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Powder inhaler

IPC classes for russian patent Powder inhaler (RU 2258539):

A61M15 - Inhaling devices

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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.

4 dwg

The technical FIELD

The invention relates to medical equipment, namely to devices designed for individual introduction of the powdered drug into the respiratory tract and lungs through the mouth and through the nose, that is to powder inhalers.

PRIOR art

The first powder inhalers for the treatment of asthma and other chronic obstructive pulmonary diseases began commercial produced by leading pharmaceutical companies of the world in the late 60-ies of the twentieth century. Since the volumes of their production and use is steadily increasing, both due to high clinical efficacy, and global environmental concerns the preservation of the ozone layer. Today, there are tens of constructions powder inhalers, commercially available in many countries around the world. The most numerous and modern class funds seems dosing powder inhalers, such as "TURBUHALER" company "ASTRA", "NOVOLIZER" company "ASTA MEDICA", "EASYHALER" company "ORION", "ZIKLOHALER" company "PULIMOOD" [1]. Such designs inhalers include multi-dose container with the medicinal powder. From the container using the built-in metering mechanism, a single dose of the powder, measured on volumetric principle kalibrovannix metering holes, moves in the air channel. Usually the content of a container designed for 100-200 single doses. To control this in the inhaler additionally establish or counter doses or container made of a transparent material that allows you to visually monitor the remaining amount of the drug.

Almost all currently released powder inhalers, except inhaler "TURBUHALER", intended for introduction into the lungs of the patient's medicines in the form of powder mixtures of fine particles of the active component with coarse particles of inert carrier such as lactose. When this mass fraction of the medium introduced into the composition of the mixture reaches 99% or more, and its particles have a size of 50-100 μm. The active component, such as salbutamol, budesonide, beclometasone, is a small mass fraction of the initial powder mixture and consists mainly of particles of respirable size with aerodynamic diameters less than 5-7 µm, which is able to penetrate to the distal lung. However, inhalation is an incomplete separation of the powder mixture, and really in the lungs gets no more than 20-30 percent of the declared quantity of the active component contained in the led of the dose of a drug. A large proportion of the part of the - up to 70 percent of the active component in the composition of large agglomerates of the initial powder mixture, not destroyed in the inhaler, is deposited in the oropharynx. There are a number of unsolicited local and systemic side effects: irritative cough, dysphonia, oropharyngeal candidiasis and others, is especially pronounced when using inhaled corticosteroids.

Thus, as the main criterion for the effectiveness of powder inhalers, you must accept the so-called "respirable dose", i.e. the mass fraction of particles of the active component deposited in the lungs for the given parameters of the respiratory maneuver. Obviously, respirable dose depends on the size of the input dose of the medicinal product and its content in the respirable fraction, which in turn are determined by the parameters of the respiratory maneuver inhalation. Typical respiratory maneuver consists of three phases: a deep breath, forced inhalation through the inhaler and breath. For powder inhalers, breath-activated, there is a threshold value of the flow rate of air that is created when inhalation, below which the value of input dose and respirable fraction will not be sufficient for the manifestation of therapeutic action of a drug.

Known metering powder ingal the tor "TURBUHALER" [1], [2], [3], [4] - multi-dose powder reservoir system, which requires setting the dose of the drug by the patient before each inhalation. Under the mouthpiece is the display window of the doses. When the device remains less than 20 doses, in the window there is a red mark.

"TURBUHALER" refers to the inhalers medium resistance passing through it to the air flow.

Patients obstructive lung diseases such as bronchial asthma, chronic bronchitis, depending on age and severity of disease are not always able to inhale through the inhaler with the best bulk velocity 60-90 l/min, providing an effective dose of a medicinal product and the high value of its respirable fraction. A well-known strong dependence of the characteristics of this type of inhalers on the magnitude of the inspiratory air flow[1], [2], [3], [4].

Thus, when the flow is equal to 30 l/min, the value of the input dose is about 70% of the measured dispenser, and the magnitude of the respirable fraction is about 15 percent.

When the flow is equal to 70 l/min, injected almost all measured dose and the magnitude of the respirable fraction exceeds 50 percent.

The marked variability of the main characteristics of the inhaler "TURBUHALER" significantly complicates the assignment of adequate dosage drug what drugs the patient.

The closest analogue may be considered dosing powder inhaler "PULVINAL" [1], [6], which relates to inhalers high resistance and ensures the efficient administration of medicine at space velocities of air flow in the range from 25 to 60 l/min

The lower threshold air flow rate can also reduce the inertial deposition of particles of the drug in the oropharynx and to increase their penetration into the lungs. However, by reducing the air flow rate to a value less 25 l/min, the efficiency of the inhaler "PULVINAL" starts to significantly decrease. So, at a speed equal to 20 l/min, the value of the input dose is reduced to about 80%, and the content of the respirable fraction is reduced to 20 percent, while at a speed of 60 l/min, nebulizer displays almost all measured dose, and the content of the respirable fraction is about 35 percent.

Thus, there is the problem of creating a powder inhaler resistance similar to the resistance, for example, the inhaler "PULVINAL", which would function effectively when the air velocity less than 20 l/min

The technical result, which is aimed by the invention, is the creation of such a powder is about inhaler, that would be dosing, simple in operation and which would ensure the effective introduction of a drug into the respiratory tract and the lungs of a person with a minimum amount of inspiratory flow.

DISCLOSURE of INVENTIONS

The technical result is achieved by the fact that the offered powder inhaler, comprising a cover protective cover case with holes for air inlet and outlet of the aerosol, the United duct, which is made of upper channels connected to the dispenser, a container for powder dispenser, made in the form of a movable plate with measuring feed slot doses of powder in the accelerating channel, characterized in that the mobile plate dispenser made extra dimensional hole, identical to the first, located at the same distance from the axis of rotation of the dispenser and offset from the first hole at a 90 degree angle so that when you turn the dispenser each from the dimensional holes alternately placed under the hole in the base of the container with powder, in one of the upper channels, each of which is divided by a partition extending from one of the walls of the acceleration channel at its output, tightly attached to the mobile plate dispenser and passing over a measuring hole on the two channels so that only one of the AC is Alov connected with dispenser, and the other channel is communicated with the first channel through the dimensional hole.

Powder inhaler shown in figures 1-4.

In figure 1 (Figure 1) presents the appearance of a powder inhaler with a protective case.

In figure 2 (Figure 2) presents Assembly drawing

powder inhaler.

In figure 3 (Figure 3) presents the execution scheme of the accelerating channel box.

In figure 4 (Figure 4) presents the image of the dispenser with measuring holes.

On the figures of the drawings presents the following positions:

1 - protective case (2),

2 - upper channels (Figure 3),

3 is a mouthpiece connected to a dispenser (2),

4 - a container (2),

5 - insert in the base of the container (2),

6 - dispenser (Figure 2),

7 - dimensional hole (Figure 4),

8 - cap (Figure 2),

9 - spring (Figure 2),

10 - extra dimensional hole (Figure 4),

11 - the wall (Figure 3).

The case of powder inhalers, are presented in figure 2, includes mouthpiece 3, connected to the dispenser, the container 4 for powder, box 5 in the base of the container 4, the dispenser 6, the cover 8, the spring 9.

We offer powder inhaler includes cover protective case 1 case with holes for air inlet and outlet of the aerosol, the United duct, which is made of the accelerating channel 2 connected to the dispenser, the container 4 on the I powder dispenser 6, made in the form of a movable plate with a measuring hole 7 for supplying doses of powder in the accelerating channel, powder inhaler differs in that the mobile plate dispenser made extra dimensional hole 10, identical to the first, located at the same distance from the axis of rotation of the dispenser and offset from the first hole at a 90 degree angle so that when you turn the dispenser each of the measuring holes alternately placed under the hole in the base of the container with powder, in one of the upper channels, each of which is divided by a partition 11 extending from one of the walls of the acceleration channel on it the output is closely adjacent to the mobile plate dispenser and passing over a measuring hole on the two channels so that only one channel is connected with the dispersant, and the other channel is communicated with the first channel through the dimensional hole.

Powder inhaler works as follows.

Located under the hole in the base of the container 4 dimensional hole 7(10) is filled with a powder of a drug. When turning the spout 6 at an angle of 90 degrees filled dimensional hole moves in one of the upper channels 2, while another dimensional hole 10 (7) moves under the hole in the base of the container 4 with the powder. Under the action of the vacuum generated in to the choose powder inhaler during inhalation of the patient, atmospheric air enters the upper channels 2 air duct, one of which is filled with powder measuring hole 7 (10). The air flow in the boost channel is divided by a partition 11 into two streams, one of which moves along the channel, directly connected with the dispersant, and the second thread is connected with the first through the measuring hole 7 (10), carrying a powder of a medicinal product and creating additional turbulence contributing to the destruction of the conglomerates of particles at the entrance to the disperser. Coming into the disperser air-powder mixture is mixed with a stream of atmospheric air entering the dispersant advanced through the other upper channel 2.

As a result of multiple collisions among themselves and with the walls of the dispersant be destruction of conglomerates of particles and generation of respirable fraction of particles of a drug. So produced aerosol enters the respiratory tract and the lungs of a patient. For the next dose of a drug powder inhaler you need to rotate the spout 6 at an angle of 90 degrees in the opposite direction. When this is filled with powder dimensional hole 10 (7) is moved in the other of the accelerating channel 2, at the same time devastated dimensional hole 7 (10) raspolagaetsja hole in the bottom of the container 4 and is filled with powder.

Thus, the proposed powder inhaler dosing is simple in operation and provides an effective introduction of the drug into the respiratory tract and the lungs of a person with a minimum amount of inspiratory flow. The proposed solution significantly simplifies the use of the powder inhaler compared with the prototype [1], [6], where for measuring a single dose of the powder is required to first turn the dispenser on the angle of rotation of 180 degrees in one direction, while holding the latch down, and then rotate the dispenser 180 degrees 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's right to follow physician's orders and in practice take prescribed drugs at the indicated dosage.

Research conducted using the proposed powder inhaler, showed that it provides an effective introduction of a drug when the air flow rate of 15 l/min It can be used for administration of medicinal preparation in the form of powder through the nose, that is the actual problem.

About 70 percent of patients with bronchial AST is th at the same time suffer from allergic rhinitis.

When you inhale one nasal passage across the proposed powder inhaler almost all patients with asthma and allergic rhinitis, were able to create a peak inspiratory flows above 15 l/min

Thus, the proposed solution allows you to expand the scope of dosing powder inhalers.

INDUSTRIAL APPLICABILITY

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. Content can be of various medicinal powder manufactured by pharmaceutical companies. Thanks to the ease of use and effectiveness, and simple production process, the offered powder inhaler may take a worthy place in the consumer market.

Sources of information

1. Medical library. Device delivery of inhaled drugs. "Russian journal of medicine Volume 10, No. 5, 2002

2. Internet:www.allergist.ru "School of bronchial asthma. Powder inhalers"

3. Internet: www.astma.com.ua "Asthma. Information. Methods of treatment. Inhalation therapy. Breath controlled powder inhalers".

4. Internet: www. Medi.ru. "Symbicort. That is Buhler. The features and benefits. AstraZeneca.

5. Internet: www.sanaris.com.ua "Beclomet Easyhaler".

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 Liebert, Inc., Volume 11, No. 5, 1998, str.

Powder inhaler, comprising a cover protective cover case with holes for air inlet and outlet of the aerosol, the United duct, which is made of upper channels connected to the dispenser, a container for powder dispenser, made in the form of a movable plate with measuring feed slot doses of powder in the accelerating channel, characterized in that the mobile plate dispenser made extra dimensional hole, identical to the first, located at the same distance from the axis of rotation of the dispenser and offset from the first hole at an angle of 90° so that by turning the dispenser each of the measuring holes alternately is placed under the hole in the base of the container with powder, in one of the upper channels, each of which is divided by a partition extending from one of the walls of the acceleration channel at its output, tightly attached to the mobile plate dispenser, and passing over a measuring hole on the two channels so that only one channel is connected with the dispersant, and the other channel is communicated with the first channel che the ez gauge hole.