Aerosol container, metered-dose spray inhaler, deposition suppression member, second body part of container body of aerosol container, and procaterol hydrochloride hydrate prefilled in aerosol container

Abstract

The present invention prevents a pharmaceutical agent from being sprayed at a higher concentration even when a metered-dose spray inhaler is used without shaking before use. An aerosol container 3 includes: a container body 30 that contains a content liquid containing a pharmaceutical agent in a pressurized state; and a metered valve mechanism 40 having a valve stem 50 and an elastic member 41 that biases the valve stem 50, the valve stem 50 being held by a bottom wall 32a of the container body 30 and having a content liquid spray orifice 54 outside the container body 30. When the valve stem 50 is relatively pushed into the container body 30 against the biasing force of the elastic member 41, a prescribed amount of the content liquid is sprayed out from the spray orifice 54. The aerosol container 3 further includes a deposition suppression member 80 that is provided on the bottom wall 32a side in the container body 30 and suppresses deposition of the pharmaceutical agent contained in the content liquid.

Description

Aerosol container, metered-dose spray inhaler, deposition suppression member, second main body of the container body of the aerosol container, aerosol container filled with procaterol hydrochloride hydrate

[0001] The present invention relates to an aerosol container, a metered-dose spray inhaler equipped with an aerosol container, a sedimentation suppression member provided in the metered-dose valve mechanism of an aerosol container, a second main body portion of the container body of an aerosol container, and aerosol container filled with procaterol hydrochloride hydrate.

[0002] Traditionally, two types of inhalers have been known for use with inhalers, such as those used to treat asthma: dry powder inhalers (DPIs) for multiple uses and metered-dose inhalers (MDIs). Metered-dose inhalers are sometimes called pressurized metered-dose inhalers (pMDIs).

[0003] The housing of a metered-dose inhaler is generally fitted with a metal aerosol container containing a drug (for example, Patent Document 1). The aerosol container generally comprises a container body, a valve stem protruding from the container body, and a coil spring built into the container body. The valve stem is biased to the closed position by the coil spring. The aerosol container contains a drug solution (contents) in which particulate drug is suspended and dispersed in liquid fluorocarbon. When the operator presses the bottom of the container body with their hand, the valve stem is pushed into the container body against the biasing force of the coil spring and connects to the metered-dose tank inside the aerosol container. As a result, the contents are ejected from the valve stem. The ejected drug-containing contents are expelled from the mouthpiece attached to the housing body through the internal flow path of the metered-dose inhaler housing body, and an aerosol is formed when the liquid fluorocarbon, which is the propellant, vaporizes.

[0004] Patent No. 5033094

[0005] When an aerosol container is left standing, the relative density difference between the drug particles and the liquid fluorocarbon (CFC) causes the particulate drug to settle and accumulate within the container. Typical CFCs or alternative CFCs used in the liquid contents include HFA134a, HFA227, HFC152a, and HFO1234ze. Their densities (at 25°C) are 1.2 g / mL for HFA134a, 1.4 g / mL for HFA227, 0.9 g / mL for HFC152a, and 1.2 g / mL for HFO1234ze. It is known that salbutamol sulfate (1.3 g / mL) and fluticasone propionate (1.3 g / mL) settle relative to HFA134a, while formoterol fumarate (1.2 g / mL) and budesonide (1.3 g / mL) float relative to HFA227.

[0006] Metered-dose inhalers are designed to dispense the correct amount (correct concentration) of medication by uniformly dispersing particulate medication in liquid fluorocarbon. Therefore, patients using a metered-dose inhaler with medication in a suspended state must shake the inhaler well before use, and the product's packaging includes a warning stating, "Shake well before use." However, it has been reported that some patients use metered-dose inhalers without shaking them at all. In this case, if the particulate medication settles at the bottom of the aerosol container and the suspension becomes concentrated, a large amount of medication exceeding the prescribed amount may be dispensed, raising concerns about potential harm to the patient's health.

[0007] This invention has been made in view of the above-mentioned problems, and aims to prevent a large amount of medication from being sprayed even when a metered-dose spray inhaler is used without shaking it before use.

[0008] To achieve the above objectives, the present invention encompasses the subject matter described in the following sections.

[0009] Item 1: An aerosol container comprising: a container body for containing a liquid contents containing a drug under pressure; a metering valve mechanism having a valve stem held in the bottom wall of the container body and having a nozzle for spraying the liquid contents outside the container body; and an elastic member for biasing the valve stem, wherein a predetermined amount of the drug is sprayed from the nozzle by the valve stem being pushed relatively into the container body against the biasing force of the elastic member, and further comprising a settling suppression member provided on the bottom wall side inside the container body to prevent the settling of the drug contained in the liquid contents.

[0010] Item 2: The aerosol container according to Item 1, wherein the metering valve mechanism comprises: a valve stem having a flow path communicating with an intake port for the contents and the spray port; a metering tank attached to the bottom wall of the container body, in which the valve stem is retractably housed; and a retaining tank placed over the metering tank and movable along the direction of movement of the valve stem, wherein the sedimentation suppression member is provided around the retaining tank.

[0011] Item 3: The aerosol container according to Item 2, wherein the sedimentation suppression member is attached to the retaining tank and is movable in conjunction with the movement of the retaining tank.

[0012] Item 4: The aerosol container according to any one of items 1 to 3, wherein a recess is formed in the bottom wall of the container body, the valve stem is supported at the bottom of the recess, and in a normal state when the liquid contents are not being sprayed, the sedimentation suppression member covers the recess.

[0013] Item 5: The aerosol container according to any one of items 1 to 4, wherein the deposition suppression member comprises one or more flat plates.

[0014] Item 6: The aerosol container according to Item 4, wherein the settling suppression member includes a filling member having a shape corresponding to the space in the recess, and a flat plate that covers the opening at the upper end of the recess in a normal state when the liquid contents are not being sprayed.

[0015] Item 7: The aerosol container according to Item 4, wherein the deposition suppression member includes a member body, the member body has a truncated conical shape with an outer diameter decreasing toward the bottom, has a space inside, and the lower part has a shape corresponding to the space in the recess.

[0016] Item 8: The aerosol container according to item 4, wherein the deposition suppression member includes a filling member having a shape corresponding to the space in the recess, and a cylindrical member located above the filling member, with an open upper end and a space inside.

[0017] Item 9: The aerosol container according to Item 4, wherein the deposition suppression member includes a member body, the member body having a space inside, and including an upper cylindrical portion and a lower protrusion which, in a normal state when the liquid contents are not being sprayed, is at least partially located within the recess.

[0018] Item 10: The aerosol container according to item 4, wherein the member body has a space inside and comprises a cylindrical portion located on the upper side and an annular projection provided on the lower side of the cylindrical portion and located in the recess in a normal state when the liquid contents are not being sprayed, and the annular projection has reinforcing ribs extending radially from the inner surface.

[0019] Item 11: The aerosol container according to Item 1, wherein the container body comprises a first main body portion and a second main body portion fitted to the first main body portion, the metering valve mechanism is held in the bottom wall of the second main body portion, and the sedimentation suppression member is provided on the bottom wall side of the second main body portion.

[0020] Item 12: The aerosol container according to any one of items 1 to 11, wherein the drug is procaterol hydrochloride hydrate.

[0021] Item 13: A metered-dose spray inhaler comprising an aerosol container as described in any one of items 1 to 12, and a housing body in which the aerosol container is housed.

[0022] Item 14: A settling suppression member used in an aerosol container, wherein the aerosol container comprises a container body that contains a liquid contents containing a drug under pressure, a metering valve mechanism having a valve stem held in the bottom wall of the container body and having a nozzle for spraying the liquid contents outside the container body, and an elastic member that biases the valve stem, wherein the valve stem is pushed relatively into the container body against the biasing force of the elastic member, thereby spraying a predetermined amount of the drug from the nozzle, and the settling suppression member is provided on the bottom wall side inside the container body to prevent the settling of the drug contained in the liquid contents.

[0023] Item 15: A second main body of an aerosol container for spraying a predetermined amount of drug from a nozzle, wherein the container body holds a liquid containing the drug under pressure, the second main body has a bottom wall and is fitted together with the first main body to constitute the aerosol container, and comprises a metering valve mechanism having a valve stem held by the bottom wall and having the nozzle for the liquid outside the container body, and an elastic member that biases the valve stem, wherein the valve stem is pushed relatively into the container body against the biasing force of the elastic member, thereby spraying a predetermined amount of drug from the nozzle, and a settling suppression member provided on the bottom wall side to prevent the settling of the drug contained in the liquid.

[0024] Item 16: Aerosol container filled with procaterol hydrochloride hydrate, comprising: a container body for containing the liquid contents containing the procaterol hydrochloride hydrate under pressure; a metering valve mechanism having a valve stem held in the bottom wall of the container body and having a nozzle for spraying the liquid contents outside the container body; and an elastic member for biasing the valve stem, wherein the valve stem is pushed relatively into the container body against the biasing force of the elastic member, thereby spraying a predetermined amount of procaterol hydrochloride hydrate from the nozzle, and further comprising a deposition suppression member provided on the bottom wall side inside the container body to prevent the deposition of procaterol hydrochloride hydrate contained in the liquid contents.

[0025] According to the present invention, even when a metered-dose spray inhaler is used without shaking it before use, it is possible to prevent a large amount of medication from being sprayed.

[0026] This is a cross-sectional view along the vertical direction showing the overall configuration of the aerosol container of a metered-dose spray inhaler according to one embodiment of the present invention, where (A) is a diagram showing the normal state when the metered-dose spray inhaler is not in use and the contents are not being sprayed, and (B) is a diagram showing the state when the contents are being sprayed. This is a cross-sectional view showing an enlarged view of the main part of the aerosol container. This is a perspective view showing the overall configuration of the metered-dose spray inhaler with the mouthpiece cap removed. This is a perspective view showing a partially cut-out view of the metered-dose spray inhaler with the mouthpiece cap attached. This is a cross-sectional view along the vertical direction of the housing body. This is a cross-sectional view showing an enlarged view of the main part of the aerosol container of another embodiment This is a cross-sectional view showing an enlarged view of the main part of an aerosol container of another embodiment. This is a cross-sectional view showing an enlarged view of the main part of an aerosol container of another embodiment. This is a perspective view of the deposition suppression member of the embodiment shown in Figure 15. This is a cross-sectional view showing an enlarged view of the main part of an aerosol container of another embodiment Comparative Example 1. This is a cross-sectional view showing an enlarged view of the main part of an aerosol container of Comparative Example 2. This figure shows the results of the evaluation tests for Examples 1-6 and Comparative Example 1. This figure shows the results of the evaluation tests for Examples 7, 8 and Comparative Example 2.

[0027] (Overall configuration of the metered-dose spray inhaler 1) One embodiment of the present invention will be described with reference to the drawings. As shown in Figures 3 and 4, the metered-dose spray inhaler 1 has an aerosol container 3 housed in a housing body 2. The aerosol container 3 contains a liquid medicine containing a suspended drug under pressurized conditions. A mouthpiece 4 is detachably attached to the housing body 2, and a mouthpiece cap 5 is detachably attached to the mouthpiece 4.

[0028] The aerosol container 3 has a generally cylindrical container body 30, with a valve stem 50 protruding from one end of the container body 30. The valve stem 50 is biased in the protruding direction by a built-in coil spring 41, which will be described later, and is always closed. Details of the aerosol container 3 will be described later.

[0029] As shown in Figures 4 and 5, the housing body 2 has a cylindrical housing portion 2a that can receive the aerosol container 3. The aerosol container 3 is inserted into the housing body 2 upside down, i.e., with the valve stem 50 facing downwards, as shown in Figures 1 to 4. As shown in Figure 5, a holding portion 2b for holding the valve stem 50 is formed inside the housing body 2. The holding portion 2b has a fitting hole 2b1 into which the valve stem 50 can be airtightly fitted. The housing body 2 further has a pore 2c that communicates with the fitting hole 2b1 and a funnel-shaped portion 2d that communicates with the pore 2c. The funnel-shaped portion 2d guides the liquid contents sprayed from the valve stem 50 into the mouthpiece 4. An operating cap 20 (Figures 3 and 4) is placed over the top of the aerosol container 3.

[0030] As shown in Figure 4, a dose counter 10 for displaying the number of doses is located inside the housing body 2. The dose counter 10 includes a support member 11 fixed to the inner surface of the housing body 2, a pair of display members 12 and 13 rotatably supported by the support member 11, and an operating lever 14 for rotating the display members 12 and 13. As shown in Figure 3, a window 2W is formed on the side of the housing body 2 for viewing the numbers (not shown) printed on the display members 12 and 13. When the operating lever 14 is operated by a counter operating mechanism (not shown), the display members 12 and 13 rotate appropriately to shift the displayed number. Note that the dose counter 10 is not required.

[0031] After removing the mouthpiece cap 5, the operator manually pushes the container body 30 of the aerosol container 3 into the housing body 2 via the operating cap 20. As a reaction, the valve stem 50 is pushed into the container body 30, and a certain amount of liquid containing the drug is sprayed from the valve stem 50. The liquid containing the drug sprayed from the valve stem 50 is ejected to the outside through the pores 2c and funnel-shaped portion 2d of the housing body 2, and through the inside of the mouthpiece 4.

[0032] After spraying the liquid containing the drug, when the force pressing on the aerosol container 3 is released, the coil spring 41 (described later) inside the aerosol container 3 pushes the container body 30 back, and the displayed value on the dose counter 10 is lowered. As the container body 30 returns to its original position, the valve stem 50 also returns to its original position, and the drug for the next spray is filled.

[0033] The configuration of the housing body 2 is known, and any configuration is acceptable as long as it can spray the liquid containing the drug from the aerosol container 3. In this embodiment, a mouthpiece 4 is attached to the housing body 2, and the liquid is sprayed into the oral cavity by inserting the mouthpiece 4 into the patient's oral cavity. However, instead of the mouthpiece 4, a component for spraying the liquid onto another part of the patient, such as the ear, may be attached.

[0034] (Configuration of Aerosol Container 3) The configuration of the aerosol container 3 is shown in FIGS. 1 and 2. The aerosol container 3 is a container for storing the content liquid in a pressurized state, and includes a container body 30, a metering valve mechanism 40 provided at the lower part of the container body 30, and a sedimentation suppression member 80.

[0035] In the following description, the vertical direction refers to the direction in which the valve stem 50 extends in the state where the aerosol container 3 is attached to the housing body 2, and refers to the relative movement direction of the valve stem 50 with respect to the container body 30. The downward direction refers to the bottom wall side of the container body 30, and the upward direction refers to the side opposite to the bottom wall side and is the upper wall side of the container body 30. When the aerosol container is pushed in, the valve stem 50 is relatively pushed upward along the vertical direction. The horizontal direction refers to the direction perpendicular to the direction in which the valve stem 50 extends, and the horizontal plane refers to the plane perpendicular to the direction in which the valve stem 50 extends. The vertical direction does not necessarily have to be along the vertical direction, and may be inclined with respect to the vertical direction as long as the content liquid can be ejected from the aerosol container 3.

[0036] (Content Liquid) The aerosol container 3 contains substances such as liquefied gas, medicine, and dispersant inside, and ejects the aerosolized medicine by vaporizing and expanding when the liquefied gas returns to normal pressure. The substances enclosed in the aerosol container 3 are referred to as the content liquid (contents). Examples of the liquefied gas include liquid freon, liquid propane, liquid dimethyl ether, etc., but the content liquid used in the metered spray inhaler is limited to liquid freon (HFA227, HFA134a, HFC152A, etc.). In this embodiment, HFO1234ze, which is a liquid freon, is used. Examples of the medicine include medicines for treating bronchial asthma, chronic bronchitis, and emphysema. In this embodiment, procaterol hydrochloride hydrate is used. Examples of the dispersant include soy lecithin, oleic acid, polysorbate 80, and ethanol. In this embodiment, ethanol is used. Note that the content liquid composition is not limited to the above.

[0037] (Container body 30) The container body 30 comprises a first main body portion 31 which is cylindrical with an open bottom and a closed top, and a second main body portion 32 which is cylindrical with an open top and a closed bottom. The first main body portion 31 and the second main body portion 32 are fitted together airtightly. The upper wall 31a of the first main body portion 31 is curved so as to be convex inward for pressure resistance. An annular groove 33 is formed on the lower side of the first main body portion 31 by deforming the first circumferential wall 31b so as to be convex inward. In the following description, the position of the annular groove 33 refers to the position along the vertical direction of the part of the annular groove 33 with the smallest inner diameter. The lower end portion 31c of the first circumferential wall 31b of the first main body portion 31 is bent inward, and the lower end abuts against the bottom wall 32a of the second main body portion 32.

[0038] The second peripheral wall 32b of the second main body 32 covers the periphery of the first peripheral wall 31b of the first main body 31, and the height (vertical length) of the second peripheral wall 32b is set to cover the annular groove 33 of the first main body 31. The upper end 32c of the second peripheral wall 32b is curved inward, and the upper end abuts against the peripheral wall of the first main body 31. A circular annular O-ring 34 is fitted into the annular groove 33 of the first main body 31 in plan view, and the O-ring 34 abuts against the annular groove 33 and the inner surface of the second peripheral wall 32b of the second main body 32, maintaining airtightness between the first main body 31 and the second main body 32. The second main body 32 is also called a mounting cup.

[0039] A circular recess 32d is formed in the center of the bottom wall 32a of the second main body 32, with a cross-sectional shape along a plane perpendicular to the vertical direction. The recess 32d comprises an inclined portion 32e that slopes inward as it goes downward, an annular recess 32f formed continuously with the inclined portion 32e and convex outward, and a flat bottom portion 32g formed continuously with the annular recess 32f. A through hole 32h is formed in the center of the bottom portion 32g of the recess 32d through which the valve stem 50 passes. The center of the through hole 32h coincides with the axes of the cylindrical first main body 31 and the second main body 32. The bottom portion 32g of the recess 32d is inclined downward toward the center, but it may be horizontal.

[0040] On the upper surface of the bottom portion 32g of the concave portion 32d, an annular diaphragm 35 having a circular planar shape is attached. The upper surface and the side surface of the diaphragm 35 abut against a fixed-quantity tank flange portion 61 of a fixed-quantity tank 60 described later. When the fixed-quantity tank flange portion 61 is fitted into an annular recessed portion 32f, the diaphragm 35 is sandwiched and fixed between the fixed-quantity tank flange portion 61 and the bottom portion 32g. The inner diameter of the central hole 35a of the diaphragm 35 is formed to be approximately the same as the outer diameter of the lower portion 52 of the valve stem 50. By allowing the valve stem 50 to penetrate through the central hole 35a, the inside of the aerosol container 3 is hermetically held while allowing the valve stem 50 to move freely in the vertical direction. The material constituting the diaphragm 35 is selected from an elastic material or a flexible material, for example, rubber or an elastomer-based material, but is not limited to this material.

[0041] Note that the configuration of the container body 30 is not limited to this embodiment, and a known container body 30 may be used.

[0042] (Fixed-Quantity Valve Mechanism 40) The fixed-quantity valve mechanism 40 is provided on the bottom wall 32a of the container body 30. The fixed-quantity valve mechanism 40 includes a valve stem 50 that is held on the bottom wall 32a of the container body 30 and has an aerosol ejection port 54 outside the container body 30, a coil spring (elastic member) 41 through which the valve stem 50 penetrates and biases the valve stem 50 downward, a fixed-quantity tank 60, and a retaining tank 70.

[0043] (Retaining Tank 70) The retaining tank 70 is cylindrical, with a small diameter section 71 on the upper side and a large diameter section 72 on the lower side. A reduced diameter section 73 is formed between the small diameter section 71 and the large diameter section 72, connecting them. The upper side of the small diameter section 71 is sealed, and the lower end of the large diameter section 72 has an opening 75. An annular flange 74 is formed at the lower end of the large diameter section 72, facing outwards. The large diameter section 72 may be designed so that its inner and outer diameters become slightly smaller as it goes upwards. The retaining tank 70 is placed over the metering tank 60 and is freely movable vertically relative to the container body 30. The liquid contents contained in the container body 30 are introduced into the retaining tank 70 through the opening 75 at the lower end of the large diameter section 72. In the normal state shown in Figure 1(A), when the metered-dose spray inhaler 1 is not in use, that is, when the liquid contents are not being sprayed, the retaining tank 70 is in its lowest position, and the opening 75 at the lower end of the large-diameter portion 72 is located within the recess 32d. In the state shown in Figure 1(B), when the metered-dose spray inhaler 1 is in use, that is, when the liquid contents are being sprayed, the retaining tank 70 is in its highest position, and the opening 75 at the lower end of the large-diameter portion 72 is located above the recess 32d.

[0044] (Quantitative Tank 60) The quantitative tank 60 is located inside the retaining tank 70 and is attached and fixed to the bottom wall 32a of the container body 30, with the valve stem 50 retractably housed inside. The quantitative tank 60 has a substantially cylindrical body portion 60b and a quantitative tank flange portion 61 provided at the lower end of the body portion 60b. A circular opening 60a is formed in the upper wall of the quantitative tank 60, and the valve stem 50 passes through the opening 60a.

[0045] The lower end of the quantitative tank 60 is open, and a quantitative tank flange 61 is formed at the lower end facing outwards. The tip of the quantitative tank flange 61 is bent downwards and is fitted into the annular recess 32f of the second main body portion 32 of the container body 30, thereby fixing the quantitative tank 60 to the bottom 32g of the recess 32d of the container body 30 via the diaphragm 35. As shown in Figure 1(A), in the normal state when the quantitative spray inhaler 1 is not in use, that is, when the liquid contents are not being sprayed, the upper end of the quantitative tank 60 is located at the same position as the upper end of the large diameter portion 72 of the retaining tank 70, or slightly above the upper end of the large diameter portion 72, in the vertical direction.

[0046] The outer diameter of the main body 60b of the quantitative tank 60 is set to be smaller than the inner diameter of the large diameter section 72 of the retaining tank 70. A gap is formed between the outer surface of the main body 60b of the quantitative tank 60 and the inner surfaces of the large diameter section 72, the reduced diameter section 73, and the small diameter section 71 of the retaining tank 70, and this gap becomes a flow path 63 through which the liquid contents pass. The liquid contents flow into the flow path 63 from the opening 75 at the lower end of the retaining tank 70.

[0047] A tank seal 62 is provided inside the metering tank 60, around the opening 60a. The tank seal 62 has a tank seal through hole 62a in its center, and the tank seal through hole 62a and the opening on the top surface of the metering tank 60 are coaxial. The tank seal 62 holds the upper portion 51 of the valve stem 50 freely movable in the vertical direction. When the metering spray inhaler 1 is in use, that is, when the liquid contents are sprayed, the opening 60a and the tank seal through hole 62a are closed by the upper portion 51 of the valve stem 50, as shown in Figure 1(B), keeping the inside of the metering tank 60 airtight. In one spray, the liquid contents contained in the metering tank 60 are sprayed at the time of spraying. In other words, the metering tank 60 determines the amount (determined amount) of liquid contents to be sprayed.

[0048] (Valve stem 50) The valve stem 50 has an internal space that forms a flow path 52a, and is divided into an upper portion 51 and a lower portion 52 at the center in the vertical direction, i.e., in the longitudinal direction. The lower portion 52 of the valve stem 50 passes through the through hole 32h of the recess 32d of the second main body portion 32 and the central hole 35a of the diaphragm 35, and the valve stem 50 is freely movable in the vertical direction relative to the container body 30 and the metering tank 60.

[0049] The upper portion 51 penetrates the inside of the coil spring 41, and a retaining portion 53 is formed on the lower side of the upper portion 51, with its diameter increasing towards the bottom. The diameter of the lower end of the retaining portion 53 is larger than the inner diameter of the inside of the coil spring 41, so the coil spring 41 does not move below the retaining portion 53. The diameter of the lower end of the retaining portion 53 is larger than the outer diameter of the lower portion 52 of the valve stem 50 and the diameter of the central hole 35a of the diaphragm through which the lower portion 52 of the valve stem 50 penetrates, so the valve stem 50 is locked to the diaphragm 35 and prevented from falling out of the container body 30. The length of the upper portion 51 is formed to be longer than the coil spring 41.

[0050] The upper portion 51 comprises a cylindrical main body portion 51a and a plate-like portion 51b that extends upward from the periphery of the main body portion 51a, has an arc-shaped cross-section along the horizontal plane, and is curved along the periphery. The cross-sectional shape of the plate-like portion 51b may be semicircular or any other shape. In other words, the upper part of the upper portion 51 is shaped as if a part of a hypothetical cylinder has been cut out along the vertical direction, and comprises a notched portion 51c, which is the cut-out portion, and a plate-like portion 51b, which is the remaining portion. The upper part of the plate-like portion 51b is fixed to the inner surface of the small-diameter portion 71 of the retaining tank 70 by welding or the like.

[0051] As shown in Figure 1(A), in the normal state when the metered-dose spray inhaler 1 is not in use, the upper part of the upper portion 51 penetrates the opening 60a on the upper surface of the metered-dose tank 60. That is, because the notch 51c is formed, the entire opening 60a of the metered-dose tank 60 is not blocked, and the notch 51c becomes a passage for the liquid contents, allowing communication between the inside of the metered-dose tank 60 and the inside of the retaining tank 70. As shown in Figure 1(B), when the metered-dose spray inhaler 1 is in use, that is, when the liquid contents are sprayed, the valve stem 50 is pushed relatively against the container body 30 against the biasing force of the coil spring 41, and the notch 51c of the valve stem 50 protrudes above the metered-dose tank 60. As a result, the entire opening 60a of the metered-dose tank 60 is blocked by the main body portion 51a of the upper portion 51 of the valve stem 50. In this embodiment, the inside of the upper portion 51 is empty space, but the inside of the upper portion 51 may be solid. "Solid" refers to a state where the entire interior is filled with material.

[0052] The lower portion 52 of the valve stem 50 is cylindrical in shape, and its lower end is an open nozzle 54 that communicates with the flow path 52a. The nozzle 54 communicates with the fitting hole 2b1, the pore 2c, and the funnel-shaped portion 2d of the housing body 2. An intake hole 55 that communicates with the flow path 52a is formed on the upper side of the peripheral wall of the lower portion 52. The intake hole 55 is located outside the metering tank 60 in the normal state when the metering spray inhaler 1 is not in use, and inside the metering tank 60 when the liquid contents are being sprayed, as provided in the lower portion 52.

[0053] (Coil spring 41) As described above, the upper portion 51 of the valve stem 50 passes through the inside of the coil spring 41, and the upper end of the coil spring 41 is in contact with the tank seal 62 of the metering tank 60. In the normal state when the metering spray inhaler 1 is not in use, the lower end of the coil spring 41 is in contact with the retaining portion 53 of the valve stem 50, biasing the valve stem 50 downward. Note that a cylindrical rubber member or the like may be used instead of the coil spring 41 as the elastic member.

[0054] (Settling Suppression Member 80) The settling suppression member 80 is intended to prevent particulate matter contained in the liquid contents from settling and concentrating on the bottom wall 32a of the container body 30, the lower flange portion 61 of the metering tank 60 located within the recess 32d, and the upper side of the lower flange portion 74 of the retaining tank 70 when the aerosol container 3 is left standing for a long period of time in the state shown in Figure 1(A). Settling refers to the particulate matter moving downward and accumulating on the surface it moves to, and adhering to the surface to the extent that it can be easily detached from the surface when vibration is applied. The settling suppression member 80 is located on the lower side inside the container body 30 and is provided around the large diameter portion 72 of the retaining tank 70. In the normal state when the metering spray inhaler 1 is not in use, the settling suppression member 80 covers at least the recess 32d of the bottom wall 32a. Covering the recess 32d includes covering the opening 32i at the upper end of the recess 32d. Furthermore, covering the recess 32d includes positioning the deposition suppression member 80 in the space of the recess 32d and covering the inclined portion 32e, the annular recess 32f, and the bottom portion 32g by contacting or leaving a space between them (hereinafter also referred to as "covering the inner surface of the recess 32d"). By covering the recess 32d with the deposition suppression member 80, when the metered-dose spray inhaler 1 is not in use, the drug is prevented from settling around the opening 75 at the lower end of the large-diameter portion 72 of the retaining tank 70 located in the recess 32d, above the flange portion 61 of the metered-dose tank, above the flange portion 74 at the bottom of the retaining tank 70, etc.

[0055] Furthermore, if the container body 30 does not have a recess 32d and the bottom wall 32a of the container body 30 is a flat surface, the sedimentation suppression member 80 prevents the drug from settling on the upper surface of the bottom wall 32a, particularly around the opening 75 at the lower end of the large diameter portion 72 of the retaining tank 70.

[0056] The sedimentation suppression member 80 shown in Figures 1 and 2 comprises an annular flat plate 81 with a circular planar shape and a hole 81a in the center, and O-rings 82A and 82B. When the flat plate 81 is attached to the large-diameter portion 72 of the retaining tank 70, the large-diameter portion 72 of the retaining tank 70 penetrates the hole 81a. The vertical position to which the flat plate 81 is attached is such that, in the normal state of the metered-dose spray inhaler 1 shown in Figure 1(A), the lower surface of the flat plate 81 abuts against the bottom wall 32a and can cover the opening 32i on the upper surface of the recess 32d.

[0057] The diameter of the hole 81a in the flat plate 81 is set to be approximately the same as or slightly larger than the outer diameter of the large-diameter portion 72 of the retaining tank 70, and the flat plate 81 is fixed in the above position in the vertical direction by being sandwiched from above and below by the O-rings 82A and 82B. In addition, if the diameter of the hole 81a in the flat plate 81 is approximately the same as the outer diameter of the large-diameter portion 72 of the retaining tank 70, the flat plate 81 may also be fixed to the large-diameter portion 72 of the retaining tank 70 by the frictional force between the inner surface of the hole 81a and the outer surface of the large-diameter portion 72 of the retaining tank 70, in addition to the O-rings 82A and 82B.

[0058] The thickness of the flat plate 81 is set to a thickness that allows the retaining tank 70 to move between the upper and lower positions. The diameter of the flat plate 81 is set to be larger than the upper diameter of the recess 32d in the bottom wall 32a of the second main body 32, and is sized to contact the bottom wall 32a around the recess 32d, and is sized to cover the upper surface of the recess 32d. In addition, the diameter of the flat plate 81 is set to be slightly smaller than the inner diameter of the position of the annular groove 33 in the first main body 31 so that the flat plate 81 does not come into contact with the annular groove 33 of the first main body 30.

[0059] The O-rings 82A and 82B have a circular annular cross-section, through which the large-diameter portion 72 of the retaining tank 70 passes, and are fixed in a predetermined position on the large-diameter portion 72 of the retaining tank 70 by frictional force. The lower O-ring 82B is located on the flange portion 74 of the retaining tank 70 and has an outer diameter that can fit into the inclined portion 32e of the second main body portion 32 of the container body 30. The flat plate 81 is positioned in contact with the lower O-ring 82B, and the upper O-ring 82A is positioned in contact with the flat plate 81; that is, the O-rings 82A and 82B are provided above and below the flat plate 81, fixing the flat plate 81 to the large-diameter portion 72 of the retaining tank 70. In this embodiment, the upper O-ring 82A is the same shape and size as the lower O-ring 82B. The O-rings 82A and 82B can have any shape as long as the flat plate 81 is held in the retaining tank 70 so as to cover the opening 32i at the upper end of the recess 32d in the bottom wall 32a of the second main body 32.

[0060] The material of the flat plate 81 is preferably polypropylene or polyethylene, and the material of the O-rings 82A and 82B is preferably rubber, such as nitrile rubber, silicone rubber, general-purpose fluororubber, ethylene propylene diene rubber, acrylic rubber, hydrogenated nitrile rubber, chloroprene rubber, butyl rubber, urethane rubber, styrene butadiene rubber, etc., but are not limited thereto. Also, the O-rings 82A and 82B are not necessarily provided, and the flat plate 81 may be fixed to the retaining tank 70 by adhesive or by frictional force between the inner surface of the hole 81a of the flat plate 81 and the outer surface of the large diameter portion 72 of the retaining tank 70.

[0061] (Operation) As shown in Figure 1(A), in the normal state when the metered-dose spray inhaler 1 is not in use, the lower surface of the retaining portion 53 of the valve stem 50 is locked to the diaphragm 35. The upper portion 51 of the valve stem 50 extends through the opening 60a on the upper surface of the metered-dose tank 60 into the inner diameter portion of the retaining tank 70. The coil spring 41 extends between the lower surface of the tank seal 62 of the metered-dose tank 60 and the retaining portion 53 of the valve stem 50, biasing the valve stem 50 downward. This positions the intake hole 55 of the lower portion 52 of the valve stem 50 outside the metered-dose tank 60. The flow path 52a of the lower portion 52 of the valve stem 50 is at atmospheric pressure, and the inside of the aerosol container 3 is kept at a high pressure sufficient to maintain the liquid fluorocarbon content.

[0062] As shown in Figure 1(B), when using the metered-dose spray inhaler 1, the user pushes the container body 30 against the housing body 2. This causes the valve stem 50 to be pushed upward relative to the container body 30 against the biasing force of the coil spring 41, and the intake hole 55 provided in the lower part 52 of the valve stem 50 moves into the metered-dose tank 60. At this time, along with the relative upward movement of the valve stem 50, the retaining tank 70 fixed to the valve stem 50 and the sedimentation suppression member 80 fixed to the retaining tank 70 also move relatively upward. As the liquefied gas in the metered-dose tank 60 vaporizes and expands, the aerosolized drug particles are pushed out from the intake hole 55 into the flow path 52a of the valve stem 50 and downward, and are sprayed from the lower nozzle 54.

[0063] When the liquid contents are sprayed as shown in Figure 1(B), the opening 60a on the top surface of the metering tank 60 is blocked by the upper portion 51 of the valve stem 50, so no new liquid contents are introduced into the metering tank 60. Therefore, when all the liquid contents in the metering tank 60 are sprayed out, the spraying stops. On the other hand, the liquid contents outside the retaining tank 70 are introduced into the retaining tank 70 through the gap between the flange portion 74 of the retaining tank 70 and the metering tank flange portion 61 of the metering tank 60, the opening 75 of the retaining tank 70, and the gap between the large diameter portion 72 of the retaining tank 70 and the main body portion 60b of the metering tank 60.

[0064] When the valve stem 50 is released, the biasing force of the coil spring 41 causes the valve stem 50, retaining tank 70, and sediment suppression member 80 to move downward relative to the aerosol container 3, returning them to the normal state shown in Figure 1(A). At this time, the notch 51c of the valve stem 50 opens the opening 60a on the upper surface of the metering tank 60, so the liquid contents in the retaining tank 70 are introduced into the metering tank 60 through the opening 60a.

[0065] It is desirable to shake the metered-dose spray inhaler 1 well before use to uniformly disperse the suspended drug contained in the liquid in the liquid Freon. However, the metered-dose spray inhaler 1 may be used without shaking after being left standing for a long time with the valve stem 50 of the aerosol container 3 facing downwards. If there is no settling suppression member 80, the drug will settle in the container body 30 due to prolonged standing, accumulating on the bottom wall 32a of the second main body part 32, and the concentration of the drug at the bottom of the container body 30 will be higher than when the drug is uniformly dispersed in the aerosol. If the metered-dose spray inhaler 1 is used in this state, the liquid with a high concentration of the drug will be introduced into the retaining tank 70, and after the valve stem 50 returns to its normal state, it will be introduced into the metered-dose tank 60. As a result, when used next time, the liquid containing a larger amount of the drug per spray (expected amount) than when shaken well before use will be sprayed.

[0066] In this embodiment, since a deposition suppression member 80 is provided, the drug accumulates on the upper surface of the deposition suppression member 80. Since the drug does not accumulate on the bottom wall 32a which is below the second main body 32, the concentration of the drug in the aerosol near the bottom wall 32a of the second main body 32 is unlikely to become high. As a result, it is less likely that a liquid containing a larger amount of drug than intended will be introduced into the quantitative tank 60, and it is possible to prevent the spraying of a liquid containing a large amount of drug.

[0067] (Other Embodiments) Figures 6 to 16 show other embodiments. These embodiments differ from the embodiment in Figure 1 in the configuration of the sedimentation suppression member 80, while other configurations are the same as those in the embodiment in Figure 1. For this reason, in the description of the other embodiments shown in Figures 6 to 16, only the configuration of the sedimentation suppression member 80 will be described, and other configurations will be denoted by the same reference numerals as in the embodiment in Figure 1 and their descriptions will be omitted. In addition, in the following description of the sedimentation suppression member 80 in Figures 6 to 16, configurations (including materials) that are not specifically described are the same as those of the sedimentation suppression member 80 shown in Figure 1.

[0068] The deposition suppression member 80 in the embodiment shown in Figure 6 comprises a first flat plate 81A, a second flat plate 81B, a third flat plate 81C, and upper and lower O-rings 82A and 82B. The third flat plate 81C is provided on the upper surface of the flange portion 74 of the retaining tank 70. The diameter of the third flat plate 81C is set to a length that allows the third flat plate 81C to be positioned within the inclined portion 32e of the second main body portion 32 of the container body 30. In this embodiment, the diameter of the third flat plate 81C is such that the position of the periphery of the flange portion 74 and the periphery of the third flat plate 81C are aligned along the vertical direction. The hole 81c of the third flat plate 81C is set to be approximately the same as or slightly larger than the outer diameter of the large diameter portion 72 of the retaining tank 70. The third flat plate 81C is movable vertically along the large-diameter portion 72 of the retaining tank 70, but may also be fixed to the upper surface of the flange portion 74 of the retaining tank 70 by the frictional force between the inner surface of the hole 81c and the outer surface of the large-diameter portion 72. The size (inner diameter) of the hole 81a in the first flat plate 81A, the hole 81b in the second flat plate 81B, and the hole 81c in the third flat plate 81C is preferably the same as or slightly larger than the outer diameter of the large-diameter portion 72 of the retaining tank 70 so that the large-diameter portion 72 passes through it, and the sizes of each hole 81a, 81b, and 81c may be the same or different.

[0069] The second flat plate 81B is located above the third flat plate 81C, and the hole 81b is set to be approximately the same as or slightly larger than the outer diameter of the large-diameter portion 72 of the retaining tank 70. The second flat plate 81B, which is installed along the large-diameter portion 72 of the retaining tank 70 and the third flat plate 81C, is movable vertically between the O-ring 82B provided above it and the third flat plate 81C. The second flat plate 81B may also be fixed to the large-diameter portion 72 of the retaining tank 70 by the frictional force between the inner surface and the outer surface of the hole 81b. The diameter of the second flat plate 81B is larger than the upper diameter of the recess 32d in the bottom wall 32a of the second main body portion 32, and is set to be large enough to contact the bottom wall 32a around the recess 32d, and large enough to cover the opening 32i at the upper end of the recess 32d. Furthermore, the second flat plate 81B is positioned such that, in the normal state of the metered-dose spray inhaler 1, its upper surface abuts against the O-ring 82B, its lower surface abuts against the bottom wall 32a, and it can cover the opening 32i at the upper end of the recess 32d.

[0070] A first flat plate 81A is provided above the O-ring 82B. The diameter of the first flat plate 81A is set to be slightly smaller than the diameter of the second flat plate 81B. In addition, the diameter of the first flat plate 81A is set to be slightly smaller than the inner diameter of the position of the annular groove 33 in the first main body portion 31 of the container body 30 so that the first flat plate 81A does not come into contact with the annular groove 33. In the normal state of the metered-dose spray inhaler 1, the position of the upper surface of the first flat plate 81A is either at the position corresponding to the position of the annular groove 33 or at a position below the position of the annular groove 33, but it may also be at a position above the position of the annular groove 33.

[0071] An O-ring 82A is provided on the upper side of the first flat plate 81A. The first flat plate 81A is fixed by being sandwiched between the O-rings 82A and 82B, with its upper and lower surfaces in contact with them. The other configurations of the first flat plate 81A, the second flat plate 81B, and the third flat plate 81C are the same as those of the flat plate 81 in the embodiment shown in Figure 1, and the other configurations of the O-rings 82A and 82B are the same as those of the O-rings 82A and 82B in the embodiment shown in Figure 1.

[0072] The deposition suppression member 80 of the embodiment shown in Figure 7 comprises a flat plate 81, an O-ring 82, and a filling member 83. The configuration of the flat plate 81 is the same as that of the second flat plate 81B in the embodiment shown in Figure 6, and the configuration of the O-ring 82 is the same as that of the O-ring 82B in the embodiment shown in Figure 6, so their explanation is omitted. In the normal state, the filling member 83 is located in the recess 32d of the bottom wall 32a, in the space surrounded by the flange 74 and large-diameter portion 72 of the retaining tank 70, the inclined portion 32e of the second main body portion 32 of the aerosol container 3, and the lower surface of the flat plate 81, and has a shape corresponding to the shape of this space and fills this space. That is, the filling member 83 has a truncated cone shape in which the diameter continuously decreases toward the bottom. The filling member 83 does not obstruct the spraying operation of the drug. A hole 83a is formed in the center of the filling member 83 along the vertical direction. The large-diameter portion 72 of the retaining tank 70 passes through the hole 83a. The filling member 83 may be sized to contact the lower surface of the flat plate 81, but a gap may be formed between it and the flat plate 81. The diameter of the hole 83a in the filling member 83 is set to be approximately the same as the outer diameter of the large-diameter portion 72 of the retaining tank 70, and the filling member 83 is fixed to the upper surface of the flange portion 74 of the retaining tank 70 by the frictional force between the inner surface of the hole 83a and the outer surface of the large-diameter portion 72 of the retaining tank 70. The diameter of the hole 83a in the filling member 83 may be set to be slightly larger than the outer diameter of the large-diameter portion 72 of the retaining tank 70, and the filling member 83 may be movable vertically between the flat plate 81 and the flange portion 74 of the retaining tank 70. The filling member 83 is solid, but a space may be formed inside it.

[0073] The deposition suppression member 80 in the embodiment shown in Figure 8 comprises a member body 84 and an O-ring 82. The member body 84 has an overall funnel shape, that is, a truncated cone shape in which the outer diameter decreases towards the bottom. Openings 84c and 84d are provided at the upper and lower ends of the member body 84, and the large-diameter portion 72 of the retaining tank 70 passes through the member body 84. The diameter of the opening 84d at the lower end of the member body 84 is set to be approximately the same as or slightly larger than the outer diameter of the large-diameter portion 72 of the retaining tank 70.

[0074] The outer diameter of the upper end portion 84b of the member body 84 is constant along the vertical direction. In the cross-section along the vertical direction shown in Figure 8, the inclination of the lower portion 84e, which is below the upper end portion 84b, is in line with the inclination of the inclined portion 32e of the second main body portion 32 of the aerosol container 3. The member body 84 has a space 84a formed inside, and the inner diameter of the internal space 84a decreases continuously from the top to the bottom. The thickness of the lower portion 84e of the member body 84 is almost constant.

[0075] The main body of the component 84 covers the recess 32d in the normal state when the metered-dose spray inhaler 1 is not in use. The main body of the component 84 covers the inner surface of the recess 32d and, by protruding above the recess 32d, covers the opening 32i at the upper end of the recess 32d. The outer diameter of the upper end 84b of the main body of the component 84 is set to be slightly smaller than the inner diameter of the position of the annular groove 33 of the first main body 31, thereby preventing the main body of the component 84 from hitting the annular groove 33 of the first main body 31 of the container body 30 even when the main body of the component 84 moves vertically as the retaining tank 70 moves. The opening 84c of the main body of the component 84 is, in the normal state, at a position corresponding to the position of the annular groove 33 of the first main body 31, or at a position below the position of the annular groove 33. The O-ring 82 contacts the inner surface of the main body of the component 84 and fixes the main body of the component 84 to the retaining tank 70. The other configurations of the O-ring 82 are the same as those of the O-rings 82A and 82B shown in Figure 1.

[0076] The deposition suppression member 80 in the embodiment shown in Figure 9 has a different shape for the member body 84 compared to the member body 84 in Figure 8. The differences will be explained below, and the same configuration as in Figure 8 will not be explained. The upper end portion 84b of the member body 84 has a constant inner and outer diameter, and the upper end portion 84b extends along the vertical direction. The member body 84 also has a bottom portion 84g at its lower end, and a through hole 84f is formed in the center of the bottom portion 84g for the retaining tank 70 to pass through. The diameter of the through hole 84f of the member body 84 is set to be approximately the same as or slightly larger than the outer diameter of the large diameter portion 72 of the retaining tank 70.

[0077] The deposition suppression member 80 of the embodiment shown in Figure 10 comprises a cylindrical member 85, a filling member 83, and an O-ring 82. The cylindrical member 85 has an internal space 85a, and the large-diameter portion 72 of the retaining tank 70 passes through the cylindrical member 85. An opening 85c is formed at the upper end of the cylindrical member 85, and a bottom portion 85e is provided at the lower end. A through hole 85f is formed in the center of the bottom portion 85e for the retaining tank 70 to pass through. The diameter of the through hole 85f is set to be approximately the same as or slightly larger than the outer diameter of the large-diameter portion 72 of the retaining tank 70. The thickness of the bottom portion 85e increases towards the center, and the area around the through hole 85f is in contact with the filling member 83. The thickness of the bottom portion 85e may be constant. The inner and outer diameters of the cylindrical member 85 are formed to be constant along the vertical direction. Furthermore, the cylindrical member 85 may have an inner diameter and outer diameter that are slightly smaller towards the bottom 85e in order to remove the cylindrical member 85 from the mold during manufacturing. In this specification, "constant inner diameter" and "constant outer diameter" include slight variations in the inner diameter and outer diameter, respectively. The outer diameter of the cylindrical member 85 is larger than the upper diameter of the recess 32d of the second main body 32 and is set to a size that abuts against the bottom wall 32a around the recess 32d, with the bottom 85e of the cylindrical member 85 covering the upper surface of the recess 32d. Also, the outer diameter of the cylindrical member 85 is smaller than the inner diameter at the position of the annular groove 33 of the first main body 31, and the opening 85c of the cylindrical member 85 is located above the position of the annular groove 33 of the first main body 31 of the container body 30. The O-ring 82 is provided so as to abut against the upper surface of the bottom 85e of the cylindrical member 85 and fixes the cylindrical member 85 to the retaining tank 70. The other components of the O-ring 82 are the same as those of O-rings 82A and 82B in Figure 1.

[0078] The filling member 83 has the same configuration as the filling member 83 in the embodiment shown in Figure 7. However, the filling member 83 does not have to be exactly the same shape as the filling member 83 in the embodiment shown in Figure 7, and the diameter of the upper end face, the diameter of the lower end face, and the height (length in the vertical direction) may be different.

[0079] The deposition suppression member 80 in the embodiment shown in Figure 11 comprises a cylindrical member 85, a filling member 83, and an O-ring 82. In its normal state, the upper end of the cylindrical member 85 is located at a position corresponding to the annular groove 33 of the first main body portion 31 of the container body 30, or at a position below the annular groove 33. That is, the vertical length of the cylindrical member 85 in the embodiment of Figure 11 is shorter than the vertical length of the cylindrical member 85 in the embodiment of Figure 10. The cross-sectional shape of the O-ring 82 is square. The other configurations are the same as in the embodiment shown in Figure 10.

[0080] The deposition suppression member 80 of the embodiment shown in Figure 12 comprises a member body 86 and an O-ring 82. The member body 86 is integrally formed with an upper cylindrical portion 86a and a lower protruding portion 86b that protrudes downward from the lower surface of the bottom portion 86j of the cylindrical portion 86a. The cylindrical portion 86a has an opening 86e on its upper side and consists of a main body portion 86i with an outer diameter that is constant along the vertical direction and a bottom portion 86j. The outer diameter of the main body portion 86i of the cylindrical portion 86a is smaller than the inner diameter at the position of the annular groove 33 of the first main body portion 31, and in the normal state, the opening 86e of the cylindrical portion 86a is at a position corresponding to the position of the annular groove 33 of the first main body portion 31 of the container body 30, or at a position below the position of the annular groove 33.

[0081] The projection 86b has a smaller outer diameter towards the bottom, and its overall shape is a truncated cone. The outer diameter of the upper end of the projection 86b is smaller than the outer diameter of the main body 86i of the cylindrical portion 86a, and this difference in outer diameter creates a stepped surface 86k on the lower surface of the bottom 86j of the cylindrical portion 86a. The projection 86b has a bottom 86f on its lower side, and a through hole 86g is formed in the center of the bottom 86f for the retaining tank 70 to pass through. The diameter of the through hole 86g is set to be approximately the same as or slightly larger than the outer diameter of the large diameter portion 72 of the retaining tank 70.

[0082] An internal space 86d is formed inside the main body 86 of the member, and the internal space 86d consists of a first space 86l within the main body 86i of the cylindrical portion 86a and a second space 86m formed continuously with the first space 86l. The second space 86m is formed continuously with the central portion and the upper portion of the protruding portion 86b in a plan view of the bottom 86j of the cylindrical portion 86a. The inner diameter of the main body 86i of the cylindrical portion 86a, i.e., the diameter of the first space 86l, is constant along the vertical direction. The diameter of the second space 86m decreases continuously toward the bottom. The diameter of the upper end of the second space 86m is smaller than the diameter of the first space 86l, and this difference in diameter forms a stepped surface 86c. The O-ring 82, which has a square cross-sectional shape, is located inside the first space 86l and is in contact with the stepped surface 86c. The O-ring 82 fixes the main body 86 of the member to the retaining tank 70. The diameter of the lower end of the second space 86m is formed to be larger than the diameter of the through hole 86g.

[0083] The deposition suppression member 80 of the embodiment shown in Figure 13 comprises a member body 87 and an O-ring 82, with the large-diameter portion 72 of the retaining tank 70 passing through it. The member body 87 is integrally formed with an upper cylindrical portion 87a and a lower protruding portion 87b that protrudes downward from the lower surface of the bottom of the cylindrical portion 87a. A space 87d is formed inside the cylindrical portion 87a. The cylindrical portion 87a has an opening 87e on its upper side, and the outer and inner diameters of the cylindrical portion 87a are constant along the vertical direction. The outer diameter of the cylindrical portion 87a is smaller than the inner diameter at the position of the annular groove 33 of the first main body portion 31, and in the normal state, the opening 87e of the cylindrical portion 87a is at a position corresponding to the position of the annular groove 33 of the first main body portion 31 of the container body 30, or at a position below the position of the annular groove 33.

[0084] The projection 87b has a truncated cone shape, with its outer diameter decreasing towards the bottom. It is solid except for the through-hole 87g, which will be described later, and does not have any internal space. Through-holes 87g are formed in the center of the bottom of the cylindrical portion 87a and in the center of the projection 87b for the retaining tank 70 to pass through. The diameter of the through-holes 87g is set to be approximately the same as or slightly larger than the outer diameter of the large-diameter portion 72 of the retaining tank 70. The outer diameter of the upper end of the projection 87b is set to be smaller than the outer diameter of the cylindrical portion 87a, so that the lower surface of the cylindrical portion 87a becomes a stepped surface 87h. In the normal state of the metered-dose spray inhaler 1 shown in Figure 13, the stepped surface 87h is in contact with the bottom wall 32a around the recess 32d. In the normal state, at any vertical position, the outer diameter of the protrusion 87b is set to be smaller than the inner diameter of the inclined portion 32e of the second main body 32 of the aerosol container 3. The outer surface of the protrusion 87b does not contact the inner surface of the inclined portion 32e, and a space exists between the protrusion 87b and the inclined portion 32e. In addition, the lower surface of the protrusion 87b does not contact the flange portion 74 of the retaining tank 70, but it may contact it.

[0085] An O-ring 82 with a square cross-section is in contact with the upper surface of the bottom of the cylindrical portion 87a, and the main body of the component 87 is fixed to the retaining tank 70 by the O-ring 82.

[0086] The deposition suppression member 80 of the embodiment shown in Figure 14 comprises a member body 87 and an O-ring 82. Hereinafter, only the differences from the embodiment shown in Figure 13 will be described. In the normal state shown in Figure 14, at any position in the vertical direction, the outer diameter of the protrusion 87b is set to be the same as the inner diameter of the inclined portion 32e of the second main body 32 of the aerosol container 3, and the lower part of the outer surface of the protrusion 87b abuts against the inner surface of the inclined portion 32e. Note that when the protrusion 87b is not located in the space surrounded by the inclined portion 32e, at least the lower part of the protrusion 87b may be formed to be slightly larger overall than the space surrounded by the inclined portion 32e. In this case, the lower part of the protrusion 87b is inserted into the inclined portion 32e while slightly deforming, and in the normal state, the lower part of the protrusion 87b and the inclined portion 32e are tightly fitted together. Also, in the normal state, the stepped surface 87h is located above the bottom wall 32a surrounding the recess 32d and does not abut against the bottom wall 32a. The lower surface of the protruding portion 87b does not come into contact with the flange portion 74 of the taining tank 70, but it may come into contact with it.

[0087] The deposition suppression member 80 of the embodiment shown in Figure 15 comprises a member body 88 and an O-ring 82. The member body 88 comprises a cylindrical portion 88a and an annular projection 88b provided on the lower side of the cylindrical portion. A space 88d is formed inside the cylindrical portion 88a. The cylindrical portion 88a has an opening 88e on its upper side. The outer diameter and inner diameter of the cylindrical portion 88a are constant along the vertical direction. On the upper side of the inner surface of the cylindrical portion 88a, slightly below the upper end, a convex ridge 88f that is convex inward is provided around the entire circumference. The outer diameter of the cylindrical portion 88a is smaller than the inner diameter at the position of the annular groove 33 of the first main body portion 31, and in the normal state, the opening 88e of the cylindrical portion 88a is at a position corresponding to the position of the annular groove 33 of the first main body portion 31 of the container body 30, or at a position below the position of the annular groove 33. A through-hole 88g is formed in the center of the bottom portion 88c of the cylindrical portion 88a for the retaining tank 70 to pass through. The diameter of the through-hole 88g is set to be approximately the same as or slightly larger than the outer diameter of the large-diameter portion 72 of the retaining tank 70.

[0088] The annular projection 88b is erected downward from the lower surface of the bottom 88c of the cylindrical portion 88a and is provided to surround the through hole 88a. The overall shape of the annular projection 88b is a truncated cone, with the outer diameter decreasing towards the bottom. The inner diameter of the annular projection 88b is slightly larger towards the bottom, but it may be the same along the vertical direction. Figure 16 is a perspective view of the member body 88 inverted. Multiple reinforcing ribs 88i are provided radially from the inner surface of the annular projection 88b at equal intervals in the circumferential direction; in this embodiment, there are six. The vertical height of the ribs 88i is set to the same height as the vertical height of the annular projection 88b. Also, the position of the radial tip surface of the ribs 88i is aligned with the position of the inner circumferential surface of the through hole 88g. The outer diameter of the upper end of the annular projection 88b is set to be smaller than the outer diameter of the cylindrical portion 88a, so that the lower surface of the cylindrical portion 88a becomes a stepped surface 88h.

[0089] An O-ring 82 with a square cross-section is in contact with the upper surface of the bottom 88c of the cylindrical portion 88a, and the member body 88 is fixed to the retaining tank 70 by the O-ring 82. In the normal state of the metered-dose spray inhaler 1, the stepped surface 88h of the cylindrical portion 88a is in contact with the bottom wall 32a surrounding the recess 32d. The annular projection 88b is not in contact with the flange 74 of the retaining tank 70, but may be in contact with it.

[0090] The aerosol containers 3 shown in Figures 1-2 and 6-16 above are aerosol containers 3 mainly used in metered-dose inhalers for adults (hereinafter also referred to as "adult aerosol containers 3").

[0091] (Other Embodiments) Figures 17 to 20 show examples of aerosol containers 3 (hereinafter also referred to as "pediatric aerosol containers 3") mainly used in metered-dose spray inhalers for children. Figures 17 to 20 show pediatric aerosol containers 3 corresponding to the adult aerosol containers 3 shown in Figures 1 and 13 to 15, respectively. In pediatric aerosol containers 3, the amount of drug to be sprayed is less than the amount sprayed in adult aerosol containers 3 shown in Figures 1 to 2 and 6 to 16, for example, set to about half the amount. In the aerosol container 3 of the present invention, the drug contained in the metered-dose tank 60 is sprayed, so the volume of the metered-dose tank 60 is adjusted to adjust the amount of drug to be sprayed. For example, in pediatric aerosol containers 3, the vertical length and inner diameter of the metered-dose tank 60 are made shorter than those of adult aerosol containers 3, and the vertical length, inner diameter, and outer diameter of the large-diameter portion 72 of the retaining tank 70 are made shorter to match the size of the metered-dose tank 60. The sizes of the holes 81a, 87g, and 88g in the sedimentation suppression member 80 through which the large-diameter portion 72 of the retaining tank 70 passes, and the inner diameter of the O-rings 82 (82A, 82B) are set to match the outer diameter of the large-diameter portion 72 of the retaining tank 70. In the embodiments shown in Figures 17 to 20, the other configurations are the same as those in the embodiments shown in Figures 1 and 13 to 15. Note that the aerosol container 3 for children may have a configuration corresponding to the aerosol container 3 for adults shown in Figures 6 to 12.

[0092] The deposition suppression member 80 is not limited to the above embodiment; for example, in Figures 7, 10, and 11, the filling member 83 may not be provided.

[0093] (Evaluation Test) The amount of drug contained in the sprayed liquid was evaluated for each of the metered-dose spray inhalers 1 containing the aerosol containers 3 of Examples 1 to 8 and Comparative Examples 1 and 2, when used without shaking.

[0094] (Contents) The contents contained in the aerosol containers 3 of Examples 1 to 8 and Comparative Examples 1 and 2 consist of liquefied gas, particulate drug, and dispersant. HFO1234ze, a liquid chlorofluorocarbon, is used as the liquefied gas, procaterol hydrochloride hydrate is used as the drug, and ethanol is used as the dispersant. In these contents, when the aerosol container 3 is left standing, the phenomenon of particulate drug settling is observed.

[0095] (Examples and Comparative Examples) Examples 1 to 6 and Comparative Example 1 are aerosol containers 3 mainly used in adult metered-dose spray inhalers 1. Comparative Example 1 has the same configuration as the aerosol container used in "Meptin Air 10 μg Inhalation 100 times" manufactured by Otsuka Pharmaceutical Co., Ltd., shown in Figure 21. Examples 1 to 6 have the same configuration as Comparative Example 1 shown in Figure 21, but are further equipped with a sedimentation suppression member 80. Examples 1 to 6 differ in the configuration of the sedimentation suppression member 80. The amount of drug per spray (assumed amount) when shaken well before use is set to 10 μg. The diameter of the large diameter portion 72 of the retaining tank 70 is 5.4 mm, and the diameter of the hole through which the large diameter portion 72 of the retaining tank 70 of the sedimentation suppression member 80 of Examples 1 to 6 passes is 5.5 mm.

[0096] The configuration of the sedimentation suppression member 80 in Examples 1 to 6 and Comparative Example 1 is as follows: Comparative Example 1: No sedimentation suppression member 80

[0097] Example 1: Configuration of the sedimentation suppression member 80: Configuration of the plate 81 of the embodiment shown in Figures 1 and 2: Diameter 16 mm, Thickness (height): 1.9 mm Configuration of the upper and lower O-rings 82A and 82B: Circular cross-sectional shape, Thickness (width) 1.9 mm, Diameter 8.6 mm, Inner diameter 4.8 mm

[0098] Example 2: Configuration of the deposition suppression member 80: Configuration of the plate 81 of the embodiment shown in Figure 7: Same as the plate 81 of Example 1 Configuration of the O-ring 82: Same as the upper and lower O-rings 82A and 82B of Example 1 Configuration of the filling member 83: Upper end diameter 9 mm, lower end diameter 7 mm, height 1.5 mm

[0099] Example 3: Configuration of the sedimentation suppression member 80: Configuration of the embodiment member body 84 shown in Figure 8: Outer diameter of the upper end 13.7 mm, outer diameter of the lower end 8 mm, inner diameter of the lower end 5.5 mm, height 5.5 mm, thickness 1.2 mm Configuration of the O-ring 82: Same as the upper and lower O-rings 82A and 82B of Example 1.

[0100] Example 4: Configuration of the sedimentation suppression member 80: Configuration of the cylindrical member 85 of the embodiment shown in Figure 10: outer diameter 13.2 mm, height 8.4 mm, thickness 1.3 mm Configuration of the filling member 83: upper end diameter 10.1 mm, lower end diameter 8 mm, height 1.5 mm Configuration of the O-ring 82: same as the upper and lower O-rings 82A and 82B of Example 1

[0101] Example 5: Configuration of the sedimentation suppression member 80: Configuration of the cylindrical member 85 of the embodiment shown in Figure 11: Outer diameter 13.2 mm, height 4.8 mm, thickness 1.3 mm Configuration of the filling member 83: Same as the filling member 83 of Example 4 Configuration of the O-ring 82: Cross-sectional shape is square, with a side length of 2 mm, diameter 8 mm, inner diameter 4 mm

[0102] Example 6: Configuration of the sedimentation suppression member 80: Embodiment shown in Figure 13 (the cylindrical member 85 and filling member 83 of Example 5 are integrally formed) Configuration of the cylindrical portion 87a of the member body 87: outer diameter 13.2 mm, height 4.7 mm, thickness 1.2 mm Configuration of the protruding portion 87b of the member body 87: upper end diameter 9.8 mm, lower end diameter 7.7 mm, height 1.4 mm Configuration of the O-ring 82: same as the O-ring 82 of Example 5

[0103] Examples 7 and 8 and Comparative Example 2 are aerosol containers 3 mainly used in pediatric metered-dose inhalers 1. Comparative Example 2 has the same configuration as the aerosol container used in "Meptin Kid Air 5 μg Inhalation 100 times" manufactured by Otsuka Pharmaceutical Co., Ltd., as shown in Figure 22. Examples 7 and 8 have the same configuration as Comparative Example 2 shown in Figure 22, but are further equipped with a deposition suppression member 80. The amount of drug per spray is set to be less than that of the adult versions in Examples 1 to 6 and Comparative Example 1, and the drug content (assumed amount) per spray when shaken well before use is set to 5 μg. The diameter of the large diameter section 72 of the retaining tank 70 is 5.1 mm, and the diameter of the hole through which the large diameter section 72 of the retaining tank 70 penetrates the deposition suppression member 80 of Examples 7 and 8 is 5.2 mm.

[0104] The configuration of the sedimentation suppression member 80 in Examples 7 and 8 and Comparative Example 2 is as follows: Comparative Example 2: No sedimentation suppression member 80

[0105] Example 7: Configuration of the sedimentation suppression member 80: Embodiment shown in Figure 17 (for children, as in Example 1) Configuration of the flat plate 81: Diameter 16 mm, Thickness (height): 1.9 mm Configuration of the upper and lower O-rings 82A and 82B: Circular cross-sectional shape, Thickness (width) 1.9 mm, Diameter 8.6 mm, Inner diameter 4.8 mm

[0106] Example 8: Configuration of the sedimentation suppression member 80: Embodiment shown in Figure 18 (for children, as in Example 6) Configuration of the cylindrical portion 87a of the member body 87: Outer diameter 13.2 mm, height 4.7 mm, thickness 1.2 mm Configuration of the protruding portion 87b of the member body 87: Upper end diameter 9.8 mm, lower end diameter 7.7 mm, height 1.4 mm Configuration of the O-ring 82: Cross-sectional shape is square, with a side length of 2 mm, diameter 8 mm, inner diameter 4 mm

[0107] (Measurement of the amount of drug contained in the sprayed liquid for Examples 1-6 and Comparative Example 1) Sample solutions and standard solutions were prepared by the following method, and measurements were performed by liquid chromatography for each of Examples 1-6 and Comparative Example 1 to calculate the amount of procaterol hydrochloride hydrate contained in the liquid sprayed in one go.

[0108] Liquid chromatography measurement conditions: Detector: UV spectrophotometer (measurement wavelength 254 nm) Column: Stainless steel tube with an inner diameter of 4.6 mm and a length of 15 cm packed with 5 μm octadecylsilylated silica gel for liquid chromatography (equivalent to TSK gel ODS - 80Ts). Column temperature: Constant temperature around 40°C

[0109] Mobile phase: Add 230 mL of methanol and 10 mL of acetic acid (100) to 760 mL of a solution of 0.87 g of sodium 1-pentanesulfonate dissolved in 1000 mL of water. Flow rate: Adjust so that the retention time of procaterol is approximately 9 minutes.

[0110] Internal standard solution: Weigh 0.1 g of methyl 4-aminobenzoate (internal standard substance), dissolve it in 23 mL of methanol, and add the sample solution preparation solvent to make a total volume of 100 mL. Take 1 mL of this solution and add the mobile phase to make a total volume of 50 mL.

[0111] Standard solution: Approximately 50 mg of procaterol hydrochloride hydrate (moisture content measured beforehand) was accurately weighed, dissolved and diluted with the mobile phase to a concentration of 10 μg / mL. 1 mL of this solution was accurately weighed, 1 mL of the internal standard solution was accurately added, and the mobile phase was added to make a total volume of 50 mL to prepare the standard solution.

[0112] Preparation of sample solutions: Each of the metered-dose spray inhalers 1 equipped with the aerosol containers 3 of Examples 1-6 and Comparative Example 1 was prepared in n units (n=2 for Comparative Example 1, n=3 each for Examples 1-5, and n=10 for Example 6). Each metered-dose spray inhaler 1 was shaken vigorously for 30 seconds and then sprayed twice. Each aerosol container 3 was removed from the housing body 2, the inside and outside of the valve stem 50 were washed with methanol, and then thoroughly dried. The containers were then left standing for 12 hours or more with the valve stem 50 facing downwards. Sample solutions 1-3 were obtained from each aerosol container 3 as follows.

[0113] (1) A stem support tip (jig) was placed at the bottom of a 30 mL beaker, and 15 mL of methanol and 1 mL of internal standard solution were accurately added. The valve stem 50 of the aerosol container 3 was pressed against the stem support tip and sprayed once. The residue inside the valve stem 50 was dropped into the 30 mL beaker, the surface of the aerosol container 3 was washed with 2 mL of methanol, and the washings were added to the liquid in the 30 mL beaker. This liquid was transferred to a 100 mL beaker, and the used 30 mL beaker was washed twice with 30 mL of sample solution preparation solvent (760 mL of a solution of 0.87 g of sodium 1-pentanesulfonate dissolved in 1000 mL of water, mixed with 10 mL of acetic acid (100)), and these washings were added to the 100 mL beaker. This liquid was filtered through a membrane filter with a pore size of 0.5 μm or less, the first filtrate 1 mL was removed, and the next filtrate was used as sample solution 1 (first time).

[0114] (2) Using another 30 mL beaker, the same procedure as in (1) was repeated to obtain sample solution 2 (second time).

[0115] (3) Using another 30 mL beaker, repeat the same operation as in (1) to obtain sample solution 3 (the third time).

[0116] For each of the standard solution and the sample solutions, perform measurement by liquid chromatography, and obtain the ratio of the peak area of procaterol to the peak area of the internal standard substance, Q S and Q T Let it be. Q S : The ratio of the peak area of procaterol to the peak area of the internal standard substance obtained by measuring the standard solution = (peak area of procaterol) / (peak area of internal standard substance) Q T : The ratio of the peak area of procaterol to the peak area of the internal standard substance obtained by measuring the sample solution = (peak area of procaterol) / (peak area of internal standard substance)

[0117] Calculate the amount (μg) of procaterol hydrochloride hydrate in each sample solution (in one injection) from the following formula 1.

[0118] (Formula 1) Amount (μg) of procaterol hydrochloride hydrate (C 16 H 22 N2O3・HCl・1 / 2 H2O) in one injection = M S × Q T / Q S × 0.2 × 1.0276 M S : The weighed amount (mg) of procaterol hydrochloride hydrate converted to the anhydrous form 1.0276: Molecular weight of procaterol hydrochloride hydrate / Molecular weight of procaterol hydrochloride = 335.83 / 326.82

[0119] Divide the calculated amount (μg) of procaterol hydrochloride hydrate in each sample solution (in one injection) by 10 and multiply by 100 to obtain the dose per injection (display amount %).

[0120] (Measurement of the amount of drug contained in the injected content solution for Examples 7 and 8 and Comparative Example 2) Only the differences from the measurements of Examples 1 to 6 and Comparative Example 1 will be described below.

[0121] Internal standard solution: Weigh 0.1 g of methyl 4-aminobenzoate (internal standard substance), dissolve it in 23 mL of methanol, and add the sample solution preparation solvent to make a total volume of 100 mL. Take 1 mL of this solution and add the mobile phase to make a total volume of 100 mL.

[0122] Standard solution: Approximately 50 mg of procaterol hydrochloride hydrate (moisture content measured beforehand) was accurately weighed, dissolved and diluted with the mobile phase to a concentration of 5 μg / mL. 1 mL of this solution was accurately weighed, 1 mL of the internal standard solution was accurately added, and the mobile phase was added to make a total volume of 50 mL to prepare the standard solution.

[0123] Preparation of sample solutions: Each of the following metered-dose spray inhalers 1, each fitted with the aerosol container 3 used in Examples 7, 8, and Comparative Example 2, was prepared in n units (n=2 for Comparative Example 2, n=3 for Example 7, and n=10 for Example 8).

[0124] (Formula 1) Procaterol hydrochloride hydrate in one spray (C 16 H 22 Amount of N2O3, HCl, and 1 / 2 H2O (in μg) = M S × Q T / Q S × 0.1 × 1.0276 M S : Amount of procaterol hydrochloride hydrate weighed (mg) converted to anhydrous form 1.0276: Molecular weight of procaterol hydrochloride hydrate / Molecular weight of procaterol hydrochloride = 335.83 / 326.82

[0125] The amount of procaterol hydrochloride hydrate (μg) in each sample solution (per spray) was calculated, divided by 5, and multiplied by 100 to obtain the amount of drug per spray (indicated amount %).

[0126] (Test Results) The test results are shown in Figures 23 and 24. The single-spray drug volume shown in Figures 23 and 24 is the average value (Examples 1-5, 7: n=3, Examples 6, 8: n=10, Comparative Examples 1, 2: n=2). That is, through the above measurements, the single-spray drug volume for n sample solutions 1 (first spray), the single-spray drug volume for n sample solutions 2 (second spray), and the single-spray drug volume for n sample solutions 3 (third spray) were obtained for each of Examples 1-8 and Comparative Examples 1 and 2. The average values ​​of the single-spray drug volumes for n sample solutions 1, n sample solutions 2, and n sample solutions 3 were calculated and used as the single-spray drug volumes shown in Figures 23 and 24.

[0127] In the evaluation test, the first spray dispensed a liquid containing a uniformly dispersed agent that had been pre-contained in the quantitative tank 60. Therefore, the amount of agent sprayed in Examples 1-8 and Comparative Examples 1 and 2 was not affected by agent sedimentation. Consequently, in Examples 1-8 and Comparative Examples 1 and 2, an amount of agent close to the expected amount was sprayed.

[0128] In the second and third sprays, the amount of drug sprayed was affected by the deposition of the drug, resulting in a larger amount of drug being sprayed in Comparative Examples 1 and 2. However, in Examples 1 to 8, although the amount of drug sprayed was greater than in the first spray, the amount of drug sprayed was less than in Comparative Examples 1 and 2. In Examples 1 to 8, it was confirmed that a sufficient amount of drug was sprayed without shaking before use.

[0129] Note that the dimensions, materials, shapes, relative arrangements, etc. of the components described as embodiments or shown in the drawings are not intended to limit the scope of the present invention, but are merely illustrative examples. Expressions indicating that things such as "in a certain direction", "along a certain direction", "the same", "identical", "equal", and "homogeneous" are in an equal state not only represent a strictly equal state, but also represent a state in which there are tolerances or differences that allow the same function to be obtained. Expressions representing triangular, quadrangular, or circular shapes not only represent geometrically precise shapes, but also represent shapes including concave and convex portions, chamfered portions, etc. within a range where the same effect can be obtained. The expressions "comprising", "having", "including", or "possessing" one component are not exclusive expressions excluding the existence of other components. "Parallel" and "orthogonal" mean substantially "parallel" and "orthogonal", and include not only a strictly "parallel" and "orthogonal" state, but also a state including an error of about several degrees. Also, there may be cases where an expression such as "... part" is used, for example, "end part". For example, the "end part" means a part having a certain range including the "end". The same applies to other expressions with "... part".

[0130] 1 Metered-dose inhaler 2 Housing body 3 Aerosol container 4 Mouthpiece 5 Mouthpiece cap 30 Container body 31 First body part 32 Second body part 32a Bottom wall 32d Recess 35 Diaphragm 40 Metering valve mechanism 41 Coil spring (elastic member) 50 Valve stem 51 Upper part 51c Notch 52 Lower part 52a Flow path 53 Retaining part 54 Injection port 55 Intake hole 60 Metering tank 60a Opening 61 Metering tank flange 62 Tank seal 70 Retaining tank 72 Large-diameter part 74 Flange 80 Deposition suppression member 81 Flat plate 81A - 81C First - third flat plates 82, 82A, 82B O-ring 83 Filling member 84, 86, 87 Member body 85 Cylindrical member 86a, 87a, 88a Cylindrical part 86b, 87b, protruding part annular protruding part 88b Annular protruding part

Claims

1. An aerosol container comprising: a container body for containing a liquid contents containing a drug under pressure; a metering valve mechanism having a valve stem held in the bottom wall of the container body and having a nozzle for spraying the liquid contents outside the container body; and an elastic member for biasing the valve stem, wherein a predetermined amount of the drug is sprayed from the nozzle by the valve stem being pushed relatively into the container body against the biasing force of the elastic member, and further comprising a settling suppression member provided on the bottom wall side inside the container body to prevent the settling of the drug contained in the liquid contents.

2. The aerosol container according to claim 1, wherein the metering valve mechanism comprises: a valve stem having a flow path communicating with an intake port for the contents and the spray port; a metering tank attached to the bottom wall of the container body, in which the valve stem is retractably housed; and a retaining tank placed over the metering tank and movable along the direction of movement of the valve stem, and the sedimentation suppression member is provided around the retaining tank.

3. The aerosol container according to claim 2, wherein the sedimentation suppression member is attached to the retaining tank and is movable in conjunction with the movement of the retaining tank.

4. The aerosol container according to any one of claims 1 to 3, wherein a recess is formed in the bottom wall of the container body, the valve stem is supported at the bottom of the recess, and in a normal state when the liquid contents are not being sprayed, the sedimentation suppression member covers the recess.

5. The aerosol container according to any one of claims 1 to 4, wherein the deposition suppression member includes one or more flat plates.

6. The aerosol container according to claim 4, wherein the settling suppression member includes a filling member having a shape corresponding to the space in the recess, and a flat plate that covers the opening at the upper end of the recess in a normal state when the liquid contents are not being sprayed.

7. The aerosol container according to claim 4, wherein the deposition suppression member includes a member body, the member body has a truncated conical shape with an outer diameter decreasing toward the bottom, has a space inside, and the lower portion has a shape corresponding to the space in the recess.

8. The aerosol container according to claim 4, wherein the deposition suppression member includes a filling member having a shape corresponding to the space in the recess, and a cylindrical member located above the filling member, with an open upper end and a space inside.

9. The aerosol container according to claim 4, wherein the deposition suppression member includes a member body, the member body having a space inside, and including a cylindrical portion located on the upper side and a protruding portion located on the lower side, at least a portion of which is located within the recess when the liquid contents are not being sprayed.

10. The aerosol container according to claim 4, wherein the settling suppression member includes a member body, the member body having a space inside and comprising a cylindrical portion located on the upper side and an annular projection provided on the lower side of the cylindrical portion and located in the recess in a normal state when the liquid contents are not being sprayed, and the annular projection has reinforcing ribs extending radially from the inner surface.

11. The aerosol container according to any one of claims 1 to 10, wherein the container body comprises a first main body portion and a second main body portion fitted to the first main body portion, the metering valve mechanism is held in the bottom wall of the second main body portion, and the sedimentation suppression member is provided on the bottom wall side of the second main body portion.

12. The aerosol container according to any one of claims 1 to 11, wherein the drug is procaterol hydrochloride hydrate.

13. A metered-dose spray inhaler comprising an aerosol container according to any one of claims 1 to 12, and a housing body in which the aerosol container is housed.

14. A settling suppression member used in an aerosol container, wherein the aerosol container comprises a container body that contains a liquid contents containing a drug under pressure, a metering valve mechanism having a valve stem held in the bottom wall of the container body and having a nozzle for spraying the liquid contents outside the container body, and an elastic member that biases the valve stem, wherein the valve stem is pushed relatively into the container body against the biasing force of the elastic member, thereby spraying a predetermined amount of drug from the nozzle, and the settling suppression member is provided on the bottom wall side inside the container body to prevent the settling of the drug contained in the liquid contents.

15. A second main body of an aerosol container for spraying a predetermined amount of drug from a nozzle, wherein the container body holds a liquid containing the drug under pressure, the second main body has a bottom wall and is fitted together with the first main body to constitute the aerosol container, and comprises a metering valve mechanism having a valve stem held by the bottom wall and having the nozzle for the liquid outside the container body, and an elastic member that biases the valve stem, wherein the valve stem is pushed relatively into the container body against the biasing force of the elastic member, thereby spraying a predetermined amount of drug from the nozzle, and a settling suppression member provided on the bottom wall side to prevent the settling of the drug contained in the liquid.

16. An aerosol container comprising: procaterol hydrochloride hydrate; a container body for containing the liquid contents containing the procaterol hydrochloride hydrate under pressure; a metering valve mechanism having a valve stem held in the bottom wall of the container body and having a nozzle for spraying the liquid contents outside the container body; and an elastic member for biasing the valve stem, wherein the valve stem is pushed relatively into the container body against the biasing force of the elastic member, thereby spraying a predetermined amount of procaterol hydrochloride hydrate from the nozzle; and a deposit suppression member provided on the bottom wall side inside the container body to prevent the deposit of procaterol hydrochloride hydrate contained in the liquid contents.

Images