Inhaler with retention 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) includes a capsule container (221) for receiving a capsule (230) containing a composition for inhalation. The inhaler (200) includes a rupture element (140) for rupturing the capsule (230) received in the capsule container (221). The inhaler (200) includes an aerosolization chamber (222) for allowing the composition to be entrained in the airflow path. The inhaler (200) includes a retaining element (250) that is movable between a first position that prevents the capsule (230) from moving from the capsule container (221) to the aerosolization chamber (222) and a second position that allows the capsule (230) to move from the capsule container (221) to the aerosolization chamber (222). Also provided is a composition that is administered to a patient using an inhaler (200).

Description

[Technical Field]

[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 the composition using an inhaler. The present disclosure further relates to a composition administered to a patient using an inhaler. [Background technology]

[0002] Inhalers are commonly used to deliver pharmaceutically active ingredients to patients' lungs to treat various medical conditions, including respiratory diseases such as asthma. Some medical conditions that can be treated by administering pharmaceutically active ingredients through an inhaler may have an acute onset. These medical conditions may include myocardial infarction, cerebrovascular accident, and asthma exacerbation. Therefore, it is important that inhalers are easy to use and can deliver pharmaceutically active ingredients to patients quickly and effectively. This can provide the best possible outcomes for patients experiencing acute onset of a medical condition. However, even if a medical condition does not have an acute onset, it is important that inhalers are easy to use and can deliver pharmaceutically active ingredients to patients quickly and effectively. For example, this can increase the likelihood that patients will continue treatment.

[0003] In some known inhalers, such as the RS01 inhaler developed by Plastiape S.p A. and described in EP1270034, the pharmaceutically active ingredient is administered in the form of a dry powder contained within a capsule. Typically, the capsules are stored separately from the inhaler in a blister package. As a result, the patient has to find the capsule, remove it from its package, open the inhaler and insert the capsule, and then close the inhaler with the capsule in place. The patient may then activate a piercing element to pierce through the capsule. Typically, the patient has to ensure that the inhaler is held upright after inserting the capsule. Otherwise, the capsule may move out of the range of the piercing element before it can be pierced. Finally, when the patient inhales on the inhaler, the capsule moves into the aerosolization chamber, rotates within the inhaler, releases the dry powder to form an aerosol, which can be inhaled and delivered to the patient's lungs. In particular, in cases where the medical condition is debilitated and / or acute onset, the patient may have difficulty performing both inserting the capsule and holding the inhaler upright or stable while experiencing the medical condition. Also, because the capsule has to be inserted and the inhaler has to be held upright or stable, the overall time taken to deliver the pharmaceutically active ingredient to the patient may be increased.

[0004] Compared with some other prior art inhalers, it is desirable to provide an inhaler for use with a capsule that can be used more easily and quickly by a patient. It is also desirable to provide an inhaler for use with a capsule that can shorten the overall time for delivering a pharmaceutically active ingredient to a patient. Accordingly, the inhaler is designed to require fewer user steps prior to inhalation. For example, WO2020 / 257845 discloses a dry powder inhaler similar to the RS01 inhaler, but the capsule can be pre-loaded. The capsule is held in place to be penetrated by an elongated prong extending from the inside of the mouthpiece cover. However, this requires the formation of an elongated feature that can be difficult to mold. Accordingly, it is desirable to provide an inhaler that can pre-load the capsule without complex components for manufacturing. SUMMARY OF THE INVENTION

[0005] According to the present disclosure, an inhaler is provided. The inhaler includes a housing defining an inlet, an outlet, and an airflow path extending from the inlet to the outlet. The inhaler includes a capsule container for receiving a capsule containing a composition for inhalation. The inhaler includes a breaking element for breaking the capsule received within the capsule container. The inhaler includes an aerosolization chamber for enabling the composition to be entrained in the airflow within the airflow path. The inhaler includes a holding element movable between a first position that prevents the capsule from moving from the capsule container to the aerosolization chamber and a second position that enables the capsule to move from the capsule container to the aerosolization chamber. The holding element extends through the inlet when the holding element is in the first position.

[0006] The retaining element prevents the capsule from moving from the capsule container to the atomization chamber when the retaining element is in the first position. This allows the capsule to be held in the vicinity of the destruction element until the user desires to use the inhaler. This means that the user may insert the capsule into the inhaler before desiring to use the inhaler. The inhaler can then be carried around, for example, in a pocket, without fear that the capsule will move out of the vicinity of the destruction element and become inaccessible for destruction. Advantageously, this may enable the user to rapidly treat their medical condition since the capsule is pre-loaded at the factory during the manufacturing and assembly process.

[0007] Since the retaining element extends through the inlet, existing features of the inhaler are used and, advantageously, no modifications to the housing or mouthpiece cover are required. Therefore, only a single additional component, which is manufactured separately from the inhaler and can then be inserted, is needed.

[0008] To use the inhaler, the retaining element can be moved to a position where the capsule is movable from the capsule container to the atomization chamber. Advantageously, this enables the patient to rapidly activate and use the inhaler. Typically, the time and effort required to move the retaining element from the first position to the second position is less than the time and effort required to locate and insert the capsule into the inhaler. This is particularly beneficial during periods when the patient may be debilitated by their medical condition.

[0009] The inhaler comprises a capsule container. Advantageously, this may ensure that the capsule is properly positioned relative to the destruction element. For example, the capsule container may position the capsule in an orientation that is optimal for rupturing the capsule. This optimal orientation may limit the force that the user needs to apply to the destruction element to break the capsule. Alternatively or additionally, the optimal orientation may result in optimal destruction of the capsule for releasing the composition.

[0010] Advantageously, the number of steps that a user has to take to inhale the composition using the inhaler is also reduced because the capsules are pre-loaded into the inhaler. The user only has to move the holding element and rupture the capsule to prepare for use of the inhaler.

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

[0012] As used herein, the term "rupture" refers to providing at least one opening in the capsule to enable the composition within the capsule to exit the capsule. Rupture can include, but is not limited to, piercing, perforating, unscrewing, tearing, and separating the capsule.

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

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

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

[0016] As used herein, the term "pharmaceutically active ingredient" refers to an ingredient that alters one or more chemical or physiological functions of a cell, tissue, organ, or organism. Pharmaceutically active ingredients can be, for example, systemic or topical agents, peptide or DNA-based agents, anti-inflammatory agents, bronchodilators, antiviral agents, antibiotic formulations, immunostimulants, immunosuppressants, anesthetics, anti-cancer agents, vitamins, hormones, anti-epileptic drugs, anti-fungal agents, antioxidants, anti-diabetic drugs, muscle relaxants, anti-HIV drugs, stimulants, cough suppressants, pain management drugs, smoking cessation aids, or alcohol abuse treatment drugs.

[0017] As used herein, references to "user" can also refer to "patient".

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

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

[0020] The airflow path may include an inlet channel that extends from an inlet to the aerosolization chamber. The inlet channel may extend in a direction transverse to the longitudinal axis of the inhaler. The inlet channel may be configured to form a cyclone within the aerosolization chamber in the airflow. The inlet channel may be configured to direct the airflow within the airflow channel towards the wall of the aerosolization chamber. The inlet channel may be configured to cause the airflow within the airflow channel to enter the aerosolization chamber in a substantially tangential direction with respect to the wall of the aerosolization chamber.

[0021] The airflow path may comprise an outlet channel extending between the atomization chamber and the outlet.

[0022] The inlet may comprise a first inlet and a second inlet. The inlet channel may be a first inlet channel extending from the first inlet to the atomization chamber. The airflow path may comprise a second inlet channel extending from the second inlet to the atomization chamber. The second inlet channel may extend in a transverse direction with respect to the atomization chamber. The second inlet channel may be configured to form a cyclone within the atomization chamber in the airflow within the atomization chamber. The second inlet channel may be configured to direct the airflow within the airflow channel towards the wall of the atomization chamber. The second inlet channel may be configured to cause the airflow to enter the atomization chamber in a substantially tangential direction with respect to the wall of the atomization chamber. The first inlet channel and the second inlet channel may cooperate to form a cyclone within the atomization chamber in the airflow within the atomization chamber.

[0023] The holding element may be separated from the housing when the holding element is in the second position. That is, the housing and the holding element do not contact each other when the holding element is in the second position. The holding element may be configured to separate from the housing when the holding element moves from the first position to the second position. Advantageously, this may prevent the holding element from interrupting the airflow within the airflow path and thus limit the amount of the composition delivered to the user.

[0024] The inhaler may comprise actuating means configured to move the holding element from the first position to the second position. Advantageously, the provision of the actuating means may enable the holding element to move rapidly from the first position to the second position. The actuating means may be mechanical actuating means.

[0025] The movement of the holding element from the first position to the second position may be configured to move the capsule from the capsule container to the aerosolization chamber. Advantageously, this may enable the composition to be delivered to the user more rapidly.

[0026] The holding element may be configured to contact the capsule within the capsule container when the holding element is in the first position. The holding element may be configured to substantially prevent movement of the capsule relative to the capsule container when the holding element is in the first position. The holding element may be configured to substantially prevent movement of the capsule relative to the capsule container by biasing the capsule against the wall of the capsule container when the holding element is in the first position. Advantageously, preventing movement of the capsule within the capsule container may prevent the capsule from being damaged or rupturing prematurely. Further, it may help to keep the capsule properly oriented relative to the destruction element.

[0027] The capsule container may comprise a capsule container opening to enable the capsule to move between the capsule container and the aerosolization chamber. The capsule container opening may be disposed at the interface between the capsule container and the aerosolization chamber. The holding element may be configured to at least partially cover the capsule container opening when the holding element is in the first position. The holding element may be configured to completely cover the capsule container opening when the holding element is in the first position. The holding element may be configured to substantially prevent airflow through the airflow path from entering the capsule container when the holding element is in the first position. Advantageously, this may prevent premature release of the composition within the ruptured capsule before the holding element moves to the second position.

[0028] The retaining element may comprise a first part and a second part. The first part may be positioned within the housing when the retaining element is in a first position. The first part may be configured to prevent the capsule from moving between the capsule container and the atomization chamber. The second part may be positioned outside the housing when the retaining element is in the first position. Advantageously, this may enable a user to pull on the second part to move the retaining element from the first position to a second position.

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

[0030] The first part may be configured to follow a swirling path within the atomization chamber when the retaining element is in the first position. For example, the swirling path may have a sinusoidal or substantially sinusoidal shape. As another example, the swirling path may have a helical or substantially helical shape. The first part may be configured to follow a swirling path from a first inlet channel to a second inlet channel. Advantageously, the swirling path may increase the resistance when moving the retaining element from the first position to the second position by introducing a non-linear portion into the retaining element. This may prevent the retaining element from accidentally moving from the first position to the second position. The swirling path of the retaining element may potentially impede the airflow into the atomization chamber. The first part may be configured to be coiled or wound within the atomization chamber when the retaining element is in the first position. The first part may be configured to unwind or uncoil the coil when the retaining element moves from the first position to the second position.

[0031] The second part may be positioned outside the inlet when the retaining element is in the first position. Accordingly, the retaining element may extend through the inlet channel when the retaining element is in the first position.

[0032] The second part may be angled with respect to the first part to prevent the second part from being inserted into the housing when the retaining element is in the first position. For example, the angle between the first part and the second part may be acute. The second part may be dimensioned to prevent the second part from being inserted into the housing when the retaining element is in the first position. Advantageously, this may prevent the second part from accidentally entering the housing and may mean that the user cannot move the retaining element from the first position to the second position.

[0033] The second part may include an opening to assist the user in moving the retaining element from the first position to the second position. The opening may be dimensioned to receive a finger of the user. Advantageously, providing the opening may facilitate the user in moving the retaining element from the first position to the second position. The opening may be particularly useful when the user does not have the strength to grip the second part 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 into the atomization chamber when the retaining element is in the first position. The retaining element may be configured to substantially prevent airflow into the inlet when the retaining element is in the first position. The retaining element may be configured to substantially prevent airflow from exiting the outlet when the retaining element is in the first position. The retaining element may be configured to substantially prevent airflow through the inlet channel when the retaining element is in the first position. The retaining element may be configured to substantially prevent airflow through the first inlet channel when the retaining element is in the first position. The retaining element may be configured to substantially prevent airflow through the second inlet channel when the retaining element is in the first position. The retaining element may be configured to substantially prevent airflow 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 block the flow through the inlet and prevent the airflow in the atomization chamber from forming a vortex. The retaining element can be moved from the first position to the second position by at least partially pulling the retaining element out of the housing through the inlet. 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 within the inlet channel when the retaining element is in the first position. The retaining element may be positioned within the second inlet channel when the retaining element is in the first position.

[0037] The inhaler may comprise a porous element. The porous element may be positioned within the airflow path between the aerosolization chamber and the outlet. That is, the porous element may be positioned within the outlet channel. The porous element may be configured to prevent the capsule from exiting the housing through the outlet. The composition and the airflow can pass through the porous element. The porous element may span an airflow path that is substantially perpendicular to the direction of the airflow. The porous element may be a perforated plate or grid. The porous element may be a mesh. Advantageously, the porous element can prevent the capsule from being inhaled by the user.

[0038] The retaining element may be adjacent to the porous element when the retaining element is in the first position. The retaining element may be able to substantially prevent airflow through the porous element when the retaining element is in the first position.

[0039] The inhaler may comprise a cover. The cover may be movable between a cover position in which the outlet is at least partially covered and an exposed position in which the outlet is not covered. The cover may at least partially cover the inlet when in the cover position.

[0040] The retaining element may be made of any suitable material. Examples of suitable materials include thermoplastic resins suitable for food or pharmaceutical applications such as, for example, 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 comprise a first housing portion and a second housing portion.

[0042] The first housing part may comprise an outlet. The first housing part may be a mouthpiece. The mouthpiece may be configured to be inserted into the user's mouth. The first housing part may be a nose piece. The nose piece may be configured to be inserted into the user's nose.

[0043] The second housing part may comprise an inlet. The second housing part may comprise a capsule container. The second housing part may comprise an aerosolization chamber. The second housing part may comprise a destruction 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 facilitates access to the aerosolization chamber and the capsule container, so that during manufacture, the capsule can be inserted into the inhaler.

[0045] The first housing part and the second housing part may be connectable by mechanical keying. The first housing part and the second housing part may be connectable by snap fitting. The first housing part and the second housing part may be connectable by screws. The first housing part and the second housing part may be connectable by screw engagement. For example, the first housing part may comprise a female screw and the second housing part may comprise a male screw. The male screw may be screwed into the female screw. The first housing part and the second housing part may be magnetically connectable.

[0046] The first housing part and the second housing part can be configured to rotate relative to each other to enable connection and separation. The first housing part may be provided with a protrusion configured to cooperate with a hole in the second housing part such that the first housing part and the second housing part must rotate relative to each other to enable connection and separation. Alternatively, the second housing part may be provided with a protrusion configured to cooperate with a hole in the first housing part such that the first housing part and the second housing part must rotate relative to each other to enable connection and separation.

[0047] The first housing part and the second housing part may be configured to move linearly relative to each other to enable connection. The first housing part may be provided with a peg configured to cooperate with a hole in the second housing part such that the first housing part and the second housing part are connected by moving the peg axially into the hole. Alternatively, the second housing part may be provided with a peg configured to cooperate with a hole in the first housing part.

[0048] Since the inhaler is pre-loaded and intended for single use, there is no need for the user to insert a capsule, and thus there is no need for a mechanism to removably couple the first and second housing parts. Therefore, the first housing part and the second housing part may be permanently connected together after the capsule is inserted. Advantageously, this prevents the user from opening the housing and thus avoids the possibility of the user accidentally removing the pre-loaded capsule before attempting to inhale and / or insert a new capsule. For example, the first housing part and the second housing part may be sealed or welded together by ultrasonic welding, laser welding, or heat staking, or the first and second housing parts may be held or sealed together by a sticker or tape.

[0049] The housing and the cover may be formed from 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 resins suitable for food or pharmaceutical applications, such as polypropylene, polyetheretherketone (PEEK), and polyethylene. The material is preferably light and not brittle. The housing may be made of acrylonitrile butadiene styrene (ABS).

[0050] The breaking element may be a rigid element having the ability to penetrate the capsule. The breaking element may be a metal element. The breaking element may be a solid pin or a hollow needle. The breaking element may be configured to move between a breaking position and a relaxed position. In the penetrating position, the breaking element may be configured to extend into the capsule container. The breaking element may be biased to the relaxed position by a biasing element. The biasing element may be a spring. The user may push the breaking element to move the breaking element from the relaxed position to the breaking position.

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

[0052] The inhaler may comprise means for preventing the breaking element from moving from the relaxed position to the breaking position when engaged. The means may be disengaged so that the breaking element can move from the relaxed position to the breaking position. The means may be a cover. The cover may be configured to at least partially cover the breaking element button so as to prevent premature breaking of the capsule, thereby preventing the breaking element from moving from the relaxed position to the breaking position.

[0053] The breaking element may be a first breaking element. The inhaler may comprise a second breaking element. The second breaking element may have any of the features described in relation to the first breaking element.

[0054] The outlet may be positioned at the proximal end of the inhaler (i.e., the upper end in the normal orientation of the inhaler). The aerosolization chamber may be positioned in the longitudinal direction between the outlet and the capsule container.

[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 of 5 millimeters to 15 millimeters, 6 millimeters to 12 millimeters, or 7 millimeters to 10 millimeters. The aerosolization chamber may have a height of 8 millimeters.

[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) of 10 millimeters to 30 millimeters, 12 millimeters to 25 millimeters, or 15 millimeters to 20 millimeters. The aerosolization chamber may have a diameter (or width) of 18 millimeters.

[0058] The capsule container may have a height dimension in the longitudinal direction. The capsule container may have a height of 5 millimeters to 15 millimeters. The capsule container may have a height of about 6 millimeters, 7 millimeters, 8 millimeters, 9 millimeters, 10 millimeters, 11 millimeters, 12 millimeters, 13 millimeters, or 14 millimeters.

[0059] The capsule container may have a width dimension in a direction transverse to the longitudinal direction. The capsule container may have a width of 5 millimeters to 10 millimeters. The capsule container may have a width of about 6 millimeters, 7 millimeters, 8 millimeters, or 9 millimeters.

[0060] The capsule container may have a length dimension and a width dimension in a direction transverse to the long axis direction. The capsule container may have a length of 10 millimeters to 30 millimeters, 12 millimeters to 20 millimeters, or 15 millimeters to 18 millimeters. The capsule container may have a length of 16 millimeters.

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

[0062] The capsule container may be elongated. Thus, the length of the capsule container may be greater than the width of the capsule container. The capsule container may be sized to receive capsules of size 0 to size 4. For example, it may be 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 manufactured from a gelling agent such as gelatin and / or polysaccharides. The capsule shell may be formed from hydroxypropyl methylcellulose (HPMC). The capsule shell may contain a plasticizer such as glycerin or sorbitol.

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

[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 have the ability to treat or prevent thromboembolic events. The pharmaceutically active ingredient may be an antiplatelet agent. For example, the pharmaceutically active ingredient may be a non-steroidal anti-inflammatory drug (NSAID). The pharmaceutically active ingredient is preferably a salicylate (salt or ester of salicylic acid), and most preferably acetylsalicylic acid or a pharmaceutically acceptable salt thereof.

[0067] The pharmaceutically active ingredient may be another type of NSAID. For example, the pharmaceutically active ingredient may be celecoxib (Celebrex), dexdetoprofen (Keral), diclofenac (Voltaren, Catapram, Voltaren-XR), diflunisal (Dolobid), etodolac (Lodine, Lodine XL), etoricoxib (Arcoxia), fenoprofen (Fenopron, Nalfon), firocoxib (Equioxx, Previcox), flurbiprofen (Ulubufen, Ansaid, Flurwood, Proben), ibuprofen (Advil, Brufen, Motrin, Nurofen, Medipren, Nuprin), indomethacin (Indocin, Indocin SR, Indocin IV), ketoprofen (Actron, Orudis, Orval, Ketoflam), ketorolac (Toradol, Sprix, Toradol IV / 1Μ, Toradol IM), licofelone (under development), lornoxicam (Xefo), loxoprofen (Loxonin, Loxamac, Οχeηο), lumiracoxib (Prexige), meclofenamic acid (Meclomen), mefenamic acid (Ponstel), meloxicam (Mobic, Meloxic, Recoxa, Mobiflex), nabumetone (Relafen), naproxen (Alleve, Anaprox, Midol Extended Relief, Naprosyn, Naprelan), nimesulide (Suride, Nimorox, Mesulid), oxaprozin (Daypro, Delan, Dulprix), parecoxib (Dynastat), piroxicam (Feldene), rofecoxib (Vioxx, Thecox, Ceeox), salsalate (Mono-Jesic, Sulfrex, Disalcid, Salsitab), sulindac (Clinoril), tenoxicam (Mobiflex), tolfenamic acid (Clotamrapid, 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 include COX-2 inhibitors, and nattokinase (enzyme (EC 3.4.21.62, extracted and purified from Japanese cuisine called natto)).

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

[0070] The pharmaceutically active ingredient is preferably 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 contains a pharmaceutically acceptable excipient. For example, the excipient may be an anticoagulant excipient, an anti-adhesive, or a lubricant. The pharmaceutically acceptable excipient may be magnesium stearate. Magnesium stearate may be present in an amount of 1% by weight or less of the composition, for example, in an amount of 0.05 - 1% by weight of the composition. For example, magnesium stearate may be present in an amount of about 0.5% by weight.

[0072] The amount or dosage 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 dosage 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 a salt thereof) in the capsule may be 5 to 300 mg, preferably 20 to 100 mg, more preferably 30 to 75 mg, and even more preferably 40 to 60 mg. For example, there may be about 50 mg of acetylsalicylic acid or a salt thereof in the capsule.

[0075] The user may require multiple dosages of the pharmaceutically active ingredient (preferably acetylsalicylic acid or a salt thereof) when treating conditions such as treating or preventing thromboembolic events. The inhaler may contain a single capsule having a predetermined dosage of the active ingredient. To administer multiple dosages, the user may require multiple inhalers, with each inhaler providing a single dosage. Each dosage may be delivered from the inhaler in a single inhalation or in more than one inhalation.

[0076] For example, the inhaler may contain 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. When treating or preventing thromboembolic events, the user may use two inhalers, with each inhaler providing a single dosage and providing a total of two dosages.

[0077] The composition is preferably a respirable dry powder consisting of respirable dry particles suitable for delivery to the user's respiratory tract (e.g., 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 to 5 μm).

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

[0080] The particles may have a geometric particle size distribution or an aerodynamic particle size distribution, and 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 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 respirable dry particles, e.g., their VMGD, can be measured using an electrical zone sensing device such as a Multisizer lie (Coulter Electronic, Luton, Beds, UK), or a laser diffraction device such as a HELOS system (Sympatec, Princeton, WO 2016 / 019253).

[0082] Experimentally, the aerodynamic particle size can be determined using time-of-flight (TOF) measurements. For example, an instrument such as a Model 3225 Aerodynamic Particle Sizer DSP Particle Size Analyzer (Amherst Process Instrument, Inc., Amherst, MA) can be used to measure the aerodynamic particle size. The aerodynamic particle sizer measures the time it takes for individual respirable dry particles to pass between two fixed laser beams. The aerodynamic particle size can also be determined directly experimentally using a conventional gravity sedimentation method where the time required for a sample of respirable dry particles to sediment a certain distance is measured. Indirect methods for measuring the mass median aerodynamic particle size include the Andersen Cascade Impactor (ACI) method and the Multi-Stage Liquid Impinger (MSLI) method. Another method for measuring the aerodynamic particle size is by the Next Generation Impactor (NGI). The NGI operates on the same principle of inertial impaction as the ACI. The NGI consists of seven stages and can be calibrated at flow rates of 30, 60, and 100 L / min. In contrast to the ACI where the impactor stages are stacked, the stages of the NGI are all in one plane. Collection cups are used to collect the particles under each stage of the NGI.

[0083] The inhaler may be disposed within a sealed container. That is, the inhaler may be sealed within the sealed container. The container may be sealed. The container may be tamper-proof. That is, the container may irreversibly change when the container is opened, such as when the container is tamper-opened. For example, the container may irreversibly break or tear upon opening. The inhaler may comprise a capsule positioned within a capsule container. The holding element may be in a first position. The container may accommodate two inhalers, each having a capsule within a capsule container and the holding element in the first position.

[0084] According to the present disclosure, an inhaler sealed within a container is provided. The inhaler comprises a housing defining an inlet, an outlet, and an airflow path extending from the inlet to the outlet. The inhaler comprises a capsule within the housing. The inhaler may be configured to break the capsule and enable a user to inhale the composition by sucking at the outlet. The inhaler sealed within the container may have any of the features of the inhalers described herein. Two inhalers may be sealed within a single container.

[0085] According to the present disclosure, a method of administering a composition using an inhaler as described herein is provided. The inhaler comprises a capsule as described herein positioned within a capsule container. The capsule contains a composition as described herein. The method includes breaking the capsule with a breaking element, moving a holding element from a first position to a second position, and inhaling the composition by sucking at the outlet. The composition may be any composition described herein.

[0086] According to the present disclosure, a composition is provided. The composition includes an antiplatelet agent for use in a method of treating, preventing, or ameliorating a thromboembolic event in a patient. The composition is administered to the patient using an inhaler described herein. The inhaler comprises a capsule described herein positioned within a capsule container. The capsule contains the composition described herein. The composition is administered by destroying the capsule with a destruction element, moving a holding element from a first position to a second position, and inhaling the composition through an outlet.

[0087] According to the present disclosure, a method of treating, preventing, or ameliorating a thromboembolic event in a patient is provided. The method includes administering to a patient in need thereof a composition comprising an antiplatelet agent. The composition is administered to the patient using an inhaler described herein. The inhaler comprises a capsule described herein positioned within a capsule container. The capsule contains the composition described herein. The composition is administered by destroying the capsule with a destruction element, moving a holding element from a first position to a second position, and inhaling the composition through an outlet.

[0088] According to the present disclosure, the use of a composition comprising an antiplatelet agent in the manufacture of a medicament for treating, preventing, or ameliorating a thromboembolic event in a patient is provided. The composition is administered to the patient using an inhaler described herein. The inhaler comprises a capsule described herein positioned within a capsule container. The capsule contains the composition described herein. The composition is administered by destroying the capsule with a destruction element, moving a holding element from a first position to a second position, and inhaling the composition through an outlet.

[0089] The antiplatelet agent for use in treating, preventing, or ameliorating a thromboembolic event can be an antiplatelet agent described herein, such as an NSAID or a P2Y12 inhibitor. The antiplatelet agent is preferably acetylsalicylic acid or a pharmaceutically acceptable salt thereof.

Brief Description of the Drawings

[0090] Here, the embodiments will be further described with reference to the figures.

[0091]

Figure 1A

Figure 1B

Figure 2A

Figure 2B

Figure 2C

Figure 3A

Figure 3B

Figure 3C

[0092] The present invention is defined in the claims. However, a non-exhaustive list of non-limiting examples is provided below. Any one or more of the features of these examples may be combined with any one or more of the features of any other example, embodiment, or aspect described herein.

[0093] Example 1. An inhaler, a housing defining an inlet, an outlet, and an airflow path extending from the inlet to the outlet, a capsule container for receiving a capsule containing a composition for inhalation, A breaking element for breaking a capsule received in a capsule container, An aerosolization chamber for enabling the composition to be taken up by an air stream in an air stream path, A holding element movable between a first position preventing the capsule from moving from the capsule container to the aerosolization chamber and a second position enabling the capsule to move from the capsule container to the aerosolization chamber, The holding element extending through an inlet when the holding element is in the first position, an inhaler.

[0094] Example 2. The inhaler according to Example 1, wherein the inhaler is a dry powder inhaler.

[0095] Example 3. The inhaler according to Example 1 or Example 2, wherein the holding element is separated from the housing when the holding element is in the second position.

[0096] Example 4. The inhaler according to any one of Examples 1 to 3, comprising actuating means configured to move the holding element from the first position to the second position.

[0097] Example 5. The inhaler according to Example 4, wherein the actuating means comprises mechanical actuating means.

[0098] Example 6. The inhaler according to any one of Examples 1 to 5, wherein the movement of the holding element from the first position to the second position is configured to move the capsule from the capsule container to the aerosolization chamber.

[0099] Example 7. The inhaler according to any one of Examples 1 to 6, wherein the holding element is configured to contact the capsule in the capsule container when the holding element is in the first position.

[0100] Example 8. An inhaler according to any one of Examples 1 to 7, wherein the holding element is configured to substantially prevent movement of the capsule relative to the capsule container when the holding element is in the first position.

[0101] Example 9. An inhaler according to any one of Examples 1 to 8, wherein the holding element is configured to substantially prevent movement of the capsule relative to the capsule container by biasing the capsule against the wall of the capsule container when the holding element is in the first position.

[0102] Example 10. An inhaler according to any one of Examples 1 to 9, wherein the capsule container comprises a capsule container opening for enabling movement of the capsule between the capsule container and the atomization chamber.

[0103] Example 11. An inhaler according to Example 10, wherein the holding element is configured to at least partially cover the capsule container opening when the holding element is in the first position.

[0104] Example 12. An inhaler according to Example 10 or Example 11, wherein the holding element is configured to substantially prevent airflow passing through the airflow path from entering the capsule container when the holding element is in the first position.

[0105] Example 13. An inhaler according to any one of Examples 1 to 12, wherein the holding element comprises a first portion and a second portion, the first portion being positioned within the housing when the holding element is in the first position, and the second portion being positioned outside the housing when the holding element is in the first position.

[0106] Example 14. An inhaler according to Example 13, wherein the first portion is positioned within the atomization chamber when the holding element is in the first position.

[0107] Example 15. The inhaler according to embodiment 14, wherein the first part is configured to follow a swirling path in the aerosolization chamber when the holding element is in the first position.

[0108] Embodiment 16. The inhaler according to embodiment 21, wherein the swirling path has a sinusoidal or helical shape.

[0109] Embodiment 17. The inhaler according to any one of embodiments 13 to 16, wherein the first part is configured to be coiled or wound within the aerosolization chamber when the holding element is in the first position.

[0110] Embodiment 18. The inhaler according to any one of embodiments 13 to 17, wherein the first part is configured to unwind or uncoil the coil when the holding element moves from the first position to the second position.

[0111] Embodiment 19. The inhaler according to any one of embodiments 13 to 18, wherein the second part is angled with respect to the first part and prevents the second part from being inserted into the housing when the holding element is in the first position.

[0112] Embodiment 20. The inhaler according to embodiment 19, wherein the angle between the first part and the second part is an acute angle.

[0113] Embodiment 21. The inhaler according to any one of embodiments 13 to 20, wherein the second part comprises an opening for assisting the user in moving the holding element from the first position to the second position.

[0114] Embodiment 22. The inhaler according to any one of embodiments 1 to 21, wherein the holding element is configured to substantially prevent airflow through the airflow path when the holding element is in the first position.

[0115] Embodiment 23. An inhaler according to any one of Examples 1 to 22, wherein the retaining element is configured to substantially prevent airflow into the inlet.

[0116] Example 24. An inhaler according to any one of Examples 1 to 23, wherein the retaining element extends through the inlet when the retaining element is in the first position.

[0117] Example 25. An inhaler according to any one of Examples 1 to 24, wherein the retaining element moves from the first position to the second position by at least partially pulling the retaining element out of the housing through the inlet.

[0118] Example 26. An inhaler according to any one of Examples 1 to 25, comprising a porous element positioned within the airflow path between the aerosolization chamber and the outlet.

[0119] Example 27. An inhaler according to Example 26, wherein the porous element is configured to prevent the capsule from exiting the housing through the outlet.

[0120] Example 28. An inhaler according to Example 27, wherein the porous element is a mesh.

[0121] Example 29. An inhaler according to any one of Examples 26 to 28, wherein the retaining element is adjacent to the porous element when the retaining element is in the first position.

[0122] Example 30. An inhaler according to any one of Examples 26 to 29, wherein the retaining element substantially prevents airflow through the porous element when the retaining element is in the first position.

[0123] Example 31. An inhaler according to any one of Examples 1 to 30, comprising a cover, the cover being movable between a cover position in which the outlet is at least partially covered and an exposed position in which the outlet is not covered.

[0124] Example 32. An inhaler according to any one of Examples 1 to 31, wherein the housing comprises a first housing part and a second housing part, the first housing part comprising an outlet, and the second housing part comprising an inlet, a capsule container, an aerosolization chamber, and a breaking element.

[0125] Example 33. An inhaler according to Example 32, wherein the first housing part and the second housing part are removably connectable.

[0126] Example 34. An inhaler according to any one of Examples 1 to 33, comprising a capsule positioned within the capsule container, the capsule containing a composition.

[0127] Example 35. An inhaler according to Example 34, wherein the composition is in the form of a dry powder.

[0128] Example 36. An inhaler according to Example 34 or Example 35, wherein the composition contains a pharmaceutically active ingredient.

[0129] Example 37. An inhaler according to Example 36, wherein the pharmaceutically active ingredient can treat or prevent thromboembolic events or is an antiplatelet agent.

[0130] Example 38. An inhaler according to Example 36 or Example 37, wherein the pharmaceutically active ingredient is a non-steroidal anti-inflammatory drug (NSAID).

[0131] Example 39. An inhaler according to any one of Examples 36 to 38, wherein the pharmaceutically active ingredient is a salicylate (salt or ester of salicylic acid), preferably acetylsalicylic acid or a pharmaceutically acceptable salt thereof.

[0132] Example 40. An inhaler according to Example 36 or Example 37, wherein the pharmaceutically active ingredient is a P2Y12 inhibitor.

[0133] Example 41. A method of administering a composition with an inhaler according to any one of Examples 1 to 40 having a capsule positioned within a capsule container, the capsule containing the composition, destroying the capsule with a destruction element, moving a holding element from a first position to a second position, and inhaling the composition by sucking on an outlet, the method comprising.

[0134] Example 42. A composition comprising an antiplatelet agent for use in a method of treating, preventing, or ameliorating a thromboembolic event in a patient, using an inhaler according to any one of Examples 1 to 40 having a capsule positioned within a capsule container and a capsule containing the composition, destroying the capsule with a destruction element, moving a holding element from a first position to a second position, and inhaling the composition by sucking on an outlet, the composition being administered to the patient by.

[0135] Example 43. A composition for use according to Example 42, wherein the antiplatelet agent is an NSAID or a P2Y12 inhibitor.

[0136] Example 44. A composition for use according to Example 43, wherein the antiplatelet agent is acetylsalicylic acid or a pharmaceutically acceptable salt thereof.

[0137] Example 45. An inhaler according to any one of Examples 1 to 40, sealed within a container, comprising: a housing having an inlet, an outlet, and an airflow path extending from the inlet to the outlet; a capsule within the housing; The inhaler is configured to allow a user to break the capsule and inhale the composition by sucking on the outlet.

[0138] Example 46. A method of administering a composition with the inhaler according to Example 45, comprising: removing the inhaler from the container; breaking the capsule; inhaling the composition by sucking on the outlet.

[0139] Example 47. A composition comprising acetylsalicylic acid or a pharmaceutically acceptable salt thereof for use in a method of treating, preventing, or ameliorating a thromboembolic event in a patient, using the inhaler according to Example 45, wherein the composition is administered to the patient by: removing the inhaler from the container; breaking the capsule;

[0140] Figures 1A and 1B show an inhaler 100 having a retaining element 150 according to a first embodiment of the present disclosure. The inhaler 100 includes a housing defining a first inlet 111, a second inlet 112, an outlet 113, and an airflow path extending from the first inlet 111 and the second inlet 112 to the outlet 113. The housing is formed from a first housing portion 101 and a second housing portion 102. Further aspects of the first housing portion 101 and the second housing portion 102 are shown in other figures.

[0141] The first housing part 101 comprises a capsule container 121 for receiving the capsule 130. The capsule 130 contains a composition for inhalation. The first housing part 101 also comprises first and second breaking elements 140 for breaking the capsule 130 received within the capsule container 121. The breaking elements 140 are needles which, in operation, create holes at each end of the capsule. The breaking elements 140 are biased to a relaxed position by springs 142. The breaking elements 140 are shown in the relaxed position in FIGS. 1A and 1B. The breaking elements 140 and the springs 142 are operatively connected to a breaking element button 141 to facilitate the actuation of the breaking elements 140. To actuate the breaking elements 140, the user presses the breaking element button 141 in a direction towards the capsule container 121. Thereby, the breaking elements 140 extend into the capsule container 121 and break the capsule 130. The breaking elements 140 can be actuated individually. The first housing part 101 also comprises an atomization chamber 122 to enable the composition within the penetrated capsule to be taken up by an air flow within an air flow path.

[0142] The inhaler 100 further comprises a holding element 150 movable between a first position that prevents the capsule 130 from moving from the capsule container 121 to the atomization chamber 122 and a second position in which the capsule 130 is movable from the capsule container 121 to the atomization chamber 122. In FIG. 1A, the holding element 150 is in a first position in which it functions as a physical barrier to prevent the capsule 130 from moving from the capsule container 121 to the atomization chamber 122 by covering an opening 123 between the capsule container 121 and the atomization chamber 122. In the second position, the holding element 150 is retracted and does not cover the opening between the capsule container 121 and the atomization chamber 122. In FIGS. 1A and 1B, the holding element is moved from the first position to the second position by a user-operated mechanism (not shown).

[0143] The second housing part 102 is provided with an outlet 113. The user may inhale the composition in the capsule 130 by sucking at the outlet 113. The first housing part 101 and the second housing part 102 are removably connectable. This provides access to the capsule container 121 and the atomization chamber 122.

[0144] Figure 1B shows the inhaler 100 of Figure 1A in use. In Figure 1B, the capsule 130 has been ruptured by the rupturing element 140. Further, the retaining element 150 has moved from a first position to a second position so as not to cover the opening 123 between the capsule container 121 and the atomization chamber 122. This enables the capsule 130 to move from the capsule container 121 to the atomization chamber 122.

[0145] The airflow path extends between the inlets 111, 112 and the outlet 113 through the atomization chamber 122. The atomization chamber 122 has a substantially circular wall. The inlet channels between the first inlet 111 and the atomization chamber 122 and between the second inlet 112 and the atomization chamber 122 are arranged such that the airflow enters the atomization chamber 122 tangentially to the circular wall of the atomization chamber 122. Thus, when the user sucks at the outlet 113 of the inhaler, air is drawn in through the first inlet 111 and the second inlet 112, forming a cyclone within the atomization chamber 122. The cyclone airflow moves the capsule 130 from the capsule container 121 to the atomization chamber 122. When the capsule 130 is within the atomization chamber 122, the cyclone airflow rotates the capsule 130 and releases the composition into the airflow so that the composition is taken into the airflow and delivered to the user via the outlet 113. The second housing part 102 includes a mesh 124 through which the composition can pass but the capsule 130 cannot pass.

[0146] Figures 2A, 2B, and 2C show three different views of the retaining element 350 according to a first embodiment of the present disclosure in a first position. For simplicity, only the first housing portion 301 is shown, but the first housing portion 301 is identical to the first housing portion 101 shown in FIGS. 1A and 1B. Therefore, the first housing portion 301 of FIGS. 2A, 2B, and 2C may be used with the second housing portion 102 shown in FIGS. 1A and 1B.

[0147] 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 bend as it moves from the first position to the second position.

[0148] The first housing portion 301 includes a first inlet channel 313 that extends between a first inlet 311 and an aerosolization chamber 322. The first inlet channel 313 includes a first wall 315 disposed opposite a second wall 316. The first housing portion 301 includes a second inlet channel 314 that extends between a second inlet 312 and the aerosolization chamber 322. The second inlet channel 314 includes a first wall 317 disposed opposite a second wall 318.

[0149] 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 through the first inlet 311 and the second inlet 312 along a sinusoidal path. Accordingly, 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. As a result, 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 the 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 the airflow through the second inlet 312. The first portion 351 of the retaining element 350 extends across the atomization chamber 322 and partially covers the opening 323 between the capsule container 321 and the atomization chamber 322. This prevents the capsule 330 from moving from the capsule container 321 to the atomization chamber 322.

[0150] In the first position, the retaining element 350 has a second portion 352 positioned outside the first housing portion 301. To move the retaining element 350 from the first position to the second position, the user pulls on the second portion 352 of the retaining element 350 to draw the retaining element 350 out of the first housing portion 301 through the first inlet 311. Since the retaining element 350 is made of a flexible material, it can bend when being drawn out of the first housing portion 301. In the second position, the retaining element 350 is separated from the first housing portion 301. The second portion 352 includes an opening 353 that assists the user in moving the retaining element 350 from the first position to the second position. The second portion 352 of the retaining element 350 is angled with respect to the first portion 351 of the retaining element to prevent it from being accidentally inserted or drawn into the first housing portion 301.

[0151] Figures 3A, 3B, and 3C show three different views of the retaining element 450 according to a second embodiment of the present disclosure in the first position. For simplicity, only the first housing portion 401 is shown, but the first housing portion 401 is the same as the first housing portion 101 shown in FIGS. 1A and 1B. Therefore, the first housing portion 401 of FIGS. 3A, 3B, and 3C may be used with the second housing portion 102 shown in FIGS. 1A and 1B.

[0152] 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 bend as it moves from the first position to the second position.

[0153] 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 atomization chamber 422. The first portion 451 of the retaining element 450 partially covers the opening 423 between the capsule container 421 and the atomization chamber 422. This prevents the capsule 430 from moving from the capsule container 421 into the atomization chamber 422. The retaining element 450 extends through the first inlet channel 413 but not through the second inlet channel 414. Nevertheless, it can be seen that the first portion 451 of the retaining element 450 is coiled so as to prevent the airflow within the second inlet channel 414 from entering into the atomization 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.

[0154] To move the retaining element 450 from the first position to the second position, the user pulls on the second portion 452 of the retaining element 450 and withdraws the retaining element 450 from the first housing portion 401 through the first inlet 411. When the retaining element 450 is withdrawn from the first housing portion 401, the first portion 451 of the retaining element 450 unwinds. In the second position, the retaining element 450 is separated from the first housing portion 401. The second portion 452 includes an opening that assists the user in moving the retaining element 450 from the first position to the second position. The second portion 452 of the retaining element 450 is angled with respect to the first portion 451 of the retaining element 450 to prevent it from being accidentally inserted or drawn into the first housing portion 401.

[0155] For the purposes of this specification and the appended claims, unless otherwise indicated, all numbers expressing amounts, quantities, percentages, and the like are to be understood as being modified in all instances by the term "about." Also, all ranges include the disclosed maximum and minimum points, as well as any intermediate ranges therebetween, which may or may not be specifically enumerated herein. Thus, in this context, the number A is to be understood as A ± 5% of A. Within this context, the number A may be considered to include numerical values that are within the general standard error of the measurement of the property being modified by the number A. The number A may deviate by the percentages recited above in some instances as used in the appended claims, provided that the amount by which A deviates does not substantially affect the basic and novel characteristics of the claimed invention. Also, all ranges include the disclosed maximum and minimum points, as well as any intermediate ranges therebetween, which may or may not be specifically enumerated herein.

Claims

1. It is an inhaler, A housing that defines an inlet, an outlet, and an airflow path extending from the inlet to the outlet, A capsule container for receiving a capsule containing a composition for inhalation, A destructive element for destroying the capsule received in the capsule container, an aerosolization chamber for enabling the composition to be incorporated into the airflow within the airflow path, A retaining element that is movable between a first position that prevents the capsule from moving from the capsule container to the aerosolization chamber and a second position that allows the capsule to move from the capsule container to the aerosolization chamber, An inhaler comprising: a retaining element extending through the inlet when the retaining element is in the first position.

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

3. The inhaler according to claim 1 or 2, wherein the retaining element moves from the first position to the second position by at least partially pulling the retaining element out of the housing through the inlet.

4. The inhaler according to claim 1, wherein the retaining element is configured to substantially prevent the capsule from moving relative to the capsule container when the retaining element is in the first position.

5. The inhaler according to claim 1, wherein the capsule container has a capsule container opening for allowing the capsule to move between the capsule container and the aerosolizing chamber, and the retaining element is configured to at least partially cover the capsule container opening when the retaining element is in the first position.

6. The inhaler according to claim 1, wherein the retaining element is configured to substantially prevent airflow through the airflow path when the retaining element is in the first position.

7. The inhaler according to claim 1, wherein the retaining element comprises a first part and a second part, the first part being positioned within the housing when the retaining element is in the first position, and the second part being positioned outside the housing when the retaining element is in the first position.

8. The inhaler according to claim 7, wherein the second portion is angled with respect 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. The inhaler according to claim 7, wherein the first portion is configured to follow a rotational path within the aerosolizing chamber when the retaining element is in the first position.

10. The inhaler according to claim 9, wherein the first portion is configured to follow a spiral path from a first inlet channel to a second inlet channel.

11. The inhaler according to claim 9, wherein the rotational path has a sinusoidal or substantially sinusoidal shape.

12. The inhaler according to claim 9, wherein the rotational path has a helical or substantially helical shape.

13. The inhaler according to claim 1, comprising a cover, wherein the cover is movable between a covered position in which the outlet is at least partially covered and an exposed position in which the outlet is not covered.

14. The inhaler according to claim 1, comprising a capsule positioned within the capsule container, wherein the capsule contains a composition, the composition contains a pharmaceutically active ingredient, and the pharmaceutically active ingredient is a salicylate (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 of treating, preventing or improving thromboembolic events in a patient, wherein the inhaler has a capsule positioned within the capsule container, and the capsule containing the composition is used Destroying the capsule with the destruction element, Moving the retaining element from the first position to the second position, A composition administered to the patient by sucking out the aforementioned outlet and inhaling the composition.

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