WO2019101136A1 - Dispositif et procédé de libération de poudre - Google Patents

Dispositif et procédé de libération de poudre Download PDF

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Publication number
WO2019101136A1
WO2019101136A1 PCT/CN2018/116943 CN2018116943W WO2019101136A1 WO 2019101136 A1 WO2019101136 A1 WO 2019101136A1 CN 2018116943 W CN2018116943 W CN 2018116943W WO 2019101136 A1 WO2019101136 A1 WO 2019101136A1
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WO
WIPO (PCT)
Prior art keywords
capsule
capsule chamber
chamber
deflecting
side wall
Prior art date
Application number
PCT/CN2018/116943
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English (en)
Chinese (zh)
Inventor
李昌辉
董平
朱雪冰
Original Assignee
正大天晴药业集团股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201711177479.6A external-priority patent/CN109821117B/xx
Application filed by 正大天晴药业集团股份有限公司 filed Critical 正大天晴药业集团股份有限公司
Priority to CN201880074883.7A priority Critical patent/CN111356495B/zh
Publication of WO2019101136A1 publication Critical patent/WO2019101136A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators

Definitions

  • the invention belongs to the field of medical instruments, and relates to a powder releasing device and method, in particular to a capsule type powder releasing device.
  • DPI dry powder inhalers
  • a capsule dry powder inhaler is a known dry powder inhaler comprising a capsule chamber and an actuation portion for opening the capsule chamber, the opening of the capsule being effected mainly by shearing, needling or cutting, wherein Acupuncture is the most common opening mechanism, such as the capsule inhaler disclosed in US 8196578 B2.
  • the powder contained in the capsule is released by the needle punching of the capsule during the atomization, and when the patient inhales a sufficient flow, the capsule starts to rotate and vibrate in the capsule chamber, with As the inspiratory flow rate increases, the speed of the capsule will increase, producing sufficient centrifugal force to release the powder from the capsule. Therefore, the capsule DPI has a problem of insufficient inspiratory flow rate for a patient whose ability to generate a sufficient inspiratory flow rate is insufficient, and is generally not recommended for children under 5 years old and patients with partial respiratory function impairment.
  • combination therapies involving different and complementary active drugs are also known, and currently, more than two, even three, combinations of four active drugs have emerged. While the combination provides additional convenience to the patient, certain pharmaceutical actives are difficult to formulate into unique combinations. For example, when formulated together, the active substances may chemically interact with each other to have a negative impact.
  • a capsule type dry powder inhaler provides an effective method of solving the above problems, the capsule type dry powder inhaler comprising at least two capsule chambers and an actuator matching the number of capsule chambers, each capsule chamber loading Capsules containing different pharmaceutically active substances can be provided by administering a combined inhaled pharmaceutical product to a patient by mixing the powder released from the capsules in each capsule chamber.
  • the invention provides a powder delivery device for inhaled administration comprising:
  • a capsule chamber that is a cylindrical chamber that can accommodate the capsule upright, the top of the capsule chamber being open;
  • An actuation portion including a lancet mounted to be movable toward a side wall of the capsule chamber to pierce the capsule, at least a portion of the actuation portion being external to the device for manipulation by a user;
  • a suction nozzle an air outlet passage extending from the top to the bottom, a screen cover fixed at a bottom opening of the air outlet passage, the screen cover being embedded with a screen mesh and detachably coupled to the top of the capsule chamber Having the screen cover the top of the capsule chamber;
  • the capsule chamber is provided at its bottom and/or side wall with a group of deflecting intake passages communicating with outside air, the group of deflecting intake passages comprising at least two central axes surrounding the capsule chamber and facing clockwise
  • the deflected deflecting intake passage is synchronized counterclockwise to provide a spiral flow of upwardly moving self-deflecting intake passage when the user inhales.
  • the deflecting intake passages in the group of deflected intake passages are identical in shape and size and are evenly arranged around the central axis of the capsule chamber.
  • the lower side of the screen is convex toward the capsule chamber.
  • the bottom of the capsule chamber is provided with an air inlet passage extending upward and communicating with the outside air to provide a bottom-up airflow.
  • the bottom of the capsule chamber or the lower portion of the side wall is provided with an air inlet passage which is open upward and communicates with the outside air to provide a bottom-through airflow, and the bottom and/or the side wall of the capsule chamber is deflected into A set of air passages to provide a spiral flow of air that rotates around the capsule chamber.
  • the intake passage at the bottom of the capsule chamber is opened upward along the central axis of the capsule chamber.
  • the intake passage at the bottom of the capsule chamber is a deflected intake passage group.
  • the deflecting intake passage group is integrally arranged at the bottom as a fixed impeller structure.
  • the opening of the deflecting air inlet passage is tangent to the side wall of the capsule chamber.
  • the side wall of the capsule chamber is provided with a group of deflecting intake passages.
  • the lower and/or middle portion of the side wall of the capsule chamber is provided with a group of deflecting intake passages.
  • the lower portion of the side wall of the capsule chamber is provided with a group of deflecting intake passages.
  • the opening of the deflecting air inlet passage is tangent to the side wall of the capsule chamber.
  • the opening of the deflecting air inlet passage of the side wall of the capsule chamber is an elongated strip arranged longitudinally along the side wall of the capsule chamber.
  • the opening of the deflecting air inlet passage of the side wall of the capsule chamber is elongated in parallel with the central axis of the capsule chamber.
  • a lower portion and/or a middle portion of the side wall of the capsule chamber is provided with a set of deflecting intake passages formed by two deflecting intake passages, and an intake passage is provided at the bottom of the capsule chamber.
  • a lower portion of the side wall of the capsule chamber is provided with a set of deflecting intake passages formed by two deflecting intake passages, and a bottom portion of the capsule chamber is provided with a direct current intake passage.
  • the capsule chamber has a diameter of 1.1 to 2.5 times the diameter of the capsule and a height of 1.02 to 2.0 times the height of the capsule.
  • the capsule chamber has a diameter of 1.2 to 1.5 times the diameter of the capsule and a height of 1.05 to 1.3 times the height of the capsule.
  • the capsule chamber has a diameter of 1.35 times the diameter of the capsule and a height of 1.15 times the height of the capsule.
  • the side wall of the capsule chamber is provided with a first deflected intake passage group, and the bottom of the capsule chamber is provided with a second deflected intake passage group.
  • the invention provides a method of releasing an inhalable powder comprising the steps of:
  • the air is sucked at the nozzle to produce a gas flow in the capsule chamber: a) a bottom-up through-flow that enters through the bottom inlet passage of the capsule chamber and is discharged from the top of the capsule chamber. And b) a spiral flow of air entering and exiting the top of the capsule chamber through the side walls of the capsule chamber, the through gas flow and the spiral flow together to promote rotation and vibration of the capsule within the capsule chamber to release the inhalable powder.
  • the present invention provides a method of releasing an inhalable powder in a capsule using the powder release device of the first aspect.
  • the method for releasing the inhalable powder of the present invention can produce a spiral flow when the user inhales, reducing the starting flow rate of the release of the inhalable powder by the capsule, allowing the user to provide less inspiratory flow to allow the capsule to rotate and vibrate at a high speed.
  • the release of inhalable powder provides access to capsule DPI for children under 5 years of age and patients with impaired respiratory function.
  • the powder releasing device of the present invention provides a yaw air passage in the capsule chamber to manufacture a spiral air flow when the user inhales, reducing the starting flow rate of the capsule rotation, and allowing the user to provide a small inspiratory flow rate to allow the capsule to be high speed.
  • Rotating drug delivery provides access to capsule DPI for children under 5 years of age and patients with impaired respiratory function.
  • a third aspect of the invention provides a dry powder inhalation device comprising:
  • a capsule chamber which is a cylindrical chamber that can accommodate the capsule upright, the top of the capsule chamber is open, and the bottom and/or the side wall is provided with an air inlet passage communicating with the outside air;
  • An actuation portion comprising a lancet mounted for movement by a user to move toward a side wall of the capsule chamber to pierce the capsule;
  • the number of capsule chambers is two to four, and all the capsule chambers are arranged in parallel as an integrally formed multi-capsule chamber, and the capsule chamber is provided with an actuation portion separately or in common, and the actuation portion is arranged in the width direction.
  • a bottom of the outlet passage below the suction nozzle is fixed with a screen cover, a screen mesh is fixed in the screen cover, and can be separately connected to the top of the multi-capsule chamber, The screen is placed over the top of all capsule chambers.
  • the side wall of the air outlet passage is provided with at least one small hole communicating with the outside air, and the small hole is opened in a direction not facing the central axis of the air outlet passage to promote the airflow in the air outlet passage when the user inhales Rotate.
  • the outlet passage gradually decreases from bottom to top, and a narrow neck is formed before reaching the suction nozzle, and the small hole of the outlet passage is disposed on the lower side of the narrow neck.
  • the number of small holes in the side wall of the air outlet passage is two, which are symmetrically opened around the central axis of the air outlet passage.
  • the bottom of each of the capsule chambers is provided with an air inlet passage to provide a bottom-up airflow when the user inhales.
  • the intake passage is open upward and communicates with outside air.
  • the intake passage at the bottom of each capsule chamber includes a deflecting intake passage group including at least two central axes surrounding the capsule chamber and synchronized in a clockwise or counterclockwise direction
  • the deflected deflecting intake passage provides a spiral flow from bottom to top as the user inhales.
  • the intake passage at the bottom of the capsule chamber is a deflected intake passage group comprising at least two deflections arranged around the central axis of the capsule chamber and synchronously deflected in a clockwise or counterclockwise direction Intake passage to provide a spiral flow from bottom to top when the user inhales.
  • the deflecting intake passages in the deflecting intake passage group of each of the capsule chambers are identical in shape and size and are evenly arranged around the central axis of the capsule chamber.
  • the opening direction of the deflecting air inlet passage at the bottom of the capsule chamber is tangent to the side wall of the capsule chamber.
  • the deflecting intake passages at the bottom of each capsule chamber are integrally arranged as a fixed impeller structure.
  • each of the capsule chamber side walls is respectively provided with a deflection air intake passage group, and the deflection air intake passage group includes at least two deflections that are arranged around the central axis of the capsule chamber and are synchronously deflected in a clockwise or counterclockwise direction.
  • the air passage provides a spiral flow of upward movement of the self-deflecting intake passage when the user inhales.
  • the deflecting intake passage group is disposed at a middle portion and/or a lower portion of a side wall of the capsule chamber.
  • the deflecting intake passage group is disposed at a lower portion of the side wall of the capsule chamber.
  • the deflecting intake passages in the deflecting intake passage group are identical in shape and size and are evenly arranged around the central axis of the capsule chamber.
  • the opening direction of the deflecting air passage is tangent to the side wall of the capsule chamber.
  • the opening of the deflecting air inlet passage of the side wall of the capsule chamber is an elongated strip arranged longitudinally along the side wall of the capsule chamber.
  • the opening of the deflecting air inlet passage of the side wall of the capsule chamber is elongated in parallel with the central axis of the capsule chamber.
  • the number of deflected intake passages of the deflecting intake passage group is two.
  • the lower portion of the side wall of the capsule chamber is provided with a set of deflecting intake passages formed by two deflecting intake passages, the bottom of which is provided with an intake passage.
  • the inlet passage and/or the top opening of the at least one capsule chamber are of a different size than the other capsule chambers such that the air flow rate within the capsule chamber is different from the other capsule chambers.
  • the at least one capsule chamber has a different inlet passage aperture than the other capsule chambers such that the air flow rate within the capsule chamber is different from the other capsule chambers.
  • the capsule chamber has a diameter of 1.1 to 2.5 times the diameter of the capsule and a height of 1.02 to 2.0 times the height of the capsule.
  • the capsule chamber has a diameter of 1.2 to 1.5 times the diameter of the capsule and a height of 1.05 to 1.3 times the height of the capsule.
  • the capsule chamber has a diameter of 1.35 times the diameter of the capsule and a height of 1.15 times the height of the capsule.
  • the multi-capsule chamber is composed of a first capsule chamber and a second capsule chamber, and two ends of the connection line between the first capsule chamber and the second capsule chamber are arranged with a first actuation portion and a second actuation portion, The actuating portion and the second actuating portion are movable intermediately from both sides to puncture the capsules in the first and second capsule chambers, respectively.
  • the multi-capsule chamber is composed of a first capsule chamber and a second capsule chamber which are closely arranged, and two ends of the connection line between the first capsule chamber and the second capsule chamber are arranged with a first actuation portion and a second The moving portion, the first actuating portion and the second actuating portion are movable from both sides to the middle to pierce the capsules in the first capsule chamber and the second capsule chamber, respectively.
  • the multi-capsule chamber is composed of a tightly arranged first capsule chamber and a second capsule chamber, and one side of the line where the first capsule chamber and the second capsule chamber are located is arranged with an actuation portion, the actuation The portion includes at least two lancets in the width direction to simultaneously pierce the capsules in the first capsule chamber and the second capsule chamber.
  • the lower part of the air outlet passage is a first sub-channel and a second sub-channel separated from the first capsule chamber and the second capsule chamber by the central baffle, the first sub-channel And the second sub-channel gradually gathers from the top of each capsule chamber from bottom to top toward the central baffle, and the cross section thereof is gradually narrowed or maintained in size to guide the first capsule chamber and the second capsule chamber when the user inhales
  • the airflow in the middle meets the upper portion of the outlet passage along the first subchannel and the second subchannel, respectively.
  • the cross sections of the first sub-channel and the second sub-channel are gradually narrowed from the top of each capsule chamber and then remain unchanged.
  • the cross section of the outlet passage is maintained constant or gradually increasing from the vicinity of the top of the center baffle toward the suction nozzle. Still more preferably, the cross section of the air outlet passage is gradually increased from the vicinity of the top of the center baffle toward the suction nozzle direction and remains unchanged.
  • the first sub-channel and the second sub-channel further comprise one or more sub- baffles, the sub- baffles further separating the first sub-channel and the second sub-channel from the top of each capsule chamber A plurality of narrow passages that gradually gather toward the center baffle.
  • the sub-baffles are lower in height than the center baffle.
  • the sub-baffle has an X-shaped cross section and is mirror-symmetrical with a central baffle as a plane of symmetry.
  • the nozzle is disposed at a sufficient intersection of the first sub-channel and the second sub-channel to the upper portion of the outlet passage, respectively, when the user inhales.
  • the outlet passage has a length of 25-36 mm, most preferably 31 mm.
  • the dry powder inhalation device has an air resistance value of 0.01 to 0.08 KPa of 0.5 minute/liter.
  • the dry powder inhalation device has an air resistance value of 0.02 - 0.05 KPa 0.5 min / liter.
  • the dry powder inhalation device has an air resistance value of 0.0325 KPa 0.5 min/liter.
  • the multi-capsule chamber is closely arranged in a triangle by the first capsule chamber, the second capsule chamber and the third capsule chamber, and the first side of the connection line between the first capsule chamber and the second capsule chamber is firstly arranged a moving portion, the first actuating portion is disposed with at least two lancets in the width direction, and is movable to the multi-capsule chamber to simultaneously pierce the capsules in the first capsule chamber and the second capsule chamber, the third actuating portion Arranging as a side of the third capsule chamber remote from the first capsule chamber and the second capsule chamber, arranged to be movable in a vertical direction of a line in which the first capsule chamber and the second capsule chamber are located to pierce the third capsule chamber Capsules.
  • the dry powder inhalation device has an air resistance value of 0.015 - 0.073 KPa 0.5 min / liter.
  • the dry powder inhalation device has an air resistance value of 0.02 - 0.04 KPa 0.5 min / liter.
  • the dry powder inhalation device has an air resistance value of 0.0305 KPa 0.5 min/liter.
  • the multi-capsule chamber is closely arranged into a square by the first capsule chamber, the second capsule chamber, the third capsule chamber and the fourth capsule chamber, and the first actuation portion and the second actuation portion are arranged On the central axis of the square and movable from both sides, the first actuation portion and the second actuation portion include at least two lancets in the width direction such that the first actuation portion simultaneously pierces the first The capsule in the capsule chamber and the second capsule chamber, the second actuator simultaneously pierces the capsule in the third capsule chamber and the fourth capsule chamber.
  • the dry powder inhalation device has an air resistance value of 0.01 to 0.06 KPa of 0.5 minute/liter.
  • the dry powder inhalation device has an air resistance value of 0.015 - 0.035 KPa 0.5 min / liter.
  • the dry powder inhalation device has an air resistance value of 0.029 KPa 0.5 min/liter.
  • the dry powder inhalation device comprises:
  • a lower housing defining a top open cavity for accommodating a plurality of capsule chambers, the lower housing side being provided with a gap matching the number and position of the actuators such that at least each of the actuation portions One part is located outside the device for the user to operate, and the internal cavity thereof communicates with the outside air;
  • a connecting plate covering the top of the lower casing, and having a hollow interface at the top of the multi-capsule chamber, the screen cover being detachably mounted to the interface so that the screen covers the top of each capsule through the interface ;
  • the upper housing extends downwardly from the top of the nozzle and defines a bottom open cavity surrounding the air outlet passage and is capped to the adapter plate when the screen cover is mounted to the interface.
  • the dry powder inhalation device comprises:
  • a lower housing defining a cavity that is open at the top and that is capable of securing a multi-capsule chamber, the lower housing side being provided with a gap that matches the number and position of the actuators such that at least each of the actuation portions One part is located outside the device for the user to operate, and a ventilating air inlet hole is provided at the side and/or the bottom portion so that the internal cavity can communicate with the outside air through the slit or the hole;
  • a connecting plate covering the top of the lower casing, and having a hollow interface at the top of the multi-capsule chamber, the screen cover being detachably mounted to the interface so that the screen covers the top of each capsule through the interface .
  • the upper housing extends downwardly from the top of the nozzle and defines a bottom open cavity surrounding the air outlet passage and is capped to the adapter plate when the screen cover is mounted to the interface.
  • the multi-capsule chamber is integrally formed with the connecting plate, and is fixed under the hollow interface of the connecting plate.
  • the notch is widened and/or extended relative to the size of the actuation portion to provide an air intake aperture.
  • the side wall of the air outlet passage is provided with at least one small hole communicating with the outside air, and the small hole is opened in a direction not facing the central axis of the air outlet passage to promote the airflow in the air outlet passage when the user inhales Rotate.
  • the upper casing, the lower casing and the connecting plates are hingedly connected together by a rotating shaft on the same side.
  • the engagement plate is integrally formed with the capsule chamber, and the interface forms a top opening of each capsule chamber.
  • the outlet passage gradually decreases from bottom to top and forms a narrow neck before reaching the nozzle.
  • the joint of the upper casing and the connecting plate is provided with a slit or a hole, so that the inner cavity thereof can communicate with the outside air through the slit or the hole;
  • the number of small holes in the air outlet passage is two, which are symmetrically opened around the central axis of the air outlet passage.
  • the small hole in the outlet passage is located in a region below the narrow neck.
  • the dry powder inhalation device of the present invention provides a drug dispenser comprising a separate product of each active component (or a mixture thereof) in a separate manner by providing a plurality of capsule chambers arranged in parallel, which is simple in structure and convenient to handle. Further, each capsule chamber can adjust the parameters of the intake passage and the outlet passage depending on the nature of the powder of the drug (composition) to set a suitable haze distribution for each active ingredient.
  • Figure 1 is a view showing the structural disassembly of a powder releasing device of the present invention.
  • Figure 2 is a cross-sectional view showing a capsule chamber of the powder releasing device shown in Figure 1.
  • Figure 3 shows a cross-sectional plan view of the capsule chamber region shown in Figure 2.
  • Figure 4 is a cross-sectional view showing another capsule chamber region of the powder releasing device shown in Figure 1.
  • Fig. 5 is a structural view showing the lower half of the section of the capsule chamber region shown in Fig. 4.
  • Figure 6 is a cross-sectional view showing another capsule chamber area of the powder releasing device shown in Figure 1.
  • Figure 7 is a cross-sectional plan view of the capsule chamber region shown in Figure 6.
  • Figure 8 is a cross-sectional view showing another capsule chamber area of the powder releasing device shown in Figure 1.
  • Figure 9 is a cross-sectional plan view of the capsule chamber region shown in Figure 8.
  • Figure 10 is a partial enlarged view of the bottom impeller of the capsule chamber shown in Figure 9.
  • Figure 11 is a cross-sectional view showing another capsule chamber area of the powder releasing device shown in Figure 1.
  • Figure 12 is a cross-sectional plan view showing the area of the capsule chamber shown in Figure 11.
  • Figure 13 is a view showing the structural disassembly of a dry powder inhalation device of the present invention.
  • Figure 14 is a partial cross-sectional view showing the dry powder inhalation device of Figure 13;
  • Figure 15 is a perspective view showing the suction nozzle of the dry powder inhalation device shown in Figure 13.
  • Figure 16 is a perspective view of the screen cover of the dry powder inhalation device of Figure 13;
  • Figure 17 is a cross-sectional plan view showing the multi-capsule chamber of the dry powder inhalation device of Figure 13;
  • Figure 18 is a cross-sectional plan view showing a multi-capsule chamber of another dry powder inhalation device of the present invention.
  • Figure 19 is a cross-sectional plan view showing a multi-capsule chamber of another dry powder inhalation device of the present invention.
  • Figure 20 is a partial cross-sectional view showing another dry powder inhalation device of the present invention.
  • Figure 21 is a cross-sectional view showing the air flow of the suction nozzle of the dry powder inhalation device shown in Figure 20.
  • Figure 22 is a plan view showing the nozzle of the dry powder inhalation device shown in Figure 20.
  • Figure 1 is a specific embodiment of a powder releasing device of the present invention comprising: (a) a capsule chamber 1 which is a cylindrical chamber for containing a capsule, a capsule The chamber 1 is provided at its top with an air outlet passage 11 at the junction of the outlet passage 11 and the capsule chamber 1 with a ventilable screen 12; (b) an actuation portion 2 comprising at least one lancet 21 mounted as The capsule chamber 1 can be moved to pierce the capsule, at least a portion of the actuator 2 is located outside the device for manipulation by the user; (c) the nozzle 3 is connected to the top of the capsule chamber 1 through the outlet passage 11. Referring to FIG.
  • the capsule chamber 1 is provided with a deflection air intake passage group communicating with the outside air.
  • the deflection air intake passage group includes at least two central axes around the capsule chamber and is clockwise.
  • the deflected deflecting intake passage 13 is synchronized counterclockwise to provide a spiral flow of air from the deflecting intake passage group to the top outlet passage 11 when the user inhales.
  • the user first opens the screen 12 mounted above the capsule chamber 1 and puts it into a capsule, then presses the actuator 2 to pierce the capsule, and the actuation portion 2 is then reset by manual or elastic means. Since the suction nozzle 3 communicates with the capsule chamber 1 through an outlet passage 11, and the capsule chamber 1 communicates with the external environment through the deflecting intake passage group, when the user inhales, the external ambient air generates a surrounding capsule chamber through the deflecting intake passage group. The spiral flow of 1 promotes rapid rotation of the punctured capsule to release the inhalable powder contained therein, and the inhalable powder moves toward the outlet passage 11 at the top of the capsule chamber 1 and enters the user through the nozzle 3.
  • the deflection air intake passage 13 of the present embodiment is deflected in a clockwise or counterclockwise direction, and does not mean that the deflection air intake passage group must be opened in the horizontal direction as long as it can provide a part of the airflow deflected in the horizontal direction.
  • the at least two yaw inlet passages 13 should be deflected as far as possible. For example, when the yaw inlet passages 13 are located on the side walls, they should all face obliquely upward, both obliquely downward or both toward the horizontal direction.
  • the powder releasing device of the present embodiment greatly reduces the requirement of the inspiratory flow rate of the user when the capsule is rotated and released in the prior art by providing the deflecting air inlet channel group in the capsule chamber 1. The powder is released more easily and reduces the amount of residue.
  • the deflecting intake passages 13 of the deflecting intake passage group are identical in shape and size and are evenly arranged around the central axis of the capsule chamber 1, providing a more uniform spiral flow. However, since the release of the inhalable powder in the capsule is achieved by the rotation and vibration of the capsule in the capsule chamber 1, it is not necessary to correct the shape and size of the deflecting intake passage 13 of the deflecting intake passage group.
  • the powder releasing device of the present embodiment greatly reduces the requirement of the inspiratory flow rate of the user during the rotation and vibration release of the capsule in the prior art by providing the deflecting air inlet channel group in the capsule chamber 1. To make it easier to release the powder and reduce the amount of residue.
  • the underside of the ventilable screen 12 is raised toward the capsule chamber 1 in a shape that provides a reduced rotational resistance of the capsule contact surface.
  • the yaw inlet passage group is disposed on the side wall of the capsule chamber 1, and the bottom of the capsule chamber 1 is further provided with an air inlet passage 14 communicating with the outside air. It is opened upward along the central axis of the capsule chamber 1 to provide a through airflow through the capsule chamber 1 from bottom to top when the user inhales.
  • the intake passage 14 at the bottom of the capsule chamber 1 can provide a through flow of air from the bottom to the top of the capsule chamber 1 when the user inhales to help the capsule tip to abut the screen ventilated at the top of the capsule chamber 1. 12 is rotated and the powder released is moved more smoothly toward the top outlet passage 11.
  • the opening of the deflecting air inlet passage 13 of the side wall of the capsule chamber 1 is disposed in an elongated shape longitudinally arranged along the side wall of the capsule chamber to provide a larger contact surface with the capsule when the user inhales.
  • the air flow causes the capsule to more easily rotate and vibrate within the capsule chamber 1 to release the inhalable powder.
  • the opening of the deflecting air inlet passage 13 of the side wall of the capsule chamber 1 is disposed in an elongated shape parallel to the central axis of the capsule chamber for the user to inhale.
  • the airflow is provided with a larger contact surface with the capsule and a better direction of force to drive the capsule to rotate and vibrate more smoothly in the capsule chamber 1 to release the inhalable powder.
  • the deflecting intake passage group is disposed at a lower portion of the side wall of the capsule chamber 1, and the bottom of the capsule chamber 1 is further provided with an intake passage 14 along the capsule chamber 1
  • the central axis is upwardly opened to provide a through airflow through the capsule chamber 1 from bottom to top when the user inhales.
  • Providing the deflecting air intake passage group at a lower portion of the side wall of the capsule chamber 1 can better provide a through airflow through the entire capsule chamber 1 from bottom to top when the user inhales, to help the capsule tip end against the top of the capsule chamber 1.
  • the vented screen 12 is rotated and the powder it releases is moved more smoothly toward the top outlet passage 11.
  • the deflecting intake passage group is disposed at a lower portion of the side wall of the capsule chamber 1, and the bottom of the capsule chamber 1 is not provided with an intake passage 14.
  • the yaw inlet channel group is provided only in the lower portion of the side wall of the capsule chamber 1, and it is also possible to provide a bottom-up airflow when the user inhales to help the capsule tip to abut the screen 12 ventilated at the top of the capsule chamber 1. Rotation, it will be appreciated that in order for the screen tip to be rotated against the screen 12 that is vented at the top of the capsule chamber 1, a through gas flow is not necessary as long as the bottom-up non-penetrating air flow is sufficient for the capsule to be lifted.
  • the bottom of the capsule chamber 1 is provided with a yaw inlet passage group.
  • the deflecting intake passage group at the bottom of the capsule chamber 1 can also be arranged to be evenly arranged around the central axis of the capsule chamber 1 and synchronously deflected in a clockwise or counterclockwise direction, which can be used when the user inhales
  • a portion of the helical flow of air deflected in a horizontal direction is provided to assist in rotation and vibration of the capsule to release the inhalable powder
  • another portion of the bottom-up through flow of air may be provided to assist in rotation of the screen 12 against the top of the capsule chamber 1
  • the powder which is released is more smoothly moved toward the top outlet passage 11, and the structure is simple, and it is two-fold.
  • the bottom deflecting intake passage group is integrally disposed as a fixed impeller structure.
  • the deflecting intake passage group of the impeller structure at the bottom of the capsule chamber 1 can be understood to be constituted by four deflecting intake passages 13 separated by four vanes.
  • both the bottom and the side walls of the capsule chamber 1 are provided with a set of deflecting intake passages.
  • the deflecting intake passage group at the bottom of the capsule chamber 1 and the deflecting intake passage group of the side wall both function to provide a deflected airflow, and the bottom deflecting intake passage group can also provide bottom-up
  • the object of the invention can likewise be achieved by the flow of gas.
  • an embodiment of the dry powder inhalation device of the present invention comprises: (a) a capsule chamber 1 (i.e., 1a and 1b in the drawing), which is a cylindrical chamber that can accommodate the capsule upright.
  • the top of the capsule chamber 1 is open, the bottom portion is provided with an air inlet passage 14 communicating with the outside air, and
  • the actuating portion 2 includes a lancet 21 mounted for user operation to move toward the side wall of the capsule chamber 1.
  • the nozzle 3 see Figs. 13, 15 and including an outlet passage 11 below (for clarity of illustration, the lower portion of the outlet 11 in Fig.
  • the capsule chamber The number of 1 is two, and the two capsule chambers 1 are arranged in parallel as an integrally formed double capsule chamber.
  • the capsule chamber 1 is separately provided with an actuating portion 2, and each actuating portion 2 is provided with two in the height direction.
  • a lancet 21 a screen cover 15 is fixed at the bottom opening of the outlet passage 11, see FIG. 16, a screen 12 is fixed in the screen cover 15, and can be separated and connected to the top of the double capsule chamber so that A screen 12 covers the top of the two capsule chambers 1.
  • the double capsule chamber is composed of the first capsule chamber 1a and the second capsule chamber 1b which are closely arranged, and the first actuator portion is disposed at both ends of the line where the first capsule chamber 1a and the second capsule chamber 1b are located.
  • 2a and the second actuating portion 2b, the first actuating portion 2a and the second actuating portion 2b are movable intermediately from both sides to pierce the capsules in the first capsule chamber 1a and the second capsule chamber 1b, respectively.
  • the user first separates the screen cover 15 from the top of the double capsule chamber to open the top of the double capsule chamber, and respectively fills each capsule chamber 1 with a capsule containing two different active ingredients, and then closes the screen cover 15 to
  • the screen 12 is caused to re-cover the top of the capsule chamber 1; subsequently, the user operates the actuation portion 2 to move from the sides to the middle to puncture the capsules in the first capsule chamber 1a and the second capsule chamber 1b, respectively, the actuation portion 2 It is reset by the elastic members commonly used in the prior art; finally, the user closely fits the mouth on the suction nozzle 3 and inhales forcefully, and the outside air enters the capsule chamber through the intake passage 14 at the bottom of the capsule chamber 1, so that the capsule The powder is oscillated and rotated at the screen 12 to release the powder, and the released powder in the capsule passes through the screen 12 into the outlet passage 11 and finally enters the human body.
  • the actuating portion 2 of the present embodiment is moved from the both sides to the middle to pierce the capsules in the first capsule chamber 1a and the second capsule chamber 1b, respectively, those skilled in the art can adjust the manner in which the actuators are arranged, for example,
  • the actuating portion 2 is disposed on one side of the line where the first capsule chamber 1a and the second capsule chamber 1b are located, and the actuating portion 2 includes at least two lancets in the width direction to be operated by an actuating portion 2
  • the capsules in the first capsule chamber 1a and the second capsule chamber 1b are simultaneously pierced.
  • each of the side walls of the capsule chamber 1 is respectively provided with a group of yaw inlet passages, the group of yaw inlet passages comprising two central axes surrounding the capsule chamber 1, and
  • the deflected deflecting intake passage 13 is synchronized in a clockwise or counterclockwise direction to provide a spiral flow of upwardly moving self-deflecting intake passage 13 when the user inhales.
  • the powder releasing device of the present embodiment provides a spiral airflow that moves upward from the deflecting intake passage 13 by providing a deflecting intake passage group on the side wall of the capsule chamber 1 when the user inhales.
  • the capsule can be rotated and vibrated more smoothly to release the inhalable powder, which greatly reduces the requirement of the inspiratory flow rate of the user in the prior art, and makes the release of the powder easier.
  • the deflecting intake passage group is disposed at a lower portion of a side wall of each of the capsule chambers 1.
  • the powder releasing device of the present embodiment can provide not only the spiral airflow that moves upward from the deflecting intake passage 13 but also the bottom intake passage 14 by providing the deflecting intake passage group at the lower portion of the capsule chamber 1.
  • the capsule is placed against the top screen 12 of the capsule chamber.
  • the opening direction of the yaw inlet passage 13 is tangential to the side wall of each of the capsule chambers 1 to cause the spiral airflow to more smoothly drive the capsule to rotate.
  • the lower portion of the air outlet passage 11 is a first sub-channel separated from the top of the first capsule chamber 1a and the second capsule chamber 1b by the central baffle 111, respectively.
  • 11a and the second sub-channel 11b, the first sub-channel 11a and the second sub-channel 11b are gradually gathered from the bottom to the center baffle 111, and the cross-section thereof is gradually narrowed and then remains unchanged for the user.
  • the airflow in the first capsule chamber 1a and the second capsule chamber 1b is guided to inhale toward the upper portion of the outlet passage 11 along the first sub-channel 11a and the second sub-channel 11b, respectively.
  • the airflow in the two capsule chambers can be gathered and merged in the area above the center flap 111, and is continuously guided to the outlet passage.
  • the upper portion flows so that the drug powder released in the two capsule chambers can be sufficiently mixed, and the collision with the channel casing can be reduced, thereby reducing the inspiratory resistance of the user.
  • the cross section of the air outlet passage 11 is gradually increased from the vicinity of the top of the center flap 111 toward the suction nozzle 3 and then remains unchanged. Since the airflow in the two capsule chambers (1a, 1b) can be gathered in the area above the center flap 111 when the user inhales, and is continuously guided to flow above the outlet passage, the outlet passage of the present embodiment The cross section of 11 is gradually increased from the vicinity of the top of the center baffle 111 toward the suction nozzle 3, and is maintained unchanged. It is advantageous for the airflow to flow upward smoothly, and the inner wall of the air outlet passage 11 can be reduced to hinder the air flow, and the drug powder in the air flow can be reduced.
  • the cross section of the air outlet passage 11 does not have to be gradually increased from the vicinity of the top of the center flap 111 toward the suction nozzle 3, and may be maintained as long as it is not reduced.
  • the first sub-channel 11a and the second sub-channel 11b further include two sub-baffles 112, and the sub-baffles 112 respectively respectively the first sub-channel 11a and the second sub-channel
  • the 11b is further divided into a plurality of narrow passages that gradually gather from the top of each capsule chamber from the bottom to the center flap 111, and the sub-baffle 112 has a lower height than the center flap 111.
  • the sub-baffle has an X-shaped cross section and is mirror-symmetrical with a central baffle as a plane of symmetry.
  • the sub-channels (11a, 11b) are further blocked by six narrow channels, each narrow channel can more accurately guide the direction in which the airflow is gathered according to its position, so that the two channels are smoothed more smoothly.
  • the airflow in the capsule chamber (1a, 1b) gathers in the area above the central baffle 111 to create an intersection and is continuously directed to flow over the outlet passage.
  • the suction nozzle 3 is disposed such that the airflow in the first capsule chamber 1a and the second capsule chamber 1b along the first sub-channel 11a and the second sub-portion, respectively, when the user inhales
  • the passage 11b is at a sufficient intersection with the upper portion of the outlet passage 11, and the outlet passage 11 has a height of 31 mm.
  • the height of the outlet passage 11 of the present embodiment refers to the distance from the top of the capsule chamber to the suction nozzle 3, as shown in Fig. 21, in the vicinity of the suction nozzle at the end of the outlet passage, the air flow in the two capsule chambers (1a, 1b) It has been fully intersected, and the mixing of the drug powder in the airflow is also sufficient. Continue to increase the length of the air outlet channel will increase the user's inspiratory resistance.
  • the dry powder inhalation device further comprises:
  • a lower casing 4 defining a cavity open at the top for accommodating the double capsule chamber, the lower casing 4 being provided with two notches 41 on the side so that at least a part of the actuation portion 2 Located outside the device for the user to operate, the notch 41 is extended and widened to the lower side with respect to the size of the actuating portion 2 to provide an air inlet hole 42 through which the internal cavity can communicate with the outside air;
  • the adapter plate 5 covers the top of the lower casing 4, and is provided with a hollow interface 51 at the top of the multi-capsule chamber.
  • the screen cover 15 is detachably mounted to the interface 51 so that the screen 12 covers the capsules.
  • an upper casing 6 extending downward from the top of the suction nozzle 3 to define a cavity that is open at the bottom and surrounds the outlet passage 11 and is closed to the adapter plate 5 when the screen cover 15 is mounted to the interface on.
  • the user first separates the lower casing 4 and the upper casing 6 to separate the screen cover 15 from the top of the double capsule chamber, and then respectively fills each capsule chamber 1 with capsules containing two different active ingredients, and then closes The housing 6 and the lower housing 4 such that the screen 12 re-covers the top of the capsule chamber 1; then, the user operates the portion of the actuator 2 outside the housing to pierce the capsule in each capsule chamber 1, the actuation portion 2 is reset by the elastic members commonly used in the prior art; finally, the user closely fits the mouth to the suction nozzle 3 and sucks in force, and the outside air enters the cavity through the air inlet 42 of the lower casing 4, And entering the capsule chamber 1 from the inlet passage 14 at the bottom of the capsule chamber 1 such that the capsule is oscillated and rotated against the screen 12 to release the powder, and the released powder in the capsule passes through the screen 12 into the outlet passage 11 and finally enters the human body. .
  • the dry powder inhaling device of the present embodiment adds the upper casing 6, the lower casing 4 and the connecting plate 5 under the premise of supporting the technical solution of the foregoing embodiment, thereby increasing the structure of the device.
  • the upper casing 6, the lower casing 4 and the adapter plate 5 are conventional components of the same type of dry powder suction device of the prior art, and the upper casing 6, the lower casing 4 and the adapter plate in this embodiment 5 is also a conventional design in the prior art.
  • the joint of the upper casing 6 and the engaging plate 5 is provided with a slit 52 such that the inner cavity thereof can pass through the slit 52 and The outside air is connected.
  • the side wall of the air outlet passage 11 is provided with a small hole 113 which is opened in a direction not facing the central axis of the air outlet passage 11 to promote the rotation of the air flow in the air outlet passage 11 when the user inhales.
  • the outside air can enter the inner cavity of the upper casing 6 through the slit, and enters the air outlet passage 11 from the small hole 113 of the air outlet passage 11, thereby causing the airflow in the air outlet passage 11 to rotate, this embodiment After the capsule powder in each capsule chamber 1 is released, it is transported in the air outlet passage 11 and sufficiently mixed by rotation, so that the speed of movement when the nozzle 3 is reached is appropriate and the composition is uniform.
  • the air outlet passage 11 is gradually reduced from bottom to top, and a narrow neck portion 114 is formed before reaching the outlet to further move the powder when it reaches the nozzle 3. The speed is right and the composition is even.
  • FIG. 18 there is shown another embodiment of the dry powder inhalation device of the present invention, wherein the multi-capsule chamber is closely arranged by the first capsule chamber 1a, the second capsule chamber 1b and the third capsule chamber 1c into a triangle, the first capsule One side of the line where the chamber 1a and the second capsule chamber 1b are located is arranged with a first actuating portion 2a, and the first actuating portion 2a is arranged with two lancets 21 in the width direction, and is movable toward the multi-capsule chamber to simultaneously stab Breaking the capsules in the first capsule chamber 1a and the second capsule chamber 1b, the second actuation portion 2b being arranged as a side of the third capsule chamber 1c remote from the first capsule chamber 1a and the second capsule chamber 1b, which is The arrangement is movable in a vertical direction of a line in which the first capsule chamber 1a and the second capsule chamber 1b are located to pierce the capsule in the third capsule chamber 1c.
  • the present embodiment provides a drug dispenser comprising three active components (or a mixture thereof) of a combination product in a separate manner by providing a three-capsule chamber, and an intake passage 14 is provided at the bottom of each capsule chamber 1,
  • the deflecting intake channel group is not provided at the side or the bottom, and other components are disposed in the same or similar manner as the other embodiments, and details are not described herein again.
  • the aperture of the bottom inlet passage 14 of one capsule chamber 1 is different from the other two capsule chambers 1 such that the inlet air flow rate of the capsule chamber 1 is different from that of the other capsule chambers 1 different.
  • the components of the combination product need to achieve a specific distribution of mist particles to maximize their effectiveness, since each component of the invention is separately dispensed in the corresponding capsule chamber 1, by adjusting the deflection
  • the structural features such as the size, position, opening angle and/or number of the intake passage 13, the intake passage 14 and/or the outlet passage 11 enable different aerodynamic parameters for each capsule chamber 1 to be simultaneously
  • the therapeutic effect of each active ingredient is maximized on the premise of administration.
  • a different air flow rate is imparted to affect the mist particle distribution of the powder in the capsule.
  • FIG. 19 there is shown another embodiment of the dry powder inhalation device of the present invention, in which the multi-capsule chamber 1 is closely arranged by the first capsule chamber 1a, the second capsule chamber 1b, the third capsule chamber 1c, and the fourth capsule chamber 1d.
  • the first actuating portion 2a and the second actuating portion 2b are arranged on a central axis of the square and are movable from both sides to the middle, the first actuating portion 2a and the second actuating portion 2b includes at least two lancets 21 in the width direction such that the first actuation portion 2a simultaneously pierces the capsules in the first capsule chamber 1a and the second capsule chamber 1b, and the second actuation portion 2b simultaneously pierces the third capsule Capsules in chamber 1c and fourth capsule chamber 1d.
  • each capsule chamber 1 of the present embodiment is provided with a deflecting intake passage group at the bottom, the deflection The intake passage group is integrally arranged as a fixed impeller structure to provide a spiral flow from bottom to top when the user inhales, effectively promoting the rotation and vibration of the capsule to release the inhalable powder, wherein the specific shape of the impeller structure Reference can be made to Figure 10.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un dispositif de libération de poudre pour une administration par inhalation, comprenant : une chambre à capsule (1), une partie d'actionnement (2) et une buse d'aspiration (3), un canal d'admission d'air de déviation (13) en communication avec l'extérieur étant disposé au niveau du fond et/ou sur une paroi latérale de la chambre à capsule (1), de telle sorte qu'un flux d'air en spirale se déplaçant vers le haut à partir du canal d'admission d'air de déviation (13) est utilisé lorsqu'un utilisateur inhale. Le dispositif permet à l'utilisateur d'utiliser un débit d'inhalation inférieur, qui peut entraîner une capsule pour administrer un médicament par rotation à grande vitesse.
PCT/CN2018/116943 2017-11-23 2018-11-22 Dispositif et procédé de libération de poudre WO2019101136A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201880074883.7A CN111356495B (zh) 2017-11-23 2018-11-22 粉末释放装置及方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201711177479.6A CN109821117B (en) 2017-11-23 Powder release device and method
CN201711177479.6 2017-11-23

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3011898B2 (ja) * 1997-02-20 2000-02-21 フォルテ グロウ メディカル株式会社 吸引器
US20040206350A1 (en) * 2002-12-19 2004-10-21 Nektar Therapeutics Aerosolization apparatus with non-circular aerosolization chamber
CN101380496A (zh) * 2007-09-03 2009-03-11 东鸿远东有限公司 吸入器
CN105107070A (zh) * 2015-09-23 2015-12-02 石家庄鑫富达医药包装有限公司 一种胶囊型干粉吸入器
CA2972826A1 (fr) * 2015-01-14 2016-07-21 Respira Therapeutics, Inc. Procedes et dispositifs de dispersion de poudre
CN208389129U (zh) * 2017-11-23 2019-01-18 正大天晴药业集团股份有限公司 一种粉末释放装置

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102006010089A1 (de) * 2006-02-24 2007-10-18 Aha-Kunststofftechnik Gmbh Trockenpulver-Inhalator
WO2008050542A1 (fr) * 2006-09-29 2008-05-02 Canon Kabushiki Kaisha Inhalateur

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3011898B2 (ja) * 1997-02-20 2000-02-21 フォルテ グロウ メディカル株式会社 吸引器
US20040206350A1 (en) * 2002-12-19 2004-10-21 Nektar Therapeutics Aerosolization apparatus with non-circular aerosolization chamber
CN101380496A (zh) * 2007-09-03 2009-03-11 东鸿远东有限公司 吸入器
CA2972826A1 (fr) * 2015-01-14 2016-07-21 Respira Therapeutics, Inc. Procedes et dispositifs de dispersion de poudre
CN105107070A (zh) * 2015-09-23 2015-12-02 石家庄鑫富达医药包装有限公司 一种胶囊型干粉吸入器
CN208389129U (zh) * 2017-11-23 2019-01-18 正大天晴药业集团股份有限公司 一种粉末释放装置

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CN109821117A (zh) 2019-05-31
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