SA92120552B1 - Medication release device - Google Patents

Abstract

Abstract: This invention relates to a standard dose inhaler for use with a pressurized aerosol container preferably operated by inhalation. The internal inhalation valve is under the effect of a preload (80) sufficient to release a drug dose, but which is prevented by the application of an air resistance force (130). The inhaler includes a release device (110) that, when pressed, equalizes the force of resistance, allowing the preload to activate the aerosol valve (135) releasing the standard amount of medication to be inhaled by the patient.

Description

A drug-releasing device Full description BACKGROUND The invention relates to a drug-releasing device and more specifically; A suitable device for releasing specific quantities of a liquid. This particular invention relates to; With a drug-releasing device of the type that enables the delivery of a standardized amount of drug in response to a patient's inhalation 0 0. Medically, standard dose inhalers are well known in the medical field. Treatment or alleviation of symptoms of respiratory problems Jie cases of asthma. Also, devices that operate by breathing (suction) are also known. It has been the subject of several patents. UK Patents YAAGYY 174744371 LM901 LM901 0, 1” 47137, 1417785, 7701 744, PI 1/2 0, US 58074918 and EC 1837485 describe inhalation-acting drug-releasing devices used in combination with A medicine container containing a pressurized aerosol solution. The device includes a pharmacological sles that includes a valve that can release a standard amount of the aerosol it contains, and that Lexie is sufficiently pressed on an internal spring that operates the valve. A release device often includes a chamber 1 with a mouthpiece, air inlets, an actuation device that causes the valve in the launcher to activate, a detent that holds said metering valve in a movable way in a charged position, and an inhalation-responsive device to release the detent so that the standard amount of aerosol expires into the Oral segment area.

The overall goal is to find consistency between the discharge of the drug from the 8680501 container and the patient's inhalation, allowing the largest dose of the drug to reach the bronchial passages within the lungs. The ratchet device is often connected to a valve that moves from the resting position to the firing position in response to the partial vacuum created by inhalation. © European Patent No. 55414 describes an inhaler with biased devices, each of which does not generate sufficient force to lower the vessel, but together generates the force necessary for this. European Patent No. 1,185,745 also describes a device that uses a magnet to control the release of an aerosol container. US Patent No. 300,974 describes devices in which an aerosol container is connected to the mouthpiece via a calibration chamber. A standard amount of aerosol is dispensed into the calibration chamber and then transferred to the mouthpiece via the inhalation valve. UK Patent No. 114054 describes a device in which an aerosol vessel is moveable by means of a cam lever system to a charged position attached to a ratchet whereby a pressure differential releases the ratchet and moves the valve of the vessel to the draining position. 0 GENERAL DESCRIPTION OF THE INVENTION This invention aims to provide a metered dose inhaler in which drug release is activated by the patient's inhalation. This invention also aims to provide a more simple and smaller inhaler device than the previous release devices. According to one aspect of the invention a release device is provided for use with a drug dispensing system 0 comprising a means for releasing a standard de ja of the drug from that system and the release device includes a means for applying a preload capable of activating the dispensing medium in the system; and a means of applying a resistive force

pneumatic device capable of preventing activation of the launch vehicle; and a release device capable of removing the pneumatic force in order to allow the preload to activate the release device and release the drug. Air may provide a means of air resistance, as it may remain on it before launch under positive pressure greater than atmospheric pressure or under negative pressure less than atmospheric pressure. 0 and the release device works to return the pressure to the level of atmospheric pressure or to the previous equilibrium; allowing full preload force to take effect. The device is especially suitable for use with pressurized aerosol solutions intended for inhalation, which are equipped with valves as drainage devices. Although this device has been described with a system using air; It is verified that in a closed system it is possible to use any suitable gas. 1 and in preferred order there is a cup for a drinking bowl 26300801 . The cup may include an external chamber with a mouthpiece that allows the patient using the device to inhale. The cup may also include one or more air inlets 6 allowing air to pass into the mouthpiece 0 and the outer chamber may contain an inner sleeve that encapsulates the main body of the aerosol container . The outer chamber is determined at 1 0 at one of its ends with a transverse member that accommodates valve 860501 and closes the Lad chamber except for allowing the aerosol outlet. A piston-like effect against the trans-member © to form the loading of the resistor in the form of a volume at dle pressure capable of resisting the energization of the aerosol valve. Ys and in another preferred order; A cup for the aerosol release container is available. The cup may include an external chamber with a mouthpiece that allows the patient using the device to inhale. The cup may also include one or more air inlets allowing air to pass into the mouthpiece 0 and may contain frond

The outer one has an inner Ada that encapsulates the top of the main body of the 8860501 receptacle. The inner bushing is preferably arranged to form one end of an airtight cylinder and piston; bellows or diaphragm “so that the movement of the internal bushing leads to an increase in the volume confined inside the cylinder and piston or bellows or diaphragm leads to vacuum or to a volume under reduced pressure that forms the resistive load (resistive force) capable of On prevent deactivation valve 8630801 . In embodiments af ¢ the launcher bushing acts as a sliding piston air-tight; Except that instead of providing a volume under high pressure, the downward movement away from the core shell leads to the generation of a volume under reduced pressure. 0 and in preferred order; The means of air resistance consists of an inner sleeve and a fixed sheathed body in the outer chamber that are connected together by means of a flexible blower or a sliding seal that is sealed against air leakage between the sleeve and a semi-cylindrical extension to the sheathed body. In another embodiment the preload takes the form of a spring acting against the aerosol valve. It is preferable that the application of the preload be by means of a lever that is hinged within a cavity in the outer chamber. 1 The lever may take the form of a detent lever which prevents the compressed spring from activating the aerosol container until it begins to operate. After completing the process, the crane is used to return the spring pressure to the compression position. Alternatively the lever may be connected by a stopper with a spring; It contacts the inner bushing so that the movement of the lever loads the spring. It is also preferable that the activation of the release device be through inhalation so that there is consistency between the release of the drug and the inhalation in the process of inhalation from it. The DULY device may include a valve yard in the transverse member. Usually, the valve yard is covered with a flexible, reversible valve flange that opens upon activation, allowing the preload to activate valve 2620501 whenever the pressure in the pneumatic medium returns to A

A state of stillness. In an embodiment in which the resistance force is positive air pressure, the opening of the valve's yard causes air to leak out of the confined volume venting the pressure built up within it - resulting in a full-force preload effect against the aerosol valve. In an embodiment in which the resisting force is the rarefied or semi-vacuum pressure, the opening of the valve yard allows air to enter the confined volume, again allowing the preload to be acted with full force against the aerosol valve. The preferred inhalation-activated method includes the AS Hall AL reed mechanism. This dy machine may be housed in the lower or upper section of the small, depending on the location of the resistance element. It is preferable that it be connected to the aforementioned blade with a valve sealing fluid so that the blade moves during inhalation 0 from the resting position to the operating position. This leads to moving the valve seal outside the range of contact with the valve yard, so the valve opens + and it is preferable that the blade mechanism be dynamically balanced and can align towards its closed position by means of a spring for example. Z. The outer room may contain air inlets that allow air to pass through to the Agel piece. The inlets may take the form of slits or an air-porous air membrane. The latter is particularly suitable 1 in aiding filtering of soil filtration. The drug may be the active substance alone or accompanied by a carrier, including a powder or gaseous carrier. A brief explanation of the drawings The following is an explanation of this invention, for example, but not limited to, by reference to the drawings Addy. Yv.

V — — Fig. 1 : is a sectional view of a nebulizer according to a first embodiment of this invention in the resting position. appearance ? Sectional view of a nebulizer according to the first embodiment of this invention during operation by the nebulizer process. oo form? : is a sectional view of an inhaler according to a second embodiment of this invention. appearance ; : - Shows an enlarged view of a diaphragm used with the embodiment shown in Figure I. Figure 2: Shows an enlarged view of a diaphragm in idle mode and in active mode. 0 Detailed description As shown in Figures 1 and 7, the inhaler consists of a main body © which is generally cylindrical in its cross section. The main body includes a rigid transverse member 01 with a Vo hole through one end of the main body © . Inside the main body © there is a bushing 01 of the same cross-section as the main body © . In general, both the bushing 01 and the main body ©1 are co-axial. The sleeve 01 contains a well-known type of cylindrical Yo-shaped aerosol release vessel. The bushing 71 also has a circumferential seal Ye in sliding, air-tight contact with the Foo Jalal bore of the main body 0 . The Ve circumferential seal may be synthetic or natural rubber. The seal may also be an O- extended around the Yas bushing. 51 of which the YL seal yo can be an integral part with the flange of the bushing.01

M

The YO aerosol release vessel has a stem 50 containing an aerosol release valve [not shown]. The hole 01 with 0 sles shank yo aerosol release is sealed against air leakage. A shoulder £0 locates the leg 50 which in turn locates the YO aerosol firing vessel within the main body* .

Ov jee dling© extends from hole 11 and continues from the shoulder fo to the firing jet #0 . As shown in Figure 1; The end of the main body © has a Te joint with a setback 10 prepared to receive a lever with a cam 71 acting on the joint 60 . and in sleep mode; The hinge extends across the setback 65 to allow the Ve-cam lever to pivot 760 . As Jody the recoil is a generally cylindrical passage VO that receives a spring Av located between a sliding stopper AS

0 and the bushing l

LS | It is evident from Figure 7 0 that the extension of the lever with a cam Laie 00 rotates the Calan Bag z

It affects the stopper, AO, to make it slide ¢, thus compressing the spring. At the opposite end of the main body © is a mouthpiece 95 separated from the main body by transverse piece 01 . The mouthpiece includes 95 chambers 001. The release jet oo protrudes into chamber 001 .

yo room 001 has one or more air inlets 015 + so that air can pass from air inlets 0 to mouthpiece 96 . lip or vane 601110 divides in its resting position; Room 001 is between the air inlets 011 and the mouthpiece 90 [Fig. 1]. The vane is hinged by means of a nail 111 so that it can move from the resting position towards the mouthpiece by means of the pressure difference between the air inlets 011 [Fig. ? ] And the mouthpiece 90.

11# Covered with flexible valve flange 171 Small valve yard 01 Includes rigid cross member 0 articulated with 106 resting in a closed position. The Cums lip works due to its biased lig design

The cross piece 01 + prevents air from flowing out from the enclosed space 11 and seals the space 0 tightly. The valve stem ©” extends across the valve seat yard 171 and articulates with the quill 011 . When the vane moves and assumes the operating position, the stem 175 moves through the valve yard 171, opening the lip 175 . The connection between the articulated joint of the valve stem 195 and the vane 011 allows a large movement of the vane to cause a small movement of the valve stem 15 which increases the force on the valve flange 1168 . ie Usage » The patient loads the aerosol release vessel with the sleeve, Ye . The aerosol canister may be held by providing the main body © with long-step screws; So that 01 is higher than the 0 ve sealant, for example, around line 1 - 1 . When a part of the main body © has been helically loosened, the inner sleeve 'Ye' can be removed by sliding and sheathed 8600501 thereafter. Thus the bushing 01 and the main body © can be returned to their position; The als device becomes usable. Yay from that; The device can be made in the form of an isolated unit. It is disposed of after 1 release of all doses of aerosol contained in the container. z When the lever 1701 is at rest [Fig. 1 ] no load is placed on it from the spring 80 on the bushing Ye and then the airspace pressure 171 is equal to atmospheric pressure. Then the lever 11 is raised to the loading position [fig. ] It causes the spring (Av) to be compressed by means of (AO salud), which in turn causes the sleeve (Yo aerosol ele ss 01) to move downward. 0 - This movement causes the air to compress in the confined space 191. He cannot Air can escape through the valve yard 171 which is covered by the valve flange 175. The increased air pressure in b acts

Cy. It also increases the effectiveness of the patio. aerosol to provide a resistive load to prevent activation of the 171-compartment valve. 071 Valve Until the force due to Yo and the vessel equals 01 Adal, the movement continues downward for both; With the sum of both the forces of the internal spring; That operates the internal valve Av the compressed spring and the position of the bushing is determined. 191 for the vessel and the force resulting from the increase in pressure in the confined space 5 which is Ay when the forces are balanced by the dimensions of the confined space and the spring constant Yo and the vessel 0 500 for the leg “Yo aerosol eles chosen so that the balance of forces occurs before moving ‎ . Directly to the extent that is sufficient to release the dose of the drug, and in that case, A. Standard 40 dowel 0 into the aerosol vessel stem and some receptacles include a loading position in Figure 7; Air trapped in the space 71 escapes when the cam lever 0 is raised. 00 ORR Ov by piercing the leg 1460; outward through Corridor 1101 more and more confined to the bottom; The greater the compression of the valve spring Yo and the container Yo and the more the bushing moves by means of the rubber skin of the valve, the air will be compressed in the inner space 195 and the stem hole. 091 confined tiny pressure difference across Lay + 95 and as the patient begins to inhale; Via the Vo 011 mouthpiece hinged at one end + differential pressure causes the quill 011 ay) to move so that the 011 and lower chamber design 0011 from rest to operating position. be the feather. To patient 011 The air in the operating position is able to flow freely from the air inlets to come into contact with the flange el to 195 upwards in the movement of the valve stem 011 movement of the vane causes compressed air to be released into the space 17© and opens it. Opening the valve flange IYO leads to valve 0 and forces Yo and the vessel Ve, causing an imbalance in the forces affecting the bushing VY, so the dose Av moves downward under the influence of the spring Yo cle dip 710 bushing YV.

11- Standard of the drug through the release jet 00 into the mouthpiece 95 at the same time that the patient inhales the inspiratory air. Thus, the patient inhales air during the inhalation process loaded with a standard dose of medication. And after the patient inhales the dose; The lever with camber 1700 returns to its resting position. oo This releases the load on the spring Av and allows the bushing 01 and bowl yo to move backwards as they come into position under the action of the internal valve spring . enclosed volume increases by 11 ; Air flows into compartment 111 through the flexible valve flange 176 until the pressure in compartment 171 returns to atmospheric pressure. In the alternative arrangement shown in FIG. “FY” the inhaler consists of a basic body 0 000 x 000 of which the cross-section is generally cylindrical; And a mouthpiece 5606 at one end with a 4-end stopper that includes air inlets 4710 at the other end. There is a well-known type of Yo aerosol release vessel shaped like a dale cylinder inside the main body of the device. Aerosol Release Canister £4 Stem Containing Valve 8620801 (not shown). The V0 orifice shall be designed to form an airtight seal on the £0 leg of the aay aerosol release canister. © 1 shoulder £0 and locates the stem 0 which in turn locates the drug release vessel Ye in the main body 4080 . Passage O extends from hole 16 ¢ and continues from shoulder 0 to intersect with the launch jet 00 . The end opposite the firing pan is located within an EY bushing of a cross-section similar to that of the 400 base body section. In general, the bushing 471 and the main body 5060 are united 0 in the axis. The bushing contacts the inner wall of the main body in a sliding, free-flowing manner and may include recessed EF grooves in its walls to allow air in the main body to easily pass along the bushing. The bushing 471 can be held in place by connecting it to the TV

- 17 -

The diaphragm £50 connected to the apex of the primary body fev as described later is 0 and so on

The £0 bushing is actively attached to the apex of the base body .

Fix one end of a molded flexible diaphragm (£50 LS) shown only in fig.; ) component

of a disk-like rigid portion 441 + and a cylindrical-walled flexible portion as dale £40 and a rigid conductive m portion £6; around the specially prepared £04 groove in the bushing; dishes on

for example . Another molded 007 lip on the diaphragm enables a snug fit on the diaphragm

One end of a compression spring 60 . Thus, the compressive spring takes its position and can influence

freely on the sleeve. The position of the end (AY) of the compression spring is determined by an annular shoulder (EA) at

An inserted body (EAL) is often cylindrical with flanges that resides in the upper part of the body (CEs lal)

0 : This graduated body includes a £40 groove into which the disc-like part is held (Cabal £6

The flexi EE is occlusal.

The connection between the diaphragm connecting part 71 and the internal Adal groove gov is consistent so that it is

Sealed against “el sell” leakage, and the shape of the upper surface of the £Y bushing corresponds to the inner shape

of the diaphragm such that the two surfaces when the inhaler is in rest mode are very close to each other and the space between them is very small.

The cylindrical insert body EA is held in position by means of end seal 407 in the

The main body of the device. This forms chamber 090 between the slots of the air inlets 4701 and part

1 ; for the barrier. The chamber shall be provided with one or more air passages 5860 so that air can pass through

From EY air intake slits to mouthpiece £00. The semi-rigid (0-disc) part of the diaphragm (£4) also contains a small valve yard, £90, which covers the sale with a valve seal (flange).

,. 480 is housed in the vane 550 and is axially connected with the graduated body 00

a

1h

The Quill +95 at rest divides Room 9950 between air inlets;107 and air passages.

0, which leads to the mouthpiece so that it moves from its resting position by means of a pressure difference

between the air inlets and the mouthpiece. When the bit moves to the working position, a stopper moves

Valve (flange) 06 enough to open the valve yard 496 . (Also, the feather can be aligned 1 6 and closed by means of a light spring, weight, or a magnet, not shown).

LS is shown in the form ©; The end of the main body with joint 0000 has a prepared return

To accept a cam + 0Y integral with a dust plug ©01 operating on the joint. It also includes recoil

z a corridor connected with a corridor, Blas molded in the enclosed wall of the main body 5060 . A cam shaft 070 extending from the lower edge of the inner bushing 471 acts on the cam so that the inner sleeve 0 is forced by the camshaft to take its upper position . When the dust cover is rotated to its open position, the cam profile allows the dust cover to move

The cam is freely downward as far as the device can be operated.

When the dust cover ©01 is in the sleep position ald it is closed; Camber #070 remains to be sold

inner sleeve 817; in its highest possible position so that the volume of internal space retained between yo diaphragm is 60lb and top surface is 7?7? The inner bushing is as low as possible as is the 410 spring

compressed. The valve yard £90 is closed by the valve seal (flange) of. Bushing 4730

off the top of the YO aerosol container, which thus becomes unloaded.

The dust plug is opened by rotating the integrated cam + OF allowing the cam + OF to descend a distance of

a a . The inner sleeve is pushed down under the action of the 460 spring. As the inner bushing moves down 0 the inner volume increases between the diaphragm £60 and the inner sleeve an equivalent linear distance of AA;

TT is less than or equal to 0 and since the valve yard is £90 closed, this results in a volume of

Low or nearly vacuum pressure in space 001 [Fig. 0] The pressure differential in

ES

. And atmospheric pressure that you take off the inner sleeve to resist the effect of the spring 6000 inner volume and start pressing Yo aerosol and when the inner sleeve moves down it will touch the bowl. Aerosol valve (not shown) The downward movement of the inner bushing continues until the compressive force in the spring is balanced

Anya is consistent. aerosol and resistive forces arising from the pressure difference and compression of the 560 © valve of the device so that this equilibrium occurs before the aerosol valve is sufficiently compressed to begin to . Work Newton to start work. Accordingly, Model 01 should provide strength within the limits of the aerosol required. 7 50 - 7 01 The spring 61 has greater force > and it is preferable that the increase be between so that the aerosol eles can also be coordinated for the balance of forces to occur before it touches the inner bushing 0 . The force of the spring is equalized by the resistance force on the inner bushing by the effect of the pressure difference, a small difference in pressure across the Lay quill. The patient inhales through the mouth piece 405; Lovie, which hinges near one end. The pressure difference causes vane 0 in the OA to move from its resting position to the operating position. And the design of the feather and the air passages

EY room 0950 so that air can flow freely in the operating position from the air inlets vo . To the patient to move the valve cover (flange) 5450 out of the closed position for a © yard. Ady J performs a movement between the veil and the sleeve 600 Valve 498 . Opening the valve yard allows air to enter the inner cavity so that the pressure in the inner space becomes atmospheric pressure. This leads to an imbalance so that the bushing and the bowl are pushed down by the . Yo and bowl 4710 Forces acting on sleeve _ 0 spring £70 causing standard dose of medication to be released through release jet 00 and into

Yv.

And 1 mouthpiece at the same time the patient inhales. Thus BAT patient air Dla standard dose of medicine . And after the patient inhales the dose; The dust plug ©01 returns to its closed position. This moves the cam ©71 rotationally and causes the cam to be pushed ove upwards. In turn, this affects the inner bushing 71 and moves it upwards to compress the spring £1 and close the Tee gap between the diaphragm and the inner bushing at its upper surface 477 . This leads to a rush of air outside the confined space 00, which flows through the valve yard £90, lifting the valve cover (lip) of And since the valve cover (flange) is slightly biased towards the closed position, it shows little resistance to the air flow outside the confined space. Thus bowl 28620501 becomes free to return 0 to its resting position under the action of its valve spring. When used: the patient loads the aerosol release container into the main body 0 and the aerosol container can be loaded by providing long-step screws into the main body 6 400 inclined around line 1 - 1. and when part of the primary body is loosened 500; The Avie can then insert the aerosol and then the main body 500 can be put back causing the internal sleeve Ve to take its position over the upper end of the container and the device becomes usable. As mentioned before; The device can be made as an isolated unit. The device can be provided with a means to control the flow of air to the user or the inhaler. Thus an acoustic device such as a sniffer whistle may be provided; Beeps when the intake air flow rate exceeds the preset limit JS over © - 00 l/min ; for example; The vocal apparatus may be located in the mouthpiece 15 or below the air inlet 470. The resulting sound warns the patient to inhale at a slower rate. YY

1f The device can also be equipped with a means to make it stop working if the air flow rate is less than a preset limit such as AY. - 01 minutes. In one embodiment the bit 500 or 011 is spring-biased so as to require a predetermined minimum rate of airflow in order to move into the working position and assist in opening the valve cover. © It is preferred to manufacture the basic body of the launcher described in the first or second embodiment of this invention; From plastic, such as polypropylene 0017070316©©6, or acetal dis!, or polystyrene, molded polystyrene sal. It may also be made of metal or other suitable material.

YV.

Claims (1)

1 - Claims 1 1 - Release device to release a metered drug into a system delivering drug Ag; This device includes: 1 - The body of the launch device; ¢ - a sleeve placed inside the said body capable of receiving a drug release device; ° - a means of releasing a standard dose of gall of comprising a means of applying a preloading force of 1 to said bushing ¢ and a means of applying an aerodynamic resistance force to said bushing l; And a release device capable of releasing the pneumatic resistance force. 1” - Device of claim 1 wherein the drug delivery system Y comprises a release vessel for inhalation aerosol under pressure equipped with a valve as v-discharge. F 1 — Inhalation-operable release device ) for use with a pressurized aerosol 7 release vessel comprising an inner sleeve capable of containing the release vessel; ¥ a means of applying a preload force to said sleeve capable of operating an internal valve 31 of the aerosol vessel to release a metered dose from the vessel; and a means of applying a force o Air resistance on the sleeve aie able to actuate the aerosol valve; and an inhalation actuator 3 release device capable of releasing the force of air resistance to allow the preload not to actuate the internal valve and release a metered dose. what - 1 0 4 - firing device according to one of claims 1 or ¥; In addition to the foregoing, it includes a container capable of receiving the launch vessel comprising an external chamber with - mouth piece; and where the inner bushing is contained within the outer chamber; The inner sleeve is able to contain the main body of the aerosol container albeit in the shape of an o> ° at least. )© - firing device according to claim of where the outer chamber comprises One or more inlets to allow air to flow into the mouthpiece. 1 - A firing device in accordance with claim 7; Where the editing device is attached Y is operated by inhalation with a movable vane; Able when inhaling to move from a position | Sleep to On. Y | of claim 6; where the vane is biased so that the ly 1-7 launcher will move to its operating position at a predetermined rate of airflow; But it does not move ¥ to stated operating mode at a rate lower than that. Sea — A) release pursuant to claim 17; where the movable vane is 7 Able to actuate the release device to allow the preload to activate the valve [-2eT080]. 1 9 - firing device according to claim “7.-; It has a preload application facility 7 is the use of a spring capable of acting on the 'y aerosol' valve -0 1 firing device in accordance with claim 7; In which the force of air resistance includes a volume of air trapped under positive pressure greater than atmospheric pressure. 1-1 a firing device of claim 01; in which the preload comprises “- a lever hinged in a return recess within the firing device where this lever* is connected to the spring by means of a stopper 0 and the spring is able to act on a bowl .aerosol ¢ -1#1 A release device of claim 01 + in which positive pressure Y is synergistically generated between both aerosol vessels; the inner bushing; And a transverse element to form a Y-piston. -1*1 firing device in accordance with Clause 7; In which the force of air resistance comprises Y the volume of air held at a negative pressure less than atmospheric pressure. lea 1 - 40 1 release according to claim 1 “+ in which negative pressure is generated within an airtight and expandable Y volume selected as a bellows bellows or 1 piston, cylinder or a certain diaphragm connected to the bushing . -1#1 firing device as per VF protection; In which the preload has a Y spring acting on the inner sleeve and said spring is compressed by an Aad © - acting on the inner sleeve. The YT) firing device pursuant to claim 15; in which said lever acts against an X cam formed on a rotatable cover; so that the opening of the said cap causes the *- lever to descend and release the stored energy to affect the inner bushing which is capable of 1 affecting the aerosol vessel lea -17 1 firing according to the element of protection? ; Cum includes, in addition to the above, an acoustic device that emits an acoustic signal when a volume of air passes through the acoustic device | . provides the inhaler with a breathing rate greater than the predetermined rate YT slid release device pursuant to claim 7; in which the release device includes a VA 1 valve; It is often covered with a valve flap cover that is able to open when the device is turned on. V8) release device for use with a drug lie delivery system incorporating an internal Y sleeve capable of containing a release vessel; and a release tool for releasing a standard dose; has a YF advance device for applying a preload force to the bushing capable of operating the release device; a means of resistance to the application of an aerodynamic force to the sleeve capable of preventing the actuation of 8 the means of release by preloading; and the preload release to release force > aerodynamic resistance to allow the preload to actuate the release. -0 1 Release device for use with a drug delivery system comprising: 7 — Dose delivery system comprising a release vessel capable of delivering a standardized ¥ dose; ; - — paddle standard dose; oy 1 bushing capable of containing said firing vessel; - © where said release means shall include a means of applying a preload to said bushing “L” capable of operating said vessel in said system; and a means of applying an air resistance force to said bushing Able to prevent operation of said vessel A and release device to release said aerodynamic force to operate said delivery system 4. Release said standard dose 0 to release medication in aerosol form Release device for use with medication container 71-1 Standard comprising: cle aX main body having two primary and secondary ends; - 01: z; - - bushing comprising sides and base; diaphragm comprising a valve yard operationally connected to said second end - © of the main body mentioned and to the said base of the said bushing; 1 a spring operationally placed at the said second end of the said main body - in order to apply a preload force to the said bushing; Where the aforementioned blade when it is in the first position mentioned J Ye closes the said valve yard tightly and when the said blade is in the second position 1 . the aforementioned valve does not close tightly to the aforementioned valve VY: ; In addition to the foregoing, it includes 71 firing devices according to the claim “77 0 1 . Air entry openings located at the aforementioned second end of the aforementioned main body. YV. d YY) a firing device pursuant to claim 71; In addition to the foregoing, it includes: Y - Oral opening formed in an integrated manner at the aforementioned first end of the aforementioned main body 1. 1 0;7”- firing device pursuant to claim 77; In addition to the foregoing, it includes: Y - a dust cover that articulates with the first end mentioned to the said main body and is able to cover the said mouth opening cum The said dust cover ¢ includes a cam; º pls -© A cam is located in the said main body and is operationally connected between said cam 1 and the said bushing 0 . : YV.