SI8211414A8 - Inhalator with dosing - Google Patents

Description

DOSAGE INHALER An art of the invention

The invention falls within the field of apparatus for introducing medicaments into the body, and in particular relates to inhalers. Designation according to the International Patent Classification; A 61 M 15/00.

Technical problem

The invention solves the problem of how to construct an inhalation device that will allow the drug to be accurately dispensed without the use of a carrier, such as lactose, or a capsule, which will allow inhalation of a single-breath drug dose, wherein the drug is in micronized form.

The state of the art

Currently there are special requirements for inhaler with a dosing koji su intended for local unošenje drugs in disajne authorities and lung P _{on the} WTO largely UNOS Very yaks drugs, dosage should be veoma'precizno. The dose of active substance to be administered can be approximately 0.1 mg each. It is also essential that the particles exiting the inhaler have a convenient size distribution, since too large particles tend to settle in the mouth.

There are more systems for local administration of drugs to the respiratory organs and to the lungs. Of these systems, mention should be made of misting devices, aerosol capsules, hole inhalers, and inhalers activated by inhalation-formed air flow, which will hereinafter be referred to as “powder inhalers” ·.

parb

'- 2c c c ee i * r c Γ f r ero

There are several types of powder inhalers available on the market. They process the supplement for pressurized aerosols when the drug is dissolved or suspended in a liquid propellant mixture. Inhaler! for powders, they have the advantage of always delivering the active substance when the patient is inhaling, or inhaling, since the cloud of particles is formed by the air flow generated by the inhalation. This solves the problem of coordinating the dispenser with aspiration to bring the active substance into the dietary organs and cry. One example of a commercially available powder inhaler is SPINHALEE. With SPINKALES, the active substance is used in micronized (to a maximum comminuted) form and is placed in a hard gelatin capsule that is punctured before use. The hard gelatin capsule is placed in a tube in a device or device that is reversed by the inhalation current of air, due to Sega, the micronized matter is withdrawn into the air current with which it enters the organs and the lungs duck.

The famous inhaler! for powder materials, however, the following are reported:

1) cannot be used for the precise and sequential distribution of powdered active substances in amounts of less than 15-20 mg, and therefore can only be used for minor strong drugs, or for very strong active substances in combination with some diluent , usually with lactose,

2) they are difficult to fill and just as difficult to clean,

3) it usually takes several inhalations to empty the capsule containing the single dose,

4) difficult to handle for patients with reduced respiratory capacity or reduced ability to use their hands,

5) Lactose, a disintegrating agent, has an irritant effect on inhalation and may increase the occurrence of caries.

There is a need for an effective powder inhaler, which is activated by the inhalation air flow, which is easily handled by the plugin, which will allow the active agent to be discharged.

Batteries in amounts up to 0.1 mg without the use of any dilution or dissolving agent, which will allow a suitable distribution of particle sizes to be introduced into the patient.

Description of the invention from the exemplary embodiment of the invention

The present invention relates to an inhaler, from the group of so-called. powdered matter inhaler, which is activated by an air stream generated by inhalation and which allows the discharging of the solid active substance in mizhanized form, with a convenient distribution or particle size distribution, in quantities starting at 0.1 mg without the use of a diluent. The dosage inhaler can be equilibrated for uptake of the active substance in amounts up to 5 mg · and by suitable modifications to the design of the dispenser, this inhaler can be used to introduce the active substance in quantities of 5 - 50 mg ·

The powder material inhaler according to the invention is activated by an air current generated by inhalation and is intended for the inhalation of Solid pharmacologically active substances in a micronized form. As described in the appended claims, the powder inhaler comprises a single nozzle, an air conduit, a dispenser comprising an active substance container and a dosing device? -, a dose for dosing the desired dose of the active substance, as well as a holding handle dispenser. The powder inhaler according to the invention is characterized in that the dispenser comprises a container for the active substance in combination with a dosing device containing a single perforated membrane, a perforated membrane holder, elements for introducing the active substance into the perioperations in the perforated membrane, being in the first position active substance in solid and micronized form introduced into openings, perforations, in a part of the membrane surface, while in the second m position, that j part of the membrane surface is placed in a duct for inhaled or inhaled air ·

The dosing device in combination with the active substance container represents essentially new elements of the powder inhaler according to the present invention.

- 4 Γ-ΓΓ. rr. r C rrrr r- rre ^r <<'rrrrr _f r

Short opla Picture

One embodiment of the inh3lator ea dosed according to the invention is described in more detail with reference to the accompanying drawings, wherein:

- Figure 1 shows a section through a metered dose inhaler according to the invention,

- Fig. 2 shows the rotary guides for introducing the active substance into the openings of the perforated membrane,

- Figure 3 shows how the active substance is introduced from the reservoirs into the openings in the perforated membrane by means of the aforementioned routers.

The dosage inhaler comprises a dispenser handle 1, which is used to feed the doses of the active substance, a nozzle 2 which may be equipped with a rotating element 3 intended to break the lumps of the active substance to the extent that education may occur, the dosing device 10 to measure the desired dose active substances and container 5 for two micronised active agents.

The dosing inhaler also contains an air duct 6 intended for the passage of aspirated air. the nozzle 2 may be provided with a rotating element 3 designed to break the clumps of active substance to which the education may occur. The breaking of any clumps of powdery matter is facilitated by air intake openings 7 arranged along the sides of the nozzle 2.

The bozator 10 comprises a container 5 for the active substance, a perforated membrane 4, a holder 9 of the perforated membrane and a dosing device 8 schematically shown in Fig. 1 for introducing the active substance into openings on the perforated membrane 4 · Bozator 10 and perforated mem * dam 4 are movable one relative to the other, between the first position in which the active substance is introduced into the openings in part of the surface of the perforated membrane by means of the dosing device 8,1 of the second position in which said part of the surface of the filled membrane 4 is introduced into the air duct 6 in the inhaler with dosing. In the first position of the membrane 4, the active substance ee feeds from the container 5 into the openings on the membrane 4 "When a is part of the surface of the membrane 4, which contains these openings,

 The active substance contained in these formulations will be entrapped at the inhalation and through the nozzle 2 inserted into the respiratory organs and the patient's lung.

The introduction of the active substance into the openings in the perforated membrane 4 is carried out in the described embodiment by means of a mechanical dosing device 6 containing elastic, spring-loaded, rectifiers 15 mounted on the holder 17 in the container 5- See figures 2 and 3.

in one embodiment, the perioperated membrane is displaced relative to the container 5 · in the other one embodiment, the dispenser 10 comprises a perforated, rotatable membrane 4 which is filled with solid active substance in micronized form.

in another preferred embodiment, the elastic prestressed rectifiers are arranged in the container 5 to introduce the active substance into the openings in the perforated membrane 4.

In another preferred embodiment, the openings in the perforated membrane 4 have the shape of a serrated cone, the larger openings being moderate to the nozzle.

Routers 15 are made of some elastic material, such as rubber or plastic. the guides are so arranged that when the active substance is introduced into the openings in the membrane 4, they touch the surface of the membrane at an angle of less than 90 °. When the elements for introducing the active substance into the diaphragm openings are constructed in this way, the additional advantage of breaking up any clumps of the active substance before breaking into the patient's body is achieved.

The rectifiers 15 are positioned so that they are placed under some pressure on the membrane surface 4 · lo to be achieved by having the rectifiers 15 exposed to the spring 12, as shown in the face

1. As shown on the same street, spring 12 is mounted and tank 5 · ^!

Alternatively, the spring can be positioned so that the diaphragm 4 is positioned in the direction of the puller 15. tioguce. ^r 'C rc r- r Γ e · e · ·' ^rr fr · r ¹ C r <c- re · •

> p f · · are 1 expensive variant. It is pivoted into the towers that the ee router 15 is pressed against the membrane 4 in such a way that the active substance enters the openings in the membrane 4 when the ee activates the handle. See alike 2 13.

In the handle 1, there is a plate 13 adjacent to the diaphragm 4 which prevents the active mixture from passing through the molds in the diaphragm 4. See alic 1. This way the plate 13 represents the bottom of these openings.

Air duct 6 passes through the handle 1 for handling. When inhaled through the nozzle 2, the air will partially pass through the nozzles 7 made in the lateral jets of the nozzle 2 and partly through the air duct 6. The air in the air duct 6 passes through the opening 14 in the handle 1 for handling. In the embodiment shown in paragraph 1, a perforated plate 18 is provided in the opening 14, which serves as a filter to prevent the ingress of particulate particles of larger dimensions into the air duct 6.

The perforated membrane 4 in the dispenser 10 may be made, as shown in Fig. 113, as a horizontal membrane. However, there are 1 other embodiments, such as, for example, a drum-shaped membrane in which the active substance is introduced into the openings of membranes from a container that may be outside the well or inside the well ·

When the membrane is made in the form of a horizontal membrane, as shown in Figure 1, the membrane can be positioned so that it can be rotated, with the other portions of the dosing unit being incomparable to one another.

It will be ensured that the amount of active substance introduced into the openings inserted into the air duct 6 is removed from the openings and withdrawn during inhalation, it is convenient for the openings in the membrane to be in the form of a conical cone, see Figure 3, whichever is wider. aperture directed toward the nozzle. Slotted cone openings make it easier to empty the openings so that the active substance is lowered. "In addition, when the container 5 is positioned between the nozzle membrane 1, the filling of the openings is facilitated if the openings are constructed as shown in Figure 3.

- 7 The openings in the perforated membranes can break any shape. Who can be circular, square, elliptical, rectangular or have other geometric shapes. The aperture surface in the membrane may represent a larger or smaller portion of the membrane surface, for example from 1 to 95>, wherein "e" membrane surface means that portion of the membrane surface which is inserted into the air duct; varies depending on the factors such as the amount of active substance to be administered per dose, the physical properties of the active substance, etc. In one preferred embodiment, the openings have a conical shape.

The perforated membrane can be made of any suitable material, metal or plastic. The magnitude of the dose of the active substance administered to the duct is determined by the size of the openings in the membrane, the thickness of the membrane, the number of openings in the membrane and the dimensions of the air ducts. One single orifice may be sufficient to eject a single dose of active substance. The dosage accuracy will depend to the greatest extent on the accuracy of the diaphragm. Examples of perforated membranes that can be used are metal mesh manufactured by Veco Beheer B.V., Eerbeek, The Netherlands. These nets come with different hole sizes. They can be shaped in the desired way, for example in the form of a drum, or in the form of flat horizontal elements. Woven meshes of metal fibers or other materials may also be used. An important factor is the accuracy of dosage that ee can achieve.

The handle 1 for the embodiment shown in Figure 1 is mounted next to the dispenser 10. The holder may be in the form of a serrated ring, as shown in Figure 2, where the nuts 11 with springs, see Figure 1, provide certain positions for the perforated diaphragm when this is moved by activating the handle 1 for handling. The handle may also be pressed in other ways, for example to act directly on the perforated membrane.

In one preferred embodiment, the container is positioned between the perforated membrane and the nozzle. See Figure 1.

- 8 r r r r r r r- r r r r r r- O · · r r r r r r r c r r c e c c c i ';' 'r e' ·

The container may be designed to accept different amounts of active material. In a dosage inhaler in which the container is not intended to be refilled with the active substance, it may contain an amount of the active ingredient for, for example, up to 200 unit doses. r tr ^ t _; , _t r. is one el «: er.t _: c ji makes it possible, which is placed with the sides of the side, or on the sides of the tank. Thus, for example, a screw or chi 16 may be positioned in sp-slot 5 as shown in Figure 1.

The conduit 6 for air may have a surface area of 25 to 350 mm. · The skins are circular in cross-section, or have some other geometric shape. If it is circular, its diameter may be between 3 and 10 mm

Among the complex and specific active substances which are suitable for the administration of a powder inhaler according to the present invention, the following may be mentioned:

- beta & receptor stimulating agents, such as adrenaline, isoprenaline, orciprenslin, salbutamol and terbutaline,

- steroids for inhalation, such as jellies,

- substances for the night nose («sniffling).

Terbutaline and budesonide are particularly suitable.

The active substance may be administered in milonized form without additional fiasco or. in a pharmaceutical codificlrovrm micronized form to obtain improved fluid properties.

F1-coated particles can be ⁺ covered with a thin layer, a film, which captures the bitter taste of the active substance, or secures a slight release of the active substance into the respiratory organs.

The present invention also relates to the use of a perforated membrane as a metering device for a solid, synchronized active substance in powder inhalers.

Teiaion 33Ϊ-970

73893

03.03.86.

F-1414/82

BEST OWNER, APPLICANT ΡΟΖΝΑΤΌΜ, WAY TO USEFULLY USE FRIENDLY FINDINGS

The inhaler according to the present invention can be made of any suitable material, metal, ceramics, plastics. It is most preferably made of plastic, preferably based on polyvinyl chloride or poly amide. It is advantageous for this plastic mass to be semi-transparent to control the remaining amount of medicament in the inhaler. The pooled inhaler pool is 78 mm. The nozzle pool is 24 mm. The diameter of the holder is 33 mm and the diameter of the grip is 24 mm. The nozzle opening is about 18 x 5 mm. The wall bracket is up to 2 mm in size. All elements are made by injection molding.

Claims (2)

PATENT APPLICATION 1. A dosage inhaler, activated by a stream of air preserved during inhalation, which is intended for the inoculation of a predetermined amount of pharmacologically active substance in micronized form, comprising a nozzle 2, an air conduit 6 connected to a nozzle 2, a dispenser 10 with a container 5 for the active substance, a movable element for distributing the active substance from the container 5 into the conduit 6, and a holder 1 for moving the movable element, characterized in that, in the form of a perforated perforated membrane (4), it is movable relative to the container (5) , an active substance distribution element mounted on a holder (9) in the dispenser (10), which is fitted with a device (8) for introducing the active substance into the openings in the diaphragm (4) in the dispenser (10), wherein the individual openings are diaphragms (4) placed alternately under the device (8) and in the conduit (4). An inhaler according to claim 1, characterized in that a spring housed in the holder (1) is depressed, the diaphragm (4) is supported by rectifiers (15) placed in the container (5), whereby cone-shaped cones are constructed in the diaphragm (4). openings directed by a larger base towards the nozzle (2).