JPH05505544A - Device for measuring the dose of powdered drugs for inhalation - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] Apparatus for measuring the dose of powdered medicine for inhalation The present invention is a device for measuring the dose of powdered medicine for inhalation. This part of the inhaler is used to measure and administer the dose of powdered medication. It contains the powdered medicament as well as the necessary mechanisms for removal from the supply.

Dosages for inhaled drugs are generally determined by proverante (propell). (ant-pressurized) dose produced by aerosol or powder inhaler. It is used. In dose aerosols, the dose is the volume of liquid in the dose valve. External humidity does not affect operation at all. powder inhaler However, the measurements are inaccurate for several reasons. Measuring or weighing the dose requires 2 It is based on two known principles. Measured and sealed in small doses of carriers, e.g. capsules. The loaded powder may be metered and dispensed into the patient's inhalation gas. Yo Large quantities of powdered drugs are metered; special mechanisms are needed to transfer the powder into the patient's inhaled air. It may be enclosed in a supply section within an inhaler having a. Such a multi-dose (multi- Dosage inhalers are more convenient for patients because of their ease of operation.

The dose of the drug inhaled with a powder inhaler ranges from one-tenth of a milligram to several tens of milligrams. It varies in the range up to regram. It is difficult to measure doses accurately enough. Therefore, the negative effects of external harmful factors on accurate measurement are more likely. This is particularly problematic in small doses. The most significant harmful factor is external moisture . Powdered drugs, for example during storage, can form clumps when exposed to moisture, which can reduce the accuracy of measurements. Decrease. Moisture intrusion into the chemicals is determined by the tightness of the chemical supply area and the hygroscopicity of the chemicals themselves. It also depends on the permeability of water vapor into the composition. Create a dehydrating agent in the chemical supply section. It is known that it can be used to alleviate moisture problems.

Moisture also has other effects on the accuracy of the drug dose sprayed from the inhaler. Boss. Moisture on the inner surface of the inhaler that comes into contact with the powdered drug being sprayed reduces the amount of drug delivered. decreases compared to the normal case. Moisture occurs when exhaled air enters through an inhaler. , or may occur if this inhaler is moved from a cold place to a warm place. this To avoid moisture problems, install a one-way valve on the inhaler to prevent the air from exhaling and flowing into the device. This can be suppressed by eliminating other airflows that enter the air.

In view of the above circumstances, a multi-dose system having a drug supply section and a dose measuring mechanism is required. The inhaler for idosage should meet the following conditions: knee large dose and Able to measure both small doses with sufficient precision - as sensitive and compact as possible Due to its unique structure, it is easy to install a one-way valve in the inhaler.

Furthermore, in terms of overall dosing costs, it is desirable to use replaceable drug supplies. preferable.

Therefore, in multi-use edible powder inhalers, the design of the drug delivery section and dose metering mechanism The preferred The structure of the new inhaler is also important. A prior art multi-use edible powder inhaler with There is no drug supply unit and dose measuring mechanism that meet the above conditions.

Finnish Patent Publication No. 69963 describes the A multi-use edible dispenser with a dispenser and a dose metering device is disclosed. this The drug container has a conical bottom with a shaft that can rotate around the long sleeve. is installed. This shaft is equipped with one or more dose recesses. The powder flows into the shaft as the shaft rotates. in this container is a dehydrating agent and a vibrato to enhance powder flow by rotating the shaft above. A tar can be installed. After half a turn of the shaft, the dose recess rotates and To the inhalation conduit located below the container reach and drop the powder into it.

Powdered drugs are protected from moisture but have very good flow or trickle properties. Necessary for uniform filling of the dose recess. Using the design shown above, the patient , if several loading operations are performed before inhalation, there is a possibility of obtaining the dose of drug. be. This drug container is not replaceable and is designed to prevent exhalation. There is also no one-way valve installed.

U.S. Pat. A multi-use edible inhaler is disclosed that has a rotating cylindrical drug container. This cylinder is , a circular bottom plate with one hole for dropping a fixed dose into the inhalation conduit is fixed. Rotate around the central axis of this cylinder. As the drug container rotates, its The holes in the floor plate are filled with powdered drug and rolled onto the lower plate in the container. the holes in the circular bottom plate, through which the powder will fall by gravity for inhalation. It is designed to be lowered.

Powdered drugs are largely protected from moisture due to their wide, insecure sliding surfaces. If unprotected and loaded several times before inhalation, there is a danger of overdosing. There is a risk. When metering small doses, gravity alone cannot complete the entire dose into the inhalation conduit. The accuracy is clearly low because it is insufficient to completely drip the liquid. In this design The effect of a one-way valve cannot be achieved. However, drug containers are replaceable. be.

Finnish patent publication no. The hole in this vent is placed over the suction conduit. A multi-use edible inhaler is disclosed. Commercially available devices disclosed in this patent , the sheet has a thin circular prism that rotates into the suction conduit during the filling operation. It has a plastic disc. A dehydrating agent is installed in the drug supply section! are doing. dehydrating agent Without it, moisture will quickly affect this powdered drug due to the wide and large sliding surface. It will have an impact. Operation of this device may pose a danger of blocking the holes in the perforated plate. The inside wall of the suction conduit becomes caked with moisture. Replace drug supply unit Can not. This mechanism can be used to measure both small and large amounts of medication. Wear. .

In the present invention, a drug container and a dose measuring device for a multi-use edible powder inhaler are provided. The precise and permanent measurement or administration of both large and small quantities of powdered drugs in should be weighed properly, powdered drugs should be well protected from external moisture, and powder should not be absorbed Replaceability simplifies the use of a one-way valve to block exhaled air through the injector. This is also an issue.

This outfit! The operation basically consists of four parts in a shaft with a circular cross section, equal to a certain dose. Rotate the drug container surrounding this shaft around the shaft to apply the desired amount of powdered drug. Fill by rolling and push this shaft out of the drug container to remove this shaft. The dose is transferred into the inhalation conduit adjacent to this dose well. Filling this recess is Rotation of the powder by gravity and fixed in the drug container and twisted against the shaft The work of the steeper element It is done.

The shaft and the sliding surface of the medicine container are in elastic contact with each other.

The device of the invention includes at least one flap-like sweaver element in the container. a dosing recess on the shaft, one end of which lies in line with the dose recess on the shaft; The other end can be rotated around the shaft, and the other end can be pulled along the surface of the shaft. The shaft then opens the dose recess filled with the drug dose. It can be moved in the longitudinal direction of the container to transport it to the bottom of the container. can.

The invention will be explained in more detail by means of the attached drawings: fig. FIG. 3 is a sectional view including a drug container in the long sleeve direction of the shaft, showing the basic configuration of the device.

fig, 2aSb and C show the longitudinal view of the shaft of the device of fig, l. The drug container is shown making one revolution: fig. 3 a and b Figure 4a and b show an example of the device of the present invention. Figure 5 shows another example of an inhaler equipped with the device of the present invention. Figs. 5 to 9 show application examples of fig. 5.

fig.l shows the basic configuration of the device of the present invention cut in the longitudinal direction of the shaft 3. Fig. 2 shows a cross section in the shaft direction. . The main body 1, gable 2, and circular shaft 3 of the drug container are assembled into a cylinder. Same as swibar element 4 which is leaning against the shaft with slight tension. This is a device with many features.

Alongside the sweeper element, the shaft 3 has a recess 5 for measuring the dose. It is provided for. The powdered drug 6 is held on the floor of the drug container 1 without being restricted. Ru. Inside this container there is a dehydrating agent, for example backed in an annular shape. It is possible to equip 7. Although the opening 8 of the shaft is in close contact, its long sleeve It is possible to move the shaft in the direction. Multiple dose recesses if required 5 can be placed in various positions on the shaft 3. sweeper element One or more points 4 may also be provided. The drug container 1 has a circular cross section. is preferred, but other shapes are also possible. Shaft 3 is a drug container Although it is preferable to install it in the center of the area, it may be installed at a position offset from the center.

The method for measuring the dose is shown in fig, 2 aSb and C. drug container rotates Then, the powdered drug initially rotates along the container (Fig. 2a). However, if you continue to rotate it, it will begin to spread and fall downward, causing the Swiver Element. It stops above point 4 (fig. 2b). When one rotation is completed, the sweeper - Element 4 fills dose recess 5 with powder under slight tension (fig. 2) c). Push the shaft 3 to move this dose out of the container and at the same time close it. Drop off excess powder at shaft opening 8. strong gas flow (e.g. by inhalation) The latter powdered medicament is emptied when the powder (induced) falls on the dose recess 5. "Recess ” refers to the indentation provided in the shaft, which indicates the respective dosage of the drug Indicates a volume that fits.

Tests have shown that a device with a single dose recess 5 and sweeper element 4 The measurement accuracy is approximately ±10% when measuring doses of 2 mg or more. Proven. In this case, it is possible to fill the drug container 1 with powder up to half the amount. However, the accuracy of the metering begins to deteriorate after about two-thirds of the powder has been used. That's it Eh, a cylindrical drug container 1 with a diameter of 2 cm and a height of 1 cm weighs or measures 2 mg. more than 200 doses (depending on the specific gravity of the powder). By the test, The fluidity of the drug in this formulation is insufficient to allow the device to operate with high precision. was also revealed. In this case, in a manner known per se, the drug container is It is necessary to vibrate it. Flowability and dose recess filling are also special adjustment of the inner container walls as well as adjusting the length and width of the per-element It is strengthened by having a unique design and installing the shaft 5 with a deflection. can be done. When measuring doses below 2 mg, use the design shown in fig. 3. It is preferable to use a shaft with an in-line diameter, and in this figure the volume of shaft 3 is preferably used. One end of the recess 5 slightly rearward is hollow. Inside the shaft 3 is a stationary tube 9. is installed. After the dose recess 5 is filled, the shaft 3 is pushed out of the container 1. while the stationary tube 9 remains at that position (fig. 3b). go As a natural gas flow (e.g. induced by inhalation) flows through the tube 9, The drug in this dose well is effectively released.

Installing the drug container 1 and its sweeper element 4 for the device of the invention Gables can be easily manufactured from plastic, and their components are They can be connected to each other, for example, by pressure bonding or ultrasonic welding. use The material may be a suitable elastic material, e.g. soft polyethylene or rather rigid. If the shaft is made of a thin elastomer, etc., the separate shaft sealant 8 is not necessary. . The preferred material for the shaft and its inner tube is polished stainless steel. be.

When loading into a high-level pharmaceutical container, one of the shaft openings must be closed. This may be done prior to attaching the gable to the container, but After it is attached, it may be introduced separately through the other shaft opening.

The device of the invention can be used separately from or together with the shaft within the body of the powder inhaler. Can be exchanged. If replacement is done independently of the shaft, do not use the drug condenser during storage. The tena's shaft opening extends through this drug container and has a It is protected by a plug that has a recess that receives the end of the shaft. empty sky After removing the container from the shaft, place the end of the shaft into this recess and insert this container. If you press the hole onto the shaft, the force will push the plug in front of it into the container. They fall apart. This container has a row of punches in itself as well as the body of the inhaler. Guided by the markings, it is placed in the appropriate position.

The device of the invention is capable of measuring very small and large amounts of powder with sufficient accuracy. . Powdered drugs are especially protected from moisture, and this design suitable for installing a block to prevent exhalation from the device. This is orchid simply manufactured This guarantee of replaceability results in reasonable maintenance costs. .

The following explanation is based on the present invention! This is an example of using it as a complete powder inhaler.

fig. 4a shows a simple device in which the transfer of the dose into the inhalation conduit 10 is performed by manually pressing button 11. This shaft is shown in fig.1. It is equipped with a block-like shaft, one end of which is held down by a spring 12. It hangs on socket 13. The drug container has a gear mechanism 1 having an annular spring. 4, the drug container is held in place by It rotates only in the opposite direction, and when it rotates, it vibrates so that the powdered drug flows smoothly. Given.

This shaft has a round groove at 15 to keep it in place. implementation The example discloses that the digital dose meter 16 is used similarly to the contacts 17. do. The second container can be replaced by unlocking the clamp unit 18. , so that the part containing the container is separated along line 19 with its shaft f ig.

4b) The part containing the relatively expensive dose meter can be used permanently.

When using this device, the drug container 1 is manually moved, e.g. , rotate it once, then press button 11, and then insert the mouthpiece through mouthpiece 20. Inhale. When released, the button returns to its original position and the dose recess is pushed into the medication container. It can be returned and used again.

fig. 5 is a more complicated example, in which the present invention measures a relatively small amount of powder. and drug particles as described in Finnish Patent Application No. 892,956. This shows a combination of portex chambers for crushing. This device includes fig. It is equipped with a shaft of the design shown in , 3. Transferring doses from drug containers is automatic and the inhaler is well protected from exhaled moisture.

The drug container has a front cover 2, which covers the portex chamber 21. Set it up to be the wall behind it! are doing. There are two meshes in the other gables of the container. One of them, 22, is in contact with the gear 24, and the other 23 is in contact with the gear 24. It is in contact with a spring 25 attached to the body of the inhaler, the purpose of which is to In addition to causing the container to vibrate during rotation, it also prevents the container from rotating in the wrong direction. The purpose is to prevent The shaft 26 is equipped with a reversing wheel. wheel) 27, a grooved cylinder 28 is installed in the same way as the gear 24, and Its end is a dowel 29 that sends a signal to the digital dose counter 16. . The shaft 3 is fitted with a transmission part 30, one end of which is directed towards the reported wheel. grooved as well as the rails at the bottom of the transmission section and the bottom of the inhaler. It is in communication with cylinder 28.

When the reversing wheel 27 rotates once, the shaft 3 enters the drug container 1. , the inner tube 9 closes the floor of the dose recess 5, fills the dose recess, and then The shaft 3 is pulled out from the drug container 1 and returned to its original position, and is inserted into the portex. Carry it into the chamber 21. During inhalation through the mouthpiece 20, the one-way valve The flap valve 32 installed as a It is conveyed into this chamber through the supply pipe 33 to the chamber. Inhaled air (inh a small amount of the alation air) passes through the tube 9 and through the dose recess 5; Combined with the vortexing in the chamber, the drug is completely removed from the dose recess.

The exhaled air enters the device through this dose recess and tube 9. however, In practice, when measuring small doses, the diameter of the hole in the floor of the dose recess is less than 1 mm; Therefore, under the flap valve that prevents exhaled air from flowing in, the patient actually has an inflow of exhaled air. This is unlikely to happen, as it seems unlikely that it will be possible to do so. .

If a block shaft is used, the flow of exhaled air through the device will be completely blocked. It will be done.

The drug container is attached to a hinged portion included in the clamp unit 18. It can be replaced by unlocking the tion) and reversing the reversing wheel 27 once.

In this way, the drug container 1 is pushed by the shaft and appears, so the shaft 3 It becomes easy to remove. Place the new container in position I as described above. (See page 6).

figs 5 to 9 are those shown in fig 5 of an inhaler with a new metering system. This is an application example of In this inhaler application, the shaft 3 has a dose recess 5. However, instead of the drug container 1 and the port linked to it, Lutex chamber 21 is movable together with its nozzle 20. drug container The separation part containing the liquid is arranged around a fixed shaft 3 having a dose recess 5! has been The shaft passes through the drug container. At the open end of the drug container The portex chamber 1 is installed with its nozzle. drug container A part of 1 has a stud protruding from its outer wall, and a spiral groove inside the device has a stud. They are mated. As the device rotates, the studs move within the spiral groove of the drug container. and push the drug container 1 to the outside along with the portex chamber, thereby Therefore, the drug container 1 moves and rotates relative to the shaft 3. slot's The shape is chosen to make a complete reciprocation in one revolution. fig, 5 shows the equipment just before inhalation. The suction recess 5 of the shaft 3 is located in the portex chamber 21. f ig, 7 shows the device in the middle of the filling operation, where the drug container 1 is Move outward relative to the foot 3, and the dose recess 5 is positioned inside the drug container 1! I will do it The sea urchin is turning. fig. 8 shows a cross-sectional view taken along the line A-A in fig. 5. 9 shows the drug substrate container 1 in an open state for exchange.

abstract The present invention provides a drug container (1), extending through it and having a small (at least one) dose recess. for measuring the dose of a powdered drug for inhalation having a shaft (3) provided with a portion (5); related to the equipment used. The container (1) has at least one container on the shaft (3). It rests on this so that it is in line with the recess, and the shaft (3) is rotated around it. a flap having one end that can be rotated and the other end that catches the surface of the /yaft; A similar sweeper element (4) is provided, after which the shaft (3) , the dose recess (5) is placed outside the container (1) with the dose of drug filled therein. It is movable in the long-sleeve direction with respect to the container (1) so as to move it to the container (1). present invention It also relates to the metering of powdered medicaments for inhalation using the device described above.

international search report I□21 engineering. 1 night/Fl 91100113 International research report PCT/FT 91100113

Claims (9)

[Claims] 1. a drug container (1) extending through it and having at least one dose recess (5); ), the apparatus having a shaft (3) provided with a This allows for alignment with at least one dose recess on said shaft (3). a shaft with one end resting on the shaft (3) and capable of rotating around said shaft (3); a flap-like sweeper element having the other end adapted to be dragged over the surface of the A contact (4) is provided, after which a fitting shaft (3) extends through the dose recess (5). , to be moved out of said container (1) together with the dose of drug filled therein; suction, characterized in that it is longitudinally movable relative to the container (1); A device for measuring the dose of powdered drugs. 2. One end of the sweeper element (4) is fixed to the wall of the container (1). and that the container (1) can rotate around the shaft (3). 2. The device according to claim 1, characterized in that: 3. a first characterized in that at least a part of the shaft (3) is hollow; The device according to item 2 or item 2. 4. characterized in that said dose recess (5) communicates with the hollow part of the shaft (3); 3. The device according to item 3. 5. The wall of the shaft (3) is provided with a recess (5) opening into the hollow part thereof. A stationary tube (9) is contained in the hollow part, and this is connected to other containers in the drug container. It extends beyond the recess (5) to near the wall and connects the shaft (3) to this container. The recess (5) is carried to the outside of the container (1) with respect to the na and the fixed tube (9). The device according to any of the above items, characterized in that it can be pushed by a distance of Place. 6. The drug container (1) is connected to the sweeper element (4) and the retraction rod. Any of the above items characterized in that it is replaceable together with the sealant (8) The device described. 7. The device is equipped with a limiter that determines the rotation direction of the container, and the limiter is characterized in that the container (1) is prevented from rotating in the opposite direction. The device according to any of the above items. 8. Equipped with a device to measure the dose of powdered inhalable drugs listed in any of the above items. Inhaler. 9. A one-way valve (32) to prevent the inflow of exhaled air through the device. 9. Inhaler according to claim 8, characterized in that it is provided with: