructions relating to the drug or placebo.

9. The device of claim 8, wherein at least a second portion of the label is at least partially transparent.

10. The device of any one of claims 1 to 9, wherein the container comprises a body portion, a neck portion, and a shoulder portion disposed at least partially between the body portion and the neck portion.

11. The device of claim 10, wherein the film does not cover the shoulder portion of the container.

12. The device of any one of claims 1 to 11, wherein at least a portion of the label is folded along a lengthwise direction of the label to define at least a first panel and a second panel, the first panel being at least partially disposed between the film and the second panel.10989-W001-SEC 13. The device of claim 12, comprising a second adhesive layer configured to couple the first panel with at least one of the film and the outer surface of the wall of the container.

14. The device of any one of claims 12 or 13, wherein a width of the second panel is larger than a width of the first panel.

15. The device of any one of claims 12 to 14, wherein the label comprises a window.

16. The device of claim 15, wherein the window is adjacent to the second panel and made at least partially of an at least partially transparent material.

17. The device of any one of claims 15 or 16, comprising a third adhesive layer configured to couple the window with at least one of the film, the outer surface of the wall of the container, and the second panel of the label.

18. The device of any one of claims 1 to 17, wherein the device is configured to deliver the at least one substance to a patient.

19. The device of any one of claims 1 to 18, wherein the container comprises a stopper configured to move with respect to the wall to expel the at least one substance from the container.

20. The device of any one of claims 1 to 19, wherein at least a portion of the wall of the container is cylindrical or substantially cylindrical.

21. The device of any one of claims 1 to 20, wherein the container comprises a needle coupled with the wall.

22. The device of any one of claims 1 to 21, wherein the container comprises at least one of a syringe and a prefilled syringe.

23. The device of any one of claims 1 to 22, comprising the at least one substance, wherein the at least one substance comprises a drug having an opalescent appearance.

24. An assembly for a container configured to store a drug or placebo, the assembly comprising:a film which is at least partially transparent and comprises:an adhesive layer configured to couple the film with an outer surface of the container, and a tinted layer configured to prevent or substantially inhibit a viewer from visually distinguishing whether at least one substance disposed in a reservoir of the container corresponds to the drug or placebo; anda label coupled with the film and comprising readable information and / or instructions relating to the drug or placebo.

25. The assembly of claim 24, wherein at least a color of the tinted layer is selected to prevent or substantially inhibit the viewer from visually distinguishing whether at least one substance disposed in the reservoir corresponds to the drug or placebo.10989-W001-SEC 26. The assembly of claim 25, wherein the color of the tinted layer is blue or substantially blue.

27. The assembly of any one of claims 25 or 26, wherein a wavelength of the color of the tinted layer is within a range between approximately 450 - 500 nanometers.

28. The assembly of any one of claims 24 to 27, wherein the tinted layer wraps around at least a portion of the container, circumscribing or substantially circumscribing the at least a portion of the container.

29. The assembly of any one of claims 24 to 27, wherein the label wraps around the container without completely circumscribing the container.

30. The assembly of any one of claims 24 to 29, wherein the label covers less than an entirety of the film such that the at least one substance disposed in the reservoir is visible through an uncovered portion of the film.

31. The assembly of any one of claims 24 to 30, wherein at least at a first portion of the label is opaque or substantially opaque and comprises the readable information and / or instructions relating to the drug or placebo.

32. The assembly of claim 31, wherein at least a second portion of the label is at least partially transparent.

33. The assembly of any one of claims 24 to 32, wherein the container comprises a body portion, a neck portion, and a shoulder portion disposed at least partially between the body portion and the neck portion.

34. The assembly of claim 33, wherein the film does not cover the shoulder portion of the container.

35. The assembly of any one of claims 24 to 34, wherein at least a portion of the label is folded along a lengthwise direction of the label to define at least a first panel and a second panel, the first panel being disposed at least partially between the film and the second panel.

36. The assembly of claim 35, comprising a second adhesive layer configured to couple the first panel with at least one of the film and the outer surface of the container.

37. The assembly of any one of claims 35 or 36, wherein a width of the second panel is larger than a width of the first panel.

38. The assembly of any one of claims 35 to 37, wherein the label comprises a window.

39. The assembly of claim 38, wherein the window is adjacent to the second panel and made at least partially of an at least partially transparent material.

40. The assembly of any one of claims 38 or 39, comprising a third adhesive layer configured to couple the window with at least one of the film, the outer surface of the container, and the second panel of the label.

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