CN107737393B - Preparation atomization flow passage for powder aerosol inhalation device - Google Patents
Preparation atomization flow passage for powder aerosol inhalation device Download PDFInfo
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- CN107737393B CN107737393B CN201710946859.5A CN201710946859A CN107737393B CN 107737393 B CN107737393 B CN 107737393B CN 201710946859 A CN201710946859 A CN 201710946859A CN 107737393 B CN107737393 B CN 107737393B
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Abstract
A preparation atomization flow passage for a powder inhalation device belongs to the field of administration instruments. The preparation atomization flow channel consists of a powder feeding channel, a tangential rotating cavity and a bending dispersion channel; at least two tangential air inlet channels are arranged on the side wall of the tangential rotating cavity; an upward preparation powder outlet is arranged in the middle of the upper part of the tangential rotating cavity; the powder feeding channel is coincident with or parallel to the transverse section of the tangential rotating cavity; the airflow in the powder inlet channel or each tangential air inlet channel enters the hollow cavity in a mode of cutting in the same plane in the lateral direction; the powder inlet channel or the gas channel of each tangential gas inlet channel is tangent to the gas rotating channel of the tangential rotating cavity, and horizontal rotating airflow is formed in the tangential rotating cavity. Because the tangential rotating cavity is in a horizontal state in actual use, the residence time of the powder agglomerates in the rotating cavity is increased, and more collision opportunities can be provided between the powder agglomerates and the wall of the rotating cavity; further dispersion of the powder agglomerate particles is facilitated.
Description
Technical Field
The invention belongs to the field of devices for inputting media into human bodies, and particularly relates to an inhalation type drug delivery device for delivering powder inhalation with specified dose into the lungs of patients through oral cavities along with respiratory airflow.
Background
An aerosol is a formulation of micronized drug or drug in capsules, vesicles or multi-dose reservoirs with carriers, which is actively inhaled by the patient in the form of a formulation of aerosolized drug into the lungs using a specially designed aerosol inhalation device or delivery device (also known as an inhalation delivery device and also known in the past as a dry powder inhalation device or dry powder delivery device).
The inhalation powder inhalation depends on the autonomous respiration of a patient to enable the medicine powder to enter a respiratory system, and has the characteristics of convenience in carrying, low cost and strong stability.
In recent years, the application range of the inhalation aerosol powder has been expanded from the traditional lung local disease therapeutic drug to the systemic administration of polypeptide proteins, antibiotics, biological drugs and cardiovascular system drugs. Especially, some biological macromolecules can achieve ideal bioavailability after inhalation-pulmonary administration of the medicine powder.
The powder inhalation device is the core of powder inhalation development, and the quality of the design directly influences the lung deposition efficiency of the powder inhalation.
In the case of Dry Powder Inhaler (DPI), the most central component is the dispersion structure, which is the degree of formulation compatibility, and directly affects the efficacy of the DPI product. The development of DPI devices with strong dispersion capacity is a key link for developing such products.
The principle of the DPI product for dispersing the preparation powder agglomerates is air flow shearing dispersion, collision dispersion and the like. The dominant dispersion is different in different DPI devices.
In chinese patent invention No. CN 100337699C, whose publication date is 9/27 of 2007, a "powder-type dispersing apparatus and method for a dry powder inhaler" is disclosed, wherein the dispersing means of the dry powder inhaler comprises: a substantially cylindrical air circulation chamber 3, at least two air feed channels (2, 9) extending tangentially to the cylindrical wall 5 at substantially opposite sides of the wall into the chamber 3 and adapted to form an annular air flow pattern within the chamber, the two air channels (2, 9) being provided with different inlets or respectively sharing the same inlet which is spaced apart to form a channel 2 which intersects the dose measuring or dose feeding region of the inhaler so that a dose of powder can be drawn into the circulation chamber 3 by air flowing through the channel, while the other channel is used as a bypass channel 9 to the circulation chamber 3 which is adapted to accelerate particles and to form a more symmetrical flow pattern within said chamber 3.
The DPI product according to the solution described in this patent has a substantially cylindrical shape in its overall shape, and a "dosing unit" for storing a powder formulation is arranged below the cylindrical body, and in use, the cylindrical DPI product is placed in a horizontal position, and a user inhales through a suction nozzle located at the top of the cylindrical body, so that the powder formulation stored in the "dosing unit" is drawn into the circulation chamber 3 via the channel 2, through the discharge channel 19 and the interface cylinder 13, and into the user's mouth.
According to the attached drawings of the specification and the relevant text in the specification of the patent, the dispersion principle of dispersing the preparation powder agglomerates in the technical scheme is analyzed as follows: the preparation powder particles enter the circulating chamber 3 tangentially along the track of a gas streamline from the powder inlet channel 2, small particles are directly sucked out through the outlet 19 along with the gas flow under the action of the shearing force of the gas flow, and large particles collide with the cavity wall surface 22 of the circulating chamber 3 due to poor flow following performance and strong centrifugal force, so that the small particles are separated from the carrier and are sucked out through the outlet 19 finally.
As can be seen from the drawings in the specification, the powder inlet channel 2 in the technical scheme is vertical to the plane (actually, the cross section of the rotating chamber) where the rotating gas streamline is located in the circulating chamber 3.
In other words, the above-mentioned separation structure is characterized in that the preparation powder enters the circulation chamber 3 which is arranged in a vertical state when in use from the powder inlet channel 2 (which is vertical to the cross section of the circulation chamber 3) which is arranged below the circulation chamber, in a direction tangential to the circulation chamber 3, and the preparation powder is decomposed and disaggregated (commonly called atomization, the same below) through the shearing action of the rotating airflow; the working principle of the device makes full use of the centrifugal force action when the particles do circular motion.
However, the technical scheme has the defects that the dispersing action of the fine powder dispersion device is purely dependent on the centrifugal action of airflow on micro powder agglomerates and the collision of the agglomerates and the wall surface of the rotating cavity caused by the centrifugal action, and the gravity of the agglomerates can interfere the effect of the dispersing process.
Disclosure of Invention
The invention aims to provide a preparation atomization flow channel for a powder aerosol inhalation device. On the basis of the structure and action mechanism of the existing separation cavity, the mutual position relation of the powder inlet channel and the rotary separation cavity is changed by redesigning the structure mode and the functional module of the dispersing flow channel, so that the detention time of large-particle preparation powder particles in the separation cavity is prolonged; the outlet of the rotary separation cavity is provided with the bending dispersion channel, and the structure and the functional mode which enable large-particle preparation powder particles to collide with the wall of the cavity body again (or for multiple times) are adopted, so that the preparation powder can be dispersed/depolymerized/atomized more thoroughly, and the separation/atomization effect of fine particles of the aerosol micropowder agglomerates is further better ensured.
The technical scheme of the invention is as follows: there is provided a formulation atomizing flow path for a powder aerosol inhalation device, said formulation atomizing flow path being provided between a powder storage/administration unit and a mouthpiece, characterized in that:
the preparation atomization flow channel at least consists of a powder feeding channel, a tangential rotating cavity and a bending dispersion channel which are sequentially communicated;
the tangential rotating cavity is a hollow cavity of a flat disc structure, the height of the hollow cavity is smaller than the diameter of the tangential rotating cavity;
on the side wall of the tangential rotation cavity; at least two tangential air inlet channels are arranged; one tangential air inlet channel is also used as a medicine inlet; the at least two tangential air inlet channels are centrosymmetrically distributed on the circumference of an enveloping circle of the tangential rotating cavity;
an upward preparation powder outlet is arranged in the middle of the upper part of the tangential rotating cavity;
the central axis of the preparation powder outlet is vertical to the plane of the horizontal central line of the tangential rotating cavity;
the outlet of the powder storage/administration unit is connected with the initial end of the powder inlet channel, and the tail end of the powder inlet channel is connected with the medicine inlet of the tangential rotating cavity; the preparation powder outlet of the tangential rotating cavity is connected with the head end of the bending dispersion channel, and the tail end of the bending dispersion channel is connected with the suction nozzle;
the transverse section of the horizontal central line of the powder feeding channel is coincident with or parallel to the transverse section of the horizontal central line of the tangential rotating cavity.
The airflow in the powder inlet channel or each tangential air inlet channel enters the hollow cavity in a mode of cutting in the same plane in the lateral direction;
the powder inlet channel or the gas channel of each tangential gas inlet channel is tangent to the gas rotating channel of the tangential rotating cavity, and a rotating gas flow is formed in the tangential rotating cavity.
The bending dispersion channel is used for carrying out secondary collision on the powder aerosol powder agglomerates separated by the tangential rotating cavity and conveying the powder aerosol powder subjected to the rotary separation and the secondary collision to the suction nozzle for a user to inhale;
when a user actually uses the powder inhalation device for medicine inhalation, the cross section of the tangential rotating cavity is in a horizontal state; or the included angle between the cross section of the tangential rotating cavity and the horizontal plane is less than 45 degrees.
Specifically, the bending dispersion channel is composed of a first communicating section, a bending section and a second communicating section which are communicated in sequence; the head end of the first communication section forms the head end of the bending dispersion channel and is correspondingly connected with the outlet of the tangential rotation cavity; the outlet end of the first communicating section is correspondingly connected with the head end of the bending section, and the tail end of the bending section is correspondingly connected with the inlet end of the second communicating section; the outlet end of the second communicating section is correspondingly connected with the suction nozzle; the first communicating section, the bending section and the second communicating section form a bending channel structure similar to a Z shape or a reverse S shape.
Further, the horizontal central line of the first communicating section is parallel to the horizontal central line of the tangential rotating cavity; the horizontal center line of the second communication section is coincident with the horizontal center line of the tangential rotating cavity; the plane of the horizontal center line of the first communicating section is parallel to the plane of the horizontal center line of the second communicating section.
The preparation atomization flow channel in the technical scheme is composed of a lower flow channel component, a middle flow channel component and an upper flow channel component.
Wherein the lower runner component forms the powder inlet channel and the bottom of the tangential rotating cavity; the flow channel middle component forms the side wall and the top of the powder feeding channel and the tangential rotating cavity, and the bottom and the side wall of the bending dispersion channel; the flow passage upper component forms the top of the bending dispersion channel.
Specifically, the cross section of the inner wall of the hollow cavity is of a polygonal structure, and the medicine inlet and each tangential air inlet channel are respectively and sequentially arranged at the odd vertex end of the polygonal structure; or the medicine inlet and each tangential air inlet channel are respectively and sequentially arranged at the even vertex end of the polygonal structure.
Furthermore, the polygonal structure is a centrosymmetric polygon or a regular polygon.
The tangential rotation cavity in the technical scheme solves the agglomeration of the preparation powder through a horizontal rotation dispersion working mode, and prolongs the retention time of the large-particle preparation powder agglomeration in the tangential rotation cavity under the action of the centrifugal force and the gravity of the particles by utilizing the action of the centrifugal force when the particles do circular motion, so that the preparation powder agglomeration is more thoroughly dispersed and is output to a bending dispersion channel through a preparation powder outlet positioned at the upper part of the tangential rotation cavity.
Furthermore, in the bending dispersion channel, the preparation powder agglomerates can collide with the wall surface of the cavity of the bending dispersion channel again due to poor flow following performance, so that the preparation powder agglomerates are further separated or atomized.
According to the technical scheme, at least one bypass air inlet is formed in at least one side of the outlet section of the bent dispersion channel and used for adjusting the integral inhalation resistance of the powder aerosol inhalation device.
Specifically, the cross-sectional area of the bypass air inlet or the sum of the cross-sectional areas of the two bypass air inlets is less than or equal to 30% of the cross-sectional area of the outlet end of the bent dispersion channel.
Compared with the prior art, the invention has the advantages that:
1. because the tangential rotating cavity is in a horizontal state in actual use, large powder agglomerates in the rotating cavity collide with the cavity wall of the tangential rotating cavity more under the action of horizontal centrifugal force; the dispersed powder rises upwards and is discharged through a preparation powder outlet at the upper part of the tangential rotating cavity, so that the rotating retention time of the powder agglomerates in the cavity of the tangential rotating cavity is prolonged under the action of gravity, and more collision opportunities can be provided between the powder agglomerates and the cavity wall of the rotating cavity;
2. because the powder inlet channel and the tangential rotating cavity are positioned on the same plane, and the gas channel of the powder inlet channel is tangential to the gas rotating channel of the tangential rotating cavity, a better airflow shearing effect can be formed in the tangential rotating cavity, and further dispersion of powder agglomerate particles is facilitated;
3. the bypass air inlet is arranged at the outlet end of the second communicating section or the side surface of the suction nozzle, and the size of the cross section area of the bypass air inlet is adjusted, so that the whole suction resistance of the powder aerosol suction device can be conveniently adjusted, and the use feeling of a user is improved.
Drawings
FIG. 1 is a schematic view of the configuration of an atomization flow channel of the preparation of the patent;
FIG. 2 is a top view of the configuration of the atomizing flow channel of the formulation of this patent;
FIG. 3 is a schematic bottom view of the device of the present invention showing the atomizing flow path and the tangential rotation chamber;
FIG. 4 is a schematic cross-sectional view taken along line E-E' of FIG. 2;
FIG. 5 is a schematic diagram of the formulation atomizing channel and tangential rotation chamber of the present patent in a cross-sectional side view;
FIG. 6 is a schematic structural view of a bend dispersion channel according to the present disclosure;
FIG. 7 is a schematic diagram illustrating the principle of dispersion of agglomerates of powder formulation by the tangential rotating chamber according to the solution of the present patent;
FIG. 8 is a schematic diagram illustrating the dispersion principle of the powder agglomerates of the preparation by bending the dispersion channel in the technical solution of the present patent;
FIG. 9 is a schematic view of the bypass air intake configuration of the present patent;
FIG. 10 is a schematic illustration of the ratio of the bypass air inlet to the cross-sectional area at the suction nozzle in the embodiment of the present patent;
fig. 11 is a graph showing the experimental distribution comparison of in vitro deposition of drug 1 (n-3);
fig. 12 is a graph showing the distribution comparison of the in vitro deposition experiment of drug 2 (n-3).
In the figure, 51 is a main air inlet, 51-2 is a medicine inlet hole, and 52 is a powder inlet channel; 53 is a tangential rotating cavity; 53-1 is the wall surface of the cavity body of the tangential rotating cavity, 53-2 is the tangential air inlet channel, 53-3 is the medicine inlet, 54 is the preparation powder outlet of the tangential rotating cavity, and 55 is the bending dispersion channel; 55-1 is a first communicating section, 55-2 is a bending section, 55-3 is a second communicating section, and 56 is a bypass air inlet; 57 is an outlet of the preparation atomization flow passage;
b is a runner lower component; c is a component in the flow channel; d is a runner upper component; f1 is a gas flow line; f2 is the granule of the preparation powder agglomerate; f3 is the trajectory of the particle;
i is the cross-sectional area of the outlet of the preparation atomization flow passage; and II is the cross-sectional area of the bypass air inlet.
Detailed Description
The invention is further illustrated with reference to the following figures and examples.
In fig. 1 to 6, the technical solution of the present invention provides a formulation atomization flow path for a powder aerosol inhalation device, the formulation atomization flow path is arranged between a powder storage/administration unit and a mouthpiece, and the invention is characterized in that:
the preparation atomization flow channel at least consists of a powder feeding channel 52, a tangential rotating cavity 53 and a bending dispersion channel 55 which are sequentially communicated;
the tangential rotating cavity is a hollow cavity of a flat disc structure, the height of the hollow cavity is smaller than the diameter of the tangential rotating cavity;
on the side wall 53-1 of the tangential rotation chamber; at least two tangential air inlet channels 53-2 (in fig. 3, three tangential air inlet channels are taken as an example, and under the simplest condition, only two tangential air inlet channels are needed to be arranged, so that a rotating airflow can be formed in the tangential rotating cavity), wherein one tangential air inlet channel is also taken as a medicine inlet 53-3; the tangential air inlet channels are distributed on the circumference of the enveloping circle of the tangential rotating cavity in a centrosymmetric manner.
In the middle of the upper part of the tangential rotation chamber, an upwardly directed formulation powder outlet 54 is provided.
The central axis of the preparation powder outlet is vertical to the plane of the horizontal central line of the tangential rotating cavity.
The outlet of the powder storage/administration unit is connected with the initial end of the powder inlet channel, and the tail end of the powder inlet channel is connected with the medicine inlet of the tangential rotating cavity; the preparation powder outlet of the tangential rotating cavity is connected with the head end of the bending dispersion channel, and the tail end of the bending dispersion channel is connected with the suction nozzle;
the transverse section of the horizontal central line of the powder feeding channel is coincident with or parallel to the transverse section of the horizontal central line of the tangential rotating cavity.
And the airflow in the powder inlet channel or each tangential air inlet channel enters the hollow cavity in a mode of cutting in the same plane in the lateral direction.
The powder inlet channel or the gas channel of each tangential gas inlet channel is tangent to the gas rotating channel of the tangential rotating cavity, and horizontal rotating airflow is formed in the tangential rotating cavity.
In fig. 4, the formulation atomization flow channel in the technical solution of the present invention structurally comprises three components, namely, a flow channel lower component B, a flow channel middle component C, and a flow channel upper component D.
As shown in fig. 5, the lower flow path member B forms the bottom of the powder inlet passage 52 and the tangential rotation chamber 53;
the lower flow passage member B is provided with a medicine inlet hole 51-2 which is arranged to correspond to an outlet (not shown) of the powder storage/administration unit.
At the head end of the powder feed passage 52, a main air inlet 51 is provided, and when a user inhales against the mouthpiece, air is inhaled from the main air inlet 51, passing through the medicine feed hole 51-2, to bring the powder particles of the preparation in the powder storage/administration unit in a predetermined dose into the powder feed passage 52.
The flow passage middle component C forms the side walls and the top of the powder feeding passage and the tangential rotating cavity, and the bottom and at least one part of the side walls of the bending dispersion passage 55; the flow path upper member D forms a top and a portion of a sidewall of the bent dispersion channel.
The three parts of the lower runner component B, the middle runner component C and the upper runner component D can be manufactured by adopting an injection molding process, and then the three parts are buckled in sequence to form a complete preparation atomization runner assembly.
In the actual manufacturing and production of the component of the preparation atomizing flow channel, the manufacturing process is not limited to the manufacturing process listed herein, and the preparation atomizing flow channel can be manufactured by other forming processes according to the technical means owned by the manufacturer, and the details are not described herein.
As can be seen from FIG. 6, the bend dispersion channel is composed of a first communicating section 55-1, a bend section 55-2 and a second communicating section 55-3 which are communicated with each other in sequence. Wherein, the head end of the first communicating section forms the head end of the bending dispersion channel and is correspondingly connected with the preparation powder outlet 54 of the tangential rotating cavity; the outlet end of the first communicating section is correspondingly connected with the head end of the bending section, and the tail end of the bending section is correspondingly connected with the inlet end of the second communicating section; the outlet end of the second communicating section is correspondingly connected with a suction nozzle (not shown in the figure).
Obviously, the first communicating section, the bending section and the second communicating section form a bending channel structure with a shape similar to a Z shape or a reverse S shape.
Obviously, as can be seen from fig. 5, the horizontal center line of the first communicating section is parallel to the horizontal center line of the tangential rotating cavity; the horizontal center line of the second communication section is coincident with the horizontal center line of the tangential rotating cavity; the plane of the horizontal center line of the first communicating section is parallel to the plane of the horizontal center line of the second communicating section.
As shown in fig. 3 and 7, the tangential rotation chamber in the present embodiment is a hollow chamber with a flat disk structure having a height smaller than its diameter.
The cross section of the inner wall of the hollow cavity is of a polygonal structure, the medicine inlet 53-3 and each tangential air inlet channel 53-2 are respectively and sequentially arranged at the odd vertex end of the polygonal structure (if the end point of the medicine inlet is the No. 1 end point, the two tangential air inlet channels are respectively arranged at the No. 3 end point and the No. 5 end point, which means that the medicine inlet and the two tangential air inlet channels are respectively arranged at the separated end points of the polygonal structure); or, it sets gradually at polygonal structure's even number apex end department respectively to advance medicine mouth and each tangential inlet channel (if be 2 number endpoints with the extreme point that advances the medicine mouth place, then two tangential inlet channels set up respectively at 4 numbers and 6 numbers endpoints, this means in fact that advances medicine mouth and two tangential inlet channels and set up respectively on polygonal structure's the endpoint of being separated by), advance the medicine mouth and each tangential inlet channel opening on the rotatory chamber lateral wall of tangential, constitute equilateral triangle (only be provided with one and advance under medicine mouth and two tangential inlet channels's the condition) or the position relation of equilateral polygon (be provided with one and advance under medicine mouth and the condition of a plurality of tangential inlet channels).
Specifically, the cross section of the inner wall of the hollow cavity is in a centrosymmetric polygon or regular polygon structure.
In fig. 7 and 8, the technical solution of the present invention is functionally composed of two parts: firstly, a bottom layer tangential air inlet and horizontal rotation dispersion structure (namely a tangential rotation cavity) 53, wherein large preparation powder agglomerates are collided with the wall surface 53-1 of a tangential rotation cavity body more under the action of centrifugal force in the rotation cavity; meanwhile, the tangential rotating cavity is in a horizontal or nearly horizontal state when in use, so that the rotating retention time of large preparation powder agglomerates in the tangential rotating cavity is prolonged based on the action of gravity, and the shearing action of air flow in the rotating cavity is relatively strong, thereby being beneficial to the dispersion of preparation powder agglomerate particles.
Secondly, the preparation powder agglomerate particles pass through the preparation powder outlet 54 of the tangential rotating cavity from the center of the tangential rotating cavity along with the airflow and enter the bending dispersion channel 55 along with the airflow, and relatively large and heavy preparation powder agglomerates in the bending dispersion channel collide with the inner wall surface of the bending dispersion channel again (or repeatedly) due to poor follow-up fluidity, so that the further separation of the preparation powder fine particles is realized.
The technical scheme of the invention is characterized in that: the powder of the formulation enters a horizontally disposed tangential rotation chamber 53 from the powder inlet passage 52 and is deagglomerated by shearing with the air flow and colliding with the wall surface 53-1 of the chamber. The centrifugal force effect when the particles do horizontal circular motion and the gravity effect of the particles are fully utilized on the working principle, so that the detention time of the preparation powder agglomerates with large particles in the cavity is prolonged under the two forces, and the preparation powder is dispersed more thoroughly.
Furthermore, according to the technical scheme of the invention, a bending dispersion channel 55 is arranged and added on the gas path or the gas channel at the rear section of the tangential rotation cavity, and in the bending dispersion channel 55, the powder agglomerate F2 collides with the wall surface of the cavity of the bending dispersion channel again (or for multiple times) due to poor flow following performance, so that the further separation of the fine particles of the preparation powder is realized.
The invention is superior to the prior similar DPI products in the principle of separation and atomization, so that the required chamber size of the tangential rotating cavity can be smaller for the same type of preparation powder, and the same dispersion performance and effect of other products can be achieved.
For example, for a given aerosol, the diameter of the inscribed circle of the dispersion chamber is 12mm and the height of the inscribed circle of the dispersion chamber is 3mm, while the diameter of the inscribed circle of the dispersion chamber in the prior art is 16mm and the height of the inscribed circle of the dispersion chamber is 4.5 mm; through actual comparison tests, the dispersion effect between the two is basically the same.
Therefore, after the dispersion/atomization mechanism and the preparation atomization flow channel structure are further optimized, the tangential rotating cavity can be designed in a smaller size on the premise of obtaining the same dispersion effect, and the whole volume of the whole powder aerosol inhalation device product can be further reduced.
Since DPI products are typically in a multi-dose filling mode (single dose, single use DPI products are rare due to cost considerations, and multiple use DPI products are typically used, referred to in the art as "multi-dose"), smaller product size designs are often required for users to carry them around, providing more convenience to the patient.
On the basis of the above structure and dispersion/atomization, as shown in fig. 9, the technical solution of the present invention further includes at least one bypass air inlet 56 (two bypass air inlets are used as an example in the figure, and two symmetrically arranged bypass air inlets are used as an example in the figure, so as to avoid the "redirection" interference on the flow channel of the formulation powder in the bent dispersion channel) on at least one side of the outlet section of the bent dispersion channel (or the outlet section of the bent dispersion channel in the figure), so as to adjust the overall inhalation resistance of the aerosol inhalation device, and thus, the device does not require much effort during inhalation.
As shown in fig. 12, the cross-sectional area of one bypass inlet, or the sum II of the cross-sectional areas of the two bypass inlets, is less than or equal to 30% of the cross-sectional area I of the outlet end of the angled dispersion channel.
In the technical scheme of the invention, the sum of the cross sectional areas of the bypass air inlets is preferably not more than 20% of the cross sectional area of the suction nozzle.
As for the administration device according to the present invention, refer to the chinese patent application with publication date of 2015, 10 and 14, publication number of CN104971411A, entitled "an administration device of powder aerosol", previously filed by the applicant, wherein the component 3 is the administration device according to the present invention, and since the quantitative drug container 3a is disposed on the upper surface of the component, the powder of the formulation in the quantitative drug container can be easily fed into the powder feeding passage through the drug feeding hole 51-2 by the gas entering from the main gas inlet 51.
Example (b):
table 1 shows the in vitro deposition experiments (n ═ 3) of the prior art and the present invention, the experiments were evaluated with two drugs, and the statistical analysis was performed on the average of the experiments, since FPF directly reflects the deagglomeration and dispersion ability of the device, the higher the number the stronger the deagglomeration and dispersion ability. As can be seen from the FPF average values of drug 1 and drug 2, the dispersion/deaggregation capacity of the present invention is not lower than in the prior art with smaller design dimensions for the tangential rotation lumen. The MMAD data for drug 1 and drug 2 in both devices are close.
The prescription of the medicament adopted by the experiment is self-research, and the flow rate of the experiment is 60L/min:
table 1 in vitro deposition experiment (n ═ 3)
Figures 11 and 12 show a comparison of the in vitro deposition experimental distribution of drug 1 and drug 2 in a prior art similar DPI product and in the present invention, respectively. As the inhalation administration technology has a therapeutic effect on fine drug particles which can effectively enter the lung, the stage1 to MOC grade in an in-vitro experiment represents that the particle size of the drug particles is smaller and smaller, and the data in the table shows that the distribution of the invention is basically equal to that of the traditional similar DPI product under the condition that a tangential rotating cavity adopts a smaller design size.
In Table 1 and FIGS. 11-12, the letter abbreviations used have the following meanings:
dd (deliver dose); fpd (fine particle dose) fine particle dose; FPF (Fine particle fraction) fine particle fraction; mmad (middle mass aerodynamic diameter) aerodynamic mass median diameter; APSD (Aerodynamic particle size distribution) aerodynamic particle size distribution.
According to the technical scheme, the structural mode and the functional module of the dispersing flow channel are redesigned, so that the mutual position relation between the powder inlet channel and the rotary separation cavity is changed, and the retention time of large-particle preparation powder particles in the separation cavity is prolonged; through set up the dispersion passageway of bending at rotatory separation chamber export, adopt and make large granule preparation powder particle and cavity wall (or many times) structure and functional mode that bump once more, dispersion preparation powder that can be more thorough, further guarantee the separation, the atomization effect of the fine granule of powder cloud miropowder agglomerate better.
The invention can be widely applied to the design and manufacture fields of powder aerosol administration devices with various specifications.
Claims (10)
1. A formulation atomizing flow path for a powder inhalation device, said formulation atomizing flow path being disposed between a powder storage/administration unit and a mouthpiece, characterized in that:
the preparation atomization flow channel at least consists of a powder feeding channel, a tangential rotating cavity and a bending dispersion channel which are sequentially communicated;
the tangential rotating cavity is a hollow cavity of a flat disc structure, the height of the hollow cavity is smaller than the diameter of the tangential rotating cavity;
on the side wall of the tangential rotation cavity; at least two tangential air inlet channels are arranged; one tangential air inlet channel is also used as a medicine inlet; the at least two tangential air inlet channels are centrosymmetrically distributed on the circumference of an enveloping circle of the tangential rotating cavity;
an upward preparation powder outlet is arranged in the middle of the upper part of the tangential rotating cavity;
the central axis of the preparation powder outlet is vertical to the plane of the horizontal central line of the tangential rotating cavity;
the outlet of the powder storage/administration unit is connected with the initial end of the powder inlet channel, and the tail end of the powder inlet channel is connected with the medicine inlet of the tangential rotating cavity; the preparation powder outlet of the tangential rotating cavity is connected with the head end of the bending dispersion channel, and the tail end of the bending dispersion channel is connected with the suction nozzle;
the transverse section of the horizontal central line of the powder feeding channel is coincident with or parallel to the transverse section of the horizontal central line of the tangential rotating cavity;
the airflow in the powder inlet channel or each tangential air inlet channel enters the hollow cavity in a mode of cutting in the same plane in the lateral direction;
the powder inlet channel or the gas channel of each tangential gas inlet channel is tangent to the gas rotating channel of the tangential rotating cavity to form rotating airflow in the tangential rotating cavity,
the bending dispersion channel is used for carrying out secondary collision on the powder aerosol powder agglomerates separated by the tangential rotating cavity and conveying the powder aerosol powder subjected to the rotary separation and the secondary collision to the suction nozzle for a user to inhale;
the bending dispersion channel consists of a first communicating section, a bending section and a second communicating section which are communicated in sequence;
the head end of the first communication section forms the head end of the bending dispersion channel and is correspondingly connected with the outlet of the tangential rotation cavity; the outlet end of the first communicating section is correspondingly connected with the head end of the bending section, and the tail end of the bending section is correspondingly connected with the inlet end of the second communicating section;
the outlet end of the second communicating section is correspondingly connected with the suction nozzle;
the first communicating section, the bending section and the second communicating section form a bending channel structure similar to a Z shape or a reverse S shape;
when a user actually uses the powder inhalation device for medicine inhalation, the cross section of the tangential rotating cavity is in a horizontal state; or the included angle between the cross section of the tangential rotating cavity and the horizontal plane is less than 45 degrees;
the preparation atomization flow channel prolongs the detention time of large-particle preparation powder particles in the separation chamber by changing the mutual position relation of the powder inlet channel and the rotary separation chamber; through set up the dispersion passageway of bending at rotatory separation chamber export, adopt and make large granule preparation powder particle and cavity wall or the structure and the functional mode that take place the collision once more, dispersion/depolymerization/atomizing preparation powder that can be more thorough, further guarantee the separation/atomization effect of the fine granule of powder aerosol miropowder agglomerate better.
2. The formulation atomizing flow channel for a dry aerosol inhalation device according to claim 1, wherein the horizontal centerline of said first communicating section is parallel to the horizontal centerline of the tangential rotary chamber; the horizontal center line of the second communication section is coincident with the horizontal center line of the tangential rotating cavity; the plane of the horizontal center line of the first communicating section is parallel to the plane of the horizontal center line of the second communicating section.
3. The formulation atomizing flow channel for a dry powder inhalation device as claimed in claim 1, wherein said formulation atomizing flow channel comprises a lower flow channel member, an intermediate flow channel member and an upper flow channel member.
4. The formulation atomizing flow channel for a powder aerosol inhalation device according to claim 3, wherein said lower flow channel member forms the bottom of the powder feed passage and the tangential rotation chamber;
the flow channel middle component forms the side wall and the top of the powder feeding channel and the tangential rotating cavity, and the bottom and the side wall of the bending dispersion channel;
the flow passage upper component forms the top of the bending dispersion channel.
5. The formulation atomizing flow path for a dry powder inhalation device according to claim 1, wherein said inner wall of said hollow chamber has a polygonal cross-section, and said inlet and said tangential inlet passages are respectively provided in the singular apex ends of said polygonal structure; or the medicine inlet and each tangential air inlet channel are respectively and sequentially arranged at the even vertex end of the polygonal structure.
6. The formulation atomizing flow channel for a powder aerosol inhalation device according to claim 5, wherein said polygonal structure is a centrosymmetric polygon or a regular polygon.
7. The formulation atomizing flow channel for a powder inhalation device according to claim 1, wherein the tangential rotation chamber is adapted to deagglomerate the formulation powder by a horizontal rotation dispersion mode, and the retention time of the agglomerates of the large-sized formulation powder in the tangential rotation chamber is extended by the centrifugal force generated when the particles make a circular motion and the gravity of the particles, so that the agglomerates of the formulation powder are more thoroughly dispersed and delivered to the bend dispersion passage through the formulation powder outlet located at the upper portion of the tangential rotation chamber.
8. The formulation atomizing flow channel for a powder inhalation device according to claim 1, wherein in said bent dispersion passage, the formulation powder agglomerates, due to their poor flow-following properties, collide with the chamber wall surface of the bent dispersion passage again, thereby achieving further separation or atomization of the formulation powder agglomerates.
9. The formulation atomizing flow channel for a powder aerosol inhalation device according to claim 1, wherein at least one bypass air inlet is provided on at least one side of the outlet section of said bent dispersion passage to adjust the overall inhalation resistance of the powder aerosol inhalation device.
10. The formulation atomizing flow channel for a powder aerosol inhalation device according to claim 9, wherein the cross-sectional area of said one bypass inlet port, or the sum of the cross-sectional areas of the two bypass inlet ports, is less than or equal to 30% of the cross-sectional area of the outlet end of the angled dispersion passage.
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| CN201710946859.5A CN107737393B (en) | 2017-10-12 | 2017-10-12 | Preparation atomization flow passage for powder aerosol inhalation device |
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| CN201710946859.5A CN107737393B (en) | 2017-10-12 | 2017-10-12 | Preparation atomization flow passage for powder aerosol inhalation device |
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| CN110201280B (en) * | 2018-02-28 | 2021-07-30 | 张江 | Suction nozzle for an inhalation device and inhalation device |
| WO2020148631A1 (en) * | 2019-01-14 | 2020-07-23 | Philip Morris Products S.A. | Dry powder inhaler device |
| CN115702961A (en) * | 2021-08-03 | 2023-02-17 | 上海臣邦医药科技股份有限公司 | Single-dose disposable powder aerosol device |
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