MXPA97002117A - Apparatus and methods for administering drugs in the form of dust s - Google Patents

Abstract

The present invention relates to a method for forming aerosol of a powder contained in a receptacle having an access surface, the method comprising: coupling a powder inlet end of a feed tube having a central axis with a penetration into the access surface, and flowing a high pressure gas stream past a portion of the feed tube that is separated from the inlet and the gas stream converges with the portion at an acute angle as limited between the gas stream and the shaft centrally at the inlet end, such that a predetermined amount of powder in the receptacle is fluidized, removed axially through the tube and dispersed in the high velocity gas stream to form an aerosol

Description

APPARATUS AND METHODS FOR ADMINISTERING MEDICATIONS IN THE FORM OF DRY POWDER BACKGROUND OF THE INVENTION 1. Field of the invention The present invention relates, in general, to methods and apparatus for the pulmonary administration of drugs. More particularly, the present invention relates to a method and apparatus for dispersing medicaments that are in the form of dry powders, for inhalation by a patient. Effective administration to a patient is a critical aspect of any successful drug therapy. There are several routes of administration and each one has its own advantages and disadvantages. Oral administration of drugs in the form of pills, capsules, elixirs, and the like is perhaps the most convenient method, but many drugs degrade in the digestive tract before they can be absorbed. This degradation is a particular problem of modern protein drugs that are rapidly degraded by the proteolytic enzymes of the digestive tract. Subcutaneous injection is often an effective route for the systemic administration of drugs, including the administration of proteins, but it enjoys low acceptance among patients.

P1--22 / 97MX patients. As the injection of drugs, for example insulin, from one to several times a day can often be a source of dissatisfaction in the patient, a variety of alternative routes of administration have been developed, including transdermal, intranasal , intrarectal, intravaginal and pulmonary. Of particular interest for the present invention is the pulmonary administration of the drugs which is based on the inhalation of a dispersion or aerosol of the drug by the patient, so that the active drug that is within the dispersion can reach the distal regions (alveolar) of the lung. It has been found that certain drugs are easily absorbed through the alveolar region directly into the bloodstream. Pulmonary administration is particularly promising for the administration of proteins and polypeptides that are difficult to administer by other routes. This pulmonary administration is effective both for systemic administration and for localized administration to treat diseases of the lungs. The pulmonary administration of drugs (including both systemic and local) can be achieved by different approaches, including liquid nebulizers, metered dose inhalers (MDI), and dispersion devices.

P11 -32 / 97MX dry powder. Dry powder dispersion devices are particularly promising in the administration of polypeptide proteins and drugs that can be easily formulated in the form of dry powders. Many of the otherwise labile polypeptides and proteins can be stably stored as spray-dried or lyophilized powders, as they are or in combination with suitable powder carriers. The possibility of administering proteins and polypeptides as dry powders is problematic in certain aspects. The dose of many polypeptide-based proteins and drugs is normally critical, so that it is necessary that any of the dry powder delivery systems be able to accurately and accurately (repeatedly) deliver the intended amount of the drug. However, many proteins and polypeptides are quite expensive, in most cases they are more expensive than conventional drugs based on the dose. In this way, the ability to efficiently administer dry powders to the target lung region, with minimal loss of the drug, is critical. It is further desired that the powder agglomerates present in the dry powder are broken sufficiently before inhalation by the patient, in order to ensure effective systemic absorption or other pulmonary administration. P1132 / 97MX A particularly promising approach for the pulmonary administration of dry powder drugs uses a device that is held by hand, which has a pump or other source of pressurized gas. A selected amount of the pressurized gas is suddenly released through a powder dispersion device, such as a Venturi tube, and the dispersed powder can be made available for inhalation by the patient. Although it has advantages in many aspects, this device that is held by hand is problematic in many others. The particles that are being administered are very fine, usually have a size in a range of between 1 μm and 5 μm, making both dispersion and handling of the powder difficult. The problems are increased by the relatively small volumes of pressurized gas, typically from 2 ml to 25 ml at a pressure of 20 to 150 psig (1.41 to 10.55 kg / cm gauge), which are available in these devices. In particular, Venturi tube dispersion devices are not suitable for difficult to disperse powders when only small volumes of pressurized gas are available. In addition, Venturi tube dispersion devices have very small dust inlet openings, which get easily clogged by the powders used for pulmonary administration. Another requirement for P1132 / 97MX Hand-held powder and other powder administration devices is the high dose concentration. It is important that the concentration of the drug in the bolus of the gas is relatively high, to reduce the number of aspirations and / or volume of each aspiration that is required to achieve the total dose. The possibility of achieving both adequate dispersion and small dispersed volumes is a considerable challenge for the technique. Therefore, it would be desirable to provide methods and systems for the dispersion of proteins, polypeptides and other drugs in the form of a dry powder, which complies with some or all of the aforementioned objectives. 2_s_ Description of the Prior Art The dry powder dispersion devices for medicaments are described in various patent documents. U.S. Patent No. 3,921,637 discloses a hand pump with needles for piercing through a single capsule of powdered medicine. The use of several discs, receptacles or strips of medicaments is described in EP 467172 (wherein a reciprocable perforation mechanism is used for the perforation of the opposite surfaces of a blister or blister package); WO91 / 02558; O93 / 09832; O94 / 08522; Patent of the States P1132 / 97MX United No. 4,627,432; 4,811,731; 5,035,237; 5, 048, 514; 4, 446, 862; and 3,425,600. Other patents showing the puncture of simple medication capsules include the numbers 4,338,931; 3,991,761; 4,249,526; 4,069,819; 4,995,385; 4,889,114; and 4,884,565; and EP 469814. Document O90 / 07351 discloses a pump device held by hand, with a loose powder container. The work of Witham and Gates, Dry Dispersion with Sonic Velocity Nozzles. { Dry dispersion with sonic velocity nozzles) presented at the Dissemination Techniques Workshop for Skeke and Obscurants, Chemical Systems Laboratory, Aberdeen Proving Ground, Maryland, on March 14 to 16, 1983, a sonic velocity disperser for dust is shown dry, intended for industrial uses and with very high flow rates. A pneumatic type powder injector having a suction stage and an injection stage is described in U.S. Patent No. 4,807,814. The device comprises an axial gas venturi and a lateral powder inlet. Pittman and Mason (1986), at the Conference on Solid Handling, Lecture C4, pages C-41 to C-51, describes an injector nozzle (Figure 2) that has an annular air inlet upstream of the venturi restriction. P1132 / 97MX SU 628930 (Extract) describes a dust disperser that is held by hand and has an axial air flow tube. SU 1003926 (Extract) discloses a gas thermal coating injector. Bubrik and Zhelonkina (1978), in "Ejector Feeders for Pneumatic Transport Systems" ("ejector feeders for pneumatic transport systems"), in Chemical and Petroleum Engineering, Consultants Bereau, New York, describes the different efficiencies in various injector designs. Zholab and Kival (1999), in Proshkovaya Metallurgiya 6: 13-16, describes the effects of the design of injectors on the particle size. Bohnet (1984) in "Calculation and Design of Gas / Solid-Injectors "(" Calculation and design of gas / solid injectors "), in the publication Powder Technology, pages 302-313, discusses the conventional design of the injectors Fox and Westawag (1988), in Powder and Bulk Engineering , March 1988, pages 33-36, discloses a Venturi eductor having an axial air inlet pipe upstream of a Venturi restriction Document NL 7712041 (Extract) exposes an ejector pump that creates suction and ejects dust Inside a separator P1132 / 97MX EP 347 779 discloses a manual powder disperser having a collapsible expansion chamber EP 490 797 discloses a manual powder disperser having a spring-loaded piston, wherein the piston carries a dispersion nozzle US Patent No. 3,994,421 discloses a hand-held powder disperser having a collapsible deceleration chamber The pulmonary administration of drugs is described in Byron nd Patton (1994) J. Aerosol Med. 7: 49-75.

SUMMARY OF THE INVENTION The present invention provides methods and an apparatus for the efficient pulmonary administration of exact, precise and repeatable doses of powdered medicaments. The present invention will be particularly useful for the administration of expensive biopharmaceuticals, such as proteins, polypeptides and drugs of polynucleic acids, but it is also useful for the systemic or localized administration of any powder medication through the lungs. The method and administration system produce the practically complete dispersion of the medicament powder, with the rupture of any agglomerate of powder, which may have formed before the P1132 / 97MX administration. The method and apparatus have particular utility in the dispersion of fine powder medicaments from unit dose receptacles, such as blister or ampoule cartridges or cartridges, or wherein the present invention can fluidize and extract substantially the entire amount of powder (usually at least 70%, more usually at least 80% and, preferably, at least 90% by weight) that is contained within the receptacle, minimizing waste and improving accuracy and accuracy of the dose. The methods and approaches will also be useful in dispersing and administering preselected metered amounts (boluses) of powdered medicaments from receptacles containing several dosage units, ie "bulk" powders contained in a single receptacle. The methods and apparatus of the present invention are particularly suited to the administration of powders formed from discrete particles in a size range of 1 μm to 5 μm. These powders, when properly dispersed in an aerosol, are optimal for administration into the alveolar regions of the lungs. However, they are particularly difficult to handle and often agglomerate to a large extent during processing, packing and handling. To date, the handling characteristics of these powders have been P1132 / 97MX improved in some cases by combining the particles of the drug that are fine with particles of larger vehicles, which can be handled more easily and has better dispersion characteristics. The use of a vehicle, however, dilutes the drug, requiring a greater volume of dispersion for a given dose of the drug. Vehicle particles can also cause shocks when inhaled and serve no additional purpose other than improving handling characteristics. This invention is capable of achieving the dispersion of fine particles of the drug in the absence of vehicle substances or with a small amount thereof, by a two-stage dispersion method. The present invention, however, will be able to function with drug compositions including these carrier particles, as well as with diluents that may be necessary to achieve the desired concentrations of the dose. First, the powders are fluidized within the receptacle, as already described, resulting in fluidized particles and agglomerates of fluidized particles, which are then dispersed in a high velocity gas stream, under conditions that break up the agglomerates. This complete dispersion can be achieved with very low volumes of air at high velocity and fluidizing air, resulting in a bolus of P1132 / 97MX very well dispersed drug that has relatively high concentrations of drug particles. Of course, the present invention is also useful with drug formulations that include a carrier diluent, or the like. The advantage of the present invention is that the use of the vehicles can normally be reduced or eliminated completely. According to the method of the present invention, the powdered medicament is contained in a receptacle having a punchable lid or other access surface. A powder inlet end of a feed tube is coupled, ie joined or inserted, with a penetration into the access surface, and a high density air stream (normally sonic providing enough shear forces to separate the agglomerates into individual particles) is flowed past a portion of the tube, such as, for example, an inlet end, to extract the powder from the receptacle, through the tube, and bring it into the stream of air flowing to form the desired aerosol. Normally, at least two separate discrete penetrations will be formed in the access surface prior to coupling the input end of the feed tube with one of the penetrations. The other penetration allows a separate stream of fluidizing air to enter P1 --- 32 / 97MX receptacle, fluidize the dust and sweep the fluidized powder receptacle to help ensure that virtually all dust (preferably at least 70%, more preferably, 80%, and even more) preference of at least 90%) is removed and enters the flowing air stream. The high pressure gas stream will be generated by the sudden release of the pressurized gas charge, through a flow path, intercepting with the inlet end of the feed tube, at an angle selected for: (1) first inducing a sufficient flow of fluidizing air through the feed tube and fluidizing and transporting the powder in the receptacle and (2) to break up the remaining agglomerates of powder as the powder exits the outlet end of the feed tube. The gas pressure before release will normally be at least about 15 psig (1.06 kg / cm2 gauge) to achieve the sonic velocity, preferably it will be at least 20 psig (1.41 kg / cm2 gauge), and with greater preference will be in the range of 20 to 150 psig (1.41 and 10.55 kg / cm2 gauge), and a range of 40 to 80 psig (2.81 to 5.62 kg / cm2 gauge) is normally used. The expanded volume of gas released (measured at a standard temperature pressure of 14.7 psig [1.03 kg / cm2 gauge] at 20 ° C) will normally remain in the P1132 / 97MX range of 2 ml and 25 ml, preferably between 4 ml and 15 ml. The release of the high pressure gas can be effected by a normal trigger or optionally by the detection of a negative pressure, which results from the inspiration made by the patient (ie can be activated by aspiration). As described in greater detail below, the high pressure gas stream will be combined with the fluidization air stream at a volume ratio (measured at normal temperature and pressure conditions), in the range of 1: 2 to 1. : 4 (high pressure gas: fluidizing air in order to produce the aerosol that is subsequently inhaled by the patient, optionally after capture in a column-type capture chamber.) The method may also comprise the step of capturing the discrete volume resulting from aerosolized powder, in a column-type capture chamber before subsequent inhalation by the patient.Thereafter, the patient can inhale the entire aerosol dose from the chamber, concurrently with the elevation and / or after the inhalation of ambient air, which sweeps the starting chamber to further ensure the efficient administration of the powder with minimal losses. air after the initial bolus of medication is inhaled, will lead to P1132 / 97MX more drug within the alveolar regions of the lung, where absorption will occur. The method optionally comprises advancing a plurality of powder container receptacles beyond the feed tube, typically in the form of a strip or disc, so that the powder can be sequentially removed and dispersed from each receptacle. In another aspect of the method of the present invention, discrete amounts of a powdered medicament can be sequentially delivered from a receptacle or container. In contrast to the methods already described, the receptacle will include a quantity of powdered medicament that is greater than that which is intended to be administered in a single bolus, which normally contains an amount that is sufficient for a large number of boluses, usually at least 5, preferably at least 10, and often 20 or more. The method comprises inserting the inlet end of the feed tube into the receptacle and flowing a high pressure gas stream past an outlet end of the feed tube in order to induce the flow of air from the receptacle to the container. through the tube. The powdered medicament is then entrained in the flow of air that passes through the feeding tube and combined with the high pressure gas stream, at one end of the tube outlet.

P1132 / 97 X power supply. The high pressure gas stream can be repeatedly routed past the outlet end of the feed tube, while the inlet end is inside the "bulk" powder container. The apparatus according to the present invention comprises a base enclosure having a support for the receptacle containing the powder, in a fluidization location. The feeding tube is mounted within the base enclosure and an optional mechanism is provided for reciprocating the receptacle, relative to the feeding tube (or extending to the feeding tube in relation to the receptacle). An example of compressed gas for generating the high pressure gas is also provided, typically in the form of a hand-operated pump, an electric pump (usually battery operated), a compressed gas container, a two fluid system or the like. . The dose of aerosol powder can be formed subsequently by reciprocating the receptacle relative to the feed tube, so that the inlet end of the tube enters the receptacle. The high pressure gas stream is released while the tube is inside or adjacent the receptacle and the resulting low pressure region at the outlet end of the feed tube expels fluidizing air towards P1132 / 97MX the interior of the receptacle (preferably from the column capture chamber that subsequently receives the aerosol, minimizing the net air introduced from the outside of the device) in order to fluidize and extract the powder out of the receptacle , through the tube, and into the high-velocity gas stream to form the desired dispersion. Normally, the capture chamber is placed on the outlet end of the feeding tube and in line with it, to contain the "column" of powdered aerosol and allow the column to rest before inhalation by the patient. The feed tube has no ejector or jet tubes within the flow path and the uninterrupted and free flow path reduces any tendency for the feed tube to clog or lose dispersion efficiency. Using air from the capture chamber as a fluidizing gas agent is advantageous because it reduces the total volume of "new" gas that is introduced into the chamber, making the capture of the dispersion gas stream to be easier (that is, the combination of the high pressure gas stream with the fluidization air stream). This recirculation of air from the capture chamber is not an essential feature of the present invention. The fluidization air can also be obtained directly from the outside of the P1132 / 97MX device. In a particular aspect of the apparatus of the present invention, the receptacle will be supported on a mechanism for advancing a continuous blanket (either a strip or a disk) carrying a plurality of receptacles beyond the fluidization location. Typically, the blanket feed mechanism includes a cartridge or carrier that holds the blanket and that is mounted reciprocatingly relative to the feed tube, so that the pockets can be advanced sequentially while the cartridge and the tube are separated, and subsequently the tube is introduced into the receptacle, moving the cartridge and the tube together. Optionally, the lid of the receptacle or other simple access surface (i.e., a surface on one side of the receptacle) will be drilled immediately prior to the introduction of the feeding tube, normally using a separate piercing mechanism that pierces the lid, as the cartridge is moving reciprocatingly relative to the feeding tube. Alternatively, the access surfaces can be pierced simultaneously with the insertion of the feeding tube. The entrance end of the feeding tube will normally have a perforation structure and / or additional drilling structures that P1132 / 97MX will be refined to form additional penetrations for fluidization air inlet. In a specific aspect of the apparatus of the present invention, the piercing mechanism will produce at least two separate holes in the lid, where one orifice receives or engages the feed tube and, the other orifice, allows the displacement air to enter to fluidize the dust and sweep the receptacle as the powder is removed through the feed tube. A conduit or other path can also be provided to direct air from the column capture chamber back into the receptacle, in order to provide, at least partially, the necessary displacement air. The orifice of the feeding tube can be formed simultaneously with the displacement of the orifice or air holes or at a different time. For example, the displacement air orifice or holes may be formed in a drilling station positioned before the dispersing station, where the feed tube orifice is formed in the dispersing station, or vice versa. It may also be desired to provide a drilling mechanism in the dispersing station, wherein the drilling writing of the feeding tube moves reciprocatingly relative to the receptacle, in a movement separated from that of the P1132 / 97MX drilling structure of the displacement air hole. The present invention also provides an apparatus for forming a powder aerosol, comprising a feed tube having an inlet end, an outlet end, and a passage or opening defining an axial flow path between the inlet end and the inlet end. exit end. At least one conduit is provided for the flow of a high velocity gas stream past the outlet end, in a direction converging with the axial flow path, at an angle between the range of 12.5 degrees to 65 degrees. . It has been found that the angle of convergence in this range induces a sufficient flow of fluidizing air in the feed tube, to efficiently empty an associated powder receptacle (removing and carrying an aerosol, typically at least 80% and, from preferably, at least 90% of the powder initially present in the receptacle) while sufficient shear energy is also provided at the outlet end to essentially break up the agglomerates that are present in the powder. The aerosol forming apparatus can include two or more separate gas conduits that converge from different sides of the flow path, typically PU32 / 97MX opposite sides (diametrically opposite). Alternatively, the high pressure gas conduit may terminate in a single annular opening, circumscribing the outlet end of the feed pipe and creating a gas flow path converging on the axial flow path. However, this last approach, in general, will be the least preferred, since it is difficult to manufacture annular openings in the required small size. The total opening area (Ai) of the high pressure gas flow (dispersion) duct or ducts will normally be in the range of 0.05 mm to 0.3 m, while the narrow supply pipe, immediately upstream of the pipe of duct or gas ducts, will have an opening area (A2) within the range of 0.5 mm2 to 10 mm2. The area (A3) and the length of the mixing volume immediately downstream of the high velocity gas conduits, preferably, is in the range of 0.6 mm2 to 11 mm2 and 0.5 mm to 3 mm. The narrowing feed tube stream will normally have an area of (A4) in the range of 0.6 mm2 to 15 mm2. The aerosol forming apparatus may further include a diffuser tube which extends from the outlet end of the mixing volume and which has an opening which, normally, but not necessarily, is aligned coaxially with the opening of the feed tube. He P1--32 / 97MX diameter of the diffuser tube opening will increase in a direction away from the outlet end of the mixing volume, typically diverging at an angle half of 2 degrees to 10 degrees over a length in the range of 0.5 mm to 5 mm, normally having an exit area that is approximately four times the entrance area (mixing volume). The diffuser tube causes, in this form, a reduction in the velocity of the gas stream escaping from the outlet end of the mixing volume, where the velocity is at a maximum, before entering the column capture chamber. . The column continues to become rapidly slower as it expands inside the chamber and reaches a still or resting state, before inhalation. This invention further provides a feeding tube unit comprising a housing, a flow directing member and a feeding tube. The unit can be replaced with the aerosol dispersion system, facilitating the removal and cleaning or exchange of the unit if it becomes clogged or plugged. The invention provides an improved apparatus for aerosolizing a powdered medicament. The apparatus is of the type in which there is a housing and a source of pressurized gas to form aerosol of the powder. This apparatus is improved by providing a cylinder of P1132 / 97MX pressurization, a slide piston inside the cylinder, and a release valve in communication with the cylinder. There is further provided a handling unit having a handle functionally attached to the piston and a means for closing the valve. In this form, the translation of the handle closes the valve and moves axially to the piston inside the cylinder to produce the pressurized gas. In one aspect, the release valve comprises a valve rod connected to a valve cone, and the means for closing the valve comprises a roller cam, adjacent to the valve rod, for transfer to the latter in order to close the valve to as the handle moves radially out of the housing. In another aspect, the handle unit further includes an articulated connection that moves over the center to hold the roller cam against the valve stem and keep the valve closed. In this form, the valve is kept closed while the piston is moved back into the housing to produce the pressurized gas. In a further aspect, the handle unit includes a hinge between the handle and the piston. In this form, the joint reciprocates the piston, between a retracted position and a loaded position, inside the cylinder, as the handle moves radially outward and radially inwardly with P1132 / 97 X relation to accommodation. With this configuration, the handle can move radially outward to close the valve and retract the piston, while the inward movement of the handle charges the cylinder with pressurized gas. In yet another aspect, a locking means is provided to prevent radial translation into the handle until the articulated connection has moved over the center to keep the valve closed. Preferably, the locking means comprises a rack and ratchet system. In another aspect, a release button is provided to move the roller cam from the position over the center to open the valve. In yet another aspect, the cylinder preferably includes a unidirectional valve to allow air to enter the cylinder as the piston is translated into the retracted position. In a particular aspect, the powder medicament is kept inside a receptacle. A feeding tube is provided with an inlet end, an outlet end and a passage or opening extending therebetween, so that the inlet end can be inserted into the receptacle. In this form, the compressed gas leaving the release valve can flow past the outlet end of the feed tube, and P1132 / 97MX the powder is extracted from the receptacle through the tube and dispersed in the compressed gas that is flowing to form the aerosol. Preferably, a means is provided for drilling at least one hole in an access surface of the receptacle, simultaneously with the insertion of the inlet end of the feed tube into the receptacle. In a preferred aspect, the piercing means comprises a pair of pointed tongues, each of which is positioned obliquely relative to the access surface of the receptacle, when the tongues are pierced through the access surface. In another particular aspect, a means is provided for reciprocably moving the receptacle towards and away from the piercing means. The translation means preferably includes a hinge on the center to close and lock the receptacle in place during insertion of the inlet end of the feed tube into the receptacle. In another aspect, a positioning pin is provided for aligning the receptacle in a preferred orientation relative to the piercing means, while inserting the inlet end of the feeding tube into the receptacle. In another more particular aspect, the handle unit includes four hinges for attaching the handle to the housing. In this way, the handle can be moved P1132 / 97MX radially outward and radially inward relative to the housing, with a generally constant force, and with a more linear movement than a simple pivot movement. In addition, these joints reduce the distance that the handle must move away from the housing, thus making manual operation of the handle unit easier. In another aspect, a means is provided in association with the housing to produce verbal operation instructions. The invention provides an apparatus for forming aerosol of a powder held in a receptacle which, as an example, has a punctifiable access surface. The apparatus includes a housing, a source of pressurized gas, a capture chamber attached to the housing and a removable transjector unit, maintained within the housing. The transjector unit includes a means for piercing the access surface of the receptacle and for receiving the pressurized gas and extracting the powder from the receptacle and introducing it into the capture chamber. In a preferred aspect, the transjector unit receives gas directly from the gas source and delivers powder directly to the capture chamber, without the powder passing through other portions of the apparatus. In a particular aspect, an interface seal is provided between the transjector unit and the P1132 / 97MX housing, so that the pressurized gas can be passed from the housing to the transjector unit, without a substantial loss of gas. Preferably, the interface seal is angled relative to a central axis of the transjector unit, in order to facilitate the removal of the transjector unit from the housing. In another aspect, a receptacle seal is provided to form a seal between the transducer and the receptacle. In a further aspect, the transjector unit is coined to be received repeatedly within the housing, in a single orientation. In another particular aspect, the capture chamber can slide axially over the housing so that it can be placed in a collapsed position, essentially covering the housing, or in an extended position, which forms an enclosure for receiving aerosolized powder. Preferably, at least one stop is provided in the housing and at least one notch is provided in the capture chamber, the stop being received within the notch when the capture chamber is in the extended position. A spring is provided to push the stop out. In another aspect, the stop generally has a V-shaped geometry. In a further aspect, the capture chamber comprises an elongated chamber body, having at least one elongated rib or ridge, P1132 / 97MX that extends longitudinally along the body. The elongated rib engages with the housing when the chamber collapses to limit the amount of dust accumulated on the chamber, which can be scraped off from the chamber by the housing. In yet another aspect, the camera body is asymmetric in a cross-sectional geometry and includes a buccal part. A lid can preferably be held removably on the mouthpiece to prevent particles and external dust from entering the chamber and to keep the powdery medicine inside the chamber, until it is ready to be inhaled. Preferably a seal is provided between the cap and the mouthpiece, preferably the seal is configured to function as an exhaust valve to allow excess gas that is inside the chamber to escape. The invention also comprises a receptacle for holding a powdered medicament, the receptacle being adapted to be received within a housing of an aerosol forming apparatus. The receptacle includes a receptacle body having a punctureable access surface and a tongue extending from the body of the receptacle. In this form, the body of the receptacle can be received within an opening in the housing, with at least a portion of the tongue P1132 / 97MX remaining outside the accommodation. In one aspect, the tongue includes a hole coined and adapted to receive an alignment pin in the aerosol forming apparatus. By wedging the hole in the tongue, the receptacle can be configured so that it can be used only with an apparatus having a matching alignment pin. In this form, the apparatus can be configured to receive only certain receptacles that have a particular medication. The invention provides an improved method for aerosolizing a powdered medicament. The method is of the type in which the powder is entrained and suspended in a flow gas stream and comprises providing a housing having a pressurization cylinder, a slide piston within the cylinder, a release valve in communication with the cylinder and a handle to move axially to the piston and to close the release valve. The handle is initially moved away from the housing to axially translate the piston into the cylinder, into a retracted position, and to close the release valve. Subsequently, the handle is moved back into the housing to move the piston to a position, where it creates a pressurized gas charge. The valve is released after loading to suddenly discharge the gas P1132 / 97MX pressurized. In a particular aspect, the translation of the handle in the direction of the housing is avoided until the release valve is closed. In this way, the premature introduction of gas to the drug is avoided until the cylinder is fully charged. In another aspect, the release valve is kept closed while the handle is moved back into the housing, so that the gas in the cylinder can be loaded by the piston. In a further aspect, the handle is generally kept parallel to the housing when it is moved. Preferably, the handle is moved into the housing to pressurize the gas while a generally constant force is applied on the handle. In another particular aspect, the powder that is suspended in the release gas is introduced into a capture chamber while a preselected amount of gas is simultaneously vented from the capture chamber. In yet another aspect, a transjector unit is provided to receive the pressurized gas and form powder aerosol. The transjector unit is held removably within the housing, so that it can be removed from it periodically for cleaning. In another aspect, verbal instructions are produced from the housing.

P1132 / 97MX operation. In yet another particular aspect, a receptacle having a punchable lid for storing the medicament is provided. The receptacle moves to the transjector unit until it penetrates the lid. Preferably, the receptacle is guided to the transjector so that the transjector penetrates the cap in a known and predictable position. The receptacle is preferably kept with the transjector unit penetrating its cap, until after the valve is released. The invention provides an example of aerosol formation of a powdered medicament. According to this method, receptacles are provided having a receptacle body and a tongue extending from the receptacle body, the powdered medicament being maintained within the receptacle bodies. One of the receptacles is inserted into a housing having an opening, the body of the receptacle is received within the opening, so that at least a portion of the tab is outside the housing. The body of the receptacle is raised and simultaneously pierced and the powdered medicament that is inside the receptacle is withdrawn in a gas stream that can be inhaled. The receptacle is lowered and the tongue is then P1132 / 97MX pulled to remove the receptacle from the housing. In one aspect, the housing has a reciprocating capture chamber for receiving the gas stream leading to the powder, the chamber preferably being deployed before the receptacle is inserted. The deployment of the chamber exposes the opening and inserting the receptacle into the opening prevents the chamber from retracting until the receptacle is removed.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic illustration of an aerosol dispersion system which is in accordance with the principles of the present invention. Figure 2 is a perspective illustration of a powder feeding tube unit, which is employed in the aerosol dispersion system of Figure 1, in which a cut is shown with its inlet end proximate to the receptacle of dust. Figure 3 illustrates a penetration pattern of the dust receptacle lid, which is preferred. Figure 4A is a cross-sectional view of a portion of the feeding tube unit illustrated in Figure 2. Figure 4B is a cross-sectional view P1-132 / 97MX taken along line 4B-4B of Figure 4A. Figure 4C is an alternative cross-sectional view taken along line 4B-4B of Figure 4A. Figure 5 is a schematic illustration showing the relative sizes and convergence angles of the feed powder opening and the dispersion gas conduits of the present invention. Figure 6 illustrates a feed tube opening in combination with a dispersion gas conduit, having an annular opening defining a conical flow path. Figure 7 is a perspective view of an alternative feeding tube unit constructed in accordance with the principles of the present invention. Figure 8 is an exploded view of the power tube unit of Figure 7. Figure 9 is a cross-sectional view of the power tube unit of Figure 7. Figure 10 illustrates a power tube unit. feeding, in a third alternative, similar to that of Figures 7-9, but which also includes self-penetration elements that allow the feeding tube and fluidization air tubes to enter a medicine receptacle powdered. P1132 / r'7MX Figure HA is a detailed and enlarged view of the self-penetrating elements of Figure 10. Figure 11B is an enlarged view of an alternative construction of a self-penetrating element. Figures 12A-12C illustrate the use of a feeding tube unit of Figures 7-9 in the dispersion of a powdered medicament from a single unit dose receptacle. Figure 13 is a perspective view of a particularly preferred apparatus for aerosolizing powdered medicament, according to the present invention. Figure 14 is a perspective view of the apparatus of Figure 13, rotated 180 degrees, and showing a capture chamber in a collapsed configuration and a mouth piece on the chamber. Figure 15 is a perspective and exploded view of the apparatus of Figure 13, there is shown a transducer unit for aerosolizing the powdered medicament according to the present invention. Figure 16 illustrates the transjector unit of Figure 15, placed on an exemplary receptacle, for storing the powdered medicament according to the present invention. Figure 17 is an exploded view of the P1132 / 97MX transjector unit of Figure 16. Figure 18 is a cross-sectional view of the transjector unit and the receptacle of Figure 16. Figure 19 illustrates the penetration of the transjector unit of Figure 19 into the receptacle . Figure 20 is a perspective view of the apparatus of Figure 13, showing the introduction of the receptacle having the medicament powder into the apparatus. Figure 20A is a top view of the receptacle that is placed on a carrier of the apparatus of Figure 13. Figure 21 is a cross-sectional side view of the apparatus of Figure 13. Figure 22 is a side view of the apparatus of the invention. Figure 13 having its outer cover removed. Figure 23 is a side view of a handle unit together with other components selected from the apparatus of Figure 13, wherein the handle unit is shown in a closed configuration. Figure 24 is a more detailed view of the selected components of the apparatus of Figure 23 and showing a release valve in an open configuration. Figure 25 illustrates the handle unit and P1132 / 97MX other selected components of Figure 23, wherein the handle unit extends to close the release valve and retract a piston according to the present invention. Figure 26 is a more detailed view of the release valve of Figure 25, shown in the closed position. Figure 27 is a perspective view of the release unit of the apparatus of Figure 13. Figure 28 is a cross-sectional view of the release valve of Figure 27, showing the valve in an open configuration. Figure 29 is a cross-sectional view of the release valve of Figure 27 where the valve is in a closed configuration.

DESCRIPTION OF SPECIFIC MODALITIES Referring to Figure 1, a system 10 for administering the powdered medicament from a plurality of receptacles 12 is shown by inserting a feeding tube unit 14. The receptacle can be of any type. way that keeps and keeps medicines and that provides a punctual access surface. As illustrated, the receptacles 12 are in a continuous blanket that P1132 / 97MX comprises individual cavities covered by a punchable cover, typically a metal foil and another conventional foil. Each receptacle will include a precise dose of the powder medication to be administered. The amount of the drug in each individual receptacle will normally be in the range of between about 1 mg to 20 mg, more usually between 2 mg to 10 mg. The continuous blanket may be in the form of a strip, a disk or a molded structure with an enclosure. The manufacture of this container is usually referred to as a blister or blister package and is well known in the pharmaceutical packaging art, so it need not be described. Although illustrated with the cartridge 22 of Figure 1, it will be appreciated that the powder dispersion systems of this invention can also be constructed to receive single dose packets carried on a receptacle. In this case, a user would insert the package so that the receptacle will be properly oriented relative to the feeding tube 40 (Figure 2) of the feeding tube unit 14. The necessary perforations in the access surface of the receptacle can be made manually before the insertion, or they can be done within the system 10 (either before the introduction of the feeding tube unit 14 or simultaneously P1132 / 97MX upon introduction) or can be pre-formed and exposed by removing the cover before inserting the package into the device. They can also provide several receptacle packages in which the package is inserted into the device in different orientations, in order to selectively expose individual receptacles to the feeding tube. A variety of design options are available when the user inserts a single receptacle, before each use. The system 10 also comprises a base register 11 and the feed tube 40 (Figure 2) of the feed tube unit 14 has an inlet end 16 and an outlet end 18. A pressurized gas agent 20 is provided within the base enclosure 11 and is placed at the end next to the supply pipe unit 14 to provide a high pressure gas stream, as will be described in greater detail in relation to Figure 2. The receptacles 12 will be mounted within the base enclosure 11 to reciprocate relative to the inlet end 16 in the feed tube unit 14. Preferably, the receptacle strip 12 will be mounted inside a cartridge 22 that is reciprocatingly mounted in the base register 11 and while the feed tube unit 14 this P1132 / 97MX fixed mounted inside the base enclosure. In this manner, the receptacles 12 can be advanced sequentially beyond a fluidization location (defined at the inlet end 16 of the feed tube unit 14) within the cartridge 22, the receptacle that is at the dispersion location or fluidization is brought in close proximity to the inlet end 16 of the feed tube, to allow the emptying of its powder content, as described in greater detail below. Both reciprocating the cartridge 22 and advancing the receptacles 12 within the cartridge can be accomplished manually by the user. Alternatively, a mechanism may be provided within the base enclosure 11 for simultaneously reciprocating the cartridge 22 and advancing the receptacle strip 12, either as part of a manual advancement mechanism or as part of a battery operated mechanism. In the embodiment of Figure 1, the penetrations will be formed in the receptacle strip cap 12 by a piercing mechanism 24. In the illustrated manner, piercing mechanism 24 will be fixedly mounted within the base enclosure 11 and will include a plurality of piercing elements. sharp penetration 26 positioned to contact and penetrate the punchable cover 92 (Figure 3) of the receptacles 12, when the cartridge 22 is reciprocated, P1132 / 97MX as illustrated in the interrupted line of Figure 1. The piercing mechanism 24 will be placed to contact a receptacle 12, which is stationed before the feeding tube unit 14. In this form, each receptacle 12 will be pierced immediately before advancing to the fluidization location. It will be appreciated that a variety of mechanisms can be provided for drilling the holes in the lid of each receptacle and for causing the receptacle to be in proximity with the supply tube unit 14. For example, the cartridge 22 can be held stationary within the container. base enclosure 11, while each of the supply pipe unit 14 and the perforating mechanism 24 can be made to reciprocate, either together or separately. Alternatively, the inlet end 16 of the feed tube unit 14 could be configured for self-penetration (Figures 10 and HA and 11B below). In the latter case, the desired pattern of penetrations would be formed in the puncturable lid of the receptacle 12, at the same time that the inlet end engages against the interior of the receptacle or is inserted therein. This invention is not limited to any particular punching and perforating and advancing mechanism that could be employed. Gas people 20 will provide a P1 1 32 / 97MX volume of high pressure air or other air to the outlet end 18 of the feed tube 40 (Figure 2) of the feed pipe unit 14, in order to induce fluidization air flow, extract powder from the receptacles 12 and disperse it within the flowing gas stream. While the high velocity air coming from the gas agent will normally be directed beyond the outlet end 18, it will be appreciated that the feeding tube 40 may extend beyond the entry point of the high velocity gas stream, for example by providing side inlets in an elongated tube. In this form, the high-velocity gas can actually be combined with the fluidizing air that carries the entrained particles within the feed tube itself. With this construction, the feeding tube 40 could define the mixing volume 60 (Figure 4A), as described below. The gas source 20 will provide gas at a relatively high pressure, being normally sufficient to provide a sonic flow beyond the outlet end 18 of the feed pipe unit 14, which is typically above 15 psig (1.06 kg / cm) gauge) and is usually at least 20 psig (1.41 kg / cm2 gauge) and is preferably in the range of 20 to 150 psig (1.41 to 10.55 kg / cm2 gauge), and more preferably in the range of 40 P1132 / 97MX at 80 psig (2.81 to 5.62 kg / cm gauge). The energy stored in the charge of the high pressure gas will be sufficient to induce the flow of air through the feeding tube 40 of the feeding tube unit 14, which in turn draws fluidizing air into the receptacle to fluidize it and extracting the expected weight of the powdered medicament, from the receptacle 12. The expanded volume of the charge will typically be in the range of between about 2 ml to 25 ml (measured at normal temperature and pressure conditions) and will normally remain in the range between approximately 4 ml and 15 ml). The volume of fluidizing gas whose flow is induced through the feed tube unit 14, by the high velocity gas stream, will normally be from 2 ml to 100 ml, preferably from 4 ml to 60 ml, measured at normal conditions of temperature and pressure. The specific manner in which the high pressure gas is flowed past the outlet end 18 of the feed pipe unit 14 will be described in greater detail in relation to Figure 2. The gas agent 20 can, in This form, be a manual pump, an electric pump, a high pressure gas cylinder or something similar. The construction of manual pumps in the hand held dust dispersion device is described in the literature of P11 32 / 97MX patents and in technical literature. Refer, for example, to document O90 / 07351. The construction of electric gas pumps, gas cylinder supplies and two fluid systems is also within the expertise of experts in this field. The gas dispersion system 10 further includes a column capture chamber 30, which is positioned on the outlet end 18 of the supply pipe unit 14, in order to capture the dust released from the pipe. The column chamber 30 will include a mouthpiece 32 at its distal end and will have sufficient internal volume to capture virtually all of the powder dispersion that is delivered from the supply tube unit 14. Typically, the volume will be in the range of 50 ml to 1000 ml, preferably between 100 ml to 750 ml. The chamber 30 will also include an ambient air inlet (not shown) which is optionally a tangential inlet as described in copending Application Serial No. 07 / 910,048, the disclosure of which is mentioned herein by reference. Alternatively, the air inlet may be axial or spiral, as described with respect to Figures 7-9 below. In operation, the dust dispersion will be introduced into the column capture chamber P1132 / 97MX 30, as illustrated by the arrows 34. The air will move through the mouthpiece 32 and optionally again through an annular opening in the feeding tube unit 14, as indicated by dates 36. , and as will be described in more detail with respect to Figure 2. This recycling of air from the column capture chamber 30, as the fluidizing gas enters, greatly reduces the total volume of the new gas being introduced. To the system. The only new gas introduced (before inhalation made by the patient) will come from the gas source 20. After all the contents of the receptacle 12 have been dispersed and captured within the column chamber 30, the patient will inhale all the aerosol dose through the mouthpiece 32, followed by inhalation of ambient air, through the chamber, to extract all the aerosol medication from the chamber. Optionally, an orifice plate or other flow limiting element can be placed in the air inlet path of the chamber, to slow inhalation and improve the penetration depth of the powder particles. Inhalation of the additional air further ensures that the powdered medicament is dispersed efficiently and carried deep into the alveolar regions of the lung, where it is available for systemic absorption or P1 1 32 / 97MX localized administration. Referring to Figure 2, the feeding tube unit 14 includes an inner tubular feeding tube 40 defining the inlet end 16 of the feeding tube unit 14, at its distal end, and an outer coaxial tube member 42, which defines an annular opening 44 for passing the return air from the chamber 30 back to the receptacle 12, as described in more detail below. The opening 46 of the inner tubular feed tube 40 extends from the inlet end 16 to the outlet end 18, where a diameter constriction or reduction is optionally formed. The constriction or narrowing is not necessary for the operation of the feeding tube unit 14 but it is the area (A2) of the outlet end of the opening 46 (Figure 4A) that determines the performance characteristics of the feeding tube. , as described in more detail below. The dispersion gas coming from the gas source 20 enters the supply pipe unit 14, through a port 50 connected to an annular opening 52. The annular opening 52, in turn, is connected to a pair of gas conduits 54 directing converging gas streams into the interior of the flow path, defined by tube aperture 46 Supply P1132 / 97MX 40. The angle at which the gas conduits 54 are oriented is selected to provide an adequate balance between the magnitude of the flow velocity induced in the powder stream drawn through the opening 46 and the magnitude of the shear forces that break up the powder agglomerates, as it passes from the outlet end 18 to an expansion section 58. The area (A2) (Figure 4A) of the narrowing 18 of the opening of the feed tube 46 will typically be in the range of 0.5 mm2 to 10 mm, preferably in the range of 1 mm2 to 4 mm. In the illustrated embodiment, the area (A4) of the upstream opening portion 46 (Figure 4A) is larger than the area A2, typically between 0.6 mm2 to 15 mm2. The upstream opening 46 could, however, have a uniform area along its entire length equal to the outlet end area (A2), although this construction would be less preferred. Referring to Figure 4A, a mixing volume 60 having a uniform cross-sectional area (which does not expand) (A3) and a length (L) is immediately placed at the outlet end 18 of the feeding tube 40. The cross-sectional area (A3) is shown as slightly larger than the area (A) of the feeding tube narrowing, exit, but this P1132 / 97MX particularity is not necessary. The exemplary area (A3) is typically in the range of 0.6 mm to 11 mm2. The length (L2) is from 1 to 5 times the diameter of the mixing volume 60 (for circular cross sections), the range from 0.5 mm to 2 mm being typical. In the illustrated embodiment, a pair of gas conduits 54 are shown (Figure 4B) as illustrated in Figure 4B. It would also be possible to use only one input stream or to provide three, four or more separate inputs, in Figure 4C four inputs 54 'are illustrated. Other configurations may also be useful, including a continuous annular opening, as described in relation to Figure 6, or combinations of perpendicular jets (for agglomerate rupture) and directed jets in the axial direction (to induce the flow of fluidizing gas ). Referring to Figure 5, the high pressure gas conduits 72 are positioned around the narrowing of the opening of the feed tube 70 at angles ai, y a2, which normally, but not necessarily, are equal. The angles a, are important to achieve both an adequate mass transfer of the powder from the receptacle and an "agglomerate break", suitable as the powder enters the mixing volume, immediately downstream of the exit orifices. the conduits 72. The angles a, will be in the interval P1132 / 97MX from 12.5 degrees to 65 degrees, preferably in the range of 25 degrees to 40 degrees. It will be appreciated that the high pressure gas openings 72, as illustrated in Figure 5, can be formed as a single conical plenum 80 terminating in an annular opening 82, as illustrated in Figure 6. The angle of convergence a, in general it will be within the range established above for a, and the total area of the annular opening 82, will be within the total area A2 for the high pressure gas openings, which are also indicated above. Typically, the overpressure conical chamber 80 will have a width w within the range of about 0.005 mm to 0.1 mm. Referring again to Figure 2, the feeding tube unit 14 functions by engaging the inlet end 16 of the feeding tube 40 with an opening 90 (Figure 3) formed within the lid 92, on a receptacle 12. As shown in FIG. illustrated, the inlet end 16 is inserted through the cover 92 and into the receptacle 12, but it will always be feasible to couple the inlet end onto the opening 90, typically using a seal packing as illustrated in Figures 7 to 10 , down. The opening 90 will be surrounded by separate openings 94 (six are illustrated) that allow the inflow of fluidized air as the powder P1132 / 97MX entrained is removed through the internal feed tube 40. The opening 90 is shown centered, but this is not necessary. In a preferred aspect of the invention, at least a portion (and preferably all) of the fluidizing air will be provided through the annular opening 44, via a port 96 in the inlet tube unit 14, placed in the bottom of the interior of the column chamber 30. This "recycled" air that comes from the column chamber 30, passes through an annular overpressure chamber 98 that comes from the port 96 into the interior of the annular opening 44. Optionally, a rubber flange or skirt 95 can be provided to prevent the loss of fluidized air from the opening 44 towards the receptacle 12. The recirculation of the fluidizing air from the column chamber 30 helps to contain the column of dispersed dust inside. of the column chamber, since it limits the amount of air that is displaced and expelled through the mouthpiece 32 or another opening within the chamber. The introduction of the inlet end 16 of the feed pipe 40 of the feed pipe unit 14, into the receptacle 12, is advantageous, but is not necessary, since it substantially facilitates the total removal of the dust (usually at least 80%). % and preferably at least 90% in P1132 / 97MX weight) from inside the receptacle. This total removal is further improved by the inflow of fluidizing air through the separate openings 94, which creates an airflow pattern that can sweep dust from all the corners of the receptacle into the dispersion opening 46. An alternative embodiment of a feeding tube unit 100 is shown in Figures 7 to 9. The feeding tube unit 100 is in general functionally equivalent to the feeding tube unit 14 and can be used instead of this in the systems of the Figure 1. The feed tube 100, however, is suitable in particular for its manufacture from molded plastic parts, or from a combination of parts made of metal and molded plastic parts. The feed tube unit 100 comprises a housing 102, a cone 104 for the direction of gas flow, a feed tube element 106 and an end piece 108, a flexible valve element 110 and an end gasket 112. The feed tube element 106 is received in an open cavity 114 positioned at a lower end of the flow direction cone 104. The flow passages inside the feed tube 106, in general, will be the same as those that P1132 / 97MX are previously described for the feeding tube unit 14, and the feeding tube unit 100 further includes a mixing volume 116, placed immediately above the open cavity 114 and an expansion region 118, placed above of the mixing volume. The dimensions of the mixing volume 116 and the expansion region 118, in general, will be the same as those previously described with respect to the feeding tube unit 14. As best seen in Figure 8, the steering cone 104 flow may include a plurality of air flow channels 120 formed on its outer surface. Normally, there will be from 1 to 10 channels, which has a total cross-sectional area of 5 mm2 to 150 mm2, preferably 40 mm2 to 100 mm2. The airflow channels 120 are generally shown in a spiral pattern in Figure 8. The spiral pattern may be preferred as it will impart a vertical flow to the replacement air entering the associated column chamber as inhale the patient. The air flow channels 120 can, however, also have a generally straight configuration that will impart a conical, but not spiral, expansion of the flow pattern to the replacement air. It would also be possible to employ airflow channels that are straight and for each other to impart a flow pattern of P1132 / 97MX replacement air generally axial towards the column chamber. It would also be possible to employ a single annular opening using pins of other non-dividing elements to support the flow direction cone, wherein the cone may be a continuous surface without discrete channels. The airflow channels 120 are enclosed by their outer ends by the inner surfaces 122 (Figure 9) of the housing. The air flow channels extend in this form from a lower end 124 to an upper end 126, providing flow paths for the replacement or "chase" air to a column chamber, as described in more detail below. The flow paths provided by the air channels 120 will also be provided to recycle the air in the reverse direction from the column chamber to an associated powder receptacle, when the powder is fluidizing. This function will be described in more detail below. The end piece 108 includes a plurality of airflow openings 126 located around a central opening 128. The flexible valve 110 lies on the airflow openings 126 and is secured between the lower end of the housing 102 and the surface P1132 / 97MX upper part of the end piece, as best seen in Figure 9. The flexible valve element 110 acts, in general, as a unidirectional valve, which allows air to enter from the outside of the tube unit. feed 100 to the region formed between the lower end of the housing 102 and the end piece 108. The high pressure air may enter the open cavity 114 formed at the outlet end of the feed tube element 106, through a port input 130, formed in housing 102 (Figure 7). For ease of understanding, the flow path from the port 130 to the cavity 114 is not shown in Figure 9. The high pressure gas supply to the cavity 114 acts to induce the flow of fluidizing air through the opening. of the feeding tube element 106 in a manner completely analogous to that previously described for the feeding tube unit 14. Referring to FIGS. 10 and HA, a modification of the feeding tube unit 100 allowing the Direct penetration of a medicine container cover. For convenience, all the elements corresponding to those shown in Figures 7 to 9 will be identified in the same way. A feeding tube penetration element 140 is P-132 / 97MX placed at the lower end of the feed tube 106. As shown in detail in Figure 11, the penetration member 140 includes a pair of transverse internal walls 142 terminating in a pointed blade structure 144. The blade structure 144 leaves four separate flow passages 146, arranged in quadrants within the feed tube 104. The flow passages 146 may, optionally, stop beyond the point of attachment of the knife structure 144 to the inner wall of the knife. guest tube. A plurality of similar penetration structures 150 are provided both for piercing the lid of the receptacle, to simultaneously provide fluidization air entry paths. Penetration structures 150 can be provided on a carrier plate 152 or on a similar support structure. The penetration structures 150 will have a conical blade structure similar to that previously described for the feed tube penetration structure 140. In this way, the structure of Figure 10 can be provided for both the penetration of the feeding tube and for the feeding tube. fluidization air penetrations peripherally positioned in the penetrable lid of a medicament receptacle, in a single movement, wherein the lid is brought against the package 112 P1132 / 97MX of unit 100 of feeding tube. Figure 11B illustrates an alternative penetration structure 151 formed by machining the end of a tube along two converging planes. The resulting pointy elements are then pressed together to form the structure having openings 153. The penetration member 151 is advantageous in that it removes the cap as it penetrates, leaving the holes 153 free to receive dust. The penetration structure 151 could be fabricated from molded plastic as well as from machined metal. Referring now to Figures 12A to 12C, the use of the feed tube unit 100 of Figures 7 to 9 will be described in greater detail. Initially, a medication receptacle R having the preformed fluidizing air and feed tube penetrations, 202 and 200, engages against the package 112, as illustrated in Figure 12A. The gasket 112 provides a seal against the penetrable lid 204 of the receptacle R. The inlet end of the feed tube 106 is shown penetrating the lid 104, but it will be appreciated that this penetration is not essential as a seal will be provided by packing 112. Penetration may be desired, however, since the flaps of the cap surrounding the penetration 200, are P1132 / 97MX will remain open. After the receptacle R is in place, a burst of high pressure air is introduced into the interior of the open cavity 114, as shown in Figure 12B. The high pressure air went beyond the outlet end of the feed tube 106, inducing a flow of fluidizing air through the receptacle R. In particular, the fluidizing air is drawn through the air flow channels 120. from the overlying column chamber (not shown) as shown by the arrows 210. The air drawn into the interior, through the airflow channels 120, enters the receptacle through the penetrations 202, fluidizing In this way the powder is drawn into the powder through the feed tube 106. The flow of air through the feed tube draws the powder into this form and combines it with the flow of high pressure gas at the outlet end. of the feeding tube. The powder, fluidizing air and combined high pressure dispersion gas are introduced into the column chamber, as shown in arrows 212. After the powder has been dispersed, the patient will inhale from the column chamber. which will cause an inverse flow of air through the air flow channels 120, as illustrated in Figure 12C, the P1132 / 97MX ambient air will enter the central opening 128 through the openings 126, as the flexible valve member 110 opens. The air entering through the openings 126 will pass mainly through the air flow channels 120. However, a portion can pass back into the interior of the receptacle R and up through the feed tube into the interior of the container. column chamber. This flow through the receptacle will further drain the receptacle from any remaining dust. Referring to Figure 13, a particularly preferred embodiment of an aerosol forming apparatus 300 will be described. The apparatus 300 includes a housing 302 and a capture chamber 304 that is slidable on the housing 302. Within the housing 302 it is kept in shape a transducer unit 306 removable. Transducer unit 306 is similar to unit 100 of the feeder tube as shown in Figures 7 to 9 and is used to introduce aerosolized medication into capture chamber 304, as shown in FIG. described in more detail below. The apparatus 300 further includes a handle unit 336 having a handle 338 which, in combination with the transducer unit 306, is used to form an aerosol of the medicament and will be described in more detail below.

P1132 / 97MX continued. The housing 302 further includes an opening 340 for receiving a receptacle 342 (see Figure 20) that carries the medicament powder. The capture chamber 304 is dimensioned to be slidably received on the housing 302, so that the capture chamber 304 can be removed from the housing 302 for cleaning, and also so that the chamber 304 can be moved between the deployed position ( see Figure 20) and the retracted position (see Figure 14) in the deployed position, the capture chamber 304 forms an enclosure for receiving aerosolized medication, introduced by the transistor unit 306, so that it can be inhaled by a patient. After inhalation, the capture chamber 304 can slide over the housing 302 to the retracted position for storage. The maintenance of the capture chamber 304 in the retracted and deployment positions is effected by two pairs of stop pins 308 and 310. The stop pins 308, 310 are received within slots 312 and 314 in the housing 302. Preferably provide the springs 316 and 318 for pushing out towards the stop pins 308, 310. The capture chamber 304 includes a camera body 320 having a lower portion 322 and an upper portion 324. In the lower portion 322 are included a pair of slits P1132 / 97MX (not shown) for engaging the stop pins 308, 310. The stop pins 308 are received in the slots when the capture chamber 304 is in the unfolded position, and the stop pins 310 are received in the slots when the camera 304 is in the retracted position. The stop pins 308 and 310 each include a V-shaped portion 326 and 328, for engaging the slits in the lower portion 322 of the capture chamber 304. The particular orientation and angle of the V-shaped portions. 326 and 328 may be varied to increase or decrease the amount of force required to deploy or retract the capture chamber 304. The mating slits of the chamber 304 may also be provided at different angles to help achieve this effect. Typically, the stop pins 310 will be configured so that it is easier to translate the camera 304 down towards the bottom of the housing 302 than to move the camera 304 up toward the top of the housing 302. In this form, the camera 304 can be placed in the retracted or storage position with a relatively small force, while a relatively larger force will be required to recover the chamber 304 from the storage position. In this way, the camera 304 will be configured to not inadvertently slide to the open position during the no P1132 / 97MX use. In a similar manner, the stop pins 308 will normally be configured so that a greater force is required to jointly withdraw the chamber 304 from the housing 302, to slide the chamber 304 over the housing, toward the stop pins 308. In this form, the removal Unnoticed camera 304 will be avoided by sliding camera 304 to the unfolded position. The capture chamber 304 is preferably asymmetric, in a cross-sectional geometry, so that the capture chamber 304 can be repeatedly placed on the housing 302 in a known orientation. This is particularly advantageous to ensure that an inhalation port 330 of a mouthpiece 331 (see Figure 14) is properly positioned relative to a firing button 418 (see Figure 21) which is used to introduce the medicament powder into the interior of the capture chamber 304. In another aspect, the camera body 320 will preferably include at least one elongated rib 324 extending longitudinally along the length of the interior of the camera body 320. The rib 334 provides for contacting the housing 302 and keeping the remainder of the camera body 320 separate from the housing 302, when the capture chamber 304 is moved to the retracted position. Normally, residual dust will remain on the walls P1132 / 97MX interior of the camera body 320 after use. As the camera body 320 slides over the housing 302 to retract the capture chamber 304, the rib 334 contracts the housing 302 to limit the amount of residual powder scraped from the camera body 320 by the housing 302. Prolonged scraping of the dust accumulated on the walls of the chamber body 320 is not desired, since the scraped powder may become agglomerated and interfere with the subsequent operation of the apparatus 320. In a further aspect, an elevated portion 335 is provided in the housing 302 to ensure an adequate fit between the bottom portion 322 and the housing 302. The camera body 320 is preferably constructed of a transparent material and will normally be constructed of plastic. Optionally, the plastic can be an inherently conductive polymer such as that described in U.S. Patent Nos. 5,342,889, 5,348,995 and 4,719,263, the exposures of which are incorporated herein by reference, to limit the amount of the accumulated electrical charge. on the walls of the camera body 320, during use. Referring to Figure 14, the capture camera 304 is shown in the retracted position and will be used to describe the operation of the port of P1132 / 97MX inhalation 330, in more detail. The capture chamber 304 includes a cover 344 that can be closed over the inhalation port 330. The cover 344 is used to prevent exterior particles or dust from entering the capture chamber 304, during storage, and also to maintain the aerosolized medication, introduced by transjector unit 306, into chamber 304, until it is ready for inhalation. Optionally, cover 344 may include a seal 346 that is received over inhalation port 330 when cover 344 is closed. Upon introducing the aerosolized medicament, the pressure within the capture chamber 304 increases. The seal 346 serves as an exhaust valve to allow some of the pressurized gas within the chamber 304 to spontaneously escape. The reduction of the chamber pressure, in this way, is advantageous to avoid the formation of a "cloud" of drug that escapes when the cover 344 is lifted for inhalation. The capture chamber 304 will preferably define an enclosed volume of about 50 ml to 750 ml and, more preferably, about 100 ml to 250 ml. When the aerosolized medicament is introduced into chamber 304, the internal pressure will increase over the ambient pressure, in proportion to the amount of net gas escaping into the chamber and the volume of the chamber, as P1132 / 97MX dictates the law of Boyles where PiV ± ~ P2V2 't = constant in equilibrium. For example, 8 ml of gas introduced into a 210 ml chamber will contribute to a pressure rise of approximately 0.6 psi. In this form, it is desired that the seal 346 approximately allow 8 ml of gas to escape so that the pressure drops by 0.6 psi. The seal 346 is preferably constructed of silicone, urethane or similar flexible elastomers, although a similar functioning valve could be achieved with a rigid valve element operated by a spring, for example a thin metal plate or mylar. Referring to Figure 15, placement of the transducer unit 306 within the housing 302 will be described in greater detail. The housing 302 includes a cylindrical opening 348 that is dimensioned to receive the transjector unit 306. The opening 348 includes a wedge slot 350 for receiving a wedged portion 352 of the unit 306. The wedge groove 350 is provided so that the unit of transducer 306 may be repeatedly placed in a known orientation when transjector unit 306 is inserted into opening 348. A tightening nut 354 is provided to ensure that transducer unit 306 enters opening 348. Locking nut 354 includes a pair of tabs 356 to allow for easier rotation of the P1132 / 97MX nut 354 when the nut 354 is secured or unlocked. To remove the transducer unit 306, the nut 354 is unscrewed and removed, and the transjector unit 306 is raised from the housing 302. Alternatively, the nut 354 can be configured to quickly fit within opening 348 and hold transducer unit 306 in place. Referring to Figures 16 and 17, the construction of the transjector unit 306 together with the receptacle 342 will be described in greater detail. As best seen in Figure 17, the transjector unit 306 includes a housing 358, a gas flow direction cone 360, a feed tube member 362 and an end piece 364, a flexible valve member 366 and an end package 368. The transjector unit 306 functions identically to the supply tube unit 100, as shown in Figures 7 to 9, regarding the extraction and aerosolization of the powdered medicament within the receptacle. The transjector unit 306 differs from the feeding tube unit 100, since the transjector unit 306 includes an alternating penetrating member 370 and a pair of penetrating structures 372. The penetrating member 370 is placed at the lower end of the feeding tube. 362 and is employed to extract the powder from the receptacle 342, as P1132 / 97MX has already been described in relation to the feeding tube unit 100, when the penetrating element 370 is inserted into the receptacle 342. The penetrating structures 372 are provided both for piercing the lid of the receptacle and for simultaneously providing trajectories of fluidization air inlet. A particular advantage of the penetration structures 372 is that they are easy to manufacture, thus reducing the overall cost of the transjector unit 306. As best shown in Figures 21, 23 and 24, the penetration structures 372 can be provided, optionally , with a plurality of points instead of a single point, to facilitate penetration into the lid of the receptacle. As best seen in Figures 18 and 19, the receptacle 342 includes a receptacle body 374 having a penetrable cap 376, which covers an enclosure 378 and a tongue 380. Within the tongue 380 is a hole 382 for aligning the receptacle 342 with the transjector unit 306, as described in greater detail below. To penetrate the lid 376, the receptacle 342 is raised (or the transducer 306 is lowered) until the penetrating member 370 and the penetrating structures 372 pierce the lid 376, as shown in Figure 19. The penetrating structures 372 remain in P1132 / "M angle relative to the penetration member 370 and function similarly to the can openers, to remove a portion of the cap 376 and form the air inlet paths.After the receptacle 342 is in place, it is introduces a burst of pressurized air into an open cavity 384 that flows past the outlet end of the feed tube 362 to pull the powdered medicament, which is inside the receptacle 342, through the transjector unit 306 , similarly to the feeding tube unit 100 which is described in Figures 12-12C, when the penetrating member 370 and the penetrating structures 372 pierce the lid 376, the end package 368 is brought into contact with the receptacle body 374 and forms a seal against receptacle 342. Referring to Figures 20 and 20A, the placement of receptacle 342 within opening 340 will be described in greater detail. 342 is administered to the opening 340 by gripping the tongue 380 and the receptacle body 374 is inserted into the opening 340, until stop flanges 375 in the receptacle body 374, engage the guide pins 377 ( see also Figure 21) on which a carrier 442 (see also Figure 22) is mounted and prevents further translation. At this point, the P1132 / 97MX orifice 382 is generally aligned with a pin 386. The receptacle 342 is then raised within the opening 340 until the hole 382 is received on the pin 386, which guides and aligns the receptacle 342 until it engages the end package 368 (see Figure 19). At all times, the tongue 380 is outside the housing 302. In this way, the premature closing of the capture chamber 304 is avoided, since the tongue 380 will prevent retraction of the capture chamber 304. The tongue 380 ensures in this so that the capture chamber 304 is always in the deployed position when the receptacle 342 is loaded into the apparatus 300. In this way, the capture chamber 304 must always be in the deployed position so that the receptacle 342 is loaded inside the apparatus. 300. Optionally, the pin 386 can be wedged to fit only in a specific orifice configuration in the receptacle 342. In this way, the apparatus can be configured to receive only specific receptacles having a given medicament. Alternatively, a plurality of corresponding pins and holes may be provided for coining the apparatus 300. Referring to Figures 21 to 27, the operation of the apparatus 300 for producing an aerosol medicament will be described. As shown in Figure 21, P1132 / 97MX the handle 338 in the handle unit 336 is operatively connected to a piston 388, which in turn is supported translatable within the cylinder 390. A link 392 is provided to connect the piston 388 with the handle 338. As is better seen in Figures 25 and 26, as the handle 338 moves radially outward and away from the housing 302, the link 392 is pulled from the cylinder 390 to lift the piston 388. When the handle 388 is fully extended (Figure 25) the piston 388 is in a retracted position. As the handle 338 moves back into the housing 302, the piston 388 moves into the cylinder 390 to pressurize the gas that is inside the cylinder 390. As best seen in Figure 21, the cylinder includes a unidirectional valve 394 that is held within a retainer 396. The unidirectional valve 394 is preferably a "duckbill" type valve that allows air to enter the cylinder 390 as the piston 388 is translated into the extended position. When the handle 338 closes, the valve 394 closes to prevent air from leaking out of the cylinder 390 through the valve 394. The pressurized air coming from the cylinder 390 is passed through an outlet or transfer tube 398 (see Figures 21 and 25) towards a valve unit of P1-32 / 97MX release 400. The release valve unit 400 in turn is brought into communication with the transjector unit 306, so that the pressurized gas can be supplied to the open cavity 384, as already described above in FIG. Figure 19. A seal 402 provides between the valve unit 400 and the transducer unit 306 to prevent high pressure air, supplied from the valve unit 400, from leaking between the interface between the valve unit 400 and the unit. of transjector 306. The seal 402 is preferably constructed of urethane, silicone or a similar elastomer, and is angled relative to a longitudinal axis of transjector unit 306. In this form, transjector unit 306 can be easily inserted and withdraw from the housing 302, while at the same time, a sufficient seal is allowed in the interface. The valve unit 400 includes a valve stem 404 and a valve cone 306 to selectively prevent air from flowing through the unit 400 and will be described in greater detail below with respect to Figures 27 through 29. In Figures 21 at 24, valve unit 400 is shown in the open position, with cone 406 not seated. In this configuration the gas that is inside the cylinder 390 will not be compressed in a P1132 / 97MX significant during the transaction of the piston 388, since the air that is inside the cylinder 390 will escape through the outlet pipe 398. When the valve unit 400 is closed, air is prevented from escaping from the outlet pipe 398 , so that only one "full stroke" of air inside the cylinder 390 can be compressed. In a particularly preferred aspect of the invention, the apparatus 300 is configured to close the valve unit 400, as the piston 388 reaches the extended position, so that the air inside the cylinder 390 can be compressed when the handle 338 moves back into the housing 302. To close the valve unit 400 in this manner, the handle unit 336 includes a hinge 408 (see Figure 22) having the rack 410 securely attached thereto. The zipper 410 includes an elongated slot 312 for receiving a valve readjustment joint 414 (refer to Figures 21 and 24). As best seen in Figures 21 and 24, the reset hinge 414 is pivotally attached to a roller cam 416. In turn, the roller cam 416 is pivotally attached to a valve release button 418. As best seen in Figures 25 and 26, as the handle 338 moves away from the housing 302 and as it reaches its position P1132 / 97MX fully extended, hinge 408 is pivotally moved around pin 420, causing the hinge of fit 414 to slide into slot 412, until it comes to a left end of slot 412. In this point, the reset hinge 414 moves in the direction of the handle 338 to pivot the roller cam 416 around the pin 422. Further translation of the handle 338 causes the roller cam 416 to lock over the center. As the roller cam 416 leans over the center, the release button 418 moves outward from the housing 302 and the valve rod 404 is urged upward by the roller to seat the cone 406 against a seat 452 (See Figure 29) by closing the valve unit 400. At the same time, the piston 388 is moved by the link 392 to the extended position. As the link 338 moves back into the housing 302, the reset hinge 414 slides into the slot 412 while the cam 416 remains on the center to keep the valve unit 400 closed. At the same time, the piston 388 moves inside the cylinder 390 to compress the air inside the cylinder 390. When the operator is ready to produce the aerosolized medication in the capture chamber 304, the release button 418 is depressed to P1132 / 97MX move to cam 416 from the center and allow valve unit 400 to open. In a particular aspect, the apparatus 300 can be configured to prevent translation of the handle 338 back to the housing 302, until the handle 338 is fully extended to place the cam 416 over the center and close the valve 400. To restrict the movement of the handle 338 in this manner, the handle unit includes a locking pawl 424 (see Figure 22) for engaging the ratchet teeth 426 on the rack 410. As the handle 338 extends to pivot the 416 around the pin 422, the pawl 424 engages the tooth 426 of the rack 410 to prevent closure of the handle 338, until the cam 416 moves over the center to close the valve unit 400. A spring locking pawl 425 is provided to push the pawl 424 against the rack tooth 426, until the cam 416 is over the center. In this form, the pumping of the handle 338 is prevented, which could prematurely supply air to the transjector unit 306. This premature administration is undesirable if the user has already loaded and punched the receptacle. Alternatively, a lock may be provided to prevent piercing of the receptacle 342 by the transjector unit 306, up to P1132 / 97MX that the valve unit 400 closes. Referring to Figures 22 and 25, the translation of the handle 338 relative to the housing 302 will be described in greater detail. The handle unit 336 further includes a hinge 430 which is pivotally connected to the housing 302 by the pin 432. Connecting the handle 338 with the hinge 392 and the hinge 408 is the hinge 434. Joints, joints 392, 408 , 430 and 434 provide a four bar linkage system that allows handle 338 to move radially outwardly from housing 302, handle 338 being maintained generally parallel to housing 302. Furthermore, when valve unit 400 is closed and the handle 338 moves back into housing 302, a substantially uniform force is required over the range of movement of the handle. In this way, as the user forces the handle 338 to return to housing 302, to compress the air in the cylinder 390, the user feels a resistive force in general equal, during the complete compression stage. In addition, the maximum distance that the handle 338 moves in translation from the housing 302 is reduced, thereby making it easier for smaller hands to work. As seen in Figures 22 and 23, the P1132 / 97MX apparatus 300 further includes a carriage unit 436 for transporting the receptacle 342 within the opening 340, so that the penetrating member 370 and the penetrating structures 372 can pierce the lid 376 of the receptacle 342. The carriage unit 436 includes a thumb lever 438 that is pivotally connected to the housing frame 302 by a pin 440. The receptacle 342 is held within a carrier 442 which, in turn, is connected to the thumb lever 438 by a joint 444. The operation of the carriage unit 436 is as follows. Initially, the receptacle 342 is inserted into the opening 340 as already described above, and the receptacle 342 rests on the carrier 442. The thumb lever 438 is then pressed to pivot the lever 438 around the pin 440 and to lift the carrier 442 to transducer unit 306. As best seen in FIG. 25, thumb lever 438 is depressed until transducer unit 306 pierces the cap on receptacle 342 and articulation 444 moves over the center. When the articulation 444 moves over the center, the receptacle 342 is locked in place against the end packs 368 of the transjector unit 306 (see Figure 25). Preferably, the carriage unit 436 is configured to compensate for excess travel of the carrier 442. In this P1122 / 97MX form, the carrier 442 will relax after the receptacle 342 is pierced by the transjector unit 306, but still provide a sufficient seal between the transjector unit 306 and the receptacle 342. To lower the carrier 444, the thumb lever 438 is raised to move joint 444 from its position on the center. The receptacle 342 can then be removed from the opening 340 by holding the tongue 380 and pulling the receptacle 342 from the opening 340. Referring to Figures 27 to 29, the construction of the release valve unit 400 will be described in greater detail. The valve unit 400 includes a housing 446 having an inlet port 448 and an outlet port 450. The outlet tube 398 that connects the cylinder 390 with the valve unit 400 passes through the inlet port 448. The seal of inter-face 402 is placed between the output port 450 and the transjector unit 306, as already described. The valve unit 400 is shown in the open state in Figure 28. When opened, the cone 406 is separated from a seat 452. The cone 406 is held within a central chamber 454 that is sealed against the outside environment. (except for the output port 450) by a diaphragm 456. When open, the air introduced into the central chamber 454 from P1132 / 97MX the inlet tube 398 passes freely around the cone 406 and leaves the outlet port 450. When it is closed (see Figure 29) the air introduced into the central chamber 454 from the outlet tube 398 forces the cone 406 is against the seat 452, which prevents the escape of compressed air from the central chamber 454. The valve unit 400 is preferably configured so that the seal between the cone 406 and the seat 452 will support up to approximately 120 psi of pressure and , more preferably, approximately 80 psi. To open the valve unit 400, the release button 418 is depressed to move the cam 416 from the position on the center and allow the cone 406 to move away from the seat 452. To force the cone 406 away from the seat 452 , a spring 457 is provided. The spring 457 is preferably selected to provide sufficient force to overcome the force on the opposite side of the cone, which is produced by the compressed air within the chamber 454. Therefore, when the button 418 is released, the spring 457 overcomes the force produced by the compressed air within the chamber 454 and will quickly force the cone 406 away from the seat 452 and allow the valve to open. The valve will open quickly to allow the compressed air in cylinder 390 and tube 398 almost P1132 / 97MX instantly leave the central chamber 454 through the output port 450, where it is administered to the transducer unit 306 as described above. In this form, the valve unit 400 operates in a "fast" manner of action to provide a precise amount of gas to the transducer unit 306, in a rapid, sudden and irreversible manner, so that the powder forms aerosol in the form enough, so that it can be repeated and predicted. Optionally, the housing 302 may also include an electronic memory chip in conjunction with a speaker to provide audible instructions to a user regarding the operation of the apparatus 300. The chip, preferably, may be an EPROM, PROM or PAL chip having information. stored electronic, which is related to the operation of the apparatus 300, and which will be configured to operate during the deployment of the capture chamber 304. In this way, as a user prepares for a treatment, he will be provided with audible instructions . Preferred instructions include the deployment of camera 304, loaded apparatus with handle unit 336, breathing instructions, and the like, as well as other pertinent information as determined by the manufacturer. Although the above invention has been described in P1132 / 97MX certain detail by way of illustration and example, for purposes of clarity of understanding, it will be obvious that changes and modifications may be practiced within the scope of the appended claims.

P1132 / 97MX

Claims (30)

1. NOVELTY OF THE INVENTION Having described the present invention, it is considered as a novelty and, therefore, the content of the following CLAIMS is claimed as property: 1. A method for forming aerosol of a powder contained in a receptacle having a surface of access, the method comprises: coupling a powder inlet end of a feeding tube with a penetration found in the access surface; and flowing a high pressure gas stream past a portion of the feed tube, so that a predetermined amount of powder in the receptacle is fluidized, axially withdrawn through the tube and dispersed in the air stream of high speed to form an aerosol. A method according to claim 1, further comprising forming the penetration into the access surface before or during the insertion of the feed tube, wherein the high pressure air stream is made to flow past the feed tube to a angle within the range of 12.5 ° to 65 ° relative to the axial direction, and wherein the predetermined amount is at least 70% by weight of the amount of the medicament P1132 / 97MX powder initially present in the receptacle. A method according to claim 1, further comprising forming at least two separate penetrations in the access surface, wherein the other penetration allows the fluidizing air to sweep the receptacle, as the powder is extracted through the feeding tube, and further comprises advancing a plurality of receptacles containing dust, beyond the feed tube, whereby the powder can be extracted sequentially and dispersed from each receptacle, wherein a fixed volume of gas High pressure in the range of 2 ml to 25 ml (under normal conditions of temperature and pressure) is flowed beyond the outlet end, resulting in a discrete volume of aerosolized powder, and also comprises capturing virtually the entire volume of the aerosolized powder in a column capture chamber, wherein the powder is available for subsequent inhalation by a patient, and wherein at least a portion of the gas in the chamber is directed back to the receptacle to provide fluidizing gas, as the powder is being withdrawn through the feed tube. 4. Apparatus for forming aerosol of a powder, contained in a receptacle, having a punctifiable access surface, the apparatus comprises: P1132 / 97MX a base enclosure; a retainer within the base enclosure for supporting the receptacle at a fluidization location; a feeding tube within the base enclosure having an inlet end in a fluidization location; and means for flowing a stream of high pressure gas past a portion of the feed tube, wherein the powder is fluidized from a receptacle in the retainer and is axially withdrawn through the tube and dispersed in the container. high pressure air stream to form an aerosol. Apparatus according to claim 4, wherein the receptacle retainer comprises means for advancing a continuous blanket carrying a plurality of receptacles thereon, whereby the individual receptacles can move sequentially toward the fluidization location, wherein the means for advancing comprises a cartridge that can be removably mounted in the base enclosure, the continuous blanket is removably mounted in the cartridge, and wherein the feeding tube is fixedly mounted within the base enclosure and wherein the means for advancing comprises means for reciprocating the cartridge relative to the feeding tube. P1132 / 97MX 6. Apparatus according to claim 4, further comprising means for piercing a hole in the access surface, before or simultaneously with the insertion of the inlet end of the feeding tube., wherein the drilling means forms at least two separate holes in the access surface, where one hole engages the feed tube and the other allows fluidization air to enter the receptacle, as the powder is extracted through the feeding tube, wherein the piercing means comprises a fixed piercing mechanism which is positioned to drill holes in the access surface of a receptacle, as the cartridge is reciprocated relative to the feeding tube, and further comprises a column capture chamber in the base enclosure and a means for directing air from the interior of the column capture chamber to the receptacle, whereby the directed air will enter the receptacle to provide fluidizing air as it the dust is extracted from it. The apparatus of claim 4, further comprising a column capture chamber positioned on the base to capture the dust dispersed in the high velocity air stream, the chamber has a buccal part at an end remote from the base, and where the P1132 / 97MX means for flowing comprises a pump or other source of pressurized gas in the base enclosure, to suddenly release a pressurized volume of air to form the high velocity air stream. 8. Apparatus for forming aerosol of a powder, the apparatus comprising: a feeding tube having an inlet end, an outlet end and an opening defining an axial flow path therebetween; and a means for flowing at least one stream of high pressure gas past the outlet end, in a direction that converges with the axial flow path at an angle in the range of 12.5 to 65 °. The apparatus of claim 8, wherein the flowing medium includes at least one gas conduit that converges with the flow path, wherein the flowing medium provides a total aperture area (A ^) within the range of 0.05 mm2 to 0.3 mm2 and the feed tube has an opening area (A2) in the range of 0.5 mm2 to 10 mm, further comprising a diffuser tube extending from the outlet end of the feed tube and having an opening aligned coaxially with the opening of the feed tube, wherein the diameter of the diffuser tube opening increases in a direction away from the outlet end of the tube. P1132 / 97MX feeding, and where the opening of the diffuser tube diverges at an angle half of 2 or to 10 ° over a length in the range of 0.5 cm to 5 cm. Apparatus according to claim 8, further comprising a mixing volume positioned between the outlet end of the feed tube and the diffuser tube, the mixing volume has a constant diameter along its length, and wherein the volume of mixing has a length ranging from one to five times its diameter. 11. An improved method for aerosolizing a powdered medicament, the method is of the type wherein the powder is entrained and suspended in a flowing gas stream, wherein the improvement comprises inserting an inlet end of the feeding tube within of a receptacle containing the powdered medicament and flowing a stream of high pressure gas past an outlet end of the feeding tube, to induce air flow from the receptacle, through the tube, and into the flow of flowing gas, where the powdered medicament is entrained in the air flow through the tube and combined with the high pressure gas stream. 12. A feeding tube unit comprising: P1132 / 97MX a housing having a cavity; a flow direction member received in the housing cavity, wherein the flow path is defined between the housing and the member; and a feed tube positioned in an axial passage of the flow direction member. A feeding tube unit according to claim 12, wherein the flow direction member is a cone having a plurality of discrete flow direction channels formed on its outer surface, further comprising an end piece placed adjacent to it. at an inlet end of the feed tube and having a plurality of holes that provide fluid access to the flow path, and further comprising a flexible valve element positioned on the end piece to allow gas to flow from the outside of the unit to the inside of the unit, but that blocks the flow from inside the unit to the outside of the unit. 14. An improved apparatus for aerosolizing a powdered medicament, the apparatus is of the type having a housing and a source of pressurized gas to form aerosol of the powder, wherein the improvement comprises: a pressurization cylinder; a sliding piston inside the cylinder; P1132 / 97MX a release valve in communication with the cylinder; and a handle unit having a handle functionally attached to the piston, and a means for closing the valve, wherein the translation of the handle closes the valve and moves axially to the piston inside the cylinder to produce the pressurized gas. An improved apparatus according to claim 14, wherein the release valve comprises a valve rod connected to a valve cone, wherein the means for closing the valve comprises a roller cam adjacent to the valve rod for transferring the rod. of valve in order to close the valve, as the handle is translated radially outwardly from the housing, wherein the handle unit further comprises a lever joint that moves over the center to hold the roller cam against the valve stem and keeping the valve closed, wherein the handle unit further includes a joint between the handle and the piston, wherein the articulation reciprocates the piston, between a retracted position and a loaded position, inside the cylinder, as the handle is translated radially outwardly and radially inwardly relative to the housing, which further comprises a med io lock to avoid the translation P1132 / 97MX radially inward from the handle until the lever joint has moved over the center, and where the locking means comprises a rack and a ratchet. 16. An improved apparatus according to claim 15, further comprising a release button for moving the roller cam from the position over the center in order to open the valve, wherein the cylinder includes a unidirectional valve to allow air to enter to the cylinder as the piston is translated into the retracted position, and wherein the handle unit includes four articulations for attaching the handle to the housing, wherein the handle can move radially outwardly and radially inward relative to the housing, with a generally constant force. 17. An improved apparatus according to claim 14, wherein the powder medicament is held within a receptacle, and further comprising a feeding tube having an inlet end, an outlet end, an opening extending between same, wherein the inlet end can be inserted into the receptacle so that the compressed gas leaving the release valve can flow past the outlet end, where dust from the receptacle is drawn through the tube and dispersed in the compressed gas P1132 / 97MX flowing to form the aerosol, further comprising means for piercing at least one hole in an access surface of the receptacle, simultaneously with the insertion of the inlet end of the feed tube into the receptacle, wherein the means The perforation comprises a pair of pointed tongues, and wherein the tongues are each placed at an oblique angle relative to the access surface of the receptacle when the tongues are pierced to traverse the access surface. An improved apparatus according to claim 17, further comprising means for reciprocatingly moving the receptacle towards and away from the piercing means, wherein the translation means comprises a hinge on the center to lock the receptacle in place. , during the insertion of the inlet end of the feeding tube into the receptacle, and further comprising a positioning pin for aligning the receptacle in a preferred orientation relative to the piercing means, while inserting the inlet end of the feeding tube inside the receptacle. 19. An apparatus for forming aerosol of a preserved powder within a receptacle, having a punctifiable access surface, the apparatus comprises: P1132 / 97MX a housing; a source of pressurized gas; a capture camera attached to the housing; and a transjector unit maintained within the housing, the transjector unit has a means for piercing the access surface of the receptacle and for receiving pressurized gas to extract the powder from the receptacle and introducing it into the capture chamber. 20. An apparatus according to claim 19, wherein the transjector unit receives gas directly from the gas source and supplies powder directly to the capture chamber, without the powder passing through other portions of the apparatus, further comprising a interface seal between the transjector unit and the housing, whereby the pressurized gas can be passed from the housing to the transjector unit without a substantial loss of gas, and where the interface seal is angled relative to the central axis of the transjector unit. 21. An apparatus according to claim 19, further comprising a receptacle seal for forming a seal between the transjector and the receptacle, wherein the transjector unit is wedged to be received repeatedly within the housing in a single orientation, wherein the Capture camera is slidable in P1132 / 97MX axial direction on the housing, whereby the capture chamber can be placed in a collapsed position essentially covering the housing, or in an extended position forming an enclosure for receiving aerosolized dust, and further comprising at least one stop bolt in the housing and for at least one notch in the capture chamber, the stop bolt is received within the notch when the capture chamber is in the extended position. 22. An apparatus according to claim 19, wherein the capture chamber further includes a buccal part, further comprising a lid that is removably supported on the mouthpiece, and further comprising a seal between the lid and the mouthpiece. . 23. A receptacle for containing a powdered medicament, the receptacle is adapted to be received within an aperture in a housing of an aerosol forming apparatus, the receptacle comprising: a receptacle body having a punctifiable access surface; and a tongue extending from the receptacle body, wherein the receptacle body can be received within the opening with at least a portion of the tongue remaining outside the housing. 24. A receptacle according to claim 23, wherein the tongue includes an adapted wedge hole. P1132 / 97MX to receive an alignment pin in the aerosol forming apparatus. 25. An improved method for aerosolizing a powdered medicament, the method is of the type wherein the powder is entrained and suspended in a flowing gas stream, wherein the improvement comprises: providing a housing having a pressurization cylinder , a slide piston inside the cylinder, a release valve in communication with the cylinder, and a handle for axially moving the piston and closing the release valve; moving the handle away from the housing to axially translate the piston inside the cylinder to a retracted position and to close the release valve; move the handle back into the housing to move the piston to a charged position and create a pressurized gas; and release the valve to suddenly discharge the pressurized gas. 26. An improved method according to claim 25, further comprising preventing translation of the handle in the direction of the housing until the release valve is closed, further comprising holding the closed release valve while moving the valve. P1132 / 97MX again handle towards the housing, where the handle moves away from the housing and towards the housing being this generally parallel to the housing, and which further comprises supplying a generally constant force when the handle is moved towards the housing, when the gas is pressurized. 27. An improved method according to claim 25, further comprising introducing the powder that is suspended in the released gas into a capture chamber while simultaneously releasing a preselected amount of gas from the capture chamber, which further comprises providing a Transjector unit to receive the pressurized gas and form powder aerosol, and periodically remove the transjector unit from the housing for cleaning. An improved method according to claim 25, further comprising providing a receptacle having a punchable lid for holding the medicament and moving the receptacle towards the transjector unit, until the transjector unit penetrates the cap, which further comprises guiding the receptacle towards the transjector so that the transjector penetrates the cap in a known and predictable position, and further comprising keeping the receptacle with the transjector unit penetrating the cap, until after the valve is P1132 / 97MX free. 29. A method for aerosolizing a powdered medicament, the method comprising: providing receptacles having a receptacle body and a tongue extending from the receptacle body, wherein the powdered medicament is held within the bodies of the medicament. receptacle; inserting a receptacle into a housing having an opening, wherein the receptacle body is received within the opening and at least a portion of the tab is outside the housing; pierce the body of the receptacle and remove the powdered medicament in a stream of gas that can be inhaled; pull the tongue to remove the receptacle from the housing. 30. A method according to claim 29, wherein the housing has a reciprocating capture chamber for receiving the gas stream carrying the powder, and further comprising the deployment of the chamber prior to the insertion of the receptacle, and wherein the Deployment of the camera exposes the opening and where the camera can not be retracted until the receptacle is removed. P1132 / 97MX