Dry powder inhaler

Abstract

A dry powder inhaler (100) comprising at least one inlet (108), at least one outlet (104), and a dosing mechanism between the at least one inlet (108) and the at least one outlet (104) for arranging a dose of dry powder medicament for delivery upon inhalation at the outlet (104), wherein the dosing mechanism comprises a dosing wheel (112) configured to hold a plurality of medicament cavities (302) for containing dry powder medicament, and a dosing element (118) movable between an inactive position and a dose administration position, the dosing element (118) being configured to enable fluid communication between at least one of the medicament cavities (302) and the outlet (104) when in the dose administration position.

Description

Technical Field

[0001] This application relates to drug inhalers, and more particularly to inhalers for delivering dry powder drugs to a user. Background Technology

[0002] Inhalers are widely used in the pharmaceutical field for the treatment of respiratory and / or other diseases. Inhalers are used to deliver large quantities of medicines, drugs, and other substances into the lungs to facilitate rapid absorption in the bloodstream and to produce a localized effect in the lungs.

[0003] Inhaled medications fall into two main categories: liquid forms, including suspensions, and powders. The choice between liquid and powder depends on the characteristics of the medication, drug, etc., to be inhaled.

[0004] The most common type of inhaler is the pressurized metered-dose inhaler. In this type of inhaler, the medication is typically stored in a solution within a pressurized canister containing the propellant, although the medication may also be in suspension. The canister is attached to a manually operated plastic actuator. When activated, the metered-dose inhaler releases a fixed dose of medication as an aerosol. Another type of inhaler is the nebulizer, which delivers the medication as an aerosol produced from an aqueous formulation.

[0005] Another type of inhaler is the dry powder inhaler. Dry powder inhalers release a measured dose of powdered medication, which is inhaled through the inhaler's mouthpiece. Typically, the measured dose is stored in one of several chambers located inside the inhaler, such as in a blister pack. Each chamber has a punctureable cover that can be punctured to release the medication before it is inhaled by the user. Chamber-based dry powder inhalers offer good hygiene and ensure that the appropriate dose of medication is delivered to the user.

[0006] However, cavity-based dry powder inhalers present certain challenges. In some implementations, it is desirable to deliver more than one medication in a combined dose. However, this may not be suitable for storing two or more medications in a single cavity. Therefore, separate cavities are used for different medications. In these cases, ensuring that two or more individual medications are properly depolymerized and mixed to provide a single dose to the user can be challenging. It may also be difficult to ensure that both cavities are opened simultaneously for combined dose delivery, especially in a reproducible manner. Existing solutions involve complex mechanisms and fail to achieve the desired delivery characteristics. Summary of the Invention

[0007] The dry powder inhaler disclosed herein provides a dispensing mechanism with a dispensing wheel and a dispensing element that allows two drug chambers to be simultaneously accessed for delivery of a combined dose. The dispensing element serves as both the access point to the drug chambers and the delivery of the drug to the user. This allows the drugs from the two separate chambers to be properly depolymerized and mixed before being inhaled by the user. This mechanism allows for repeatable dose delivery. Compared to currently known mechanisms for providing multiple drug combination doses, this mechanism has a simpler structure.

[0008] The method for encapsulating dry powder medications disclosed herein, and the encapsulation produced by this method, provides for the filling of multiple cavities in a linear array prior to assembly into an inhaler. This allows multiple cavities to be easily filled and sealed, enabling the multiple cavities to be provided in a combined dose, especially compared to when the cavities are arranged in an annular form in which the encapsulation is assembled into the inhaler. Since the seal acts as a barrier to the outside, the encapsulation also provides, for example, protection against moisture.

[0009] According to one aspect, a dry powder inhaler is provided, comprising: at least one inlet; at least one outlet; and a dispensing mechanism located between the at least one inlet and the at least one outlet, the dispensing mechanism being configured to deliver a dose of dry powder medication such that the dose can be delivered upon inhalation at the outlet, wherein the dispensing mechanism includes: a dispensing wheel configured to hold a plurality of drug cavities for containing the dry powder medication; and a dispensing element movable between an inactive position and a dose-application position, the dispensing element being configured to enable fluid communication between at least one cavity in the drug cavities and the outlet when in the dose-application position.

[0010] Optionally, the dispensing wheel is configured to rotate relative to the dispensing element between multiple dose delivery positions. Optionally, each dose delivery position corresponds to the alignment between one or more drug chambers and the dispensing element. Optionally, each dose delivery position corresponds to the alignment between two drug chambers and the dispensing element.

[0011] Optionally, the dry powder inhaler further includes a gear system configured to rotate the dispensing wheel relative to the dispensing element and / or actuate the dispensing element between an inactive position and a dosage administration position. Optionally, in the inactive position, the dispensing element is disposed within the dispensing wheel. Optionally, the gear system includes a first gear mechanism and a second gear mechanism, the first gear mechanism being configured to rotate the dispensing wheel, the second gear mechanism being configured to actuate the dispensing element, and the first and second gear mechanisms being configured to interact such that rotation of the dispensing wheel and actuation of the dispensing element are provided in the same action.

[0012] Optionally, the dispensing element includes a manifold arranged to provide fluid communication between an inlet and at least one drug cavity in a drug cavity, and between the at least one drug cavity and an outlet, when in the dosage administration position. Optionally, the manifold includes at least one first conduit and at least one second conduit, wherein, when in the dosage administration position, the at least one first conduit is arranged to provide fluid communication between at least one drug cavity and the at least one second conduit, and the at least one second conduit is arranged to provide fluid communication between the at least one first conduit and an outlet. Optionally, the manifold includes two first conduits, each arranged to provide fluid communication between a corresponding drug cavity and the at least one second conduit when in the dosage administration position. Optionally, the manifold includes two second conduits, each arranged to provide fluid communication between the at least one first conduit and an outlet when in the dosage administration position. Optionally, the manifold further includes at least one third conduit arranged to provide fluid communication between an inlet and the at least one first conduit and / or between an inlet and the at least one second conduit when in the dosage administration position.

[0013] Optionally, each drug cavity is sealed by a sealing element, and wherein the dispensing element is configured to at least partially remove the sealing element from at least one drug cavity when moving from the never-activated position to the dosage application position, thereby enabling fluid communication between the at least one drug cavity and the outlet when in the dosage application position. Optionally, the dispensing element is configured to simultaneously at least partially remove the sealing element from both drug cavities when moving from the never-activated position to the dosage application position, thereby enabling fluid communication between the two drug cavities and the outlet when in the dosage application position. Optionally, the sealing element is a membrane or foil. Optionally, the dispensing element is configured to at least partially remove the sealing element by peeling it off from at least one drug cavity when moving from the never-activated position to the dosage application position. Attached Figure Description

[0014] Exemplary embodiments of the present disclosure will now be described with reference to the accompanying drawings, in which:

[0015] Figure 1 An inhaler according to this disclosure is shown;

[0016] Figure 2 An exploded view of an inhaler according to this disclosure is shown;

[0017] Figures 3A to 3E A dispensing element actuated by a gear mechanism according to this disclosure is shown;

[0018] Figures 4A to 4E The dispensing element is schematically shown moving from a non-activated position to a dosage application position;

[0019] Figure 5 This is a flowchart illustrating a method for encapsulating dry powder drugs;

[0020] Figures 6A to 6C The different stages of a method for encapsulating dry powder drugs are shown;

[0021] Figure 7 This is a flowchart illustrating a method for assembling a package into a dry powder inhaler;

[0022] Figures 8A to 8D The different stages of assembling the package into the inhaler are shown; and

[0023] Figures 9A to 9I Alternative configurations for the dispensing element are shown.

[0024] Throughout the instruction manual and accompanying drawings, the same reference numerals indicate the same parts. Detailed Implementation

[0025] Figure 1 An inhaler 100 according to the present disclosure is shown. The inhaler 100 includes a housing 102, a mouthpiece 104, and a cover 106. (See reference 106 for details.) Figure 2 The housing 102 includes components that allow medication to be delivered to the user. The mouthpiece 104 includes at least one outlet that provides fluid communication between the inhaler 100 and the user during inhalation. When the inhaler 100 is not in use, a cover 106 covers the mouthpiece 104. The cover 106 can be attached to the housing 102 such that it can be moved from a first position covering the mouthpiece 104 to a second position where the mouthpiece 104 is accessible to the user. For example, the cover 106 can be rotatably attached to the housing 102. In some embodiments, the angle between the first and second positions is 90°. When the cover 106 is in the open second position, the user can place their mouth on the mouthpiece 104 and inhale the medication stored inside the inhaler 104.

[0026] Figure 2 An exploded view of an inhaler, such as inhaler 100, is shown. Figure 2 As shown, the housing 102 includes a front portion 102a and a rear portion 102b, with a plurality of components assembled between the front portion 102a and the rear portion 102b, which allow medication to be delivered to the user via the mouthpiece 104.

[0027] The front portion 102a includes a first inlet 108a, and the rear portion 102b includes a second inlet 108b. Inlets 108a and 108b can be, for example... Figure 2The grille shown may be in the form of other openings or orifices that allow air to pass from the outside of housing 102 to the inside. It should be understood that the location and configuration of inlet 108 may differ from... Figure 2 The locations and configurations shown are as follows. For example, only a portion of housing 102 may include inlet 108. In another example, a portion of housing 102 may include multiple inlets 108. In yet another example, both portions of housing 102 may include multiple inlets 108. In some embodiments, inlet 108 may be part of nozzle 104. Other suitable implementations of inlets that allow air to pass from the outside of housing 102 to the inside will be readily conceived by those skilled in the art.

[0028] The mouthpiece 104 includes at least one outlet that allows air to travel outward from the interior of the housing 102. The user can inhale at the outlet of the mouthpiece 104, causing air to be drawn into inlets 108a to 108b, carrying dry powder medication from inside the housing 102, and passing through the outlet for inhalation by the user. This will be referred to... Figures 3A to 3E as well as Figures 4A to 4E To explain in more detail, a conduit 110 may be provided to provide fluid communication between the nozzle 104 and the interior of the housing 102.

[0029] The inhaler 100 includes a dispensing mechanism disposed inside the housing 102. The dispensing mechanism includes a dispensing wheel 112 and a dispensing element 118. The dispensing mechanism arranges a dose of dry powder medication such that the dose can be delivered to the user at the outlet of the mouthpiece 104 during inhalation.

[0030] The dispensing wheel 112 includes a base 114 and a pair of drug holding supports 116a to 116b. The dispensing wheel 112 is configured to hold a plurality of drug cavities containing dry powder drugs. The plurality of drug cavities may be in the form of blister packs or the like. In some examples, the plurality of drug cavities are arranged as shown in the reference. Figure 5 The package is in the form of an annular package as shown in Figure 8. The base 114 acts as a spacer to maintain the annular shape and hold the cavities at a fixed distance from each other. As will be discussed below, drug holding supports 116a to 116b hold the multiple drug cavities in place and provide rotation for the dispensing wheel 112. Specifically, supports 116a to 116b are rotatable relative to the base 114. In some implementations, supports 116a to 116b can hold the drug cavities sufficiently in place, thus eliminating the need for the base 114.

[0031] In some implementations, the dispensing wheel 112 is configured to rotate cooperatively with the assembled drug chambers about a common central axis. For example, drug holding supports 116a to 116b can hold multiple drug chambers in place, and the supports 116a to 116b and the chambers rotate cooperatively. This rotation can occur between multiple dose delivery positions. Each dose delivery position may correspond to the alignment of one or more drug chambers with the dispensing element 118 and / or the nozzle 104. Thus, when the dispensing wheel 112 is in the dose delivery position, dry powder medication can be delivered to the user from at least one drug chamber via the dispensing element 118 and the nozzle 104, as will be referred to Figures 4A to 4E Explanation. In some examples, each dose delivery position corresponds to the alignment of the two drug cavities with the dispensing element 118 and / or the nozzle 104.

[0032] The dispensing element 118 is configured to enable fluid communication between at least one drug chamber in the drug chamber and the outlet of the mouthpiece 104 during user inhalation. To achieve this, the dispensing element 118 can be actuated between an inactive position and a dosing position in which the dispensing element 118 and the outlet of the mouthpiece 104 are in fluid communication. This will be referred to... Figures 3A to 3E as well as Figures 4A to 4E To explain in more detail. In some examples, the inactive position is within the dispensing wheel 112. That is, in the inactive position, the dispensing element 118 is located inside the circumference of the dispensing wheel 112. In these implementations, the base 114 may include an opening such that the dispensing element 118 can pass through the base 114 as it moves between the inactive position and the dosage application position.

[0033] The rotation of the dispensing wheel 112 and the movement of the dispensing element 118 are achieved by a gear system including a first gear mechanism 120 and a second gear mechanism 122. The first gear mechanism includes a gear shaft 120a, a gear 120b, and a protrusion 120c. The second gear mechanism includes a gear shaft 122a, a first gear 122b, and a second gear 122c. The gear 120b of the first gear mechanism 120 interacts with the first gear 122b of the second gear mechanism 122. The protrusion 120c of the first gear mechanism 120 interacts with corresponding teeth on the supports 116a to 116b. The second gear 122c of the second gear mechanism 122 interacts with corresponding teeth on the dispensing element 118. The gear mechanisms 120 and 122 extend through a hole in the dispensing wheel 112. A hole 124a in the front portion 102a of the housing 102 allows the first gear mechanism 120 to be connected to the engagement portion of the cover 106. A corresponding hole 124b may also be present in the rear portion 102b of the housing 102 for connecting the cover 106 to the first gear mechanism 120.

[0034] When the cover 106 moves from a first position covering the mouthpiece 104 to a second position where the mouthpiece 104 is accessible to the user, the gear 120b and protrusion 120c of the first gear mechanism 120 rotate about the gear shaft 120a. As the gear 120b rotates about the gear shaft 120a, the interaction between the gear 120b and the first gear 122b of the second gear mechanism 122 causes the first gear 122b and the second gear 122c to rotate about the gear shaft 122a. Then, the interaction between the second gear 122c and the dispensing element 118 causes the dispensing element 118 to translate between an inactive position and a dosage application position. When the cover 106 moves back from the second position to the first position, the interaction between the protrusion 120c of the first gear mechanism 120 and the teeth of the supports 116a to 116b causes the dispensing wheel 112 to rotate between the first dosage delivery position and the second dosage delivery position. Therefore, the single gear system enables both the rotation of the dispensing wheel 112 and the movement of the dispensing element 118 to be achieved in a single action of the cover 106.

[0035] Gear shafts 120a and 122a are mounted on a first disc 126a. The first disc 126a and the second disc 126b are configured to be connected and used to hold the dispensing wheel 112 in place during rotation. This is achieved through the interaction between a hole in the base 114 and the shaft mounted on the first disc 126a. The second disc 126b includes an opening 128 that allows air to be drawn in and into the dispensing mechanism through inlets 108a to 108b during intake.

[0036] Once gear 112 is assembled with gear mechanisms 120, 122 and first disc 126a and second disc 126b, housing 102 can be closed to provide the assembled inhaler 100.

[0037] Figures 3A to 3E A dispensing mechanism is shown, and in particular, a dispensing wheel 112 and a dispensing element 118 actuated by gear mechanisms 120 and 122 are shown. Figures 3A to 3E In each of these, the dispensing mechanism is shown as having a drug chamber, but the housing 102, base 114, a support 116b, and plates 126a to 126b are removed. The dispensing mechanism is shown in outline on the left and in cross-section on the right.

[0038] exist Figure 3A In this embodiment, the cover 106 (not shown) is in the first position covering the nozzle 104, and the dispensing element 118 is in the inactive position. In this implementation, the inactive position is located within the dispensing wheel 112. (Refer to...) Figure 7 as well as Figures 8A to 8DExplained, the drug chamber 302 is assembled on the dispensing wheel 112 and held in place by supports 116a to 116b of the dispensing wheel 112. Figure 3A In this configuration, the dispensing wheel 112 is in the first dose delivery position, aligning the first pair of drug cavities 302a with the dispensing element 118. The teeth of the second gear 122c of the second gear mechanism 122 interact with the teeth 304 of the dispensing element 118 such that movement of the second gear mechanism 122 causes movement of the dispensing element 118. In some implementations, the cover 106 can rotate up to 20° from the first position without actuating the gear mechanisms 120, 122.

[0039] exist Figure 3B In this configuration, the cover 106 has been rotated such that gear mechanisms 120, 122 are actuated. Therefore, gear 120b of the first gear mechanism 120 rotates clockwise, and conversely, the second gear 122c of the second gear mechanism 122 rotates counterclockwise. Consequently, the dispensing element 118 moves upward to a position between the inactive position and the dosage application position. In this position, the dispensing element 118 penetrates the first pair of drug cavities 302a, thereby removing the seal, as will be referred to... Figures 4A to 4E Explanation. In some implementations, when the dispensing element 118 is located between the inactive position and the dosage application position, the cover 106 rotates between 20° and 85° from the first position.

[0040] exist Figure 3C In this position, the cover 106 has been rotated to the second position, causing gears 120b and 122c to rotate further and the dispensing element 118 to move into the dosage administration position. At least one end of the dispensing element 118 has passed through the first pair of drug cavities 302a, thereby establishing fluid communication between the dispensing element 118 and the conduit 110. In this position, the user can inhale medication from the inhaler, as will be described in reference to... Figures 4A to 4E Explanation. In some implementations, when the dispensing element 118 is in the dosage administration position, the cover 106 rotates between 85° and 90° from the first position. This provides a safety margin for proper operation of the inhaler.

[0041] exist Figure 3D In the middle, the cover 106 has rotated away from the second position and returned towards the first position, causing the gear mechanisms 120, 122 to engage with... Figures 3A to 3CThe opposite is actuated. Therefore, gear 120b of the first gear mechanism 120 has rotated counterclockwise, causing the second gear 122c of the second gear mechanism 122 to rotate clockwise, and the dispensing element 118 to move back to a position between the inactive position and the dosage application position. As the gear mechanisms 120, 122 continue to rotate, the protrusion 120c of the first gear mechanism 120 begins to interact with the corresponding tooth 306a of the support 116a (it should be understood that the protrusion 120c also begins to interact with the corresponding tooth of the support 116b, not shown). This causes the supports 116a to 116b to rotate from the first dispensing position toward the second dispensing position. In some implementations, when the dispensing element 118 is between the inactive position and the dosage application position, the rotation of the cover 106 from the first position is between 90° and 20°.

[0042] exist Figure 3E In this configuration, the cover 106 has returned to the first position, and gears 120b and 122c further rotate to move the dispensing element 118 back to the inactive position. The interaction between the protrusion 120c and the teeth of the supports 116a to 116b has caused the supports 116a to 116b to rotate counterclockwise to the second dose delivery position, as can be seen from the new position of the teeth 306a of the supports 116a. Now, the second pair of drug cavities 302b adjacent to the first pair of drug cavities 302a are aligned with the dispensing element 118. In some implementations, when the dispensing element 118 is in the inactive position, the cover 106 rotates between 20° and 0° from the first position, and the supports 116a to 116b are actuated to move the second pair of drug cavities 302b into the second dose delivery position. The dispensing mechanism is now ready to be actuated again to allow the user to inhale a new dose from the second pair of drug cavities 302b. Therefore, the dispensing mechanism enables both the rotation of the dispensing wheel 112 and the movement of the dispensing element 118 to be achieved in a single action of the cover 106.

[0043] Figures 4A to 4E The dispensing element 118 is schematically shown in cross-section. Specifically, Figures 4A to 4E This illustrates how the dispensing element 118 interacts with the drug chamber to remove the seal and provide fluid communication between at least one drug chamber within the drug chamber and the outlet of the nozzle 104. (See diagram) Figures 4A to 4E As shown, the dispensing element 118 includes a manifold 400 having multiple channels arranged to provide fluid communication between at least one drug chamber in the drug chamber and the outlet of the mouthpiece 104 when the dispensing element 118 is in the dosage administration position. The manifold 400 allows air to be drawn in from inlets 108a to 108b and through the dispensing element 118, wherein dry powder medication is entrained and delivered to the user at the outlet of the mouthpiece 104. Figures 4A to 4EIn this context, dashed lines represent open boundaries of specific features and do not represent any physical elements.

[0044] Figure 4A The dispensing element 118 in its inactive position is schematically shown. As described above, a pair of drug chambers 402a to 402b are arranged on the dispensing wheel 112. Each drug chamber 402a to 402b includes a volume portion 403a to 403b for receiving and / or storing dry powder drug. The drug chambers 402a to 402b can be arranged such that the volume portions 403a to 403b face inward, i.e., the open sides of the volume portions of the two drug chambers 402a to 402b face each other. (Refer to...) Figure 5 Figure 8 describes the structure of the drug cavities 402a to 402b in more detail. Drug cavities 402a to 402b can contain either the same drug or different corresponding drugs. In some implementations, one of the cavities 402a to 402b may be empty or not present at all. Therefore, the inhaler 100 is capable of providing single-dose or dual-dose delivery.

[0045] Volumes 403a to 403b contain dry powder medication and are sealed by a sealing element 404, indicated by a dashed line, to provide sealed medication cavities 402a to 402b. The sealing element may be a film or foil, such as aluminum foil. The sealing element 404 may include a first portion 406a sealing the first medication volume 403a, a second portion 406b sealing the second medication volume 403b, and a third portion 406c spanning the gap between the medication cavities 402a and 402b.

[0046] The dispensing element 118 includes at least one first conduit 408a to 408b, at least one second conduit 410a to 410b, and at least one third conduit 412. In the inactive position, there is no fluid communication between the dispensing element 118 and the pair of conduits 110a to 110b leading to the mouthpiece 104 of the inhaler 100. Although in Figures 4A to 4E The diagram shows two first catheters 408a to 408b, two second catheters 410a to 410b, a third catheter 412, and two conduits 110a to 110b. However, it should be understood that different numbers and configurations of catheters can be implemented, as will be shown in reference to... Figures 9A to 9I Explanation.

[0047] The first conduits 408a to 408b and the second conduits 410a to 410b are in fluid communication with each other. The third conduit 412 is in fluid communication with at least the first conduits 408a to 408b. The third conduit 412 has an open end 414 in fluid communication with inlets 108a to 108b (not shown). In some implementations, the third conduit 412 is in fluid communication with inlets 108a to 108b via an internal volume portion of the housing 102. That is, there is no specific structural element inside the housing 102 connecting inlets 108a to 108b to the third conduit 412. In other implementations, a channel may be provided to directly connect inlets 108a to 108b to the open end 414 of the third conduit 412.

[0048] Figure 4B A dosing element 118 is shown in a first position between the inactive position and the dosing application position. As described above, the dosing element 118 is actuated, for example, by a second gear mechanism 122 in the direction of arrow 416. In this position, the front portion 418 of the dosing element contacts the third portion 406c of the sealing element 404.

[0049] Figure 4C The dispensing element 118 is shown in a second position between the inactive position and the dosage administration position. The dispensing element 118 is actuated, for example, by a second gear mechanism 122 in the direction of arrow 416. In this position, the front portion 418 of the dispensing element pushes the sealing element 404 in the direction of arrow 416 such that the first portion 406a and the second portion 406b begin to peel off from their respective drug cavities 402a to 402b.

[0050] Figure 4DThe dispensing element 118 is shown in the dosage administration position. In this position, the first portion 406a and the second portion 406b have been detached from their respective drug cavities 402a to 402b, such that the volumes 403a to 403b of the drug cavities 402a to 402b are at least partially open. First conduits 408a to 408b are aligned with their respective drug cavities 402a to 402b, such that the first conduits 408a to 408b are in fluid communication with their respective drug cavities 402a to 402b. Furthermore, second conduits 410a to 410b are aligned with conduits 110a to 110b leading to the mouthpiece 104 of the inhaler 100, such that the second conduits 410a to 410b are in fluid communication with the outlet of the mouthpiece 104. Since the third conduit 412 is in fluid communication with inlets 108a to 108b and the first conduits 408a to 408b, the first conduits 408a to 408b are in fluid communication with the second conduits 410a to 410b, and the second conduits 410a to 410b are in fluid communication with conduits 110a to 110b, a fluid path is provided between the inlets 108a to 108b, the volume portions 403a to 403b of the drug chambers 402a to 402b, and the outlet of the nozzle 104.

[0051] Figure 4E The diagram illustrates the fluid communication provided by the dispensing element 118 at the dosage administration position. During user inhalation, the pressure difference across the dispensing element 118 draws air from inlets 108a to 108b into the third conduit 412. This air enters and passes through the first conduits 408a to 408b, thus entraining dry powder medication from the drug chambers 402a to 402b. The dry powder medication from each chamber 402a to 402b is then mixed in the region between the first conduits 408a and 408b and downstream of the first conduits 408a to 408b. The air, now containing the mixed dry powder medication, then enters the second conduits 410a to 410b and reaches the conduits 110a to 110b. The air and the mixed dry powder medication are then inhaled by the user through the outlet of the mouthpiece 104.

[0052] The dry powder inhaler disclosed herein provides a dispensing mechanism with a dispensing wheel 112 and a dispensing element 118 that allows two drug chambers 402a to 402b to be simultaneously accessed for delivery of a combined dose. The dispensing element 118 serves as both a mechanism for accessing the drug chambers 402a to 402b and for delivering the drug to the user. This allows the drugs from the two separate chambers to be properly depolymerized and mixed before being inhaled by the user. This mechanism allows for repeatable dose delivery because the dispensing mechanism enables both rotation of the dispensing wheel 112 and movement of the dispensing element 118 to be achieved in a single action of the cover 106. This mechanism has a simpler structure compared to currently known mechanisms for delivering combined doses of multiple drugs.

[0053] Figure 5 This is a flowchart illustrating a method 500 for encapsulating dry powder drugs. Figures 6A to 6C The packaging at different stages of the process is shown. The packaging can be used in a dry powder inhaler as described above.

[0054] At step 502, the first plurality of drug chambers are assembled into the first row. Each drug chamber in the first row may include a volume for receiving dry powder drug. Each drug chamber in the first row may be as shown in the reference. Figures 4A to 4E The discussed drug cavity 402a, and each volume section can be as referenced Figures 4A to 4E The volumetric portion 403a under discussion. In some implementations, multiple drug cavities in the first row are assembled adjacent to each other. That is, at least a portion of a given cavity is in contact with at least a portion of the next cavity in the row. In this implementation, the cavities can be formed or manufactured as an integral structure. In other implementations, there can be gaps between consecutive cavities in the first row, and the cavities can be connected by suitable connecting elements. The cavities in the first row can have a tapered structure, such that these cavities can be assembled into a ring shape, as will be referred to Figures 8A to 8C Explanation.

[0055] At step 504, a second plurality of drug cavities are assembled into the second row. The second row is arranged parallel to and spaced apart from the first row. That is, there is a constant distance along its length between the two rows. Each drug cavity in the second row may include a volume for containing dry powder drug. Each drug cavity in the first row may be as described in reference... Figures 4A to 4E The discussed drug cavity 402b, and each volume section may be as referenced Figures 4A to 4E The volumetric portion 403b under discussion. In some implementations, multiple drug cavities in the second row are assembled adjacently. In this implementation, the cavities can be formed or manufactured as an integral structure. In other implementations, gaps can be present between consecutive cavities in the second row, and the cavities can be connected by suitable connecting elements. The cavities in the second row can have a tapered structure, allowing them to be assembled into a ring shape, as will be referred to... Figures 8A to 8C Explanation.

[0056] Figure 6A The first and second rows of cavities assembled according to steps 502 and 504 are shown. Figure 6A As shown, the first row 602 includes a first plurality of cavities 606a, each of the first plurality of cavities 606a including a corresponding volume portion 608a. The second row 604 includes a second plurality of cavities 606b, each of the second plurality of cavities 606b including a corresponding volume portion 608b. These rows are assembled parallel to each other and spaced apart from each other. Figure 6AIn this implementation, cavities 606 in each row 602, 604 are assembled adjacently. Volumes 608a to 608b are open to allow dry powder drugs to be deposited into them.

[0057] Each cavity in the first row 602 forms a pair with its corresponding cavity in the second row 604. Each pair can then be delivered to the user as part of the same dose. In some implementations, the number of cavities in the first row 602 is the same as the number of cavities in the second row 604, such that a corresponding number of pairs are formed. Any suitable number of cavities can be present in each row. For example, each row may include 10 to 100 cavities. In some implementations, each row includes 30 or 60 cavities.

[0058] At step 506, the dry powder drug is deposited into the volume of at least one cavity. In some implementations, the dry powder drug is deposited into the volume of one or more cavities in the first row 602. In some implementations, the dry powder drug is deposited into the volume of one or more cavities in the second row 604. In some implementations, the dry powder drug is deposited into the volume of all cavities in one or both rows. As described above, in some implementations, a first drug may be deposited in one or more cavities of the first row 602, and a second drug different from the first drug may be deposited in one or more cavities of the second row 604. In this way, two different drugs that cannot be formulated and / or stored together can be delivered to the user in a single dose. In other implementations, a single drug may be deposited in one or more cavities of two rows.

[0059] In some implementations, not all cavities are filled with dry powder medication. For example, some cavities in one or two rows may be empty. In another example, at least one cavity may be a "dummy" cavity, meaning the cavity structure has no volumetric portion for containing the medication. This allows for different dosing schemes. In one implementation, only one row may include any cavity.

[0060] At step 508, each pair of cavities is sealed using a corresponding removable sealing element. That is, a single sealing element is applied to the cavities of the first row and the corresponding cavities of the second row. The sealing element is attached to the top surface of each cavity in the corresponding pair such that the corresponding volume is covered and a sealed cavity is provided. Each sealing element can be as shown in the reference... Figures 4A to 4EThe sealing element 404 is discussed. The sealing element can be a membrane or foil, such as aluminum foil. In some implementations, the sealing element is heat-sealed to the corresponding cavity, but other sealing methods known in the art, such as adhesive bonding, inductive sealing, ultrasonic welding, etc., can also be used. Each removable sealing element is configured to be peeled from the cavity by applying pressure to a portion of the sealing element between the first and second rows, as shown in the reference. Figures 4A to 4E Explanation.

[0061] In some implementations, sealing each pair of cavities includes sealing each pair with a strip made of sealing material. The strip made of sealing material can be applied to the cavities using any of the techniques discussed above. The strip made of sealing material can be longer than the width of the package. That is, each strip can have a length greater than the distance from the outer edge of the first row to the outer edge of the second row. Figure 6B An example of a sealing element 610 in the form of strips of sealing material applied to a cavity in this manner is shown. In these implementations, the method then includes trimming each strip of sealing material to the width of the package. Figure 6C An example of a sealing element 610 trimmed to the width of the cavity in this manner is shown, wherein a portion 612 of the sealing element 610 spans the gap between the first row 602 and the second row 604 (equivalent to...). Figures 4A to 4E Part 3 (406c) shown.

[0062] like Figure 6C As shown, the final package 600 includes a first row 602 having a first plurality of drug cavities 606a and a second row 604 having a second plurality of drug cavities 606b parallel to and spaced apart from the first row 602. Each cavity 606a in the first row and the corresponding cavity 606b in the second row form a pair. Dry powder drug is deposited into the volume portion of at least one of the cavities 606a to 606b. A plurality of removable sealing elements 610 seal the volume portions 608 of the respective pairs of cavities 606a to 606b. Each sealing element 610 is configured to be peeled off from the cavities 606a to 606b by applying pressure to a portion 612 of the sealing element 610 between the first row 602 and the second row 604.

[0063] Figure 7 This is a flowchart illustrating a method 700 for assembling a package 600 into a dry powder inhaler. Figures 8A to 8C The packaged components are shown at different stages of the assembly process.

[0064] At step 702, each removable sealing element is folded so that the volume portions of each cavity in the corresponding alignment face each other. Figure 8A It shows relative to its in Figure 6CCavities 606a to 606b are arranged at a 90° angle. Cavities 606a to 606b are folded inward such that the top surface of each correspondingly aligned cavity faces each other. One side of the portion 612 of the sealing element 610 between the first and second rows is exposed to receive the dispensing element 118 of the inhaler. Note that the encapsulation 600 is in Figure 8A It is shown as from its in Figure 6C The orientation is flipped.

[0065] At step 704, the package 600 is wound into a ring shape for assembly onto the dispensing wheel 112 of the inhaler. Figure 8B The coiled package 600 is shown before it is assembled into the inhaler. Each portion 612 of the sealing element 610 spanning the gap between the first row 602 and the second row 604 is exposed to receive the inwardly facing side of the dispensing element 118 for interaction with the dispensing element 118.

[0066] At step 706, the package 600 is assembled onto the dispensing wheel 112 of the inhaler. Specifically, the package can be assembled onto the base 114 such that the base 114 holds the cavities in an annular configuration at a fixed distance from each other. Then, the supports 116a to 116b are attached to the package 600 from each side. The supports 116a to 116b can be attached to the package 600 by any suitable means, such as by a clamping mechanism or snap-fit ​​engagement. Figure 8C The dispensing wheel 112 and the package 600 are shown in their respective parts before they are assembled.

[0067] At step 708, the assembled dispensing wheel 112 is installed into the inhaler. This may include attaching the dispensing wheel 112 to the discs 126a to 126b. Figure 8D A dispensing wheel 112 with a first disc-shaped element 126 mounted is shown. As illustrated, the base 114 includes bores for receiving shafts of gear mechanisms 120, 122. As described above, the dispensing wheel 112 is rotatable relative to the dispensing element 118 of the inhaler 100 between multiple dose delivery positions. This allows different pairs of cavities 606a to 606b in the package 600 to be accessed by the dispensing element 118 at each dose delivery position.

[0068] As described above, when the package is assembled on the dispensing wheel 112, at least one pair of cavities 606a to 606b can be in the dose delivery position. The dispensing element 118 can move from an inactive position inside the dispensing wheel 112 to the dose application position. (See reference...) Figures 4A to 4EAs described, the dispensing element 118 detaches the removable sealing element 610 from the paired cavities 606a to 606b in the dose delivery position, such that when the dispensing element 118 is in the dose administration position, fluid communication is provided between the volumes 608a to 608b of the cavities 606a to 606b in the dose delivery position and the outlet of the inhaler 100. The dispensing element 118 can then return to the inactive position, and the dispensing wheel 112 can rotate to the next dose delivery position to prepare for administering the next dose.

[0069] The method for encapsulating dry powder drugs disclosed herein, and the encapsulation produced by this method, provides for the filling of multiple volumes in a linear array prior to assembly into an inhaler. This allows multiple cavities to be easily filled and sealed, such that the multiple cavities are provided in a combined dose.

[0070] Figures 9A to 9I An alternative arrangement of the dispensing element 118 is schematically shown. Figures 9A to 9I The number and configuration of the conduits of the dispensing element 118 shown are similar to those of the other elements. Figures 4A to 4E The dispensing element 118 shown is different, but it still provides fluid communication between at least one drug chamber and the nozzle outlet when in the dosage administration position. Figures 9A to 9I In this context, dashed lines represent open boundaries of specific features and do not represent any physical elements.

[0071] Figure 9A It schematically shows the relationship with Figures 4A to 4E The dispensing element shown is similar to dispensing element 118. However, instead of two second conduits 410 and corresponding tubing 110, there is only a single second conduit 410 and corresponding tubing 110. Therefore, the dry powder medication from both drug chambers 402a to 402b follows the same path to the outlet of the inhaler. Although the second conduit 410 and tubing 110 are shown located on the same side of dispensing element 118 as the first drug chamber 402a, it should be understood that they can be present at any suitable location on dispensing element 118 to provide fluid communication with the outlet. This arrangement provides a simple structure for both dispensing element 118 and the inhaler as it provides only a single path to the outlet.

[0072] Figure 9B It schematically shows the relationship with Figures 4A to 4EThe dispensing element shown is similar to dispensing element 118. However, the front portion 418 of dispensing element 118 is attached with a separator 902. The separator 902 is used to isolate the first catheter 408a and the second catheter 410a from the first catheter 408b and the second catheter 410b. That is, each drug cavity 402a to 402b has its own corresponding path to the inhaler outlet. This arrangement will reduce the mixing of the drug in each drug cavity 402a to 402b before it reaches the outlet.

[0073] Figure 9C It schematically shows the relationship with Figures 4A to 4E The dispensing element shown is similar to dispensing element 118. However, there is only a single first conduit 408, instead of two first conduits 408. Therefore, only dry powder drug from a single lumen is supplied to the outlet. It should be understood that by having only a single drug lumen (or a single row of drug lumen) in the dose delivery location or by filling only the single drug lumen in the center with dry powder drug, it is possible to utilize... Figures 4A to 4E The same dispensing element 118 shown is used to provide a similar effect.

[0074] Figure 9D It schematically shows the relationship with Figures 4A to 4E The dispensing element shown is similar to dispensing element 118. However, instead of a single third catheter, two third catheters 412a to 412b are provided. Each third catheter 412a to 412b is in fluid communication with a corresponding first catheter 408a to 408b. Each first catheter 408a to 408b is in fluid communication with a second catheter 410a to 410b. Each third catheter 412a to 412b may be in fluid communication with a corresponding inlet 108a to 108b, or the third catheters 412a to 412b may be in fluid communication with the same inlet. This can provide an alternative flow scheme for entraining medication from cavities 402a to 402b.

[0075] Figure 9E It schematically shows the relationship with Figure 9D The dispensing element shown is similar to dispensing element 118. However, the two third conduits 412a to 412b are in fluid communication with the corresponding first conduits 408a to 408b and the corresponding second conduits 410a to 410b. That is, two separate flow paths are provided in dispensing element 118, wherein each drug cavity 402a to 402b has its own corresponding path. This arrangement will prevent the drug from mixing in each drug cavity 402a to 402b before it reaches the outlet.

[0076] Figure 9F It schematically shows the relationship with Figure 9DThe dispensing element shown is similar to dispensing element 118. However, only a single second conduit 410 and corresponding tubing 110 are present. Therefore, dry powder medication from both drug chambers 402a to 402b follows the same path to the inhaler outlet. Although the second conduit 410 and tubing 110 are shown located on the same side of dispensing element 118 as the first drug chamber 402a, it should be understood that they can be present at any suitable location on dispensing element 118 to provide fluid communication with the outlet. This provides an alternative flow scheme and a combination of simple structures for entraining medication from the chambers.

[0077] Figure 9G It schematically shows the relationship with Figure 9A and Figure 9C The dispensing element shown is similar to dispensing element 118. However, there is only a single second conduit 410 and a corresponding conduit 110, and only a single first conduit 408 and a corresponding drug chamber 402. Therefore, the dry powder drug from a single chamber is supplied to the outlet via a single path. This provides a simple structure for implementations requiring only a single type of drug.

[0078] Figure 9H It schematically shows the relationship with Figure 9G The dispensing element shown is similar to dispensing element 118. However, it is provided with two third conduits 412a to 412b. Each third conduit 412a to 412b is in fluid communication with the first conduit 408. Thus, air from one third conduit 412a is used to entrain the dry powder drug from the drug chamber 402, and air from each of the third conduits 412a to 412b is used to deliver the dry powder drug to the outlet via a single path. This provides a simple structure and alternative flow scheme for implementations requiring only a single type of drug.

[0079] Figure 9I It schematically shows the relationship with Figure 9H The dispensing element shown is similar to dispensing element 118. However, it is provided with two first conduits 410a to 410b and corresponding pipes 110a to 110b. Therefore, air from the first conduit 412a is used to entrain the dry powder drug from the drug chamber 402, and air from each of the third conduits 412a to 412b is used to deliver the dry powder drug to the outlet via two flow paths. This provides an alternative flow scheme for implementations requiring only a single type of drug.

[0080] Figures 9A to 9IThe dispensing element 118 shown is merely an example, and those skilled in the art will understand that different components may be added, removed, or combined to provide such a dispensing element 118 that provides fluid communication between at least one drug cavity and the outlet of the mouthpiece when in the dosage administration position.

[0081] The dry powder inhaler disclosed herein provides a dispensing mechanism with a dispensing wheel and a dispensing element that allows two drug chambers to be simultaneously accessed for delivery of a combined dose. The dispensing element serves as a mechanism for both accessing the drug chambers and delivering the drug to the user. This allows the drugs from the two separate drug chambers to be properly depolymerized and mixed before being inhaled by the user. This mechanism allows for repeatable dose delivery. Compared to currently known mechanisms for delivering combined doses of multiple drugs, this mechanism has a simpler structure.

[0082] The method for encapsulating dry powder drugs disclosed herein, and the encapsulation produced by this method, provides for the filling of multiple cavities in a linear array prior to assembly into an inhaler. This allows multiple drug cavities to be easily filled and sealed, enabling delivery in combined doses.

[0083] As used herein, the term "comprising / including" does not exclude the presence of other elements or steps. Furthermore, although individually listed, multiple means, elements, or method steps may be implemented, for example, by a single unit or processor. Additionally, although individual features may be included in different claims, these features can be advantageously combined, and inclusion in different claims does not imply that such combination of features is impractical and / or disadvantageous. Moreover, singular references do not exclude plural cases. The terms "a," "an," "first," "second," etc., do not exclude multiple cases. Reference numerals in the claims are provided as illustrative examples only and should not be construed as limiting the scope of the claims in any way.

Claims

1. A dry powder inhaler, comprising: At least one entry point; At least one export; as well as A dispensing mechanism, located between the at least one inlet and the at least one outlet, for dispensing a dose of dry powder drug such that the dose can be delivered upon inhalation at the outlet, wherein the dispensing mechanism includes: A dispensing wheel, configured to hold a plurality of drug cavities for containing dry powder drugs; and A dispensing element movable between an inactive position and a dosage administration position, the dispensing element being configured such that, when in the dosage administration position, fluid communication is established between two drug chambers within the drug cavity and the outlet. Each drug chamber is sealed by a sealing element, wherein the dispensing element is configured to at least partially remove the sealing element from both drug chambers simultaneously upon moving from the inactive position to the dosage administration position, thereby enabling fluid communication between the two drug chambers and the outlet when in the dosage administration position. Each drug chamber (402a, 402b) includes a volume portion (403a, 403b), wherein the open sides of the volume portions (403a, 403b) of the two drug chambers (402a, 402b) face each other.

2. The dry powder inhaler according to claim 1, wherein, The dispensing wheel is configured to rotate relative to the dispensing element between multiple dose delivery locations.

3. The dry powder inhaler of claim 1 or 2 further includes a gear system configured to rotate the dispensing wheel relative to the dispensing element and / or actuate the dispensing element between the inactive position and the dose administration position.

4. The dry powder inhaler according to claim 1 or 2, wherein, In the inactive position, the dispensing element is arranged inside the dispensing wheel.

5. The dry powder inhaler according to claim 3, wherein, The gear system includes a first gear mechanism and a second gear mechanism; The first gear mechanism is configured to rotate the dispensing wheel; The second gear mechanism is configured to actuate the dispensing element; and The first gear mechanism and the second gear mechanism are configured to interact such that the rotation of the dispensing wheel and the actuation of the dispensing element are provided in the same action.

6. The dry powder inhaler according to claim 1 or 2, wherein, The dispensing element includes a manifold arranged to provide fluid communication between the inlet and at least one of the drug chambers, and between the at least one drug chamber and the outlet, when the dosage administration position is in place.

7. The dry powder inhaler according to claim 6, wherein, The manifold includes at least one first catheter and at least one second catheter, wherein, when in the dose administration position: The at least one first catheter is arranged to provide fluid communication between at least one drug lumen and the at least one second catheter; and The at least one second conduit is arranged to provide fluid communication between the at least one first conduit and the outlet.

8. The dry powder inhaler according to claim 7, wherein, The manifold includes two first catheters, each arranged to provide fluid communication between a corresponding drug cavity and the at least one second catheter when the dose is administered.

9. The dry powder inhaler according to claim 7, wherein, The manifold includes two second conduits, each arranged to provide fluid communication between the at least one first conduit and the outlet when the dose is administered.

10. The dry powder inhaler according to claim 7, wherein, The manifold also includes at least one third catheter arranged to provide fluid communication between the inlet and the at least one first catheter and / or between the inlet and the at least one second catheter when the dose is administered.

11. The dry powder inhaler according to claim 1, wherein, The sealing element is a membrane or foil.

12. The dry powder inhaler according to claim 1, wherein, The dispensing element is configured to at least partially remove the sealing element by peeling it off from the two drug cavities when moving from the inactive position to the dosage administration position.

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