MXPA06006284A

MXPA06006284A - Portable gas operating inhaler

Info

Publication number: MXPA06006284A
Application number: MXPA/A/2006/006284A
Authority: MX
Inventors: C Gamard Stephan; R Bielec Bryan
Original assignee: R Bielec Bryan; C Gamard Stephan; Praxair Technology Inc
Priority date: 2003-12-04
Filing date: 2006-06-02
Publication date: 2006-12-13

Abstract

The invention relates to an inhaler comprising a compressed gas, such as Heliox gas in a first chamber which is in communication with an equalization chamber having pressure lower than the pressure of the gas in the first compressed chamber and having a drug storage chamber which is detachably coupled to the equalization chamber operable such that a portion of the compressed gas from the equalization chamber fluidizes and aerosolizes the drug to produce a drug cloud and which can then be injected into a spacer where it can be inhaled by a user.

Description

PORTABLE INHALER THAT WORKS WITH GAS Field of the Invention This invention relates to the field of inhalers used to deliver a medicament to a patient through the patient's lungs, and more particularly to an improved gas inhaler. BACKGROUND OF THE INVENTION Definitions As used herein the term "Heliox" is defined as a mixture of helium and oxygen whose physical properties are summarized in Table 1 depending on the concentration of helium. Table 1: Physical properties of Heliox at 273 ° K, 1 atmosphere.

As used herein the term "ambient air" is defined as the air that normally exists around us, which is inhaled or exhaled from the environment, or that is pumped to a mechanical device manually from the environment and then inhaled. As used herein the term "aerosol formation or atomization" is primarily defined as the generation and then the breaking of a liquid film into primary goiites and satellites, with a size of generally 1 to 20 microns, although the physical form of the particles in an aerosol, as used herein it may be liquid droplets or dry solid powder particles. As used herein, the term "fluidization" is defined as the deagglomeration of a compact mass of a microbiotic dry powder drug of a preferred particle size in the range of 1 to 5 microns in a cloud, the target being generation. of particles in the preferred range of 1-150 microns, and more preferably in the range of 1 to 3 microns. As used herein, the term "heterodisperse aerosol" or "cloud of monodisperse particles" should be defined as a dispensable form of a liquid formulation of a drug or a solid powder formulation of a drug such that the particles have all the same or almost the same size. As used herein the term "alveoli" are deep air sacs in the lungs at the terminal end of the smallest and last branch of the bronchioles, where exchange of gases takes place between the air space in the lungs and the lung. arterial blood The drug material in small particles can enter the alveolar spaces, depending on their size characteristics and their disposition. After entering the alveoli, the drug material that surrounded by the alveolar macrophages, which exist around each alveolus under its layer of surfactant and enters the acinus via the terminal bronchial lumen. The drug particles can be absorbed from the lung mainly by means of alveolar macrophages. As used herein, the term "fine particle dose" will mean particles that are preferably about 5 μm or less, generally 3 μm or less, and more preferably 2 μm or less. As used herein the term "respirable fraction" (RF) is a dose fraction of aerosol drug particles small enough in diameter to escape from the tracheal filtering machinery and deposit in the lungs. As the term "dry powder formulation" is used herein and "liquid formulation" are the pharmacologically active drug itself, or with any of the following including but not limited to propellants, carriers, excipients, surfactants, anti-mycobanes, flavorings and other additions to the formulation that improve production, stability of the shelf life, the generation of particles, supply to the desired place in the lungs, and absorption, transfer to macrophages and to another base processed from space with air to tissue and blood, or taste. General Medical Background The supply of therapeutic drugs through the lungs for respiratory or non-respiratory systemic diseases has increasingly been recognized as a viable alternative if it is not superior for the administration of drugs orally / nasally, rectally, transderally, by injection medium with intravenous needle, intramuscular needle injection, or needleless injection by means of a jet of gas through the skin and into the muscle. Approximately 1 million patients in the United States receive intravenous morphine to relieve chronic and terminal pain. Morphine actually acts more quickly with respect to pain management when inhaled than when injected. In addition there is an important effort to change the inhalers driven with a CFC propellant or another based on vapor pressure by an alternative technology, due to environmental problems. But all forms of oral and rectal administration ideally require a drug in liquid form. Forms of drugs in solid particles have been explored for needleless injection. driven by gas through the skin to deposit in the muscle for a prolonged or planned release of the drug substance. In each of those non-pulmonary methods of drug administration, much larger doses of the pharmaceutical substance than that required for actual therapeutic effectiveness in the target system must be administered to ensure that the required therapeutic amount of the pharmaceutical substance is actually supplied to the target system or site. This represents a risk factor for the patient, in that there is a therapeutic variable with respect to the amount of dose delivered to a target system or site. The exception is when the target is very local to the site of administration (eg mouth, colon, a section of skin, an area of a muscle, etc.). In addition, many new drugs that are being developed by companies in the field of biotechnology that are based on peptides and proteins, exist in the form of dry powder in its optimal and / or more stable form, and thus these drugs can not be injected using a method with or without a needle, or administered transdermally. Drugs based on peptides and genetically produced proteins are also very sensitive to being altered in vivo by environmental factors such as enzymes and acids. If those sensitive drug molecules in the form of dry powder are administered orally, they are subject to enzymes and acids in the digestive tract. This can reduce the amount of those sensitive therapeutic molecules available for absorption in the blood in their original therapeutic structure, increasing the need to initially deliver a higher oral dose. Oral drug administration is neither pleasant, nor socially acceptable, not commercially viable except in extreme cases in which there is no other selection. The intravenous needle method for administering therapeutic drugs in liquid form in the arm or femorally results in dilution and loss of drug potency as the blood passes through the venous system back to the heart, then to the lungs, and finally in the arterial circulation for its supply. The intramuscular injection with needle helps a trajectory in which part of the administered dose can be lost. The same applies to gas-free needle injection, in which the drug substance must pass through the skin, into the muscle (usually and mainly) into the venous blood system and then into the arterial system. Therefore, it is necessary to inject more drug, regardless of the method, than what is really needed to obtain the desired therapeutic effect, in for example a specific organic system or a receptor target in an organ fed by arterial blood. However, by introducing a pharmaceutical substance into the arterial bloodstream at its source, the lungs, a bolus of drug delivered to the target is less diluted and therefore it is required that less drug be deposited in vivo at the site or point of entry of the drug. administration (the alveoli). The supply of drugs through the lungs is the optimal method to treat diseases in the lungs. further, drugs delivered through the lungs for something other than respiratory diseases, go quickly and directly to the arterial blood, then to the heart and then to the other critical organs such as the brain, liver and lungs, and the receiving sites that are in them. This reduces the effect of dilution on the therapeutic dose administered in the bloodstream. In addition, there is minimal enzyme or acid activity in the lungs compared to the stomach, which can impact the therapeutic molecular integrity of sensitive drug molecules such as peptides and genetically engineered proteins. The pulmonary supply of the drug depending on the drug and the disease, can: a) improve the efficacy of a drug; b) improving the bioavailability of a drug, which is particularly important for biological compounds such as peptides and proteins; c) improving targeting to a receiving organ or site by reducing unwanted side effects (which is an important consideration with for example anticancer agents); and d) copying the biological pattern of a disease or heart rhythm, for example as in the case of prolonged-release antihypertensive drugs designed to coincide with the increase in morning blood pressure. Specially, a new method for the pulmonary supply of existing drugs, can extend its therapeutic indications, reduce the cost and make possible a faster time for its commercialization. Since drugs administered by the pulmonary route do not require sterility, a sterile device or a sterile environment, they are ideal for drug delivery in difficult environments. The North American patent no. 6, 125, 844 discloses an apparatus for the gas-assisted portable application of a medicament without the use of a fluorocarbon propellant. The apparatus consists of a pressurized supply of gas containing a therapeutic gas or a mixture of therapeutic gases and one or more mixed drugs, connected to a pressure regulator, the pressure regulator being connected to a gas release switch that is connected to a pressure regulator. a respiratory activator. The respiratory activator is connected to a suction chamber, in use when a patient inhales from the vacuum chamber, inhalation causes the respiratory activator to engage with the gas release switch to release the therapeutic gas / drug mixture in the chamber of aspiration, wherein the therapeutic gas and the medication in the aspiration chamber are simultaneously delivered to a patient during inhalation. Alternatively, the medicament can be stored in a separate reservoir for drug adjacent to the pressurized supply of therapeutic gas, the medicament being withdrawn into the aspiration chamber by means of a venturi assembly. The variables that affect which particulate drugs generated by the inhaler are delivered to the correct place routinely mentioned in the medical literature include: a) those that are related to breathing including the volume of inspiration, the inspiratory flow rate (speed ), the breath retention period after inspiration of a dose, the total volume of the lung at the time the bolus of the drug is administered and the expiratory flow rate; b) those that are related to the particles including the aerosol particle size, the shape, the density of the liquid drug particles or powder, and the size distribution in the nine aerosol of solid or liquid powder produced; and c) the patient's medical status, and in particular the condition of the patient's respiratory system. The goal with any method and technology that includes inhalers, is: generate particles in the optimal size range for the deep supply in the lungs, and b) make the administered particles pass the upper trachea where they would be lost in the turbulence and impacted in the middle lung (to treat respiratory diseases) and deep lung (to deliver the drugs to the target area where they can enter the arterial blood). Contrary to drugs administered intravenously, drugs administered through the lungs are not subject to first pass through hepatic metabolism. They are also less subject to reacting with or being affected by fewer receptors before reaching their intended target either in the lungs or in the systems, resulting in the need for a reduced amount of drug, if the particle size is optimized and the supply to the target site in the lungs. However, because any systemic medication administered by the lungs goes directly to the heart first, the side effects on the heart of the excipients and the drugs administered by means of this method are a problem. As an example of the effect that fast-acting drugs administered through the lungs can have systemically, the administration of the morphine analgesic through the lungs has a faster effect than morphine administered intravenously. Recognition of the ability to deliver systemic therapeutic drugs by inhalation due to the physiological properties of the pulmonary or circulatory system, has led to a large number of therapeutic drugs being developed and evaluated for administration by inhalation to treat non-respiratory diseases.

A key problem is to maximize the number of those small particles that are supplied to the terminal branches of the bronchioles and alveoli. Small particles with a size preferably of 1 μm-3μm, are optimal for this purpose. Generally, in this range conventional inhalers only supply approximately 10-20% of the amount of particulate drug delivered by conventional inhalers. Drugs in large molecules, such as the peptides and proteins that are now possible thanks to genetic engineering, do not easily pass through the surface of the trachea because it is coated with a layer of cells covered in mucus with a ciliated some depth, making it highly impermeable. The alveoli, however, have a single cell layer that allows absorption into the bloodstream. The alveoli are the gateway to the arterial blood and are the base of the lungs. Thus, to reach the alveoli, a particulate drug must be administered in small particles, and the inhalation must be moderate, slow and deep. Large particles will impact the oropharyngeal area or settle in the upper bronchi. If the particles are too small and / or ultra-light, they will be exhaled (the latter will be especially true if the air is the tidal front of the gas carrying the ultra-light particles). The longer passages through which the air travels and the drug particles generate turbulence that also produces the impact and loss of the drug particles. A desired objective is to increase the laminar flow of the gas stream in the larger air passages, so that the particles reach the smaller passages where the laminar flow is induced naturally. If there are constrictions in the bronchi or bronchioles, resulting for example from asthma, the turbulence and the impact rate of the drug particles may also increase at the constriction points. Any variability in the dose deposited in the lungs, and where it is deposited in the lungs, could have a major effect on the treatment due to the narrow therapeutic range of many drugs, and the potency of those drugs. A well-known example is insulin. The aerosol particles are deposited in the trachea by means of gravitational sedimentation, inertial impact and diffusion. The three mechanisms act simultaneously. However, the first two are the main methods that apply to the deposition of large particles. Diffusion is the primary factor of the deposition of smaller particles in the peripheral regions of the lung. The optimum size of the drug particles to be delivered to the alveoli are generally in the range of 1 to 3 microns, and generally particles smaller than 2 microns reach the alveoli. The diameter of the therapeutically useful particles is generally between 0.5 and 5 microns. The particles of 1 -5 microns are deposited in the upper trachea, while particles with diameters generally less than 3 microns in diameter reach the bronchioles and terminal alveoli and are optimal for transfer into the arterial blood. The penetration depth of a particle in the bronchial tree is inversely proportional to the particle size of up to 1 μm. Particles smaller than 1 μm, however, are so light that a large proportion does not deposit in the lungs. The lower trachea are the optimal sites for the treatment by inhalation of obstructive pulmonary diseases. Diffusion is a process that is applied to particles smaller than about 3 microns. The maximum collection of particles in the depth of the lung is through the process of sedimentation. Some of the sub-micron particles of a drug can be exhaled because its sedimentation may not be high enough in air, which is usually the environmental gas that enters and the environmental gas in the lungs. In the prior art, both metered dose inhalers (MDl) or dry powder inhalers (DPI) use air as the exclusive or primary means to transport fluidized powder or atomized liquid medication into the lungs. In the case of MDl, it is assumed that the propellant evaporates as intended or constitutes a very small fraction of the total gas inhaled from the volume in a total manner with the dose of drug and air. Heliox has been administered to a patient with a hospital equipment prior to the administration of a solid or liquid powder aerosol drug. Heliox has also been used to administer a liquid drug using a nebulizer, which is a different type of device for the pulmonary administration of drugs that lasts from 1 0-60 minutes. This is different from the "explosions" received through the inhaler. Additionally, in both cases, the systems in which Heliox was used were designed for the physical properties of air and not Heliox, and thus were not optimized for Heliox. The prior art and medical publications related to inhalers address other factors but do not focus on the specific gas involved in transporting the particles to the lung. In the case of IPRs, gas is always assumed or specifically indicated to be air. In the case of MDl, the "gas" is always assumed to be a liquid propellant that has a vapor pressure. CFC in most cases, and it is only a negligible fraction of the volume inhaled, the rest being air. MDl is a metered dose inhaler consisting of a propellant that generates a vapor pressure and a drug in the form of a suspension or solution, where when the device is activated the vapor pressure of that propellant pushes a predetermined amount of liquid through the device. the nozzle generating an aerosol for inhalation. MDl contains suspensions or solutions of a drug, a propellant and a surfactant that acts as a lubricant to prevent particles from clumping together and to reduce obstructions in the aereosol nozzle. MDl is based on the use of propellants that have a higher vapor pressure. The higher the vapor pressure the faster the drug containing liquid can be expelled from the nozzle and thus a thinner liquid laminate is formed, and smaller particles are produced. The vapor pressure is therefore directly related to the speed generated and the fraction of fine or desirably small particles that are generated. The pressurized aerosols historically used chlorofluorocarbon (or CFR) that generate a pressure of about 400 kPa or more. The aerosol cloud therefore emerges from the can (or any suitable container) at a high speed. In addition, the drug crystals are initially trapped within larger droplets of propellant whose median mass diameter may exceed 30 μm. Large particles traveling at high speeds are very susceptible to oropharyngeal deposition by inertial impact. As the propellant evaporates and the particles slow down when the device moves away from the mouth, or when an MDl spacer is used, on average only about 20% of the original or nominal dose actually enters the lungs. In an MDI, the generation of an aerosol occurs in what can only be described as an explosive way since the propellant containing the therapeutic solution or suspension disintegrates as it passes through the aerosol nozzle at a very high velocity . As the propellant jet evaporates rapidly, the liquid particles are rapidly reduced in diameter to the state of a "dry solute". The velocity of the discharged particles is transferred to the particles that evaporate as they leave the device and move towards the air stream. This speed is much higher than the inhalation speed by the user. The result may be the impact of the particles in the oropharyngeal area. A spacer that is described later is a solution to this problem, by reducing the speed of the "Cloud" of the particles before inhalation. Another technique is to use the "open mouth" method that involves activating the device a few centimeters away from the open mouth. MDl containing a suspension require agitation before use. MDl that contain a solution do not need it. This presents a problem that uses more than one type of drug, this is one in suspension and another in solution, since the patient may shake the wrong MDl or may not shake the MDl that needs to be shaken before use. The latter would result in the wrong dose of the medication being supplied and inhaled. This is an advantage of the use of IPR, since there is no need to make the decision to "shake or not shake". MDl containing a propellant and a suspension or solution also present a challenge with regard to stability over a range of temperature. A problem as much as MDl and DPI is that there is often poor coordination between the patient oppressing the actuator and the moment of inhalation. One solution is to use a spacer between the device and the patient, which will also allow the heavier particles to settle before the patient inhales. Another problem with MDl is that they rely on propellants that rely on vaporization to generate pressure and a drop in temperature occurs when vaporization occurs. The vaporized propellant can stick to the back of the user's throat before it has completely evaporated if a spacer is not used. This can lead to a reflex cough that interrupts the continuous and deep inhalation required for optimal drug delivery. In addition, the humidity of the water in the mouth will quickly condense in the cold vapor, causing the small droplets of medicine to coagulate and fall, reducing the percentage of medication actually delivered beyond the oropharyngeal area. DPI is a dry powder inhaler consisting of a micronized dry powder drug provided in a compact form and contained in a unit dose container or reservoir, which is fluidized by the flow of a gas and is inhaled by the patient. The micronized dry powder formulations are very soluble and dissolve rapidly in the fluid layer on the surface of the deep lung before passing through a single cell layer of the alveoli. They are then deposited in the alveolar region and can be absorbed into the bloodstream without using what is commonly called penetration enhancers. Dry powder aerosols can carry approximately five times more medication in a single aspiration than MDI systems and many more times than liquid or nebulizer systems. The micronized dry powder drugs used in inhalers are generally produced with an original particle range of 1-150 microns. A single charged dose may consist of 5 mg to 20 mg of the dry powder drug. A smaller total amount of dry powder drug is possible with purer medications, or with medications that do not require or that are packaged without excipients. Examples of carriers of excipients used in dry powder drug formulations include lactose, trehalose, or crystalline or non-crystalline mannitol. Trehalose or mannitol, which are spray-dried sugars, are better dispersing agents than lactose. Thus, the "pharmaceutical substance" in a DPI consists of the pure drug, plus a sugar if an excipient is used, in comparison with the multitude of constituents contained in an MD l. This multitude of constituents in an MDl increases the work involved in the production of the product and its packaging, can affect the stability of the formulation, can cause aerosolization problems by clogging the nozzle and may require agitation or non-agitation of the MDl inhaler prior to use. DPI devices that provide ace compressed or assisted fluidization with a propellant / impeller, which bases the fluidization on the inhalation of the patient produce a better variability in the dose and in the formation of the particle size. The speed, rate of increase and continuous event of this inhalation are variables that can affect the fluidization of the powdered drug and the effective delivery of the particles with the optimum particle size deep in the lungs. The higher the gas velocity, the finer the particles created during fluidization would be, but the greater the possibility that the particles will impact in the oreopharyngeal area during inhalation, where the velocity of the gas that fluidizes the dry powder drug will be derives from the "suction" or negative pressure of an inhalation source. Devices that rely on the force of patient inhalation also operate based on the "suction" or pull effect of that gas flow, ie, a negative pressure, to separate and fluidize the powdered drug. This is less effective than when a highly directed direct current of high pressure gas is supplied consistently at the same pressure. Some DPIs use compressed air generated by means of a pumping mechanism, which the patient uses, whereby the pressure is released for the fluidization of the powder drug when the system is operated. The pressure and therefore the velocity, of a gas that can be generated by means of a hand pump or an inhaler device, is much less than is available from a compressed gas cartridge. The uniformity of fluidization of the dry powder would therefore be less using a manual pump, with the possibility of therefore generally greater percentages of larger particles, which result in a variable or inconsistent loss of drug in the oropharyngeal and superiors The higher the velocity of the gas that sticks in the dry powder, the greater the velocity of the dust being dislodged and the induced turbulence, which can create a cloud of particles for inhalation. In the case of dry powder inhalers, the ramp velocity at the speed required to disaggregate or deagglomerate the dry powder in the form of fine particles, it is a factor as important as the speed to determine effectiveness.

Systems that use dry powder drug in capsules require the patient to load the capsules individually, whether the system can be loaded with one dose at a time or several doses for the use of multiple doses over a period of time. In some devices, the capsule breaks to release the dust contained therein. A DPI produces a fluidized drug and sends it through a narrow space, increasing the velocity of gas and dust to improve deagglomeration by means of turbulence and reducing the number of large particles by means of impact and settlement. Frequently, a baffle is also included in the system to trap the larger particles. A problem encountered when using compressed gas vs. A manual pump for general compressed air DI P (or a liquid MDl driven by means of CFC vapor pressure) is that the compressed gas pressure will be reduced with use. In the case of DPI, the gas pressure is constant during each dose fluidization procedure. In the case of gas-driven MDl, the pressure available for atomization decreases with time near the end of its capacity, unless the MDl has a cut that does not allow the administration of doses beyond a certain minimum pressure required to achieve enough atomization. A spacer is a tubular device of plastic or metal that is placed between the inhaler device and the patient and in which the inhaler device supplies the particle cloud generated by fluidization of dry powder or liquid atomization. A spacer may have open ends, allowing a reduction in gas velocity, or closed ends (retention chamber) to reduce the loss of inhaled dose due to poor coordination between hand and inhalation. The spacer reduces the velocity of the gas mass and the particles that come out of the inhaler, traps the larger particles by means of impact and settling and provides better control of the speed and time of inhalation, supply of the particle size range desired, and reduced oropharyngeal loss of particles due to impact, versus direct inhalation of the inhalation device. It also reduces the effect on the throat by inhaling a cold gas such as freon. The separated ones have been incorporated in the routine use of MDl. The speed of inhalation fiow in the inhalers driven by the inhalation determines the quality of the aerosol cloud, the higher the fluidization rate of the dried powder drug, the finer the particles produced will be. However, inhaling the particles at a rapid rate leads to the impact of higher percentages of the particles in the back of the throat. Heliox, which is a commercial combination of 70% or 80% helium in oxygen, has been used for more than 70 years in respiratory therapy. Heliox is supplied in some hospitals and emergency rooms in a large gas cylinder. The most popular types are the "K" cylinder that has a height of 51 inches (129.54cm), 9 inches in diameter (22.86cm) and weighs 130 pounds (59kg) when fully filled. Heliox is supplied at 2,200 psig and requires a two-stage pressure regulator to reduce the pressure for administration to patients. However, due to its volume and the requirement of sophisticated pressure and flow regulators, it is used only in research and hospital facilities. The gas flow within the tracheobronchial tree is complex and depends on many factors. For a given pressure gradient, the volumetric flow rate of a gas is inversely proportional to the square root of its density. In accordance with the present invention, it has been found that replacing helium with nitrogen in the inhaled gas mixtures results in an increase in the gas flow velocity because the density of helium is much smaller than that of nitrogen. The resistance to gas flow within the tracheobronchial tree is the result of acceleration and friction by convection. Convection acceleration is the increase in the linear velocity of fluid molecules in a flow system in which the cross-sectional area is reduced. The resistance to friction can be turbulent or laminar depending on the nature of the flow. Since the resistance associated with these factors depends on the density, the breathing of a less dense gas must decrease the resistance to the flow and consequently reduce the respiratory work. An obstruction in the upper tracts causes a resistance to flow that is mainly by convection and is turbulent and therefore susceptible to modulation through a change in gas density. For respiratory treatment it is desirable to create a minimum pressure drop flow or flow resistance. The flow to the gas in the respiratory can be laminar, turbulent or a combination of the two. The turbulence is predicted by means of a high Reynolds number, which is a quantity without units proportional to the product of the gas velocity, the diameter of the trachea and the density of the gas divided by the viscosity. The Reynolds number is also expressed as the ratio of kinetic to viscous forces. The lower density of helium when replaced by nitrogen, reduces the number of Reynolds and can convert the turbulent flow to laminar in several parts of the trachea. Turbulence is highly dependent on surface stiffness, such that flow in a rough cavity can be turbulent even if the Reynolds number predicts laminar flow. Even in the absence of turbulent flow, the lower density of helium improves flow and reduces the work of breathing along the broncho-restricted trachea. The effectiveness of Heliox in respiratory therapy occurs because it is a low density gas. The rate of diffusion of a gas through a narrow orifice is inversely proportional to the square root of its density (Graham's Law). When an area of stenosis occurs in the trachea, there is resistance to flow at the site of stenosis. The resistance varies directly with the density of the gas. Current below the stenosis, the air flow becomes turbulent. By replacing helium with nitrogen in the inspired air, the resistance in the stenotic air and current turbulence below the stenosis is reduced or reduced or eliminated. In the tracheobronchial tree there is usually a laminar flow that is generally less than 2 mm in diameter. Turbulent flow has been observed in the upper respiratory tract, the glottis, and the central trachea. This upper portion of the trachea, especially the throat, and the main bronchioles, are considered in the region where turbulent intensity is sensitive to gas density. Since the resistance of the trachea in the turbulent flow is directly related to the density of the gas, Heliox, with its lower density than nitrogen or oxygen, results in a lower resistance of the trachea. The Heliox also reduces the resistance of the trachea to reduce the Reynolds number, so that some areas of turbulent flow become laminar flow. The higher flow rate of Heliox has the ability to remain laminar at speeds below which the air would be turbulent. Heliox does not need to be laminar to provide high flow rates its benefits remain under turbulent conditions. Some have the misconception that due to its lower density, helium is less viscous than air, so that it flows more quickly. Actually, the absolute viscosity of helium is slightly higher than that of air, and its kinematic viscosity (absolute viscosity divided by density) is about seven times that of air. So from the point of view of fluid dynamics, helium is more viscous than air. The linear relationship between helium concentration and resistance to flow is predictable based on fluid mechanics. Helium has two important effects in reducing resistance in an obstructed airway. First helium reduces the likelihood of turbulence. The airflow in the upper trachea is turbulent except at rest, due to the rough walls of the trachea and the relatively short lengths of the trachea segments compared to their diameters. The probability of turbulent flow is predicted by the Reynolds number: Rs = p? U) μ in which: D = diameter of the mouth, trachea or throat (cm) V = gas velocity (cm / sec) p = gas density (g / cc) μ = viscosity (g / cm / sec) In Second, the flow of air through an orifice requires an increase in pressure to maintain the flow: where Pa-Pb is the difference in pressure caused by the orifice (dynes / cm2) and Co > is the discharge coefficient, which depends on the edge of the hole edge. U0 = velocity through the orifice ß = is the ratio of the diameter of the orifice to the diameter of the tube Pa = pressure upstream before the orifice PD = pressure upstream down the orifice p = density In summary the Heliox is more beneficial due to its lower density. Compared to air, it flows at a higher flow rate for fixed pressure gradients or needs a lower pressure gradient or breathing work (or patient inhalation effort) for a given rate of luxury. This is true even under turbulent conditions. There is a medical literature in which Heliox has been provided to a patient before the dose with an inhaler based on the CFC-based propellant. There is also a study in which the small volume of Heliox (40-70 ml) was supplied as a bolus but with a low respiration during the pulmonary administration of a particulate material to see if the particles diffuse more deeply into the lungs in case same inside the Heliox gas. There is also a literature in which Heliox was used with a nebulizer to provide a medication in liquid form. Most of the time the gas flow velocity is based on that used for air. In other cases in which the velocity of the gas flow is altered, the aerosol nozzle used is designated for air and not for Helium or pure helium, so that the particle size distribution was not suitable for the change Of gas. Two factors that can influence the delivery of an optimally fluidized dry powder drug formulation are static electricity and moisture. It is desirable to avoid tripartition of a charge of static electricity to fine particles, especially those with a size of 1 m or less. The static charge will form a force of attraction on the particles causing them to agglomerate, returning them to a collective size that is not suitable for the deep supply in the lungs. This type of cohesion of the particles is highly desirable because few particles that are attracted to each other can double or triple the rate of terminal settlement. There is a key reason why inhalers that use inhaled air, propeller-driven air, or compressed air pumps have more than 50% of the drug dissolved in the mouth and throat before they enter the lungs. The moisture in the fluidizing gas can also result in particle agglomeration. It is a disadvantage of using inhaled air, ambient air driven through a propeller, or compressed air using a hand pump that is part of an inhaler. If an inhaler is used in a humid geographic location or during wet season conditions, moisture may affect the dose of drug particles in the range of sizes required for penetration deep into the lung, thus affecting the dose. In addition, if moisture comes into contact with the powder before it is fluidized, moisture can accumulate in the outer layer of the powder, forming lumps before fluidization occurs. The system of the present invention can be light enough to be portable and small enough to be used from a child to an adult. It is an object of the present invention to provide an inhaler that can deliver particles of suitable sizes to the lungs efficiently using a propellant with sufficient pressure to fluidize or atomize a drug to be used by a patient. SUMMARY OF THE INVENTION The present invention describes in detail an inhaler for medical purposes where the main carrier gas is Helium or helium. One embodiment of the invention is an inhaler for delivering a drug to a user. The inhaler comprises: a first chamber suitable for first containing a compressed gas at a first pressure; a second chamber in selective communication with the first chamber, the second chamber is adapted to contain a second compressed gas at a second pressure lower than the first pressure, the first and second chamber cooperate to give that second pressure of compressed gas within the second camera; a means for administering two different volumes of gas in successive applications of the second chamber; a storage section coupled to the second chamber, the storage section is adapted to contain a drug and operate in such a way that a portion of the second compressed gas can be fluidized and atomized the drug to thereby produce a cloud of the drug.; and a nozzle coupled to the storage section, the nozzle is suitable for receiving the drug cloud and transporting the drug cloud to a user.

The inhaler consists of three mostly independent parts: a high pressure can, a drug delivery support and a spacer. The three parts can be separated from each other to be fixed in a non-separable way. The can can have a resealable filler hole and the drug support can be removable and have a resealable filler means. The high-pressure can contains Helium or pressurized helium and supplies two constant volumes of gas at a fixed pressure regardless of the internal pressure in the can. A volume of gas can go directly to the spacer to purge it of ambient air, while the second volume smaller, gas volume will interact with the drug. The drug drum contains several doses of the drug in liquid or powder form that will be nebulized or liquefied using the second volume of gas in the can. Finally a spacer is used to contain and mix the two gas volumes of the can and open to the patient. Alternatively, only one volume of gas can be emitted by the can to purge and nebulize the drug in a process. These aspects as well as others will be evident when reading the following description and the corresponding drawings. The drawings cover only some embodiments of the invention to explain their general functionality. There is ample space for design changes in the technical aspect of gas supply, for example. No figure was drawn to scale. In order to place the helium can / heliox on the market, it is necessary to produce a product of weight and dimensions similar to the current MDl. The weight when full is estimated to be 50 grams. Helium by itself is a light gas will contribute only slightly to the overall mass of the can. In fact 300 ml of pure helium weighs 50 mg, so 100 doses of 300 ml would only weigh 5 grams. Therefore it is preferable to minimize the weight of the can. Its size however depends on the internal pressure of the gas, but the pressure will limit the total amount of gas in the device, or the total number of available doses. We base our calculations on the average dimensions of cans of 80 mm in height by 40 mm in diameter, which contain only 100 g of gas. Assuming 10 doses or 3 liters of gas, the can will need a pressure of 500 psg. The device would then weigh 50 grams using steel (stainless or carbon). If we want to supply 50 doses (comparable to the existing MDl) the can would then be pressurized to 3200 psig and weigh 320 g (steel). See table 2 for details. Table 2: Design of the proposed can. Weight 80 mm, diameter 40 mm (dimensions based on existing MDl) The general dimensions of the can are modified due to its high thickness. An optimization of the dimensions of the can can easily be performed to have a general weight, an internal pressure and number of acceptable available doses. For example a container of 25 cd to 1600 psig can then supply 10 doses, weighing 30 g. A helium can can not be compared to the MDl described here. For a number of similar doses, it will be too heavy and will be pressurized to dangerous levels. This is due to the fact that the can needs a much larger amount of gas per dose to fully use the properties of helium. The solution is to design the can for a very limited number of uses. The synchronization of the number of doses available in the can with the number of drug packages in the drum (plus a residual volume needed to supply the gas) ensures that patients will never operate their devices without the necessary drug. A cylinder containing a necessary amount of helium / Heliox for 10 doses would weigh approximately 450 grams full (37 grams of material, less than 1 gram for gas), which is comparable to existing devices. Finally, it would only be sold together with the existing DPIs in terms of the number of available doses, but with a much better efficiency due to the use of Helixo / heelo for better drug delivery and the absence of synchronization between the patient's hand and respiration. . In order to help level the cost of the inhaler during a longer period of use, the can can be refillable. In this case, the user will also have a larger cylinder of Helium / Heliox at high pressure in the home and fill this smaller can of inhaler with a simple process after a certain number of uses, for example 10. This idea is novel for inhalers and would allow the patient to use their inhalers for months at a time without a refill by health care providers. In this case the drug drum may contain a much higher number of doses. The filling of the cartridge could be done without modifications or with very reduced modifications to the currently proposed cartridge and the gas supply designs. The maximum pressure of the can is 500 psig. An E cylinder typically fills up to 2200 psig for a total content of 623 liters for 100% helium or 708 liters for pure oxygen. Using a cylinder E to fill the can with a basic regulator set for the 500 psig supply would allow the can to be filled with 1600 doses or 580 liters based on the content of the helium cylinder E. Practically, the Heliox tank of the home would have a standard regulator set for a 500 psig application. The simplest way to fill the can is to have a separate valve in the can for filler purposes only. The valve could be similar to a one-way fill valve like the one used in balls for example and be located on the top or on the side of the lamp to avoid any interference with the measuring chamber inside the can. For aesthetic and safety reasons, it is preferable that no extension protrude from the cylinder. The valve would only open if the proper spigot of the home's fill tank is inserted, and due to the cylinder regulator of the hearth, it would fill the portable cylinder to exactly 500 psig, or 10 doses. The operation would only require the user to push the cylinder over the valve stem and it would only last a few seconds. A pressure gauge in the cylinder of the hearth would allow the user to know when the pressure drops below 500 psig, the pressure when the cylinder is considered to have reached the end of its useful life. Alternatively a counter device would allow the user to know how many fillings are available in the home cylinder. The entire filling system will only require the regulator on the top of the standard medical cylinder along with the specific spike and the pressure meter or dose counter. This clearly limits the overall cost of the device. Renting the cylinder case to the user would reduce costs additionally by reusing the device and refilling it in specialized facilities in a manner similar to existing oxygen cylinders.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a side view of an inhaler, diffuser and spacer according to the invention; Figure 2 is a side view of a piston-chamber assembly for supplying the two volumes of gas; Figure 3 is an alternative to Figure 2 to supply two volumes of gas using two gas orifices, one being a calibrated orifice; Figure 4 is a side view of a drum assembly. Figure 4A is a sectional view A-A of the drum of Figure 4 used to contain a drug according to the invention; Figure 5 is an alternative to Figure 4. Figure 6 is a side view showing the coupling of the drum and an equalization chamber; Figure 7 is an enlarged side view of a tube containing a liquid drug; Figure 8 is an enlarged side view of an alternative embodiment of a tube containing a liquid drug; Figure 9 is a side view of a tube suitable to be coupled to a fixed nozzle. Figure 10 is a side view of an alternative coupling of a tube with a fixed nozzle; Figure 11 is a side view of a spacer according to the invention; Figure 12 is a side view of another embodiment of an inhaler and diffuser according to the invention. DETAILED DESCRIPTION OF THE PREFERRED MODALITIES Referring to Figure 1, an inhaler 30 according to the invention is shown. The inhaler 30 has a high-pressure chamber 30 coupled to an equalization chamber 34. The high-pressure chamber 32 is a small low-carbon, cold-rolled steel vessel containing gas 52 compressed at a pressure of approximately 30 psig and 1600 psig, preferably between 1 00 psig and 500 psig. The gas 52 is a gas that preferably contains from 0% to 100% helium, the rest if necessary is oxygen. Other compressed gases could also be used. It is preferred that the ace that is used be still dry gas. Storage at high pressure allows the Heliox to be stored at a content preferably with a volume of 10 to 100, but still provide enough gas for a large number of inhalations. For example 100 ce of Heliox at 200 atmospheres will expand 200 times in volume to a volume of 20 liters when the gas is released at atmospheric pressure. To provide Heliox at a constant pressure the storage pressure in the chamber 32 must be significantly greater than the regulating pressure. When the feeding pressure of the compressed Heliox falls below the pressure required to fluidize the powder (or atomize the liquid) to the established uniform standard, then the inhaler would no longer operate and a cutting mechanism is therefore desirable. The chamber could have a resealable filler hole 31 by means of which a user could couple the can to a larger tank of high pressure Heliox. The high pressure chamber 32 includes a housing 36 which defines a third chamber 38. The housing 36 includes a hole 40 in its upper part and a gas passage 42 in one side. The third chamber 38 communicates with the high pressure chamber 32 and the equalization chamber 34. The equalization chamber 34 is needed to produce a consistent volume of gas throughout the life cycle of the high pressure can 32 regardless of its internal pressure. This is achieved with the aid of a simple regulator by means of the diaphragm plate 56. The gas will flow from the upper chamber 32 to the equalization chamber 34 until the equalization chamber 34 has reached its nominal pressure, the constant value is much smaller than the high pressure at which the gas is stored in the can 32. The equalization chamber 34 includes a housing 58 which has a gasket 46. The gasket 46 includes a gas passage 48 on one side thereof for allowing the gas placed in the third chamber 38 to communicate with the second chamber 34. A piston 44 is slidably mounted within the lining 46 and inside the housing 36. The piston 44 includes a communication hole 50. The piston 44 is pushed down with a spring 60 located inside the chamber 38 to allow gas communication between the chambers 32 and 34. When the can 32 is separated from the inhaler, the spring 60 pushes the piston 44 sealing the can when closing the orifice 42. When the can is inserted into the inhaler, the tip of the piston 44 will rest on the diaphragm 56, and push the piston 44 into the chamber 38 of such The high pressure gas passage 42 communicates with the communication hole 50. The communication hole 50 is designed to selectively allow the gas stored in the high pressure chamber 32 to communicate with the gas 54 stored in the chamber. equalization 34. A pressure plate 56 is also disposed within the housing 58. One side of the pressure plate 56 is coupled to the piston 44. Through the use of the high pressure chamber 32 and the equalization chamber 34, the Inhaler 30 produces a desired gas pressure without requiring an external pump or inhalation pressure from a patient. When the pressure inside the equalization chamber 34 is too low to allow the inhaler 30 to be used, it is desirable that the high pressure Heliox 52 of the high pressure chamber 32 be filled in the equalization chamber 34. The spring 60 and the pressure plate 56 are designed to facilitate this operation. As indicated above, the piston 44 has a communication hole 50 that selectively allows a high pressure chamber 32 to communicate with the equalization chamber 34 through the gas passage 42 and 48 when the passages 42, 48 are aligned with the communication hole 50. The gas 52 applies pressure against a small area defined by the upper part of the piston 44. The net force of the gas 52 pressing on the piston 44 is the pressure of the gas multiplied by the surface area of the part upper piston 44. This net force applied by the high pressure side of the high pressure chamber 32 on the piston 44 works with the thrust force of the spring 50 and against the force applied by the gas 54 on the pressure plate 56 The spring constant of the spring 60 and the surface area of the pressure plate 56 are selected in such a way that when the equalization chamber 34 has received sufficient pressure to use the inhaler 30, the force applied by the gas on the pressure plate 56 will exceed that of the force produced by the gas 52 on the piston 44 on the high pressure side of the device and the force of the spring 60. At that moment the force applied by the gas 54 will cause the piston 44 to move upwardly within the housings 58 and 36. As the piston 44 moves upward, the communication hole 50 will move away from the gas passage 48 effectively stopping any entry Heliox at high additional pressure 52 to the equalization chamber 34. The spring 60 will push the piston 44 downward to allow gas to pass from the chamber 32 to the chamber 34 regardless of what pressure is inside the chamber 32. that the surface of the pressure plate 56 is quite important, the two main forces that balance the piston are the spring force and the pressure force of the equalization chamber 34. The spring constant of the res. 60 and the area of the pressure plate 56 are thus selected for a specific pressure such that a patient will always receive the same volume of gas and dose for their applications, regardless of the pressure change in the high pressure chamber 32. Once the gas has been delivered (this is the inhaler 30 has been operated and the medicine in the inhaler 30 has been supplied to the patient), the pressure exerted by the gas 54 on the pressure plate 56 is smaller and the Heliox a High pressure 52 together with the spring will push the piston 44 downwardly allowing the cycle described above to repeat until the equalization chamber 34 again has a desired gas pressure. An alternative to this delivery system can be realized using a mechanical drive by the user. As the high pressure chamber is reduced 32, the piston will allow the gas to escape from this passage at high pressure 42 and be stored in a secondary chamber. The amount of gas released in the equilibrium chamber 34 is then defined by the volume of this secondary chamber. The gas is released from this chamber in the balancing chamber 34 when the high pressure cylinder 32 returns to its original position. In this configuration, housing 58 could be used as the secondary chamber. The high pressure Heliox 52 can store at for example 1600 psig. The equalization chamber 34 effectively decompresses this gas in such a way that it has a pressure of for example 32 to 200 psig. Using 22 ml of Heliox 200 psig, the gas will expand to 3300 ml at a pressure of one atmosphere. This is a sufficient amount of gas for the gas supply in one inhalation. It should be noted that the equalization chamber 34 may be a part of the separable high pressure can 32. In other words, the design of the supply of a constant volume of gas may be an internal mechanism inherent to a high pressure can that the user You can independently buy the rest of the inhaler or it can be part of the same inhaler. The equalization chamber 34 contains a fixed volume of pressurized gas 54. This gas will be released in two volumes widely different from the rest of the inhaler. The first volume released is approximately 270 ml of gas, the second is only 1/10 of that volume or 30 ml. It is proposed here that the creation of the two volumes occurs in separate activations, either triggered manually by the user (this is by pressing the trigger twice or in two positions) or sequentially within the device. The drawings show 2 different embodiments of the invention: mainly by supplying two volumes of gas using the two-chamber piston (figure 2) or with the use of two gas orifices, or a calibrated orifice (figure 3). Option 1: The supply of two volumes can be done first by having two chambers as shown in Figure 2. The novelty lies in the presence of two internal chambers and a single piston shape, selectively isolating the chambers. Option 1 also allows the supply of two volumes of gas to be an internal component of the high-pressure can 32. The two-volume supply can be inherent to the design of the can where the two chambers are an internal mechanism of the can , together with the equalization camera. It is for this reason that the valve assembly has been designed to closely resemble the existing MDl can design. If it is believed that the supply of two volumes belongs to the inhaler, the shape of the piston can be changed to facilitate its manufacture. The shape of the piston is adapted to supply first with a deep oppressive activation a high volume of gas (this is 270 ml) that can be used to purge the spacer. Using a shallow oppressive activation will provide a much smaller volume of gas (ie 30 ml) to nebulize the drug. The release of the spigot valve allows the two chambers to communicate with the equalization chamber by filling them for the next use. The equalization chamber 201 includes an internal housing 203 which defines two cameras of different sizes 204 and 205. The housing 203 includes a hole 2088 at the top to communicate with the equalization chamber. First the camera 204 communicates with a second chamber 205 by means of the hole 209, and on the outside by means of the hole 210 in the main piston 202. the second chamber 205 communicates with the equalization chamber 201 and the first chamber 204 by means of of the holes 208 and 209 in the housing 203. A piston 202 is slidably mounted within the lining 203. The piston 202 includes a communication hole 201 having a hollow passage terminated in the bottom of the piston. The communication hole 21 0 is designed to selectively allow the gas stored in the chamber 204 to communicate with the outside of the can. The unique shape of the piston 202 allows the operation of two processes. During rest the piston 202 is pushed down by means of the spring 206 located within the housing 203, isolating the cameras with an insulating ring. The communication holes 208 and 209 are open allowing filling of the second and third chambers 204 and 205 from the equalization chamber 201. When the user wishes to supply the first volume of gas, the piston 202 is slid up relative to the chamber 201. The hole 21 0 is now communicating with the chamber 204, releasing the first large initial volume of gas. In this position, the piston 202 pushes against the hole surrounding the insulating ring 209, closing the hole 209 and the insulating chamber 204 of the chamber 205. All the gas in the chamber 204 will come out until equilibrium is reached in the external part. From the can. To release the second gas volume, the piston 202 moves more upwards. The gas can now flow from the chamber 204 to the chamber 205 through the orifice 209, and to the outside via the orifice 21 0. The O-ring 207 fixed to the piston 202 will now isolate the chamber 205 from the main high-pressure gas at the can 201 when sealing the orifice 208. Since the orifice 208 has a diameter smaller than the piston, it will also limit the maximum upward movement of the piston 202 and the amount of general gas delivered in a dose. Since the chamber 205 is much smaller than the chamber 204, it will supply a smaller volume of gas to be used for drug delivery. Option 2: The other option is to control the supply of two volumes using calibrated holes. In this case the design of the high pressure can is similar to the existing ones, the novelty lies in the design of the main chamber of the inhaler. The main process is located inside the inhaler, communicating with the equalization chamber 34 by means of a piston 302 as seen in figure 3. In this case, the can 32 together with the equalization 34 can be a disposable article of the inhaler , now referred to in general terms as can 301, The supply of the two volumes is inherent to the body of the inhaler. The piston 302 is opened by means of the valve 31 1 activated by the user. The valve 31 1 is enclosed within a gasket 312 having two gas passages 315A and 315B connecting the high pressure gas from the can 201 to the remainder of the inhaler. For example, a hole with a diameter of 0.004"(0.01 cm) will allow in a half second a volume of 21 ml of pure helium at 00 psig while 315A is a larger hole sealed, by the secondary piston 31 3. The piston 313 is pushed against the lining 312 by means of the large diameter of the valve 31 1. When the valve 31 1 is pushed up for the first time, it pushes the piston 302 releasing the high pressure gas from the can 301 outwards by means of the holes 309 and 310. The hollow diameter of the piston 31 1 is now at the same level as the secondary piston 313. Aided by the spring 314, the piston 313 slides towards the valve 31 1 opening the channel 315A. pressure flows through both holes 31 5A and 315B producing the large amount of gas needed for the purge bolus When the second volume of gas is desired, valve 31 1 is pushed further up Due to the expansion in diameter of the v valve, the piston 31 pushes back 3 to 312 sealing the hole 315A. The high-pressure gas can only flow only through the calibrated hole 315B creating the small amount of ace needed to mix and nebulize the drug. The valve 31 1 is again pushed back, releasing the piston 302 and sealing the can 301. The equalization chamber 34 after the process described above now has a desired gas pressure 54 therein. After actuation of the inhaler 30, the gas 54 will be used when being injected into a gas passage 62 of the storage or doctor or drum section 64. Referring now to Figures 1 and 4-6, the drum section 64 includes a housing 65 containing a rotary drum 64 includes a housing 65 that contains a rotating drum 66 and includes a gas passage 62. An elastic material 67 is disposed between a drum section 66 and a housing 65 such that the drum 66 can rotate freely within the housing 65 but still retains the drugs stored in it. Drum 66 is made of plastic or coated plastic to reduce or eliminate static electricity, which can lead to the agglomeration of the particles of the injected drug. The drum 6 includes a plurality of tubes 66, 70 that are substantially cylindrical and extend longitudinally. Drum 66 further includes a substantially cylindrical bore 72 that also extends longitudinally. The tubes 68 contain a powdered medicament formulation that is to be administered to a patient, while the tubes 70 are empty and hollow to allow gas communication 54 from the equalization chamber 34 to a spacer 96 such that the spacer 96 can be filled quickly with several hundred milliliters of Heliox before the injection of the fluidized dry powder into the spacer 96. Figure 1 shows a mode in which the drum 66 includes the tubes 68 and thus a spacer is not pre-purged . This is especially useful when the spacer has a small size, Fig. 4 shows a mode of the drum 66 including the tubes 70. Fig. 4A shows a cross-sectional view along the line AA of Fig. 4. As shown in Figs. 4A, the tubes 70 are empty and have a diameter that is greater than the diameter of the tubes 68. The tubes 68 contain a medicament powder 76. The diameter of each of the tubes 68 is dependent on volume and weight of the dry powder of a specific medicine that is going to be supplied. Both tubes 68 and 70 are packed inside the rotary drum 66 to maximize the number of available doses per rotary drum. For each drug filled tube 68 there is a corresponding hollow tube 70. A preferred arrangement for the drug filled tubes and empty hollow tubes to be placed in vertical pairs with each other. A multitude of those pairs can exist. The dried powder drugs can be found in particle ranges from slightly less than 1 m to 5 microns. A range of fluidized particles of less than 1 micron to 3 microns is very beneficial for the optimal supply of the drug to the deep part of the lung in the case of systemic diseases. However the particle sizes must be optimized for both delivery systems, this is the design of the inhaler and the target site in the lung. Therapeutic drugs for treating the upper lung or media for respiratory diseases, can be up to a size of 5 microns in its final fluidized form and delivered. Referring to Figure 4, when the rotating drum 66 is to be used, the drum is placed on the spindle 78 such that the use 78 is inserted in the perforation 72 and the drum is coaxial with the spindle. As indicated by the arrows 82, the rotating drum 66 can be selectively positioned and removed from the use 78. A plurality of ducts 809 are placed between the gas passage 62 and both tubes 68 and 79 to provide a gas communication between those elements. Two ducts 80 can be used to feed the Heliox from the equalization chamber 34 to the spacer 96, the gas flow being presented through the ducts 80 first to the tubes 70 and then to the corresponding tubes 68. After the assigned number of tubes for each concentric ring has been emptied, the ducts move to a different concentric ring and to the corresponding tubes. This can be achieved by means of a coupling switch with the drum 66, or an operator contact switch by a low current level. Alternatively a duct 80 can provide gas to both tubes 68, 70, which are in a moving assembly, and which changes position when moving from one concentric ring of tubes to another. For example this can be done by means of a set of gears (not shown). The multi-dose barrel will rotate after (or before) each use using a gear drive activated by means of an external trigger. Pipe 80 will gradually move to an internal concentric tube (if the tubes are placed in a spiral pattern or to the next concentric filled tube if all tubes are concentric). The duct 80 can also be dropped suddenly after completing the majority of one rotation. This is achieved by removing the last tooth from the gear so that the duct 80 can be pushed into an inner race with the help of a spring (not shown). In another modality of the drum 66, illustrated in Figure 5, all of the tubes 68 in the drum 66 contain the dry powder drug and there are no corresponding hollow tubes 70. Instead the Heliox is used to fill the spacer 96 is canalized through a use 78 in which the drum 66 is mounted and rotated. This allows to double the number of tubes in the drum 66 which contain the dry powder pharmaceutical formulation. In both embodiments, shown in Figures 4 and 5, the tubes 68 shown in dark indicate that the tubes 86a and 86b still have medicament therein. The tubes 68 that are open indicate that the tubes no longer have medication to distribute. In this embodiment, only one duct 80 must be coupled each time to a corresponding tube 68. This is because the spindle 78 is used to provide gas communication 54 with the spacer 96. The additional ducts could be used for a concentric tube ring 68. different. The embodiment of Figure 5 would increase the number of tubes containing the powder or liquid medicament in the rotary drum 66, by raising the multi-dose capacity of a single disposable plastic barrel. If a modality of Figure 5 were used, the ducts 80 would act as a source of propellant and fluidizing energy for the drug in the tubes. Each duct is activated by mechanical means when the ducts must be used. Alternatively, a simple needle from the Heliox source can change the position to access each circular row of tubes that carry drug successively. As shown in Figures 1, 4 and 5, a clear sealed plastic coating 86 is placed on the front 86a and rear 86b of the drum 66 covering all the tubes 68. The plastic coating 86 contains and protects the powder drug dry 76 of the moisture, provides an antimicrobial barrier and keeps the tubes 68 clean and free of moisture for the generation of predoses from the injection of Heliox gas into the spacer 96. The plastic coating 86 will have a surface resistance marginally lower than the pressure of the gas 54. When the gas 54 is injected into the drug filled tube 68, the plastic coating 86a bursts inwardly into the tube 68. A pressure buildup of the Heliox 54 then occurs in the tube 68, and explosively ruptures. the plastic coating 86b that exists on the side of the tube 68 that faces the spacer, thereby fluidizing the powder 76 into the environment of the spacer. The coupling of the rotary drum 66 with the ducts 80 is illustrated with reference to Figure 6. The rotating drum 66 includes a receptacle 88 for sealingly receiving the duct 80 therein. The rotary drum 66 can be designed in such a way that the plastic cover 86a covers the entire front part of the rotary drum 66 and the receptacle 88 is fixed on the plastic cover 86a. Alternatively, the receptacle 88 may have a plastic membrane similar to the plastic coating 86 formed therein. The duct 80 includes level portions 90 made of a strong but foldable material such that when the ducts 8 are inserted into the receptacle 88, a small amount of physical pressure is required to maintain a seal based on a hermetic friction between the receptacle 88. and the duct during the injection of Heliox gas. The receptacle 88 further has a trapezoidal shaped appendix 92 designed to receive the duct 80 in a pressure-tight fit base required for the operation and fluidization of the drug powder. Alternative modes of rotating drums 66 are shown in FIGS. 7 and 8 where the tubes 68 may contain, instead of the powdered drug 76, a liquid drug 69 disposed therein. In the embodiment shown in Figure 7, a micropore spray nozzle 71 is placed in the tube 68 at an opposite end of the duct 80. As in the case of the above embodiments, the plastic coating 86 holds the liquid drug 69 within the tube 68 until it is desired that the liquid drug 69 be administered. In this modality, a space 85 is provided between the aerosol nozzle 71 and the plastic coating 86B.

Space 85 could be 0.25 inches (0.63cm). The aerosol nozzle 71 is a rigid structure with micropores. The plastic coating 86B will expand and stretch before it breaks such that it should not rest on the top of the aerosol nozzle 71. The space 85 will also prevent the plastic coating 86 from sticking to the holes for the aerosol in the aerosol nozzle 71 when the plastic coating 86 is broken. Referring to FIGS. 9 and 10, another embodiment of the tube 68 is shown. this mode, again the tube 68 is divided into a liquid containing part 68 a and a liquid transporting part 68b. The liquid drug 69 is contained within the part of the liquid container 68a by the use of plastic coatings 86a, b. The tube 68 further includes a friction seat 124 which is designed to selectively couple with a fixed nozzle 126 of the spacer. In Figure 10, spindle 79 is shown as the conduit of the compressed gas. However, it should be clear that tubes 70 could also be used in a drum 66 having a friction feel 124 that engages a friction nozzle 126. In the embodiments shown, where a fixed nozzle is implemented, when the drum 66 rotates To align a new drug to be administered, the drum moves forward to the spacer 96 and is adjusted by pressure on the. This forward movement can be performed mechanically or manually by the patient. In all the embodiments described above, when the gas 54 is applied to the tube 68, the application causes an explosion of the plastic coating 86a which explodes in the chamber 68. This explosion combined with the combination of gas pressure plus the drug 69, 76 inside the tube 68 destroys the plastic coating 86b that covers the other side of the tube 68. This explosion of the plastic coating 86 provides a large explosive and subsequently turbulent effect to fluidize the powder drug 78 or atomize the liquid drug 69. The combination of drug Heliox is then introduced into a spacer 96 (FIG. 1) which has an environment of approximately 270 ml of Heliox gas. An advantage of this method is that the ducts do not have to penetrate a previous vapor barrier that can clog the duct but the ducts provide a gas to destroy the plastic coating based on a predetermined resistance of the plastic film and the pressure of gas. The disposable multi-dose drum 66 is designed in such a way that it can only be inserted into the spindle 78 in which it rotates in the correct manner. This is a position in which the front part of the drum 66 is correctly inserted in a juxtaposed manner to where the ducts of the Heliox source (s) are located. Referring now to the figure, the operation of the inhaler 30 will now be explained. An activation trigger 94 is located in the drum section 64. The trigger 94 may have several stops such as a multi-action pistol trigger or may have an activating button piston with the same multi-action inductive activities. When the trigger 94 is depressed, the drum 66 rotates around the spindle 78 to a correct position for the next dose. A door of an inhalation port 98 coupled to the nozzle 99 of the spacer 96 is closed thus preventing the user from inhaling the gas placed within the spacer 96. Alternatively the door of the inhalation port 98 could first be left open in such a way that the air in the spacer 96 be purged more efficiently (as described below). After this the door of the inhalation port 98 closes as before. Still another embodiment includes a pressure / vacuum port combination (not shown) that is opened to let air out during the purge phase and closes during the supply phase of the drug. If a mode shown in the drawings is used, an amount of 230-270 ml of Heliox gas is injected into the spacer 96 of the equalization chamber 34 to the gas passage 62 through the tubes 70 or the spindle 78, through another passage of has 63 (not shown in the figures) in the housing 65 and finally through the compressed gas inlet port of the spacer 96. The air in the spacer 96 is pushed out or purged through a pressure port 1 00 to ensure that almost 1 00% of Heliox is present in the environment of the environmental spacer, as possible. The Heliox gas provides both an environment in the spacer for the settlement of the heaviest undesirable particles and provides a frontal bolus gas frontal wave in which the fraction of fine particles desired during inhalation will be found. This will cause a sufficient volume of Heliox gas to have the desired effect on the supply of particles deep in the lung. In the embodiment shown in Figure 1, the spacer 96 is not necessarily pre-purged. Therefore the entire volume of Heliox in the equalization chamber is used only to fluidize and deliver only the drug. If a pre-purge is desired, the first volume of Heliox supplied by any option presented in Figures 2 and 3 is first sent through the tubes 70 and 78 to purge the interior of the spacer 96 then the drum 66 rotates, allowing the second volume of Heliox fog the drug. A double action trigger can be used to activate the process in sequence as presented in Figures 2 and 3. When the filling process of the spacer 96 is completed, the inhaler 30, based on an automatically or manually activated sequence, is completed. by trigger 94, it triggers 30 to 70 ml of gas 54 obtained by means of the options presented in figures 2 and 3 to tube 68 containing the drug formulation. The gas fluidizes the powdered drug 76 (or atomizes drug 69), driving the drug through the drug entry port 68 to the spacer 96 and causes turbulence that helps to further fluidize and deagglomerate the drug. In fact, a port could be used to supply both the compressed gas alone and a combination of the compressed gas and the drug. Alternatively, the Heliox 534 gas used to atomize the drug 76 or 69 may be provided in two pulses of, for example, 60% and 40% of the total volume intended. This method ensures that all the powder 76 in the tube 68 is injected into the spacer 96 and further adds turbulence to the spacer 96 such that the particles remain separated. In a predetermined period of time after, for example, 0.5 to 5 seconds, a mechanical timer opens the inhalation port 98 in such a way that the patient can inhale a cloud of particles. A combination of a spring, a gear and a wire (not shown) attached to the trigger 94 can be used to cause the door of the inhalation port 98 to close when the trigger is depressed. The depression of the trigger 94 also activates the purge of Heliox at the same time. When the patient releases the trigger 94, the spring, the gear and the wire open the door of the inhalation port 98 and the drug delivery is started. A vacuum / pressure valve 104 will automatically close until the inhalation port 98 opens and will equalize the pressure within the spacer 96 until the patient has finished inhaling. As the patient inhales the particle cloud, a vacuum begins to form in the spacer 96. At a certain pressure, the vacuum / pressure valve 104 opens allowing ambient air to enter the spacer 96. When opening the valve pressure / empty 104, the patient can continue a uniform deep inhalation of ambient air after the Heliox bolus or gas front containing the particle cloud. The vacuum / pressure valve 104 also ensures that the largest particles that can settle to the bottom of the spacer 96 are not inhaled by a user. The vacuum / pressure valve 104 can be opened / closed automatically. For example, it can be made from a piece of a flexible metal strip. At atmospheric pressure the strip will be perfectly aligned with the wall of the spacer 96. When the Heliox accumulates excess pressure during the purge, the vacuum pressure valve 1 04 will roll up, keeping the Heliox inside. When the door of the inhalation port 98 is opened by means of the trigger wire, the pressure will fall to normal. During drug delivery, the patient will breathe a much greater volume of gases (500 ml to 1.5 liters) than 230-270 ml. During inhalation, a vacuum will form as Heliox is inhaled with the drug. Now the metal strip will roll inward to allow air to enter. This structure prevents the excess pressure or speed of the Heliox / drug combination. Furthermore, since the entire process occurs in a few seconds, it is not necessary to make the system leak proof or strong enough to withstand any particular high pressure. The spacer 96 provides the following benefits: a) reduces the velocity of the Heliox gas plus the drug formulation injected into the spacer; b) allows sufficient turbulence to keep the small desirable particles suspended and separated; c) allows heavier particles unsuitable for the supply of the drug to the lung, settle or become trapped in the spacer; and d) provides a bolus, cartridge or initial gas front plus drug formulation that is 100% Heliox, followed by air as part of the same continuous breath. The spacer 96 may later be provided with a flavored receptacle 100 placed on the outer top of the spacer near where a patient's nose would be. The receptacle 1 10 can be a flavored strip containing vanilla essence, mint, or other flavor, and is placed close to the nose to make the use of the inhaler pleasant for children and older adults who represent the majority of users . The spacer 96 would be constructed as a plastic or provided with an internal coating that eliminates the generation of static electricity. This is because the static electricity imparted to the drug particles injected into the spacer could result in agglomeration and adversely affect the dose delivered to the patient. It is desirable that the spacer 96 incorporate in its door of the inhalation port 98 an apparatus to prevent accidental exhalation of the patient in the spacer 96 prior to inhalation, to avoid mixing of the exhaled gases with the Heliox and the drug cloud of suspended particles and avoid the agglomeration of the particles due to exhaled moisture. It is also desirable for the door of the inhalation port 98 to be closed after the introduction of the Heliox ambient atmosphere and the Heliox formulation plus the drug in the spacer 96, so that only the Heliox is in the spacer 96 u a minimum amount of that Heliox is lost outside the spacer 96. The spacer 96 may be made of rough materials on its surface. The rough surface fulfills two different purposes. It can reduce the speed of the Heliox-powder mixture to a laminar flow by inducing a drag force of additional boundary layers. The rough surface can also provide a trap for retaining the larger particles. After the injection of the Heliox gas and the Heliox formulation plus the drug into the spacer, it is further desirable to immediately reduce the velocity of the Heliox before the turbulent flow to the laminar flow. An impact plate (ball or other object) and a diffuser can achieve this speed reduction, referring again to Figure 1, a diffuser is placed between the spacer 96 and the drum section 64. The diffuser 1 12 includes a ball of impact 1 14 in a portion of the diffuser 1 12 that is close to the gas passage. The impact ball 14 is used to reduce the high initial velocity of the highly turbulent gas and the drug entering the diffuser 1 12. When the gas and the drug are injected into the diffuser 1 12, a flow of high energy can be concentrated in the center of the unit. The impact ball 1 14 helps to avoid this channel effect. The diffuser 1 12 has the shape of an expansion cone to reduce the gas mixture. The size of the diffuser 1 12 is dependent on the speed of the desired gas-dust mixture that sticks to the back of the throat. The speed must be sufficiently reduced in such a way that the flow is laminar. At an inhalation flow rate of 60 L / min (often the necessary flow rate required by some DPI to release the drug), the Reynolds number is 670 for pure helium compared to 5400 for air. When using a certain mixture of helium and air, the Reynolds number changes accordingly, as shown in Table 2. Even if the Reynolds number is low enough to enter the laminar category, the flow may still be turbulent due to the roughness of the surface for example. The spacer 96 can be combined with a diffuser 1 12 in such a way that the larger particles can fall out of the particle cloud in the spacer 96. Table 2: Effect of the helium concentration on the flow rate * T = turbulent, Tras = translational, L = laminar The function of the impact ball 1 14 can be incorporated in the spacer 96. The spacer 96 could include an impact plate disposed at one end of the spacer 96 near the door of the spacer 96. inhalation port 98. In this design, the injected Heliox stream and the drug particles would stick against the impact plate causing an impact and turbulence, and resulting in a reduction in the viscosity of the particle cloud. The impact plate could be tilted in such a way that injected Heliox and drug particles would impact the plate with reflection, resulting in an accelerated settling of the heavier particles and the formation of a cloud of desired particles containing the fraction one of the desired particles. The diffuser 1 12 and the spacer 96 may also include a flow rectifying device. For example, the diffuser 1 12 the spacer 96 can be sub-divided into parallel channels. The channels will absorb all the energy of the random movement of a turbulent flow. The channels will absorb all the energy of the random movement of a turbulent flow. Referring to Fig. 11, there is shown a flow rectifying device that can be used in the spacer 96. The spacer 96 further includes a plurality of shelves 122 disposed near the door of the inhalation port 98. The shelves 122 function in such a way that the gas 54 passes over or just above and below the shelves 122, thus helping to induce a rectified flow of the Heliox and the particles in the patient. It should be clarified that the spacer and diffuser 1 12 are merely additional options that could be used with the inhaler 30. A patient using the inhaler 30 can use only a spacer 96, only a diffuser 1 12, or no annex. If the spacer 96 is not used, the nozzle 99 should be placed at the end of the diffuser 1 12. If the diffuser 1 12 is also not used, then the nozzle 99 should be placed on one end of the gas passage 62. It should also be clear that when the nozzle 99 is not placed in the spacer 96, it is not necessary to include the inhalation port 98 further. Referring to FIG. 12, another embodiment of the invention is shown. Similar elements have the same reference numbers described above and their description is omitted for brevity. The inhaler has a venturi section 142 coupled to the chamber 34. The venturi section 142 includes a reservoir for liquid drugs 144 having a liquid drug reservoir 146 contained therein. A gas passage 148 selectively provides communication between the equalization chamber 34 and a venturi 150. The venturi 150 inlet communicates with the gas passage 148. The outlet of the venturi 150 communicates with a diffuser 1 12. The throat of the venturi 150 communicates with the vent. venturi 150 communicates with a liquid measuring tube 1 52 coupled to the liquid drug reservoir 144. As one of ordinary skill in the art would understand, when the gas 52 passes through the venturi 150, since the throat of the venturi 150 is In a restricted manner, a reduction in gas pressure 54 is experienced in the venturi throat 150. This apparent vacuum sucks an amount of the liquid drug 146 from the reservoir for liquid drug 144. This amount of liquid drug 146 is atomized by means of gas 54 and it is injected into the diffuser 1 12. Clearly the diffuser 122 is not necessary since the gas / drug combination could go directly to the spacer 96 or to the patient. Another mode of the invention would use ultrasonic nebulization. Ultrasonic nebulization is more efficient in delivering particles of the appropriate sizes and reducing the dead (unused) volume of the medication. Its main disadvantage arises from an increase in temperature during prolonged use. This is avoided in the present invention since the nebulization would only occur by means of short emissions. Although not used as extensively as the Venturi principle, at the core of the new inhaler drug delivery systems such as AeroDose (Aerogen ln., Sunnyvale, Ca, patent USD474536), the Premaire Metered Solution inhaler (Sheffield Pharmaceuticals), or the vibrating membrane nebulizer (Pari GmbH, Germany). Ultrasonic nebulization uses the excitation of a piezoelectric crystal that vibrates at high frequency to create waves in the liquified drug solution placed directly on the crystal. The oscillatory waves then interrupt the surface and create a geyser-like behavior on the surface, nebulizing the drug that is often carried by the Heliox gas that passes over the surface on its way to the spacer. The practical means are not specifically addressed here, only the concept of adding ultrasonic nebulization to the helium / heliox inhaler. Ultrasonic nebulization can easily be adapted to the present invention. In all of the above arrangements, the spacer is designed to result in the total volume of Heliox gas to be injected as both a gas bolus and the drug dose. The spacer is designed in such a way that the Heliox gas displaces the ambient air found in the spacer before the introduction of Heliox and then replaces it with Heliox gas and the drug formulation. Sufficient gas pressure is needed to optimally fluidize the powder (or atomize the liquid drug) in a way that particles of the desired size range and grouping are generated. It is therefore desirable to have a pressure cut-off valve that when the pressure in the equalization chamber 34 is insufficient to provide a sufficient volume of Heliox to fill the spacer 96 and a pressure wave to optimally fluidize or atomise the drug, the The inhaler will stop working. This cutting switch would consist of a spike hook that serves to unlock the trigger 94. The spike hook could be coupled to a spring that in turn could be coupled to a diaphragm. Thus when the pressure in the equalization chamber 34 is high enough, the diaphragm could be pushed into the equalization chamber 34, thus lengthening the spring. This elongation of the spring releases the trigger hook 94 and allows the trigger 94 to operate. When there is insufficient pressure in the equalization chamber 34, the hook engages the trigger 94 and prevents the trigger from operating. Another embodiment includes the use of a pre-calibrated Heliox gas cylinder that will provide more than enough Heliox for all of the medication within the drum 66. In addition a flag or signal activated by pressure, could be implemented to indicate that a cartridge needs to be replaced .

Since it is critical that patients have access to the medication when they need it, a counting method concerning the number of remaining doses is desired. A counting method can be placed above or in each drug tube in the drum 55 with an indicator to indicate the number of remaining doses. Each application of the trigger 94 will rotate the drum 66 once and when the medication is empty, the indicator on the drum 66 will indicate that there is no medication remaining in the device. As the inhaler according to the invention can supply different drugs using different drug multidose drums, a transparent label with black letters indicating the drug and the potency and a color band with a code system can be fixed to the outside of each drum. This transparent label material will not obstruct the contents of the tubes within the barrel containing the drug formulation. These features also provide an additional safety measure by allowing a vidual verification of the remaining doses, in addition to that provided by the simple automatic counting mechanism that is a part of the device that tells the user how many doses have been used, or how many doses are left. . The "zero" setting of the device can be done manually or it can be done automatically by means of a barrel characteristic such as an appendix. An advantage of this system is that the tubes containing the drug in a disposable single unit dose baril may contain the same drug or a sequence of drugs that are to be taken during the course of a day. For example tubes 1, 2,3,4 can contain a group of sequential drugs and tubes 5,6,7,8 a repetition of the same group of drugs with each dose, for example, inside tubes 1 -4 They will be inhaled every 6 hours. Examples of drug classes that are being investigated and formulated for pulmonary administration, which may be administered with the invention, include but are not limited to those for chronic obstructive pulmonary diseases such as the classes of agents commonly referred to anticholinergic agents, beta-andrenergic agents, corticosteroids, antiproteinases and mucolytics, include those specific drugs. Other therapeutic drugs for respiratory diseases used in the form of dry powder and / or liquid with which the invention could also be used include, but are not limited to benzamil, fenamil, isoproterenol, metaproterenol, beta 2 agonists in general, proctaterol, salbutamol , fenoterol, ipratropium, fulutropium, oxitropium, beclomethasone dipropionate, fluticasone propionate, salmeterol xinafoate, albuterol, terbutaline sulfate, budesonide, beclomethasone dipropianate monohydrate, surfactants such as colfosceril palmitate, cetyl alcohol and tyloxapol, P2Y2 agonists ( rapidly stimulates mucus and can potentially be used for CORD and OF), atomized dextran (for OF), and mannitol powders (for induced bronchial problems.) An example of another therapeutic drug that could be delivered by means of the invention is pentamidine for therapy related to AIDS.

Examples of protein and peptide hormone drugs that can be administered with the invention, which may or may not be glycosylated, including somatostatin, oxytocin, desmopressin, LHRH, nafarelin, leuprolide, ACTH analogue, secretin, glucagon, calcitonin, GHRH, hormone growth, insulin, parathyroid, estradiol and follicle stimulating hormone and prostaglandin E1. In addition, genes, oligonucleotides, anti-coagulants such as heparin and tPA, anti-infection to treat systemic infections by bacteria or fungi, enzymes, enzyme inhibitors, vaccines, anesthetics, analgesics, and agents that can activate and deactivate certain types of receptors, or improve your response, they are possible therapeutic drugs or action-inducing substances that can be supplied by means of the invention. Ergotamine for the treatment of pains caused by migraine and nicotine to replace and eventually eliminate desire for tobacco are also formulations that can be administered by the invention together with insulin. In addition, controlled release drugs such as those based on liposomes which are designed for pulmonary delivery to treat respiratory and systemic diseases for a period of time due to the chronic nature of the disease or the way in which the disease responds to the medication, or the way in which the medication operates. The existing DPIs only use the inhalation of the patient, inhalation of the patient assisted by a propellant, or compressed air generated by a manual pump in the DPI, to fluidize the dry powder drug formulation. A DPI also compressed air in a plastic cushion containing the dry powder drug formulation to aid fluidization. The present invention offers several advantages over those methods for fluidizing a dry powder drug formulation. First the gas volume (Heliox) and its pressure are independent of the operator's inhalation speed, the ability to generate a given level of inhalation velocity (if as in some devices, a minimum threshold is required to release the dust for the fluidization), or physical movement. No need to check or replace batteries periodically as in the case of systems that work with a propeller. Compressed air does not have to be pumped before each dose. DPIs that are based on inhalation power, a propeller or manually pumped compressed air, all use air that is from the environment where the user is present. If the air is moist, it can cause the agglomeration of the micronized dry powder drug formulation, resulting in larger particles that may not reach the upper lung, leaving only the deep lung. A source of compressed Heliox produced from the factory can be produced as a dried dry gas, eliminating this problem in humid climates. This in turn would cause variability in the fluidization, deagglomeration and post-clustering of dry powder drug formulations, which in turn affect the fine particle fraction available for pulmonary administration and effective therapy. A pressurized Heliox source produced in the factory also provides the advantage of a high velocity gas stream, which provides the advantage of a stronger impact on the fluidization of a dry powder drug formulation, compared to the force generated by the air inhaled, the air produced by the propeller operated with batteries or the compressed air pumped by hand. The result is that the powder can be fluidized and deagglomerated more completely, the result being a more consistent and effective use of a unit dose of the formulation and potentially a reduction in the powder formulation the nominal drug that must be loaded into the inhaler already which is supplied more consistently. The use of tubes, instead of ampoules and dust deposits as in the prior art, allows the effect of the gas pressure to be increased in terms of the velocity generated and the impact of the gas on the gas particles. The use of a disposable drum with multiple unit doses with pre-filled drug formulation tubes prepared under factory-controlled conditions, is an improvement over the prior art using a permanently open barrel at one end in which the user must insert capsules, and after use remove the capsules. First there is the factor of user variability when loading the capsules in the prior art, and to load the correct capsules if the user takes more than one medication that can be administered by the system. Second, dust may remain on the capsule and tube due to physical obstruction of airflow and debris after the capsule has been punctured. Thirdly because the broken capsules have to be removed by the user since the barrel is fixed and not only used and discarded, there are also dust residues in the tube. This residual powder can alter the dose delivered to the patient when another capsule is placed in the tube and used or worse, if another drug is administered, the two powders can be mixed with an unknown variable, or perhaps an undesired effect on the system of the patient. Another advantage of the compressed low molecular weight Heliox gas is that it can be used to deliver liquid pharmaceutical formulations. Heliox is a much better liquid aerosol / atomizer forming agent due to its high release rate and does not have the same cooling characteristics of liquid CFCs. In the present invention, the multi-dose insert containing multiple sealed unit doses of liquid drug or a reservoir of a multi-dose liquid drug source is stored separately from the compressed gas. In contrast in MDl, the propellant and the drug formulation are stored together, along with many other additive ingredients. In the case of suspensions formulations of liquid drugs, the MDl must be shaken before each use to try to achieve a consistently uniform dosage. Additionally, changes in temperature can cause the pharmaceutical compound that is packaged with the propellant to separate from the solution.

The uniquely designed spacer reduces the high velocity of the Heliox gas and the dry powder particles or atomized droplets of liquid drug that have been generated, resulting in a desired settling within the spacer of larger particles that are neither desirable nor desirable. nor effective for the supply of pulmonary drugs. The spacer is existing are filled with ambient air before the entrance of the DPI MDl of air plus the powder drug or liquid drug droplets. In the present invention, the spacer is pre-filled with Heliox gas before mixing the Heliox gas and the powder separator or liquid droplets entering the spacer. This provides a unique gaseous environment for a) differential settlement of particles heavier than air, and b) a large-volume bolus of Heliox plus a desired fraction of fine particles that is then inhaled by the patient, followed by an ase of Continuous inhalation with air, Heliox and particles are inhaled from the tidal front of inhaled gas. The spacer may also have laminar flow shelves, which help to induce the laminar flow of Heliox plus the trapped particles from the "cloud" of the fluidized powder or fluidized drug formulation after inhalation by the patient. The separator reduces the velocity of the gas stream to an acceptable cloud of particles, the unwanted particles settle and the resulting cloud of remaining particles in the desired particle range can be inhaled. Laminar flow shelves help introduce a laminar flow into the helium gas spacer and trapped particles.

Then after inhalation it is very desirable to prevent the particles in the desired particle range from settling. With a viscous friction greater than the gravitational settling velocity, the fine solid particles can be suspended indefinitely without settling. On the other hand, an additional viscous friction would cause an excessive pressure drop. Therefore it is desirable to control the viscosity. The ability of this invention to generate a high initial turbulent flow and provide a rapid deceleration of flow is important for the performance of the inhaler for the delivery of the powder drug. A high-pressure chamber and an equalization chamber are provided in such a way that the Heliox gas can be stored efficiently under a high pressure and also be used as a propellant to fluidize or atomize a drug with a lower pressure. Using a mechanical means to systematically provide two widely different volumes of gas allows first creating a gas bolus then a second volume of gas to fluidize or nebulize the drug, independently of variable activation by the user. By providing a disposable chamber for storing the medicament, a user does not have to manually insert and withdraw the drugs and there is no concern that the tubes carrying those drugs are contaminated with the previously administered medicament. By injecting some Heliox into a hermetically sealed spacer, before injecting a combination of Heliox / drug into the same spacer. The heavier particles in the Heliox / drug combination can settle faster than in the air. Also a large-volume bolus of Heliox plus a fraction of desired fine particles can be inhaled by the patient, followed by inhalation of air, with Heliox and inhaled particles being from the inhaled gas tidal front. The drug / Heliox combination in the spacer is also much less susceptible to external factors such as humidity in the ambient air as the spacer seals tightly. Finally, when using Heliox as a propellant, a fluidized or atomized drug by means of this propellant has more opportunity to navigate the respiratory tract and reach the desired position in the lung. The main costs of the inhaler are the drug and the manufactures and the parts. The cost of Heliox although it is in itself an expensive gas, it is lower than other costs. There is therefore an incentive for the patient to use the inhaler for a period of time greater than the limited number of doses available in the can. Providing the user with means to fill his can in the home allows him to continue using this inhaler for periods of time without going to the pharmacy or the doctor. The higher cost of the inhaler would be compensated by the longer use time. Although the preferred embodiments of the invention have been described, various embodiments for carrying out the principles described herein are contemplated as belonging to the scope of the following claims. Therefore, it is understood that the scope of the invention will not be limited unless otherwise stated in the claims.

Claims

REIVI NDICATIONS 1. An inhaler for delivering a drug to a user, the inhaler consists of: a first chamber suitable for containing a first compressed gas at a first pressure; a second chamber in selective communication with the first chamber, the second chamber is adapted to contain a second compressed gas at a second pressure lower than the first pressure, the first and second chamber cooperate to obtain the second pressure of compressed gas within the second camera; means for managing two different volumes of gas in successive applications from the second chamber; a storage section coupled to the second chamber, the storage section is adapted to contain a drug and operate in such a way that a portion of the second compressed gas can fluidize and atomize the drug to thereby produce a cloud of the drug; and a nozzle coupled to the storage section, that nozzle is suitable for receiving the drug cloud and transporting the drug cloud to a user. The inhaler of claim 1 in which the first chamber contains a first compressed gas at between about 50 and 4000 psig, and the second chamber contains a second compressed gas at between about 20 and 100 psig. The inhaler of claim 1 further comprising: a first housing disposed within the first chamber, the first housing having a first hole, the first housing defining a third chamber internal to the first housing; a second housing disposed within the second chamber having a second hole; a piston slidably positioned within the first and second housings, the piston has a third hole; wherein the first, second and third holes are positioned in such a way that a first position of the piston within the first and second housings selectively allow communication between the first and second chamber and the second position of the piston within the housings first and second. second they do not allow communication between the first and second cameras. The inhaler of claim 3 in which the piston is coupled to a second chamber through a second member in such a way that the piston is pushed towards the second chamber. The inhaler of claim 4 wherein: the first chamber contains the first compressed gas and the first compressed g applies a first force on the piston to the second chamber; and the second chamber contains the second compressed gas and the second compressed gas applies a second force on the piston to the first chamber; and the first force, and the second force together with a third force caused by a spring in the first housing to ensure that the second compressed gas is stored in the second chamber at the second pressure. The inhaler of claim 1 wherein the means for delivering two volumes of high pressure gas from the second chamber is due to a piston in a special manner that allows successive communication between two chambers of different capacity. The inhaler of claim 1 wherein the means for delivering two volumes of high pressure gas from the second chamber are due to two different orifices. 8. The inhaler of claim 7 wherein the orifice of the first chamber is a bore calibrated to deliver a selected amount of gas. The inhaler of claim 7 wherein the second orifice is larger than the first orifice and is selectively opened by means of a piston to supply a larger amount of gas than the gas in the first orifice. The inhaler of claim 7, wherein the opening of the first and second orifices is selected by means of the movement of a piston. eleven . The inhaler of claim 1 wherein the storage section is in the form of a drum and has: at least a first tube that extends through the storage section and that is appropriate to allow the second compressed gas to pass through; and at least one second tube extending through the storage section, the second tube being suitable for containing therein the drug. The inhaler of claim 1 wherein: the second chamber further includes at least one duct extending therefrom; and the at least one duct is coupled to the storage section and the duct is suitable for providing gas communication from the second chamber and the storage section. The inhaler of claim 1 wherein the second tube consists of at least first and second parts engageable with each other, the first part is suitable for containing the drug and has a sealing cover at its ends. The inhaler of claim 1 wherein a drug in liquid or powder form is stored in the second tube. 15. The inhaler of claim 14 wherein the second tube further has an aerosol nozzle at one of its ends. The inhaler of claim 14 in which the second tube further includes a friction seat at one end thereof and a fixed nozzle is engageable with the friction seat to provide communication between the second tubes and the nozzle. The inhaler of claim 14 wherein the second tube has an end coupled to a fixed nozzle to provide communication between the second tube and the nozzle 18. The inhaler of claim 1 wherein the second chamber further includes a hollow spindle extending from that chamber and the spindle is coupled to and extends through the storage section to provide gaseous communication from the second chamber to the storage section; and the storage section includes a tube that extends through the storage section and the tube is suitable for containing a drug. 19. The inhaler according to claim 1 in which: the second chamber further includes at least one duct extending therefrom and the at least one duct is coupled to the storage section and operates for the duct to provide gaseous communication from the second chamber to the storage section. 20. The inhaler of claim 19 wherein the drug is in liquid or powder form in the tube which is also sealed with a coating on its ends. twenty-one . The inhaler of claim 20 wherein the tube further comprises an aerosol nozzle at its end. 22. The inhaler of claim 1 wherein the compressed Heliox or helium gas is stored in the first and second chambers. 23. The inhaler of claim 1 further comprising a spacer disposed between the storage section and the nozzle, the spacer serves to receive a drug cloud from the storage section and transport the drug cloud to the nozzle. The inhaler of claim 23, wherein the spacer comprises: an inlet port hermetically coupled to the storage section; and a port of the inhalation port coupled to the nozzle, the door of the inhalation port and the port of entry serve to allow the spacer to be selectively hermetically sealed from the environment surrounding the spacer. 25. The inhaler of claim 23 in which the spacer comprises a pressure port, the pressure port serves to selectively allow removal of the gas within the spacer when the drug cloud is received in the spacer. 26. The inhaler of claim 23 in which the spacer comprises a pressure / vacuum port, the pressure / vacuum port serves to selectively allow air to enter the spacer when the user inhales a drug cloud. 27. The inhaler of claim 23, wherein the spacer further comprises a scented receptacle. 28. The inhaler of claim 23, wherein the spacer comprises one. plurality of shelves, these shelves serve to facilitate the laminar flow of a drug cloud through the spacer. 29. The inhaler of claim 1 further having a diffuser disposed between the storage section and the nozzle. 30. The inhaler of claim 23 wherein the diffuser comprises a plurality of shelves, these shelves serve to facilitate the laminar flow of a drug cloud through the diffuser. 31 A spacer for use with an inhaler, the spacer is suitable for transporting a drug cloud from a nebulizer source of the drug to a user, the spacer comprising: a spacer with a suitable inlet port to be hermetically coupled to a source of a drug atomized or fluidized; and a door for an inhalation port of the spacer coupled to the nozzle, the door of the inhalation port and the inlet port allow the spacer to be selectively hermetically sealed from the. environment surrounding the separator. 32. The spacer of claim 31 wherein the spacer further comprises a pressure port, the pressure port serves to selectively allow removal of the gas within the spacer when the drug cloud is received in the spacer. 33. The spacer of claim 31 further has a pressure valve, the valve serves to selectively allow ambient air to enter the spacer when the user inhales the drug cloud. 34. The inhaler of claim 1 wherein the first chamber has a filling and resealing hole suitable for easily filling the chamber. 35. An inhaler for introducing a drug to a user, the inhaler comprising: a first chamber containing a first compressed gas at a first pressure; a second chamber in selective communication with the first chamber, the second chamber contains a second compressed gas at a second pressure lower than the first pressure, the first and second chamber cooperate to obtain the second pressure of compressed gas within the second chamber after the use of the inhaler; means for managing two different volumes of gas in successive applications from the second chamber; a venturi section coupled to the second chamber, the venturi section contains a drug and serves to receive a portion of the second compressed gas from the second chamber to atomize the drug to thereby produce a cloud of the drug; and a nozzle coupled to the venturi section, and suitable for receiving the drug cloud and transporting the drug cloud to a user. 36. The inhaler of claim 35, further comprising a drug reservoir coupled to the venturi. 37. The inhaler of claim 35, wherein the compressed gas is helium or Heliox. 38. In method for introducing a drug from an inhaler to a spacer, the method comprises the steps of: providing a propellant gas at a predetermined pressure in an inhaler; provide a source of drug in the inhaler; injecting the propellant gas into a portion of the drug to atomise and fluidize the drug in the inhaler, thereby producing a cloud of drug in the inhaler, thereby producing a cloud of drug; and inject the drug cloud into the spacer. 39. The method of claim 38 further comprising after step d, introducing a flow of the drug cloud into the spacer. 40. The method of claim 38 wherein the propellant gas is Helium or helium. 41 The method of claim 38 wherein the propellant gas pressure is between about 200 psig and 50 psig. 42. The method of claim 38, wherein the drum is disposed between the propellant gas and the spacer, the drum includes a first hollow tube passing through it and a second tube passing through it, the second tube contains the drug: act of injecting propellant gas into the spacer is done through the first tube; and the act of applying the drug is done through the second tube. 43. The method of claim 42, further comprising that after the act of injecting the drug cloud into the spacer, induce a laminar flow of the drug cloud within the spacer. 44. The inhaler of claim 35 in the lime means for supplying two volumes of high pressure gas of the second chamber are due to a piston in a special manner that allows successive communication between two chambers of different capacity. 45. The inhaler of claim 35 wherein the means for delivering two volumes of high pressure gas from the second chamber are due to two different orifices. 46. The inhaler of the claim 45 in which the orifice of the first chamber is a bore calibrated to supply a selected amount of gas. 47. The inhaler of claim 45 wherein the second orifice is larger than the first orifice and is selectively opened by means of a piston to supply a greater amount of gas than the gas in the first orifice. 48. The inhaler of claim 45 wherein the opening of the first and second orifices is selected by means of the movement of a piston. 49. An inhaler to administer a drug to a user, the inhaler presents: a gas chamber suitable to contain a compressed gas; a storage section removably coupled with the gas chamber, the storage section is suitable for containing a drug; and a nozzle coupled to the storage section. 50. An inhaler for administering a drug to a user, the inhaler has: a gas chamber suitable for containing a compressed gas; a storage section removably coupled with the gas chamber, the storage section is suitable for containing a drug and presenting ultrasonic means for atomizing a drug; and a nozzle coupled to the storage section.