KR20190135727A - Device for inhalation - Google Patents

Abstract

A device for inhalation according to one embodiment of the present invention comprises a main body unit; a flow path unit provided inside the main body unit and providing a passage for moving particles including a drug; and a guide unit which is formed spirally extending along the inner circumferential surface of the flow path unit to guide the flow of particles passing through the flow path unit into the spiral flow.

Description

Inhalation Device {DEVICE FOR INHALATION}

The present invention relates to a device for inhalation.

In general, a dry powder inhaler (DPI) is a breath-actuated inhaler that delivers micronized drug particles to the organs and bronchus, which is the target organ, and includes drug stability, patient compliance, and portability. In terms of sex, it is being replaced by conventional inhalers, quantitative inhalers and fume inhalers.

On the other hand, in order for the drug filled in the powder inhaler to show the correct action in the target organ and the side effects of the drug in the target organ are suppressed, the delivery efficiency in which the drug released from the powder inhaler is delivered to the target organ is important.

The delivery efficiency of the drug is known to be determined by the Aerodynamic Diameter, it is known that the drug particles having aerodynamic diameter of 1um to 5um is delivered to the target organ.

As such, the aerodynamic diameter is an important factor in determining the potency and side effects of the drug, which is a parameter derived from drugs such as drug particle size, cohesion and adhesion, and electrostatic attraction of the drug and carrier, air resistance, flow rate, aerodynamics, etc. Parameters from environmental inhalers and environmental parameters.

Drugs filled in the powdered inhaler are generally micronized to achieve the desired aerodynamic drug particle size, whereby the drug particles filled in the powdered inhaler tend to agglomerate to form aggregates.

As the aerodynamic diameter of the drug is increased by the aggregate thus formed, there is a problem that the drug released from the powder inhaler adheres to the upper airway, and the drug released from the powder inhaler is delivered to the target organ. There is a problem that the transfer efficiency is lowered.

Korean Unexamined Patent Publication No. 10-2018-0030198 (published Mar. 21, 2018)

The present invention provides an inhalation device capable of effectively delivering a drug released from a powdered inhaler to a target organ.

According to one embodiment of the invention, the main body; A flow path part provided inside the main body part and providing a passage for moving particles including drugs; And a guide part formed spirally extending along the inner circumferential surface of the flow path part to guide the flow of the particles passing through the flow path part into a spiral flow.

The guide unit may include: a first guide protrusion protruding spirally from an inner circumferential surface of the flow path unit; And a second guide protrusion that spirally protrudes from an inner circumferential surface of the flow path portion, wherein the first guide protrusion and the second guide protrusion may be alternately formed.

In addition, the first guide protrusion and the second guide protrusion may be formed in a symmetrical shape with respect to the center line of the flow path part.

In addition, a central flow path may be formed between the end face of the first guide protrusion and the end face of the second guide protrusion in the center of the flow path part.

In addition, it may further include a mounting portion extending from the periphery of the main body portion, and selectively mounted to the powder inhaler.

The apparatus may further include a communication unit provided in the main body portion between the mounting portion and the flow path portion.

In addition, the communicating portion may have a diameter larger than the diameter of the flow path portion.

According to one embodiment of the present invention, there is an effect that the drug released from the powder inhaler can be effectively delivered to the target organ.

1 is a view showing a state in which the inhalation device according to an embodiment of the present invention is mounted on a powder type inhaler.
FIG. 2 is a perspective view illustrating the suction device of FIG. 1. FIG.
FIG. 3 is a view illustrating the inside of the inhalation device of FIG. 1.
4 is a plan view of the inhalation device of FIG. 1.
FIG. 5 is a view illustrating an inlet of a flow path of the suction device of FIG. 1. FIG.
FIG. 6 is a perspective view schematically illustrating the first guide protrusion of the suction device of FIG. 1. FIG.
FIG. 7 is a perspective view schematically illustrating a second guide protrusion of the suction device of FIG. 1. FIG.
FIG. 8 is a measurement of an axial velocity magnitude of airflow of a powder inhaler equipped with a non-spiral suction device and a powder inhaler equipped with a suction device according to an embodiment of the present invention. One result is shown.
FIG. 9 illustrates a radial velocity magnitude of airflow of a powder inhaler equipped with a non-spiral inhalation device and a powder inhaler equipped with an inhalation device according to an embodiment of the present invention. Results are shown.
FIG. 10 shows a result of measuring streamlined airflow of a powder inhaler equipped with a non-spiral inhalation device and a powder inhaler equipped with an inhalation device according to an embodiment of the present invention.
Figure 11 shows the results of measuring the drug particle behavior of the powder inhaler equipped with a non-spiral inhalation device, and the powder inhaler equipped with an inhalation device according to an embodiment of the present invention.
12 is a graph measuring the drug particle mass distribution of a powder inhaler equipped with a non-spiral inhalation device and a powder inhaler equipped with an inhalation device according to an embodiment of the present invention.
Figure 13 shows the results of photographing the drug particle release aspect of the powder inhaler equipped with a non-spiral inhalation device, and the powder inhaler equipped with an inhalation device according to an embodiment of the present invention.
FIG. 14 is a graph measuring aerosol performance of a powder inhaler equipped with a non-spiral inhalation device and a powder inhaler equipped with an inhalation device according to an embodiment of the present invention.

Hereinafter, with reference to the accompanying drawings will be described in detail the configuration and operation according to the embodiment of the present invention. The following description is one of several aspects of the invention that can be claimed, and the following description may form part of the detailed description of the invention.

However, in describing the present invention, a detailed description of known configurations or functions may be omitted to clarify the present invention.

As the invention allows for various changes and numerous embodiments, particular embodiments will be illustrated in the drawings and described in detail. However, this is not intended to limit the present invention to specific embodiments, it should be understood to include all changes, equivalents, and substitutes included in the spirit and scope of the present invention.

Terms including ordinal numbers such as first and second may be used to describe various components, but the components are not limited by such terms. These terms are only used to distinguish one component from another.

The terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting of the present invention. Singular expressions include plural expressions unless the context clearly indicates otherwise.

In addition, in the present specification, the direction expression of up, down, side, etc. are described based on the illustration of the drawings, and it will be apparent that it may be expressed differently when the direction of the corresponding object is changed.

Hereinafter, a suction device 1 according to an embodiment of the present invention will be described with reference to the drawings.

Referring to FIG. 1, the inhalation device 1 according to an embodiment of the present invention may be selectively mounted on the powder inhaler 2, and the particles containing the drug passing through the inhalation device 1 may be used. By inducing the flow into the helical flow, even if the drugs in the powder inhaler 2 are aggregated to form aggregates, the formed aggregates can be dispersed into fine drug particles. Thus, the drug released from the powder inhaler 2 can be effectively delivered to the target organ through the inhalation device 1.

2 to 7, the suction device 1 according to an embodiment of the present invention includes a main body 10, a flow path 20, a guide 30, a mounting portion 40, and a communication portion ( 50).

At least a part of the main body 10 may be inserted into the mouth of the user, and when the user inhales air while the upper end of the main body 10 is inserted into the mouth of the user, the powder inhaler 2 is filled. Drug can be delivered to the target organ.

In this case, in order to easily insert the main body 10 into the mouth of the user, the main body 10 may have a diameter that increases in diameter from the upper end to the lower end, that is, the closer to the mounting part 40.

The body part 10 may include, for example, a synthetic resin such as an acrylic-based resin. However, this is only an example, and this does not limit the spirit of the present invention. The material of the main body 10 can be variously modified with a polyethylene-based resin or a polypropylene-based resin that is harmless to a human body.

On the other hand, the body portion 10 may be formed to have a length of 2cm to 8cm as an example. If the length of the body portion 10 is less than 2 cm, the length of the flow path portion 20 to be formed inside the body portion 10 is also shortened so that the flow of particles containing drugs cannot be induced into the helical flow. If the length of the 10 exceeds 8cm, the suction force to be provided from the user should be large corresponding to the length of the body portion 10, there is a difficulty in using.

The flow path part 20 may be provided inside the body part 10 to provide a passage for moving particles including drugs.

For example, the flow path part 20 may be provided in a circular hollow, and the diameter of the flow path part 20 may be 0.2 cm to 2 cm. When the diameter of the flow path part 20 is less than 0.2 cm, air and drugs are not smoothly discharged through the flow path part 20, and when the diameter of the flow path part 20 exceeds 2 cm, the air flows through the flow path part 20. And the degree to which the drug is released may be so great that it is inconvenient to use.

The guide part 30 may induce a flow of particles passing through the flow path part 20 into a helical flow.

To this end, the guide part 30 may extend in a spiral form along the inner circumferential surface of the flow path part 20. In this case, the guide part 30 may include the first guide protrusion 31 spirally protruding from the inner circumferential surface of the flow path part 20 and the second guide protrusion 32 spirally protruding from the inner circumferential surface of the flow path part 20. It may include.

The first guide protrusion 31 and the second guide protrusion 32 may be alternately formed. As such, the flow of particles passing through the guide part 30 is directed toward the center of the flow path part 20 due to the first guide protrusion 31 and the second guide protrusion 32 having a staggered structure in opposite directions. It can be led to a swirling flow, for example a helical flow. In addition, agglomerates formed by agglomeration of the drugs of the powder inhaler 2 may be dispersed into fine drug particles again by the shear force formed in the process of inducing the flow of the particles into the spiral flow.

The first guide protrusion 31 and the second guide protrusion 32 may be formed in a symmetrical shape with respect to the center line of the flow path part 20. The shape of the first guide protrusion 31 and the second guide protrusion 32 will be described. The first guide protrusion 31 has a first side surface 311, a second side surface 312, and a distal end surface 313. The second guide protrusion 32 may include the first side surface 321, the second side surface 322, and the end surface 323.

At this time, the space between the first side surface 311 or the second side surface 312 of the first guide protrusion 31 and the second side surface 322 or the first side surface 321 of the second guide protrusion 32 is reduced. The spiral flow path of the particles can be established. In addition, a central flow path 21 may be formed between the end surface 313 of the first guide protrusion 31 and the end surface 323 of the second guide protrusion 32. Particles containing the drug may flow through the central flow passage 21.

The mounting portion 40 is a portion selectively mounted on the powder inhaler 2 and may extend from the circumference of the body portion 10 to the radially outer side of the body portion 10.

At this time, the mounting portion 40 may be formed to be curved to the inner surface of the mounting portion 40 in contact with the powder inhaler 2 in order to increase the adhesion with the powder inhaler 2, the circumference of the mounting portion 40 It may be made of a curved surface.

Meanwhile, a fixing rib 41 may be disposed in the mounting portion 40, and the fixing rib 41 may extend downward from at least a portion of the circumference of the communication portion 50. Accordingly, when the mounting portion 40 is mounted on the powder inhaler 2, the inner surface of the fixed rib 41 comes into contact with the outer surface of the powder inhaler 2 within the mounting portion 40, thereby providing a device for inhalation. Separation of (1) from the powder inhaler 2 can be prevented.

The communication part 50 is a part provided inside the main body part 10 between the mounting part 40 and the flow path part 20, and may communicate between the powder inhaler 2 and the flow path part 20.

On the other hand, the communication unit 50 may have a diameter larger than the diameter of the flow path unit 20 as an example. Accordingly, the drug of the powder inhaler 2 may be smoothly sucked through the communicating part 50 and provided to the flow path part 20.

<Example>

Using a 3D printer (IM-96, Carima, Korea), a suction device 1 including a guide portion 30 extending spirally along the inner circumferential surface of the flow path portion 20 was manufactured.

Comparative Example

A non-spiral suction device was prepared in which the inner circumferential surface of the flow path portion was flat.

Experimental Example 1 Axial velocity magnitude of airflow measurement

The non-spiral suction device according to the comparative example is mounted on the powder inhaler 2, and the suction device 1 according to the embodiment is mounted on the powder inhaler 2, and then Computational Fluid Dynamics, Numerical analysis was performed using CFD).

At this time, the flow rates of the non-helical suction device according to the comparative example and the suction device 1 according to the embodiment were set to 28.3 L / min, 60 L / min and 90 L / min. Part (a) shown in FIG. 8 shows the air flow during the initial release of air and drug release through the non-spiral inhalation device according to the comparative example and the inhalation device 1 according to the embodiment, and in FIG. Part (b) shown shows the air flow after the initial release.

Referring to part (a) of FIG. 8, during the initial discharge, the flow path portion of the non-spiral suction device showed rapid air flow in one direction, for example, away from the flow path portion, and the periphery of the flow path portion was in the other direction. For example, it can be seen that the slow air flow in the direction closer to the flow path. On the other hand, it can be seen that during the initial release the flow path 20 of the inhalation device 1 according to the embodiment shows a relatively low and uniform air flow.

 Referring to part (b) of FIG. 8, in the case of the non-helical suction device after the initial discharge, the air flow is sharply slowed, but the suction device 1 according to the embodiment has an air flow after the initial discharge. It can be seen that it is not concentrated in the center part.

On the other hand, as the flow rates increased to 28.3 L / min, 60 L / min and 90 L / min, in the case of the non-helical suction device according to the comparative example, the air flow was biased around the center, and the flow rate deviation increased.

On the contrary, even if the flow rates increased to 28.3 L / min, 60 L / min and 90 L / min, the inhalation device 1 according to the embodiment does not have a centered air flow, and no concentration section of the flow rate occurred.

Experimental Example 2 Measurement of Radial Velocity Magnitude of Airflow

The non-spiral suction device according to the comparative example is mounted on the powder inhaler 2, and the suction device 1 according to the embodiment is mounted on the powder inhaler 2, and then computational fluid dynamics (CFD) is used. Numerical analysis was performed.

At this time, the flow rates of the non-helical suction device according to the comparative example and the suction device 1 according to the embodiment were set to 28.3 L / min, 60 L / min and 90 L / min. In addition, the radial velocity magnitude of the air flow in the cross section at positions 1 mm, 5 mm and 10 mm from the flow path portion of the non-helical suction device according to the comparative example and the flow path portion 20 of the suction device 1 according to the embodiment, respectively. Measured.

Referring to FIG. 9, in the case of the suction device according to the comparative example, the air flow velocity was strongly concentrated in the center portion at positions 1 mm, 5 mm, and 10 mm away from the flow path portion, and velocity layers were vertically oriented. It appeared clearly.

On the contrary, in the case of the suction device 1 according to the embodiment, air is rotated along the guide part 30 of the suction device 1 according to the embodiment so that the rotational flow of air continues in the guide part 30. As a result, the air flow rate was not concentrated in the center portion of the positions 1 mm, 5 mm, and 10 mm away from the flow path portion 20, and showed a slow and uniform air flow rate.

On the other hand, as the flow rates increased to 28.3 L / min, 60 L / min and 90 L / min, in the case of the non-helical suction device according to the comparative example, the air flow was biased around the center, and the flow rate deviation increased.

On the other hand, even if the flow rate is increased to 28.3L / min, 60L / min and 90L / min, the inhalation device 1 according to the embodiment is not biased around the air flow, the concentration section of the flow rate did not occur.

Experimental Example 3 Streamlined Airflow Measurement

The non-spiral suction device according to the comparative example is mounted on the powder inhaler 2, and the suction device 1 according to the embodiment is mounted on the powder inhaler 2, and then computational fluid dynamics (CFD) is used. Numerical analysis was performed.

At this time, the flow rates of the non-helical suction device according to the comparative example and the suction device 1 according to the embodiment were set to 28.3 L / min, 60 L / min and 90 L / min.

Referring to FIG. 10, a strong linear movement in the center was observed during the initial release of air and drug release through the non-spiral inhalation device according to the comparative example at flow rates of 28.3 L / min, 60 L / min and 90 L / min. , The turbulence of fractional shape was shown.

On the other hand, strong rotation due to the shape of the guide part 30 during the initial release of air and drug release through the inhalation device 1 according to the embodiment at flow rates of 28.3 L / min, 60 L / min and 90 L / min It showed turbulence. The air flow pattern was similar to the shape of the guide portion 30 regardless of the flow rate.

Experimental Example 4 Measurement of Drug Particle Behavior

The non-spiral suction device according to the comparative example is mounted on the powder inhaler 2, and the suction device 1 according to the embodiment is mounted on the powder inhaler 2, and then computational fluid dynamics (CFD) is used. Numerical analysis was performed.

At this time, the flow rates of the non-helical suction device according to the comparative example and the suction device 1 according to the embodiment were set to 28.3 L / min, 60 L / min and 90 L / min. In addition, the Eulerian-fluid / Lagrangian-particle equation was used to simulate the drug particle behavior of the non-spiral inhalation device according to the comparative example and the inhalation device 1 according to the embodiment for a time between 0 ms and 10 ms.

Referring to FIG. 11, in the case of the non-spiral inhalation device according to the comparative example, the movement of the drug particles appeared in a linear direction, and it was confirmed that the flow of the drug particles was divided into several stages at 60 L / min and 90 L / min sections. .

In contrast, the inhalation device 1 according to the embodiment has a uniform distribution of drug particles while the released drug particles form a uniform turbulence as a whole.

Experimental Example 5 Measurement of Drug Particle Mass Distribution

A non-spiral suction device according to a comparative example was mounted on the powder inhaler 2, and the suction device 1 according to the embodiment was mounted on the powder inhaler 2.

Next, when the non-spiral suction device according to the comparative example and the suction device 1 according to the embodiment were sucked at a flow rate of 60 L / min, a distance of 1 mm upward from the flow path portion of the non-helical suction device according to the comparative example The mass distribution of the drug particles passing through the separated points and the points spaced 1 mm upward from the flow path part 200 of the inhalation device 1 according to the embodiment was measured by time.

Referring to FIG. 12, the non-spiral inhalation device according to the comparative example showed two concentrated drug mass distributions within 1 ms, and the inhalation device 1 according to the embodiment showed one concentrated drug mass between 1 ms and 2 ms. Distribution.

Experimental Example 6 Measurement of Drug Particle Release Pattern

A non-spiral suction device according to a comparative example is mounted on a powder inhaler 2 filled with aformoterol tartrate, budesonide, and lactose mixture (0.04: 2.0: 97.96), and the suction device according to the embodiment (1) ) Was mounted on a powder inhaler 2 filled with aformoterol tartrate, budesonide, lactose mixture (0.04: 2.0: 97.96).

Subsequently, when the non-helical suction device according to the comparative example and the suction device 1 according to the embodiment were sucked at a flow rate of 60 L / min, the release pattern of the drug particles was measured using a Particle Image Velocimetry (PIV). Photographed using. At this time, the imaging was performed at 25 ms, 50 ms, 70 ms and 100 ms after the release of the drug.

Referring to FIG. 13, in the case of the non-spiral inhalation device according to the comparative example, at 25, 50, 70, and 100 ms after the release of the drug, the drug particles were released in fractional form, and some aggregates were released at a high rate. It confirmed that it became.

On the other hand, in the inhalation device 1 according to the embodiment the drug particles were released in the V-shape at the time of 25ms, 50ms, 70ms and 100ms after the release of the drug, the number of drug particles released at a high rate in the comparative example It can be seen that significantly lower than the non-spiral suction device according to.

Experimental Example 7 Aerosol Performance Measurement

Non-spiral inhalation device according to Comparative Example and inhalation device according to Example using Anderson Cascade Impactor (ACI) (TE-20-800, TISCH Environmental, Inc., OH, USA) The aerosol performance of was measured.

At this time, the experiment was performed at a flow rate of 60 L / min, quantifying each stage, and through the results,% ED (emitted dose), MMAD (mass median aerodynamic diameter), GSD (geometric standard deviation),% FPF (fine particle) fraction) was calculated.

Referring to FIG. 14, the% ED of the powder inhaler 2 equipped with the non-spiral inhalation device according to the comparative example and the powder inhaler 2 equipped with the inhalation device 1 according to the embodiment is 90%. It appeared as above.

In addition, in the case of the powder inhaler 2 equipped with the non-spiral inhalation device according to the comparative example,% FPF was found to be 17.2 ± 0.7%, and in the case of the inhalation device 1 according to the embodiment,% FPF was 22.6 ± 4.6%.

Further, in the case of the powder inhaler 2 equipped with the non-spiral suction device according to the comparative example, the MMAD was found to be 4.4 ± 0.4 μm, and in the case of the suction device 1 according to the embodiment, the MMAD was 1.7 ±. 0.6 μm.

In addition, in the case of the powder inhaler 2 equipped with the non-spiral inhalation device according to the comparative example, the GSD was 2.8 ± 0.2, and in the case of the inhalation device 1 according to the embodiment, the GSD was 1.6 ± 0.1. Appeared.

That is, the powder inhaler 2 equipped with the inhalation device 1 according to the embodiment has a separation particle diameter of the drug particles relatively compared to the powder inhaler 2 equipped with the non-spiral inhalation device according to the comparative example. It was found that the drug particle distribution was low at 0 to 2 stages with a large cut-off diameter), and the drug particle distribution was high at 4 to 6 stages where the separation particle diameter of the drug particles was relatively small.

Although the embodiments of the present invention have been described above with reference to the accompanying drawings, those skilled in the art to which the present invention pertains may be embodied in other specific forms without changing the technical spirit or essential features of the present invention. I can understand that you can. For example, those skilled in the art can change the material, size, etc. of each component according to the application field, or combine or replace the embodiments in a form that is not clearly disclosed in the embodiments of the present invention, this is also the present invention It will not go beyond the scope of the. Therefore, the above-described embodiments are to be considered in all respects as illustrative and not restrictive, and such modified embodiments should be included in the technical spirit described in the claims of the present invention.

1: device for inhalation 2: powder inhaler
10: main body 20: flow path
21: central flow path 30: guide portion
31: first guide projection 311, 321: first side
312, 322: second side 313, 323: distal face
32: second guide projection 40: mounting portion
41: fixed rib 50: communication part

Claims (8)

Main body;
A flow path part provided inside the main body part and providing a passage for moving particles including drugs; And
And a guide part extending in a spiral direction along an inner circumferential surface of the flow path part to guide the flow of the particles passing through the flow path part into a spiral flow.
Inhalation device. The method of claim 1,
The guide unit,
A first guide protrusion protruding spirally from an inner circumferential surface of the flow path portion; And
A second guide protrusion protruding helically from the inner circumferential surface of the flow path part,
The first guide protrusion and the second guide protrusion are formed to cross each other,
Inhalation device. The method of claim 2,
The first guide protrusion and the second guide protrusion is formed in a symmetrical shape with respect to the center line of the flow path portion,
Inhalation device. The method of claim 2,
Wherein the helical flow path of the particles is established by the space between the first side or the second side of the first guide protrusion and the second side or the first side of the second guide protrusion,
Inhalation device. The method of claim 2,
In the center of the flow path portion is formed a central flow path between the end surface of the first guide projection and the end surface of the second guide projection,
Inhalation device. The method of claim 1,
It further extends from the circumference of the main body portion, further comprising a mounting portion selectively mounted to the powder inhaler,
Inhalation device. The method of claim 6,
Further comprising a communication unit provided in the main body portion between the mounting portion and the flow path portion,
Inhalation device. The method of claim 7, wherein
The communicating portion has a diameter larger than the diameter of the flow path portion,
Inhalation device.

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