FI79947B - PERFORATED MEMBERS FOR USING VIDEO DOSERANDE ANDNINGSAPPARAT. - Google Patents

Description

1 79947

Routed membrane for use as a dispensing and transfer device in a dispensing breathing apparatus

Separated from patent application 822 423.

This invention relates to a perforated membrane for use in a metered dose inhaler for activation by the flow of air generated by inhalation and for use in inhaling a solid, pharmacologically active mixture in injectable form.

Specific requirements have been set for respiratory devices intended for the local distribution of respiratory and pulmonary drugs. Because most highly effective drugs must be dispensed, the accuracy of the dose must be high. The dose to be divided into the active mixture may be as low as 0.1 mg. It is also important that the dispersion of particles exiting the metered dose inhaler is of a suitable size because particles that are too large tend to remain in the mouth.

Several systems are suitable for the local distribution of respiratory and pulmonary drugs. These systems include nebulizers, pressurized aerosols, pressurized breathing apparatus, and breathing apparatus that are activated by the airflow generated by inhalation, hereinafter referred to as "powder breathing apparatus."

Several types of powder respirators are available in the market.

They complement pressure aerosols in which the drug is dissolved or suspended in a liquid propellant mixture. The advantage of powder inhalation devices is that they always deliver the active mixture when the patient inhales, because the airflow produced by the inhalation has created a cloud of particles. At the same time, the problem of coordinating dosing activation with inhalation to deliver the active test to the respiratory and lung organs has been solved. For example, those on the market

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The powder inhaler is a spinhaler. The Spinhalerieea active mixture is used in the form of a syringe inside a hard gelatin capsule which is perforated before use. The hard gelatin capsule is placed in the tube of a device whose airflow generated by the inhalation tube causes it to rotate, thereby transferring the syringe mixture to the airflow which carries it with the airflow to the patient's respiratory tract and lungs.

However, previously known powder inhalers have drawbacks: 1) they cannot be used for accurate and reproducible delivery of an effective syringe mixture in amounts of less than 15-20 mg and are therefore only useful as less effective active mixtures or high potency active mixtures with a diluent, usually lactose ; 2) they are difficult to fill and clean; 3) multiple inhalations are usually required to empty the single dose contained in the capsule; 4) it is difficult to treat patients with impaired breathing or the ability to use their hands; 5) lactose, the diluent is very disturbing when inhaled and may cause an increased incidence of tooth decay.

There is a lack of an efficient powder respirator activated by the airflow generated by the inhalation, which is easy for the patient to handle, which allows the active ingredient to be dispensed in amounts up to 0.1 mg without the need to add any diluent and disperses the particles to a suitable size.

The object of the present invention is to provide a dosing and transfer device for a dispensing breathing apparatus, the so-called "powder inhaler", which is activated by the 3,79947 air flow generated by inhalation and which allows the solid active mixture to be dispensed in spray form, dispersed to a suitable size. . The dosing and transfer device can be designed for dispensing amounts of up to 5 mg of active compound. By appropriately designing the device, it can also be used to dispense 5-50 mg of active compound.

This is achieved according to the invention by using a routed membrane in the inhaler as a delivery and transfer device for the solid undiluted pharmacologically active substance in micronized form, as set out in the appended claim 1.

An embodiment of the dispensing and transfer device according to the invention in a dispensing breathing apparatus will now be described in more detail with reference to Figures 1, 2 and 3.

Figure 1 is a sectional view of a dispensing respirator.

Figure 2 shows scrapers in storage that are used to guide active ee into holes in a routed film.

Figure 3 shows how the active ee is fed from the storage unit to the holes of the perforated film by means of said scrapers.

The dispensing powder respirator comprises a control unit 1 used to supply doses of active mixture, a mouthpiece 2, which may be provided with a rotating device 3 for disintegrating any accumulated particles of active mixtures, a dosing pulse 10 for measuring the intended dosing of the active mixture and solidifying the storage space 5.

The metered-dose respirator also comprises an air duct 6 for the passage of inhaled air. The mouthpiece 2 can be provided with a rotating device 3 for disintegrating the effluent particles of the active prey formed 4,79947. Dispersion of any particulate deposits is facilitated by air inlets 7 located on the side of the mouthpiece 2.

The dosing unit 10 comprises a storage space for the active prey, a perforated film 4, a perforated film holder and a dosing device Θ schematically shown in Fig. 1 for guiding the active prey into the holes of the perforated film 4. The dosing unit 10 and the perforated membrane 4 are positioned movably relative to each other between a first position in which the dosing device Θ leads to a hole in a portion of the perforated membrane 4 and a second position in which said portion of the tensioned membrane 4 is inserted into the airway 6 of the inhaler. In said first position of the film 4, the active mixture is introduced from the storage space 5 into the holes of the film 4. When a portion of the membrane 4 containing such holes filled with the active prey is then injected into the air duct 6, the active mixture contained in the holes travels by inhalation and enters the patient's respiratory tract and lungs through the mouthpiece 2.

In the described embodiment, the introduction of the active prey into the holes of the perforated film 4 is made by a mechanical device Θ comprising flexible, spring-loaded scrapers 15 mounted on a holder 17 in the storage space 5. See Figures 2 and 3.

In a preferred embodiment, the perforated film 4 is positioned relative to the movable storage space 5.

In another preferred embodiment, the dosing support unit comprises a perforated membrane 4 which can be rotated relative to the storage space 5.

In another embodiment, flexible, spring-loaded scrapers 15 are placed in the storage space 5 for guiding the active prey into the holes of the perforated film 4.

In another preferred embodiment, the holes in the routed film 4 are frustoconical, with a large opening directed towards the mouthpiece.

s 79947

The scrapers 15 are suitably made of a flexible material, for example rubber or plastic. The scrapers are preferably positioned so that when the active mixture enters the 4o holes of the film, they contact the surface of the film at an angle of less than 90 °. When the device for introducing the active mixture into the holes of the film is thus placed, the additional advantage is provided that any accumulations of the active mixture are disintegrated before distribution.

The scrapers 15 are preferably positioned so that they press against the surface of the film 4. This is accomplished, as shown in Figure 1, by causing the spring 12 to tension the scrapers 15.

The spring 12 is placed in the storage space 5, as shown in Fig. 1.

Alternatively, the spring may be positioned so that the membrane 4 is pressed against the scrapers 15. In such a case, the spring should be located outside the storage space 5, preferably mounted on the control unit 1. Further variations are possible. The essential basic condition is that the scrapers 15 are pressed against the membrane 4 so that the active mixture enters the holes of the membrane 4 when the control unit is operating. See Figures 2 and 3.

A plate 13 is placed in the control unit 1, immediately next to the membrane 4, which prevents the active mixture from passing through the holes in the membrane 4. See Figure 1. Thus, the plate comprises the bottom of the holes.

The air line 6 passes through the control unit 1. When inhaled through the mouthpiece 2, the air flow passes partly through the air inlets 7 located on the side of the mouthpiece 2, partly through the air duct 6. The air in the air duct 6 passes through its opening 7 79947 to the control unit 1. In the embodiment shown in Fig. 1, a perforated plate 18 is placed as a filter in the opening 14 to prevent larger harmful particles from entering the air duct 6.

When a film in the form of a horizontal plane is used, as shown in Fig. 1, the film can be mounted so that it cannot be moved by rotating it, as a result of which the other parts of the dispensing respirator are fixed relative to each other.

In order to ensure that the amount of active mixture filled in the holes inserted in the air duct 6 is detached from the thighs and introduced by inhalation, said holes in the film are preferably formed as frustocones, see Figure 3, with a larger opening towards the mouthpiece. Holes in the shape of broken cones make it easier to empty the holes so that the active mixture comes off more easily. In addition, when the storage space 5 is placed between the membrane and the mouthpiece, it is also easier to fill the holes if the holes have been designed, as shown in Fig. 3. The pattern of the holes in the perforated films can be freely determined. They can be round, square, oval, rectangular or other geometric shapes. The perforated area of the film may be a large or small part of the area of the film, for example from 1 to 95%, as a result of which the expression "film area" means that part of the area of the film which is applied to the air duct. The number of holes in the membrane area may vary depending on such factors as the amount of active ingredient to be dispensed per dose, the medical properties of the active ingredient, etc. In a preferred embodiment, the shape of the holes is conical.

The perforated film can be made of any suitable material, for example metal or plastic. The dosage of the active compound to be dispensed is determined by the size of the film holes, the film thickness, the number of film holes and the size of the air duct 7,79947. A single hole may be sufficient to dispense a given dose of active mixture. The accuracy of the dosage depends mainly on the accuracy of the film preparation. Examples of routed films that can be used are metal meshes manufactured by Veco Beheer B.V., Eerbeek in the Netherlands. These nets can be obtained with holes of different sizes. They may be formed as desired, for example in the form of a drum, or they may be used in the form of horizontal flat films. Nets woven of metal, fibers or other materials may also be used. An important factor is the achievable dosing accuracy.

In the embodiment shown in Fig. 1, the control unit 1 is placed next to the dosing unit 10. The control unit can be made in the shape of a toothed ring, as shown in Fig. 2, using spring-loaded pins 11, see Fig. 1, to provide separate positions of the routed film as it is pushed forward under the action of the guide gutter 1. The control unit may be positioned differently, for example by placing it to act directly on the perforated film.

In a preferred embodiment, the storage space is placed between the perforated film and the mouthpiece. See Figure 1. The storage space can be arranged to accommodate a varying amount of active mixture. In a metered dose breathing kit in which the storage space is not made for refilling the active mixture, it may contain an amount of active mixture corresponding to, for example, up to about 200 preference units. In a metered dose inhaler where the storage space is to be refilled, a device is required that can be placed on the top or sides of the storage space. For example, the screw or pin 16 may be placed in a storage space, as shown in Figure 1.

6 79947 2

The surface area of the air duct 6 may be 25-350 mm. The air duct may be round or its geometric shape may be different. Joe it is round so its diameter may be 3-10 mm.

Among the groups of mixtures and special mixtures suitable for distribution in the powder inhaler according to the invention, mention may be made of: - beta-receptor stimulants such as adrenaline, isoprenaline, orciprenaline, salbutamol and tributaline, - budesonide-like steroids for inhalation,

Tributalin and budesonide are very helpful.

The active mixture can be dispensed in a syringe form without additives or in a pharmaceutically modified syringe form to provide improved flow properties. The spray particles can be covered with a film, for example, to mask the bitter taste of the active mixture or to provide a slow release of the active mixture in the respiratory tract.

9,79947

Avdelad frän patentansanan 822423.

For example, upstream of a perforated membrane for use in a metered dose inhaler may be used to prepare a vehicle for inhalation and for inhalation of a pharmacologically active substance in a micronized form.

Speciella krav ställs pä dosinhalatorer avsedda för lokal administrering av läkemedel account luftvägarna och lungorna. Eftersom det mestadels gäller att administrera mycket poten-ta läkemedel mäste doseringsnoggrannheten property stor. The active ingredient may be administered at a rate of 0.1 mg. In addition, the particulate matter in the dosage form can be stored in such a way that the particulate matter has a tendency to be deposited in the egg.

This flertal system finns tillgängliga för lokal administrering av läkemedel account luftvägarna och account lungorna. These systems include a nebulizer, a metered dose isolator, a pump-inhaler and an inhaler with drives in the air. . inandning, nedan kallade "pulverinhalatorer".

That the type of powder inhaler finns tillgängliga pä marknaden. However, in addition to the addition of a metered dose, the solution may be suspended or suspended. The powder inhaler is provided with all of the equipment in the feed phase, the particulate particles being generated from the air in the feed. Problems with the coordination of the implementation of the data for the implementation of the network account and the account of the long-term account are taken. That exempts the powder halator from the end of the life of the spinhaler.

I SpinhalerR används verksubstansen i mikroniserad form, innesluten i en härdgelatinkapsel som perforeras före använ-dandet. The gelatin capsule is placed in an anchorage of 10,79947 with a rotor of the airflow, the color of which is micronized to the airflow and upwards of the airflow to the patient airflow and lungor.

In particular, the pulverulent inhaler is used in the preparation of 1 to 1 mg or more of micronized substances in the formulation of micronized substances in a quantitative formulation of 15 to 20 mg of the substance itself in the form of a substance in the form of a substance. combinations of wood sprays, lactated milk; 2) is not included in the list and the contract; 3) the reverse of the rules for the use of the capsule and the capsule; 4) it is necessary for the patient to enter the environment and the environment or the environment; 5) spädningsmedlet lactakt är mycket störande vid inhalation och kan ge ökad kariesfrekvens.

In addition to the use of an effective powder inhaler, the drives are used as a means of delivering, in addition to the patient, the dispensing of the active substance in the game and the presence of 0.1 mg of the active ingredient in the formulation. som administreras.

The conditions of use of the feed and the transport system and the transport system, i.e. s.k. a powder inhaler, which drivs in the formulation and has a low dispensing capacity of the micronized form in the fast form and in the form of a thickening and does not exceed 0.1 mg after application of the formulation. Dosage inhaler 79947 can be constructed for administration of the drug and is added up to 5 mg. These can be used in the formulation of the dosage form for the administration of the active ingredient in a game of 5-50 mg.

These devices can be used as an inhaler in the form of an inhaler and a transport device for the preparation, release, pharmacologically active substance in micronized form and perforated membrane, as described in claim 1.

In the form of uptake and transport means, up to and including transport operations may be carried out with reference to Figures 1, 2 and 3.

Figure 1 shows that the genome contains a genomic dosinhalator.

Figure 2 shows a scraper in the front chamber, which shows the scrap for the infrared substrate in the perforated membrane.

Figure 3 shows the presence of a backing membrane in the perforated membrane of the perforated membrane.

Dosinhalatorn innefattar en maneuvers 1 in the case of frammatning from doser av versubstenen, to munstycke 2 som kan resi försett med en roterande anordning 3 for sön-derslagning av eventuellt bildade aggregat av verksubstenen, a doseringsenhet förrädskammare 5 för fast mikroniserad Aktiv substans.

Dosinhalatorn innehäller vidare en luftkanal 6 avsedd för passage av inandningsluften. Munstycket 2 can be used as a rotary anchor 3 to be able to use the image aggregate. Desintegre- 12 79947 ringen av eventuella partikelaggregat underlättas av vid aidan pä munstycket 2 anordnade luftintag 7.

The dosage unit 10 is an integral part of the chamber 5 for the perforation of the membrane 4, and the cradle 9 for the perforated membrane, and the dosage arrangement 8, the schematic of which is shown in Figure 1, for the installation of the membrane 10 and the volume of the diaphragm. perforated membrane 4 is provided with an anchor plate and a retaining plate of the upper part of the diaphragm 4, and the position of the perforated membrane of the 4th membrane the membranes 4 are positioned in the plurality of cells 5 and i in the membrane 4. munstycket 2 account patientens luftvägar och lungor.

In the case of a backing and a helium, the perforated membrane 4 is shown in the form of a mechanical anchorage 8 with the aid of an elastic, a sheave of scrap 15, mounted in a hollow 17 and a chamber 5. See Figures 2 and 3.

In this case, the perforated form is perforated in the membrane 4 and the perforated membrane is discharged into the chamber 5.

In this case, the perforated form of the perforated dosage form 10 and perforated membrane 4 are rotated and somewhat open to the charge of the substrate and the micronized fast form.

In this case, the above-mentioned form is elastic, and the final scraper form 15 is used in the outer chamber 5 for 79947 to infrared in the perforated chamber and the perforated plate 4.

In this case, the peripheral formulation is equipped with a perforated membrane 4 which is designed to be used as a means of repairing the equipment.

Scraper 15 is warmed to a resilient material, to exempt rubber or plastic. The screws are heated to a temperature of 90 ° C in a membrane with a temperature of 90 ° C. In this case, the transformation of the anchorage from the substrate and the diaphragm into a diaphragm can be carried out in the event of an aggregation of the substrate in the form of an administration.

Scrap 15 is shown as an anchor in the truncated membrane 4. In addition, in Figure 1, the genome in scrap 15 is shown in Figure 12. The 12 is an anchor in Figure 5, which is shown in Figure 1.

Alternatively, the anchor may be anchored to the membrane 4 for a period of 15 minutes. The anchor may be anchored to the membrane 5, warming the assembly and maneuvers 1. Ytterligare variationer är tänkbara. In this case, a scraper 15 is applied to the membrane 4 at the end of the operation of the net substance in the membrane 4 without maneuvering. See Figure 2 and Figure 3.

In the maneuver 1, the integrated circuit membrane 4, the plate 13 is arranged with a fixed value to pass through the diaphragm 4. As shown in Fig. 1. The platen 13 is provided with a means for increasing the diaphragm.

Airflow 6 passerar genomic maneuvers 1. In the genome of the airplane 2, the airflow 2 is connected to the airplane 2 by means of air ducts 7 of the airflow channel 79947 utilization for the use of the filter 14 and the filter in the form of a perforated plate 18 for the perch, in particular for the air in the air ducts 6.

In the form of a membrane in the form of a horizontal plan, as illustrated in Figure 1, the membrane may be mounted on a wall, the color of which is limited to the dosage form.

For the sake of the fleece, the fleece and the fleece can be fed to the funnel 6 of the furrow in the furrow of the furrow of the furrow of the furrow of the fuse. Conformity of the horseradish underlining the genome of the horseradish of the horseradish. In this case, the fall of the chamber 5 is arranged in the form of a diaphragm and a chamber under the headform of the headform of the whole of Figure 3.

The perforation of the perforated membranes can be carried out by the user. De kan vara circulära, kvadratiska, elliptiska, rektangulära eller ha annan geometrisk shape. Hälarean pä membranet kan utgöra en större eller mindre del av membran-ytan t.ex. frän 1 account 95%, varvid med "membranyta" avses den delyta av membranet som förs in i luftkanalen. Antalet hälrum i membranytan kan variera beroende pä Factor som den mängd verksubstans som skall administreras per dos, verksubstansens fysikaliska egenskaper etc. I use the form of a conical form.

The perforated membranes can be used to separate the heated material, e.g. metal or plastic. The capacity of the active substance of the membrane is determined by the administration of the storage of the membrane, the transmission of the membrane, the transmission of the membrane and the storage is 79947 of the air ducts. That own resources may be used for the distribution of the substance. The dosage units are framed from the nucleus and the membrane.

The exempted head perforated membrane is made of metal in the case of Veco Beheer BV., Eerbeek, The Netherlands. Dessa nät kan erhällas med olika maskstorlek. De kan forms pä önskat sätt, t.ex. the trapform or the other side of the horizon, Plana membran. Även vävda nät av metall, av fiber eller av annat material kan användas. This measure is not justified.

The maneuvers 1 are arranged, and the headforms of Fig. 1, in addition to the dosage form 10. The maneuvers are embodied in a ring, illustrated in Fig. 2, the color of which is provided by the pin 11, and in Fig. 1, the headform of the membrane när det frammatas genom päverkan av manöverorganet 1. Manö-verorganet kan anordnas även pä annat sätt, t.ex. This is a direct guide to the perforated membrane.

In the case of a chamber, it is possible to use a perforated membrane and a body. See figure 1.

The Community Chamber of Commerce may, in the case of variables, play a role. I and the metered dose inhaler are used in the first instance of the active substance in the case of active substances. upp account omkring 200 doser. The dosage inhaler for the chamber is not included in the field, but also for the placebo head or the side chamber of the chamber. Exemptions for screws or plugs 16 in the case of a single chamber are shown in Figure 1.

Luftkanalen 6 kan ha en tvärsnittsyta av 25-350 mm2. The air channel can be circulated or if it has a geometric shape. In the circular shape the diameter of the spare part is 3 mm 10 mm.

79947 BC

These substances are specific and specific to the administration of a powder inhaler or to a ligand upstream of the following: beta-receptor stimulators such as adrenaline, isoprenaline, orci-prenaline, salbutamol and terbutaline, steroid for inhalation, such as inhalation, inhalation,

Specifically användbara är terbutalin och Budesonid.

The active substance can be administered in micronized form after the other component or in a pharmaceutical modifier in micronized form for upstream of the flame retardant. The micronized particles can be used in the form of film to mask the active substance in the form of an active substance or in the form of a solid or solid substance in the air.

Claims (7)

17 79947 Use of a perforated membrane as a dosing and delivery device for undiluted pharmacologically active substance in micronized solid form at predetermined doses of 0.1 to 50 mg of said substance per dosing event, the membrane being mounted in an inhaler comprising a mouthpiece (2), an air duct (6) ) connected to the mouthpiece for conveying inhaled air, a dosing unit (10) comprising a storage space (5) for the active substance and a movable element (4) consisting of said torn film for transferring the substance from the storage space (5) to the air duct (6), the control unit (1) to move the torn film relative to the storage space with the torn film mounted on the holder (9) in the dispensing unit (10) and a plate (13) placed near the film (4) to prevent the active ingredient from passing through the holes of the film (4) when forced into the dispensing device ( 8), the membrane being movably mounted relative to said device (8), i.e. that in the first position the active substance in micronized solid form is introduced into holes in a part of the surface of the film (4), and in the second position said part of the surface of the film (4) is retained in the air duct (6). Use of a perforated film according to claim 1, characterized in that the torn film (4) is rotatable. Use of a perforated film according to claim 1 or 2, characterized in that the dispensing device (8) comprises spring-loaded scrapers (15) arranged in the storage space (5). Use of a perforated film according to claim 3, characterized in that the torn film (4) is pressed against the scrapers (15) by means of a spring. 18 79947 Use of a perforated film according to claim 2, 3 or 4, characterized in that the holes of the perforated film (4) are in the shape of frustocones, their larger opening being directed towards the mouthpiece (2). Use of a perforated film according to one of Claims 1 to 5, characterized in that the size and number of holes in the part of the film (4) intended for dosing is selected so that the dose size becomes 0.1 to 5 mg of active ingredient. agent. Use of a perforated film according to one of Claims 1 to 5, characterized in that the size and number of holes in the part of the film (4) intended for dosing are selected so that the dose size becomes 5 to 50 mg of active substance.