Inhaler

Abstract

A device for inhaling an active agent is provided that is switchable from a first configuration to a second configuration. The device comprises two flexible substrates and a membrane disposed between the two flexible substrates, the two flexible substrates being connected at two opposing edges and unconnected at a further two opposing edges. When the device is in the second configuration, the active agent disposed on the membrane is inhalable by a user.Methods of using the device are also provided.

Description

Technical Field

[0001] The present invention relates to an apparatus for delivering an active agent to a patient, and more particularly, to an apparatus for delivering an active agent to a patient's lungs, such as an inhalation device.

Background Art

[0002] There are multiple active agents useful for the treatment of various diseases or conditions that need to be administered to patients through the lungs, that is, they are lung delivery active agents. Such lung delivery active agents typically use a device such as an inhaler that allows the patient to directly inhale the active agent into the lungs.

[0003] Typically, inhalers in the art are designed to provide a single delivery system to the patient that is used multiple times to minimize waste, is portable by the patient, and provides a reliable delivery system when needed by the patient. For example, for a patient suffering from asthma, it is important that the delivery system be accessible at any time when suffering from an asthma attack in order to deliver the necessary active agent quickly and effectively.

[0004] However, such inhalation devices have the problem that the active agent and the carrier used to enable normal delivery of the active agent to the patient's lungs agglomerate and need to be crushed before use. Furthermore, many devices are intended for multiple uses and thus must include multiple administrations of the 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 involve the apparatus including a crushing and diffusion chamber to ensure that the active agent is suitably crushed and has the function of accurately metering the active agent for each administration, which is accompanied by further complication, and as a result, the device is larger and less convenient for the patient to carry and use.

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

[0007] As a result, at least one object of the present invention is to provide an improved device for delivering an active agent to a patient's lungs. SUMMARY OF THE INVENTION

[0008] According to a first aspect of the present invention, there is provided an apparatus comprising two flexible substrates and a membrane disposed between the two flexible substrates, each of the two flexible substrates including at least one deformable element, the two flexible substrates being connected at two opposing edges and not connected at two further opposing edges, the apparatus being configured to switch between 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, thereby forming a channel between the two flexible substrates, wherein when the apparatus is in the second configuration, the membrane is configured to extend into the channel between the two flexible substrates, whereby when the apparatus is in the second configuration, an active agent provided on the membrane is inhalable by a user, and the at least one deformable element of each flexible substrate biases the apparatus into a second configuration in which a first opening of the channel formed between the two flexible substrates has a substantially regular shape and a second opening of the channel formed between the two flexible substrates has a substantially irregular shape.

[0009] Surprisingly, the inventors have found that the device of this aspect provides a simple way to deliver an active agent to a patient's lungs. The device is compact, portable and easy to use.

[0010] As used herein, the term "extends into the channel" means that the membrane extends across the channel and closes at least a portion of the cross-section of the channel.

[0011] A substantially regular shape may be a shape having an aspect ratio of about 3:1 to 1:3, or about 3:2 to 2:3.

[0012] A substantially irregular shape may 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. As used herein, an aspect ratio of 3:1 has a height of 3 relative to a width of 1, or that ratio.

[0013] 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.

[0014] The second opening of the channel may comprise at least two opposing curved sides. The second opening of the channel may be biconvex. A biconvex opening is convex on both sides or surfaces of the opening.

[0015] 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 should understand 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 opposing edges and are switchable 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 opposing edges that are not connected may be curved.

[0016] Typically, the two flexible substrates may be a uniform substrate, or a substantially uniform substrate, that may be bent to switch from a first configuration to a second configuration. However, at least one of the two flexible substrates may include two or more regions having different rigidities, such that at least one of the two or more regions is more rigid and has higher bend resistance, and at least one of the two or more regions is less rigid and has lower bend resistance. For example, one or both of the flexible substrates may include 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 the first configuration to the second configuration, and the one or more rigid regions may remain substantially flat. The flexible regions may form hinges in the flexible substrates. The flexible regions may be shaped such that the device is biased toward the second configuration. In some embodiments, the or each flexible portion may correspond to at least one deformable element.

[0017] At least one deformable element of each flexible substrate may be a cut (i.e., marked or severed) line along at least a portion of the flexible substrate. At least one deformable element of each flexible substrate may be a flexible line extending along at least a portion of the flexible substrate. At least one deformable element of each flexible substrate may be a fold in the flexible substrate.

[0018] At least one deformable element of each flexible substrate may be formed by a series of perforations in the flexible substrate.

[0019] At least one deformable element of each flexible substrate may be formed by a portion of the flexible substrate that is thinner than most of the flexible substrate.

[0020] Each flexible substrate may include a first flexible layer and a second layer that is less flexible than the first flexible layer. The second layer may include a plurality of portions. Each 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 said or each of the plurality of portions may abut against each other to form a fault line between adjacent portions. At least one deformable element of each flexible substrate may correspond to the fault line between adjacent portions.

[0021] At least one deformable element may function as a hinge, whereby when the device switches between a first configuration and a second configuration, each flexible substrate bends around the at least one deformable element when the device switches between the first configuration and the second configuration.

[0022] At least one deformable element may include 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 be connected to the second portion along at least part of the length of the flexible substrate.

[0023] The first portion may be linear or straight. The first portion may be aligned with the axis of the device extending along the length of the channel. The first portion may be angled with respect to the axis of the device. For example, the first portion may be angled at an angle of 1° to 40° with respect to the axis of the device. The first portion may be angled at an angle of 1° to 25° with respect to the axis of the device. Thus, the first portion may extend from the first opening of the flexible substrate towards the second opening of the flexible substrate. The first portion may be curved.

[0024] The second portion may be linear or straight. The second portion may be angled with respect to the axis of the device extending along the length of the channel.

[0025] The second part may be curved. The second part may curve towards one of the connected edges of the flexible substrate. The second part may curve towards one or more corners of the flexible substrate. The second part may curve towards a corner of the flexible substrate.

[0026] In embodiments where the first part and the second part are curved, the first part may curve at a rate smaller than the rate of the second part. The first part may curve at a rate larger than the rate of the second part. Thus, at least two deformable elements may curve at a first rate in a portion corresponding to the first part and at a second rate in a portion corresponding to the second part.

[0027] Each flexible substrate may include 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 the center line or central axis of the flexible substrate extending along the length of the flexible substrate. The plane of symmetry may be oriented at 90° with respect to the major plane of the flexible substrate. Thus, the device may be symmetric about at least one plane of symmetry.

[0028] Switching from the first configuration to the second configuration subjects the flexible substrate to sufficient force such that they bend around at least one deformable element.

[0029] At least one deformable element may be configured to lock the device in the second configuration once the device has switched from the first configuration to the second configuration. Thus, 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 the user.

[0030] 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 switches from the first configuration to the second configuration.

[0031] At least one locking mechanism may be formed by at least a part of at least one deformable element of the first flexible substrate and the second flexible substrate. In an embodiment where at least one deformable element includes a curved second portion, at least one locking mechanism may be formed by at least a part of the curved second portion of at least one deformable element of the first flexible substrate and at least a part of the curved second portion of at least one deformable element of the second flexible substrate. The locking mechanism may be a recess of the device body formed when the device switches from the first configuration to the second configuration. When the recess is formed, the recess may lock the device in the second configuration.

[0032] In some embodiments, when at least one locking mechanism switches to the locked position, at least one locking mechanism may generate an audible cue. At least one locking mechanism may generate, for example, a popping noise.

[0033] 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 the outer surface of the flexible substrate. The polymer or plastic coating may be provided on the 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.

[0034] One or both of the two flexible substrates may be degradable. One or both of the two flexible substrates may be biodegradable. For example, the device may be decomposed when in contact with water or in the presence of bacteria or the like.

[0035] The membrane and the activator on the membrane may be protected from moisture, light, oxygen, and contamination. The membrane may be held within a protective pocket between two flexible substrates. When the device switches from a first configuration to a second configuration, the protective pocket may open to expose the membrane and the activator on the membrane. The protective pocket may include a material resistant to water, oxygen, and / or light. For example, the protective pocket may include a metal foil such as aluminum, or a polymer or plastic film.

[0036] When the device is in at least the first configuration, the membrane may be blocked by a barrier material on at least one side of the membrane. The barrier material may form a barrier membrane or a barrier film across the membrane. The barrier material and the membrane may hold an activator therebetween when the device is in the first configuration. Accordingly, the activator may be protected from the environment by the membrane and the barrier material. The barrier material may be disposed adjacent to the membrane. The barrier material may be disposed on the side of the membrane facing a first opening of the device. Accordingly, during use, air may be inhaled through the second opening, through the device, through the membrane, through the barrier material, and into the first opening.

[0037] The barrier material may be disposed on each side of the membrane to form a first barrier and a second barrier, whereby both the membrane and the activator are held between the first barrier and the second barrier.

[0038] 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 the substrate on or within which the membrane is supported.

[0039] When the device switches from the first configuration to the second configuration, the barrier material may be broken or removed to expose the activator.

[0040] When the device is in the second configuration and the user inhales through the device's channel, the barrier material may be broken or removed to expose the active agent. When the device is in the second configuration and the user inhales through the device's channel, the barrier material may rupture to expose the active agent.

[0041] The barrier material may be disposed on either side of the membrane to form a protective pocket, and when the device is in the first configuration, the membrane and the active agent are held therein. The barrier material of the protective pocket may be destroyed, or may be broken or removed, when the device switches from the first configuration to the second configuration. The barrier material of the protective pocket may be destroyed, or may be broken or removed, when the user inhales through the device.

[0042] The barrier material may include a material resistant to water, oxygen, and / or light. For example, the barrier material may include a metal foil such as aluminum, or may include a polymer or plastic film.

[0043] At least a part of at least one side of one or both of the two flexible substrates may include a metal coating. For example, at least a part of the 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.

[0044] In some embodiments, the metal coating substantially covers the entire inner surface of both of the two flexible substrates. In some embodiments, the metal coating covers a part of the inner surface of both of the two flexible substrates. The part may be adjacent to one of the non-connected opposing ends of both of the two flexible substrates. The part may be in the middle between the two non-connected opposing ends of both of the two flexible substrates.

[0045] Typically, when the device is in a first configuration and the two flexible substrates are substantially flat, the metal coating is arranged such that the membrane is at least partially covered by the metal coating. In some embodiments where the two flexible substrates include a metal coating, the membrane is contained within an envelope, such as an envelope that includes the metal coating of the two flexible substrates. The envelope may be sealed so that the membrane is sealed inside the envelope. Accordingly, the active agent provided on the membrane may be protected from moisture, oxygen, light, and contamination.

[0046] The envelope may be sealed adjacent to the membrane. In embodiments where the entire inner surfaces of both of the two flexible substrates are substantially covered by a metal coating, the envelope formed by the metal coating may be sealed adjacent to one or both of the opposing ends of the two flexible substrates that are not connected.

[0047] The device may be a device that is used only once. That is, the membrane between the two flexible substrates may contain a single dose of the active agent, and once the device is used on a patient, the device may be discarded and replaced with a new device.

[0048] In embodiments where the two flexible substrates are biodegradable, the discarded device may be decomposed when contacted with water or the like, thereby minimizing waste. In embodiments where the device comprises cardboard or polymer or plastic, the device may be recycled to minimize waste.

[0049] Typically, the active agent is disposed on 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 such that when air passes through the membrane during use, the active agent is removed from the membrane and floats in the air. The active agent may be constrained or loosely attached to the membrane by an electrostatic charge. The charge applied to the membrane and / or the active agent may be adjusted such that the active agent is securely held on the membrane prior to use, yet still lifted from the membrane during use. As a result, the active agent may be easily inhaled into the lungs by the patient.

[0050] In some embodiments, the membrane may include particles, and the particles may include one or more active agents. The particles may also include a carrier, vehicle, or excipient. The carrier, vehicle, or excipient may contribute to preventing aggregation of the particles while the device is in a first configuration prior to use. The carrier, vehicle, or excipient may enhance the ability of the active agent or each active agent to float in the air when air passes through the channels of the device when the patient inhales. The carrier, vehicle, or excipient may prevent the particles from aggregating on the membrane.

[0051] Typically, the active agent on the membrane is sufficient for the user to receive a full single dose of the active agent when inhaling from the device. Accordingly, the amount of active agent on the membrane may correspond to a full single dose. In some embodiments, some of the active agent may remain on the membrane when the user inhales from the device. Accordingly, the amount of active agent on the membrane may correspond to an amount greater than a full single dose such that the amount of active agent actually inhaled by the user is a full dose. Preferably, the membrane is gas permeable to allow air to pass through the membrane during use.

[0052] The membrane may be substantially continuous and may provide a substantially continuous surface on which the active agent can be mounted. For example, the membrane may have pores small enough to allow air to pass through the membrane but prevent the particles of the active agent from passing through.

[0053] The membrane may be a mesh. The mesh may include a fiber network. The fiber network may be woven together to form the mesh. The fiber network may be connected to nodes to form the mesh. The particles of the active agent may be attached to the surface of the fibers of the mesh. The particles of the active agent may be constrained to the membrane by an electrostatic charge or may be loosely attached. The charge applied to the membrane and / or the particles of the active agent may be adjusted before use so that the particles of the active agent are securely held on the membrane, yet still lifted from the membrane during use.

[0054] The membrane may include a polymer. For example, the membrane may include polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polypropylene, polyethylene, polyurethane, polylactic acid, polyglycolic acid, polycaprolactone, poly(dioxanone) or copolymers thereof. The membrane may include polyethylene or polypropylene.

[0055] In embodiments where the membrane is substantially continuous, to ensure that a sufficient air flow through the channel can be formed during use, the membrane may extend over only a portion of the cross-section of the channel. Thus, there may be a gap in the cross-section of the channel to allow an increase in the air flow through the channel.

[0056] The membrane may be flat or substantially flat. Alternatively, the membrane may include a recess. In embodiments where the membrane includes a recess, most of the active agent of the membrane may be disposed within the recess. Thus, the recess may extend away from the outlet of the device and towards the inlet of the device. In some embodiments, during use, the recess may fold up when the user inhales through the device. Thus, the active agent held within the recess may be propelled in the direction of the air flow. When the device is in the second configuration, the membrane may spread across the entire cross-section of the channel and block the entire cross-section of the channel. Typically, the membrane spreads across a channel between opposing open edges of a flexible substrate. When the device is in the second configuration, the membrane may spread across or block a portion of the channel. As a result, there may be a portion of the channel through which air can pass through the channel without passing through the membrane and a portion of the channel through which air needs to pass through the membrane.

[0057] Typically, the membrane is flexible and, when the device is in the first configuration, is folded or collapsed.

[0058] The membrane may be mounted on a support within the channel. The support may include a gas-impermeable material that closes the channel and at least one aperture. The membrane may be mounted within at least one aperture. Thus, the air flow through the channel may be restricted by the aperture within the support, thereby increasing the rate of air flow through the membrane (so-called 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.

[0059] In some embodiments, the support may include at least two apertures, and the membrane may be supported across each aperture. Thus, the first membrane may be supported within the first aperture, and the second membrane may be supported within the second aperture. The first membrane may have a first active agent. The second membrane may have a second active agent. Thus, when a user inhales through the device, the device may be configured to deliver two active agents to the user simultaneously. 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.

[0060] Alternatively, the first membrane may have a first active agent, and the second membrane may have the first active agent. Thus, the device may provide a larger dose of the first active agent than a device having a single membrane.

[0061] When the device is in a first configuration, the support may occlude the channel. When the device is in a first configuration, the support may adopt a bent configuration, or a folded configuration, or another reversibly collapsed configuration. When the device is switched to a second configuration, the support may open outwardly, expand into the channel of the device, and occlude the channel of the device. Typically, the support may open outwardly into an open configuration and the support may not open further. Thus, the support may ensure that the device cannot be switched by the user beyond the second configuration, thereby ensuring that an optimal airflow is achieved by the device when the user inhales through the device in the second configuration.

[0062] The support may include at least one fold, whereby when the device is in a first configuration, the support is folded around at least one fold, and when the device is in a second configuration, the support is expanded and substantially unfolded. The at least one fold may extend across at least a portion of the membrane mounted on the support.

[0063] The support may include at least two folding portions. Each of the at least two folding portions may enable the support to be folded in an opposing direction. For example, the first folding portion may enable the support to be folded in a first direction, and the second folding portion may enable the support to be folded in a second direction opposite thereto. When the device is in the first configuration, the support may be folded around at least two folding portions, and when the device is in the second configuration, the support may be extended and substantially unfolded. One or more of the at least two folding portions may extend across at least a part of the membrane mounted on the support.

[0064] The support may include at least three folding portions. Each of the at least three folding portions may enable the support to be folded in an opposing direction. For example, the first folding portion may enable the support to be folded in a first direction, the second folding portion may enable the support to be folded in a second direction opposite thereto, and the third folding portion may enable the support to be folded in the first direction. Accordingly, the support may be folded in a bellows-like pattern. One or more of the at least three folding portions may extend across at least a part of the membrane mounted on the support. The at least three folding portions may divide the support into at least four parts. The support may be divided into two central portions and two peripheral portions. The membrane may be mounted across an aperture in one of the four parts. The membrane may be mounted across apertures in two of the four parts. The membrane may be mounted across the two central portions. The support may be mounted on a first flexible substrate by a first peripheral portion. The support may be mounted on a second flexible substrate by a second peripheral portion.

[0065] The support may include at least four folding portions. Each of the at least four folding portions may enable the support to be folded in the direction in which the support faces. For example, the first folding portion may enable the support to be folded in the first direction, the second folding portion may enable the support to be folded in the second direction opposite thereto, the third folding portion may enable the support to be folded in the first direction, and the fourth folding portion may enable the support to be folded in the second direction opposite thereto. Accordingly, the support may be folded in a bellows-like manner. One or more of the at least four folding portions may extend over at least a part of the membrane mounted on the support. Alternatively, the membrane may be disposed between two adjacent folding portions. The at least four folding portions 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 parts may include a central part between two adjacent parts. The membrane may be mounted across an aperture in one of the four parts. The membrane may be mounted across two of the four parts. The membrane may be mounted across an aperture in the central part. The support may be mounted on the first flexible substrate by the first peripheral part. The support may be mounted on the second flexible substrate by the second peripheral part.

[0066] When folded, the support may include or form a housing. The active agent may be disposed on the side of the membrane inside the housing of the folded support when the device is in the first configuration. Accordingly, the active agent may be protected within the housing before use. In an embodiment where the support includes at least four folding portions, when the support is folded, the membrane may be disposed within the housing.

[0067] When folded, the support may include a sealant adjacent to the edge of the housing. The sealant may protect the active agent when the device is in the first configuration.

[0068] The support may be disposed at the center of the channel, whereby the support is substantially equidistant from the first opening and the second opening. The support may be disposed adjacent to, or closest to, the first opening. The support may be disposed adjacent to, or closest to, the second opening.

[0069] Typically, the membrane is configured to ensure that there is sufficient airflow through the device to remove from the membrane and deliver to the patient's lungs a sufficient amount of the active agent or particles containing the active agent to provide the required dosage of the active agent when the patient inhales through one of the openings of the channel during use.

[0070] Preferably, the active agent is effective when delivered to the patient's lungs. Accordingly, the device of this aspect is suitable for use in delivering any active agent that may be delivered to the patient's lungs.

[0071] Typically, the active agent is provided as a dry powder. The dry powder may contain particles. The particles may contain the active agent. The particles may contain a carrier.

[0072] The active agent may be a bronchodilator. For example, the active agent may be salbutamol, salmeterol, formoterol, ventolin or other such active agents.

[0073] 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 fever, yellow fever, etc.

[0074] The active agent may treat pain. For example, the active agent may be in an inhalable form such as tramadol, gabapentin, Vicodin (registered trademark), ibuprofen, acetaminophen, hydrocodone, naproxen, methadone, codeine, hydroxyzine, paracetamol, aspirin, etc.

[0075] The active agent may be used for the treatment of diabetes. For example, the active agent may be in an inhalable form such as insulin, canagliflozin, alogliptin benzoate, dapagliflozin, empagliflozin, ranibizumab, dulaglutide, pioglitazone hydrochloride, and glimepiride.

[0076] The active agent may be used for the treatment or prevention of migraine. The active agent may be a triptan (or 5HT agonist) such as almotriptan (e.g., Almogran (trademark)), eletriptan (e.g., Relpax (trademark)), frovatriptan (e.g., Migard (trademark)), naratriptan (e.g., Naramig (trademark)), rizatriptan (e.g., Maxalt (trademark)), sumatriptan (e.g., Imigran (trademark)), zolmitriptan (e.g., Zomig (trademark)), metoclopramide, rimegepant, lasmiditan, etc.

[0077] The active agent may be a hormonal agent such as an inhalable form of oxytocin, etc. The active agent may prevent postpartum hemorrhage.

[0078] The active agent may be used for the treatment of sexual health disorders. For example, the active agent may be in an inhalable form of sildenafil, tadalafil, or vardenafil.

[0079] The active agent may be used for the treatment of nausea. For example, the active agent may be in an inhalable form of ondansetron, domperidone, dolasetron, or dronabinol.

[0080] The active agent may be used for the treatment of allergies. For example, the active agent may be in an inhalable form of loratadine, cetirizine, chlorpheniramine, diphenhydramine, or fexofenadine.

[0081] The active agent may be used for the treatment of epilepsy. For example, the active agent may be in an inhalable form of levetiracetam, lacosamide, or lamotrigine. The active agent may be used for the treatment of asthma.

[0082] The active agent may be used for the treatment of multiple sclerosis and / or related symptoms. For example, the active agent may be in an inhalable form of teriflunomide or fingolimod.

[0083] The active agent may be used for the treatment of Parkinson's disease. For example, the active agent may be in an inhalable form of pramipexole, rotigotine, ropinirole, carbidopa-levodopa.

[0084] The active agent may be used for the treatment of motor neuron disease (MND) and / or related symptoms. For example, the active agent may be in an inhalable form of riluzole.

[0085] 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 a herbal agent. The active agent may be any other non-medical inhalable agent that can be manufactured as an inhalable dry powder.

[0086] During use, the first opening of the channel may be the air outlet and the second opening of the channel may be the air inlet such that air is taken into the channel through the air inlet and sucked out of the channel through the air outlet. Accordingly, the air inlet may have an irregular shape and the air outlet may have a regular shape, whereby the air flow through the channel accelerates from the air inlet towards the air outlet. The active agent may be provided on one side of the membrane. The active agent may be provided on the side of the membrane facing the air outlet.

[0087] The device may be protected from moisture. The device may be stored in a waterproof package before use. The device may include one or more seals. The device may include one or more seals, whereby the membrane is sealed within the device and thereby protected from moisture. For example, the device may include a seal adjacent to each opening. In another example, the device may include seals on both sides of the membrane. During use, the operation of switching the device from a first position to a second position such that the membrane and any activator mounted thereon are exposed may break the seal or each seal.

[0088] In embodiments where the two flexible substrates include a metal coating, the device may include a seal at each opening of the channel and seals on both sides of the metal coating.

[0089] The device may include one or more reinforcing elements. The or each reinforcing element may bias the device towards a second configuration. The or each reinforcing element may provide a biasing force that is insufficient to switch the device from a first configuration to a second configuration, and the reinforcing element or each reinforcing element may complement the force applied by the user to open the device or switch the device from a first configuration to a second configuration.

[0090] 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 to one or more of the openings of the channel. When a threshold pressure is applied by the user to two opposing connected edges, the reinforcing element may enable the device to switch more easily from a first configuration to a second configuration.

[0091] The or each reinforcing element may extend across one or both of the flexible substrates. The or each reinforcing element may extend across the width of the channel. That is, the or each reinforcing element may extend between the connected edges of the or each flexible substrate.

[0092] When the or each reinforcing element may be shaped to facilitate the opening of the channel when the two flexible substrates are bent. For example, the or each reinforcing element may be curved or bent such that when pressure is applied to the opposing connected edges, the device is biased into the second configuration.

[0093] The device may be sized to fit within the user's hand. In some embodiments, the device may be sized to fit within the user's wallet or coin purse. For example, the device may be the size of a typical credit card etc. (i.e., generally having two major dimensions of about 80 - 90 mm × 50 - 60 mm, such as 86 mm × 54 mm etc. in a plane). As a result, the device may be held within the wallet or coin purse by the user, ensuring that the user can easily pick up the device when administration of the active agent is required. In some embodiments, the channel is configured to optimize the air flow through the channel.

[0094] The cross-sectional area of the channel may be reduced from the air inlet towards the air outlet such that the air flow through the channel is accelerated from the air inlet to the air outlet.

[0095] The cross-sectional area of the channel may decrease in a portion of the channel. The cross-sectional area of the channel may decrease in a portion of the channel between the air inlet and the air outlet.

[0096] 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 may be greater at the second opening than at the first opening when viewed from the side, and the width of the channel may be greater at the first opening than at the second opening when viewed from above. In at least one embodiment, the cross-section of the channel may have a "trumpet-shaped" configuration.

[0097] 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 is larger than the cross-section of the second portion. In at least one dimension, the cross-section of the channel in the first portion is smaller than the cross-section of the second portion. Thus, when the rate of air flow through the channel is constant, the air needs to move more rapidly through the second portion compared to the first portion.

[0098] The second portion may comprise an aperture that constricts the channel. The membrane may extend across the aperture such that air flowing through the second portion needs to flow across the membrane. Thus, the air moves faster across the membrane than across the first portion of the channel, thereby imposing a greater force on the activator present on the membrane and lifting the activator into the air stream.

[0099] 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 comprise features such as a fold that defines the width of the channel, or a more pliable portion. For example, the two flexible substrates may comprise a fold that extends along the length of the two flexible substrates and is spaced apart from the opposing connected edges of the two flexible substrates. In use, when the user switches the device from a first configuration to a second configuration, the channel is formed between the two folds and the two flexible substrates remain substantially flat between the fold and the associated connected edge on either side of the channel.

[0100] The device may include elements that constrain the maximum range to which the two flexible substrates can be bent to switch the device to the second configuration. For example, when the device is in the second configuration, the separation of the two flexible substrates may be determined by the length of the or each connector, and the device may comprise one or more connectors attached to each of the two flexible substrates. The one or more connectors may be attached within the channel to the inner surface of each of the two flexible substrates. The one or more connectors may be attached to the outer surface of each of the two flexible substrates. Alternatively, the device may comprise one or more connectors extending across the width of the device that constrain the maximum range to which at least one of the two flexible substrates can be bent. The device may comprise a rigid tertiary structure or a triangular lock folding portion that defines the maximum range to which the channel of the device can open.

[0101] The device may comprise a mouthpiece adjacent to or at the air outlet. Thus, in use, when the device is in the second configuration, the user may place their mouth in contact with the mouthpiece and then inhale through the mouthpiece. The mouthpiece may be the air outlet. The mouthpiece may be configured to provide support for the user's lips during use.

[0102] In a second aspect, the present invention extends to a method of using a device according to the first aspect, the method comprising: (i) providing a device according to the first aspect; (ii) applying pressure to the two opposed connected edges of the two flexible substrates of the device, thereby switching the device from the first configuration to the second configuration; (iii) inhaling adjacent to the opening of the device in the second configuration, thereby inhaling an active agent from the membrane of the device through the channel to the lungs. comprising.

[0103] When the device is in the second configuration, the user may bring their mouth into contact with the opening of the channel. Thus, the user may inhale from 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 passing into the user's mouth passes through the channel of the device, thereby transporting the active agent from the membrane of the device.

[0104] The user may apply pressure to the opposing edges of the two flexible substrates by squeezing them towards each other.

[0105] In embodiments where the device includes a seal, typically step (ii) breaks the seal, thereby exposing the membrane of the device.

[0106] In embodiments where the device is provided in packaging, typically the device is removed from the packaging before step (ii). Once the user inhales through the device, the device may be discarded.

[0107] In some embodiments, the device may lock when switching from the first configuration to the second configuration, thereby locking the device in the second configuration. Thus, the device may be held in the second configuration without the user continuously applying force.

[0108] According to a third aspect of the present invention, there is provided an apparatus comprising two flexible substrates and a membrane disposed between the two flexible substrates, wherein each of the two flexible substrates includes at least one deformable element, the two flexible substrates are connected at two opposing edges and not connected at two further opposing edges, the apparatus is configured to switch between 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, thereby forming a channel between the two flexible substrates, when the apparatus is in the second configuration, the membrane is configured to extend into the channel between the two flexible substrates, whereby when the apparatus is in the second configuration, an active agent provided on the membrane can be inhaled by a user, and the at least one deformable element of each flexible substrate biases the apparatus into the 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 bi-convex.

[0109] Optional and preferred features of the apparatus of the first aspect are optional and preferred features of the apparatus of the third aspect, where appropriate and where there is no contradiction with the features described in the third aspect.

Brief Description of the Drawings

[0110] Here, embodiments of the present invention will be described by way of non-limiting examples with reference to the accompanying drawings.

[0111]

Figure 1

[0112]

Figure 2A

Figure 2B

[0113]

Figure 3A

Figure 3B

[0114]

Figure 4A

Figure 4B

Figure 5

[0115]

Figure 6A

Figure 6B

[0116]

Figure 7A

Figure 7B

Figure 7C

[0117]

Figure 8A

Figure 8B

DETAILED DESCRIPTION OF THE INVENTION

[0118] The following provides a detailed description of the creation and use of various embodiments of the present invention, but it should be understood that the present invention provides a number of applicable inventive concepts that can be embodied in a wide range of specific contexts. The specific embodiments described herein merely exemplify specific ways of creating and using the present invention and do not define the scope of the present invention.

[0119] To facilitate understanding of the present invention, a plurality of terms are defined below. The terms defined herein have meanings generally understood by those skilled in the relevant art of the present invention. Terms such as "a", "an", and "the" are not intended to refer only to a single entity, but include the general classification to which a particular example used in the description belongs. The terms herein are used to describe specific embodiments of the present invention, but their use, except as set forth in the claims, does not define the present invention.

[0120] Referring to FIGS. 1, 2A, and 2B, an apparatus 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 that faces 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 that faces the third edge 10.

[0121] The first flexible substrate 2 includes a first cut line 14 (functioning as a first deformable element) and a second cut line 16 (functioning as a second deformable element). The first cut line 14 includes a linear portion 18 (functioning as a first part of the first deformable element) and a curved portion 20 (functioning as a second part of the first deformable element). The second cut line 16 includes a linear portion 22 (functioning as a first part of the second deformable element) and a curved portion 24 (functioning as a second part of the second deformable element). The first cut line 14 and the second cut line 16 are symmetrically arranged around a central axis 26 extending along the length of the first flexible substrate 2. The curved portion 24 of the first cut line 14 extends from the linear portion 22 to the first corner 28 of the first flexible substrate 2. The curved portion 24 of the second cut line 16 extends from the linear portion 22 of the second cut line 16 to the second corner 30 of the first flexible substrate 2.

[0122] The second flexible substrate 4 includes a first cut line 32 and a second cut line 34 corresponding to the first cut line 14 and the second cut line 16 of the first flexible substrate 2.

[0123] Referring to FIGS. 3A and 3B, the device 1 further includes a support 36 disposed between the first flexible substrate 2 and the second flexible substrate 4. The support 36 includes an aperture 38 spanned by a membrane 40. An activatable agent 42 in an inhalable form is supported on a first side 44 of the membrane 40. As shown in FIGS. 3A and 3B, the support 36 has four folding portions 46, whereby the support 36 can be folded in a bellows-like manner (e.g., see FIG. 3B). The membrane 40 is disposed at the center of the support 36 having folding portions 48 on either side of the membrane 40. The support 36 is further folded adjacent to the sides to provide a first attachment surface 50 and a second attachment surface 52, which are used to contact and be fixed to the first flexible substrate 2 and the second flexible substrate 4, respectively. Thus, when the support 36 is folded around the four folding portions 46, the membrane 40 is held within a pocket 54 (corresponding to the housing), thereby protecting the activatable agent 42 supported on the membrane 40.

[0124] Before 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.

[0125] During use, the user applies a force to the first and second edges 6, 8, and the first flexible substrate 2 is connected to the second flexible substrate 4. By applying this force, the first flexible substrate 2 and the second flexible substrate 4 bend outwardly from each other. When the first flexible substrate 2 and the second flexible substrate 4 bend, they bend around the first cut line 14 and the second cut line 16 until the device 1 reaches the second configuration. Accordingly, a channel 58 is formed between the first flexible substrate 2 and the second flexible substrate 4 and has a rectangular first end 60 and a biconvex second end 62, whereby 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 smaller than the width of the first end 60.

[0126] Furthermore, the support 36 is expanded, whereby the support 36 spreads into the channel 58 and is disposed closer to the first end 60 of the channel 58 than to the second end 62 of the channel 58.

[0127] 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 that spreads into the channel 58 is lifted from the membrane 40 and inhaled by the user. Once the active agent 42 has been inhaled, the device 1 may be disposed of by the user.

[0128] Referring to FIGS. 4A, 4B, and 5, in an alternative embodiment, the support 100 comprises three folding portions 102 that extend through the center 104 of the membrane 106 as shown in FIGS. 4A and 4B. FIG. 5 shows a side view of the folded configuration 110 of the support 100 attached to the first flexible substrate 112 and the second flexible substrate 114 by welding 116.

[0129] In a further alternative embodiment, referring to FIGS. 6A and 6B, the support 200 includes a first aperture 202a and a second aperture 202b, with a first membrane 204 extending across the first aperture 202a and a second membrane 206 extending across the second aperture 202b. The support 200 includes three folding portions 208 disposed between the first aperture 202a and second aperture 202b and the first membrane 204 and second membrane 206. The first membrane 204 supports a first active agent 210, and the second membrane 206 also supports the first active agent 210. Accordingly, the device is configured to deliver a greater dosage of the first active agent 210 than a device having a support with a single membrane.

[0130] Alternatively, the first membrane 204 supports a first active agent 212 and the second membrane 206 supports a second active agent 214. Accordingly, the device is configured to deliver two active agents simultaneously.

[0131] In yet a further embodiment, referring to FIGS. 7A, 7B, and 7C, the device 300 includes 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 switches from a first configuration to a second configuration, the first locking mechanism 302 and the second locking mechanism 304 are pushed out by the user until they snap into a locked position. Accordingly, the device is locked in the second configuration, whereby the user need not maintain force to hold the device 300 in the second configuration.

[0132] The first flexible substrate 312 and the second flexible substrate 320 include a grip portion 322. The grip portion 322 has a surface that is textured to enhance the user's ability to grip the device in the second configuration and may function as an indicator to the user of where force should be applied to switch the device from the first configuration to the second configuration.

[0133] In an alternative embodiment, referring to FIGS. 8A and 8B, apparatus 400 by any of the foregoing apparatuses further includes a membrane 402 mounted within a support 404 and a barrier film 406 (functioning as a barrier material) disposed 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 weld 412 and removably attached to the second flexible substrate 410 of the first configuration. The activator 414 is held between the barrier film 406 and the membrane 402 prior to use. When the apparatus 400 switches to the second configuration, the membrane 402 closes a 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 the channel 416, and the barrier film 406 pivots around the weld 412 away from the second flexible substrate 410 and toward the first flexible substrate 408, thereby releasing the activator 414 from the membrane 402 to the user.

[0134] Those skilled in the art will understand that the above embodiments are examples, and the features of each disclosed embodiment may be combined with the features of other embodiments. Further variations and modifications are contemplated herein and are included within the scope of the present invention.

Claims

1. An apparatus comprising two flexible substrates and a membrane disposed between the two flexible substrates, wherein each of the two flexible substrates includes at least one deformable element, the two flexible substrates are connected at two opposing edges and are not connected at two further opposing edges, the apparatus is configured to switch between a first configuration in which the two flexible substrates are flat and in contact with each other and a second configuration in which the two flexible substrates are bent, thereby forming a channel between the two flexible substrates, when the apparatus is in the second configuration, the membrane is configured to extend into the channel between the two flexible substrates, whereby when the apparatus is in the second configuration, an active agent provided on the membrane is inhalable by a user, and the at least one deformable element of each flexible substrate biases the apparatus into a second configuration in which a first opening of the channel formed between the two flexible substrates is rectangular in shape and a second opening of the channel formed between the two flexible substrates is bi-convex in shape.

2. The apparatus according to claim 1, wherein the two flexible substrates are rectangular.

3. The apparatus according to claim 1 or claim 2, wherein the at least one deformable element of each flexible substrate is a marked line along at least a part of the flexible substrate, a flexible line extending along at least a part of the flexible substrate, or a crease in the flexible substrate.

4. The apparatus according to any one of claims 1 to 3, wherein the at least one deformable element includes a first part and a second part.

5. The apparatus according to any one of claims 1 to 4, wherein the first flexible substrate of the two flexible substrates includes at least two deformable elements and the second flexible substrate of the two flexible substrates includes at least two deformable elements.

6. The apparatus according to any one of claims 1 to 5, wherein the membrane is mounted in the channel on a support.

7. The apparatus according to claim 6, wherein the support includes an aperture and the membrane extends into the aperture, thereby closing the channel.

8. The support includes at least one folding portion, whereby when the device is in the first configuration, the support is crushed and in a folded state, and when the device is in the second configuration, the support expands and is in an open state. The device according to claim 6 or claim 7.

9. The support forms a housing when in the folded state, and the active agent is protected within the housing. The device according to claim 8.

10. The height of the channel is greater at the second opening than at the first opening, and the width of the channel is greater at the first opening than at the second opening. The device according to any one of claims 1 to 9.

Images