RU2258539C1 - Powder inhaler - Google Patents

Abstract

FIELD: medicinal equipment.

SUBSTANCE: powder inhaler has casing equipped with air inlet apertures and aerosol discharge aperture and adapted to be covered with protective casing. Said apertures are connected with air pipeline equipped with speeding-up channels connected with disperser. Powder inhaler is further equipped with container for storage of powder, and dosing device formed as movable plate with measuring aperture for feeding of powder dose into speeding-up channel. Movable plate of dosing device is equipped with additional measuring aperture identical to above mentioned measuring aperture and spaced from axis of rotation of dosing device by the same distance and offset relative first mentioned aperture by angle of 90° so that upon turning of dosing device each of said measuring apertures is alternatively arranged under aperture in base of container for powder or under one of speeding-up channels. Each of speeding-up channels is separated by partition wall protruding from one of speeding-up channel walls at its outlet end. Said wall tightly adheres to movable plate of dosing device and is extending above measuring aperture across two channels so that one of channels is connected with disperser and other channel is communicating with first channel through measuring aperture.

EFFECT: increased efficiency in introducing of medicinal preparation into individual's respiratory tracts and lungs with minimal value of created inspiration flow.

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Description

FIELD OF TECHNOLOGY

The invention relates to medical equipment, namely to devices intended for the individual administration of powdered drugs into the respiratory tract and lungs of a person through the mouth and nose, that is, to powder inhalers.

BACKGROUND OF THE INVENTION

The first powder inhalers for the treatment of bronchial asthma and other chronic obstructive pulmonary diseases began to be manufactured industrially by the leading pharmaceutical companies of the world in the late 60s of the twentieth century. Since then, the volumes of their production and use have been steadily increasing, due to both high clinical efficacy and global environmental considerations for the conservation of the ozone layer of the Earth. Today, dozens of designs of powder inhalers are commercially available in many countries of the world. The most numerous and modern class of products is represented by metered-dose powder inhalers, for example, such as TURBUHALER by ASTRA, NOVOLIZER by ASTA MEDICA, EASYHALER by ORION, CYCLOCHALER by PULMOMED [1]. Such inhaler designs include a multi-dose drug powder container. Using a built-in dispensing mechanism, a single dose of powder, measured according to the volume principle in calibrated dispensing holes, is transported into the air channel from the container. Typically, the contents of the container is designed for 100-200 unit doses. To control this, either a dose counter is additionally installed in the inhaler, or the container is made of a transparent material that allows you to visually monitor the remaining amount of the drug.

Almost all currently available powder inhalers, with the exception of the TURBUHALER inhaler, are intended for the administration to the patient’s lungs of medicines in the form of powder mixtures of finely divided particles of the active component with coarse particles of an inert carrier such as lactose. In this case, the mass fraction of the carrier introduced into the mixture reaches 99 percent or more, and its particles have sizes of 50-100 microns. The active component, for example, salbutamol, budesonide, beclomethasone, makes up a small mass fraction of the initial powder mixture and mainly includes particles of respirable sizes with aerodynamic diameters of less than 5-7 microns, which are able to penetrate the distal parts of the lungs. However, with inhalation, an incomplete separation of the powder mixture occurs and actually no more than 20-30 percent of the declared amount of the active component contained in the administered dose of the drug enters the lungs. A large proportion of particles — up to 70 percent of the active component in the large agglomerates of the initial powder mixture that did not break down in the inhaler, is deposited in the oropharynx. At the same time, a number of undesirable local and systemic side effects are observed: irritative cough, dysphonia, oropharyngeal candidiasis, etc., especially pronounced when using inhaled glucocorticosteroids.

Thus, as the main criterion for the effectiveness of powder inhalers, it is necessary to take the so-called "respirable dose", that is, the mass fraction of particles of the active component that are deposited in the lungs at given parameters of the respiratory maneuver. It is obvious that the respirable dose depends on the magnitude of the administered dose of the drug and its content in the respirable fraction, which in turn are determined by the parameters of the respiratory maneuver during inhalation. A typical breathing maneuver consists of three phases: deep exhalation, forced inhalation through an inhaler, and breath holding. For a powder inhaler activated by inhalation, there is a threshold value of the air volumetric velocity created during inhalation, below which the magnitude of the administered dose and respirable fraction will be insufficient for the therapeutic effect of the drug.

The well-known metering powder inhaler "TURBUHALER" [1], [2], [3], [4] is a multi-dose reservoir powder system that requires the patient to set a dose of the drug before each inhalation. Under the mouthpiece is the dose indicator window. When less than 20 doses remain in the device, a red mark appears in the window.

"TURBUHALER" refers to a medium-resistance inhaler that passes through it.

Patients with obstructive pulmonary diseases, such as, for example, bronchial asthma, chronic bronchitis, depending on the age and severity of the disease, are not always able to breathe through this inhaler with an optimal volumetric rate of 60-90 l / min, which provides an effective dose of the drug and the high value of its respirable fraction. The strong dependence of the characteristics of this type of inhaler on the value of the inspiratory air flow is known [1], [2], [3], [4].

So, with a flow equal to 30 l / min, the dose administered is about 70% of the metered dose, and the respirable fraction is about 15 percent.

With a flow of 70 l / min, almost the entire measured dose is administered, and the size of the respirable fraction exceeds 50 percent.

The noted variability of the main characteristics of the TURBUHALER inhaler significantly complicates the appointment of an adequate dosage of drugs to the patient.

The closest analogue can be considered the PULVINAL dosing powder inhaler [1], [6], which refers to high-resistance inhalers and ensures the effective administration of drugs at air volumetric flow rates in the range of 25 to 60 l / min.

A decrease in the threshold value of the air flow rate also allows to reduce the inertial deposition of particles of drugs in the oropharynx and increase their penetration into the lungs. However, when the airflow rate decreases to a value less than 25 l / min, the effectiveness of the PULVINAL inhaler begins to noticeably decrease. So, at a speed of 20 l / min, the administered dose decreases to about 80%, and the content of the respirable fraction decreases to 20 percent, while at a speed of 60 l / min, almost the entire measured dose is taken out of the inhaler, and the content of the respirable fraction is approximately 35 percent.

Thus, there is the problem of creating a high-resistance powder inhaler that is close in resistance, for example, to the PULVINAL inhaler, which would function effectively at air flow rates of less than 20 l / min.

The technical result, the achievement of which the present invention is directed, is the creation of such a powder inhaler that would be metered, easy to use and which would ensure the effective administration of the drug into the respiratory tract and lungs of a person with a minimum amount of inspiratory flow created.

SUMMARY OF THE INVENTION

The technical result is achieved by the fact that a powder inhaler is provided, including a housing covered with a protective cover with openings for air inlet and aerosol outlet connected by an air duct, in which booster channels connected to the dispersant are made, a powder container and a dispenser made in the form of a movable plate with a measured a hole for supplying a dose of powder to the booster channel, characterized in that an additional measuring hole is made in the movable plate of the dispenser, identical to the first, located on the same distance from the axis of rotation of the dispenser and offset from the first hole by an angle of 90 degrees so that when the dispenser is rotated, each of the measuring holes is alternately placed either under the hole in the base of the powder container, or in one of the booster channels, each of which is divided by a partition, departing from one of the walls of the booster channel at its exit, tightly adjacent to the movable plate of the dispenser and passing over the measuring hole into two channels so that only one of the channels is connected to the dispersant, and the other channel It communicates with the first passage through the dimensional hole.

A powder inhaler is shown in figures 1-4.

Figure 1 (Figure 1) shows the appearance of a powder inhaler with a protective case.

Figure 2 (Figure 2) presents an assembly drawing

powder inhaler.

Figure 3 (Figure 3) shows a diagram of the execution of the upper channels in the insert.

Figure 4 (Figure 4) shows an image of a dispenser with measuring holes.

In the drawings, the following positions are presented:

1 - a protective cover (Figure 2),

2 - booster channels (Figure 3),

3 - a mouthpiece connected to a dispersant (Figure 2),

4 - container (Figure 2),

5 - insert into the base of the container (Figure 2),

6 - dispenser (Figure 2),

7 - measuring hole (Figure 4),

8 - plug (Figure 2),

9 - spring (Figure 2),

10 - additional measuring hole (Figure 4),

11 - a partition (Figure 3).

The powder inhaler body shown in FIG. 2 includes a mouthpiece 3 connected to a dispersant, a powder container 4, an insert 5 in the base of the container 4, a dispenser 6, a plug 8, a spring 9.

The proposed powder inhaler includes a housing covered with a protective cover 1 with openings for air inlet and aerosol outlet connected by an air duct, in which acceleration channels 2 are made, connected to a dispersant, a powder container 4 and a dispenser 6 made in the form of a movable plate with a measuring hole 7 for feeding a dose of powder into the booster channel, while the powder inhaler is characterized in that an additional metering hole 10, identical to the first, located in the same section, is made in the movable plate of the dispenser away from the axis of rotation of the dispenser and offset from the first hole by an angle of 90 degrees so that when the dispenser is rotated, each of the measuring holes is alternately placed either under the hole in the base of the powder container, or in one of the booster channels, each of which is separated by a partition 11 from one of the walls of the booster channel at its outlet, which is adjacent to the movable plate of the dispenser and passes over the measuring hole into two channels so that only one of the channels is connected to the dispersant, and the other channel is connected Xia with the first channel through dimensional hole.

A powder inhaler works as follows.

Located under the hole in the base of the container 4, the measuring hole 7 (10) is filled with the powder of the drug. When the dispenser 6 is rotated through an angle of 90 degrees, the filled measuring hole moves into one of the accelerating channels 2, while the other measuring hole 10 (7) moves under the hole in the base of the powder container 4. Under the action of the rarefaction created in the powder inhaler casing during the patient’s inhalation, atmospheric air enters the accelerating channels 2 of the air duct, in one of which there is a measuring hole 7 filled with powder (10). The air flow in this accelerating channel is divided by a partition 11 into two streams, one of which moves along a channel directly connected to the dispersant, and the second stream is connected to the first through a measuring hole 7 (10), entraining the drug powder and creating additional turbulence contributing to the destruction of conglomerates of particles at the entrance to the dispersant. The air-powder mixture entering the dispersant is mixed with the stream of atmospheric air entering the dispersant additionally through another accelerating channel 2.

As a result of multiple collisions between themselves and with the walls of the dispersant, particle conglomerates are destroyed and a respirable fraction of the drug particles is generated. The aerosol thus formed enters the respiratory tract and lungs of the patient. To introduce the next dose of the drug using a powder inhaler, it is necessary to turn the dispenser 6 at an angle of 90 degrees in the opposite direction. In this case, the measuring hole 10 (7) filled with powder is moved to another accelerating channel 2, while the empty measuring hole 7 (10) is located under the hole in the base of the container 4 and is filled with powder.

Thus, the proposed powder inhaler is metered, easy to use and provides an effective introduction of the drug into the respiratory tract and lungs of a person with a minimum amount of created inspiratory flow. The proposed solution significantly simplifies the use of a powder inhaler compared to the prototype [1], [6], in which to measure a single dose of powder, you first need to turn the dispenser an angle of rotation of 180 degrees in one direction, while holding the latch in the pressed position, and then turn 180 degree dispenser in the opposite direction.

Using the proposed powder inhaler, it is possible to increase the so-called “compliance” - the ability and desire of the patient to correctly follow the doctor’s instructions and in practice to take the prescribed drugs in the specified dosage.

Studies conducted using the proposed powder inhaler, showed that it provides effective administration of the drug at an air flow rate of 15 l / min. This allows you to use it to administer a drug in powder form through the nose, which is an urgent task.

Approximately 70 percent of patients with asthma simultaneously suffer from allergic rhinitis.

When inhaling in one nasal passage through the proposed powder inhaler, almost all patients suffering from bronchial asthma and allergic rhinitis were able to create peak inspiratory flows above 15 l / min.

Thus, the proposed technical solution allows to expand the scope of metering powder inhalers.

INDUSTRIAL APPLICABILITY

The powder inhaler has a fairly simple device that allows you to quickly establish its serial production, as it can be made of transparent and opaque plastic and other similar materials. Filling can be various medicinal powder mixtures made by pharmaceutical enterprises. Due to the ease of use and impact efficiency, as well as the simple manufacturing process, the proposed powder inhaler can take its rightful place in the consumer market.

Sources of information

1. Medical library. Delivery devices for inhaled drugs. Russian Medical Journal Volume 10, No 5, 2002

2. Internet: www.allergist.ru “School of bronchial asthma. Powder Inhalers

3. Internet: www.astma.com.ua “Asthma. Information. Treatment methods. Inhalation therapy. Inhaled, controlled powder inhalers. ”

4. Internet: www. Medi.ru. “Symbicort. Turbuhaler. Features and benefits. AstraZeneca. "

5. Internet: www.sanaris.com.ua "Beklomet Izheiler".

6. "The Effect of Flow Rate on Drug Delivery from the Pulvinal, a High-Resistance Dry Powder Inhaler." B.J.MEAKIN, Journal of Aerosol Medicine, Ed. Mary Ann Libert, Inc., Volume 11, No. 5, 1998, p. 143152.

Claims (1)

A powder inhaler comprising a housing covered with a protective cover with openings for air inlet and aerosol outlet connected by an air duct in which booster channels are connected to a dispersant, a powder container and a dispenser made in the form of a movable plate with a measuring hole for feeding a dose of powder into the booster channel, characterized in that an additional measuring hole is made in the movable plate of the dispenser, identical to the first, located at the same distance from the axis of rotation of the dispenser and offset from relative to the first hole through an angle of 90 ° so that when the dispenser is rotated, each of the measuring holes is alternately placed either under the hole in the base of the powder container or in one of the booster channels, each of which is divided by a partition extending from one of the walls of the booster channel to an outlet tightly adjacent to the movable plate of the dispenser, and passing over the measuring hole into two channels so that only one of the channels is connected to the dispersant, and the other channel communicates with the first channel through the measuring hole.

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