Inhaler comprising retaining element

Abstract

An inhaler (200) is provided that includes a housing defining an inlet (111), an outlet (113), and an airflow path extending from the inlet (111) to the outlet (113). The inhaler (200) comprises a capsule receptacle (221) for receiving a capsule (230) containing a composition for inhalation. The inhaler (200) comprises a rupture element (140) for rupture of the bladder (230) received in the bladder receptacle (221). The inhaler (200) includes an aerosolization chamber (222) for allowing the composition to be entrained in the airflow within the airflow path. The inhaler (200) comprises a retaining element (250) movable between a first position in which movement of the bladder (230) from the bladder housing (221) to the aerosolization chamber (222) is prevented and a second position in which the bladder (230) is movable from the bladder housing (221) to the aerosolization chamber (222). A composition for administration to a patient using an inhaler (200) is also provided.

Description

[0001] The present disclosure relates to an inhaler. In particular, the present disclosure relates to an inhaler for use with a capsule containing a composition for inhalation. The present disclosure also relates to a method of administering a composition using an inhaler. The present disclosure also relates to a composition administered to a patient using an inhaler.

[0002] Inhalers are commonly used to deliver pharmaceutically active ingredients to the lungs of patients so that treatment may include various medical conditions such as respiratory diseases such as asthma. Some medical conditions that can be treated by using pharmaceutically active ingredients via inhalers may have acute attacks. These medical conditions may include myocardial infarction, cerebrovascular accident and asthma exacerbation. Therefore, it is important that inhalers are simple to use and can quickly and effectively deliver pharmaceutically active ingredients to patients. This can allow the best possible prognosis of patients who experience acute attacks of medical conditions. However, even when medical conditions do not have acute attacks, it is also important that inhalers are simple to use and can quickly and effectively deliver pharmaceutically active ingredients to patients. For example, this may make patients more likely to adhere to their treatment.

[0003] In some known inhalers, such as the RS01 inhaler developed by Plastiape Sp A. and described in EP1270034, pharmaceutically active ingredients are applied in the form of dry powder contained in the capsule. Usually, the capsule is stored in a blister pack separately from the inhaler. Therefore, the patient must locate the capsule, extract the capsule from its packaging, open the inhaler to insert the capsule, and then close the inhaler when the capsule is in place. The patient can then actuate the piercing element to pierce the capsule. Usually, the patient must ensure that the inhaler remains upright after inserting the capsule, otherwise the capsule may move to the reach of the piercing element before the capsule can be pierced. Finally, the patient draws on the inhaler, which moves the capsule into the aerosolization chamber and spins in the inhaler and releases the dry powder to form an aerosol that can be inhaled and delivered to the patient's lungs. It may be challenging for the patient to insert the capsule and keep the inhaler upright or stable when experiencing a medical condition, particularly when the medical condition makes the body weak and / or has an acute attack. Having to insert the capsule and hold the inhaler upright or steady may also increase the overall time it takes to deliver the pharmaceutically active ingredient to the patient.

[0004] It is desirable to provide an inhaler for use with a capsule that may be easier and quicker for a patient to use than some other prior art inhalers. It is also desirable to provide an inhaler for use with a capsule that may reduce the total time for delivering a pharmaceutically active ingredient to a patient. Therefore, inhalers have been designed that require fewer user steps before inhalation. For example, WO 2020 / 257845 discloses a dry powder inhaler similar to the RS01 inhaler, but which may be pre-loaded with a capsule. The capsule is held in place so as to be pierced by an elongated tip extending from the inside of the mouthpiece cover. However, this requires forming a long, thin feature that may be difficult to mold. Therefore, it is desirable to provide an inhaler that may be pre-loaded with a capsule without making complex parts.

[0005] According to the present disclosure, a kind of inhaler is provided. The inhaler comprises a housing, and the housing defines an inlet, an outlet and an airflow path extending from the inlet to the outlet. The inhaler comprises a capsule receiving portion for receiving a capsule, and the capsule contains a composition for inhalation. The inhaler comprises a rupture element, and the rupture element is used to rupture the capsule received in the capsule receiving portion. The inhaler comprises an aerosolization chamber, and the aerosolization chamber is used to allow the composition to be entrained in the airflow in the airflow path. The inhaler comprises a retaining element, and the retaining element is movable between a first position preventing the capsule from moving from the capsule receiving portion to the aerosolization chamber and a second position in which the capsule can move from the capsule receiving portion to the aerosolization chamber. The retaining element extends through the inlet when the retaining element is in the first position.

[0006] When the retaining element is in the first position, the retaining element prevents the capsule from moving from the capsule receiving portion to the aerosolization chamber. This can keep the capsule near the rupture element until the user wishes to use the inhaler. This means that the capsule can be inserted into the inhaler before the user wishes to use the inhaler. The inhaler can then be carried in a pocket, for example, without worrying that the capsule moves away from the rupture element so that it cannot rupture. Advantageously, this can allow the user to quickly treat its medical condition because the capsule has been pre-loaded in the factory during production and assembly processes.

[0007] Since the retaining element extends through the inlet, it uses existing features of the inhaler and advantageously does not require modifications to the housing or mouthpiece cover. Thus, only a single additional component is required, which can be manufactured separately from the inhaler and then inserted.

[0008] In order to use the inhaler, the retaining element can be moved to a position where the capsule can be moved from the capsule receiving portion to the aerosolization chamber. Advantageously, this allows the patient to quickly activate the inhaler for use. Usually, the time and energy required for moving the retaining element from the first position to the second position is less than the time and energy required for positioning the capsule and inserting it into the inhaler. This is particularly useful during the time when the patient may be weak due to a medical condition.

[0009] The inhaler includes a capsule receiving portion. Advantageously, this can ensure that the capsule is properly positioned relative to the rupture element. For example, the capsule receiving portion can position the capsule in an orientation that is optimal for rupturing the capsule. This optimal orientation can limit the force that the user needs to apply to the rupture element in order to rupture the capsule. Alternatively or in addition, the optimal orientation can result in optimal rupture of the capsule in order to release the composition.

[0010] Also advantageously, because the capsule is pre-loaded into the inhaler, the number of steps that the user needs to take in order to use the inhaler to inhale the composition is reduced. The user only needs to move the retaining element and rupture the capsule in order to prepare the inhaler for use.

[0011] The inhaler is intended for a single use so that the composition in the pre-loaded capsule is inhaled. It is not expected that the user will remove the used capsule and insert another capsule for subsequent use. Therefore, if the expected dose is greater than the contents of a single capsule, two or more inhalers can be supplied together, for example, in a single package.

[0012] As used herein, the term "rupturing" refers to providing at least one opening in a capsule for allowing the composition within the capsule to exit the capsule. Rupture may include, but is not limited to, puncturing, perforating, twisting, tearing, and separating the capsule.

[0013] As used herein, the term "proximal end" refers to the end of the inhaler or component of the inhaler closest to the outlet. The term "distal end" refers to the end of the inhaler or component of the inhaler opposite to the proximal end of the inhaler or component of the inhaler.

[0014] As used herein, the term "longitudinal" refers to a direction or axis extending between the proximal and distal ends of an inhaler or a component of an inhaler.

[0015] As used herein, the term "gas flow" refers to any suitable gaseous flow for inhalation by a user and entraining the composition. For example, the gaseous flow can be a flow of air, a flow of oxygen, or a flow of nitrous oxide.

[0016] As used herein, the term "pharmaceutically active ingredient" refers to an ingredient that changes one or more chemical or physiological functions of a cell, tissue, organ, or organism. The pharmaceutically active ingredient can be, for example, a systemic or local drug, a peptide or DNA-based drug, an anti-inflammatory agent, a bronchodilator, an antiviral agent, an antibiotic agent, an immunostimulant, an immunosuppressant, an anesthetic, an anticancer agent, a vitamin, a hormone, an anti-epileptic agent, an antifungal agent, an antioxidant, an antidiabetic agent, a muscle relaxant, an anti-HIV agent, a stimulant, an antitussive agent, a pain control agent, a smoking cessation agent, or an alcohol abuse agent.

[0017] As used herein, reference to a "user" may also refer to a "patient."

[0018] The inhaler may be a dry powder inhaler.

[0019] The airflow path can extend through the aerosolization chamber. The airflow path can be configured to form a cyclone (or vortex) in the aerosolization chamber by the airflow in the aerosolization chamber. The cyclonic airflow can move the capsule from the capsule receiving portion to the aerosolization chamber. The cyclonic airflow can rotate the capsule in the aerosolization chamber and release the composition into the airflow in the airflow path.

[0020] The airflow path may include an inlet passage extending from the inlet to the aerosolization chamber. The inlet passage may extend in a direction transverse to the longitudinal axis of the inhaler. The inlet passage may be configured to form a cyclone in the aerosolization chamber with the airflow in the aerosolization chamber. The inlet passage may be configured to guide the airflow in the airflow passage toward the wall of the aerosolization chamber. The inlet passage may be configured to allow the airflow in the airflow passage to enter the aerosolization chamber in a direction substantially tangent to the wall of the aerosolization chamber.

[0021] The air flow path may include an outlet passage extending between the aerosolization chamber and the outlet.

[0022] The inlet may include a first inlet and a second inlet. The inlet channel may be a first inlet channel extending from the first inlet to the aerosolization chamber. The airflow path may include a second inlet channel extending from the second inlet to the aerosolization chamber. The second inlet channel may extend to the aerosolization chamber in a lateral direction. The second inlet channel may be configured to cause the airflow in the aerosolization chamber to form a cyclone in the aerosolization chamber. The second inlet channel may be configured to guide the airflow in the airflow channel toward the wall of the aerosolization chamber. The second inlet channel may be configured to cause the airflow to enter the aerosolization chamber in a direction substantially tangential to the wall of the aerosolization chamber. The first inlet channel and the second inlet channel may cooperate to cause the airflow in the aerosolization chamber to form a cyclone in the aerosolization chamber.

[0023] The retaining element can be separated from the housing when the retaining element is in the second position. That is, when the retaining element is in the second position, the housing and the retaining element do not contact each other. The retaining element can be configured to be separated from the housing when the retaining element moves from the first position to the second position. Advantageously, this can prevent the retaining element from disrupting the airflow in the airflow path and therefore limiting the amount of the composition delivered to the user.

[0024] The inhaler may include an actuating device configured to move the retaining element from the first position to the second position. Advantageously, the provision of the actuating device may allow the retaining element to be quickly moved from the first position to the second position. The actuating device may be a mechanical actuating device.

[0025] Movement of the retaining element from the first position to the second position may be configured to move the capsule from the capsule receptacle to the aerosolisation chamber. Advantageously, this may allow the composition to be delivered to the user more quickly.

[0026] The retaining element may be configured to contact the bladder within the bladder receiving portion when the retaining element is in the first position. The retaining element may be configured to substantially prevent movement of the bladder relative to the bladder receiving portion when the retaining element is in the first position. The retaining element may be configured to substantially prevent movement of the bladder relative to the bladder receiving portion by urging the bladder against a wall of the bladder receiving portion when the retaining element is in the first position. Advantageously, preventing movement of the bladder within the bladder receiving portion may prevent damage to the bladder or premature rupture. Additionally, this may help keep the bladder properly oriented relative to the rupturing element.

[0027] The capsule receiving portion may include a capsule receiving portion opening, and the capsule receiving portion opening is used to allow the capsule to move between the capsule receiving portion and the aerosolization chamber. The capsule receiving portion opening may be arranged at the interface between the capsule receiving portion and the aerosolization chamber. The retaining element may be configured to at least partially cover the capsule receiving portion opening when the retaining element is in the first position. The retaining element may be configured to completely cover the capsule receiving portion opening when the retaining element is in the first position. The retaining element may be configured to substantially prevent the airflow through the airflow path from entering the capsule receiving portion when the retaining element is in the first position. Advantageously, this can prevent the composition in the ruptured capsule from being released prematurely before the retaining element has moved to the second position.

[0028] The retaining element may include a first portion and a second portion. When the retaining element is in the first position, the first portion may be positioned within the housing. The first portion may be configured to prevent the capsule from moving between the capsule receiving portion and the aerosolization chamber. When the retaining element is in the first position, the second portion may be positioned outside the housing. Advantageously, this may allow a user to pull the second portion to move the retaining element from the first position to the second position.

[0029] The first portion may be positioned within the aerosolization chamber when the retaining element is in the first position.

[0030] The first portion can be configured to follow a winding path within the aerosolization chamber when the retaining element is in the first position. For example, the winding path can have a sinusoidal shape or an approximately sinusoidal shape. As another example, the winding path can have a spiral shape or an approximately spiral shape. The first portion can be configured to follow a winding path from the first inlet channel to the second inlet channel. Advantageously, by introducing a non-straight portion into the retaining element, the winding path can increase the resistance to moving the retaining element from the first position to the second position. This can prevent the retaining element from accidentally moving from the first position to the second position. The winding path of the retaining element can enable the retaining element to prevent the airflow from entering the aerosolization chamber. The first portion can be configured to be coiled or wrapped around the aerosolization chamber when the retaining element is in the first position. The first portion can be configured to unfold or unwind when the retaining element moves from the first position to the second position.

[0031] When the retaining element is in the first position, the second portion may be positioned outside the inlet. Thus, when the retaining element is in the first position, the retaining element may extend through the inlet passage.

[0032] The second portion may be angled relative to the first portion to prevent the second portion from being inserted into the housing when the retaining element is in the first position. For example, the angle between the first portion and the second portion may be an acute angle. The second portion may be sized to prevent the second portion from being inserted into the housing when the retaining element is in the first position. Advantageously, this may prevent the second portion from accidentally entering the housing, which may mean that a user is unable to move the retaining element from the first position to the second position.

[0033] The second portion may include an aperture to assist a user in moving the retaining element from the first position to the second position. The aperture may be sized to facilitate insertion of a user's finger. Advantageously, providing an aperture may make it easier for a user to move the retaining element from the first position to the second position. The aperture may be particularly useful in situations where a user may not have the strength to grip the second portion between their fingers.

[0034] The retaining element may be configured to substantially prevent airflow through the airflow path when the retaining element is in the first position. Advantageously, this may prompt the user to move the retaining element to the second position before inhaling on the inhaler.

[0035] The retaining element may be configured to substantially prevent airflow from the inlet to the outlet when the retaining element is in the first position. The retaining element may be configured to substantially prevent airflow from entering the aerosolization chamber when the retaining element is in the first position. The retaining element may be configured to substantially prevent airflow from entering the inlet when the retaining element is in the first position. The retaining element may be configured to substantially prevent airflow from leaving the outlet when the retaining element is in the first position. The retaining element may be configured to substantially prevent airflow from passing through the inlet channel when the retaining element is in the first position. The retaining element may be configured to substantially prevent airflow from passing through the first inlet channel when the retaining element is in the first position. The retaining element may be configured to substantially prevent airflow from passing through the second inlet channel when the retaining element is in the first position. The retaining element may be configured to substantially prevent airflow from passing through the outlet channel when the retaining element is in the first position.

[0036] The retaining element may extend through the inlet when the retaining element is in the first position. Advantageously, this may hinder the flow through the inlet and prevent the airflow in the aerosolization chamber from forming eddies. The retaining element may be moved from the first position to the second position by at least partially withdrawing the retaining element from the housing through the inlet. When the retaining element is in the first position, the retaining element may extend from the first inlet to the second inlet. When the retaining element is in the first position, the retaining element may be positioned in the inlet passage. When the retaining element is in the first position, the retaining element may be positioned in the second inlet passage.

[0037] The inhaler may include a porous element. The porous element may be positioned in the airflow path between the aerosolization chamber and the outlet. That is, the porous element may be positioned in the outlet passage. The porous element may be configured to prevent the capsule from leaving the housing via the outlet. The composition and the airflow may pass through the porous element. The porous element may span the airflow path substantially perpendicular to the airflow direction. The porous element may be a perforated plate or a grid. The porous element may be a mesh. Advantageously, the porous element may prevent the capsule from being inhaled by the user.

[0038] When the retaining element is in the first position, the retaining element may abut the porous element.When the retaining element is in the first position, the retaining element may substantially prevent airflow through the porous element.

[0039] The inhaler may include a cover. The cover is movable between a covering position in which the outlet is at least partially covered and an uncovered position in which the outlet is not covered. When in the covering position, the cover may at least partially cover the inlet.

[0040] The retaining element may be made of any suitable material. Examples of suitable materials include thermoplastic materials suitable for food or pharmaceutical applications, such as polypropylene, polyetheretherketone (PEEK), and polyethylene. The retaining element may be made of acrylonitrile butadiene styrene (ABS). The retaining element may be made of foil. The retaining element may be made of metal foil. The retaining element may be made of aluminum foil. The retaining element may be made of a flexible material.

[0041] The housing may include a first housing portion and a second housing portion.

[0042] The first housing portion may include an outlet. The first housing portion may be a mouthpiece. The mouthpiece may be configured to be inserted into a user's mouth. The first housing portion may be a nosepiece. The nosepiece may be configured to be inserted into a user's nose.

[0043] The second housing portion may include an inlet. The second housing portion may include a capsule receptacle. The second housing portion may include an aerosolization chamber. The second housing portion may include a rupture element.

[0044] The first housing part and the second housing part may be connectable. That is, the connection between the first housing part and the second housing part may facilitate access to the aerosolization chamber and the capsule receptacle so that the capsule may be inserted into the inhaler during production.

[0045] The first housing portion and the second housing portion may be coupled by mechanical keying. The first housing portion and the second housing portion may be coupled by snap fit. The first housing portion and the second housing portion may be coupled by screws. The first housing portion and the second housing portion may be coupled by threaded engagement. For example, the first housing portion may include an internal thread and the second housing portion may include an external thread. The external thread may be screwed into the internal thread. The first housing portion and the second housing portion may be magnetically coupled.

[0046] The first housing portion and the second housing portion may be configured to rotate relative to each other to allow coupling and separation. The first housing portion may include a protrusion configured to cooperate with a hole in the second housing portion such that the first housing portion and the second housing portion must be rotated relative to each other to allow coupling and separation. Alternatively, the second housing portion may include a protrusion configured to cooperate with a hole in the first housing portion such that the first housing portion and the second housing portion must be rotated relative to each other to allow coupling and separation.

[0047] The first housing portion and the second housing portion may be configured to move linearly relative to each other to allow coupling. The first housing portion may include a spike configured to cooperate with a hole in the second housing portion such that the first housing portion and the second housing portion are coupled by longitudinally moving the spike into the hole. Alternatively, the second housing portion may include a spike configured to cooperate with a hole in the first housing portion.

[0048] Because inhaler is preloaded and expects single use, therefore need not have the mechanism for removably coupling the first housing portion and the second housing portion, because the user does not need to insert capsule.Therefore, the first housing portion and the second housing portion can be permanently coupled together after the capsule has been inserted.Advantageously, this prevents the user from opening the housing, and therefore avoids the user from mistakenly removing the possibility of preloading the capsule before sucking and / or attempting to insert a new capsule.For example, the first housing portion and the second housing portion can be sealed or welded together by ultrasonic welding, laser welding or hot melting, or the first housing portion and the second housing portion can be kept or sealed together by sticker or adhesive tape.

[0049] The housing and lid may be formed of any suitable material or combination of materials. Examples of suitable materials include metals, alloys, plastics, or composite materials containing one or more of these materials, or thermoplastic materials suitable for food or pharmaceutical applications, such as polypropylene, polyetheretherketone (PEEK), and polyethylene. Preferably, the material is lightweight and non-brittle. The housing may be made of acrylonitrile butadiene styrene (ABS).

[0050] The rupture element may be a rigid element capable of piercing the capsule. The rupture element may be a metal element. The rupture element may be a solid pin or a hollow needle. The rupture element may be configured to move between a rupture position and a relaxed position. In the piercing position, the rupture element may be configured to extend into the capsule receptacle. The rupture element may be biased to the relaxed position by a biasing element. The biasing element may be a spring. A user may press the rupture element to move the rupture element from the relaxed position to the rupture position.

[0051] The rupture element may be operably connected to a rupture element button. The rupture element button may be configured to be operated to move the rupture element from the relaxed position to the rupture position. The rupture element button may be a push button.

[0052] The inhaler may include a device that prevents the rupture element from moving from the relaxed position to the rupture position when engaged. The device may be disengaged to allow the rupture element to move from the relaxed position to the rupture position. The device may be a cover. The cover may be configured to at least partially cover the rupture element button to prevent the rupture element from moving from the relaxed position to the rupture position, and thereby prevent premature rupture of the capsule.

[0053] The rupture element may be a first rupture element. The inhaler may include a second rupture element. The second rupture element may have any of the features described with respect to the first rupture element.

[0054] The outlet may be located at the proximal end of the inhaler (ie the upper end in the normal orientation of the inhaler).The aerosolization chamber may be located in the longitudinal direction between the outlet and the capsule receiving portion.

[0055] The aerosolization chamber may be cylindrical.

[0056] The aerosolization chamber may have a height dimension in the longitudinal direction. The aerosolization chamber may have a height between 5 mm and 15 mm, between 6 mm and 12 mm, or between 7 mm and 10 mm. The aerosolization chamber may have a height of 8 mm.

[0057] The aerosolization chamber may have a diameter (or width) dimension in a direction transverse to the longitudinal direction. The aerosolization chamber may have a diameter (or width) between 10 mm and 30 mm, between 12 mm and 25 mm, between 15 mm and 20 mm. The aerosolization chamber may have a diameter (or width) of 18 mm.

[0058] The bladder receiving portion may have a height dimension in the longitudinal direction. The bladder receiving portion may have a height between 5 mm and 15 mm. The bladder receiving portion may have a height of approximately 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, or 14 mm.

[0059] The bladder receiving portion may have a width dimension in a direction transverse to the longitudinal direction. The bladder receiving portion may have a width between 5 mm and 10 mm. The bladder receiving portion may have a width of approximately 6 mm, 7 mm, 8 mm or 9 mm.

[0060] The bladder receiving portion may have a length dimension in a direction transverse to the longitudinal direction and the width dimension. The bladder receiving portion may have a length between 10 mm and 30 mm, between 12 mm and 20 mm, between 15 mm and 18 mm. The bladder receiving portion may have a length of 16 mm.

[0061] The inhaler may include a capsule positioned within the capsule receptacle. The capsule may contain the composition.

[0062] The bladder receiving portion can be elongated. Thus, the length of the bladder receiving portion can be greater than the width of the bladder receiving portion. The bladder receiving portion can be sized to receive bladders from size 0 to size 4. For example, size 0, size 1, size 2, size 3, or size 4.

[0063] The capsule may include a capsule shell for encapsulating the composition. The capsule may be any suitable pharmaceutical capsule, such as a hard shell capsule. The capsule shell may be made of a gelling agent such as gelatin and / or a polysaccharide. The capsule shell may be formed of hydroxypropyl methylcellulose (HPMC). The capsule shell may contain a plasticizer, such as glycerol or sorbitol.

[0064] The bladder may be of any suitable size. The bladder may be a size 0 to size 4 bladder, such as a size 3 bladder.

[0065] The composition may be in the form of a dry powder suitable for dry powder inhalation.

[0066] Preferably, the composition comprises a pharmaceutically active ingredient. The pharmaceutically active ingredient may be able to treat or prevent thromboembolic events. The pharmaceutically active ingredient may be an antiplatelet drug. For example, the pharmaceutically active ingredient may be a nonsteroidal anti-inflammatory drug (NSAID). Preferably, the pharmaceutically active ingredient is a salicylate (salt or ester of salicylic acid), most preferably acetylsalicylic acid or a pharmaceutically acceptable salt thereof.

[0067] The pharmaceutically active ingredient can be another type of NSAID. For example, the pharmaceutically active ingredient can be Celecoxib (Celebrex), Dexdetoprofen (Keral), Diclofenac (Voltaren, Cataflam, Voltaren-XR), Diflunisal (Dolobid), Etodolac (Lodine, Lodine XL), Etoricoxib (Algix), Fenoprofen (Fenopron, Nalfron), Firocoxib (Equioxx, Previcox), Flurbiprofen (Urbifen, Ansaid, Flurwood, Proben), Ibuprofen (Advil, Brufen, Motrin, Nurofen, Medipren, Nuprin), Indomethacin (Indocin, IndocinSR, Indocin IV), Ketoprofen (Actron, Orudis, Oruvail, Ketoflam), Ketorolac (Toradol, Sprix, Toradol IV / 1Μ, Toradol IM), Licofelone (under development), Lomoxicam (Xefo), Loxoprofen (Loxonin, Loxomac, Oxenol), Lumiracoxib (Prexige), Meclofenamic acid (Meclomen), Mefenamic acid (Ponstel), Meloxicam (Movalis, Mel ox, Recoxa, Mobic), Nabumetone (Relafen), Naproxen (Aleve, Anaprox, MidolExtendedRelief, Naprosyn, Naprelan), Nimesulide (Sulide, Nimalox, Mesulid), Oxaporozin (Daypro, Dayrun, Duraprox), Parecoxib (Dynastat), Piroxicam (Feldene), Rofecoxib (Vioxx, Ceoxx, Ceeoxx), Salsalate (Mono-Gesic, Salflex, Disalcid, Salsitab), Sulindac (Clinoril), Tenoxicam (Mobi flex), Tolfenamic acid (Clotam Rapid, Tufnil), or Valdecoxib (Bextra).

[0068] The pharmaceutically active ingredient may be an alternative to NSAIDs. Such alternatives include P2Y12 inhibitors. Examples of P2Y12 inhibitors include Plavix (clopidogrel), ticlopidine, ticagrelor, prasugrel, and cangrelor. Other pharmaceutically active ingredients may include COX-2 inhibitors and nattokinase, an enzyme (EC 3.4.21.62, extracted and purified from a Japanese food called natto).

[0069] The composition may comprise both acetylsalicylic acid or a pharmaceutically acceptable salt thereof and a P2Y12 inhibitor.

[0070] Preferably, the pharmaceutically active ingredient is at least 80% by weight of the composition, preferably at least 90% by weight, more preferably at least 95% by weight. For example, at least 95% by weight of the composition in the capsule may be acetylsalicylic acid or a pharmaceutically acceptable salt thereof.

[0071] The composition preferably comprises a pharmaceutically acceptable excipient. For example, the excipient may be an anti-aggregation excipient, an anti-adhesive agent or a lubricant. The pharmaceutically acceptable excipient may be magnesium stearate. Magnesium stearate may be present in an amount of 1 wt % or less of the composition, such as 0.05 wt % to 1 wt % of the composition. For example, magnesium stearate may be present in an amount of about 0.5 wt %.

[0072] The amount or dose of the pharmaceutically active ingredient (preferably acetylsalicylic acid or a salt thereof) in the capsule is preferably 100 mg or less, more preferably 75 mg or less, even more preferably 60 mg or less.

[0073] The amount or dose of the pharmaceutically active ingredient, preferably acetylsalicylic acid or a salt thereof, in the capsule may be at least 5 mg, preferably at least 20 mg, more preferably at least 30 mg, even more preferably at least 40 mg.

[0074] The amount or dosage of the pharmaceutically active ingredient (preferably acetylsalicylic acid or its salt) in the capsule may be 5-300 mg, preferably 20-100 mg, more preferably 30-75 mg, even more preferably 40-60 mg. For example, there may be about 50 mg of acetylsalicylic acid or its salt in the capsule.

[0075] When treating a condition (such as treating or preventing a thromboembolic event), a user may require multiple doses of a pharmaceutically active ingredient (preferably acetylsalicylic acid or a salt thereof). An inhaler may include a single capsule having a predetermined dose of the active ingredient. To administer multiple doses, a user may require multiple inhalers, each of which provides a single dose. Each dose may be delivered from an inhaler in a single inhalation or in two or more inhalations.

[0076] For example, the inhaler may comprise a single capsule and the capsule may contain less than 100 mg (preferably about 50 mg) of acetylsalicylic acid or a salt thereof in dry powder form. In treating or preventing a thromboembolic event, the user may use two inhalers, each providing a single dose, to provide a total of two doses.

[0077] The composition is preferably a respirable dry powder, which consists of respirable dry particles suitable for delivery to the respiratory tract of a user (eg, pulmonary delivery) by inhalation.

[0078] The particles may have a mass median aerodynamic diameter (MMAD) of 10 μm or less, preferably 5 μm or less, such as 0.5-5 μm.

[0079] The particles may have a volume median geometric diameter (VMGD) of 10 μm or less, preferably 5 μm or less (such as 0.5-5 μm) as measured by HELOS / RODOS at 1.0 bar.

[0080] The particles may have a geometric diameter distribution or an aerodynamic diameter distribution wherein the particles exhibit a DV90 of less than 10 μm, a DV50 of less than 4 μm, and a DV10 of less than 1 μm; or preferably exhibit a DV90 of less than 6 μm, a DV50 of less than 3 μm, and a DV10 of less than 1 μm.

[0081] The diameter of the respirable dry particles, e.g. their VMGD, can be measured using an electrical area sensing instrument such as the Multisizer lies (Coulter Electronic, Luton, beds, England), or a laser diffraction instrument such as the HELOS system (Sympatec, Princeton, WO 2016 / 019253).

[0082] Experimentally, the aerodynamic diameter can be determined using a time-of-flight (TOF) measurement. For example, an instrument such as the 3225 Aerosizer DSP particle size analyzer (Amherst Process Instrument, Inc., Amherst, MA) can be used to measure the aerodynamic diameter. Aerosizer measures the time taken for a single respirable dry particle to pass between two fixed laser beams. The aerodynamic diameter can also be determined directly experimentally using a conventional gravity sedimentation method, in which the time required for a sample of respirable dry particles to settle a certain distance is measured. Indirect methods for measuring mass median aerodynamic diameter include Andersen cascade impactor (ACI) and multi-stage liquid impactor (MSLI) methods. Another method for measuring aerodynamic diameter is through the next generation impactor (NGI). NGI operates according to the inertial impact principle similar to ACI. NGI consists of seven stages and can be calibrated at flow rates of 30, 60 and 100 L / min. Compared with the ACI with stacked impactor stages, the stages of NGI are all in one plane. The collection cup is used to collect particles below each stage of NGI.

[0083] The inhaler can be arranged in a sealed container. That is, the inhaler can be sealed in a sealed container. The container can be hermetically sealed. The container can be tamper-proof. That is, when the container is damaged, for example, when the container is unsealed, the container can be irreversibly changed. For example, the container can be irreversibly torn or torn apart when unsealed. The inhaler can include a capsule positioned in a capsule receiving portion. The retaining element can be in a first position. The container can include two inhalers, each of which includes a capsule in a capsule receiving portion and the retaining element is in a first position.

[0084] According to the present disclosure, a kind of inhaler that is hermetically sealed in a container is provided.The inhaler comprises a housing, and the housing defines an inlet, an outlet, and an airflow path extending from the inlet to the outlet.The inhaler comprises a capsule in the housing.The inhaler can be configured to rupture the capsule to allow the composition to be inhaled by the user who sucks on the outlet.The inhaler that is hermetically sealed in the container can have any feature of the inhaler described herein.Two inhalers can be hermetically sealed in a single container.

[0085] According to the present disclosure, there is provided a method of administering a composition using an inhaler as described herein. The inhaler comprises a capsule as described herein positioned within a capsule receptacle. The capsule contains a composition as described herein. The method comprises rupturing the capsule with a rupturing element; moving a retaining element from a first position to a second position; and drawing on an outlet to inhale the composition. The composition may be any composition described herein.

[0086] According to the present disclosure, a composition is provided. The composition comprises an antiplatelet drug used in a method for treating, preventing or ameliorating a thromboembolic event in a patient. The composition is administered to a patient using an inhaler as described herein. The inhaler comprises a capsule as described herein positioned within a capsule receptacle. The capsule comprises a composition as described herein. The composition is administered by: rupturing the capsule with a rupturing element; moving a retaining element from a first position to a second position; and suctioning on an outlet to inhale the composition.

[0087] According to the present disclosure, a method for treating, preventing or ameliorating a thromboembolic event in a patient is provided. The method comprises administering a composition comprising an antiplatelet drug to a patient in need thereof. The composition is administered to the patient using an inhaler as described herein. The inhaler comprises a capsule as described herein positioned within a capsule receptacle. The capsule comprises a composition as described herein. The composition is administered by: rupturing the capsule with a rupturing element; moving a retaining element from a first position to a second position; and suctioning on an outlet to inhale the composition.

[0088] According to the present disclosure, there is provided a use of a composition comprising an antiplatelet drug in the manufacture of a medicament for treating, preventing or ameliorating a thromboembolic event in a patient. The composition is administered to a patient using an inhaler as described herein. The inhaler comprises a capsule as described herein positioned within a capsule receptacle. The capsule contains a composition as described herein. The composition is administered by: rupturing the capsule with a rupturing element; moving a retaining element from a first position to a second position; and suctioning on an outlet to inhale the composition.

[0089] The antiplatelet drug used to treat, prevent or improve thromboembolic events may be an antiplatelet drug as described herein, such as an NSAID or a P2Y12 inhibitor. Preferably, the antiplatelet drug is acetylsalicylic acid or a pharmaceutically acceptable salt thereof.

[0090] The present invention is defined in the claims. However, a non-exhaustive list of non-limiting examples is provided below. Any one or more features of these examples may be combined with any one or more features of another example, embodiment or aspect described herein.

[0091] Ex1. An inhaler, comprising:

[0092] a housing defining an inlet, an outlet, and an airflow path extending from the inlet to the outlet;

[0093] a capsule receiving portion for receiving a capsule containing a composition for inhalation;

[0094] a rupture element for rupturing the capsule received in the capsule receiving portion;

[0095] an aerosolization chamber for allowing the composition to be entrained in an airflow within the airflow path; and

[0096] a retaining element movable between a first position preventing the capsule from moving from the capsule receiving portion to the aerosolization chamber and a second position enabling the capsule to move from the capsule receiving portion to the aerosolization chamber;

[0097] Wherein the retaining element extends through the inlet when the retaining element is in the first position.

[0098] Ex2. An inhaler according to Ex1, wherein the inhaler is a dry powder inhaler.

[0099] Ex3. An inhaler according to Ex1 or Ex2, wherein the retaining element is separated from the housing when the retaining element is in the second position.

[0100] Ex4. An inhaler according to any preceding example, comprising an actuation device configured to move the retaining element from the first position to the second position.

[0101] Ex5. An inhaler according to Ex4, wherein the actuating means comprises a mechanical actuating means.

[0102] Ex6. The inhaler according to any preceding example, wherein movement of the retaining element from the first position to the second position is configured to move the capsule from the capsule receptacle to the aerosolization chamber.

[0103] Ex7. An inhaler according to any preceding example, wherein the retaining element is configured to contact the capsule within the capsule receptacle when the retaining element is in the first position.

[0104] Ex8. The inhaler according to any preceding example, wherein the retaining element is configured to substantially prevent movement of the capsule relative to the capsule receptacle when the retaining element is in the first position.

[0105] Ex9. An inhaler according to any preceding example, wherein the retaining element is configured to substantially prevent movement of the capsule relative to the capsule receiving portion by urging the capsule against a wall of the capsule receiving portion when the retaining element is in the first position.

[0106] Ex10. An inhaler according to any preceding example, wherein the capsule housing comprises a capsule housing opening for allowing the capsule to move between the capsule housing and the aerosolization chamber.

[0107] Ex11. The inhaler according to Ex10, wherein the retaining element is configured to at least partially cover the capsule receiving portion opening when the retaining element is in the first position.

[0108] Ex12. An inhaler according to Ex10 or Ex11, wherein the retaining element is configured to substantially prevent airflow through the airflow path from entering the capsule receptacle when the retaining element is in the first position.

[0109] Ex13. An inhaler according to any of the preceding examples, wherein the retaining element comprises a first portion and a second portion, wherein the first portion is positioned inside the housing when the retaining element is in the first position, and the second portion is positioned outside the housing when the retaining element is in the first position.

[0110] Ex14. An inhaler according to Ex13, wherein the first portion is positioned within the aerosolization chamber when the retaining element is in the first position.

[0111] Ex15. An inhaler according to Ex14, wherein the first portion is configured to follow a winding path within the aerosolization chamber when the retaining element is in the first position.

[0112] Ex16. An inhaler according to Ex21, wherein the winding path has a sinusoidal shape or a spiral shape.

[0113] Ex17. An inhaler according to any one of Ex13 to Ex16, wherein the first portion is configured to be coiled or wrapped within the aerosolization chamber when the retaining element is in the first position.

[0114] Ex18. The inhaler according to any one of Ex13 to Ex17, wherein the first portion is configured to unfold or unwind when the retaining element moves from the first position to the second position.

[0115] Ex19. An inhaler according to any one of Ex13 to Ex18, wherein the second portion is angled relative to the first portion to prevent the second portion from being inserted into the housing when the retaining element is in the first position.

[0116] Ex20. The inhaler according to Ex19, wherein the angle between the first portion and the second portion is an acute angle.

[0117] Ex21. An inhaler according to Ex13 to Ex20, wherein the second portion comprises an aperture to assist a user in moving the retaining element from the first position to the second position.

[0118] Ex22. The inhaler according to any preceding example, wherein the retaining element is configured to substantially prevent airflow through the airflow path when the retaining element is in the first position.

[0119] Ex23. An inhaler according to any preceding example, wherein the retaining element is configured to substantially prevent airflow into the inlet.

[0120] Ex24. An inhaler according to any preceding example, wherein the retaining element extends through the inlet when the retaining element is in the first position.

[0121] Ex25. An inhaler according to any one of Ex1 to Ex24, wherein the retaining element is moved from the first position to the second position by at least partially withdrawing the retaining element from the housing through the inlet.

[0122] Ex26. An inhaler according to any preceding example, comprising a porous element positioned in the airflow path between the aerosolization chamber and the outlet.

[0123] Ex27. An inhaler according to Ex26, wherein the porous element is configured to prevent the capsule from leaving the housing via the outlet.

[0124] Ex28. An inhaler according to Ex27, wherein the porous element is a mesh.

[0125] Ex29. An inhaler according to any one of Ex26 to Ex28, wherein the retaining element abuts the porous element when the retaining element is in the first position.

[0126] Ex30. An inhaler according to any one of Ex26 to Ex29, wherein the retaining element substantially prevents airflow through the porous element when the retaining element is in the first position.

[0127] Ex31. An inhaler according to any preceding example, comprising a cover, wherein the cover is movable between a covering position in which the outlet is at least partially covered and an uncovered position in which the outlet is not covered.

[0128] Ex32. An inhaler according to any preceding example, wherein the housing comprises a first housing portion and a second housing portion, wherein the first housing portion comprises the outlet and the second housing portion comprises the inlet, the capsule receiving portion, the aerosolization chamber and the rupture element.

[0129] Ex33. An inhaler according to Ex32, wherein the first housing portion and the second housing portion are removably coupled.

[0130] Ex34. An inhaler according to any preceding example, comprising the capsule positioned within the capsule receiving portion, the capsule containing a composition.

[0131] Ex35. An inhaler according to Ex34, wherein the composition is in the form of a dry powder.

[0132] Ex36. An inhaler according to Ex34 or Ex35, wherein the composition comprises a pharmaceutically active ingredient.

[0133] Ex37. An inhaler according to Ex36, wherein the pharmaceutically active ingredient is capable of treating or preventing thromboembolic events, or is an antiplatelet drug.

[0134] Ex38. An inhaler according to Ex36 or Ex37, wherein the pharmaceutically active ingredient is a non-steroidal anti-inflammatory drug (NSAID).

[0135] Ex39. An inhaler according to any one of Ex36 to Ex38, wherein the pharmaceutically active ingredient is a salicylate (a salt or ester of salicylic acid), preferably acetylsalicylic acid or a pharmaceutically acceptable salt thereof.

[0136] Ex40. An inhaler according to Ex36 or Ex37, wherein the pharmaceutically active ingredient is a P2Y12 inhibitor.

[0137] Ex41. A method of administering a composition using an inhaler according to any one of Ex1 to Ex40, the inhaler having a capsule positioned within the capsule receiving portion and the capsule containing the composition, the method comprising:

[0138] rupturing the capsule with the rupturing element;

[0139] moving the retaining element from the first position to the second position; and

[0140] Suction is applied to the outlet to inhale the composition.

[0141] Ex42. A composition comprising an antiplatelet drug for use in a method for treating, preventing or ameliorating a thromboembolic event in a patient, wherein the composition is administered to the patient using the inhaler of any one of Ex1 to Ex40, the inhaler having the capsule positioned in the capsule receiving portion and the capsule containing the composition:

[0142] rupturing the capsule with the rupturing element;

[0143] moving the retaining element from the first position to the second position; and

[0144] Suction is applied to the outlet to inhale the composition.

[0145] Ex43. A composition for use according to Ex42, wherein the antiplatelet drug is an NSAID or a P2Y12 inhibitor.

[0146] Ex44. A composition for use according to Ex43, wherein the antiplatelet drug is acetylsalicylic acid or a pharmaceutically acceptable salt thereof.

[0147] Ex45. The inhaler of any one of Ex1 to Ex40, which is hermetically sealed in a container, comprising:

[0148] a housing comprising an inlet, an outlet, and an airflow path extending from the inlet to the outlet; and

[0149] a capsule within the housing,

[0150] wherein the inhaler is configured to rupture the capsule to allow the composition to be inhaled by a user drawing on the outlet.

[0151] Ex46. A method of administering a composition using an inhaler of Ex45, the method comprising:

[0152] removing the inhaler from the container;

[0153] rupturing the capsule; and

[0154] Suction is applied to the outlet to inhale the composition.

[0155] Ex47. A composition comprising acetylsalicylic acid or a pharmaceutically acceptable salt thereof for use in a method for treating, preventing or ameliorating a thromboembolic event in a patient, wherein the composition is administered to the patient using the inhaler of Ex45 by the following operation:

[0156] removing the inhaler from the container;

[0157] rupturing the capsule; and

[0158] Suction is applied to the outlet to inhale the composition.

[0159] Examples will now be further described with reference to the accompanying drawings, in which:

[0160] Figure 1A shows a cross-sectional view of an inhaler with a retaining element, illustrating the general principles of the present disclosure;

[0161] Figure 1B Shows Figure 1A A perspective cross-sectional view of an inhaler in use;

[0162] Figure 2A shows a perspective view of a first housing portion of an inhaler having a retaining element according to a first example of the present disclosure;

[0163] Figure 2B Shows Figure 2A a top view of a first housing portion;

[0164] Figure 2C Shown is a cut along line AA Figure 2A and 2B a cross-sectional side view of a first housing portion;

[0165] Figure 3A shows a perspective view of a first housing portion of an inhaler having a retaining element according to a second example of the present disclosure;

[0166] Figure 3B Shows Figure 3A a top view of a first housing portion; and

[0167] Figure 3C Shown is a cut along line BB Figure 3A and 3B sectional side view of the first housing portion.

[0168] Figure 1A and 1B Shown is an inhaler 100 with a retaining element 150 according to a first example of the present disclosure. Inhaler 100 comprises a housing, which defines a first inlet 111, a second inlet 112, an outlet 113 and an air flow path extending from the first inlet 111 and the second inlet 112 to the outlet 113. The housing is formed by a first housing portion 101 and a second housing portion 102. Other aspects of the first housing portion 101 and the second housing portion 102 will be shown in other figures.

[0169] The first housing portion 101 includes a capsule receiving portion 121 for receiving a capsule 130. The capsule 130 contains a composition for inhalation. The first housing portion 101 also includes a first rupture element and a second rupture element 140 for rupturing the capsule 130 received in the capsule receiving portion 121. The rupture element 140 is a needle that creates a hole in each end of the capsule when actuated. The rupture element 140 is biased to a relaxed position by a spring 142. The rupture element 140 is Figure 1A and 1B 140 is shown in a relaxed position. The rupture element 140 and the spring 142 are operably connected to the rupture element button 141 to facilitate actuation of the rupture element 140. To actuate the rupture element 140, the user presses the rupture element button 141 in a direction toward the capsule receptacle 121. This causes the rupture element 140 to extend into the capsule receptacle 121 and rupture the capsule 130. The rupture element 140 can be actuated individually. The first housing portion 101 also includes an aerosolization chamber 122, which is used to allow the composition in the punctured capsule to be entrained in the airflow within the airflow path.

[0170] The inhaler 100 further includes a retaining element 150 that is movable between a first position that prevents the capsule 130 from moving from the capsule receiving portion 121 to the aerosolization chamber 122 and a second position in which the capsule 130 can move from the capsule receiving portion 121 to the aerosolization chamber 122. Figure 1A In the first position, the retaining element 150 is in a first position, in which the retaining element 150 acts as a physical barrier to prevent the capsule 130 from moving from the capsule receiving portion 121 to the aerosolizing chamber 122 by covering the opening 123 between the capsule receiving portion 121 and the aerosolizing chamber 122. In the second position, the retaining element 150 is retracted and does not cover the opening between the capsule receiving portion 121 and the aerosolizing chamber 122. Figure 1A and 1B In the embodiment of the present invention, the retaining element is moved from a first position to a second position by a user-operated mechanism (not shown).

[0171] The second housing portion 102 includes an outlet 113. A user can draw on the outlet 113 to inhale the composition within the capsule 130. The first housing portion 101 and the second housing portion 102 are removably coupled. This provides access to the capsule receptacle 121 and the aerosolization chamber 122.

[0172] Figure 1B Shown during use Figure 1A Inhaler 100. Figure 1B , the capsule 130 has been ruptured by the rupture element 140. In addition, the retaining element 150 has been moved from the first position to the second position so that the opening 123 between the capsule receiving portion 121 and the aerosolization chamber 122 is not covered. This allows the capsule 130 to move from the capsule receiving portion 121 to the aerosolization chamber 122.

[0173] Airflow path extends through aerosolization chamber 122 between inlet 111,112 and outlet 113.Aerosolization chamber 122 has a substantially annular wall. The inlet passage between the first inlet 111 and aerosolization chamber 122 and the inlet passage between the second inlet 112 and aerosolization chamber 122 are arranged to make airflow enter aerosolization chamber 122 in a direction tangent to the annular wall of aerosolization chamber 122. Therefore, when the user draws suction on the outlet 113 of the inhaler, air is drawn through the first inlet 111 and the second inlet 112 and forms a cyclone in aerosolization chamber 122. Cyclone airflow moves capsule 130 from capsule accommodation portion 121 to aerosolization chamber 122. Once capsule 130 is in aerosolization chamber 122, cyclone airflow just rotates capsule 130 and releases composition into the airflow so that composition is entrained in the airflow and is delivered to the user via outlet 113. The second housing portion 102 includes a mesh 124 that allows the composition to pass therethrough but does not allow the bladder 130 to pass therethrough.

[0174] Figure 2A , 2B 2C show three different views of the retaining element 350 in the first position according to the first example of the present disclosure. For simplicity, only the first housing portion 301 is shown, however, the first housing portion 301 and Figure 1A and 1B The first housing portion 101 shown in FIG. 1 is identical to the first housing portion 101 shown in FIG. Figure 2A , 2B and the first housing portion 301 in 2C can be connected with Figure 1A and 1B 1 and 2. The second housing portion 102 shown in FIG.

[0175] The retaining element 350 is in the form of a strip having a generally rectangular cross-section and is made of a flexible material that allows the retaining element 350 to flex as it moves from the first position to the second position.

[0176] The first housing portion 301 includes a first inlet passage 313 extending between a first inlet 311 and an aerosolization chamber 322. The first inlet passage 313 includes a first wall 315 disposed opposite to a second wall 316. The first housing portion 301 includes a second inlet passage 314 extending between a second inlet 312 and an aerosolization chamber 322. The second inlet passage 314 includes a first wall 317 disposed opposite to a second wall 318.

[0177] In the first position, the retaining element 350 has a first portion 351 positioned within the first housing portion 301. The retaining element 350 extends through both the first inlet channel 313 and the second inlet channel 314. The first portion 351 of the retaining element 350 extends along a sinusoidal path through the first inlet 311 and the second inlet 312. Therefore, the section of the retaining element 350 positioned within the first inlet channel 313 and the section of the retaining element 350 positioned within the second inlet channel 314 are curved. Therefore, the section of the retaining element 350 positioned within the first inlet channel 313 contacts both the first wall 315 and the second wall 316 of the first inlet channel 313. This prevents airflow through the first inlet 311. Similarly, the section of the retaining element 350 positioned within the second inlet channel 314 contacts both the first wall 317 and the second wall 318 of the second inlet channel 314. This prevents airflow through the second inlet 312. The first portion 351 of the retaining element 350 extends across the aerosolization chamber 322 and partially covers the opening 323 between the capsule receiving portion 321 and the aerosolization chamber 322. This prevents the capsule 330 from moving from the capsule receiving portion 321 to the aerosolization chamber 322.

[0178] In the first position, the retaining element 350 has a second portion 352 positioned outside the first housing portion 301. In order to move the retaining element 350 from the first position to the second position, the user pulls the second portion 352 of the retaining element 350 so as to extract the retaining element 350 from the first housing portion 301 through the first inlet 311. The retaining element 350 can bend when it is extracted from the first housing portion 301 because it is made of a flexible material. In the second position, the retaining element 350 is separated from the first housing portion 301. The second portion 352 includes an orifice 353 to help the user move the retaining element 350 from the first position to the second position. The second portion 352 of the retaining element 350 is angled relative to the first portion 351 of the retaining element to prevent it from being accidentally inserted or retracted into the first housing portion 301.

[0179] Figure 3A , 3B 3C and 3C show three different views of the retaining element 450 in the first position according to the second example of the present disclosure. For simplicity, only the first housing portion 401 is shown, however, the first housing portion 401 and Figure 1A and 1B The first housing portion 101 shown in FIG. 1 is identical to the first housing portion 101 shown in FIG. Figure 3A , 3B and the first housing portion 401 in 3C can be connected with Figure 1A and 1B 1 and 2. The second housing portion 102 shown in FIG.

[0180] The retaining element 450 is in the form of a strip having a generally rectangular cross-section and is made of a flexible material that allows the retaining element 450 to flex as it moves from the first position to the second position.

[0181] In the first position, the retaining element 450 has a first portion 451 positioned within the first housing portion 401. The first portion 451 of the retaining element 450 is coiled within the aerosolization chamber 422. The first portion 451 of the retaining element 450 partially covers the opening 423 between the capsule receiving portion 421 and the aerosolization chamber 422. This prevents the capsule 430 from moving from the capsule receiving portion 421 to the aerosolization chamber 422. The retaining element 450 extends through the first inlet channel 413 but does not extend through the second inlet channel 414. However, it can be seen that the first portion 451 of the retaining element 450 is coiled so that it prevents the airflow within the second inlet channel 414 from entering the aerosolization chamber 422. It can be seen that the second portion 452 of the retaining element 450 prevents air from flowing into the first inlet 411.

[0182] In order to move the retaining element 450 from the first position to the second position, the user pulls the second portion 452 of the retaining element 450 so as to extract the retaining element 450 from the first housing portion 401 through the first inlet 411. When the retaining element 450 is extracted from the first housing portion 401, the first portion 451 of the retaining element 450 is unfolded. In the second position, the retaining element 450 is separated from the first housing portion 401. The second portion 452 includes an aperture to help the user move the retaining element 450 from the first position to the second position. The second portion 452 of the retaining element 450 is angled relative to the first portion 451 of the retaining element 450 to prevent it from being accidentally inserted or retracted into the first housing portion 401.

[0183] For the purpose of this specification and the appended claims, unless otherwise indicated, all numbers representing amounts, quantities, percentages, etc. should be understood to be modified by the term "about" in all cases. Moreover, all ranges include the disclosed maximum and minimum points, and include any intermediate ranges therein that may or may not be specifically listed in this article. Therefore, in this context, the number A is understood to be A±5%A. In this context, the number A can be regarded as including the numerical value within the general standard error for the measurement of the attribute modified by the number A. In certain cases used in the appended claims, the number A may deviate from the percentages listed above, provided that the amount of A deviation does not substantially affect the basic features and novel features of the invention claimed for protection. Moreover, all ranges include the disclosed maximum and minimum points, and include any intermediate ranges therein that may or may not be specifically listed in this article.

Claims

1. An inhaler comprising: a housing defining an inlet, an outlet, and an airflow path extending from the inlet to the outlet; a capsule receiving portion for receiving a capsule containing a composition for inhalation; a rupture element for rupturing the capsule received in the capsule receiving portion; an aerosolization chamber for allowing the composition to be entrained in the airflow within the airflow path; as well as a retaining element movable between a first position preventing the capsule from moving from the capsule receiving portion to the aerosolization chamber and a second position enabling the capsule to move from the capsule receiving portion to the aerosolization chamber, Wherein the retaining element extends through the inlet when the retaining element is in the first position.

2. The inhaler of claim 1, wherein the retaining element is separated from the housing when the retaining element is in the second position.

3. An inhaler according to claim 1 or 2, wherein the retaining element is moved from the first position to the second position by at least partially withdrawing the retaining element from the housing through the inlet.

4. An inhaler according to any preceding claim, wherein the retaining element is configured to substantially prevent movement of the capsule relative to the capsule receptacle when the retaining element is in the first position.

5. An inhaler according to any preceding claim, wherein the capsule receptacle comprises a capsule receptacle opening for allowing the capsule to move between the capsule receptacle and the aerosolisation chamber, wherein the retaining element is configured to at least partially cover the capsule receptacle opening when the retaining element is in the first position.

6. An inhaler according to any preceding claim, wherein the retaining element is configured to substantially prevent airflow through the airflow path when the retaining element is in the first position.

7. An inhaler according to any preceding claim, wherein the retaining element comprises a first part and a second part, wherein the first part is positioned inside the housing when the retaining element is in the first position, and the second part is positioned outside the housing when the retaining element is in the first position.

8. An inhaler according to claim 7, wherein the second portion is angled relative to the first portion to prevent the second portion from being inserted into the housing when the retaining element is in the first position.

9. An inhaler according to claim 7 or claim 8, wherein the first portion is configured to follow a winding path within the aerosolisation chamber when the retaining element is in the first position.

10. An inhaler according to claim 9, wherein the first portion is configured to follow a winding path from the first inlet passage to the second inlet passage.

11. An inhaler according to claim 9 or claim 10, wherein the winding path has a sinusoidal or near-sinusoidal shape.

12. The inhaler of claim 9, wherein the winding path has a spiral shape or a near-spiral shape.

13. An inhaler according to any preceding claim, comprising a cover, wherein the cover is movable between a covering position in which the outlet is at least partially covered and an uncovered position in which the outlet is not covered.

14. An inhaler according to any preceding claim, comprising a capsule positioned within the capsule receptacle, the capsule comprising a composition, wherein the composition comprises a pharmaceutically active ingredient and wherein the pharmaceutically active ingredient is a salicylate (a salt or ester of salicylic acid), preferably acetylsalicylic acid or a pharmaceutically acceptable salt thereof.

15. A composition comprising acetylsalicylic acid or a pharmaceutically acceptable salt thereof for use in a method for treating, preventing or ameliorating a thromboembolic event in a patient, wherein the composition is administered to the patient using an inhaler according to any one of claims 1 to 14, the inhaler having a capsule positioned in the capsule receiving portion and the capsule containing the composition by: rupturing the capsule with the rupturing element; moving the retaining element from the first position to the second position; and Suction is applied to the outlet to inhale the composition.

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