UA65606C2 - Packaging for medicinal liquid - Google Patents

Abstract

According to the invention, film bags are used as primary packaging for liquids and permit the liquid to be withdrawn without considerable exertion of force. The invention provides a container for a medicinal liquid which is both gas and liquid tight and which can be stored for many months. The container is comprised of a collapsible film on which a dimensionally stable flange (12) is attached. The flange is designed so that it can be attached onto a dispensing support (67). The container can be situated in a dimensionally stable sleeve (142). The medicinal liquid does not come in contact with air and is protected against the effects of light. The medicinal liquid can be withdrawn from the film bag, for example, in many partial quantities over a long period of time, whereby each partial quantity is reduced into an aerosol by means of an atomizer.

Description

The present invention relates to a hydraulically and gas-tight container for medical fluid.

The purpose of the invention is to provide the possibility of more economical production of such containers intended for one-time use and easier handling of them without reducing their consumer properties.

Application EP 0182094 A2 describes a package in the form of a bottle, which has a non-deformable external capacity and an internal capacity that is located in it, which is made in the form of an easily deformable bag for the filler. The workpiece is obtained in the form of two sections of simultaneously extruded coaxial sleeves.

Both of these areas are made of two thermoplastics that do not come into contact with each other. The workpiece is formed by expanding by blowing in an inflatable mold. There is a weld in the flat bottom of the internal capacity.

The flat bottom, molded to the external capacity, has a slit-like opening. In the area of the hole for taking the liquid, the external capacity and the internal capacity are connected to each other with a geometric closure. This package is made mainly in one work operation.

The filler is removed by a pump located in the hole for taking liquid, while the internal capacity is deformed with a decrease in its volume. Through an open gap in the flat bottom of the outer container, air flows into the space between the outer container and the deformed inner container, preventing rarefaction in this intermediate space. Except for the area of the hole for taking liquid, the inner capacity has no permanent contact with the outer capacity. The package may be provided with a submersible tube which reaches almost to the flat bottom and which holds the internal capacity in an elongated position. Optimal use and complete emptying of this packaging is possible only with its specific spatial location.

In the application ER 0620165 A! described package, made in the type of bag from a sleeve of multilayer film.

The multilayer film is made of at least one outer layer of polymer film and an inner layer of metal foil. The package is sealed from both ends in a bag type manner. The package has a thinner section provided for its opening, which allows you to conveniently open it in this place. Such a bag is used to store the hardening/curing mass, which is squeezed out of the bag by an extruding device.

In the application ER 0068653 A!7! described is a single-use, flexible container made of film and/or foil, and crumpled/flattenable, used in a reusable suction cup. One end of this capacity is open, the other end is sealed with a weld and has a tab. The tongue is clamped in the slot at the bottom of the suction cup, which ensures that the capacity made according to the package type is kept in the suction cup in a permanently elongated position.

Proceeding from the above, the basis of this invention was the task of creating a hydraulically and gas-tight container for a medical liquid, the volume of which can be filled in accordance with its intended purpose and which, with a small dilution, plastically and irreversibly crumples/flattens in a given way , can be almost completely emptied.

The specified task is solved according to the invention with the help of a hydraulically and gas-tight container for medical liquid, which is distinguished by the presence of: a sealed on both sides, made of film and/or foil package, which is deformed by external pressure, and which flattens/crumples when there is a pressure difference between the internal cavity capacity and the space surrounding it is less than 300 hPa (30 Ombar), a non-deformable flange tightly attached to a package made of film and/or foil and made in the form of a removable connecting element for attaching the capacity to the nozzle for taking liquid, at least one weld that closes a package made of film and/or foil from at least one end, and which passes mainly perpendicular to the axis of the package, the sealing area in the non-deformable flange and the place of taking the liquid in the area of the non-deformable flange.

In another embodiment, the flattened/crumpled package made of film and/or foil can be deformed and flattened/creased by external pressure already at a pressure drop of less than 150 hPA (150 mbar), or preferably less than 80 hPA (8 Ohmbar).

A bag made of film and/or foil can be sealed at both ends with a welded seam. In this case, a non-deformable flange is hermetically welded to the side of this package, preferably near the end of the package. However, the package made of film and/or foil can also be hermetically sealed with a weld seam at one end, and closed with a non-deformable flange at the other end. In this case, the end of the package is welded to a non-deformable flange, preferably along its perimeter.

A non-deformable flange can be formed in various ways. In the case when it is located at the end of a film and/or foil package as its cover, it can be formed rotationally symmetrically, according to the size of the end of the package. A non-deformable flange can be provided with a guide channel, into which a nozzle is inserted for taking liquid and in which this nozzle is located in the fitted capacity.

It may be advisable to provide the guide channel with a press fit that covers the nozzle for taking the liquid. The press fit can be a section of the guide channel consisting of a smooth wall with an inner diameter only slightly different from the outer diameter of the nozzle for taking liquid. In the following version, several protrusions can be provided on the section of the guide channel, on its inner wall. These protrusions can be, for example, three symmetrically located and elongated protrusions running in the axial direction. Further, several protrusions located along the axis at some distance from each other, passing in the azimuthal direction, creating, for example, two rings, or consisting of several ring sections can be provided. In addition, the protrusions can take place in the form of a spiral; they can consist of several spiral sections distributed along the inner wall of the guide channel, or from one spiral section, the length of which is longer than the perimeter of the guide channel. Such a press fit allows you to put the capacity on the nozzle for taking liquid, as well as ensure a fairly tight fit of the non-deformable flange on the nozzle. In addition, the capacity after its emptying can be removed from the nozzle to take liquid without damaging the nozzle.

The non-deformable flange is made of rubber, metal or plastic, preferably thermoplastic. It may be appropriate to make a non-deformable flange from the same plastic as the film and/or foil package or the inside of the package.

A welded seam on one or both sides of a package made of film and/or foil can be made O-; X- or T-shaped; it runs mainly perpendicular to the axis of the package. In part, it can have an extension in the direction of the axis of the package, thus contributing to a certain deformation of the package when taking liquid.

A sealing area may be provided inside or at one end of the guide channel.

The sealing section can be made in the form of a ring located in a groove provided in the inner wall of the guide channel. The ring can have a round or mostly rectangular cross-section. If necessary, the ring is provided with a sealing edge. The ring can be made of elastomer, thermoplastic elastomer or rubber. The sealing section hydraulically and gas-tightly closes the filling volume of the capacity fitted on the nozzle for taking liquid from the ingress of ambient air. It allows you to withdraw the emptied capacity from the nozzle. The sealing section is necessary in case the sealing action of the press fit is insufficient.

The place where the fluid is taken is mostly performed as a puncture site. At the puncture site, a punctured membrane can be provided, which protrudes when the capacity is placed on the nozzle for taking liquid. The membrane is preferably located in a bag of film and/or foil between the sealing area and the cavity that is filled with liquid. The perforated membrane can be located at one of the ends or inside the guide channel. Preferably, it is located directly at the end of the guide channel or near its end facing the cavity that is filled with liquid. It can be part of a non-deformable flange or part of a package. In case it is part of a non-deforming flange, it can be manufactured simultaneously with this non-deforming flange. It can be made of the same plastic as the non-deformable flange. The perforated membrane serves for the cavity of the bag, which is filled, as well as ensuring the originality of the lid package.

In another embodiment, the place of taking the liquid can be sealed with a heat-sealing film or foil, which is removed before placing the container on the nozzle for taking liquid or the container that is punctured when it is placed on this nozzle.

The non-deformable flange can be solid or folded. In the preferred version, the folded flange can be made of two parts. The outer part of the flange is hermetically connected to the package made of film and/or foil. This outer part has an opening that is hermetically closed by the inner part. Both parts can be screwed to each other using threads or connected to each other by a latch or ultrasonic welding. A solid flange is similar in design to a flange made of two parts, but does not have connecting elements.

A non-deformable flange can be simultaneously manufactured with a press fit, a groove for the sealing area and a pierced membrane.

A package made of film and/or foil can be made of a sleeve that does not have any welding seam in the axial direction of the package. In addition, this package may be made of a single film and/or foil and have one or two longitudinal welds. It can be made in the form of a flat bag, or in the form of a bag with side folds. A package with a longitudinal weld is preferred.

Welded seams on bags made of film and/or foil can be from 0.7 mm to 3 mm wide; their width is selected depending on the requirements for tightness and strength of the seam. The wide longitudinal seams on the package can be folded over after welding so that they practically fit the package on the outside and the package itself is only slightly wider than its width in the part that has not undergone welding between the welds.

The package can be made of metal or made of a metal alloy - mainly aluminum, gold or copper - foil, or plastic, preferably thermoplastic. In another embodiment, the package can be made of a multi-layer film made of plastic and metal. A multilayer film is preferably made of two or three layers of film that are connected to each other. Further, the package can be made of a polymer film with a layer of metal, glass or ceramics applied to it, for example, by sputtering. The thickness of polymer or metal films is several microns. The thickness of the deposited metal, glass or ceramic layer varies within fractions of a micron.

A two-layer film can consist of layers of metal foil and polymer film connected to each other. Metal foil creates the outer or inner side of the multilayer film. In another embodiment, the multilayer film is made from two different polymers.

A three-layer film mainly consists of two layers of polymer film with a layer of metal foil placed between them. All three layers are connected to each other. Instead of metal foil, you can use a layer of glass or ceramics, for example, silicon oxide (5iOx), which is sprayed onto a polymer film.

In the following variant, the inner layer of the multilayer film is made of a copolymer, for example, a polyethylene copolymer based on ethylene and acrylic acid. For the outer polymer layer of a multilayer film, a polymer is preferably used, for example, polyethylene terephthalate, (with a melting temperature higher than the melting temperature of the polymer of the inner layer. This technical solution facilitates welding of the polymer of the inner layer at the seams during the manufacture of the package.

If necessary, an adhesive layer may be present between two layers of the multilayer film.

Film bags can be made from a polymer film with a thickness of 20-100 microns. In addition, the bags can be made from a multi-layered film, which has an inner layer of polymer film with a thickness of 20-100 microns and an outer layer of metal foil with a thickness of 20-100 microns. Further, they can be made from a multi-layer film, which has an inner layer of polymer film 20-100 µm thick, a middle layer of metal foil 8-20 µm thick, and an outer layer of polymer film 10-40 µm thick.

The welds on the film and/or foil package, as well as the welds between the package and the non-deformable flange, are obtained by known methods, such as thermal welding, ultrasonic welding, or induction welding in the case of using multilayer films with a metal layer, while the welds are preferably compressed together in a heated state. Similar methods are described, for example, in EP 0111131 and EP 0130239.

A non-deformable rubber or metal flange can be connected to a package made of film and/or foil by gluing or, if necessary, by vulcanization.

The capacity can be in a non-deformable metal or plastic shell (sleeve) made in the form of a sleeve, one end of which has a detachable or non-detachable connection with a non-deformable flange, and the other end, if necessary, is closed with a bottom. The sleeve can be made mostly closed from all sides.

However, it has at least one hole, or has a gap at the connection point with the flange. In addition, the sleeve can be made in the form of a non-deformable basket with many holes. Instead of a sleeve, the container may have a non-deformable IO-shaped clamp attached at the ends on each side to a non-deformable flange, the lateral length of which is greater than the length of the package.

The capacity located in the sleeve is connected to the sleeve only by a non-deformable flange. The seam-sealed end, or both seam-sealed ends of the package, are not connected to the sleeve.

When the liquid passes from the capacity to the nozzle for taking the liquid, the bag made of film and/or foil flattens under the influence of pressure from the outside, becoming flat. Through the hole in the sleeve or through the gap between the sleeve and the non-deformable flange, air enters the space between the sleeve and the bag, equalizing the pressure. Thus, no vent/valve is needed in the bag, and the liquid in the bag does not come into contact with the air.

A package made of film and/or foil has a diffusion density in relation to medical liquids and their components, as well as in relation to gases. The material for making the package and, if necessary, the composition of the multilayer film are selected accordingly. Having a diffusion density in relation to this invention means that the amount of liquid (measured in terms of ethanol at room temperature) that is lost in capacity due to diffusion is less than 0.bmg per day, preferably less than 0.4mg per day, most preferably less than 0.2mg per day day, in particular, less than 0.1 mg per day.

The inner layer of the film or the inner side of the bag is in contact with the liquid filling the bag. For this film, a material is selected that is not corroded by the liquid and does not spoil the liquid. This film layer is preferably made of heat-sealing film.

One of the layers of the film or, for example, a sprayed layer, creates a barrier preventing the diffusion of liquid or its components, as well as the diffusion of gases from the bag or inside the bag. It may be appropriate to protect the said diffusion barrier layer from mechanical damage and from the destruction of this barrier when the film bends with another layer of polymer film, which is applied to the specified diffusion barrier layer, in order to prevent the diffusion of liquids and gases for a long time.

Since the bag made of film and/or foil has a diffusion density in relation to gases, the rarefaction that occurs in this bag when liquid is taken cannot be compensated by the gas penetrating inside it, and the bag is guaranteed to flatten even when the liquid is taken from the container very slowly. The liquid can also be taken from the bag in many divided, for example, 200 dosage doses over a long period of time, for example, three months.

The capacity, located in a practically closed sleeve, is not accessible to external influences and cannot be damaged during its storage and when it is put on the nozzle for taking liquid. A generally closed or basket-like sleeve provided with many holes or a non-deformable clamp facilitate storage of a container with a thin-walled bag made of film and/or foil and its handling when putting it on the nozzle for taking liquid and when removing the empty container from the nozzle.

The nozzle for taking liquid can be, for example, a hollow piston of an aerosol apparatus for medical liquids. A similar aerosol apparatus is described, for example, in OE 19536902/5 and in M/O-97/12687 (specifically in the examples shown in fig.ba and 66). The hollow piston of this aerosol device is made in the form of a nozzle for taking the medical liquid contained in the capacity, which is offered according to the invention. The capacity is placed on a hollow piston located mainly on the axis of the aerosol apparatus, while the end of the piston pierces the place of taking the liquid and is thus immersed in the medical liquid. The sealing section in the non-deformable flange hermetically closes the inner space of the capacity in relation to the outer wall of the hollow piston. A press fit can mechanically hold the capacity on a hollow piston.

Perhaps it will be appropriate to provide between the capacity and the nozzle for taking liquid instead of a press fit (connection with force locking), or in addition to it, a removable connection with geometric locking between the non-deformable flange of the capacity and a device for taking liquid, for example, an aerosol device Such a connection can be made in the form of a plug-in connection, which is clipped with several hooks that are clipped, located in the connecting element of the device for taking liquid. When the container is inserted into the fluid collection device, the snap-in hooks engage a notch in the flange, such as a circular groove, or engage the edge of a non-deformable flange. The ends of these snap-on hooks are preferably round or chamfered in both directions of movement of the container, allowing the empty container to be removed and the full container inserted into the liquid collection device with moderate effort.

The capacity proposed in the invention is most suitable for its use as a replacement cartridge/cartridge for inhalation solutions of drugs in aerosol devices that do not contain working gases. The capacity filling volume can be 0.5-5 milliliters, preferably 1-4 ml and most preferably 1-Zml or 2-4 ml. These costs are taken in portioned doses of 10-50 microliters, preferably 15-20 microliters.

The diameter of the shell made in the form of a sleeve can be 10-30 mm, preferably 12-17 mm. The length of the container, including the part of the non-deformable flange protruding from the sleeve, can be 20-60 mm, preferably 30-50 mm.

The container proposed in the invention serves as a primary package containing a medical liquid,

for example, a drug dissolved in a solvent. As a solvent suitable for use, for example, water, ethanol or their mixtures. For example, berotec (fenoterol hydrobromide; 1-(3,5-dihydroxyphenyl)-2-((1-(4-hydroxybenzyl)ethyl|amino|ethanol hydrobromide), "atrovent" (ipratropium bromide), "bSerodual" (fenoterol hydrobromide in combination with ipratropium bromide), "salbutamol" (or "albuterol"), "combivent", "oxyvent" (oxytropium bromide), Va 679 (tiotropium bromide) and VEA 2108 (tropenol ether and di- (-2-С4Нз5.СНг)-glycolic acid), "flunisolide", "budesonide", "beclomethasone", etc.

In the international application M/O-98/27959, stabilized ready-to-use aqueous solutions of medicinal products, intended for obtaining inhalation aerosols that do not contain a working gas, are described. This application refers to the formulations claimed and given in the examples of the above-mentioned application.

Suitable ready-to-use medicinal products in the form of alcohol solutions are given, for example, in the international application UHO 97/01329. .

The capacity proposed in the invention has the following advantages: the possibility of economic manufacture, suitability for one-time use and only a small need for material; possibility of sterile manufacturing, sterile filling and sterile sealing/heat sealing; " the possibility of using this capacity for inhalation of prescribed medicines, present in the form of alcohol, water-alcohol or water solutions; sterile taking of the liquid, which is not accompanied by air suction. The liquid does not come into contact with air, oxygen or carbon dioxide; the capacity proposed in the invention , allows you to take a medical liquid without gas bubbles getting into this liquid; the capacity is hermetic with respect to the diffusion of liquids and gases; when filled, the capacity, depending on the medicine filling it, can be stored for several years and meets the requirements of all official pharmacopoeias; it can be easily deformed already with slight dilution; in a flattened, fallen state, it remains flat and almost oblong, practically maintaining its original length after emptying; it does not need any valve/valve to equalize the pressure after taking part of the liquid; a significant degree of emptying of the capacity is ensured even when changing its polo turning and turning upside down; the package made of film and/or foil is connected only with a non-deformable flange. It is not fixed on the shell made in the form of a sleeve, which is available if necessary; by changing the length and/or diameter of the film and/or foil package, it is possible within certain limits to easily adjust the volume of its filling in accordance with the given value; filling the capacity can be carried out before closing it, before performing a single or second weld; a separate cover is not required; the capacity can be used with or without a shell made in the form of a sleeve; the capacity, which is located in a shell made in the form of a sleeve, is protected from damage from the outside; the liquid in a bag made of film and/or foil is protected by an opaque bag made of film and/or foil, or closed from all sides by an opaque shell made in the form of a sleeve from the action of light; in a simple way and without rotation, the capacity can be inserted into the device for taking liquid and removed from it.

The capacity offered by the invention is explained below by way of an example of its implementation with reference to the attached drawings, which show:

Figures 1-3 show in an oblique projection various versions of the package sealed from both ends of film and/or foil.

Figure 1 shows a package (11) made of a sleeve of film and/or foil, with a cylindrical non-deformable flange (12) and an O-shaped transverse seam (13) that seals one end of the package, and which runs partially in the longitudinal direction of this package. The edge (14) of the flange is connected to the other end of the package.

A hole (15) is located on the axis of the flange, into which a nozzle can be inserted for taking liquid.

Fig. 2 shows a package (21), framed by heat-welded edges, made of two layers of film and/or foil lying one on top of the other. It has two welds (22) running in the longitudinal direction of the package and one weld (23) running in the transverse direction at one of its ends. The other end of the bag is connected to an almond-shaped (fish-shaped) non-deformable flange (24). In the middle of the flange there is a hole (25) into which a nozzle for taking liquid can be inserted.

Fig. 3C shows a package (31) with lateral folds located on both longitudinal sides, sealed at both ends in each case with one transverse weld (32). On one flat side of the package, a non-deformable flange (33) is welded from above. In the hole (34) of the flange, a pipe can be inserted for taking liquid.

Fig. 4-7 shows in cross-section different versions of the non-deformable flange.

Fig. 4 shows a longitudinal section of a solid flange (41) with a pressed-fit cylindrical guide channel (42) under a cylindrical nozzle for taking liquid. The outer end of the guide channel is beveled, the other end is closed by a membrane (43), located with an inclination to the axis of the flange. This flange is made in one operation. The edge of the flange is connected to the bag (44) of film or foil.

Fig. 5a shows a longitudinal cross-section, and Fig. 56 shows a folded cylindrical flange in a cross-section along the A-A plane in Fig. 5a. Its lower part (51) is connected to a bag made of film and/or foil. The upper part (52) sits in the opening of the lower part. The upper part has a guide channel (54) in which there are provided three elongated, passing in the axial direction of the flange, protrusions (55), which serve as a press fit under the nozzle for taking liquid, and also one annular protrusion (56), which serves as consolidation. The lower part (51) and the upper part (52) of the flange are welded to each other on their contact surface (57). The inlet opening with the inlet funnel of the guide channel is sealed with heat-sealing film (58).

Figure b shows a folded cylindrical non-deformable flange. The lower part (61) of the flange is connected to the bag (63) made of film and/or foil, the upper part (62) fits into the ring-shaped lower part. In the upper part, as a seal, a ring (64) of circular cross-section is provided, which is held by a pressed gland (65). The opening of the oil seal serves as the guide channel of the nozzle for taking liquid. On the inner side of the seal, a circular protrusion (66) is provided in the upper part, made in the form of a press fit.

A nozzle (67) is inserted into the guide channel for taking liquid. The press fit (66) made in the form of a protrusion holds the capacity on the nozzle for taking liquid. The lower part (61) and the upper part (62) of the flange are welded to each other on their contact surface (68).

Fig. 7 shows another folded flange. The lower part (71) of the flange is connected to the package (73) made of film and/or foil. The upper part (72) is located in the ring-shaped lower part, which has a ledge. The upper part has as a seal a flat ring (74), which is held by a pressed gland (75). Under the flat seal there is a guide channel (76) under the nozzle for taking liquid. The press fit consists of two circular protrusions (77) that go inside the guide channel according to the thread type. Near the lower end of the guide channel, perpendicular to the axis of the flange, there is a membrane (78), which is punctured when the capacity is placed on the nozzle for taking liquid. The membrane is made in one operation together with the upper part of the flange. The lower part and the upper part are connected to each other on their contact surface (79).

Fig.da shows a continuous non-deformable flange (81) located on the side of a package (82) made of film and/or foil in cross section. The flange has a hole (83), which serves as a press fit under the nozzle for taking liquid. This flange is sealed on the outside with heat sealing film (84). When the capacity is placed on the pipe (85) with a beveled end, the package is punctured from the inner end (86) of the guide channel.

Fig. 8b shows a cross-section of a three-layer laminated film, which is usually offered by the trade, from which the package is made. The inner layer (87) of the film with a thickness of 40 μm is made of polyethylene, the middle layer (88) of the film with a thickness of 12 μm is an anti-diffusion barrier layer of aluminum and the outer layer (89) of the film with a thickness of 12 μm is made of polyethylene terephthalate.

Figures 9-11 show in a side view and in a cross-section (fig. 96b and 106) or in a top view of the end of the package (fig. 11b6) various options for performing a weld that seals a package made of film and/or foil from at least one the end

Fig.da shows an O-shaped weld (91), which partially passes in the longitudinal direction of the package (92) made of film and/or foil, passing from one side to the weld (93), which goes in the longitudinal direction of the package. Fig. 96 shows the cross-section of the package in the B-B plane according to Fig. 9a. In the welds, the inner layer of the folded multilayer film (94) is welded.

Fig. 10 shows an M-shaped weld (101), which partially runs in the longitudinal direction of the package.

In this case, the package is made of a film sleeve that does not have a longitudinal seam. In Fig. 1, the O package is shown in a cross-section along the C-C plane in Fig. 10a. A folded single-layer film (103) is welded in the weld.

Fig. 1a shows a side view of the T-shaped weld (111), and Fig. 11b shows a top view of the welded end of the package (112) made of film and/or foil. The total length of the three branches of the T-weld is equal to the width of the flat folded package outside the T-weld.

A bag welded with a T-, M- or T-shaped seam in the section of the transverse seam is not larger than the diameter of the shell made in the form of a sleeve, into which, if necessary, this bag is inserted.

The production and filling of the capacity proposed in the invention is schematically shown in an oblique projection in Fig. 12 and 13.

The folded strip of film and/or foil is welded longitudinally along the cut sides with a weld seam, divided into segments and a sleeve is formed from it (Fig. 12a). The lower part of the cylindrical flange, made by pressure casting, consisting of two parts, is welded to one end of a similar segment of the sleeve.

The second end of this segment is welded with an O-shaped transverse seam (fig. 12b and 12c). The finished capacity (Fig. 128c) is inserted into a cylindrical aluminum shell made in the form of a sleeve, the edge of which is pressed into the groove that runs along the edge of the cylindrical flange. As a result, the capacity turns out to be firmly connected to the shell made in the form of a sleeve. The empty capacity in the sleeve is filled with liquid through the lower part of the flange, which has a hole (Fig. 12d). After filling, the upper part of the flange is pressed into its lower part (fig. 12e), tightly connecting both of these parts to each other. The manufactured element (Fig. 12e) is ready for its installation on the nozzle for taking liquid.

The following manufacturing method is shown in Fig. 13. The segment of the sleeve, which has a longitudinal seam, made of film and/or foil (Fig. 1Za) is connected at one end with a continuous flange sealed with heat-sealing film and/or foil (Fig. 13b). From the second open end of the sleeve, the capacity is filled with liquid (Fig. 13c).

The open end of the sleeve is sealed with an O-shaped transverse seam (Fig. 13d). The filled capacity is inserted into a plastic shell made in the form of a sleeve, a plastic sleeve (Fig. 1Zd). The edge of the plastic sleeve is clipped onto the edge of the non-deformable flange.

The manufactured element (Fig. 13Ze) is ready for its installation on the nozzle for taking liquid.

Fig. 14 shows a partial cross-section of a typical, liquid-filled capacity (141) proposed in the invention, which is located in a metal shell made in the form of a sleeve, a metal sleeve (142). The film or foil package is O-welded at one end and welded to the edge (144) of the lower part (145) of the two-part cylindrical non-deformable flange. The metal sleeve has a bottom (146) with an opening through which air can enter the space between the metal sleeve and the film and/or foil package. The open end of the sleeve is pressed into a groove (147) in the edge of the lower part (145) of the flange. The sleeve is rigidly connected to the flange. The upper part (148) of the flange is inserted into the hole in its lower part. The lower and upper parts of the flange are connected by a latch (149) and have a flat seal (150). The guide channel (151) is closed from its inner end with a membrane (152), and from the outer end it is sealed with a heat-sealing film and/or foil (153).

The metal sleeve shown in Fig. 14 is made of aluminum. Its length is 4 mm, the outer diameter is 17 mm, and the walls are 0.5 mm thick. The two-piece flange is made of injection-molded polyethylene. The upper part of the flange, including the membrane, is made in one technological operation. The guide channel in the upper part of the flange has an inner diameter of 2.5 mm in the place of the press fit and is inserted into the tension on the nozzle for taking liquid.

Figures 15a and 156 show a snap-on connector that is inserted with a geometric lock that connects a non-deformable container flange to a connector in a liquid collection device.

Fig. 15a shows a cross-section of the connecting element (154), which is located in the device for taking liquid, and on the axis of which there is a nozzle (67) for taking liquid. The nozzle is surrounded by a plurality of snap-in hooks (155) whose snap-in ends (156) have a circular cross-section.

Snap-in hooks are spaced apart and can have an azimuth width of 10 to 60 degrees.

A section (157) may be provided between the two snap hooks (155) that does not have a snap hook end. This area with a geometric closure is adjacent to the outer wall of the inserted capacity.

Fig. 156b shows a side view of the end (142) of the capacity located in the shell/sleeve, the non-deformable flange (148) of which protrudes from the sleeve. In the section of the part of the flange that goes into the sleeve, the sleeve in accordance with Fig. 14 preferably has a circular groove (158), into which the ends (156) of the hooks inserted into the connecting element (154) of the capacity, which are clipped in, enter with engagement, providing as a result removable and geometrically closed connection of the capacity with the connecting element.

Figures 1ba and 166 show another version of the removable, with geometric closure, plug-in connection.

Fig. 1ba shows a cross-section of the connecting element (161), which is located in the device for taking liquid, and on the axis of which there is a nozzle (67) for taking liquid. The spigot is surrounded by a plurality of tongue-shaped snap-in hooks (162) with snap-in ends (163) whose sides are chamfered in both directions of capacity movement. Hooks that snap are separated from each other by a certain azimuthal interval.

Fig. 16b shows a side view of the end of the capacity located in the shell/sleeve (142), the non-deformable flange of which protrudes from the shell/sleeve. The ends of the snapping hooks (163) are engaged in the capacity (154) inserted in the connecting element in the circular groove (147) of the part of the non-deformable flange (148) protruding from the shell/sleeve, providing as a result a detachable and geometrical lock with uniting the capacity with the connecting element. r kp uch y 4 me zh y duet ry ty Cats mae sh a y zv 37 y vnoy all g to

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Claims (33)

1. Hermetic capacity for medical liquid, which can be attached to the nozzle of an aerosol sprayer, which is a hollow piston, while the capacity has a packaging bag (11, 21, 31) closed at both ends, sealed at least from one end by at least one welding seam (13, 23, 32), which runs mainly perpendicular to the axis of the package, and the packaging package is made with the possibility of deformation under the influence of external pressure when the pressure difference between the internal cavity of the capacity and the surrounding space is less than 300 hPa (300 mbar), non-deformable flange ( 15, 25, 34), which is tightly attached to the packaging bag and is made in the form of a removable connecting element, which serves to attach the container to the nozzle (67) for the withdrawal of liquid, the guide channel (42, 54) in the non-deformable flange, which differs due to the fact that inside the guide channel there is a sealing section (56, 64, 74) and/or a section (55, 66, 77) for landing with tension of the sampling nozzle in the liquid and in the zone of the guide channel, a place for liquid selection is provided, which, when using the capacity, is pierced by a hollow piston in such a way that the hollow piston is immersed in the medical liquid. 2. The capacity according to claim 1, which is characterized by the fact that the packaging bag is made with the possibility of deformation at a pressure drop of less than 150 hPa (150 mbar), preferably less than 80 hPa (80 mbar). 3. A container according to claim 1 or 2, which is characterized by having a packaging bag (31), which is sealed at both ends by a weld seam (32), and a non-deformable flange (34), which is tightly attached to this packaging bag. 4. The capacity according to claim 1 or 2, which differs in that it has a packaging bag (11, 21), which is sealed at one end with a weld seam (13, 23), and at the other end is tightly closed with a non-deformable flange (12, 24). 5. The container according to any of claims 1-4, which is characterized by the fact that it has a non-deformable, preferably rotationally symmetrical flange (41, 51, 61), the size of which is coordinated with the size of the packaging bag and which closes this bag from one end. 6. A container according to any one of claims 1-5, which is characterized by having a guide channel (42, 54) with a sealing area (56, 64, 74). 7. A container according to any of claims 1-6, which is characterized by the fact that it has a non-deformable flange, inside the guide channel of which a section (55, 66, 77) is provided for landing with a tension of a nozzle for taking liquid. 8. The container according to any of claims 1-7, which is characterized by having a non-deformable flange made of thermoplastic. 9. A container according to any of claims 1-8, which is characterized by having an O- or M-shaped weld (91, 101) that runs mainly perpendicular to the axis of the package and partially along the axis of the package, or has T -shaped weld (111). 10. The capacity according to any of claims 1-9, which is characterized by the fact that the sealing area is formed by a ring (64, 74) of elastic material located in the groove. 11. The capacity according to any of claims 1-10, which is characterized by the fact that the place of liquid selection is made in the form of a place that is punctured. 12. A container according to any one of claims 1-11, which is characterized in that the place of liquid selection has a membrane that is pierced. 13. A container according to any one of claims 1-12, which is characterized in that the place of liquid sampling has a membrane that can be pierced, while the membrane (43, 78) is located at the end or inside the guide channel or this membrane (86) is part of the package. 14. The container according to any of claims 1-13, which is characterized by the fact that the place of liquid selection is sealed with a welded film (58, 84, 151). 15. A container according to any one of claims 1-14, which is characterized in that it has a packaging bag (11, 21, 31) made of a polymer film or of a metal foil or a foil based on a metal alloy, or a packaging bag made of combined film, which consists of plastic and metal, or a packaging bag made of polymer film with a layer of metal, glass or ceramics. 16. A container according to any one of claims 1-15, characterized in that it has a packaging bag that has an inner layer of polymer film and an outer layer of metal or two layers of polymer film of different polymers. 17. A container according to any one of claims 1-15, which is characterized in that it has a packaging bag, which has an inner layer made of a copolymer, preferably a copolymer of polyethylene based on ethylene and acrylic acid, a middle layer of metal foil or polymer film , which serves as a diffusion barrier, or a middle layer of metal, glass or ceramics, which serves as a diffusion barrier, and an outer layer of a polymer film, the melting temperature of which is higher than the melting temperature of the polymer film of the inner layer, preferably made of polyethylene terephthalate. 18. A container according to any one of claims 1-17, characterized in that it has a packaging bag made of a polymer film with a thickness of 20-100 μm, or a packaging bag made of a combined film that includes an inner layer of a polymer film with a thickness of 20 -100 μm and an outer layer of metal foil 8-20 μm thick, or a packaging bag made of a combined film that includes an inner layer of polymer film 20-100 μm thick, a middle layer of metal foil 8-20 μm thick and an outer layer from a polymer film with a thickness of 10-40 microns. 19. The capacity according to any of claims 1-18, which differs in that its volume is from 0.5 to 5 ml, preferably from TT to 4 ml. 20. The capacity according to any of claims 1-19, which differs in that its volume is from 1 to 3 ml or from 2 to 4 ml. 21. The capacity according to any one of claims 1-20, which is characterized by the fact that it is in a non-deformable sleeve-like metal or plastic shell (142) connected to a flange. 22. The capacity according to any of claims 1-21, which is characterized by the fact that it is located in a non-deformable sleeve-like shell with a diameter of 10 to 30 mm, preferably from 12 to 17 mm. 23. The capacity according to any one of claims 1-22, which is characterized by the fact that it is in a non-deformable sleeve-like shell from which a non-deformable flange protrudes, while the total length of the capacity is from 20 to 60 mm, preferably from 30 to 50 mm. 24. A container according to any one of claims 21-23, characterized in that it has a sleeve-like shell that is substantially closed on all sides, which has an opening or slot at the junction with the flange, or has a sleeve-like shell made in the form of a braid with many holes, or has a staple. 25. A container according to any one of claims 21-24, characterized in that it has a circular groove (158; 147) in the non-deformable flange. 26. A container according to any one of claims 1-25, which is characterized by the fact that it is intended as a primary package for a medical liquid that is taken from the packaging bag in several portions. 27. The capacity according to any one of claims 1-26, which is characterized by the fact that it is intended as a primary package for medical liquid, which is selected in portions of 10-50 μl, preferably 15-20 μl. 28. A container according to any one of claims 1-27, characterized in that it is designed as a replaceable cartridge containing a medicament for inhalation in the form of a solution in ethanol, ethanol/water or water. 29. A container according to any one of claims 1-28, which is characterized in that it is intended as a replaceable cartridge containing a medicament for inhalation, which includes one or more active substances, such as berotec (fenoterol hydrobromide; hydrobromide 1-(3 . ), Ba 679 (tiotropium bromide), BEA 2108 (tropene ether of di-(2-thienyl)glycolic acid), beclomethasone, flunisolide, budesonide. 30. A container according to any one of claims 1-29, which is characterized by the fact that it is intended for use with a medicinal product for the treatment of diseases with the help of inhaled active substances. 31. The capacity according to any one of claims 1-30, which is characterized in that the aerosol sprayer is a device for the selection of liquid, having an adapter (154, 161), which is made with the possibility of inserting a capacity into it by means of a removable connection on clips located between the adapter (154, 161) of the device for the selection of liquid and the non-deformable flange of the capacity. 32. The capacity according to claim 31, which differs in that the circular groove (158, 147) in the non-deformable flange is made with the possibility of engaging thickenings (156, 163), which are pinched, hook fasteners (155, 162) made on the adapter ( 154, 161) when inserting capacity into it. 33. An aerosol sprayer with a replaceable cartridge in the form of a container for medical liquid according to any one of claims 1-32, and the inhaler has a nozzle (67) made in the form of a hollow piston for withdrawing liquid from this container.