• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    ABSTRACT En torrpulverinhalator (100) är tillhandahallen. Inhalatom (100) innefattar ett inlopp (101) och ett utlopp, dar en forbindelse mellan namnda inlopp (101) och namnda utlopp (102) innefattar en dosforbindelse (107) i ett dosadministreringslage. En fOrsta lakemedelsreservoar (109) for att inrymma ett tonpulverlakemedel och en andra lakemedelsreservoar (110) for att inrymma ett andra torrpulverlakemedel tillhandahalls vidare. En doseringsmekanism (104, 108) tillhandahals for att ta ut en inhaleraruppmatt dos av torrpulver i den forsta och andra lakemedelsreservoaren (109, 110) i ett dosuppsamlingslage fran reservoarema (109, 110) in i namnda dosforbindelse (107) i dosadministreringslaget. En metod for att bereda en dos är ocksa tillhandahallen. Att publiceras med Figur 1
    公开号:SE1450409A1
    申请号:SE1450409
    申请日:2014-04-03
    公开日:2015-10-04
    发明作者:Orest Lastow；Lars Arvidsson
    申请人:Iconovo Ab；
    IPC主号:
    专利说明:

    TECHNICAL FIELD This invention relates generally to drug inhalers and more particularly to dry powder inhalers. The inhaler comprises at least one air inlet and at least one air outlet, and a reservoir containing a dry drug powder. The inhaler has an air flow from at least one air inlet to at least one air outlet when a user inhales through said at least one outlet to deliver said dry drug powder while inhaling the user.
    Background In the pharmaceutical field, with respect to the treatment of respiratory and / or other diseases, inhalers are widely used. Many drugs, medicines and other substances are inhaled with these inhalers into the lungs for rapid uptake into the bloodstream and for local action in the lungs.
    Inhaled drugs can be divided into two main categories. They can be in the form of water shoes, containing suspensions, or powders. The choice of category depends on the properties of the drug, medicine, etc., to be inhaled.
    The most common type of inhaler is a dose-controlled inhalation spray. In this type of inhaler, the drug is usually stored in a solution in a pressurized container containing a propellant, it can also be as a suspension.
    The container is attached to a plastic activation control device that manually activates the inhaler.
    Upon activation, release the inhaler a metered dose of the drug in aerosol form.
    Another type of inhaler is a nebulizer that delivers the drug as an aerosol created from an aqueous drug preparation. The type referred to herein is an additional type of inhaler, namely a dry powder inhaler.
    A dry powder inhaler releases a pre-fed, encapsulated or metered-in dose of powdered inhaled drug which is inhaled through the inhaler. Inhalers with a dose of drug powder metered by the inhaler are usually inhalers with a drug reservoir containing a tout drug powder from which a metered dose is taken using various dose control arrangements, and said doses are then inhaled. Dry powder inhalers need to deliver a particle size that is substantially less than 5 micrometers and preferably between 1 micrometer and 3.3 micrometers, for maximum effect. Such small particles are, however, very cohesive due to the high surface energy. The agglomeration can be confused by moisture, and when the drug comprises more than one active substance, because the different active substances can have such properties as forming agglomerates with each other or with pharmaceutical carriers etc. Agglomerates of small particles are a problem which results in the active the particles leave the inhaler as large agglomerates. Agglomerate consisting of small particles is a problem that results in the active particles leaving the inhaler as large agglomerates.
    EP0237507 discloses such a powder inhaler with a dose measured by the inhaler, which comprises a drug container, a dosing mechanism and a flow path from an air inlet to an air / drug outlet. In the river course there are deflectors to increase the deaggregation of the drug. However, this inhaler is limited to medicinal products with an active substance or substances which are compatible with each other during storage. Further, drugs will accumulate on the deflectors which reduces the uniformity of the dosage.
    An additional problem with prior art inhalers is that they are either suitable for micronized preparations or preparations with carriers - never both or combinations of these.
    In view of these shortcomings and limitations of the prior art, a dry powder inhaler is needed with which an efficient and satisfactory dispersion of the dry powder is achieved, where the inhaler can administer drugs consisting of substances which are incompatible in mixing, and an inhaler with Okad deaggregation and a more uniform dosage, as well as an inhaler suitable for both micronized and / or barred preparations.
    SUMMARY OF THE INVENTION Accordingly, the present invention aims to reduce, mitigate or eliminate one or more of the above-identified shortcomings of the prior art and disadvantages alone or in any combination and to solve at least one of the above-mentioned problems by providing a dry powder inhaler for medicaments comprising ; at least one inlet and at least one outlet, used in a connection between said at least one inlet and said at least one outlet comprising at least one dose compound in a dose administration layer; a first drug reservoir for containing a first drug as dry powder; a second drug reservoir for containing a second drug as dry powder; a dosing mechanism for withdrawing a dose of dry powder measured by the inhaler in the first and second drug reservoirs of a dose collection layer from the reservoirs into said dose compound in the dose administration layer.
    A method of preparing a dose for inhalation with an inhaler is also provided for the same purpose.
    Additional advantageous embodiments will be apparent from the appended claims.
    Brief description of the drawings.
    These and other aspects, features and advantages which the invention is capable of, will become apparent and elucidated in the following description of embodiments of the present invention with reference to the accompanying drawings, in which; Fig. 1 is a cross-sectional view along the longitudinal axis of an inhaler according to an embodiment of the dose administration layer of the present invention; Fig. 2 is a perspective and cross-sectional view of an inhaler according to an embodiment of the present invention; Fig. 3 is a perspective and cross-sectional view of an inhaler according to an embodiment of the present invention, focused on the arrangement of the openings in a dose counter; Fig. 4 is a perspective and cross-sectional view of an inhaler according to an embodiment of the present invention, focused on the arrangement of the openings in a dose counter; Fig. 5 is a perspective and cross-sectional view of an inhaler according to an embodiment of the present invention, focused on the arrangement of drug scrapers over the opening in the dose counter; Fig. 6 is a perspective and cross-sectional view of an inhaler according to an embodiment of the present invention, focused on the arrangement of drug scrapers and drug in the opening; Fig. 7 is a cross-sectional view along a longitudinal axis of an inhaler according to an embodiment of the present invention, focused on the arrangement of drug scrapers in the opening in the dose counter; and Fig. 8 is a cross-sectional view along a longitudinal axis of an inhaler according to an embodiment, in which the air and the air / drug flowing through this inhaler are shown.
    DESCRIPTION OF EMBODIMENTS The following description focuses on an embodiment of the present invention applicable to a drug inhaler, and in particular to a dry powder inhaler having more than one drug reservoir, such as two. drug containers. However, this should not be construed as limiting the invention to this embodiment but may be applied to many other inhalers having an inlet and an outlet as well as a drug reservoir.
    Figures 1 to 7 illustrate a dry powder inhaler for drug 100.
    The dry powder inhaler for medicament 100 comprises air inlet 101 and an air outlet 102.
    The outlet 102 is located at the first end of the dry powder inhaler 100 for medicament 100, while the inlets 101 are located in a zone opposite the second spirit of the dry powder inhaler for medicament 100. The outlet 102 is located centrally, along the longitudinal axis of the dry powder inhaler for medicament 100. The inlets 101 may be located along a radial, relative to the longitudinal axis of the dry powder inhaler 100, the periphery of the dry powder inhaler 100, so that the inlets 101 direct inhaled air transversely and radially towards the central portion of the dry powder inhaler 100.
    However, as described in the embodiment of Figure 4, which will be described further below, the inlets 101 may also be positioned in a direction parallel to the central axis of the dry powder inhaler 100.
    The number of inlets and outlets may differ from that described in Figures 1 to 4. The number of inlets may, for example, be adjusted according to need and specific inhaler design, so that a number of smaller inlets, to reduce the pressure drop across the inhaler, are located along the circumference of dry powder inhaler 100. This is not shown.
    Correspondingly, the number of air outlets can be adjusted according to the needs and specific inhaler design.
    The various parts of the dry powder inhaler 100 may be made of a suitable material, such as plastic which can be injection molded, such as thermoplastic.
    The dry powder inhaler 100 comprises three main parts in the form of an upper proximal reservoir housing 103, a dose counter 104, and a lower remote knob 105. The reservoir housing 103 and the knob cooperate so as to house the dose counter 104 between the two. The knob 105 cooperates with the dose counter 104, so that the dose counter 104 can be rotated, by rotation and rotation of the knob 105, between a dose administration member and a dose collection member. This can be accomplished by connecting the dose counter 104 and the knob 105 via interconnecting grooves and ribs, or by allowing the knob 105 to extend longitudinally and centrally to the dose counter 104 and connect thereto, as shown, for example, in Figure 1. The rotation of the dose counter 104 is preferred. to have two final layers, corresponding to the dose administration layer and the dose collection layer, in relation to the reservoir housing 103, on one edge.
    In the dose administration lid, the inlets 101 are in fluid communication with the mixing and deaggregation chamber 106 via dose connections 107. The dose compounds 107 then pass through the openings 108 in the dose counter 104. Consequently, the openings 108, in the dose administration floor, lie above the connections 107. rotated away from the river connection to the inlets 101 and the chamber 106. Instead, the openings 108 are rotated into the drug reservoirs 109, 110, used in the openings 108 may collect a drug contained in the reservoirs 109, 110. The drug contained in the drug reservoir 109 may be a drug differs from the drug contained in the drug reservoir 110. Due to the fact that there are two reservoirs 109, 110, the inhaler 100 can deliver two substances in an inhalation, where the said two substances are otherwise incompatible, in the sense that these two substances are not possible to include in a common reservoir, pa so that a dry powder inhaler device 100 in which an effective and satisfactory dispersion of a dry powder is obtained, where the inhaler 100 can administer medicaments which comprise substances which may be incompatible in a mixture or which by other shells are preferred to have in separate reservoirs.
    It is possible to arrange the dose counter 104 and the openings 108 dry, so that when a first group of two openings 108 are laid over the connections 107, i.e. in the dose administration lid, a second group of two openings 108 are positioned in the respective drug reservoir 109, 110. Further, the distribution of the openings 108 on the dose counter 104 is such that the dose counter can be rotated in only one direction, which means that the second group of two openings 108 are laid over the connections 107, the first group of openings 108 are positioned in the drug reservoir 109, 110, respectively. It is also possible to rotate the dose counter 104 in a first direction to place the openings 108 over the connections 107 in the dose administration sheet, and then to rotate the dose counter 104 in the opposite direction to the dose collection sheet, to then again rotate the dose counter in the first direction towards the dose administration sheet. When the dose counter 104 is rotated in a first direction into the dose administration layer and the opposite direction into the dose collection layer, the dose counter 104 may have rotation stop in the dose administration layer and in the dose collection layer, respectively, to ensure good fit over the connections 107 and positioning in the respective drug reservoir 109, 110.
    It is also possible to provide the inhaler with more than two, such as three, four, five or six reservoirs 109, 110, with the same arrangement of inlets, outlets, connections, dose counters, openings etc. within the scope of the present invention.
    It is also possible to provide the inhaler with 100 with a different dosing mechanism than the one described above, such as for instance an electric drive of different parts, and use of paddles instead of dosing disc 4. However, the use of dosing disc 104 and its cooperation with the knob 105 and reservoirs 109, 110 possible a very cost-effective solution which at the same time ensures a high dose accuracy and the other advantages as described herein.
    The dosage compounds 107 are - in the embodiment described in Figure 1 - S-shaped.
    The S-shape is such that the connections 107 start at the inlets 101 and extend downstream (during inhalation) in a central and transverse direction, and then they bend neatly and distally to extend into a longitudinal and distal direction to - in dose administration drug - pass through the openings 108. In this way, when the drug is positioned in the openings 108, the change of river direction will increase the turbulence in the air flow, which contributes to the initial deaggregation of the drug in the openings 108. This ensures that all drugs in the openings 108 will follow the air flow in the connection into the chamber 106, and not to remain partially in the openings 108. Downstream (liters again during inhalation) about the openings 108, again the connections 107 will bend to be directed in a central and transverse direction, to end in chamber 106. Distally below the openings 108, when the connections 107 bend centrally and transversely, ledges 111 are formed. ledges 111 state that the medicament which is intended to be kept in the openings 108 before inhalation, where this medicament can fall down, can still follow the inhaled air into chamber 106. This means, for example, that the reservoirs 109, 110 may comprise a dry powder medicament in the form of baths. a toner powdered formulation in the form of a micronized preparation or a bar-based preparation or mixtures thereof. The inhaler 1007 may then comprise, for example, a dry powder leach in the form of a micronized preparation in the first reservoir 109 and a dry powder leach in the form of a bar-based preparation in the second reservoir 110.
    The direction of the two connections 107 when they enter the chamber 106 are arranged so that the air flows, and consequently the drug flow during inhalation, when the inhaler 100 is in the dose administration layer, intersect or coincide. In this way, the drug in the drug rivers will physically interact to drive the deaggregation of the drugs, which may increase the dose uniformity, as the need for deflectors is then reduced. This feature also adds the ability to combine or customize the inhaler 100 to deliver micronized formulations and / or bar-based formulations. Of course, it is also possible to combine the feature with crossing or coincident flow from the two connections 107 with deflectors, although the need for these is reduced.
    Depending on the drug to be administered, and the preparation thereof, the openings 108 may be more than one opening 108 per compound 107, such as a group of openings 108, shown in Figure 4. Some drugs have aggregation properties, which make it difficult to retain the drug as a "plug" in the opening 108. Consequently, it may be preferable to open several openings 108 of relatively smaller diameter. Alternatively, this may be to deliver a smaller amount of powder. This feature also adds the ability to combine or customize the inhaler 100 to deliver micronized formulations and / or bar-based formulations.
    During inhalation, the drug will follow the air flow through the compounds 107, into the chamber 106, whereby the air / drug streams from the various compounds 107 will intersect, so that the drug agglomerates will collide to drive the deaggregation, after which a jet of finely dispersed l and air will continue through an inhalation chimney 112 out of the inhaler 100 through outlet 102, into the lungs of the inhaler. The chimney 112 increases the formation of the jet, which enables a maintained law aggregation of drugs, and thereby increases the potential for drugs to reach far into the lung of the patient. The chimney is generally rudder-shaped, but may alternatively be provided with deflectors, to further increase the formation of a jet. Such deflectors may be bumps or helical ribs extending along the length of the chimney from the chamber 106 to the outlet 102. The chimney 112 need not necessarily be directed upwards; it can equally be directed neat or at the sides, whereby the outlet 102 of course instead also. is located on the bottom and on the side, respectively. In addition, the chimney 112 need not be mostly tubular, but may be NO or sinusoidal, depending on where on the inhaler 100 it is preferred to position the outlet 112. For flow characteristics and dose reliability and maintenance, it is preferred to have it aligned and substantially tubular. optional with deflectors. The main shape of the chimney 112 can also be such that it has differences in cross-sectional area, such as cone-shaped. In this way, the flow rate in the chimney can be regulated to aid the deaggregation of selected parts.
    As shown in Figures 2 and 7, the reservoirs 109, 110 may be provided with drug scrapers 113. The scrapers 113 are suspended from the bottom of the reservoirs 109, 110, so. that they abut the dose counter 104. The scrapers pass over the openings 108 in the dose counter 104, so that excess drug is removed from the openings 108, to ensure a correct dose volume. The scrapers 113 will also come. to help compact the drug in the openings 108, which improves the retention of drug in the openings 108 once the dose counter has been rotated to the dose administration layer. Since the scrapers 113 are suspended in the reservoirs 109, 110, they will automatically slide along the uppermost surface of the dose counter 104 when the dose counter 104 is rotated between the dose administration layer and the dose collection layer. Preferably, each reservoir 109, 110 has a number of scrapers 113 evenly distributed along the bottom of the reservoirs 109, 110. In this way, the scrapers 113 help not only to obtain correct dose volume and dose compaction, but also in the distribution of drug at the bottom of the reservoirs 109, 110. For example, the number of scrapers 113 per reservoir 109, 110 may be selected in the range of 1 to 6, say as 2 to 4, said. It is also possible for the scrapers 113 to be arranged in an uneven distribution in the reservoirs 109, 110, if certain reservoirs are configured so that an uneven distribution of the scrapers 113 will have a favorable effect on the distribution of the drug along the bottom of the reservoirs 109, 110.
    As shown in Figure 7, which is an enlargement of a cross section of a scraper 113, the scraper 113 may comprise a scraper base 113a and a scraper tip 113b. The scraper base 113a is suspended in the reservoirs 109, 110. The scraper tip 113b extends distally, out from the scraper base 113a. In order to increase the efficiency of the scraper 113 with respect to the scraping on the dose counter 104, the scraper base 113a may be made of a resilient material. Such a resilient material can be a rubber material. However, the scraper tip 113b is preferably made of plastic material, such as a thermoplastic material, of the same type as the rest of the inhaler 100, such as the dose counter 104, to allow better force-distributing properties and improved interaction with the opening 108. The scraper tip 113b may have an angled tip. 113c. The angled tip 113c further enhances the interaction between the edge of the opening 108.
    In use, the user will simply rotate the dose counter 104 in a direction of the dose collection layer if the dose counter is in the dose administration layer. Thereafter, the dose counter 104 is rotated in the opposite direction to reach the dose administration layer. Of course, if the dose counter 104 is already in the dose collection layer, the first rotation to the dose collection layer will be excluded. During these rotations, the scraper 113 will fill the openings 108 of the dose counter 104 in the reservoirs 109, 110 - the scraper 113 contributes to the filling when rotated in both directions. After the dose counter 104 has been rotated to the dose administration layer, the openings 108 are filled with drug - alternatively two different drugs - and in river connection with the compound 107. Then the user again opens his mouth to the outlet 102 and inhales. During inhalation, the air A enters the inhaler 100 through the inlets 101 and flows through the connections 107 to carry drug or drug M into the openings 108, according to Figure 8. The flow of air / drug AM will then enter chamber 106. In the chamber 106, the flow of air / drug AM from the compounds will intersect, so that deaggregation of the drug M will increase. The flow properties, such as jet formation, will also increase. Thereafter, the air / drug flow AM - now including the air / drug flow from both compounds 107, will ascend through the inhaler chimney 112 and out and into the user's lungs through outlet 102.
    Although the present invention has been described above with reference to specific embodiments, it is not intended to be limited to a specific form described herein. Rather, the invention is limited only by the appended claims.
    In the claims, the term "comprising" does not exclude the presence of other elements or steps. In addition, even if individually listed, a plurality of means, elements or steps can be realized by a single unit or processor. In addition, if individual characteristics must be included in different requirements, these can possibly be combined advantageously, and the introduction of different requirements did not mean that a combination of characteristics is not feasible and / or advantageous. Darn11 does not exclude the singular references a plurality. The terms "one", "one", "first", "second" etc. do not exclude a plurality. References in the claims are provided as illustrative examples only and should not be construed as limiting the scope of the requirements for any salt.
    权利要求:
    Claims (10)
    [1]
    A dry powder inhaler (100) comprising: at least one inlet (101) and at least one outlet (102), wherein a connection between said at least one inlet (101) and said at least one outlet (102) comprises at least one dose connection (107) in a dose administration team; a first drug reservoir (109) for housing a first dry powder drug; a second drug reservoir (110) for housing a second dry powder drug; a dosing mechanism (104, 108) for withdrawing a dose of the dry powder measured by the inhaler in the first and second drug reservoirs (109, 110) in a dose collection layer from the reservoirs (109, 110) into said dose compound (107) in the dose administration layer; the metering mechanism (104, 108) comprising a metering disk (104) having at least one opening (108) per reservoir (109, 110), the metering disk (104) being rotatable between the metering layer, the apertures (108) being positioned in the reservoirs (109, 110). 110), and the dose administration layer, the apertures (108) communicating with said dose compound (107); wherein the dry powder inhaler further comprises a dose compound (107) per reservoir (109, 110), wherein said dose compounds (107) extend from an inlet (101) each to a mixing and deaggregation chamber (106), the dose compounds (107) comprising a ledge (111), which are located below the respective opening (108) in the dose administration layer.
    [2]
    The inhaler (100) of claim 1, wherein the dose counter (104) is configured such that a first set of two openings (108) overlaps with the connections (107) in dose administration layers, while a second set of two openings (108) is positioned in respective drug reservoir (109, 110) in dose collection mode.
    [3]
    The inhaler (100) of claim 1, wherein a distribution of the openings (108) on the dose counter (104) is Adana that the second set of two openings (108) overlap with the connections (107) in a dose administration layer while the first set of openings (108) are positioned in the respective drug reservoir (109, 110) in dose collection layers. 2
    [4]
    The inhaler (100) of claim 1, wherein the dose counter (104) is provided with a stop of rotation in the dose administration layer and the dose collection layer, respectively.
    [5]
    The inhaler (100) of claim 1, wherein said dose compounds (107) have directions when they enter the chamber (106) which intersect or coincide with each other.
    [6]
    The inhaler of claim 1, wherein the dose compounds (107) are S-shaped between the inlets (101) and the chamber (106).
    [7]
    The inhaler (100) of claim 1, comprising an inhalation chimney (112) connecting the chamber (106) and the outlet (102).
    [8]
    The inhaler (100) of claim 7, wherein the chimney (112) comprises deflectors.
    [9]
    The inhaler (100) according to any of the foregoing seas, wherein the first (109) and second reservoirs (110) comprise a dry powder lacquer in the form of a micronized composition or a bar-based composition, or mixtures thereof.
    [10]
    The inhaler (100) of any one of claims 1 to 8, wherein the first reservoir (109) comprises a dry powder leach in the form of a micronized composition and the second reservoir (110) comprises a dry powder lacquer in the form of a barbar-based composition. 1/4 107 106 111 102
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    同族专利:
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    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    US4805811A|1985-03-29|1989-02-21|Aktiebolaget Draco|Dosage device|
    SE453566B|1986-03-07|1988-02-15|Draco Ab|POWDER INHALATOR DEVICE|
    SE466684B|1989-03-07|1992-03-23|Draco Ab|DEVICE INHALATOR AND PROCEDURE TO REGISTER WITH THE DEVICE INHALATOR MEDICATION|
    DE4415462C1|1994-05-03|1995-08-31|Transcoject Marketing Gmbh|Inhaler for powdered medicine etc.|
    GB9928265D0|1999-12-01|2000-01-26|Innovata Biomed Ltd|Inhaler|
    US7258118B2|2002-01-24|2007-08-21|Sofotec Gmbh & Co, Kg|Pharmaceutical powder cartridge, and inhaler equipped with same|
    DE102005046645B3|2005-09-29|2006-07-20|Braunform Gmbh|Medical powder inhaler has at least two reservoir containers from which different powders can be separately forwarded into a metering unit so that they are mixed together when traveling along an inhalation tube|
    RU2376040C1|2008-05-27|2009-12-20|Александр Григорьевич Чучалин|Powder inhaler|
    BR112012011249A2|2009-11-13|2016-04-12|Schering Corp|powder dispenser, drug, and drug product|
    EP2498846A4|2009-11-13|2014-08-27|Merck Sharp & Dohme|Drug products, dry powder inhalers and polyflux collider arrangements|
    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    SE1450409A|SE538400C2|2014-04-03|2014-04-03|Dry powder inhaler|SE1450409A| SE538400C2|2014-04-03|2014-04-03|Dry powder inhaler|
    ES15712983T| ES2745152T3|2014-04-03|2015-04-02|Dry powder inhaler|
    EP15712983.4A| EP3125976B1|2014-04-03|2015-04-02|Dry powder inhaler|
    JP2016560669A| JP6595500B2|2014-04-03|2015-04-02|Dry powder inhaler|
    PCT/EP2015/057314| WO2015150517A1|2014-04-03|2015-04-02|Dry powder inhaler|
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