Inhaler

Abstract

A device for inhaling an active agent is provided that is switchable from a first configuration to a second configuration. The device includes two flexible substrates and a membrane located between the two flexible substrates, the two flexible substrates being connected at two opposite edges and not connected at two further opposite edges. An active agent provided on the membrane can be inhaled by a user when the device is in the second configuration. The membrane has a first portion and a second portion, the second portion preventing passage of the active agent through the membrane. A method of using the device is also provided.

Description

[Technical field]

[0001] The present invention relates to devices for delivering an active agent to a patient, and more particularly to devices, such as inhaler devices, for delivering an active agent to the lungs of a patient. [Background technology]

[0002] There are a number of active agents useful for treating various diseases or conditions that need to be administered to a patient via the lungs, i.e., they are pulmonary delivered active agents. Such pulmonary delivered active agents typically use a device, e.g., an inhaler device, that allows the patient to inhale the active agent directly into the lungs.

[0003] Inhalers in the art are usually designed to be used multiple times to minimize waste and to provide the patient with a single delivery system that is portable and provides a reliable delivery system when needed.For example, for patients suffering from asthma, it is important that a delivery system is available at all times when the patient may suffer from an asthma attack to deliver the required active agent quickly and efficiently.

[0004] However, such inhaler devices have suffered from clumping of the active agent and the carrier used to enable the active agent to be successfully delivered to the patient's lungs, and the need for the active agent and carrier to be crushed prior to use. Furthermore, many devices are intended for multiple uses and therefore must contain multiple doses of active agent. For each use, the active agent must be accurately and reliably metered so that each dose is the same.

[0005] Solutions to these problems have involved increasingly complex devices that include disintegration and dispersion chambers to ensure that the active agent is suitably disintegrated, and features for accurately metering the active agent per dose, resulting in devices that are increasingly bulky and inconvenient for patients to carry and use.

[0006] Thus, there is a need for an improved inhaler device that is convenient and reliable for patients to carry.

[0007] A single-use compact inhaler system that offers significant advantages over conventional inhaler systems and includes a membrane spanning a channel between two flexible substrates is described in International Patent Application No. WO2019 / 008336.

[0008] However, challenges remain to load the active agent onto the membrane in a manner that allows the active agent to be retained on the membrane prior to use, but also allows the active agent to be released during use.

[0009] Thus, there remains a need for improved inhaler devices.

[0010] Accordingly, at least one object of the present invention is to provide an improved device for delivering an active agent to the lungs of a patient. Summary of the Invention

[0011] According to a first aspect, there is provided an inhaler device comprising two flexible substrates and a membrane located between said two flexible substrates, each of said two flexible substrates having at least one deformable element, said two flexible substrates being connected at two mutually opposing edges and not connected at two further mutually opposing edges, said device being capable of being configured in a first configuration in which said two flexible substrates are substantially flat and in contact with each other, and in which said two flexible substrates are bent such that a channel is formed between said two flexible substrates having a first opening at one end of said channel and a second opening at an opposite end of said channel. and a second configuration in which the membrane is configured to switch between a first opening and a second configuration in which the membrane is configured to span the channel between the two flexible substrates when the device is in the second configuration, such that an active agent provided on the membrane may be inhaled by a user when the device is in the second configuration, the membrane having a first portion facing the first opening and a second portion facing the second opening, the first portion configured to releasably retain the active agent and the second portion configured to prevent the passage of the active agent through the second portion.

[0012] Typically, a first opening of the channel may be an air outlet and a second opening of the channel may be an air inlet, such that during use air is drawn into the channel via the air inlet and out of the channel via the air outlet.

[0013] The two further opposite edges that are not connected can be edges of the inhaler device when the inhaler device is in the first configuration. The two further opposite edges that are not connected can be edges of the inhaler device when the inhaler device is in the second configuration. The first opening of the channel and the second opening of the channel can be adjacent or can be at two opposite edges that are not connected to the two flexible substrates. Thus, the channel can extend between two opposite edges that are not connected to each other.

[0014] Thus, during use, the active agent held on or within the first portion of the membrane is released and inhaled by the user as air is drawn through the channel out the second opening, through the membrane and out the first opening.

[0015] The inventors have found that the device of this embodiment provides a simple method of delivering an active agent to the lungs of a patient, and the device is compact, portable and easy to use.

[0016] As used herein, the term "spanning a channel" refers to the membrane extending across the channel to occlude at least a portion of the cross-section of the channel.

[0017] It has further been found that by providing the membrane with a first portion configured to releasably retain an active agent, the membrane can be readily loaded with the active agent during manufacture, while a second portion of the membrane prevents the active agent from being lost through the membrane during manufacture.

[0018] Still further, by providing the membrane with a second portion configured to prevent passage of active agent through the second portion, it is ensured that active agent cannot be lost through the second opening during use when a user exhales into the inhaler device before inhaling.

[0019] The first portion may be at least 50% of the membrane. The first portion may be at least 60% of the membrane. The first portion may be at least 70% of the membrane. The first portion may be at least 80% of the membrane. At least 50% of the membrane's depth may be the first portion of the membrane, such that when viewed from the side, at least 50% of the membrane's depth is comprised of the first portion. At least 60% of the membrane's depth may be the first portion of the membrane, such that when viewed from the side, at least 60% of the membrane's depth is comprised of the first portion. At least 70% of the membrane's depth may be the first portion of the membrane, such that when viewed from the side, at least 70% of the membrane's depth is comprised of the first portion. At least 80% of the membrane's depth may be the first portion of the membrane, such that when viewed from the side, at least 80% of the membrane's depth is comprised of the first portion.

[0020] The membrane can be about 50% to about 99% of the first portion. The membrane can be about 60% to about 99% of the first portion. The membrane can be about 70% to about 99% of the first portion. The membrane can be about 80% to about 99% of the first portion. The membrane can be about 50% to about 95% of the first portion. The membrane can be about 50% to about 90% of the first portion. The membrane can be about 50% to about 80% of the first portion. The membrane can be about 50% to about 70% of the first portion.

[0021] The second portion may act as a backing layer over the first portion.

[0022] The membrane comprises a first major surface and an opposing second major surface. The first portion of the membrane may comprise the first major surface of the membrane. The second portion of the membrane may comprise the second major surface of the membrane.

[0023] The first portion of the membrane may be gas permeable to allow air to pass through the membrane during use. The second portion of the membrane may be gas permeable to allow air to pass through the membrane during use. Preferably, the first portion of the membrane and the second portion of the membrane are gas permeable to allow air to pass through the membrane during use.

[0024] The first portion of the membrane may be porous. The second portion of the membrane may be porous. Typically, the first portion of the membrane may be more porous than the second portion of the membrane. Thus, the first portion of the membrane may have a higher porosity than the second portion of the membrane.

[0025] Usually, the membrane is a single membrane. The first and second parts may be parts of the same membrane. Thus, the first and second parts may abut or contact each other such that there is no space or gap between them. The first part may occlude the second part. Thus, the first and second parts may completely overlap each other. The first and second parts may overlap each other for at least a large portion of their surface area. The first and second parts may, for example, be different layers of material laminated together.

[0026] The active agent may comprise particles of the active agent. Thus, the active agent may be a particulate active agent.

[0027] Typically, the second portion of the membrane may be impermeable to the active agent.

[0028] The first portion of the membrane may comprise a first plurality of apertures or pores. The second portion of the membrane may comprise a second plurality of apertures or pores. The apertures or pores of the first plurality of apertures or pores may be larger than the apertures or pores of the second plurality of apertures or pores. The average size of the apertures or pores of the first plurality of apertures or pores may be larger than the average size of the apertures or pores of the second plurality of apertures or pores.

[0029] Typically, the first plurality of apertures or pores may allow particles of the active agent to at least partially penetrate into the first portion of the membrane, and thus at least a majority of the first plurality of apertures or pores are significantly larger than the particles of the active agent.

[0030] Typically, the second plurality of apertures or pores may prevent particles of active agent from penetrating or partially penetrating into the second portion of the membrane.

[0031] Particles of active agents typically used in inhaler devices have an average diameter of less than 100 μm, less than 50 μm, less than 25 μm, less than 10 μm, or less than 5 μm. The particles may have an average diameter of 0.5 μm to 100 μm. The particles may have an average diameter of 0.5 μm to 50 μm. The particles may have an average diameter of 0.5 μm to 25 μm. The particles may have an average diameter of 0.5 μm to 10 μm. The particles may have an average diameter of 0.5 μm to 5 μm. The particles may have an average diameter of 1 μm to 100 μm. The particles may have an average diameter of 1 μm to 50 μm. The particles may have an average diameter of 1 μm to 25 μm. The particles may have an average diameter of 1 μm to 10 μm. The particles may have an average diameter of 1 μm to 5 μm.

[0032] Thus, the first plurality of apertures or pores may be greater than 100 μm in at least a major dimension, greater than 50 μm in at least a major dimension, greater than 25 μm in at least a major dimension, greater than 10 μm in at least a major dimension, or greater than 5 μm in at least a major dimension, when the particles of active agent have an average diameter of less than 100 μm, less than 50 μm, less than 25 μm, less than 10 μm, or less than 5 μm, respectively.

[0033] In some embodiments, the first portion of the membrane may be substantially continuous and provide a substantially continuous surface on which the active agent may be retained prior to use. The first portion of the membrane may have pores that allow air to pass across the first portion of the membrane, but are small enough to prevent particles of the active agent from passing through.

[0034] In some embodiments, the second portion of the membrane may be substantially continuous and provide a substantially continuous surface onto which the active agent may be placed, for example, the second portion of the membrane may have pores that allow air to pass across the second portion of the membrane, but are small enough to prevent particles of the active agent from passing through.

[0035] In some embodiments, the first portion of the membrane may comprise a monolithic material. The monolithic material may comprise a plurality of holes or apertures. The plurality of holes or apertures may be arranged in an orderly manner on the first portion. For example, the plurality of holes or apertures may be arranged in an array. The plurality of holes or apertures may be arranged in a disordered manner on the first portion.

[0036] In some embodiments, the second part of the membrane can comprise a monolithic material. The monolithic material can comprise a plurality of holes or apertures. The plurality of holes or apertures can be arranged in an orderly manner on the first part. For example, the plurality of holes or apertures can be arranged in an array. The plurality of holes or apertures can be arranged in a disorderly manner on the first part. The holes or apertures of the plurality of holes or apertures can be significantly smaller than the diameter of the particles of the active agent held on or in the membrane.

[0037] In some embodiments, the first portion of the membrane may comprise a mesh. The mesh may include a fiber netting. The fiber netting may be woven together to form a mesh. The fiber netting may be connected at nodes to form a mesh. The particles of active agent may be adhered to a surface of the fibers of the mesh. The particles of active agent may be bound or loosely attached to the first portion of the membrane by a static charge. The charge applied to the first portion of the membrane and / or the particles of active agent may be adjusted to ensure that the particles of active agent are retained on the first portion of the membrane before use but are still lifted from the first portion of the membrane during use.

[0038] In some embodiments, the second portion of the membrane may comprise a mesh. The mesh may include a fiber web. The fiber web may be woven together to form the mesh. The fiber web may be connected at nodes to form the mesh.

[0039] In embodiments in which the first and second portions of the membrane comprise meshes, the mesh of the first portion may have larger gaps, holes, or voids than the mesh of the second portion. The mesh of the first portion may allow particles of active agent to pass through or penetrate the mesh, such that the particles of active agent may be dispersed within the mesh of the first portion. In contrast, the mesh of the second portion may have smaller gaps, holes, or voids, generally significantly smaller than the particles of active agent, such that the mesh of the second portion is substantially impermeable to the particles of active agent. Thus, the membrane may be configured to retain and release particles of active agent, while also ensuring that the membrane can be more reliably loaded with particles of active agent during manufacturing.

[0040] In some embodiments, a first portion of the membrane may comprise a mesh and a second portion of the membrane may be substantially continuous.

[0041] The first portion may comprise a foam material. The foam material may be an open cell foam material. The open cell foam material may comprise large voids connected together. The first portion may comprise strands of material that may form a scaffold around the voids.

[0042] For the avoidance of doubt, any embodiment of the first portion of the membrane may be combined with any embodiment of the second portion of the membrane described above.

[0043] The membrane may comprise a polymer. For example, the membrane may comprise polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polypropylene, polyethylene, polyurethane, polylactic acid, polyglycolic acid, polycaprolactone, poly(dioxanone), or copolymers thereof. The membrane may comprise polyethylene or polypropylene.

[0044] The first portion of the membrane may comprise the same material as the second portion of the membrane. The first portion of the membrane may be the more porous portion of the membrane and the second portion of the membrane may be the less porous portion of the membrane. Thus, the porosity of the first portion of the membrane may be greater than the porosity of the second portion of the membrane. The first portion of the membrane may be the less dense portion of the membrane and the second portion of the membrane may be the more dense portion of the membrane. Thus, the density of the first portion of the membrane may be less than the density of the second portion of the membrane.

[0045] The first portion of the membrane may comprise a material that is different from the material of the second portion of the membrane.

[0046] The first portion of the membrane may include a coating. The coating may modify a surface property of the first portion of the membrane. The coating may enhance one or more surface properties of the first portion of the membrane. The coating may enhance the hydrophobicity of the surface of the first portion of the membrane. The coating may enhance the hydrophilicity of the surface of the first portion of the membrane. The coating may change the ability of the surface of the first portion of the membrane to retain an electric charge. Thus, the coating may enhance or reduce the charge of the surface of the first portion of the membrane.

[0047] The coating may comprise an excipient. The coating may comprise one or more of the excipients selected from the group consisting of: magnesium stearate; microcrystalline cellulose, modified cellulose, such as hydroxyalkylcellulose including hydroxypropylcellulose and hydroxypropylmethylcellulose (HPMC), alkylcellulose, such as methylcellulose, ethylcellulose, or propylcellulose, and carboxyalkylcellulose, such as cellulose including carboxymethylcellulose (CMC) and croscarmellose; starch; modified starch, such as sodium starch glycolate and pregelatinized starch; silicone / titanium dioxide; stearic acid and stearic acid salts, such as calcium stearate; gelatin; talc; sucrose; polyvinylpyrrolidone (povidone) and cross-linked polyvinyl N-pyrrolidone (crospovidone); calcium phosphate; shellac and glaze.

[0048] In some embodiments, the membrane may be a laminated membrane comprising two or more layers laminated together. A first portion of the membrane may correspond to one or more layers of the laminated membrane. A second portion of the membrane may correspond to one or more layers of the laminated membrane. Typically, the first portion corresponds to a different layer of the laminated membrane than the layers of the second portion.

[0049] In some embodiments, the membrane comprises a first membrane and a second membrane located adjacent to each other or in contact with each other. The first membrane may be directly fixed to the second membrane. For example, the first membrane may be adhered, bonded, or otherwise fixed to at least a portion of the second membrane. The first membrane may be indirectly fixed to the second membrane via a support or via one or both of two flexible substrates, such that the first membrane is not directly adhered, bonded, or otherwise fixed to the second membrane. Thus, the first portion of the membrane may be the first membrane, and the second portion of the membrane may be the second membrane. Typically, the membrane does not comprise a space or gap between the first membrane and the second membrane.

[0050] In embodiments where the membrane is substantially continuous, the membrane may span only a portion of the cross-section of the channel to ensure that sufficient airflow can be generated through the channel during use, and therefore there may be gaps in the cross-section of the channel that allow for increased airflow through the channel.

[0051] The membrane may be flat or substantially flat. Alternatively, the membrane may include a recessed portion. In embodiments where the membrane includes a recessed portion, the majority of the active agent of the membrane may be located within the recessed portion. Thus, the recessed portion may extend away from the outlet of the device toward the inlet of the device. In some embodiments, during use, the recessed portion may turn up as the user inhales through the device. Thus, the active agent held within the recessed portion may be propelled in the direction of airflow. When the device is in the second configuration, the membrane may extend across the entire cross-section of the channel and occlude the entire cross-section of the channel. Typically, the membrane extends across the channel between the opposite open edges of the flexible substrate. When the device is in the second configuration, the membrane may extend across a portion of the channel or occlude a portion of the channel. As a result, there may be portions of the channel through which air can pass without passing through the membrane and portions of the channel through which air must pass through the membrane.

[0052] Typically, the membrane may be flexible and may be folded or collapsed when the device is in the first configuration.

[0053] The membrane may be configured to be compressed or condensed when the inhaler device is in the first configuration. The membrane may be configured to expand when the inhaler device switches from the first configuration to the second configuration. The expansion of the membrane may urge the device into the second configuration.

[0054] During manufacture, the active agent may be trapped within the first portion of the membrane when the membrane is compressed, and thus, during use, when the device is switched from the first configuration to the second configuration, the membrane may expand and the active agent may be free or allowed to pass out of the first portion of the membrane when a user inhales through the inhaler device.

[0055] Typically, the active agent is located on or within the membrane. The active agent may be on the surface of the membrane. For example, the active agent may be in particulate form, and the particles may be attached to the surface of the membrane. The active agent may be loosely attached to the surface of the membrane, so that when air passes through the membrane during use, the active agent is removed from the membrane and becomes airborne. The active agent may be bound or loosely attached on the membrane by electrostatic charge. The charge applied to the membrane and / or the active agent may be adjusted to ensure that the active agent is retained on the membrane before use, but still lifted from the membrane during use. As a result, the active agent may be easily inhaled by the patient into his or her lungs.

[0056] The active agent may be provided between the first and second portions. The first portion may be configured to releasably hold the active agent between the first and second portions prior to use. During use, the active agent may pass through the first portion to the first opening. Thus, the first portion may act as a filter to ensure that large aggregates of the active agent are not inhaled by the user during use. The first portion may be connected to the second portion around the periphery of the membrane. The active agent may be provided between the first and second portions, away from the periphery of the membrane. The first portion may be bonded to the second portion around the periphery of the membrane. The periphery of the membrane may be adjacent to the wall of the channel.

[0057] In some embodiments, the particles of the active agent may also include a carrier, vehicle or excipient. The carrier, vehicle or excipient may help prevent the particles from aggregating while the device is in the first configuration before use. The carrier, vehicle or excipient may enhance the ability of the or each active agent to become airborne when air passes through the channels of the device, for example, when the patient inhales. The carrier, vehicle or excipient may prevent the particles from aggregating on the membrane.

[0058] Typically, the amount of active agent on the membrane is sufficient for the user to receive a full dose of active agent when inhaling through the device. Thus, the amount of active agent on the membrane may correspond to a single full dose. In some embodiments, some active agent may remain on the membrane when the user inhales through the device. Thus, the amount of active agent on the membrane may correspond to more than a single full dose, so that the amount of active agent actually inhaled by the user is a single full dose.

[0059] The membrane may be attached to a support within the channel. The support may comprise a gas impermeable material closing the channel and comprising at least one aperture. The membrane may be attached within the at least one aperture. Air flow through the channel may thus be constrained by the aperture in the support, thereby increasing the rate of air flow through the membrane (i.e., the Venturi effect), thereby increasing the force exerted by the air flow on the active agent on the membrane to lift the active agent from the membrane into the air flow.

[0060] In some embodiments, the support may have at least two apertures and a membrane may be supported across each aperture. Thus, a first membrane may be supported within the first aperture and a second membrane may be supported within the second aperture. The first membrane may be provided with a first active agent. The second membrane may be provided with a second active agent. Thus, the device may be configured to deliver two active agents simultaneously to a user when the user inhales through the device. The first active agent may be provided in a first unit dose. The second active agent may be provided in a second unit dose. The first unit dose may be different from the second unit dose. The first unit dose may be the same as the second unit dose.

[0061] Alternatively, the first membrane may be provided with a first active agent and the second membrane may be provided with a first active agent, such that the device may provide a larger dosage of the first active agent than a device having a single membrane.

[0062] When the device is in the first configuration, the support may occlude the channel. When the device is in the first configuration, the support may adopt a bent or folded or otherwise reversibly collapsed configuration. When the device is switched to the second configuration, the support may unfold to span across and occlude the channel of the device. Typically, the support may unfold to an open configuration, and the support may not open any further. Thus, the support may ensure that the device cannot be moved beyond the second configuration by the user, thereby ensuring that optimal airflow is achieved by the device when the user inhales through the device in the second configuration.

[0063] The support may include at least one fold line such that when the device is in the first configuration, the support is folded about the at least one fold line and when the device is in the second configuration, the support is stretched and substantially unfolded. The at least one fold line may extend across at least a portion of the membrane mounted on the support.

[0064] The support may include at least two fold lines. Each of the at least two fold lines may allow the support to be folded in an opposite direction to each other. For example, a first fold line may allow the support to be folded in a first direction and a second fold line may allow the support to be folded in an opposite second direction. When the device is in a first configuration, the support may be folded about the at least two fold lines, and when the device is in a second configuration, the support may be stretched and substantially unfolded. One or more of the at least two fold lines may extend across at least a portion of the membrane mounted on the support.

[0065] The support may comprise at least three fold lines. Each of the at least three fold lines may allow the support to be folded in an opposite direction to each other. For example, a first fold line may allow the support to be folded in a first direction, a second fold line may allow the support to be folded in an opposite second direction, and a third fold line may allow the support to be folded in the first direction. Thus, the support may be folded in a bellows-type manner. One or more of the at least three fold lines may extend across at least a portion of the membrane mounted on the support. The at least three fold lines may divide the support into at least four parts. The support may be divided into two central parts and two peripheral parts. The membrane may be mounted across an aperture in one of the four parts. The membrane may be mounted across an aperture in two of the four parts. The membrane may be attached across two central portions. The support may be attached to a first flexible substrate by a first peripheral portion. The support may be attached to a second flexible substrate by a second peripheral portion.

[0066] The support may comprise at least four fold lines. Each of the at least four fold lines may allow the support to be folded in an opposite direction to each other. For example, a first fold line may allow the support to be folded in a first direction, a second fold line may allow the support to be folded in an opposite second direction, a third fold line may allow the support to be folded in the first direction, and a fourth fold line may allow the support to be folded in the opposite second direction. Thus, the support may be folded in an accordion-type manner. One or more of the at least four fold lines may extend over at least a portion of the membrane mounted on the support. Alternatively, the membrane may be located between two adjacent fold lines. The at least four fold lines may divide the support into at least five parts. The support may be divided into three central parts and two peripheral parts. The three central portions may include a central portion between two adjacent portions. The membrane may be attached across an aperture in one of the four portions. The membrane may be attached across two of the four portions. The membrane may be attached across an aperture in the central portion. The support may be attached to the first flexible substrate by a first peripheral portion. The support may be attached to the second flexible substrate by a second peripheral portion.

[0067] The support may comprise or form a closed space when folded. The active agent may be located on a face of the membrane that is inside the closed space of the folded support when the device is in the first configuration. Thus, the active agent may be protected within the closed space prior to use. In an embodiment in which the support includes at least four fold lines, the membrane may be located within the closed space when the support is folded.

[0068] The support may include a seal adjacent an edge of the closed space when the support is folded. The seal may protect the active agent when the device is in the first configuration.

[0069] The support may be located in the center of the channel such that the support is substantially equidistant from the first opening and the second opening. The support may be located adjacent to or proximate to the first opening. The support may be located adjacent to or proximate to the second opening.

[0070] Typically, the membrane is configured to ensure that, in use, when a patient inhales at one of the channel openings, airflow through the device is sufficient to remove a sufficient amount of the active agent, or particles containing the active agent, from the membrane and direct it into the patient's lungs to provide the required dose of active agent.

[0071] Preferably, the active agent is effective when delivered to the lungs of a patient, and thus the device of this embodiment is suitable for use for the delivery of any active agent that can be delivered to the lungs of a patient.

[0072] Typically, the active agent is provided as a dry powder. The dry powder may comprise particles. The particles may comprise the active agent. The particles may comprise a carrier.

[0073] The active agent may be a bronchodilator, for example, the active agent may be salbutamol, salmeterol, formoterol, ventolin or other such active agent.

[0074] The active agent may be a vaccine. For example, the active agent may be an inhalable vaccine against diseases such as cholera, diphtheria, anthrax, tetanus, hepatitis A or B, influenza, measles, meningitis, polio, rabies, pneumonia, rotavirus, smallpox, typhoid, yellow fever, coronavirus, etc.

[0075] The active agent may treat pain. For example, the active agent may be an inhalable form of tramadol, gabapentin, Vicodin®, ibuprofen, acetaminophen, hydrocodone, naproxen, methadone, codeine, hydroxyzine, paracetamol, aspirin, etc.

[0076] The active agent may be used to treat diabetes. For example, the active agent may be an inhalable form of insulin, canagliflozin, alogliptin benzoate, dapaglifozin, empagliflozin, ranibizumab, dulaglutide, pioglitazone hydrochloride, glimepiride, and the like.

[0077] The active agent may be used to treat or prevent migraine. The active agent may be a triptan (or 5HT agonist), such as almotriptan (e.g., Almogran™), eletriptan (e.g., Relpax™), frovatriptan (e.g., Migard™), naratriptan (e.g., Naramig™), rizatriptan (e.g., Maxalt™), sumatriptan (e.g., Imigran™), zolmitriptan (e.g., Zomig™), metoclopramide, rimegepant, lasmiditan, etc.

[0078] The active agent may be a hormone, such as an inhalable form of oxytocin. The active agent may prevent postpartum hemorrhage.

[0079] The active agent may be used to treat sexual health disorders. For example, the active agent may be an inhalable form of sildenafil, tadalafil or vardenafil.

[0080] The active agent may be used to treat nausea. For example, the active agent may be an inhalable form of ondansetron, domperidone, dolasetron, or dronabinol.

[0081] The active agent may be used to treat allergies. For example, the active agent may be an inhalable form of loratadine, cetirizine, chlorpheniramine, diphenhydramine, or fexofenadine.

[0082] The active agent may be used to treat epilepsy. For example, the active agent may be an inhalable form of levetiracetam, lacosamide, or lamotrigine.

[0083] The active agent may be used to treat asthma.

[0084] The active agent may be used to treat multiple sclerosis and / or associated conditions. For example, the active agent may be an inhalable form of teriflunomide or fingolimod.

[0085] The active agent may be used to treat Parkinson's disease. For example, the active agent may be an inhalable form of pramipexole, rotigotine, ropinirole, carbidopa-levodopa.

[0086] The active agent may be used to treat motor neurone disease (MND) and / or associated symptoms. For example, the active agent may be an inhalable form of riluzole.

[0087] The active agent may be used to treat depression. For example, the active agent may be a psychoactive agent, such as a cannabinoid, a selective serotonin reuptake inhibitor (SSRI).

[0088] The active agent may be used to treat an infectious disease. The active agent may be used to treat a viral infection. The active agent may be used to treat a bacterial infection.

[0089] The active agent may be a vitamin, a dietary supplement, a probiotic, or a natural stimulant, such as caffeine, or a natural relaxant, such as chamomile extract, or an herbal medicine. The active agent may be any other non-medicinal inhalable drug that can be manufactured as an inhalable dry powder.

[0090] In some embodiments, at least one deformable element of each flexible substrate may bias the device into a second configuration in which a first opening of the channel formed between the two flexible substrates is substantially regular in shape and a second opening of the channel formed between the two flexible substrates is substantially irregular in shape.

[0091] A substantially regular shape can be a shape having an aspect ratio of about 3:1 to 1:3 or about 3:2 to 2:3.

[0092] A substantially irregular shape can be a shape having an aspect ratio greater than about 3:1, or less than about 1:3, or greater than about 3:2, or less than about 2:3.

[0093] As used herein, a 3:1 aspect ratio has 3 heights for every 1 width, or has that ratio.

[0094] The first opening of the channel may be polygonal. The first opening of the channel may be substantially rectangular. For example, the first opening of the channel may be substantially rectangular or square. The first opening of the channel may be substantially rectangular with curved or rounded corners.

[0095] The second opening of the channel may comprise at least two oppositely curved sides. The second opening of the channel may be biconvex. A biconvex opening is convex on both sides or surfaces of the opening.

[0096] Thus, in some embodiments, at least one deformable element on each flexible substrate may bias the device into a second configuration in which a first opening of the channel formed between the two flexible substrates is substantially rectangular and a second opening of the channel formed between the two flexible substrates is substantially biconvex.

[0097] Typically, the two flexible substrates are of the same shape. In some embodiments, the two flexible substrates may be rectangular. In some embodiments, the two flexible substrates may be square. Alternatively, in other embodiments, the two flexible substrates may be rectangular. Those skilled in the art will appreciate that alternative shapes of the two flexible substrates are within the scope of the present disclosure, as long as the two flexible substrates are connected at two opposite edges and can be switched between a first configuration and a second configuration. For example, the two flexible substrates may be trapezoidal, hexagonal, octagonal, etc. In another example, the two opposite edges that are not connected may be curved.

[0098] Typically, the two flexible substrates may be uniform or substantially uniform substrates that may be bent to switch from a first configuration to a second configuration. However, at least one of the two flexible substrates may have two or more regions with different stiffness, such that at least one of the two or more regions is more stiff and resistant to bending, and at least one of the two or more regions is less stiff and resistant to bending. For example, one or both of the flexible substrates may comprise one or more flexible portions and one or more rigid portions. The one or more rigid portions may resist bending, and the one or more flexible portions may bend easily. As a result, during use, one or more flexible regions of at least one of the two flexible substrates may bend to allow the device to switch from a first configuration to a second configuration, while the one or more rigid regions remain substantially flat. The flexible regions may form hinges in the flexible substrate. The flexible region may be shaped such that the device is biased into the second configuration. In some embodiments, the or each flexible portion may correspond to at least one deformable element. The at least one deformable element of each flexible substrate may be a score line (i.e., a mark or score line) along at least a portion of the flexible substrate. The at least one deformable element of each flexible substrate may be a line of flexibility extending along at least a portion of the flexible substrate. The at least one deformable element of each flexible substrate may be a crease in the flexible substrate.

[0099] At least one deformable element of each flexible substrate may be formed by a series of perforations in the flexible substrate.

[0100] At least one deformable element of each flexible substrate may be formed by a portion of the flexible substrate that is thinner than the majority of the flexible substrate.

[0101] Each flexible substrate may comprise a first flexible layer and a second layer less flexible than the first flexible layer. The second layer may comprise a plurality of portions. Each portion of the plurality of portions may be at least partially separated from each other by a space or gap. At least one deformable element of each flexible substrate may correspond to a space or gap between adjacent portions of the second layer. Alternatively, the or each portion of the plurality of portions may abut each other, forming a fault line between the adjacent portions. At least one deformable element of each flexible substrate may correspond to a fault line between the adjacent portions.

[0102] At least one deformable element may function as a hinge such that each flexible substrate bends about the at least one deformable element when the device switches between the first and second configurations.

[0103] At least one deformable element may comprise a first portion and a second portion. The first portion may be adjacent to a first opening of the channel when the device is in the second configuration, and the second portion may be adjacent to a second opening of the channel when the device is in the second configuration. The first portion may connect to the second portion partway along the length of the flexible substrate.

[0104] The first portion may be linear or straight. The first portion may be aligned with an axis of the device that extends along the length of the channel. The first portion may be oriented at an angle relative to the axis of the device. For example, the first portion may be oriented at an angle of 1° to 40° relative to the axis of the device. The first portion may be oriented at an angle of 1° to 25° relative to the axis of the device. Thus, the first portion may extend from a first opening in the flexible substrate toward a second opening in the flexible substrate.

[0105] The first portion may be curved.

[0106] The second portion may be linear or straight. The second portion may be oriented at an angle relative to an axis of the device that extends along the length of the channel.

[0107] The second portion may be curved. The second portion may be curved toward one of the connected edges of the flexible substrate. The second portion may be curved toward one or more corners of the flexible substrate. The second portion may be curved relative to a corner of the flexible substrate.

[0108] In embodiments in which the first and second portions are curved, the first portion may be curved at a rate less than the rate of the second portion. The first portion may be curved at a rate greater than the rate of the second portion. Thus, the at least two deformable elements may be curved at a first rate in a portion corresponding to the first portion and at a second rate in a portion corresponding to the second portion.

[0109] Each flexible substrate may comprise at least two deformable elements. The at least two deformable elements may be symmetrically arranged on the flexible substrate. The plane of symmetry may extend along a centerline or central axis of the flexible substrate extending along the length of the flexible substrate. The plane of symmetry may be oriented at 90° to a major plane of the flexible substrate. Thus, the device may be symmetric about at least one plane of symmetry.

[0110] Switching from the first configuration to the second configuration may impose a force on the at least one deformable element sufficient to cause the flexible substrate to bend around them.

[0111] The at least one deformable element may be configured to lock the device in the second configuration when the device is switched from the first configuration to the second configuration, such that once the device is in the second configuration, the device may be maintained in the second configuration without the application of an external force by a user.

[0112] The device may further comprise at least one locking mechanism. The at least one locking mechanism may be configured to lock the device in the second configuration. The at least one locking mechanism may be configured to lock the device in the second configuration when the device is switched from the first configuration to the second configuration.

[0113] The at least one locking mechanism may be formed by at least a portion of the at least one deformable element of the first flexible substrate and the second flexible substrate. In embodiments in which the at least one deformable element includes a curved second portion, the at least one locking mechanism may be formed by at least a portion of the curved second portion of the at least one deformable element of the first flexible substrate and at least a portion of the curved second portion of the at least one deformable element of the second flexible substrate. The locking mechanism may be an indentation in the device body that is formed when the device switches from the first configuration to the second configuration. When the indentation is formed, the indentation may lock the device into the second configuration.

[0114] In some embodiments, the at least one locking mechanism may generate an audible cue when the at least one locking mechanism is moved to the locked position. The at least one locking mechanism may, for example, generate a popping noise.

[0115] The flexible substrate may include cardboard or corrugated board. The flexible substrate may include a polymer or plastic. The polymer or plastic may be a thermoplastic. The polymer or plastic may be a thermoplastic selected from the group consisting of polypropylene (PP), polyethylene terephthalate (PET), and high density polyethylene (HDPE). The flexible substrate may include a combination of cardboard and a polymer or plastic, for example, a cardboard or corrugated board substrate having a polymer or plastic coating. The polymer or plastic coating may be provided on an outer surface of the flexible substrate. The polymer or plastic coating may be provided on an inner surface of the flexible substrate. The polymer or plastic coating may be provided on both the inner and outer surfaces of the flexible substrate.

[0116] One or both of the two flexible substrates may be degradable. One or both of the two flexible substrates may be biodegradable. One or both of the two flexible substrates may comprise a biopolymer. The biopolymer may be a polypeptide, a nucleic acid, or a polysaccharide. For example, the device may degrade when in contact with water, exposure to light, or in the presence of bacteria, etc.

[0117] The membrane and the active agent thereon may be protected from moisture, light, oxygen and contamination. The membrane may be held in a protective pocket between two flexible substrates. When the device is switched from the first configuration to the second configuration, the protective pocket may open to expose the membrane and the active agent thereon. The protective pocket may comprise a material that is resistant to water, oxygen and / or light. For example, the protective pocket may comprise a metal foil, such as aluminum, or a polymer or plastic film.

[0118] The membrane may be occluded by a barrier material on at least one side of the membrane when the device is in at least the first configuration. The barrier material may form a barrier membrane or film across the membrane. The barrier material and the membrane may hold the active agent between them when the device is in the first configuration. Thus, the active agent may be protected from the environment by the membrane and the barrier material. The barrier material may be located adjacent to the membrane. The barrier material may be located on a side of the membrane facing the first opening of the device. Thus, during use, air may be drawn through the device from the second opening, through the membrane, through the barrier material, and into the first opening.

[0119] The barrier materials may be located on each side of the membrane to form a first barrier and a second barrier such that the membrane and the active agent are both retained between the first barrier and the second barrier.

[0120] The barrier material may be attached to one or more of the flexible substrates. The barrier material may be attached to the membrane. The barrier material may be attached to a substrate on or within which the membrane is supported.

[0121] The barrier material may be breached or removed to expose the active agent when the device is switched from the first configuration to the second configuration.

[0122] The barrier material may be ruptured or removed to expose the active agent when a user inhales through the channel of the device while the device is in the second configuration. The barrier material may be ruptured to expose the active agent when a user inhales through the channel of the device while the device is in the second configuration.

[0123] The barrier material may be located on both sides of the membrane to form a protective pocket within which the membrane and active agent are retained when the device is in the first configuration. The barrier material of the protective pocket may be destroyed, breached, or removed when the device is switched from the first configuration to the second configuration. The barrier material of the protective pocket may be destroyed, breached, or removed when a user inhales through the device.

[0124] The barrier material may include a material that is resistant to water, oxygen and / or light. For example, the barrier material may include a metal foil, such as aluminum, or a polymer or plastic film.

[0125] At least a portion of at least one surface of one or both of the two flexible substrates may include a metal coating. For example, at least a portion of an inner surface of the two flexible substrates may include a metal coating. The metal coating may be a foil coating or the like. The metal coating may include, for example, aluminum, copper, or tin.

[0126] In some embodiments, the metal coating covers substantially the entire interior surface of both of the two flexible substrates. In some embodiments, the metal coating covers a portion of the interior surface of both of the two flexible substrates. The portion may be adjacent to one of the opposing non-connected ends of both of the two flexible substrates. The portion may be midway between the two opposing non-connected ends of both of the two flexible substrates.

[0127] Typically, the metal coating is located such that when the device is in the first configuration and the two flexible substrates are substantially flat, the membrane is at least partially covered by the metal coating. In some embodiments in which the two flexible substrates include a metal coating, the membrane is contained within an envelope or the like, and the envelope includes the metal coating of the two flexible substrates. The envelope may be sealed such that the membrane is sealed within the envelope. Thus, the active agent provided on the membrane may be protected from moisture, oxygen, light and contamination.

[0128] The envelope may be sealed adjacent to the membrane. In embodiments in which the entire interior surfaces of both of the two flexible substrates are substantially covered with a metal coating, the envelope formed by the metal coating may be sealed adjacent to one or both of the opposing non-connected ends of the two flexible substrates.

[0129] The device may be a single-use device, i.e., the membrane between the two flexible substrates may contain a single dose of active agent, and once the patient has used the device, the device may be discarded and replaced with a new device.

[0130] In embodiments where the two flexible substrates are biodegradable, the discarded device may decompose when contacted with water or the like, thereby minimizing waste. In embodiments where the device comprises cardboard or polymers or plastics, the device may be recycled, minimizing waste.

[0131] The device may be protected from moisture. The device may be stored in a waterproof package prior to use. The device may include one or more sealants. The device may include one or more sealants such that the membrane is sealed within the device and is thereby protected from moisture. For example, the device may have a sealant adjacent to each opening. In another example, the device may have a sealant on both sides of the membrane. During use, the act of switching the device from a first position to a second position may break the or each sealant such that the membrane and any active agent placed thereon are exposed.

[0132] In embodiments in which two flexible substrates include a metal coating, the device may have a seal at each opening of the channel and a seal on both sides of the metal coating.

[0133] The device may include one or more stiffening elements. The or each stiffening element may bias the device toward the second configuration. The or each stiffening element may provide a biasing force insufficient to switch the device from the first configuration to the second configuration, where the or each stiffening element supplements a force applied by a user to open or switch the device from the first configuration to the second configuration.

[0134] The device may include one or more reinforcing elements in a central region of the device. The device may include one or more reinforcing elements adjacent one or more of the openings of the channel. The reinforcing elements may allow the device to more easily switch from the first configuration to the second configuration when a threshold pressure is applied by a user to the two opposing connected edges.

[0135] The or each reinforcing element may extend across one or both flexible substrates. The or each reinforcing element may extend across the width of the channel, i.e. the or each reinforcing element may extend between connected edges of the or each flexible substrate.

[0136] The or each stiffening element may be shaped to facilitate opening of the channel when the two flexible substrates are bent, for example the or each stiffening element may be curved or bent such that when pressure is applied to the connected edges opposite each other the device is biased into the second configuration.

[0137] The device may be sized to fit within a user's hand. In some embodiments, the device may be sized to fit within a user's wallet or purse. For example, the device may be the size of a typical credit card or the like (i.e., generally flat with two major dimensions of approximately 80-90 mm x 50-60 mm, e.g., 86 mm x 54 mm). As a result, the device may be held by the user in his or her wallet or purse, ensuring that the device is readily available to the user when administration of an active agent is required.

[0138] In some embodiments, the channels are configured to optimize airflow through the channels.

[0139] The cross-sectional area of ​​the channel may decrease from the air inlet to the air outlet such that air flow through the channel is accelerated from the air inlet to the air outlet.

[0140] The cross-sectional area of ​​the channel may be reduced in a portion of the channel.The cross-sectional area of ​​the channel may be reduced in a portion of the channel between the air inlet and the air outlet.

[0141] Typically, the height of the channel in one dimension may be greater at the second opening than at the first opening. The width of the channel may be greater at the first opening than at the second opening. For example, the height of the channel when viewed from the side may be greater at the second opening than at the first opening, and the width of the channel when viewed from above may be greater at the first opening than at the second opening.

[0142] In at least one embodiment, a cross-section of the channel may have a "trumpet-like" shape. The channel may comprise a first portion and a second portion. In at least one dimension, the cross-section of the channel in the first portion may be larger than the cross-section of the second portion. In at least one dimension, the cross-section of the channel in the first portion may be smaller than the cross-section of the second portion. Thus, for a constant rate of air flow through the channel, the air must travel more quickly through the second portion as compared to the first portion.

[0143] The second portion may include an aperture that constrains the channel. The membrane may span the aperture such that air flowing through the second portion must flow through the membrane. Thus, the air moves faster through the membrane than through the first portion of the channel, thereby exerting a greater force on the active agent present on the membrane, lifting the active agent into the airflow.

[0144] In some embodiments, the channel may extend across the entire width of the two flexible substrates. In alternative embodiments, the channel may extend across only a portion of the entire width of the two flexible substrates. The two flexible substrates may include features such as folds or more pliable portions that define the width of the channel. For example, the two flexible substrates may include a fold extending along the length of the two flexible substrates, spaced apart from opposite connected edges of the two flexible substrates. In use, when a user switches the device from a first configuration to a second configuration, a channel is formed between the two folds, and the two flexible substrates remain substantially flat between the folds and the associated connected edges on either side of the channel.

[0145] The device may include an element that constrains the maximum extent to which the two flexible substrates can be bent to switch the device to the second configuration. For example, the device may include one or more connectors attached to each of the two flexible substrates such that the separation of the two flexible substrates when the device is in the second configuration is determined by the length of the or each connector. The one or more connectors may be attached to the inner surface of each of the two flexible substrates within the channel. The one or more connectors may be attached to the outer surface of each of the two flexible substrates. Alternatively, the device may include one or more connectors that extend across the width of the device, constraining the maximum extent to which at least one of the two flexible substrates can be bent. The device may include a rigid tertiary structure or triangular locking fold line that defines the maximum extent to which the channel of the device can be opened.

[0146] The device may include a mouthpiece adjacent to or at the air outlet. Thus, during use, when the device is in the second configuration, a user may inhale through the mouthpiece after contacting their mouth with the mouthpiece. The mouthpiece may be an air outlet. The mouthpiece may be configured to provide support for the user's lips during use.

[0147] The present invention extends in a second aspect to a method of using an apparatus according to the first aspect, the method comprising the steps of: (i) providing an apparatus according to a first aspect; (ii) applying pressure to two opposite connected edges of two flexible substrates of the device, thereby switching the device from the first configuration to the second configuration; and (iii) inhaling adjacent the opening of the device in the second configuration, thereby drawing the active agent through the membrane of the device, through the channel, and into the lungs.

[0148] When the device is in the second configuration, the user may place their mouth against the opening of the channel. The user may then inhale through the device in step (iii). A seal may be formed between the device and the user's mouth. Thus, when the user inhales, all or substantially all of the air flowing into the user's mouth passes through the channel of the device, thereby carrying the active agent through the membrane of the device.

[0149] A user may apply pressure to two opposing edges of two flexible substrates by squeezing the edges towards each other.

[0150] In embodiments in which the device includes a sealant, step (ii) typically involves rupturing said sealant, thereby exposing the membrane of the device.

[0151] In embodiments in which the device is provided in packaging, prior to step (ii) the device will typically be removed from the packaging.

[0152] Once the user has inhaled through the device, the device may be discarded.

[0153] In some embodiments, the device may lock when switched from the first configuration to the second configuration, thereby locking the device in the second configuration, such that the device may be held in the second configuration without the user continually applying a force.

[0154] According to a third aspect, there is provided an inhaler device comprising a membrane located within a channel having a first opening and an opposite second opening, the membrane configured to span the inhaler channel such that an active agent provided on the membrane may be inhaled by a user through the channel. The membrane may have a first portion facing the first opening and a second portion facing the second opening, the first portion configured to releasably retain the active agent and the second portion configured to prevent the passage of the active agent through the second portion.

[0155] Typically, a first opening of the channel may be an air outlet and a second opening of the channel may be an air inlet, such that during use air is drawn into the channel via the air inlet and out of the channel via the air outlet.

[0156] As used herein, the term "spanning a channel" refers to the membrane extending across the channel to occlude at least a portion of the cross-section of the channel.

[0157] It has further been found that by providing the membrane with a first portion configured to releasably retain an active agent, the membrane can be readily loaded with the active agent during manufacture, while a second portion of the membrane prevents the active agent from being lost through the membrane during manufacture.

[0158] Still further, by providing the membrane with a second portion configured to prevent passage of active agent through the second portion, it is ensured that active agent cannot be lost through the second opening during use when a user exhales into the inhaler device before inhaling.

[0159] The inhaler may comprise a body. The body may be tubular. Thus, the body may be a tube. The channel may correspond to the interior of the tubular body. The body may comprise a longitudinal axis extending along the length of the body. The body may be flexible. The body may comprise a flexible portion. The flexible portion may be more flexible than the remainder of the body. The flexible portion may allow one of the first opening and the opposing second opening to be reoriented relative to the other. For example, the first opening may be reoriented relative to the second opening by bending the body at the flexible portion. Conversely, the second opening may be reoriented relative to the first opening by bending the body at the flexible portion.

[0160] The first opening may comprise a covering. The second opening may comprise a covering. The first opening and the second opening may comprise a covering. The covering of the first opening and / or the second opening may block the first opening and / or the second opening. The covering of the first opening and / or the second opening may seal the first opening and / or the second opening. In embodiments where the first opening and the second opening are sealed by a cover, the interior of the inhaler may be sealed from the exterior of the inhaler by the cover.

[0161] Typically, prior to use, the covering of the first opening and / or the second opening may be removed.

[0162] The membrane may be provided in the channel substantially mid-way between the first opening and the second opening. Thus, the membrane may be provided substantially in the middle of the channel between the first opening and the second opening. The membrane may be provided adjacent to the first opening. The membrane may be provided adjacent to the second opening. The membrane may be provided in the half of the channel adjacent to the first opening. The membrane may be provided in the half of the channel adjacent to the second opening.

[0163] In embodiments in which the body comprises a flexible portion, the membrane may be provided within the channel in the flexible portion. The membrane may be provided within the channel in a portion of the channel that is not the flexible portion.

[0164] Typically, during use, a user may insert the first opening into their mouth and inhale through the inhaler device, thereby delivering the active agent from the first portion of the membrane through their mouth and into the user's lungs. Alternatively, a user may insert the first opening into a nostril of their nose and inhale through the device, thereby inhaling the active agent from the first portion of the membrane through their nose and into their lungs or into the user's sinuses.

[0165] In embodiments in which the body comprises a flexible portion, a user may bend the inhaler device and insert the second opening into their mouth and the first opening into a nostril of their nose. The user may then breathe through the device, thereby delivering the active agent through the first portion of the membrane, through their nose, and into the user's lungs or into the user's sinuses.

[0166] The first portion of the membrane can be at least 50% of the membrane. The first portion of the membrane can be at least 60% of the membrane. The first portion of the membrane can be at least 70% of the membrane. The first portion of the membrane may be at least 80% of the membrane. At least 50% of the depth of the membrane may be the first portion of the membrane, so that when viewed from the side, at least 50% of the membrane's depth is comprised of the first portion. At least 60% of the membrane's depth may be the first portion of the membrane, so that when viewed from the side, at least 60% of the membrane's depth is comprised of the first portion. At least 70% of the membrane's depth may be the first portion of the membrane, so that when viewed from the side, at least 70% of the membrane's depth is comprised of the first portion. At least 80% of the membrane's depth may be the first portion of the membrane, so that when viewed from the side, at least 80% of the membrane's depth is comprised of the first portion.

[0167] The membrane can be about 50% to about 99% of the first portion. The membrane can be about 60% to about 99% of the first portion. The membrane can be about 70% to about 99% of the first portion. The membrane can be about 80% to about 99% of the first portion. The membrane can be about 50% to about 95% of the first portion. The membrane can be about 50% to about 90% of the first portion. The membrane can be about 50% to about 80% of the first portion. The membrane can be about 50% to about 70% of the first portion.

[0168] The second portion may act as a backing layer over the first portion.

[0169] The membrane comprises a first major surface and an opposing second major surface. The first portion of the membrane may comprise the first major surface of the membrane. The second portion of the membrane may comprise the second major surface of the membrane.

[0170] The first portion of the membrane may be gas permeable to allow air to pass through the membrane during use. The second portion of the membrane may be gas permeable to allow air to pass through the membrane during use. Preferably, the first portion of the membrane and the second portion of the membrane are gas permeable to allow air to pass through the membrane during use.

[0171] The first portion of the membrane may be porous. The second portion of the membrane may be porous. Typically, the first portion of the membrane may be more porous than the second portion of the membrane. Thus, the first portion of the membrane may have a higher porosity than the second portion of the membrane.

[0172] Usually, the membrane is a single membrane. The first and second parts may be parts of the same membrane. Thus, the first and second parts may abut or contact each other such that there is no space between them. The first part may occlude the second part. Thus, the first and second parts may completely overlap each other. The first and second parts may overlap each other for at least a majority of their surface extent. The first and second parts may, for example, be different layers of material laminated together.

[0173] The active agent may be provided between the first and second portions. The first portion may be configured to releasably hold the active agent between the first and second portions prior to use. During use, the active agent may pass through the first portion to the first opening. Thus, the first portion may act as a filter to ensure that large aggregates of the active agent are not inhaled by the user during use. The first portion may be connected to the second portion around the periphery of the membrane. The active agent may be provided between the first and second portions, away from the periphery of the membrane. The first portion may be bonded to the second portion around the periphery of the membrane. The periphery of the membrane may be adjacent to the wall of the channel.

[0174] The active agent may comprise particles of the active agent. Thus, the active agent may be a particulate active agent.

[0175] Typically, the second portion of the membrane may be impermeable to the active agent.

[0176] The first portion of the membrane may comprise a first plurality of apertures or pores. The second portion of the membrane may comprise a second plurality of apertures or pores. The apertures or pores of the first plurality of apertures or pores may be larger than the apertures or pores of the second plurality of apertures or pores. The average size of the apertures or pores of the first plurality of apertures or pores may be larger than the average size of the apertures or pores of the second plurality of apertures or pores.

[0177] Typically, the first plurality of apertures or pores may allow particles of the active agent to at least partially penetrate into the first portion of the membrane, and thus at least a majority of the first plurality of apertures or pores are significantly larger than the particles of the active agent.

[0178] Typically, the second plurality of apertures or pores may prevent particles of active agent from penetrating or partially penetrating into the second portion of the membrane.

[0179] For the avoidance of doubt, features of the membrane of the first embodiment are features of the membrane of the third embodiment and vice versa. [Brief description of the drawings]

[0180] Embodiments of the invention will now be described, by way of non-limiting example, with reference to the accompanying drawings, in which:

[0181] [Figure 1A] FIG. 2 is a schematic side view of a section of a device according to one embodiment, prior to inhalation. [Figure 1B]FIG. 2 is a schematic side view of a section of a device according to one embodiment during inhalation. [Figure 2A] FIG. 2 is a schematic side view of a section of a device according to one embodiment, prior to inhalation. [Figure 2B] FIG. 2 is a schematic side view of a section of a device according to one embodiment during inhalation. [Diagram 3] FIG. 2 is an enlarged view of an open cell foam material. [Figure 4] 1 is a cross-section of a membrane according to one embodiment. [Diagram 5] 1A-1D are diagrams of a device according to one embodiment showing the device A) in a first configuration and B) in a second configuration. [Figure 6A] FIG. 2 is a front (outlet end) view of the device according to one embodiment in a second configuration. [Figure 6B] FIG. 2 is a view of an apparatus according to one embodiment in a second configuration, viewed from the rear (inlet end). [Figure 7A] FIG. 2 is a diagram of a membrane support according to one embodiment in a flat configuration. [Figure 7B] FIG. 2 is a diagram of a membrane support according to one embodiment in a folded configuration. [Figure 8A] FIG. 2 is a diagram of a membrane support according to one embodiment in a flat configuration. [Figure 8B] FIG. 2 illustrates a membrane support according to one embodiment in a folded configuration. [Figure 9] FIG. 2 is a side view of a membrane support according to one embodiment in a folded configuration. [Figure 10A] FIG. 2 is a diagram of a membrane support according to one embodiment in a flat configuration. [Figure 10B] FIG. 2 is a diagram of a membrane support according to one embodiment in a folded configuration. [Figure 11A] FIG. 2 is a diagram of an apparatus according to one embodiment from a top perspective. [Figure 11B] FIG. 1 is a diagram of an apparatus according to one embodiment from a side perspective. [Figure 11C]FIG. 2 is a diagram of an apparatus according to one embodiment from an oblique perspective. [Figure 12] FIG. 1 is a perspective view of an apparatus according to one embodiment. [Figure 13] FIG. 1 is a perspective view of an apparatus according to one embodiment. [Figure 14A] FIG. 2 is a schematic side view of a section of a device according to one embodiment prior to inhalation. [Figure 14B] FIG. 1 is a schematic side view of a section of a device according to one embodiment during inhalation. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0182] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The following detailed description of how to make and use various embodiments of the invention is provided, with the understanding that the invention provides many applicable inventive concepts that can be embodied in a wide variety of specific contexts. The specific embodiments described herein are merely illustrative of specific ways to make and use the invention and do not delimit the scope of the invention.

[0183] To facilitate understanding of the present invention, several terms are defined below. Terms defined herein have meanings commonly understood by those skilled in the art to which the present invention pertains. Terms such as "a", "an" and "the" are not intended to refer to a single entity only, but include a general classification to which a particular example may belong that may be used in the description. Although the terms herein are used to describe certain embodiments of the present invention, their use does not define the present invention, except as outlined in the claims.

[0184] 5 and 6A and 6B, a device 1 is provided that includes a first flexible substrate 2 and a second flexible substrate 4. The first flexible substrate 2 and the second flexible substrate 4 are rectangular. The first flexible substrate 2 and the second flexible substrate 4 are connected to each other along a first edge 6 and along a second edge 8 opposite the first edge 6. The first flexible substrate 2 and the second flexible substrate 4 are not connected to each other along a third edge 10 and along a fourth edge 12 opposite the third edge 10.

[0185] The first flexible substrate 2 includes a first score line 14 (acting as a first deformable element) and a second score line 16 (acting as a second deformable element). The first score line 14 includes a linear portion 18 (acting as a first portion of the first deformable element) and a curved portion 20 (acting as a second portion of the first deformable element). The second score line 16 includes a linear portion 22 (acting as a first portion of the second deformable element) and a curved portion 24 (acting as a second portion of the second deformable element). The first score line 14 and the second score line 16 are symmetrically disposed about a central axis 26 that extends along the length of the first flexible substrate 2. The curved portion 20 of the first score line 14 extends from the linear portion 18 to a first corner 28 of the first flexible substrate 2. The curved portion 24 of the second score line 16 extends from the linear portion 22 of the second score line 16 to a second corner 30 of the first flexible substrate 2 .

[0186] The second flexible substrate 4 includes first and second score lines 32 , 34 that correspond to the first and second score lines 14 , 16 of the first flexible substrate 2 .

[0187] 7A and 7B, the device 1 further comprises a support 36 located between the first flexible substrate 2 and the second flexible substrate 4. The support 36 includes an aperture 38 across which the membrane 40 extends. An inhalable form of an active agent 42 is supported on a first surface 44 of the membrane 40. As shown in FIGS. 7A and 7B, the support 36 has four fold lines 46, which allow the support 36 to be folded in a bellows-like manner (see, for example, FIG. 7B). The membrane 40 is located at the center of the support 36 with fold lines 48 on both sides of the membrane 40. The support 36 is further folded adjacent both sides to provide a first attachment surface 50 and a second attachment surface 52, which are used to contact and be secured to the first flexible substrate 2 and the second flexible substrate 4, respectively. Thus, when the support 36 is folded about the four fold lines 46, the membrane 40 is retained within the pockets 54 (corresponding to closed spaces), thereby protecting the active agent 42 supported on the membrane 40.

[0188] 1A and 1B, the membrane 40 comprises a first portion 40a and a second portion 40b. The first portion 40a comprises a first surface 44. The first portion 40a comprises a mesh having an open structure. The second portion 40b comprises a mesh having a closed structure. Accordingly, the mesh of the first portion 40a comprises pores larger than the diameter of the particles of the active agent, and the mesh of the second portion 40b comprises pores significantly smaller than the diameter of the particles of the active agent. Thus, the particles of the active agent may penetrate into the mesh of the first portion 40a of the membrane 40 and may not penetrate into the mesh of the second portion 40b of the membrane 40, so that the particles of the active agent may not pass through the second portion 40b of the membrane 40.

[0189] Prior to use, the device 1 is in a first configuration 56 in which the first flexible substrate 2 and the second flexible substrate 4 are substantially flat and the support 36 is folded between the first flexible substrate 2 and the second flexible substrate 4.

[0190] In use, a user applies force to the first and second edges 6, 8 where the first flexible substrate 2 is connected to the second flexible substrate 4. This application of force causes the first flexible substrate 2 and the second flexible substrate 4 to bend outwardly from each other. As the first flexible substrate 2 and the second flexible substrate 4 bend, they bend around the first score line 14 and the second score line 16 until the device 1 is in the second configuration. Thus, a channel 58 is formed between the first flexible substrate 2 and the second flexible substrate 4 having a rectangular shaped first end 60 and a biconvex shaped second end 62, such that the height of the second end 62 is significantly greater than the height of the first end 60 and the width of the second end 62 is significantly less than the width of the first end 60.

[0191] In addition, the support 36 is stretched such that the support 36 spans the channel 58 and is located closer to a first end 60 of the channel 58 than to a second end 62 of the channel 58 .

[0192] The user then inserts the first end 60 of the device 1 into their mouth and inhales through the device 1. At least a portion of the active agent 42 supported on the membrane 40 spanning the channel 58 is lifted from the membrane 40 and inhaled by the user. Airflow through the membrane is shown in FIG.

[0193] Once the active agent 42 has been inhaled, the device 1 may be discarded by the user.

[0194] 8A, 8B, and 5, in an alternative embodiment, support 100 includes three fold lines 102, with one fold line extending through the central portion 104 of membrane 106 as shown in Figures 8A and 8B. Figure 9 shows a side view of support 100 in a folded configuration attached to first and second flexible substrates 112 and 114 by welds 116.

[0195] In an alternative embodiment, the first portion of the membrane comprises an open cell reticulated foam, such as that shown in FIG.

[0196] In a further alternative embodiment, referring to Figures 10A and 10B, a support 200 includes a first aperture 202a and a second aperture 202b, with a first membrane 204 spanning the first aperture 202a and a second membrane 206 spanning the second aperture 202b. The support 200 includes three fold lines 208, one fold line located between the first aperture 202a and the second aperture 202b and the first membrane 204 and the second membrane 206. The first membrane 204 supports a first active agent 212, and the second membrane 206 also supports the first active agent 212. Thus, the device is configured to deliver a larger dose of the first active agent 212 than a device having a support including a single membrane.

[0197] Alternatively, the first membrane 204 supports a first active agent 212 and the second membrane 206 supports a second active agent 214. Thus, the device is configured to deliver two active agents simultaneously.

[0198] In yet a further embodiment, referring to Figures 11A, 11B and 11C, the device 300 comprises a first locking mechanism 302 and a second locking mechanism 304. The first locking mechanism 302 is formed by a first portion 306 of a curved portion 308 of a first score line 310 of a first flexible substrate 312 and a first portion 314 of a curved portion 316 of a first score line 318 of a second flexible substrate 320. When the device 300 is switched from the first configuration to the second configuration, the first locking mechanism 302 and the second locking mechanism 304 are pressed by a user until they pop out into a locked position. In response, the device is locked in the second configuration, so that the user does not need to maintain force to hold the device 300 in the second configuration.

[0199] First flexible substrate 312 and second flexible substrate 320 include grip portion 322. Grip portion 322 has a textured surface to enhance the ability of a user to grip the device in the second configuration and may act as an indicator to the user of where force should be applied to switch the device from the first configuration to the second configuration.

[0200] In an alternative embodiment, referring to Figures 2A and 2B, a device 400 according to any of the previously described devices further comprises a membrane 402 with a first portion 402a and a second portion 402b mounted in a support 404, and a barrier film 406 (acting as a barrier material) located between a first flexible substrate 408 and a second flexible substrate 410. The barrier film 406 is welded to the first flexible substrate 408 at a weld 412 and releasably attached to the second flexible substrate 410 in the first configuration. An active agent 414 is held between the barrier film 406 and the membrane 402 prior to use. When the device 400 is switched to the second configuration, the membrane 402 closes the channel 416 formed between the first flexible substrate 408 and the second flexible substrate 410, and the barrier film 406 is removed from the second flexible substrate 410. During use, the user inhales through channel 416 and the barrier film 406 pivots about weld 412 away from the second flexible substrate 410 and toward the first flexible substrate 408, thereby releasing the active agent 414 from the membrane 402 to the user.

[0201] 12, device 500 comprises a body 502 and a membrane 504. Body 502 comprises a first opening 506, a second opening 508, and a channel 510 extending from first opening 506 to second opening 508. Membrane 504 spans and occludes channel 510. Membrane 504 comprises a first portion 512 facing first opening 506 and a second portion 514 facing second opening 508. A particulate active agent is provided in powder form on first portion 512 of membrane 504.

[0202] The first portion 512 comprises a mesh having an open structure. The second portion 514 comprises a mesh having a closed structure. Accordingly, the mesh of the first portion 512 comprises pores larger than the diameter of the particles of the active agent, and the mesh of the second portion 514 comprises pores significantly smaller than the diameter of the particles of the active agent. Thus, the particles of the active agent may penetrate into the mesh of the first portion 512 of the membrane 504 and may not penetrate into the mesh of the second portion 514, such that the particles of the active agent may not pass through the second portion 514 of the membrane 504.

[0203] The first opening 506 and the second opening 508 are covered by a film (not shown) that seals the channel 510 and the membrane 504 spanning the channel 510 from the outside atmosphere.

[0204] Prior to use, the film is removed from the first opening 506 and the second opening 508 .

[0205] During use, a user inhales through the first opening 506 such that the active agent is lifted from the first portion 512 of the membrane 504 and delivered to the user's lungs.

[0206] 13, device 600 comprises a body 602 and a membrane 604. Body 602 comprises a first opening 606, a second opening 608, and a channel 610 extending from first opening 606 to second opening 608. The body further comprises a flexible portion 612. Membrane 604 spans across and occludes channel 610. Membrane 604 comprises a first portion 614 facing first opening 606 and a second portion 616 facing second opening 608. A particulate active agent is provided in powder form on first portion 614 of membrane 604.

[0207] The first portion 614 comprises a mesh having an open structure. The second portion 616 comprises a mesh having a closed structure. Accordingly, the mesh of the first portion 614 comprises pores larger than the diameter of the particles of the active agent, and the mesh of the second portion 616 comprises pores significantly smaller than the diameter of the particles of the active agent. Thus, the particles of the active agent may penetrate into the mesh of the first portion 614 of the membrane 604 and may not penetrate into the mesh of the second portion 616 of the membrane 604, such that the particles of the active agent may not pass through the second portion 616 of the membrane 604.

[0208] The first opening 606 and the second opening 608 are covered by a film (not shown) that seals the channel 610 and the membrane 604 spanning the channel 610 from the outside atmosphere.

[0209] Prior to use, the film is removed from the first opening 606 and the second opening 608. The body 602 can be bent at the flexible portion 612 so that the first opening 606 can be reoriented relative to the second opening 608.

[0210] During use, a user inhales through the first opening 606 such that the active agent is lifted from the first portion 614 of the membrane 604 and delivered to the user's lungs.

[0211] In a further alternative embodiment, referring to Figures 14A and 14B, a membrane 700 is provided in a support 706 in a channel defined by channel walls 702, 704 such that the membrane spans the channel. The membrane 700 comprises a first portion 700a and a second portion 700b. The first portion 700a comprises a first surface of the membrane. The first portion 700a comprises a mesh having an open structure. The second portion 700b comprises a mesh having a closed structure. Particles 710 of an active agent are provided between the first portion 700a and the second portion 700b. Accordingly, the mesh of the first portion 700a comprises pores larger than the diameter of the particles 710 of the active agent, and the mesh of the second portion 700b comprises pores significantly smaller than the diameter of the particles 710 of the active agent. Thus, the particles 710 of the active agent may penetrate into the mesh of the first portion 700a of the membrane 700 and not into the mesh of the second portion 700b, such that the particles 710 of the active agent may not pass through the second portion 700b of the membrane 700.

[0212] During use, a user inhales through the channel (see FIG. 14B) and particles 710 of active agent pass through first portion 700a to the user's lungs. First portion 700a acts as a filter to prevent the passage of clumps or agglomerates of active agent particles, thus controlling the particle size of active agent delivered to the user's lungs.

[0213] Those skilled in the art will understand that the above-described embodiments are examples, and that the features of each disclosed embodiment may be combined with the features of other embodiments. Further variations and modifications are contemplated herein and are encompassed by the present invention. (Other possible items) (Item 1) 1. An inhaler device comprising two flexible substrates and a membrane located between the two flexible substrates, each of the two flexible substrates having at least one deformable element, the two flexible substrates being connected at two opposing edges and unconnected at two further opposing edges, the inhaler device being capable of being moved in a first configuration in which the two flexible substrates are substantially flat and in contact with each other, and a second configuration in which the two flexible substrates are bent such that a channel is formed between the two flexible substrates having a first opening at one end of the channel and a second opening at an opposite end of the channel. an inhaler device configured to switch between a first configuration and a second configuration, wherein the membrane is configured to span the channel between the two flexible substrates when the inhaler device is in the second configuration, such that an active agent provided on the membrane can be inhaled by a user when the inhaler device is in the second configuration, the membrane having a first portion facing the first opening and a second portion facing the second opening, the first portion configured to releasably retain the active agent and the second portion configured to prevent passage of the active agent through the second portion. (Item 2) 2. The inhaler device of claim 1, wherein the membrane has a first major surface and an opposing second major surface, the first portion of the membrane comprising the first major surface and the second portion of the membrane comprising the second major surface. (Item 3) 3. The inhaler device of claim 1 or 2, wherein the first portion of the membrane comprises a first plurality of apertures or pores. (Item 4) 4. The inhaler device of any one of the preceding claims, wherein the second portion of the membrane comprises a second plurality of apertures or pores. (Item 5) 5. The inhaler device of claim 4 when dependent on claim 3, wherein an aperture or pore of the first plurality of apertures or pores is larger than an aperture or pore of the second plurality of apertures or pores. (Item 6) 6. An inhaler device according to any one of the preceding claims, wherein the first portion of the membrane is substantially continuous. (Item 7) 7. An inhaler device according to any one of the preceding claims, wherein the second portion of the membrane is substantially continuous. (Item 8) 8. The inhaler device according to any one of the preceding claims, wherein the first part of the membrane and / or the second part of the membrane comprise a monolithic material. (Item 9) 6. The inhaler device according to any one of the preceding claims, wherein the first portion of the membrane comprises a mesh and / or the second portion of the membrane comprises a mesh. (Item 10) 10. The inhaler device of claim 9, wherein the first portion of the membrane and the second portion of the membrane comprise a mesh, and the mesh of the first portion of the membrane has larger gaps, holes, or voids than the mesh of the second portion of the membrane. (Item 11) 11. The inhaler device according to any one of the preceding claims, wherein the active agent comprises particles of an active agent, and the second portion of the membrane is substantially impermeable to the particles of the active agent. (Item 12) 12. The inhaler device according to any one of the preceding claims, wherein the first portion of the membrane comprises the same material as the second portion of the membrane. (Item 13) 13. The inhaler device according to any one of the preceding claims, wherein the first portion of the membrane has a lower density than the second portion of the membrane. (Item 14) 14. The inhaler device according to any one of the preceding items, wherein the membrane is a laminated membrane having two or more layers laminated together. (Item 15) 15. The inhaler device of claim 14, wherein the first portion of the membrane corresponds to one or more layers of the laminated membrane. (Item 16) 16. The inhaler device of claim 14 or 15, wherein the second portion of the membrane corresponds to one or more layers of the laminated membrane. (Item 17) 1. An inhaler device comprising a membrane positioned within a channel having a first opening and an opposing second opening, the membrane configured to span the inhaler channel such that an active agent provided on the membrane can be inhaled by a user through the inhaler channel, the membrane may have a first portion facing the first opening and a second portion facing the second opening, the first portion configured to releasably retain the active agent and the second portion configured to prevent passage of the active agent through the second portion.

Claims

1. 1. An inhaler device comprising two flexible substrates and a membrane located between the two flexible substrates, each of the two flexible substrates having at least one deformable element, the two flexible substrates being connected at two opposing edges and unconnected at two further opposing edges, the inhaler device being capable of being moved in a first configuration in which the two flexible substrates are substantially flat and in contact with each other, and a second configuration in which the two flexible substrates are bent such that a channel is formed between the two flexible substrates having a first opening at one end of the channel and a second opening at an opposite end of the channel. an inhaler device configured to switch between a first configuration and a second configuration, wherein the membrane is configured to span the channel between the two flexible substrates when the inhaler device is in the second configuration, such that an active agent provided on the membrane can be inhaled by a user when the inhaler device is in the second configuration, the membrane having a first portion facing the first opening and a second portion facing the second opening, the first portion configured to releasably retain the active agent and the second portion configured to prevent passage of the active agent through the second portion.

2. 2. The inhaler device of claim 1, wherein the membrane has a first major surface and an opposite second major surface, the first portion of the membrane comprising the first major surface and the second portion of the membrane comprising the second major surface.

3. The inhaler device of claim 1 , wherein the first portion of the membrane includes a first plurality of apertures or pores.

4. The inhaler device of claim 3 , wherein the second portion of the membrane includes a second plurality of apertures or pores.

5. 5. The inhaler device of claim 4, wherein the apertures or pores of the first plurality of apertures or pores are larger than the apertures or pores of the second plurality of apertures or pores.

6. 10. The inhaler device of claim 1, wherein the first portion of the membrane is substantially continuous.

7. 2. The inhaler device of claim 1, wherein the second portion of the membrane is substantially continuous.

8. 2. The inhaler device of claim 1, wherein the first portion of the membrane and / or the second portion of the membrane comprise a monolithic material.

9. 2. The inhaler device of claim 1, wherein the first portion of the membrane comprises a mesh and / or the second portion of the membrane comprises a mesh.

10. 10. The inhaler device of claim 9, wherein the first portion of the membrane and the second portion of the membrane comprise a mesh, and the mesh of the first portion of the membrane has larger gaps, holes, or voids than the mesh of the second portion of the membrane.

11. 10. The inhaler device of claim 1, wherein the active agent comprises particles of an active agent, and the second portion of the membrane is substantially impermeable to the particles of the active agent.

12. 2. The inhaler device of claim 1, wherein the first portion of the membrane comprises the same material as the second portion of the membrane.

13. 2. The inhaler device of claim 1, wherein the first portion of the membrane has a lower density than the second portion of the membrane.

14. 14. An inhaler device according to any one of claims 1 to 13, wherein the membrane is a laminated membrane having two or more layers laminated together.

15. 15. The inhaler device of claim 14, wherein the first portion of the membrane corresponds to one or more layers of the laminated membrane.

16. 15. The inhaler device of claim 14, wherein the second portion of the membrane corresponds to one or more layers of the laminated membrane.

17. An inhaler device comprising a membrane positioned within a channel having a first opening and an opposing second opening, the membrane configured to span the inhaler channel such that an active agent provided on the membrane can be inhaled by a user through the inhaler channel, the membrane may have a first portion facing the first opening and a second portion facing the second opening, the first portion configured to releasably retain the active agent and the second portion configured to prevent passage of the active agent through the second portion.

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