Secondary packaging configured to hold an apparatus for administering a drug and / or to prevent its inadvertent actuation

Abstract

A secondary packaging configured to prevent inadvertent actuation of a device for administering a drug includes a body that defines a cavity for at least partially surrounding the device for administering the drug. An active polymer component can optionally be placed within an internal compartment of the secondary packaging. The active polymer component can include a mixture of 3A molecular sieves, a base polymer, and optionally a channeling agent.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Application No. 63 / 484,097, filed on February 9, 2023, entitled "SECONDARY PACKAGING CONFIGURED TO HOLD AND / OR PREVENT INADVERTENT ACTUATION OF A DEVICE FOR ADMINISTERING MEDICINE OR A DRUG", and U.S. Provisional Application No. 63 / 367,753, filed on July 6, 2022, entitled "PACKAGING CONFIGURED TO PREVENT INADVERTENT ACTUATION OF A DEVICE DESIGN TO ADMINISTER MEDICINE OR A DRUG", the entire disclosures of which are incorporated herein by reference.

[0002] The technology of the present disclosure generally relates to packaging configured to hold a device designed to administer a content such as, but not limited to, a drug, or to prevent inadvertent opening and / or actuation of the device. More specifically, in any one embodiment, the technology of the present disclosure relates to secondary packaging configured to hold an inhaler therein or to prevent inadvertent opening and / or actuation of the inhaler.

Background Art

[0003] Devices for administering or dispensing a content such as a drug are often stored or transported in secondary packaging. This secondary packaging protects the device(s), and for example, when the device is removed from the secondary packaging for use by an end - user or a medical professional, it can be discarded or reused.

[0004] The secondary packaging can contain a desiccant plug inside, as disclosed in U.S. Patent No. 10,765,602. The desiccant can maintain or extend the effective life of the drug within the device.

[0005] The secondary packaging may sometimes and / or in certain situations or uses accidentally open. If the secondary packaging accidentally opens, the device(s) inside can be unnecessarily or undesirably exposed to the external environment. Such exposure can waste or degrade the contents of the device (e.g., when the drug in the delivery device degrades in the presence of moisture), damage the device, or place it in an inappropriate location. This is particularly problematic when the drug is expensive or difficult to obtain, or when it is difficult for the user to quickly and reliably obtain an alternative drug necessary for the treatment of a critical condition. SUMMARY OF THE INVENTION

[0006] To overcome the above and other disadvantages of the prior art, the applicant has investigated and identified various ways to prevent accidental opening of the secondary packaging.

[0007] The applicant unexpectedly discovered that certain desiccant formulations used within the secondary packaging can contribute to accidental opening of the packaging lid. In particular, the applicant discovered that some desiccant formulations can cause an increased internal pressure within the sealed secondary packaging. This pressure increase can cause or contribute to accidental opening of the secondary packaging lid.

[0008] Accordingly, the applicant unexpectedly discovered that by using a specific type of desiccant formulation, the pressure generated within the sealed secondary packaging can be reduced or assisted in being reduced, thereby preventing or at least reducing the likelihood of accidental opening of the secondary packaging lid.

[0009] An object of any one embodiment of the technology of the present disclosure is to provide a cap and container assembly that safely seals and encloses a pharmaceutical administration device therein, and at the same time includes components that prevent premature discharge of the pharmaceutical and / or opening of the cap with respect to the container assembly.

[0010] Another object of any one embodiment of the technology of the present disclosure is to provide a pharmaceutical delivery system that houses or stores the pharmaceutical administration device so that the pharmaceutical administration device can be easily and quickly removed from the container for use.

[0011] The following detailed description of the technology of the present disclosure will be better understood when read in conjunction with the accompanying drawings. Like numbers indicate like elements throughout. For purposes of illustrating the technology of the present disclosure, various exemplary embodiments are shown in the drawings. However, it should be understood that the technology of the present disclosure is not limited to the specific arrangements and means shown. The drawings are as follows.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0013] In this specification, systems, devices, and methods are described as examples and embodiments. Those skilled in the art will recognize that the technology of the present disclosure is not limited to the described embodiments or drawings. On the contrary, the technology of the present disclosure encompasses all modifications, equivalents, and alternatives within the spirit and scope of the appended claims. The features of any one embodiment disclosed herein can be omitted or incorporated into another embodiment.

[0014] Any headings used in this specification are for organizational purposes only and do not imply a limitation of this specification or the claims. As used herein, the word "may" is used in a permissive sense (i.e., having the possibility of doing) rather than in a mandatory sense (i.e., must do). Unless specifically stated herein, the terms "a", "an", and "the" are not limited to one element and should instead be read to mean "at least one". The terms include the above words, their derivatives, and words having similar meanings.

[0015] As used herein, "and / or" means that any or both of the items thus separated by that term are involved. For example, the phrase "A and / or B" will mean either A alone, B alone, or both A and B.

[0016] As used herein, "generally" means "in general" in relation to the term being modified, as understood by one of ordinary skill in the art.

[0017] For example, without limitation, directional terms used herein such as top, bottom, left, right, upper, lower, front, rear, and derivatives thereof relate to the orientation of the elements shown in the drawings and are not intended to limit the claims unless explicitly stated herein.

[0018] Generally speaking, as used herein, the term "moisture tight" is defined such that the ingress of moisture (after 3 days) is less than 1500 μg of water, in another embodiment less than 500 μg of water, in a further embodiment less than 300 μg of water, and in yet another embodiment less than 150 μg of water, as determined by the following test method: (a) Place 1 ± 0.25 grams of molecular sieve in a container and record the weight; (b) Completely close the container; (c) Place the closed container in an environmental chamber at a relative humidity of 80% and 72°F; (d) After 1 day, weigh the container containing the molecular sieve; (e) After 4 days, weigh the container containing the molecular sieve; (f) Subtract the sample from day 1 from the sample on day 4 to calculate the amount of moisture ingress into the container in micrograms of water. The preferred rate of moisture ingress into a moisture-tight sealed container manufactured in accordance with aspects of the concepts of the present disclosure is water in the range of about 200 - 300 μg / day or less. Thus, a "moisture tight" seal is a sealing engagement that, alone or in combination with additional sealing engagements, serves to make the container "moisture tight" in accordance with the above definition.

[0019] The term "moisture tight" is further discussed and / or defined in U.S. Patent No. 11,192,698, U.S. Patent No. 11,325,771, and U.S. Patent Application Publication No. 2021 / 0008771, which are each incorporated herein by reference. For example, U.S. Patent No. 11,192,698 (see, e.g., FIGS. 1, 2, 7, 9) discloses an elastomeric seal on the inner surface of a lid, optionally in the form of an annular ring. This seal can be configured to engage at least a portion of the body when the cap is in the closed position to form a supplemental moisture tight seal between the cap and the body. Such a feature can optionally form at least one aspect of the technology of the present disclosure.

[0020] As used herein, the term "resealable" means that the lid of a container can be opened (e.g., more than 10 times), or reopened, and closed, or reclosed, and still maintain its moisture tight properties.

[0021] As used herein, the term "secondary" in the phrase "secondary packaging" means that the packaging is not intended to directly contain or hold the contents consumed by the user, but rather is intended to hold a packaging or drug delivery device that directly contains or holds the contents consumed by the user.

[0022] Like reference numerals refer to like parts throughout the figures, and referring now to the various figures in detail, FIGS. 1 - 4 show a secondary packaging generally designated 10 and at least one device, generally designated 12, such as a pharmaceutical administration device. Each device 12 can be configured to store, release, and / or administer contents therein, such as, but not limited to, a drug. The secondary packaging 10 can be configured to hold or contain one or more devices 12 therein and prevent inadvertent actuation of the devices 12.

[0023] Device 12 can optionally be an inhaler such as, but not limited to, a nasal drug delivery device, a nasal inhaler, a metered dose inhaler (MDI), a dry powder inhaler (DPI), and a soft mist inhaler (SMI). Device 12 can be any of a wide range of pharmaceutical delivery devices and pharmaceuticals.

[0024] Device 12 can optionally include a spring to facilitate movement (e.g., extension and retraction) of device 12 from an operating position where at least a portion of the contents of device 12 is released or administered to a non-operating position where the contents of device 12 are prevented from exiting. However, device 12 can be any structure configured to store, release, and / or administer the contents held therein, such as an eye dropper or a tear spray, so device 12 is not limited to being an inhaler.

[0025] In any one embodiment, device 12 can employ a platform known as AMORPHOX™ as a carrier for nasal drug delivery and is effective against low molecular weight and high molecular weight substances. AMORPHOX™ can also function as a carrier for enzymes and spike proteins (including Sars-Cov2).

[0026] Optionally, the active pharmaceutical ingredient (API) stored within and / or delivered by device 12 can be one or more of naloxone, ketamine, midazolam, fentanyl, lorazepam, glucagon, nalmeffene, epinephrine, apomorphine, cetrorelix, loxapine, eletriptan, ketorolac, and / or olanzapine.

[0027] Optionally, device 12 can be employed to store and / or deliver, for example, insulin and / or epinephrine, and / or pharmaceuticals for treating or alleviating the symptoms of diabetes or asthma.

[0028] Device 12 may be pre-filled and provide the pharmaceutical in a dosage form. In particular, device 12 can be a dispensing device that delivers the drug in a dispersed form, such as a metered aerosol or spray device. Device 12 can be pre-filled with the finished dosage form(s) of the pharmaceutical(s). Embodiments include devices such as those referred to in 68 Fed. Reg. 36,675, 36,676, 36,680 (June 18, 2003). Exemplary embodiments include nasal aerosol and spray devices.

[0029] Secondary packaging 10 is particularly suitable for use with device 10, which is used for the administration of powder pharmaceuticals, such as intranasal delivery powders. The pharmaceutical can be anything that can be delivered by a dispensing device. The pharmaceutical(s) can be associated with one or more other ingredients, as for example, referred to in Title 21, Code of Federal Regulations, Section 314.3.

[0030] In any embodiment, the drug stored within device 12 is a powder pharmaceutical, such as glucagon. Device 12 can be configured to deliver glucagon or another drug as a simple one-time use nasal powder. This is a significant advantage over complex systems that require mixing a liquid and a powder and then injecting the solution. Use of device 12 by a patient has been determined to bring blood glucose levels closer to normal within 30 minutes after ingestion of the powdered glucagon.

[0031] In another optional embodiment, the drug is a nasal AMG504-1 product (manufactured by Locemia Solutions, Quebec, Canada) that contains 2 mg of glucagon in 20 mg of dry powder or 3 mg of glucagon in 30 mg of dry powder according to a single dose. This nasal powder can be administered using a one-step dispensing device for single use. By simply inserting the tip of the device into one nostril and pressing down on an actuator 41 connected to a piston (not shown) that discharges the powder into the nostril, a single dose can be delivered. Since it is absorbed from the nasal mucosa, no patient cooperation measures are required. The glucagon formulation is provided within the device 12, and as a result, the effectiveness of both the glucagon and its delivery device will be very effectively protected.

[0032] In any one embodiment, as shown in FIGS. 3 and 4, the device 12 includes a body 40 disposed generally longitudinally along a device axis DA, and the body 40 has a discharge end 42 and an actuator end 44 on the opposite side thereof. The device 12 can include a drug reservoir 46 defined by the body 40 and capable of containing the drug to be dispensed. The drug can be dispensed through a drug discharge port 48 that can include an opening in communication with the drug reservoir 46.

[0033] The device 12 can optionally include an actuator 41 at the actuator end 44 for injecting a chemical from the reservoir 46 through the discharge port 46. The actuator 41 can optionally extend from the actuator end 44 of the body 40. The actuator 41 can optionally be linearly movable from an extended position (not shown) to a depressed position (see FIGS. 3 and 4). The chemical discharge port 48 can block communication with the chemical reservoir 46 when the actuator 41 is in the extended position, keeping the contained chemical in a sealed state. The actuator 41 can be operable to discharge the chemical from the reservoir 46 during axial movement from the extended position to the depressed position. During such movement, communication can be established between the discharge port 48 and the reservoir 46, enabling dispensing of the chemical. Further details regarding the device 12 or similar devices that may be used in accordance with any aspect of the disclosed technology are disclosed in U.S. Patent No. 10,894,133, which is hereby incorporated by reference in its entirety.

[0034] The secondary package 10 can include a body or container 14 that defines a cavity 16 for at least partially surrounding the device 12. The body 14 of the secondary package 10 can include a base 18 and side walls 20 that extend upwardly therefrom to form the cavity 16. The end of the side wall 20 opposite the base 18 can include an edge 22 that surrounds and / or defines an opening 24 leading to the cavity 16. Optionally, the body 14 can be cylindrical.

[0035] In this optional embodiment, the body 14 of the secondary package 10 is cylindrical or bottle-shaped, and the side walls 20 can be circular and integral. However, the body or container according to the concepts of the present disclosure can have other shapes, such as a rectangular cube, and thus can have more than a single continuous (e.g., round) side wall.

[0036] As shown in FIGS. 3 and 4, at least a part of the cavity 16 can be spaced inwardly from the inner surface of the side wall 20 and / or upwardly from the inner surface of the base 18. This spacing can be the result of the object 19 being placed or installed within the body 14. The object 19 can be fixed relative to the body 14. Optionally, the object 19 can be an active member such as (but not limited to) a desiccant or an oxygen scavenger. The size, shape, configuration, and / or location of the object 19 can contribute to preventing inadvertent operation of the device 12.

[0037] Optionally, the object 19 can be formed as part of a two-shot injection molding process or an overmolding process with the body 14. Optionally, the object 19 can be formed as a separate plug from the body 14, which plug is, for example, inserted into the body 14 and optionally interlocked in a mating shape or optionally press-fitted into the body 14.

[0038] As shown in FIGS. 1 to 4, the secondary packaging 10 can include a cover or cap 26. Optionally, the cap 26 is rigid. In this optional embodiment, optionally, the cap 26 is movable relative to the body 14 between a closed position (e.g., FIGS. 1, 2, and 4) where the cap 26 and the body 14 can form a seal such as (but not limited to) a moisture seal and / or an airtight seal, and an open position (e.g., FIG. 3) where the opening 24 of the body 14 is exposed. In one embodiment, the cap 26 can include an active member.

[0039] Referring to FIGS. 1 and 3, the cap 26 can include an annular skirt portion 28 that extends downwardly (either directly or indirectly) from the top or the periphery of the base 30 of the cap 26. In this optional embodiment, the base 30 is at least partially planar. Alternatively, the base 30 can be partially or fully arched or flat. Optionally, as shown in FIGS. 1, 3, and 4, the base 30 can include an upper plane 30a spaced from a lower plane 30b, and these planes can be connected by vertical or inclined planes. Thus, in any one embodiment, the base 30 can form part of a cup shape. The skirt portion 28 can include a first end adjacent to the base 30 and a second free end on the opposite side. The cap 26 is optionally made mainly of one or more injection-moldable thermoplastic materials such as polyolefins such as polypropylene or polyethylene.

[0040] Optionally, the cap 26 can be connected to the body 14 by a hinge 27. The hinge 27 can be in the form of a living hinge that includes a continuous material bridge connecting the cap 26 to the body 14. At least a part of the hinge 27 can be flat instead of conforming to the radius of curvature of the body 14.

[0041] In an alternative embodiment, the hinge 27 can be an axially extending member that extends horizontally along the outside of the body 14. This shaft can be held at a position spaced from the outside of the outside of the body 14 by, for example, a pair of outwardly extending flanges. In this embodiment, the cap 26 can include a partially cylindrical member that is received on the shaft and pivots around the shaft. Alternatively, these structures can be reversed so that the cap 26 includes a pivot axis and the body 14 includes a cylindrical part. In these alternative embodiments, the cap 26 and the body 14 can be formed separately and assembled together.

[0042] The cap 26 can be optionally resealable with respect to the body 14, whether or not the secondary package 10 includes a hinge 27 or the cap 26 and the body 14 are fully separable.

[0043] Optionally, when the device 12 is within the cavity 16, at least a portion of the device 12 can be configured to prevent movement of the device 12 that would result in drug release or administration if the device 12 were to move, and / or include means for preventing it.

[0044] More particularly, in any one embodiment as shown in FIGS. 3 and 4, at least one or two or more spaced-apart protrusions 34 extend from the inner surface of the cap 26. Each protrusion 34 can be positioned and / or configured to abut against a non-actuator portion of the device 12. This one or more protrusions 34 can keep the device 12 within the cavity 16 even when no pressure is applied to the actuator 44 while the cap 26 is in the closed position. In particular, each protrusion 34 can extend from the cap 16 towards the bottom wall 18 when the cap 16 is in the closed position. In one embodiment, each protrusion 34 is integrally formed from the same material as the cap 26 using a molding process. In other embodiments, each protrusion 34 can be formed separately and firmly fixed to the cap 26 by adhesion or other means.

[0045] Each protrusion 34 can optionally be made of a material that provides a rigid structure. In one embodiment, the protrusion 34 is configured to maintain the relative orientation and positioning with respect to the cap 26 (or to each other in the case of multiple caps) and the non-actuator portion of the body 40 of the device 12 to avoid movement of the end of the protrusion 34 to an undesirable position that could cause premature activation of the device 12. The rigid protrusion 34 can maintain the relative axial and radial positions with respect to the cap 26 and the device 12.

[0046] The device 12 is shown in Figures 2 - 4 as received within the body 14 of the secondary package 10. At least a portion of the actuator 44 can extend upward beyond a plane defined by the opening 24 and extending parallel to the bottom wall 18 when the device 12 is properly and / or fully inserted within the body 14.

[0047] Optionally, as shown in Figures 3 and 4, the body 18 of the device 12 can include a circumferential surface or wall 45. When the device 12 is within the secondary package 10, the circumferential surface or wall 45 surrounds and is coaxial with the actuator 44 about the device axis DA and faces in a direction opposite to the bottom wall 18. Each projection 34 can extend axially parallel to the device axis DA when the cap 26 is in the closed position. Optionally, each projection 34 can have an end contact surface positioned to abut against the circumferential surface 45, which represents a non - actuator portion. The non - actuator portion is located radially outward of the actuator 44 and away from the actuator 44 when the device 12 is urged to move axially in a direction away from the bottom wall 18. The rigid projections 34 maintain the axial and radial positions of the end contact surface relative to the cap 26 and the circumferential surface 45 of the device 12. Each projection 34 may include support ribs along its radially outer surface. Other portions of the device 12 may be used as the non - actuator portion contacted by the projection(s) 34.

[0048] Optionally, each projection 34 is provided to prevent the device 12 from moving a distance such that the actuator 44 contacts the inner axial surface of the cap 26 away from the bottom wall 18. Such contact could cause damage to the device 12 or premature discharge of the drug.

[0049] Each protrusion 34 is positioned and configured to prevent movement of the device 12 within the secondary package 10 such that movement of the device 12 away from the bottom wall 18 and toward the cap 26 is at most a predetermined amount. In some embodiments, there may be continuous contact between each protrusion 34 and the circumferential surface 45 when the cap 26 is in the closed position (see FIG. 3). However, in some embodiments, there may not be continuous contact between each protrusion 34 and the circumferential surface 45. For example, in any one embodiment, a first gap or space (not shown) can be provided between the end contact surface of each protrusion 34 and the circumferential surface 45. The first gap can optionally be between 0.1 mm and 1.865 mm. When an external force is applied to move the device 12 away from the bottom wall 18, the contact surface of each protrusion 34 can function as a stop to prevent or limit such movement.

[0050] Optionally, as shown in FIGS. 3 and 4, a second cap G2 can be installed between the end face of the actuator 44 and the inner surface of the base 30 of the cap 26. The second gap G2 can be at least slightly larger than the first gap G1, thereby preventing the actuator 44 from contacting the inner surface of the base 30.

[0051] In any one embodiment, two spaced-apart protrusions 34 are circumferentially disposed apart from each other, and the hinge 27 is circumferentially disposed between these two protrusions 34.

[0052] Optionally, a plug or lip seal can extend downwardly and / or inwardly from the base 30, such as from the upper plane 30a or the lower plane 30b of the cap 26, for example, as described in Applicant's U.S. Patent No. 11,352,177. U.S. Patent No. 11,352,177 is hereby incorporated by reference in its entirety.

[0053] For certain applications, a child-resistant cap may be desirable, but is not required for all applications. Accordingly, both child-resistant and non-child-resistant caps are contemplated. Where a child-resistant function is provided, the child-resistant function may optionally require that a force in more than a single direction be applied to the cap to remove the cap from the body. For example, the cap may require that the user press the cap downward (a first direction) and then rotate it (a second direction) to remove the cap from the body. Alternative child-resistant functions are also contemplated as needed.

[0054] In any one embodiment, at least one or both of the body 14 and the cap 26 are formed by injection molding, such as a two-shot injection molding process. The applicant unexpectedly discovered that this also helps prevent problems with the prior operation of the device 12.

[0055] Optionally, the secondary package 10, such as its cap 26 and / or body 14, can include an active polymer component affixed to or integrated with the article 19, the active member, or a portion thereof. For example, the active polymer component can be part of the molding process of the body 14 and / or the cap 26 such that the end user cannot visually identify or physically / manually separate the active polymer component from the body 14 and / or the cap 26. Optionally, the body 14 and / or the cap 26 can be formed by a two-shot or three-shot injection molding process as described in detail below.

[0056] The active polymer component can include a base polymer admixed with one or more activators (e.g., mineral desiccants), and thus, in this specification, may be referred to as an activator - admixed polymer or an admixed polymer. The activator in the active polymer component may include an absorbent material, a release material, and / or an activating material. Optionally, the active polymer component is a three - phase desiccant - admixed polymer. The active polymer component can be provided in different shapes, volumes, and / or configurations. In an exemplary embodiment, the active polymer component is in the form of a solid plug or a generally flat member that extends within the internal space of the cap 26.

[0057] In one embodiment, the active polymer component is a desiccant - admixed polymer that is a single component made of a single piece of material. The admixed polymer may include a base polymer (for structure), a desiccant (or other activator), and optionally a channeling agent, whether or not a desiccant or another activator is admixed. Such types of active - admixed polymers, as well as their manufacturing and use methods, are disclosed, for example, in the applicant's U.S. Pat. Nos. 5,911,937, 6,214,255, 6,130,263, 6,080,350, 6,174,952, 6,124,006, and 6,221,446, as well as U.S. Patent Publication No. 2016 / 0039955. Optionally, the admixed polymer may be an unfixed film, or optionally, in the form of a film thermally fixed to a surface.

[0058] Alternatively, the desiccant may include unfixed desiccant beads or sachets containing them. The exemplary embodiments herein, for example, reflect an active polymer component attached to the cap 26, but it is contemplated that the activator can be placed at other locations and / or positions, such as on the sidewall of the body.

[0059] In embodiments where each active member contains a desiccant, moisture absorption is desired. However, if moisture absorption is not desired, the active member can include an alternative active agent. For example, in another embodiment, the active member contains a material selected from the group consisting of activated carbon, carbon black, ketjen black, and diamond powder. In a further embodiment, the active agent including one or more layers of the active member contains materials such as absorbent microparticles, BaTiO3, SrTiO3, SiO2, Al2O3, ZnO, TiO2, MnO, CuO, Sb2O3, silica, calcium oxide, and ion exchange resin. In yet another embodiment, the absorbent-containing layer of the active member contains two or more types of absorbents. Suitable absorbents are selected to achieve absorption of a desired vapor or gas for the desired end use (e.g., absorption of moisture, oxygen, carbon dioxide, nitrogen, or other undesirable gases or vapors).

[0060] The active member (regardless of whether it is a desiccant, oxygen scavenger, release material or component, etc., or a combination thereof) is capable of acting, interacting, or reacting with a selected material (e.g., moisture or oxygen). Examples of such actions or interactions can include absorption, adsorption (generally, sorption), or release of the selected material. Each active member can be formed, for example, by extrusion or molding. Optionally, the active member can be formed in a desired shape or pattern (e.g., on a substrate) via an in-line melt adhesion thermal bonding process.

[0061] The active member can contain an "active ingredient" in a substrate. The active ingredient(s) can be immiscible with the substrate (e.g., a polymer), and when mixed and heated with the base polymer and the channeling agent, does not melt, i.e., has a melting point higher than the melting point of either the base polymer or the channeling agent, and / or (ii) acts on, interacts with, or reacts with the selected material. The term "active ingredient" may include, but is not limited to, materials that absorb, adsorb, or release the selected material(s). According to the technology of the present disclosure, the active ingredient may be in the form of particles such as minerals (e.g., molecular sieves or silica gel in the case of desiccants), but the technology of the present disclosure should not be considered limited to only particulate activators. For example, in some embodiments, the oxygen scavenging formulation may be made from a resin that functions as an activator or as a component of an activator.

[0062] As used herein, the term "substrate" is a component (preferably a polymer) of the incorporated active material other than the activator that provides the structure for the incorporated materials.

[0063] As used herein, the term "base polymer" optionally is a polymer having a gas transmission rate of the selected material, which gas transmission rate is substantially lower than, lower than, or substantially equivalent to that of the channeling agent. By way of example, such a transmission rate is the water vapor transmission rate in embodiments where the selected material is moisture and the active ingredient is a water-absorbing desiccant. The main function of the base polymer is to provide a structure for the incorporated polymer. Suitable base polymers include thermoplastic polymers such as polyolefins like polypropylene and polyethylene, polyisoprene, polybutadiene, polybutene, polysiloxane, polycarbonate, polyamide, ethylene-vinyl acetate copolymer, ethylene-methacrylate copolymer, poly(vinyl chloride), polystyrene, polyester, polyanhydride, polyacrylonitrile, polysulfone, polyacrylate ester, acrylic acid, polyurethane, and polyacetal, or copolymers or mixtures thereof.

[0064] Referring to such a comparison of the water vapor transmission rates of the base polymer and the channeling agent, in one embodiment, the channeling agent has a water vapor transmission rate that is at least 2 times that of the base polymer. In another embodiment, the channeling agent has a water vapor transmission rate that is at least 5 times that of the base polymer. In another embodiment, the channeling agent has a water vapor transmission rate that is at least 10 times that of the base polymer. In yet another embodiment, the channeling agent has a water vapor transmission rate that is at least 20 times that of the base polymer. In still another embodiment, the channeling agent has a water vapor transmission rate that is at least 50 times that of the base polymer. In yet another embodiment, the channeling agent has a water vapor transmission rate that is at least 100 times that of the base polymer.

[0065] As used herein, the term "channeling agent" or "channeling agents" is defined as a material that is immiscible with the base polymer and has an affinity for transporting gaseous substances at a faster rate than the base polymer. Optionally, the channeling agent can form channels through the incorporated polymer when formed by mixing the base polymer and the channeling agent. Optionally, such channels can allow a selected material to permeate through the incorporated polymer at a faster rate than in the case of the base polymer alone.

[0066] As used herein, the term "channel" or "interconnected channel" is defined as a passage formed by a channeling agent that penetrates the base polymer and may be interconnected with each other.

[0067] As used herein, the term "incorporated polymer" is defined as a monolithic material formed from at least a base polymer and an activator, and optionally a channeling agent that is incorporated or distributed throughout. Thus, incorporated polymers include two-phase polymers and three-phase polymers. "Mineral-filled polymer" is a type of incorporated polymer where the activator is in the form of a mineral, such as mineral particles like molecular sieves or silica gel. The term "incorporated material" is used herein to mean a monolithic material containing an activator incorporated into a substrate, which may or may not be a polymer.

[0068] As used herein, the term "monolithic", "monolithic structure", or "monolithic composition" is defined as a composition or material that does not consist of two or more distinct macroscopic layers or parts. Thus, "monolithic compositions" do not include multilayer composites.

[0069] As used herein, the term "phase" is defined as a part or component of a monolithic structure or monolithic composition that is uniformly distributed throughout to impart its monolithic properties to the structure or composition.

[0070] As used herein, the term "selected material" is defined as a material that acts on, is acted upon by, interacts or reacts with an active agent and can be transmitted through the channels of the incorporated polymer. For example, in embodiments where a desiccant is used as the active agent, the selected material may be moisture or a gas that can be absorbed by the desiccant. In embodiments where a releasing material is used as the active agent, the selected material may be an agent released by the releasing material, such as moisture, a fragrance, or an antibacterial agent (e.g., chlorine dioxide). In embodiments where an adsorbing material is used as the active component, the selected material may be a particular volatile organic compound, and the adsorbing material may be activated carbon.

[0071] As used herein, the term "three-phase" is defined as a monolithic composition or monolithic structure that includes three or more phases. An example of a three-phase composition according to the techniques of the present disclosure can be an incorporated polymer formed from a base polymer, an active agent, and a channeling agent. Optionally, the three-phase composition or three-phase structure may include an additional phase, such as a colorant.

[0072] The incorporated polymer may be a two-phase formulation (i.e., including a base polymer and an active component without a channeling agent), or a three-phase formulation (i.e., including a base polymer, an active agent, and a channeling agent). The incorporated polymer is described, for example, in U.S. Pat. Nos. 5,911,937, 6,080,350, 6,124,006, 6,130,263, 6,194,079, 6,214,255, 6,486,231, and 7,005,459, and U.S. Patent Publication No. 2016 / 0039955.

[0073] The incorporated material or incorporated polymer includes a substrate (e.g., a polymer) for providing structure, optionally a channeling agent and an activator. The channeling agent forms microscopic interconnected channels through the incorporated polymer. At least a portion of the active ingredient is contained within the channels such that these channels communicate between the active ingredient and the outside of the incorporated polymer through microscopic channel openings formed on the outer surface of the incorporated polymer. The active ingredient can be, for example, any one of various absorption, adsorption, or release materials as described in more detail below. Although a channeling component is preferred, the techniques of the present disclosure broadly include incorporated materials that optionally do not include a channeling agent, such as a two-phase polymer.

[0074] In any embodiment, suitable channeling agents may include polyglycols such as polyethylene glycol (PEG), ethylene vinyl alcohol (EVOH), polyvinyl alcohol (PVOH), glycerin polyamine, polyurethane, and polycarboxylic acids including polyacrylic acid or polymethacrylic acid. Alternatively, the channeling agent can be a water-insoluble polymer such as a propylene oxide polymesate-monobutyl ether, such as Polyglykol B01 / 240 manufactured by CLARIANT. In other embodiments, the channeling agent can be a propylene oxide polymesate-monobutyl ether such as Polyglykol B01 / 20 manufactured by CLARIANT, a propylene oxide polymesate such as Polyglykol D01 / 240 manufactured by CLARIANT, ethylene vinyl acetate, nylon 6, nylon 66, or any combination of the foregoing.

[0075] Suitable active ingredients according to the technology of the present disclosure include absorbent materials such as dry compounds. When the active agent is a desiccant, any desiccant suitable for a given application may be used. Usually, physical absorption desiccants are preferred for many applications. These may include molecular sieves, silica gel, clay, and starch. Alternatively, the desiccant may be a chemical compound that forms crystals containing water or a compound that reacts with water to form a new compound.

[0076] Optionally, in any embodiment, the active agent may be an oxygen scavenger, such as an oxygen scavenging resin formulation.

[0077] In any one embodiment, the active agent is 3A molecular sieve or includes 3A molecular sieve. The pore size of molecular sieves is often measured in angstroms (A), and 3A molecular sieve refers to a pore size of 3 angstroms. The applicant unexpectedly discovered that the use of 3A molecular sieve, particularly when compared to 4A molecular sieve and / or when using 3A molecular sieve instead of 4A molecular sieve, helps reduce the pressure increase during the necessary tests of the secondary packaging 10. By reducing the pressure increase, the risk of the secondary packaging 10 accidentally opening and contaminating the device 12 or causing early activation is reduced. Additional advantages regarding 3A molecular sieve are described in the applicant's WO2022 / 032278, which is incorporated herein by reference.

[0078] Optionally, the mass of the object 19 is exactly or approximately 14.6 grams, which includes exactly or approximately 9.2 grams of 3A molecular sieve. Optionally, the mass of the object 19 can be 13 - 16 grams. Optionally, the mass of the 3A molecular sieve can be 8 - 10 grams.

[0079] The applicant believes that due to the smaller Ångström size of the 3A molecular sieve compared to the 4A molecular sieve, off-gas is reduced, thereby reducing the off-gas pressure and / or reducing the pressure within the secondary packaging 10. This is particularly applicable during tests that require long periods of time (e.g., 96 hours) as the time during which the secondary packaging 10 must be maintained in a high temperature (e.g., 50 °C) or low temperature environment. Prior to this unexpected discovery, 3A molecular sieves were used when additional absorption capacity was desired.

[0080] Figure 5 shows the comparative test results of a 3A molecular sieve desiccant and a 4A molecular sieve desiccant, graphing the amount of gas released over time. The test was conducted by exposing various samples of 3A and 4A molecular sieves to a temperature of 50 °C for 184 hours. 14-gram samples of 3A and 4A molecular sieves were each placed in a sealed tube and connected to a graduated cylinder placed in water. During the experiment, all the gas released from the samples placed in the sealed tubes was directly stored in the graduated cylinder. In this way, the amount of gas released could be observed.

[0081] As shown in Figure 5, after exposure to 50 °C for 184 hours, it was observed that the 3A-based formulation sample (14 grams of the compound) released approximately 7.2 mL of gas. For the 4A-based formulation, the same amount of the compound released 46 mL of gas, which was approximately 7 times that of the 3A-based formulation. These results are consistent with the pressure monitoring tests conducted, as discussed below.

[0082] Figure 6 shows the results of the pressure monitoring test of the secondary packaging 10 of the technology of the present disclosure. The purpose of this test was to measure the overpressure difference in the headspace of the secondary packaging material 10 using a 3A molecular sieve desiccant and the packaging material using a 4A molecular sieve desiccant when both were exposed to a temperature of 50 °C for 7 days.

[0083] One STAR ODDI (trademark) data logger was used for each of the two secondary packages (such as vials). Each vial was exposed to a temperature of 50 °C for 7 days (without relative humidity control). After 7 days, data were extracted from the data logger and analyzed. Pressure was measured every 15 minutes for 7 days.

[0084] When both 3A and 4A based desiccant vials were exposed to a temperature of 50 °C, an initial increase in pressure inside the vial due to gas expansion was observed. This pressure increase continued for several hours until the pressure inside the vial reached approximately 100 mBar. At this stage, no difference was seen between the two desiccant formulations.

[0085] However, after exposure to 50 °C for approximately 5 hours, a significant difference was observed between the vials using 3A molecular sieve and those using 4A molecular sieve. In particular, the pressure inside the vials made of or using 4A molecular sieve increased to approximately 200 mBar after 7 days, while the pressure inside the vials made of or using 3A molecular sieve decreased from 100 mBar at peak to approximately 50 mBar during this period.

[0086] 4A molecular sieves were found to release a significant amount of gas in the headspace of the vial when exposed to a temperature of 50 °C. Therefore, when the vial was made airtight, the overpressure inside the vial reached 200 mBar. In contrast, 3A molecular sieves did not release such an amount of gas, and the overpressure inside the vial after 7 days was very low. These findings are important in at least two respects. First, when measuring the final pressure under the described conditions, it was shown that the packaging using 3A molecular sieves had a significantly lower internal pressure than the packaging using the same mass of 4A molecular sieves. Second, not only did the final pressure significantly decrease with 3A molecular sieves, but after initially reaching a peak, the pressure decreased in the packaging using 3A molecular sieves, while the pressure continued to rise in the packaging using 4A molecular sieves. These results are noteworthy. Practically, the pressure inside the packaging using 3A molecular sieves is significantly lower, so the probability of accidental opening is much lower than that of the packaging using the same mass of 4A molecular sieves.

[0087] Figures 7 to 12 show another embodiment of the technology of the present disclosure. Similar or identical structures between the embodiments of Figures 7 to 12 and the embodiments of Figures 1 to 4 are identified in Figures 7 to 12 by reference numerals that are 100 greater in size than those in Figures 1 to 4. Regarding certain similarities between the embodiments of Figures 1 to 4 and the embodiments of Figures 7 to 12, in this specification, for the sake of brevity, the description thereof may be omitted only for convenience. The features of one embodiment can be omitted from or added to other embodiments.

[0088] Optionally, the maximum height of the secondary packaging 110 is 81.17 mm, or optionally, it is 79 mm to 83 mm. Optionally, the maximum diameter of the main body 114 of the secondary packaging 110 is 34.98 mm, or optionally, it is 33 mm to 36 mm. Optionally, the maximum width of the secondary packaging 110 (i.e., the cap 126 + the hinge 127) is 43.97 mm, or optionally, it is 42 mm to 45 mm. Optionally, the internal volume of the secondary packaging is 36,651 mm3 and optionally 30,000 to 40,000 mm 3 and optionally 34,000 to 38,000 mm 3 is.

[0089] Referring to FIGS. 7-9A, the cap 126 can optionally be formed of a semi-rigid material, and the hinge 127 can be directly molded onto the body 114 of the secondary package 110. One or more of these components can optionally be formed from polypropylene.

[0090] Referring to FIGS. 7 and 8, the object 119 can optionally include a plurality of fins or ribs 119a that extend inwardly from the body 114 and are circumferentially spaced apart. Each fin 119a can be tapered such that its width, measured radially from the geometric center of the body 114 to its outer wall, is smaller at or near the top of the fin 119a than at or near the bottom of the fin 119a. Such a shape or configuration can facilitate the insertion of a device (not shown) into the secondary package 110 and / or can facilitate preventing inadvertent actuation of the device. Further, such a shape can increase the surface area of the object 119, which can be beneficial if the object is an active polymer. In this way, the object 119 can have a more exposed surface area that can be used to provide a desired activity, such as moisture adsorption. In the same or different embodiments, the thickness of each fin 119a, measured perpendicular to the width, can be the same throughout the height of the fin 119a. Alternatively or additionally, the object 119 can form a cylinder that receives at least a portion of the device therein.

[0091] As shown in FIGS. 7 to 9B, the cap 126 can optionally include a tab 156 that extends laterally outward therefrom. The tab 156 can be sized, shaped, and / or configured to be engaged by a user, such as by the user's thumb, to assist in moving the cap 126 between the open and closed positions. The tab 156 can optionally be disposed diametrically opposite the hinge 127.

[0092] Referring to FIGS. 10 to 12, the cap 126 and / or the body 114 can be formed with a locking function. The locking function can be configured to hold the cap 126 in the closed position relative to the body when there is no intended separation or relative movement between the two components of the cap 126 and the body, even when there is internal pressure within the cavity of the body 114. Such a locking mechanism can be any type that provides sufficient security to hold the components in the locked state while being releasable moderately as desired.

[0093] Optionally, the locking function can include at least one rib 150 designed to prevent unintentional opening and / or pre-opening of the secondary package 110. The center of the locking function can be installed on the side opposite the hinge 127, i.e., at a position approximately 180° from the center of the hinge 127. Such a configuration will help to maximize the closing effect of the locking function and ensure a consistent opening and closing force for the secondary package 110. As shown in FIG. 11, each rib 150 can be installed under the edge 122 and / or the lip 123 of the body 114.

[0094] In any embodiment, two ribs 150 spaced apart can extend radially outward from the sidewall of the body 114, and the cap 126 can include two openings 152 spaced apart correspondingly, which are attached to the lower surface of the tab 156 of the cap 126 and have latches 151 hanging down therefrom. Each opening 152 can be sized, shaped, and / or configured to receive at least a portion of one of the ribs 150 when the cap 126 is in the closed position (see FIG. 10).

[0095] In the operation of any one embodiment, the user applies an axial force (e.g., an upward force) to the lower side of the tab 156, and the flexibility of the tab 156 causes the tab 156 to pivot at least slightly (e.g., upward), thereby moving the latch 151 (e.g., outward), so that each opening 152 is disengaged from and / or separated from its respective rib 150, and the latch 151 releases its respective rib 150, enabling the cap 126 to move from the closed position to the open position.

[0096] In any one embodiment, to release the locking function, no operation other than holding the body 114 (e.g., by hand) and applying an upward force to the lower side of the tab 156 is required.

[0097] As some variations, one rib, or more than two ribs, may be present for one or more corresponding openings. An additional alternative of the locking function according to any aspect of the disclosed concept is any version of the attachment mechanism disclosed in the applicant's U.S. Patent No. 11,352,177 disclosed above.

[0098] Optionally, in any embodiment, the locking function can be implemented in combination with an annular skirt portion 28 extending downward from the peripheral edge of the base of the caps 26, 126. In such an embodiment, the annular skirt portion or a part thereof can function as the hanging latch described above.

[0099] Optionally, the technology of the present disclosure can include an edge of the body having an outer surface that includes an undercut with respect to the central axis of the body. The undercut can have a surface that mates with a corresponding surface of the skirt in a snap-fit closure configuration when the cap is closed. The snap-fit closure configuration can prevent accidental opening of the cap and can form a hermetic seal between the body and the cap. An example of such an arrangement is shown and described in Applicant's U.S. Patent No. 11,192,698, which is hereby incorporated by reference in its entirety.

[0100] Optionally, by combining a snap-fit closure and a hermetic seal between the body and the cap with a locking function, accidental opening of the cap relative to the body, which is at least partially due to, for example, pressure accumulation within the package, can be further prevented from occurring. Such a combination of snap-fit and sealing / closure can be possible between the skirt portion and the body, the locking function, or both.

[0101] The following exemplary embodiments further illustrate optional aspects of the technology of the present disclosure and are part of the forms for carrying out the present invention. These exemplary embodiments are not strictly the claims of the present application but are presented in a form substantially similar to the claims (each having a numerical indication followed by a capital letter). The following exemplary embodiments refer to each other in a subordinate relationship as "embodiments" rather than "claims".

[0102] 1A. An apparatus for administering a drug, and A secondary package configured to surround the apparatus, the secondary package being configured to resist or prevent its accidental opening, the secondary package comprising a body defining a cavity for at least partially surrounding the apparatus for administering the drug, the apparatus being within the cavity, the secondary package; A combination comprising.

[0103] The combination of Embodiment 1A, wherein the device is a nasal drug delivery device.

[0104] The combination of Embodiment 2A, wherein the nasal drug delivery device is reconfigurable between a deactivated configuration in which the nasal drug delivery device does not release or administer the drug and an activated configuration in which the nasal drug delivery device releases or administers the drug.

[0105] A secondary package configured to prevent inadvertent actuation of an inhaler, comprising a body defining a cavity for at least partially surrounding the inhaler, the body including means for preventing movement of the inhaler such that the inhaler would release or administer a drug.

[0106] A secondary package configured to hold a device for administering a drug, a body defining a cavity for at least partially surrounding the device for administering the drug, a cap movable relative to the body between a closed position and an open position, comprising wherein at least one of the body and the lid includes an active polymer component formed of a base polymer admixed with 3A molecular sieves.

[0107] The secondary package of Embodiment 1C, wherein the body has a base and side walls extending upward therefrom.

[0108] The secondary package of Embodiment 2C, wherein an end of the side wall opposite the base includes an edge defining an opening leading to the cavity.

[0109] The secondary package of Embodiment 3C, wherein the cap is pivotally attached to the body between the closed position in which the cap and the body form a moisture seal and the open position in which the opening of the body is exposed.

[0110] 5C. The secondary packaging of Embodiment 4C, wherein the cap includes an annular skirt portion extending downward from a peripheral edge of a base of the cap, and the skirt portion has a first end portion close to the base and a second free end portion on the opposite side.

[0111] 6C. The secondary packaging of Embodiment 4C or 5C, wherein the cap includes a tamper-evident function therein or thereon.

[0112] 7C. The secondary packaging of Embodiment 4C or 5C, wherein the cap includes a latch for maintaining the cap in the closed position with respect to the body, in or on the cap.

[0113] 8C. The secondary packaging of Embodiment 3C, wherein the edge extends laterally outward from the side wall and parallel to the base of the body.

[0114] 9C. The secondary packaging of any one of Embodiments 1C to 8C, wherein an inner surface of the base of the cap includes a stepped configuration having two spaced surfaces, and when the cap is in the closed position, the two surfaces each extend parallel to the base of the body.

[0115] 10C. The secondary packaging of Embodiment 9C, wherein at least one of the two spaced surfaces is configured to contact at least a part of the device to prevent the device from being reconfigured from the deactivated position to the activated position.

[0116] 11C. The secondary packaging of any one of Embodiments 1C to 10C, wherein the base of the cap is planar or arched.

[0117] 1D. A secondary packaging configured to hold a device for administering a drug, a body defining a cavity for at least partially surrounding the device for administering the drug, A cap movable relative to the body between a closed position and an open position, the cap including therein or thereon a latch for maintaining the cap in the closed position relative to the body. At least one of the body and the lid includes an active polymer component formed of a base polymer mixed with 3A molecular sieves. At least one of the body and the cap is formed by a two-shot injection molding process, a secondary packaging.

[0118] 2D. The secondary packaging of Embodiment 1D, wherein the body and the cap are combined to form a vial.

[0119] 1E. A nasal drug delivery system, and A secondary packaging in the form of a vial configured to hold the nasal drug delivery system, the combination comprising: the secondary packaging includes A body defining a cavity for at least partially surrounding the device for administering the drug, A cap movable relative to the body between a closed position and an open position, the cap including therein or thereon a latch for maintaining the cap in the closed position relative to the body. At least one of the body and the lid includes an active polymer component formed of a base polymer mixed with 3A molecular sieves. At least one of the body and the cap is formed by a two-shot injection molding process, a combination.

[0120] 1F. A method of manufacturing a secondary packaging configured to hold a device for administering a drug, the method comprising: Two-shot injection molding the body and the cap of the secondary packaging, At least one of the body and the cap includes an active polymer component formed of a base polymer mixed with 3A molecular sieves.

[0121] A secondary packaging configured to hold a device for administering a drug, a body defining a cavity for at least partially surrounding the device for administering the drug, a cap attached to at least a part of the body by a hinge, the cap being movable relative to the body between a closed position and an open position, the body and the cap together defining an internal compartment for housing the device when the cap is in the closed position, the cap; a 3A molecular sieve installed in the internal compartment; and a secondary packaging comprising the same.

[0122] A secondary packaging according to Embodiment 1G, wherein the 3A molecular sieve is part of an active polymer component, and the active polymer component further comprises a base polymer and optionally a channeling agent.

[0123] A secondary packaging configured to hold a device for administering a drug, a body defining a cavity for at least partially surrounding the device for administering the drug, a cap attached to at least a part of the body by a hinge, the cap being movable relative to the body between a closed position and an open position, the cap; and a secondary packaging, wherein at least one of the body and the lid comprises or is attached to an active polymer component comprising a 3A molecular sieve. A secondary packaging according to Embodiment 1H, wherein the 3A molecular sieve does not generate additional pressure within the body after the cap has been in the closed position for 7 days.

[0124] A secondary packaging according to Embodiment 1H, wherein the 3A molecular sieve does not generate additional pressure within the body after the cap has been in the closed position for 7 days.

[0125] 3H. After the cap has been in the closed position for 7 days, the 3A molecular sieve generates less off-gas than the 4A molecular sieve, and the 3A molecular sieve does not generate additional pressure inside the main body when the cap is in the closed position. The secondary packaging of Embodiment 1H.

[0126] 4H. The secondary packaging according to any one of Embodiments 1H to 3H, wherein the main body and the cap are placed in an environment of at least 40 degrees Celsius.

[0127] 5H. The secondary packaging according to any one of Embodiments 1H to 3H, wherein the main body and the cap are placed in an environment of at least 50 degrees Celsius.

[0128] 6H. The secondary packaging of Embodiment 1H, wherein the pressure inside the main body when the cap is in the closed position decreases after 7 days.

[0129] 7H. The secondary packaging of Embodiment 6H, wherein the pressure inside the main body when the cap is in the closed position is less than 50 mBar after 6 days.

[0130] 8H. The secondary packaging according to any one of Embodiments 1H to 7H, wherein the main body has a base and side walls extending upward therefrom.

[0131] 9H. The secondary packaging of Embodiment 8H, wherein the end of the side wall opposite to the base includes an edge defining an opening leading to the cavity.

[0132] 10H. The secondary packaging of Embodiment 9H, wherein the cap includes an annular skirt portion extending downward from the peripheral edge of the base of the cap, and the skirt portion has a first end close to the base and a second free end on the opposite side.

[0133] 11H. The secondary packaging according to Embodiment 9H or 10H, wherein the cap includes a tamper-evident function therein or thereon.

[0134] 12H. The secondary packaging of embodiment 9H or 10H, wherein the cap includes, within or on it, a latch for maintaining the cap in the closed position relative to the body.

[0135] 13H. The secondary packaging of embodiment 9H, wherein the edge extends laterally outward from the side wall and is parallel to the base of the body.

[0136] 14H. The secondary packaging of any of embodiments 1H - 13H, wherein the inner surface of the base of the cap includes a stepped configuration having two spaced surfaces which, when the cap is in the closed position, each extend parallel to the base of the body.

[0137] 15H. The secondary packaging of embodiment 14H, wherein at least one of the two spaced surfaces is configured to contact at least a portion of the device to prevent the device from being reconfigured from the deactivated position to the activated position.

[0138] 16H. The secondary packaging of any of embodiments 1H - 15H, wherein the base of the cap is planar or arched.

[0139] 17H. The secondary packaging of any of embodiments 1H - 16H, wherein the contaminating polymer composition includes a base polymer and optionally a channeling agent.

[0140] 18H. The secondary packaging of any of embodiments 1H - 17H, wherein at least one of the body and the cap is formed by a two - shot injection molding process.

[0141] 19H. The secondary packaging of any of embodiments 1H - 18H, wherein the body and the cap are combined to form a vial.

[0142] 1I. A nasal drug delivery system and A secondary packaging in the form of a vial configured to hold the nasal drug delivery system, the secondary packaging being A body defining a cavity for at least partially surrounding the device for administering the drug, A cap movable relative to the body between a closed position and an open position, the cap including therein or thereon a latch for maintaining the cap in the closed position relative to the body, At least one of the body and the lid includes an active polymer component including 3A molecular sieves, At least one of the body and the cap is formed by a two-shot injection molding process, a combination.

[0143] 1J. A method of manufacturing a secondary package configured to hold a device for administering a drug, Two-shot injection molding the body and cap of the secondary package, Inserting an active polymer component including 3A molecular sieves into one of the body and the cap, a method.

[0144] 1K. A method of preventing the container from accidentally opening due to an increase in pressure inside the container, Optionally, when the container is installed in an environment of 50 degrees Celsius or higher, providing the container with an active polymer agent including 3A molecular sieves, a method.

[0145] 2K. Further including maintaining the cap of the body of the container in a closed position and making the container airtight for at least 7 days, The pressure in the headspace of the container drops after 7 days and optionally drops to 100 mBar or less, the method of Embodiment 1K.

[0146] Although the technology of the present disclosure has been described in detail, it will be apparent to those skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope thereof with respect to its specific examples. Therefore, the technology of the present disclosure is not limited to the specific embodiments disclosed, and it is contemplated to include modifications within the spirit and scope of the technology of the present disclosure.

Claims

1. A secondary package configured to hold a device for administering a drug, A body defining a cavity to at least partially surround the device for administering the drug, A cap attached to at least a portion of the body by a hinge, wherein the cap is movable relative to the body between a closed position and an open position, and together the body and the cap define an internal compartment for housing the device when the cap is in the closed position, A secondary package comprising an active polymer component, which is installed in the internal compartment and configured to receive at least a portion of the device therein, the active polymer component comprising a mixture of a 3A molecular sieve, a base polymer, and optionally a channeling agent.

2. The secondary packaging according to claim 1, wherein the main body is cylindrical and comprises a base and a side wall extending upward therefrom.

3. The secondary packaging according to claim 2, wherein the end of the side wall opposite to the base includes an edge that defines an opening leading to the cavity.

4. The secondary packaging according to claim 3, wherein the cap has an annular skirt portion extending downward from the peripheral edge of the base of the cap, and the skirt portion has a first end adjacent to the base and a second free end on the opposite side.

5. The secondary packaging according to claim 4, wherein the edge portion has an outer surface including an undercut with respect to the central axis of the main body, the undercut has a surface that engages with the corresponding surface of the skirt portion in a snap-fit ​​closure configuration when the cap is closed, the snap-fit ​​closure configuration prevents the cap from being opened unintentionally and forms a moist seal between the main body and the cap.

6. The secondary packaging according to claim 2, wherein the cap further comprises a latch that engages with the fitting shape of the cap in the closed position to maintain the cap in the closed position, thereby preventing the cap from being opened unintentionally.

7. The secondary packaging according to claim 6, wherein the latch includes at least one opening, and the body includes at least one rib configured to engage with the at least one opening in a snap-fit ​​configuration.

8. The secondary packaging according to claim 6, further comprising a plug or lip seal extending from the base of the cap, wherein the plug or lip seal is configured to engage with the inner surface of the side wall to form a moist seal between the cap and the body.

9. The secondary packaging according to claim 5, further comprising an elastomer sealing portion on the lower side of the cap, wherein the elastomer sealing portion is configured to engage with at least a part of the main body when the cap is in the closed position to form a moist seal between the cap and the main body.

10. The secondary packaging according to claim 2, wherein the active polymer component is optionally attached to or integral with the side wall of the main body by a multi-shot injection molding process, and the active polymer component includes a central axial cavity configured to receive and surround a part of the device.

11. The secondary packaging according to claim 10, wherein the central cavity is terminated by an annular shelf configured to provide a seating surface on the annular flange of the main body of the device.

12. The secondary packaging according to claim 1, wherein the internal compartment has a volume of 15 mL to 120 mL, optionally 15 mL to 100 mL, optionally 15 mL to 80 mL, optionally 15 mL to 60 mL, optionally 15 mL to 50 mL, or optionally 20 mL to 40 mL.

13. The secondary packaging according to claim 1, wherein the molecular sieve 3A is present in the active polymer component in an amount of 30% to 80%, optionally 30% to 75%, optionally 30% to 70%, optionally 35% to 70%, optionally 40% to 70%, optionally 45% to 65%, and optionally 50% to 60% by weight of the mixture.

14. The secondary packaging according to claim 1, wherein when the cap is in the closed position, the secondary packaging is moist and airtight, and at a storage temperature of 50°C, the active polymer component causes an initial release of gas, accumulating pressure in the internal compartment, reaching a peak pressure, and then the pressure in the internal compartment decreases while the cap remains in the closed position.

15. The secondary packaging according to claim 14, wherein the final pressure measured after 7 days under these conditions is less than the peak pressure, optionally 40% to 75% of the peak pressure, optionally 40% to 70% of the peak pressure, optionally 40% to 60% of the peak pressure, optionally 45% to 55% of the peak pressure, or optionally about 50% of the peak pressure.

16. The secondary packaging according to claim 14, wherein the peak pressure is reached within one day, optionally within 18 hours, optionally within 12 hours, optionally between 2 and 10 hours, optionally between 3 and 8 hours, or optionally by approximately 5 hours after the cap is placed in the closed position.

17. The secondary packaging according to claim 15, wherein the peak pressure is 80 mBar to 120 mBar and the final pressure is 40 mBar to 60 mBar.

18. The secondary packaging according to claim 14, wherein the pressure accumulated in the internal compartment is not sufficient to cause the cap to open unintentionally.

19. The secondary packaging according to claim 1, wherein the cap comprises a base, and at least a portion of the base is arched so as to project vertically above the edge when the cap is in the closed position, thereby forming a recess in the cap configured to accommodate a portion of the device.

20. A drug delivery system comprising a secondary package according to any one of claims 1 to 19 and a drug delivery device stored therein.

21. The drug delivery system according to claim 20, comprising a body having an outlet end defining a drug discharge port and an actuator end on the opposite side thereof, the drug delivery system comprising a drug reservoir in which a drug is stored, the drug delivery system further comprising an actuator for discharging the drug from the reservoir through the discharge port, the actuator extending from the actuator end of the body, the actuator being linearly movable from an extended position to a depressed position, the discharge port being sealed when the actuator is in the extended position, the discharge port being opened when the actuator is in the depressed position, and the actuator being operable to discharge the drug from the reservoir when moved axially from the extended position to the depressed position.

22. The drug delivery system according to claim 21, wherein the drug delivery device is configured for intranasal administration, and the drug is in the form of a liquid, aerosol, gel, or powder at the time of administration.

23. The drug delivery system according to claim 22, wherein the drug is a formulation comprising one or more active pharmaceutical ingredients: naloxone, ketamine, midazolam, fentanyl, lorazepam, nalmefene, epinephrine, apomorphine, cetrorelix, roxapine, eletriptan, ketorolac, glucagon, and olanzapine.

24. A method for providing storage stability to a drug contained in a drug delivery device stored in a secondary package, wherein the secondary package has a cap and a body, the cap is pivotable relative to the body on a hinge, and storage stability is maintained by providing an environment with low or no relative humidity, and by preventing the cap from opening unintentionally while the drug delivery device is stored in the secondary package. The method includes placing an active polymer component in an internal compartment formed by the cap and the body when the cap is in a closed position relative to the body. The method wherein the active polymer component comprises a base polymer and a 3A molecular sieve.

25. The method according to claim 24, wherein the active polymer component further comprises a channeling agent.

26. Inserting the drug delivery device into the secondary packaging, A method comprising moving the cap from an open position to a closed position relative to the main body, thereby sealing the drug delivery device within the secondary packaging, The method according to claim 24, wherein the secondary packaging prevents unintentional operation of the drug delivery device and creates an environment with low or no relative humidity within the closed cavity of the secondary packaging.

27. Moving the cap from the closed position relative to the main body, Removing the drug delivery device from the secondary packaging, The method according to claim 26, further comprising administering the drug in the drug delivery device to a patient.

28. A method for treating a patient who requires a drug administered intranasally, the method being: The present invention provides the secondary packaging according to any one of claims 1 to 19, together with a drug delivery device stored therein, wherein the drug delivery device comprises a body having an outlet end defining a drug discharge port and an actuator end opposite thereto, the drug delivery device includes a drug reservoir for storing a drug therein, the drug delivery device further includes an actuator for dispensing the drug from the reservoir through the discharge port, the actuator extending from the actuator end of the body, the actuator being linearly movable from an extended position to a depressed position, the discharge port being sealed when the actuator is in the extended position and open when the actuator is in the depressed position, and the actuator being operable to discharge the drug from the reservoir when moving axially from the extended position to the depressed position. Removing the drug delivery device from the secondary packaging, Inserting the discharge end into the patient's nostril, A method comprising activating the drug delivery device and administering the drug to the patient intranasally.

29. When the secondary packaging is in the closed position, the use of 3A molecular sieve desiccant and the moisture-tight properties of the secondary packaging provide an environment with low or no relative humidity inside the secondary packaging, and The method according to claim 28, wherein the storage stability of the drug is maintained by preventing the cap from being unintentionally opened while the drug delivery device is stored in the secondary packaging.

30. The method according to claim 28, wherein the drug is a preparation comprising one or more active pharmaceutical ingredients: naloxone, ketamine, midazolam, fentanyl, lorazepam, nalmefene, epinephrine, apomorphine, cetrorelix, roxapine, eletriptan, ketorolac, glucagon, and olanzapine.

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