HK1034231A1 - Application of container for a medicinal liquid to an atomiser and atomiser with said container - Google Patents

Abstract

A gas and liquid tight container for a medicinal fluid is new. A gas and liquid tight container comprises a film bag (11) closed at both ends, which can be deformed at a differential pressure below 30 kilopascals. The bag has a flange (15) which can be attached to a dispensing support, and the bag is sealed at one end by a weld seam. The medicinal fluid does not come into contact with air and is protected from light. A liquid removal point is located near the flange.

Description

Application of medical liquid container to atomizer and atomizer with container

The invention relates to the use of a gas-and liquid-tight medical liquid container for a propellant-free atomizer and an atomizer with such a container.

EP-0182094 a2 discloses a bottle-type package comprising a rigid outer container and an inner container disposed within the outer container and being an easily deformable bag for storing the filling material. The preform is produced by co-extruding two coaxial tubular parts comprising two thermoplastic materials not joined together, the preform being expanded in a blow mould with a weld seam on the flat bottom of the inner container, the flat bottom being formed on the outer container with a slit-type opening. The outer container and the inner container are positively locked in engagement in the region of the discharge opening, the package being produced essentially in one process step.

The filling material is discharged from the container using a pump arranged in the discharge opening, in which case the inner container is deformed as the volume decreases, air enters the space between the outer container and the deformed inner container through a slit in the flat bottom of the outer container, thus preventing a pressure drop in the intermediate space. The inner container is not in fixed contact with the outer container except in the region of the discharge opening. The package may be provided with a dip tube which extends almost to a flat bottom and holds the inner container in an extended state, the package being well usable and completely empty only when it is in a known spatial position.

Tubular bags of composite foil are described in EP-0620165 a 1. The composite foil comprises at least one externally disposed plastic foil and one internally disposed metal foil, tubular bags being closed at both ends in a bag-like configuration, the bags being provided with a desired breaking point for reliable opening at the site, the function of such tubular bags being to store the hardenable material, which is expelled from the tubular bag by means of a expelling device.

EP-0068653 a1 describes a flexible and compressible container for single use and made of a foil and usable with reusable suction bottles. The container is open at one end and closed at the other end by a weld and is provided with a clip. The clip is clipped into a gap on the bottom of the pipette bottle, which keeps the pouch container securely in the extended state of the pipette bottle.

The object of the invention is to use a gas-and liquid-tight container as a replaceable medical liquid cartridge for a propellant-free atomizer, which container for single use can be manufactured more economically without impairing its usability and is easier to handle.

The above object is achieved according to the invention by the use of a gas-and liquid-tight container as a replaceable medical liquid cartridge for a propellant-free atomizer having a discharge connection in the form of a hollow plunger, wherein the container comprises:

-a foil pouch closed at both ends, at least one of which is closed by a welded seam extending substantially transversely to the pouch axis, the foil pouch being deformed by external pressure when the pressure difference between the interior space of the container and its surroundings is below 300 mbar,

a flange of stable shape, which is sealingly arranged on the foil pouch and is designed as a detachable connection for placing the container on said discharge nipple,

-a guide passage in the flange,

wherein a sealing point and/or a press-fit structure surrounding the discharge connection is formed in the guide channel, and

in the region of the guide channel, there is a discharge point for the liquid, into which guide channel the hollow plunger projects during use, so as to be immersed in the medical liquid.

When the above application is carried out according to the invention, an atomiser with the above-mentioned container is obtained.

In one embodiment, the compressible foil pouches may be deformed and compressed by external pressure at a pressure difference below 150hPa (150 mbar) or preferably below 80hPa (80 mbar).

The foil pouch may be closed at both ends by a welded seam, in which case the flange with the stable shape is seal welded to the side of the foil pouch, preferably near one end of the foil pouch. The foil pouch can also be sealed closed at one end by a welded seam and at the other end by a flange having a stable shape. In this case, it is preferable that one end of the foil bag is welded to a flange having a stable shape on the periphery of the foil bag.

The flange with a stable shape may have different shapes and, if arranged on the foil bag end as a locking means, may have a rotationally symmetrical form and may be adapted to the dimensions of the foil bag end. The flange with a stable shape can be provided with a guide channel in which the discharge connection can be introduced. When the container is mounted, the outlet connection is arranged in the guide channel.

The guide channel may need to have a press fit comprising the discharge connection, which press fit is a part of the guide channel comprising a smooth inner side wall having an inner diameter slightly different from the outer diameter of the discharge connection. In another embodiment, a plurality of projections may be provided in a portion of the guide passage on the inner side wall, and the projections may be, for example, three projections having an elongated configuration and extending axially symmetrically. It is furthermore possible to provide a plurality of projections axially spaced apart from one another and extending in the azimuthal direction, for example forming two rings or comprising a plurality of ring portions. Also, the projections may extend in a spiral configuration; it may comprise a plurality of spiral portions distributed on the inner side wall of the guide passage, or a spiral portion having a larger circumference than the guide passage. Such a press fit enables the container to be fitted to the outlet nipple and the flange to be fitted sufficiently firmly to the outlet nipple, and furthermore, when the container is emptied, the container can be withdrawn from the outlet nipple without damaging the outlet nipple.

The flange having a stable shape may be formed of a rubber, metal or plastic material, preferably a thermoplastic material, to form the foil bag or the same plastic material inside the foil bag to produce the flange having a stable shape is suitable.

The weld on one or both sides of the foil pouch may be of U-shaped, V-shaped, or T-shaped configuration, extending substantially transversely to the pouch axis, and may extend over an axial portion of the pouch, thereby promoting a defined deformation of the foil pouch upon withdrawal of fluid.

The guide passage may be provided with a sealing location at one end or within it, which may be a ring located in a groove located on the inner side wall of the guide passage, which ring may be O-shaped or substantially rectangular in cross-section, which ring may be provided with a sealing lip. The ring may be constructed of an elastomer, a thermoplastic elastomer, or rubber. This sealing position closes a filling space or chamber of the container, which is fitted to the outlet nipple in an air-tight and liquid-tight manner to the ambient air, which makes it possible to withdraw the empty container from the outlet nipple, which sealing position is required if the sealing effect of the press fit is insufficient.

The discharge position is preferably in the form of a perforation, to which a pierceable membrane can be fitted, which membrane is pierced when the container is fitted to the discharge nipple, the membrane preferably being located between the sealing position and the liquid chamber or space in the foil pouch. The pierceable membrane may be arranged at or in one end of the guide passage, preferably directly at or near the end of the guide passage facing the liquid space, and it may be part of a flange or a foil pouch having a stable shape. If part of the flange, which can be produced simultaneously with the flange, the same plastic material as the flange can be used, the pierceable membrane acting as a primary locking means for the filling space in the foil pouch.

In a further embodiment, the discharge point can be sealed with a sealing foil which is pulled off before the container is fitted to the discharge spout or which is pierced when the container is fitted to the discharge spout.

The flange having a stable shape may be in one or more parts, preferably two-part flanges, the outwardly arranged part of the flange being sealingly connected to the foil bag. The outer part includes an opening that is sealed closed to the inner part. The two parts may be screwed together or joined by a snap connection or ultrasonic welding. The single component flange is similar to the two component flange but without any connecting components.

A flange with a stable shape can be produced simultaneously with the press-fit, the groove for the sealing position, and the pierceable membrane.

The foil pouch may consist of a tube, without a weld seam extending in the axial direction of the foil pouch, or it may be made of a foil and may have one or two weld seams extending in the longitudinal direction, either in the form of a flat pouch or a side-folded pouch, preferably a pouch with a weld seam extending in the longitudinal direction.

The weld seam on the foil bag may be 0.7 mm to 3 mm wide, the width being selected for seal integrity and weld seam durability, and the wide longitudinal seam on the foil bag may be bent after the welding operation so that it is substantially snug on the outside of the foil bag, and the foil bag is only slightly wider than the width of the unwelded portion between the weld seams.

The foil pouch may be constructed of a metal or metal alloy foil, preferably aluminum, gold, or copper, or a plastic material, preferably a thermoplastic material. In another embodiment, the foil pouch may consist of a composite foil of plastic material and metal, preferably two or three foils joined together, and may also consist of a plastic foil onto which a layer of metal, glass or ceramic is applied, for example by vapour deposition. The foil of plastic material or metal may have a thickness of several micrometers, the thickness of the vapour-deposited layer of metal, glass or ceramic being in the sub-micrometer range.

The composite foil formed by the two foils may be a metal foil and a plastic foil joined together, the metal foil forming the inner or outer layer of the composite foil, in another embodiment the composite foil is formed by two different plastic foils.

The composite foil containing the three foils is preferably a foil made of two plastic foils with a metal in between, all three foils being joined together. Instead of using a metal foil, the composite foil can have a layer of glass or ceramic, for example silicon oxide (SiO) produced by vapour deposition on a plastic foil_x)。

In another embodiment, the inner foil of the composite foil is composed of a copolymer, for example a polyethylene copolymer of ethylene-acrylic acid. The outer plastic foil of the composite foil is preferably a plastic material, such as polyethylene terephthalate, having a higher melting point than the inner foil plastic material, which facilitates welding of the inner foil plastic material weld seam during production of the foil pouch.

In the composite foil, there may be an adhesive layer between the two foils.

The foil pouch may be formed from a plastic foil 20 to 100 microns thick, or a composite foil having an inner foil of plastic material 20 to 100 microns thick and an outer foil of metal 8 to 20 microns thick, or a composite foil having an inner foil of plastic material 20 to 100 microns thick, an intermediate foil of metal 8 to 20 microns thick, and an outer foil of plastic material 10 to 40 microns thick.

In the case of composite foils with a metal layer, the welding seams on the foil bags and the welding points between the foil bags and the flanges with a stable shape, which are preferably pressed together under heat, are produced by known methods such as thermal welding, ultrasonic welding or induction welding, as described in EP-0111131 and EP-0130239, for example.

The flange, which has a stable shape and is made of rubber or metal, can be connected to the foil pouch by gluing or possibly vulcanization.

The container may be arranged in a stable-shaped casing comprising metal or plastic material, one end of which may or may not be detachably connected to a flange having a stable shape, and the other end of which may be closed with a bottom. The housing may be substantially completely enclosed around, but it includes at least one opening, or there may be a gap where it connects to the flange. The housing may also be in the form of a basket having a stable shape and having a plurality of openings. Instead of the housing, the container can be arranged in a U-shaped stirrup with a stable shape, wherein the ends of the legs of the U-shaped stirrup are fixed to flanges with a stable shape and the legs are longer than the foil bags.

A container arranged in a housing is connected to the housing only on a flange having a stable shape, one or both ends of a foil pouch closed with a welded seam being not connected to the housing.

When liquid is moved from the container into the discharge nozzle, the foil bag is pressed flat by the external pressure, and air enters the space between the housing and the foil bag through the opening in the housing or through the gap between the housing and the flange with a stable shape and provides a pressure balance, which means that no valve is needed for the foil bag and the liquid in the foil bag is not in contact with the air.

The foil pouch is diffusion-sealed to the medical liquid and its components and to gases, the material used for the foil pouch and the possible composite foil structure being suitably selected, with diffusion sealing according to the invention meaning that the liquid loss of the container due to diffusion is less than 0.6 mg per day (measured with ethanol at room temperature), preferably less than 0.4 mg, particularly preferably less than 0.2 mg, in particular less than 0.1 mg.

The foil, preferably a weldable foil, or the inner side of the foil pouch, is in contact with the liquid introduced into the pouch, the material of which is chosen to be non-erodible and non-harmful to the liquid.

The foil or layer, which is applied, for example, by vapour deposition, is a diffusion barrier preventing diffusion of the liquid or component and diffusion of gases into and out of the foil pouch, which diffusion barrier is protected against mechanical damage and tearing when the foil is bent with another plastic foil applied over the diffusion barrier, so that diffusion of the liquid or gas is permanently prevented.

Since the foil pouch is diffusion-tight to gases, the pressure drop in the foil pouch due to the discharge of liquid cannot be compensated for by the gas that has diffused in, and the foil pouch is reliably compressed even with a very slow discharge of liquid from the container. The liquid may also be withdrawn from the foil pouch in a number of sub-portions, e.g. 200 meters, over a long period of time, e.g. three months.

The container arranged in a substantially closed housing is not damaged from the outside and is not damaged during storage and assembly on the outlet connection. A substantially closed housing or basket-shaped housing with a plurality of openings or a stirrup with a stable shape facilitates storage and handling of the container of the thin-thickness foil pouch when fitted to the discharge nozzle and when the empty container is withdrawn from the discharge nozzle.

The discharge connection is, for example, a hollow plunger of a nebulizer for medical liquids, of the type described in DE-19536902.5 and WO-97/12687 (in particular in fig. 6a and 6 b). The hollow plunger of the atomizer is constructed in the form of a discharge nozzle for the medical liquid contained in the container according to the invention, which container is fitted onto the hollow plunger, which is preferably fitted on the atomizer axis, in which case the end point of the hollow plunger projects into the discharge position and is thus immersed in the medical liquid. The sealing position in the flange with a stable shape is such that the interior of the container is closed in a sealing manner against the outer wall of the hollow plunger, which press-fit can mechanically hold the container sufficiently firmly on the hollow plunger.

Between the container and the discharge connection, it is possible to provide a detachable positive-locking connection between the flange having a stable shape and the discharge device, such as an atomizer, without the use of this press-fit (positive-locking connection) or in addition to this press-fit. Such a connection may be in the form of a push-on snap connection comprising a plurality of snap hooks mounted in a connection portion of the discharge device. When the container is loaded into the dispensing device, the snap hooks engage into the opening of the flange, for example into a circumferentially extending groove or behind the edge of the flange having a stable shape. The snap head is preferably rounded or inclined in both directions of container movement so that an empty container can be removed with the appropriate force and a filled container can be loaded into the discharge device with the appropriate force.

The container according to the invention is particularly suitable as a replaceable cartridge for a propellant-free atomizer, which container is filled with an inhalable medicinal solution. The full volume of the container may be 0.5 ml to 5 ml, preferably 1 ml to 4 ml, particularly preferably 1 ml to 3 ml, or 2 ml to 4 ml. These solutions are expelled in a partial manner, with individual doses of 10 to 50 microliters, preferably 15 to 20 microliters.

The housing may be 10 mm to 30 mm in diameter, preferably 12 mm to 17 mm, and the length of the container including the portion of the flange having the stable shape protruding out of the housing is 20 mm to 60 mm, preferably 30 mm to 50 mm.

The container according to the invention serves as a primary packaging means for containing a medical liquid, e.g. comprising a medicament dissolved in a solvent, e.g. water, ethanol, or a mixture thereof. The medicaments used were as follows: berotec (phenoprophyrin-hydrobromide; 1- (3, 5-dihydroxyphenyl) -2- [ [1- (4-hydroxybenzyl) -ethyl ] -amino ] -ethanol-hydrobromide), atropine (Atrovent) [ ipratropium bromide ], Berodual (Berodual) (a combination of phenoprophyrin-hydrobromide and ipratropium bromide), Salbutamol (or Albuterol)), combiframe (Combivent), oxivan (Oxivent) [ scopolamine (oxiranum bromide) ], Ba679(tiotropium bromide), BEA 2108 (di- (2-thienyl) -glycoltropenol ester), 9-desfluroxyphyllum (flusolid), budesonide (budesonide), and other.

WO-98/27959 describes the production of stabilized aqueous pharmaceutical formulations for inhalation of propellant-free aerosols, please refer to the formulations applied therein and listed in the examples.

Suitable pharmaceutical preparations in ethanol solution are listed, for example, in WO-97/01329. Reference is made in particular to the active substances specified therein (see pages 2 and 3 therein) and to the stabilizing formulations in the claims.

The container according to the invention has the following advantages:

can be manufactured economically, is suitable for single use and requires only a small amount of material.

Can be produced in a sterile state and filled and sealed in a sterile state.

-for inhalation the medicament is in the form of ethanol, ethanol/water or aqueous solution.

-draining the liquid in a sterile state; in which case no air is drawn into the container and the liquid does not contact air, oxygen or carbon dioxide.

The container according to the invention allows to expel the medicinal liquid without air bubbles.

Maintaining a seal against diffusion of liquids and gases.

Can be stored in a filled state for several years according to the individual relevant medicament and meet all official prescriptions.

Easily deformable under slight pressure, remaining flat and substantially pulled out in the compressed state, and returning to its original length after emptying.

No valve member is needed for pressure equalization after partial liquid discharge.

The container can be substantially emptied, even in a wave position and upside down.

The foil pouch is only connected to the flange with a stable shape, and not to the housing if present.

By varying the length and/or diameter of the foil bag, its filling volume can be easily adjusted to a predetermined value within a specific range.

Before the single or second weld seam is produced, it can be filled before locking, without a separate locking device.

The container may or may not use a housing.

The container placed in the housing is not damaged from the outside.

By means of an opaque foil bag or an opaque casing which is completely closed around it, the liquid in the foil bag is protected from light.

In a simple manner and without rotation, the discharge device is loaded and unloaded.

The container of the present invention is described in detail with reference to the accompanying drawings and examples.

Fig. 1 to 3 are perspective views of different versions of a foil pouch closed at both ends.

Fig. 1 shows a tubular bag 11 having a cylindrical flange 12 of stable shape, and a U-shaped transverse seam 13 closing one end of the tubular bag and extending partly in its longitudinal direction. The flange edge 14 is connected to the other end of the tubular bag and a hole 15 is arranged on the flange axis, into which hole 15a discharge nipple can be introduced.

Fig. 2 shows a sealed-edge bag 21, which consists of two foils laminated to one another and has two welded seams 22 extending in the longitudinal direction of the bag and having a welded seam 23 extending in the transverse direction at one end and being connected at the other end to a stably shaped and fish-shaped flange 24, in the center of which a hole 25 is arranged, into which hole 25 a discharge nipple can be inserted.

Fig. 3 shows a side-folded bag 31 having folds on both longitudinal sides, which is closed at both ends by respective transversely extending weld seams 32, to which a flange 33 of stable shape is welded on one flat side, the discharge nozzle being insertable into a hole 34 of the flange.

Fig. 4 to 7 are cross-sectional views of different embodiments of a flange having a stable shape.

Fig. 4 is a longitudinal section through a one-piece flange 41 with a cylindrical guide passage 42, which guide passage 42 is press-fitted to the cylindrical outlet nipple. The outer end of the guide channel is inclined and the other end is closed by a membrane 43 inclined to the axis of the flange, which is produced in a single process, the edge of the flange being connected to a foil pouch 44.

Fig. 5a shows a multi-part cylindrical flange in longitudinal direction, and fig. 5b shows a cross-section taken along the line a-a in fig. 5a, the lower part 51 being connected to a foil bag 53, the upper part 52 being fitted in the opening of the lower part, the upper part being provided with a guide channel 54 in which three elongated ridges 55 extend in axial direction of the flange and act as a press fit for the discharge nipple and as a seal for the annular ridge 56. The lower part 51 and the upper part 52 are welded together at their contact surfaces 57, the entrance of the oblique insertion surface with the guide passage being sealed by a sealing foil 58.

Fig. 6 shows a multi-part cylindrical flange of stable shape, with the lower part 61 connected to the foil bag 63, the upper part 62 projecting into the annular lower part, an O-ring 64 arranged in the upper part 62 for sealing, which O-ring 64 is held in place by a gland 65 pressed in place, the opening in the gland 65 serving as a guide channel for the discharge nipple, and a peripheral extension ridge 66 arranged in the upper part 62 in pressed-in fashion inside the seal. The outlet nipple 67 is inserted into the guide channel, the container is held on the outlet nipple by a ridge-type press-fit 66, and the lower part 61 and the upper part 62 are welded together at their contact surfaces 68.

Fig. 7 shows a further multi-part flange, the lower part 71 being connected to a foil bag 73, the upper part 72 being arranged in an annular lower part provided with a shoulder, the upper part comprising a flat ring 74 as a seal, which flat ring 74 is held in place by a gland 75 pressed into place. A guide passage 76 for the discharge nipple is arranged below the flat seal. The press fit includes two ridges 77 in the guide channel extending around it in a screw-like configuration. The membrane 78 is perpendicular to the axis of the flange near the lower end of the guide channel and the membrane 78 is pierced when the container is mounted on the discharge nipple. The membrane is made in one process with the upper part, which are joined together on their contact surfaces 79.

Fig. 8a is a cross-sectional view of a one-part flange 81 with a stable shape and arranged on the side of a foil pouch 82, which flange has an opening 83 which serves as a press-fit for the discharge nipple, the flange being sealed on its outer side by a sealing foil 84. When the container is mounted on a discharge nozzle 85 having a beveled end, the foil pouch is pierced at the inner end 86 of the guide passage.

Fig. 8b shows a cross-sectional view through a commercially available laminated foil comprising three layers constituting the foil pouch: the inner foil 87 is polyethylene (40 microns thick), the middle foil 88 is a diffusion barrier for aluminum (12 microns thick), and the outer foil 89 is polyethylene terephthalate (12 microns thick).

Fig. 9 to 11 show various embodiments of a weld seam with which the foil pouch is closed at least at one end, shown in side view and in cross-sectional view (fig. 9b and 10b) or in top view of the pouch end (fig. 11 b).

Fig. 9a shows a U-shaped welded seam 91 which extends in the longitudinal direction of the foil pouch 92 and on one side extends in the longitudinal direction into a welded seam 93 of the foil pouch. Fig. 9B is a cross-sectional view through the foil pouch, taken along line B-B in fig. 9a, with the inner layer of the folded multilayer foil 94 being welded in the weld.

Fig. 10a shows a V-shaped weld seam 101 extending in the longitudinal part of the foil pouch, which in this case comprises a tubular foil without longitudinal seams. Fig. 10b shows a cross-sectional view through the foil pouch, taken along the line C-C in fig. 10a, with the folded single-layer foil 103 welded in the weld.

Fig. 11a shows a side view of a T-shaped welded seam 111, while fig. 11b shows a top view at the welded end of the foil pouch 112, the three legs of the T-shaped seam having overall a length equal to the total width of the flattened foil pouch outside the T-shaped seam.

The foil pouch to which the U, V, T-type seam is welded is no larger than the diameter of the housing into which it is inserted in the region of the transverse seam.

The filling and manufacture of the container of the present invention is shown schematically in the perspective views of fig. 12 and 13.

A folded foil strip has a longitudinal welded seam on its cut side, which is cut into sections and formed into a tube (fig. 12 a). The lower part of the two-part cylindrical flange produced by the injection moulding process is welded to one end of this type of tubular section, which is welded at the other end with a U-shaped transverse seam (figures 12b and 12 c). The finished container (fig. 12c) is pushed into a cylindrical aluminum shell (fig. 12d) with the rim of the shell pressed into a groove or channel at the edge of the cylindrical flange. The container is fixedly joined to the housing in such a way that the empty container in the housing is filled with fluid through a flanged lower part provided with an opening (fig. 12e), after which the flanged upper part is pressed into the lower part (fig. 12f) and the two parts are sealingly joined together, and the finished part produced (fig. 12g) is ready for mounting on the discharge nipple.

Another manufacturing method is shown in fig. 13, where a slit foil pouch tube section (fig. 13a) is connected at one end to a one-piece flange closed with a sealing foil (fig. 13 b). The container is filled with fluid through the other open end of the foil tube (fig. 13c), which is closed by a U-shaped transverse seam (fig. 13d), and is enclosed in a housing of plastic material (fig. 13e), which is snap-fitted to a flange edge of stable shape, and the finished part (fig. 13f) is ready for fitting onto the discharge nipple.

Fig. 14 is a partial cross-sectional view of an exemplary container 141 filled with a fluid and disposed in a metal housing 142 according to the present invention. The foil bag is welded at one end with a U-shaped seam 143 and at the other end to the edge 144 of the lower part 145 of the two-part cylindrical flange with a stable shape. The metal shell has a bottom 146 in which there is a hole through which air can pass into the space between the metal shell and the foil pouch. The open end of the housing is pressed into a groove or channel 147 in the edge of the lower member 145. The housing is fixedly attached to a flange, the upper part 148 of which fits into the opening of the lower part, the lower and upper parts being connected by a snap-action lock 149 and provided with a flat seal 150. The guide channel 151 is closed at its inner end by a membrane 152 and at its outer end by a sealing foil 153.

The metal housing shown in fig. 14 is made of aluminum, and is 43 mm long with an outer diameter of 17 mm and a wall thickness of 0.5 mm. The two-part flange consists of polyethylene and is produced in an injection moulding process, the flange upper part comprising the membrane being produced in one step in this procedure, the guide channel in the flange upper part being 2.5 mm in internal diameter at the press-fit location and fitting firmly on the discharge connection.

Fig. 15a and 15b show a detachable, form-fitting, insertable latching connection between a flange of the container with a stable shape and a connection of the dispensing device.

Fig. 15a shows a cross-sectional view through the outlet connection 154, with the outlet connection 67 on its axis. The discharge connection is surrounded by snap hooks 155 with a circular cross-section snap head 156, which are separated from one another by gaps and can comprise an azimuthal width of 10 to 60 degrees. A part 157 without any snap head, which bears in a form-fitting manner on the outer wall of the insertion container, is located between the snap hooks 155.

Fig. 15b is a side view of the container end in the housing 142 with its stably shaped flange 148 extending out of the housing, and corresponding to fig. 14, the housing has a peripheral extension 158, preferably in the region of the flange member extending into the housing. When fitted into the coupling part 154, the snap head 156 of the container is inserted into the groove 158, so that the container is detachably connected to the coupling part in a form-fitting manner.

Fig. 16a and 16b show a further embodiment of a detachable, form-fitting, insertable latch connection.

Fig. 16a shows a cross-sectional view through a discharge device connection 161, which connection 161 contains a discharge nipple 67 on its axis. The discharge nozzle is surrounded by a plurality of clip-type snap hooks 162 having snap heads 163, the flanks of the snap hooks 163 being inclined in the two directions of movement of the container, the snap hooks being arranged at different azimuthal angles with respect to one another.

Fig. 16b is a side view of the container end in the housing 142 with its stably shaped flange 148 extending from the housing. When the container is fitted into the connecting portion 154, the snap head 163 engages into the peripheral extension 147 of the flange 148 having a stable shape protruding out of the housing part, so that the container is detachably connected to the connecting portion in a form-fitting manner.

Claims (32)

1. Use of a gas-tight and liquid-tight container as a replaceable medical liquid cartridge for a propellant-free atomizer having a discharge nozzle in the form of a hollow plunger, wherein the container comprises:

-a foil pouch (11, 21, 31) closed at both ends, at least one of which is closed by a weld seam (13, 23, 32) extending substantially transversely to the pouch axis, the foil pouch being deformed by external pressure when the pressure difference between the interior space of the container and its surroundings is below 300hPa (300 mbar),

-a flange (15, 25, 34) of stable shape, sealingly arranged on the foil pouch and designed as a detachable connection for placing the container on said discharge nipple (67),

-a guide passage (42, 54) in the flange,

-wherein a sealing point (56, 64, 74) and/or a press-fit structure (55, 66, 77) surrounding the discharge nipple are formed in the guide channel, and

in the region of the guide channel, there is a discharge point for the liquid, into which guide channel the hollow plunger projects during use, so as to be immersed in the medical liquid.

2. Use according to claim 1, characterized in that: the foil bags are deformable at a pressure difference below 150hPa (150 mbar).

3. Use according to claim 1 or 2, characterized in that: the foil pouch (31) is closed at both ends by a welded seam (32), and the container has a stably shaped flange (34) sealingly mounted to the foil pouch (31).

4. Use according to claim 1 or 2, characterized in that: the foil bags (11, 21) are sealed closed at one end by a welded seam (13, 23) and at the other end by a flange (12, 24) having a stable shape.

5. Use according to claim 1 or 2, characterized in that: the flange (41, 51, 61) of the container, which has a stable shape, is rotationally symmetrical and dimensioned to the dimensions of the foil pouch, which is closed at one end by means of the flange.

6. Use according to claim 1 or 2, characterized in that: the flange having a stable shape is composed of a thermoplastic plastic material.

7. Use according to claim 1 or 2, characterized in that: the weld seam (91, 101) is of a U-shaped or V-shaped configuration extending primarily transversely to the bag axis and partially axially along the bag, or the weld seam (111) is of a T-shaped configuration.

8. Use according to claim 1 or 2, characterized in that: a ring (64, 74) of elastomeric material is disposed in the groove at the seal location.

9. Use according to claim 1 or 2, characterized in that: the discharge portion is in the form of a perforated portion.

10. Use according to claim 1 or 2, characterized in that: the discharge portion is provided with a pierceable membrane.

11. Use according to claim 1 or 2, characterized in that: the discharge portion is provided with a pierceable membrane, wherein,

the membrane (43, 78) being arranged at the end of or in the guide passage, or

-the membrane (86) is part of a foil pouch.

12. Use according to claim 1 or 2, characterized in that: the discharge area is sealed with a sealing foil (58, 84, 151).

13. Use according to claim 1 or 2, characterized in that: the foil bag (11, 21, 31) is made of plastic material or metal alloy foil, or

Made of a composite foil of plastic material and metal, or

Made of plastic foil with a metal, glass or ceramic layer.

14. Use according to claim 1 or 2, characterized in that: the foil bag has an inner foil of plastic material and an outer foil of metal, or has two layers of foils of different plastic materials.

15. Use according to claim 1 or 2, characterized in that: the foil bag is provided with

An inner foil made of a copolymer, and

an anti-diffusion intermediate foil consisting of a metal or plastic material or an anti-diffusion intermediate layer consisting of a metal, glass or ceramic material, and

-an outer foil of a plastic material having a melting point higher than the melting point of the inner foil.

16. Use according to claim 1 or 2, characterized in that:

the foil pouch is made of a plastic foil 20 to 100 micrometers thick, or a composite foil having an inner plastic material foil 20 to 100 micrometers thick and an outer metal foil 8 to 20 micrometers thick, or a composite foil having an inner plastic material foil 20 to 100 micrometers thick and an intermediate metal foil 8 to 20 micrometers thick and an outer plastic material foil 10 to 40 micrometers thick.

17. Use according to claim 1 or 2, characterized in that: the fill volume is 0.5 ml to 5 ml.

18. Use according to claim 1 or 2, characterized in that: the fill volume is 1 ml to 4 ml or 2 ml to 4 ml.

19. Use according to claim 1 or 2, characterized in that the container is arranged in a metal or plastic housing (142) with a stable shape connected to its flange.

20. Use according to claim 1 or 2, wherein the container is arranged in a housing of stable shape with a diameter of 10 mm to 30 mm.

21. Use according to claim 1 or 2, wherein the container is arranged in a housing having a stable shape, from which the flange extends, wherein the overall length is 20 mm to 60 mm.

22. Use according to claim 19, characterized in that: the housing is substantially completely closed and comprises an opening or is provided with a gap at the location of the connection to the flange, or the housing is designed as a basket with a plurality of openings, or the housing is designed as a stirrup.

23. Use according to claim 19, characterised in that in the flange with a stable shape there are peripheral extension grooves (158, 147).

24. Use according to claim 1 or 2, wherein said container serves as an original package for the removal of medical liquid from the foil pouch in multiple portions.

25. Use according to claim 1 or 2, wherein the container is used as a primary package for medical liquids to be taken out in portions in doses of 10 microliter to 50 microliter.

26. Use according to claim 1 or 2, wherein the container is provided as a cartridge containing an inhalable pharmaceutical formulation in the form of ethanol or ethanol/water or aqueous solution.

27. Use according to claim 1 or 2, wherein the container is provided as a cartridge for an inhalable pharmaceutical formulation containing one or more of the following active substances, such as: bexate (phenoxelol-hydrobromide); 1- (3, 5-dihydrophenyl) -2- [ [1- (4-hydroxybenzyl) -ethyl ] -amino ] -ethanol-hydrobromide), atropine (ipratropium bromide), dyclonidine (a combination of phenoprophyramine-hydrobromide and ipratropium bromide), albuterol (or albuterol), combivant (combivant), oxivan (scopolamine bromo), Ba679(tiotropium bromide), BEA 2108 (bis- (2-thienyl) -tropenol glycolate), beclomethasone (Beclomethason), 9-defluorinated fluocinolone acetonide, budesonide.

28. Use according to claim 1 or 2, wherein the container is provided with a pharmaceutical formulation for treatment of a disease by an inhalable substance.

29. Use according to claim 1 or 2, characterized in that the atomiser is a discharge device with a connection into which the receptacle can be inserted by means of a detachable, form-fitting, insertable snap-in connection between the connection (154, 161) and a flange (148) of the receptacle with a stable shape.

30. Use according to claim 29, wherein: in the flange having a stable shape there is a peripheral extension (158, 147) in which snap heads (156, 163) of snap hooks (155, 162) provided on the connection portion (154, 161) engage when the container is fitted into the connection portion.

31. A propellant-free atomiser with a replaceable medical liquid cartridge, wherein the medical liquid cartridge is an air-tight and liquid-tight container and the atomiser has a discharge nozzle in the form of a hollow plunger, wherein the container comprises:

-a foil pouch (11, 21, 31) closed at both ends, at least one of which is closed by a weld seam (13, 23, 32) extending substantially transversely to the pouch axis, the foil pouch being deformed by external pressure when the pressure difference between the interior space of the container and its surroundings is below 300hPa (300 mbar),

-a flange (15, 25, 34) of stable shape, sealingly arranged on the foil pouch and designed as a detachable connection for placing the container on said discharge nipple (67),

-a guide passage (42, 54) in the flange,

-wherein a sealing point (56, 64, 74) and/or a press-fit structure (55, 66, 77) surrounding the discharge nipple are formed in the guide channel, and

in the region of the guide channel, there is a discharge point for the liquid, into which guide channel the hollow plunger projects during use, so as to be immersed in the medical liquid.

32. A nebulizer according to claim 31, wherein: the foil bags are deformable at a pressure difference below 150hPa (150 mbar).