WO2020249180A1

WO2020249180A1 - Container closure device

Info

Publication number: WO2020249180A1
Application number: PCT/EP2019/000345
Authority: WO
Inventors: Stefan Pörtl
Original assignee: Poertl Stefan
Priority date: 2018-06-14
Filing date: 2019-12-18
Publication date: 2020-12-17
Also published as: EP3807166A1; DE202018002832U1; WO2019238263A1; EP3983306A1

Abstract

The invention relates to a container closure device (1, 1', 1'') having a housing (2), said container closure device comprising a first housing portion (2a), a second housing portion (2b), a lid-like or cap-like closure (3) and at least one region for receiving a primary packaging means (4) that comprises a primary-packaging-means chamber (4a), wherein the at least one primary-packaging-means chamber (4a) is delimited at a first end by a breakable and/or dissolvable element (5). The breakable and/or dissolvable element (5) of the primary packaging means (4) is designed and arranged such that the container (B) can be combined with/closed by the container closure device (1) in such a way and the breakable and/or dissolvable element (5) can be broken or dissolved in such a way that the contents of the primary-packaging-means chamber (4a) come or can come into direct contact with the contents of the container (B) as soon as the container (B) is closed by the container closure element (1).

Description

Container closure device

The present invention relates to a container closure device with at least one area for receiving a primary packaging means and for releasably fixed connection with containers, in particular bottles such as e.g. Beverage bottles or infusion bottles for the production of individual and / or ready-to-use mixtures of substances. Further aspects of the disclosure relate to a primary packaging means, a kit and a container.

In many technical fields it is necessary or desirable to bring different substances into contact with one another only before immediate use or consumption in order to mix, mix, disperse, suspend or dissolve them in one another.

In the medical-pharmaceutical field, for example, drug products are used in which in a container - e.g. in a bottle or ampoule - a solution is presented to which immediately before use a pharmaceutically active drug to be dissolved or suspended in the solution, for example in the form of a powder or granulate, for example because it is chemically unstable in the dissolved or suspended state is added. As a result, the drug dissolves or is suspended in the solution. The solution prepared in this way can then be administered to the patient. The problem with the production of such ready-to-use solutions immediately before application is, however, that the individual components - in the aforementioned example the solution and the powder or granular drug - have to be mixed with one another in such a way that sterility is maintained. This is particularly important in the case of medicaments to be administered parenterally, for example in the case of antibiotics to be administered intravenously. In order to mix the solution and the drug to be dissolved in a sterile manner, additional devices, e.g. Transfer cannulas, required. In addition to the need for additional devices, the disadvantage here is that numerous application errors can occur, as a result of which the patient tolerance of the ready-to-use medicament can be adversely affected.

There is also a need in the food and beverage industry, different ones

To pack the components of food separately from each other and only mix them together immediately before consumption, for example to improve the food To achieve taste in the ready-to-eat product or to increase its shelf life. When the individual components are mixed, the sterility problem described above plays less of a role, but rather user-friendliness is in the foreground. For example, mixed drinks / instant drinks are usually produced in such a way that an aroma substance in solid (powder or granulate), liquid (syrup) or thixotropic (concentrate, paste) form is mixed with water / mineral water. While the water / mineral water is usually bottled, the flavor substances are packaged differently in terms of type and quantity. Mixing then requires opening and, if necessary, reclosing the individual containers (such as bags, bags, cans, glasses, drinking cups, etc.) as well as mixing aids such as mixers or spoons. Carrying along the individual utensils and storing torn packs is often problematic. This is particularly important in (outdoor) leisure and / or fitness areas. Mixing in the correct ratio is sometimes problematic, depending on the situation and the user.

In various areas of the chemical industry, it is also desired and / or necessary to combine various individual components into a ready-to-use mixture shortly before use. Examples are the areas of the paint and building materials industry, which sell a large number of multi-component products. Examples are products which contain a curing agent (hardener) that may only be added to the component or components to be cured of the respective product immediately before use. Above all, the correct mixing ratio of the individual components plays a decisive role, which can be problematic depending on the user situation. In order to solve this problem, containers are usually sold which contain the individual components in separate containers, either the mixing ratios can be found in the instructions for use, or corresponding proportions are packaged ready for use. Disadvantages here are again the reclosing of the respective containers for the individual components and the finding of the correct mixing ratio for applications with incomplete consumption. In order to solve the aforementioned problems of the prior art, containers (for example in the form of bottles) are used in the pharmaceutical and food sectors, which are closed with a releasably firmly connected closure lid, the lid having a chamber which can be opened by pressing in a stopper Releases chamber contents so that it can mix with the contents of the container. The resulting mixture of substances can be removed / consumed by removing the cover.

US 2006/231428 A discloses a powder / liquid dispenser using a hollow cylindrical plastic body with a first vertical cylindrical portion which is sealed at its upper end and is integral at its lower end. A second vertical cylindrical section, which is open at both ends, is arranged below and connected to the first section. The second section has an internal thread. A thin horizontal penetrable circular membrane is attached to the second section in the area common to both the first and second sections. A flat cylindrical annular member has an open central region and an upper circular vertically upwardly extending cutting edge that is spaced inwardly from the periphery of the member. The element is positioned in the common area under the membrane with the edge being located on the membrane.

In view of the above problems and the proposed solutions available in the prior art, there is a need for easy-to-use, chamber-containing closure devices for containers, e.g. Bottles, for the production of individual ready-to-use or ready-to-eat mixtures. In particular there is a need for container closure devices which can be used with different containers, e.g. Bottles that can be freely combined.

According to the invention, this object is achieved by providing a container closure device with a housing

- A first housing section containing means for a fixed or detachable fixed connection to a container,

- A second housing section containing means for fixed or detachable fixed attachment of a lid or cap-like closure, and

- a lid or cap-like closure which is releasably fixedly attached to the second housing section or fixedly attached to the second housing section and designed to be reclosable,

- At least one area for receiving a primary packaging material comprising a primary packaging material chamber, the at least one primary packaging material chamber being delimited at a first end by a breakable and / or dissolvable element;

characterized in that the breakable and / or dissolvable element of the primary packaging is designed and arranged in such a way that the connecting / closing of the container with the container closing device and the breaking or dissolving of the breakable and / or dissolvable element take place in such a way that the contents of the primary packaging chamber are in direct contact with the contents of the container gets or can get as soon as the container is closed with the container closure device.

The container closure device preferably also has a holding / locking means which fixes the primary packaging means in the area for receiving the primary packaging means of the container closure device. The holding / locking means can, for example, be a rib, projection or the like which is provided on the inner wall of the housing and blocks the primary packaging means in the axial direction. In particular, the holding / locking means can be designed in such a way that the primary packaging means is stopped on the holding / locking means when it is introduced through the opening of the second housing section (ie the proximal end) of the container closure device and does not move further in the direction of introduction or in the longitudinal direction of the first housing section can move, and releasably fixed within the container closure device in the at least one area for receiving a primary packaging means, for example is clamped / pinched.

Alternatively, the housing, or a section of the housing comprising the area for receiving a primary packaging means, can have a conical shape. At In this embodiment, the express provision of a holding / locking means, such as a rib or some other type of radially inwardly directed projection, on the container closure device can be dispensed with.

In one embodiment, an inner cross-section of an opening in the first housing section is designed for the introduction of a primary packaging means, such as a cartridge, cartridge, bag or sachet. Here, the primary packaging is introduced through the opening of the first housing section into the area for receiving the primary packaging.

Alternatively, an inner cross-section of an opening of the second housing section is designed for the introduction of a primary packaging means, such as a cartridge, cartridge, bag or sachet. Here, the primary packaging is introduced through the opening in the second housing section into the area for receiving the primary packaging.

An inner cross section of an opening of the first housing section and an inner cross section of an opening of the second housing section are preferably designed to enable the primary packaging material to be introduced both through the end of the first housing section and through the end of the second housing section. Such a design of the container closure device takes the individual situation of the filling process into account. Thus, depending on the application, it can be advantageous to introduce the primary packaging via the second housing section (proximal end of the container closure device) or via the first housing section (distal end of the container closure device) into the section for receiving the primary packaging of the container closure device according to the invention.

The lid or cap-like closure preferably comprises fastening means which are compatible with the fastening means contained on the housing section. Furthermore, the lid or cap-like closure is preferably designed and arranged in such a way that the at least one primary packaging means is inside of the area for receiving the primary packaging of the container closure device is clamped in by the lid or cap-like closure when the closure is connected to the container closure device on the housing section in a force-locking manner.

A break-open element is preferably arranged in the interior of the housing or part of the housing is designed as a break-open element. The break-open element is designed and arranged in such a way that it breaks open the breakable element of the primary packaging material during the connection / opening of the container to the container closure device in such a way that the contents of the primary packaging material chamber come or can come into direct contact with the contents of the container as soon as the container is releasably firmly connected or closed with the primary packaging-loaded container closure device according to the invention. With the embodiment mentioned, a separate step for opening the primary packaging is not necessary. Rather, a fluid connection is automatically established between the interior of the primary packaging material chamber and the interior of the container when the container closure device has been attached to the container. In this way, for example, external influences when mixing the substances - such as the introduction of germs - can be avoided.

The breakable element and / or the break-open element are preferably arranged at right angles to the inside of the housing. Alternatively, the breakable element and / or the break-open element are arranged on the inside of the housing at an angle which is different from 90 °. The provision of an angle different from 90 ° between the inside of the housing and the breakable element and / or break-open element enables a break-open process, for example a cutting process, to be individually adapted to the preferred geometry of the primary packaging means. The breakable element and the break-open element are preferably arranged parallel to one another. The breakable element and the break-open element are preferably not arranged parallel to one another.

The break-open element is preferably comprising a cutting ring Cutting element and / or designed as at least one conical, arrow-shaped or pyramid-shaped mandrel. The break-open element is arranged in such a way that the cutting element of the cutting ring or the at least one conical, arrow-shaped or pyramid-shaped mandrel points in the direction of the breakable element and optionally runs essentially perpendicular to it.

The ring-shaped cutting element is preferably interrupted in at least one area of the ring in such a way that a tab is formed on the same when the breakable element is broken open. In this way, a fluid connection between the interior of the primary packaging material chamber and the interior of the container is created at the tab.

The cutting element of the cutting ring is preferably designed as a circumferential cutting element, the circumferential cutting element being beveled so that its cutting surface does not run parallel to the breakable element so that a tab is formed when the breakable element (5) is broken open. In this way, a fluid connection between the interior of the primary packaging material chamber and the interior of the container is created at the tab.

The break-open element is particularly preferably designed and arranged as a piston centered in the container closure device. This has the advantage that the break-open element is designed to be stable and can transmit high forces. In particular in an embodiment in which the break-open element is arranged axially movably within the container closure device according to the invention, it is ensured, especially when the container closure device is used several times, that the break-open element cannot break off during the opening process and fall into the container. This also compensates for manufacturing tolerances on the part of the breakable and / or dissolvable element, for example if the latter is made thicker / tougher than actually intended for the respective application. According to the invention, the container closure device is preferably intended for multiple use. The break-open element is preferably arranged axially movably on the inside of the housing, with a squeeze / spacer element which can be deformed by the application of pressure and which separates the break-open element or at least its cutting element and / or spike (s) from the break-open element between the break-open element and the dissolvable or break-open element Element or at least separated from its breakable area if and as long as the container closure device is not yet connected to a container (B) or does not yet close it. The QuetsclWDistanzelement on the one hand prevents premature and unintentional breaking of the dissolvable and / or breakable element, in particular before the container closure device is firmly connected to a container. On the other hand, the QuetsclWDistanzelement serves to dampen the breaking open of the dissolvable or breakable element. In this way, breaking up can take place in a controlled manner. Finally, through the provision of a squeeze-off spacer element, feedback can be given to the user who, due to the increased force required when screwing the container closure device onto the container, for example haptically recognizes that the opening element and the dissolvable or breakable element are being brought close to one another. The holding / locking means preferably corresponds to at least part of the squeeze / spacer element.

A movement of the break-open element in the direction of the breakable and / or dissolvable element is preferably brought about by the process of connecting / closing the container to the container closure device or by the mechanism on which the connection / closure of the container to the container closure device is based. Such a movement can be achieved, for example, in that the break-open element is mounted freely or at least with play between the break-open / break-open element and the container.

The movement of the break-open element in the direction of the break-open element is preferably effected in that the container, as a result of the connection / opening of the container with the container closure device, contacts or directly contacts the break-open element with its container opening to be closed and the Connection A / unlocking operation causes the movement of the breaker element.

Preferably, the break-open element is attached to the QuetsclWDistanzelement in such a way that when connecting / closing the container with the container closure device between the opening of the container and the QuetsclWDistanzelement so that when connecting / closing the container with the container closure device, the QuetsclW spacer is compressed, the break open element in Direction of the dissolvable and / or breakable element is moved.

In a preferred embodiment, the pinch spacer element is attached to the container closure device. For example, the squeeze / spacer element is fixedly attached to the inside of the housing of the container closure device. Here, in a particularly preferred embodiment, the squeeze / spacer element can also take on the function of the locking / fixing element.

As an alternative, the pinch spacer element is preferably attached to the primary packaging material chamber.

The break-open element is preferably arranged outside the primary packaging material chamber. Alternatively, the break-open element can also be arranged within the primary packaging material chamber.

The movably arranged break-open element is preferably connected to the housing via a tongue-and-groove system extending in the direction of movement between the inside of the housing and the movably arranged break-open element.

The movably arranged break-open element is preferably releasably and firmly locked on the housing when the container is not connected / closed to the container closure device. The lid or cap-like closure preferably has a resealable opening through which the common contents of the container and chamber can be removed when the resealable opening is in the open position and the container is closed with the container closure device. By providing a resealable opening, it can be avoided that the container closure device first has to be removed from the container after the substances contained in the primary packaging chamber and container have been mixed, in order to remove the mixture. Instead, the mixture produced can be removed through the resealable opening, which further increases the probability of any residues present in the primary packaging material chamber being flushed out during the removal process.

The means for the releasably fixed connection in the housing section are preferably selected from screw, plug / press, latching, clamping or clamping means.

The container is preferably a bottle, for example a beverage or infusion bottle.

The container closure device is preferably designed for releasably fixed pre-assembly on a container in such a way that the integrity of the primary packaging material chamber is not impaired, the content of the primary packaging material chamber coming or being able to come into direct contact with the content of the container only as part of a further assembly step. For example, the container closure device can initially be screwed on loosely and only screwed tight shortly before the user takes in the contents of the primary packaging chamber mixed with the container contents.

Another aspect of the present invention relates to a primary packaging means for introduction into a container closure device. The primary packaging includes

- A primary packaging housing, which at least one Primary packaging chamber defined,

- The at least one primary packaging material chamber being delimited at a first end by a breakable and / or dissolvable element;

- wherein the breakable and / or dissolvable element is designed as a breakable and / or dissolvable section of the primary packaging material housing or is a breakable and / or dissolvable element which is firmly connected to the primary packaging material housing on a wall section of the primary packaging material housing.

The at least one primary packaging material chamber is preferably delimited at a second end by a second breakable and / or dissolvable element, which is different from or the same as the breakable and / or dissolvable element in terms of its design and / or composition. If a variant is chosen in which the breakable and / or dissolvable element and the second breakable and / or dissolvable element are identical in terms of design and / or composition, this basically enables a symmetrical design of the primary packaging material in such a way that the primary packaging material is not oriented when the container closure device is filled Role play. If, on the other hand, a variant is selected in which the breakable and / or dissolvable element and the second breakable and / or dissolvable element are different in terms of design and / or composition, one and the same primary packaging means can be provided for differently designed container closure devices (for example with or without a break-open element).

An external cross-sectional view of the primary packaging material housing preferably corresponds to an internal cross-sectional view of the area for receiving the primary packaging material of the container closure device, the primary packaging material being in particular cylindrical or conical.

A cross-sectional view of the primary packaging means housing in FIG proximal direction of a cross-sectional view of the primary packaging material housing in the distal direction. In particular, the primary packaging can be cylindrical. Such a symmetrical configuration of the primary packaging means enables greater flexibility when filling the container closure device, since the orientation of the primary packaging means preferably does not play a role.

The breakable and / or breakable element is preferably designed as a breakable element and is arranged on an inwardly protruding fold of the primary packaging means.

The breakable element is preferably designed as a membrane, which preferably has a thickness of less than 0.5 mm.

The breakable element is preferably made of plastic, paper, rubber, metal or combinations thereof.

The primary packaging preferably contains at least one food product or at least one drug. Preferably at least one medicament or food product to be dissolved, dispersed or suspended in a liquid before ingestion or before administration. The term food product includes all forms of substances suitable for nutrition, such as electrolyte compositions,

Food supplements, flavorings or combinations thereof, as well as any foodstuffs for enteral and parenteral nutrition.

The at least one food product or at least one drug can be contained in the primary packaging in solid, liquid or thixotropic form or in the form of corresponding pharmaceutical compositions. The primary packaging chamber contents are preferably powdery, liquid or thixotropic. The breakable and / or dissolvable element is designed so that it is inert to the contents of the primary packaging. "Inert" means that Element is not breakable or dissolvable by interactions with the at least one food product or the at least one drug or the corresponding pharmaceutical compositions. The breakable and / or dissolvable element for the chamber contents is preferably tight in each case, ie no chamber contents escape from the primary packaging material chamber before breaking or dissolving.

The breakable and / or dissolvable element is preferably at least partially dissolvable, preferably completely dissolvable, in the contents of the container that is to be connected to the container closure device according to the invention, loaded with primary packaging material. The breakable and / or dissolvable element is preferably completely dissolvable at room temperature as well as at elevated temperature in the liquids in which the chamber contents of the primary packaging means, e.g. the at least one food product or at least one drug is to be introduced before ingestion or before administration. The contents of the container are particularly preferably aqueous liquids.

The breakable and / or dissolvable element is particularly preferably completely dissolvable in aqueous liquids at room temperature and also in liquids at elevated temperature.

The aqueous liquid is preferably a drink or an aqueous pharmaceutical composition, for example an infusion solution.

The breakable and / or dissolvable element preferably consists of a physiologically harmless material. The breakable and / or dissolvable element is more preferably tasteless, ie the breakable and / or dissolvable element dissolved in the liquid does not affect the taste of the liquid including the medicament or food product dissolved, dispersed or suspended in the liquid. Preferably comprises, more preferably consists, the breakable and / or dissolvable element of at least one substance selected from the group consisting of polyvinyl alcohol (PVA), polyethylene oxide, polysaccharides, polyacrylamide, gelatin, alginates, pectins, gellan, agar-agar, locust bean gum and / or mixtures thereof.

In particular, the breakable and / or dissolvable element comprises at least one polysaccharide selected from the group consisting of gelatin, alginates, pectins, gellan, modified cellulose, cellulose ethers, modified starches, carageen, agar-agar and / or mixtures thereof.

Alternatively, the breakable and / or dissolvable element comprises at least one mono-, di- and / or trisaccharide, it being possible for the mono-, di- and / or trisaccharide to be at least partially substituted by carboxylic acid groups and / or hydroxyl groups. In such an embodiment, the membrane preferably comprises glucose, fructose, galactose, sucrose, maltose, xylitol / xylitol, sorbitol or mixtures thereof. In a further embodiment, the membrane consists of one of the above-mentioned components or mixtures thereof.

According to a particularly preferred embodiment, the primary packaging consists of a material which is biodegradable or essentially biodegradable, preferably compostable in accordance with EN / DIN 13432. The primary packaging housing preferably comprises at least one biodegradable plastic, the at least one plastic preferably being selected from the group consisting of polyesters, polylactic acids, polyhydroxyalkanoates (PHA), starch, cellulose and mixtures thereof. The primary packaging housing is particularly preferably made of at least one biodegradable plastic, the at least one plastic preferably being selected from the group consisting of polyesters, polylactic acids, polyhydroxyalkanoates (PHA), starch, cellulose and mixtures thereof The primary packaging preferably comprises a removable protective flap which is designed and arranged and which covers the breakable and / or dissolvable element, the protective flap being provided to be removed before the primary packaging is introduced into the container closure device. The provision of the aforementioned protective flap enables, for example, improved sterility in the production and use of the container closure device according to the invention.

The breakable and / or dissolvable element can preferably be configured as a dissolvable element and the second breakable and / or dissolvable element can be configured as a non-dissolvable element. Alternatively, the breakable and / or dissolvable element can be configured as a non-dissolvable element and the second breakable and / or dissolvable element can be configured as a dissolvable element.

Preferably, the primary packaging housing is at least one of heat-resistant or resistant to UV radiation. The primary packaging material housing preferably has an inner wall which has at least one smooth section, a structured section, or a section that is self-cleaning in accordance with the lotus effect.

Preferably, the primary packaging further comprises a deformable squeezing / spacer element which is arranged and designed to separate a break-open element or at least its cutting element and / or mandrel (s) from the break-open element or at least from its break-open area. The break-open element is then preferably arranged in a fixed / immovable manner in the interior of the primary packaging material chamber. In contrast, the breakable element can be designed as a movable element which can be moved in the direction of the break-open element. The spacer / squeeze element can, for example, be arranged on the periphery of the frangible element and can, for example, be annular and compressible. The spacer / squeezing element can in particular be firmly connected to the break-open element. As a result of connecting the container closure device to the container, the Spacer / pinch element pressed together. The compression of the spacer / squeeze element causes the frangible element to be moved in the direction of the frangible element. Preferably, the spacer / squeezing element can simultaneously assume a sealing function. The spacer / squeeze element can thus serve as a sealing element for producing a media-tight connection between the container closure device and the container.

The primary packaging is preferably a flexible primary packaging, in particular a sachet or pad.

Another aspect relates to a kit containing at least one primary packaging as defined above and a container closure device as defined above.

Another aspect relates to a kit containing at least one primary packaging means as defined above and a container closure device as defined above, an outer cross section of the primary packaging means and an inner cross section of the container closure device being designed and arranged to enable the primary packaging means to be received in the container closure device.

Another aspect relates to a kit containing at least one primary packaging means as defined above and a container closure device as defined above, wherein an outer surface of the primary packaging means is essentially cylindrical with a primary packaging means outer radius, wherein an inner surface of the container closure device is at least partially essentially cylindrical with a container closure device inner radius, and wherein the primary packaging material outer radius is substantially the

Container closure device inner radius corresponds.

The primary packaging chamber preferably contains a substance to be dissolved, dispersed or suspended in the contents of the container in solid, liquid or thixotropic form, the substance being selected from medicaments, Electrolyte compositions, nutritional supplements, flavorings, or combinations thereof.

Another aspect relates to a kit containing at least one container closure device as defined above and at least one container which can be releasably firmly connected / closed with the closure device. The kit preferably contains at least one primary packaging as defined above.

Another aspect relates to a container comprising at least two primary packaging means as defined above. The at least two primary packaging means preferably each have at least one chamber content which is different in terms of type and / or quantity.

A further aspect relates to a container comprising a container closure device as defined above and at least two primary packaging means as defined above.

Another aspect relates to a container comprising at least two container closure devices as defined above and optionally at least one container which can be releasably and firmly connected / closed with each of the at least two container closure devices.

The container is preferably a medical product, in which the at least two primary packaging means each contain a drug to be dissolved, dispersed or suspended in the contents of the container in solid, liquid or thixotropic form, in which the at least two primary packaging means contain the drug in a different amount, in which the Amount contained in a primary packaging means in each case results in a patient group-specific dosage.

Alternatively, the container is preferably a food product, in which the at least two primary packaging means are each one to be dissolved in the contents of the container, to be dispersed or suspended substance in solid, liquid or thixotropic form, in which the substance is selected from electrolyte compositions, dietary supplements, flavorings or combinations thereof, in which the chamber contents of the at least two primary packaging materials are different in terms of type and / or amount.

The container is preferably a disposable or reusable, plastic, metal or glass bottle, which optionally contains a drinkable liquid.

The container closure device according to the invention is suitable for overcoming the problems of the prior art mentioned at the beginning. It is particularly suitable for the production of an individual, ready-to-use or ready-to-eat substance mixture by simply bringing together separately packaged substances in solid, liquid, thixotropic or gaseous aggregate state and eliminating application errors when combining the substances. The container closure device according to the invention is particularly suitable in the embodiment of an extension of a bottle neck of a commercially available one-way or reusable, plastic or glass beverage bottle for the production of an individual beverage. Depending on the desired application situation, the contents of the beverage bottle (e.g. drinking water) can contain various substances, such as Electrolyte compositions, food supplements (proteins, amino acids, vitamins, etc.), flavorings / aromatic substances and the like are added, which are packaged within the primary packaging chamber of the container closure device according to the invention. This eliminates the need for consumers to buy ready-mixed drinks, for example. Instead, the device according to the invention can be used to produce individual beverage mixes in situations in which, although sufficient water is available, the transport of several different beverage bottles is not possible or is undesirable.

In addition, the container closure device according to the invention is suitable for

Provision of a medical product, comprising at least one container, for example in the form of a bottle - for example an amber glass bottle - and in which there is a dissolving, dispersing or suspending medium which is used to dissolve, Dispersing or suspending a medicament, for example an antibiotic, is suitable. The medical product furthermore contains at least one, preferably two or more container closure devices according to the invention, each of which contains a medicament to be dissolved, dispersed or suspended in the primary packaging material chamber. If the medical product contains two or more container closure devices according to the invention, each container closure device can contain the medicament in its primary packaging chamber in a different amount which is suitable for certain patient groups, for example certain age groups of patients. Such a medical product has the advantage that the amount of medium in the container can be selected uniformly regardless of the patient group and a patient-specific dosage can be achieved by simply connecting the container to the container closure device that contains the correct amount of medicament for the application. This eliminates the need for the manufacturer to provide different container sizes and thus different packaging sizes for patient-specific dosages. In addition, the probability of application / operator errors is advantageously reduced.

The present invention therefore also relates to a medical product as described above.

Embodiments of the present invention are explained by way of example using the figures. Show exemplary

FIG. 1 shows a schematic representation of an embodiment of the container closure device according to the invention prior to connection / closure with a container;

FIG. 2 a schematic representation of the container closure device according to FIG. 1 after connecting A / opening the container to the container closure device;

FIG. 3 is a schematic representation of a second embodiment of FIG

Container closure device;

FIG. 4 is a schematic representation of a third embodiment of FIG Container closure device; and

FIG. 5A to FIG. 5E different configurations of a break-open element.

In or the present disclosure, a “distal end of the container closure device” denotes the end D which is located furthest from the person holding the container closure device, which corresponds to the end of the container closure device which is intended for connection to a container. The “proximal end of the container closure device” denotes the end P of the container closure device that is closest to the person. The "proximal end of the

Container closure device ”is opposite the“ distal end of the container closure device ”. Correspondingly, a “distal direction” denotes a direction which, starting from the container closure device, points towards the container. A “proximal direction” refers to a direction that is opposite to the “distal direction”.

FIG. 1 schematically shows an example of an embodiment of a container closure device 1 according to the invention before the connection / closure with a container B. The container closure device 1 has a housing 2. Housing 2 comprises a first housing section 2a with a thread GB for releasably fixed connection with container B. Housing 2 furthermore comprises a second housing section 2b with a thread G3 for releasably fixed attachment of a lid or cap-like closure 3.Housing 2 furthermore comprises at least one area for receiving primary packaging 4. Primary packaging 4 comprises at least one primary packaging chamber 4a. Primary packaging material chamber 4a is delimited at least at one distal end by a breakable and / or dissolvable element 5. Element 5 is designed and arranged in such a way that the connection A / opening of container B to container closure device 1 and the breaking or dissolving of element 5 take place in such a way that the contents of primary packaging material chamber 4a come or can come into direct contact with the contents of container B. as soon as container B is closed with container closure device 1.

Container closure device 1 optionally further comprises a holding / locking means H, which primary packaging means 4 in the area for receiving primary packaging means 4 from Container closure device 1 fixed. In another embodiment, the housing 2 can have a conical shape, for example. In this way, the express provision of a holding / locking means H, such as a rib or some other type of radially inwardly directed projection, can be applied

Container closure device 1 can be dispensed with.

Optionally, a cross-sectional view of a housing of primary packaging 4 in the proximal direction corresponds to a cross-sectional view of the housing from FIG

Primary packaging 4 in the distal direction. In this way it is possible to design the filling of the container closure device 1 independently of the orientation of the primary packaging means 4. In such a case it did not matter whether primary packaging 4 in FIG. 1 is introduced into the container closure device 1 rotated by 180 ° around an axis perpendicular to the plane of the drawing. In particular, the housing 2 has a cylindrical shape, for example. Such a configuration of primary packaging means 4 makes it easier to scale the filling of container closure device 1 to large numbers. It should be noted, however, that such a symmetrical configuration of primary packaging means 4 is associated, for example, with the provision of a second breakable and / or dissolvable element, which element 5 would be arranged opposite one another.

The container closure device 1 can also have a break-open element 7. Break-open element 7 can be arranged in the form of a cutting ring outside the primary packaging material chamber 4a and designed as a movable element. In particular, the break-open element 7 can be moved in the direction of element 5. In one example, a cutting surface of break-open element 7 and a surface of element 5 run approximately parallel to one another. Break-open element 7 can, for example, have a cutting element 7a which is oriented approximately perpendicular to the surface of element 5. Primary packaging means 4 is prevented from moving in the proximal direction in housing section 2b (proximal end of container closure device 1) by closure 3.

The container closure device 1 is preferably designed to be detachably fixed

Preassembly on container B in such a way that the integrity of the primary packaging material chamber 4a is not impaired, only in the course of a further assembly step of the

Contents of primary packaging material chamber 4a in direct contact with the contents of

Container B gets or can get. For example, thread GB from The container closure device 1 is initially screwed on loosely and only screwed tight shortly before the user takes in the contents of the primary packaging chamber mixed with the container contents.

FIG. 2 shows the embodiment of the container closure device 1 corresponding to the configuration according to FIG. 1, but after the connection / closing of container B with container closure device 1. In one example, container closure device 1 is screwed onto an external thread of container B by means of thread GB. During the screwing process, the container neck moves into the interior of the container closure device 1 and in this way presses the, for example, movably designed break-open element 7 in the direction of the primary packaging 4. In this case, for example, cutting element 7a can sever element 5 in order to establish a fluid connection between primary packaging chamber 4a and the interior of container B without the contents of primary packaging material chamber 4a coming into contact with the outside environment of container closure device 1 or container B. In this way, the two contents can be mixed in a sterile manner.

FIG. 3 schematically shows an example of a second embodiment of a container closure device V. The container closure device V has a break-open element 7 'which is arranged in a fixed / immovable manner in the interior of the primary packaging material chamber 4a'. Break-open element 7 'in the form of a cutting ring has, for example, a cutting element 7a' which is oriented approximately perpendicular to a surface of element 5 '. Element 5 'of the alternative embodiment is designed as a movable element which can be moved in the direction of break-open element 7'. Element 5 'is connected at its periphery to a, for example, ring-shaped and compressible spacer / pinch element 8. Spacer / squeeze element 8 is, for example, firmly connected to break-open element 7 '. As a result of the connection of the container closure device 1 'to the container B, the spacer / pinch element 8 is compressed. The compression of spacer / squeezing element 8 causes element 5 'to move in the direction of break-open element 7'. Spacer / squeeze element 8 can, for example, simultaneously take on a sealing function. Spacer / squeeze element 8 can thus be used as a sealing element for producing a media-tight connection between the container closure device 1 and container B are used. Primary packaging 4 'is prevented from moving in the proximal direction in housing section 2b (proximal end of container closure device 1') by closure 3.

4 schematically shows an example of a third embodiment of a container closure device 1 ″. Element 5 ″ of the container closure device 1 ″ according to the third embodiment is fixed / immovable connected to the housing 2 in the housing section 2a. Primary packaging material chamber 4a ″ is in the direction of the housing section 2a to the environment Element 5 ″ is attached to an inside of housing 2 at an angle that differs from 90 °. Break-open element 7 is arranged in the form of a cutting ring outside of primary packaging chamber 4a ″ at an angle of approximately 90 ° to the inside of housing 2. Break-open element 7 can for example be designed as a movable element which can be moved in the direction of element 5 ". Break-open element 7 can for example have a cutting element 7a which is oriented at an angle to a surface of element 5". The angle between cutting element 7a and the surface of element 5 “is due to the inclined anor Elongation of element 5 “differs from 90 °. Primary packaging means 4 ″ is prevented from moving in the proximal direction in housing section 2b (proximal end of container closure device 1 ″) by closure 3. In the housing sections 2a and 2b, threads GB and G3 can be provided in each case in order to achieve releasably fixed connections to the container B or closure 3. Container closure device 1 ″ further comprises a holding / locking means H ″, which fixes primary packaging means 4 ″ in the area for receiving primary packaging 4 ″ of container closure device 1 ″.

FIG. 5A to 5E show different configurations of break-open element 7 in the form of a cutting ring, comprising a flat section for connection to housing 2 - e.g. a perforated disk L and a cutting element 7a, which can be a bevel of the flat section.

FIG. 5A schematically and by way of example, a plan view of cutting ring 7.

FIG. 5B shows a schematic and exemplary side view of cutting ring 7. The cutting surface of cutting element 7a runs in the horizontal direction parallel to a flat section L of break-open element 7.

FIG. 5C shows schematically and by way of example a variant of cutting ring 7 from FIG. 5B with serrated cutting surface of cutting element 7a.

FIG. 5D shows schematically and by way of example a side view of cutting ring 7. Cutting element 7a is beveled here. As a result, the cutting surface of cutting element 7a does not run parallel to the flat section of break-open element 7 in the horizontal direction.

FIG. 5E shows, schematically and by way of example, a side view of cutting ring 7. Cutting element 7a has a notch K here. As a result, the cutting surface of cutting element 7a is interrupted horizontally.

Claims

Expectations

1. Container closure device (1, V, 1 ″) comprising a housing (2)

- A first housing section (2a) containing means (GB) for a fixed or detachable fixed connection to a container (B),

- A second housing section (2b) containing means (G3) for the fixed or detachable fixed attachment of a lid or cap-like closure (3), and

- a lid or cap-like closure (3) which is detachably fixedly attached to the second housing section (2b) or fixedly attached to the second housing section (2b) and is designed to be reclosable,

- At least one area for receiving a primary packaging (4) comprising a primary packaging chamber (4a), the at least one primary packaging chamber (4a) being delimited at a first end by a breakable and / or dissolvable element (5);

characterized in that the breakable and / or dissolvable element (5) of the primary packaging means (4) is designed and arranged in such a way that the connecting / closing of the container (B) with the container closure device (1) and the breaking or dissolving of the breakable and / or dissolvable element (5) such that the contents of the primary packaging material chamber (4a) come or can come into direct contact with the contents of the container (B) as soon as the container (B) is closed with the container closure device (1).

2. Container closure device (1, 1 ', 1 ") according to claim 1, wherein the container closure device (1, V, 1") further has a holding / locking means (H) which the primary packaging means (4) in the area for receiving the primary packaging means (4) of the container closure device (1, 1 ', 1 “).

3. Container closure device (1, 1 ', 1 ”) according to one of the preceding Claims, wherein an inner cross-section of an opening of the first housing section (2a) and an inner cross-section of an opening of the second housing section (2b) are designed to allow the primary packaging means (4) according to one of the preceding embodiments to be introduced both through the end of the first housing section (2a) as well as through the end of the second housing section (2b).

4. Container closure device (1, 1 ’, 1”) according to one of the preceding claims, further comprising a break-open element (7) arranged in the housing section (2a).

5. Container closure device (1, 1 ', 1 ”) according to one of the preceding claims, wherein the break-open element (7) is arranged axially movably on the inside of the housing (2), wherein between the break-open element (7) and the dissolvable or breakable element (5) a QuetsctWDistanzelement (8) deformable by the application of pressure is arranged, which separates the break-open element (7) or at least its cutting element (7a) and / or mandrel (s) from the breakable element (5) or at least from its breakable area, if and as long as the container closure device (1, 1 ', 1 ”) is not yet connected to a container (B) or does not yet close it.

6. Container closure device (1, 1 ', 1 ”) according to one of the preceding claims, wherein the break-open element (7) is attached to the squeeze / spacer element (8) in such a way that it opens up when connecting / opening the container (B) with the Container closure device (1, 1 ', 1 ”) is located between the opening of the container (B) and the squeezing element (8), so that when the container (B) is connected to the container closure device (1, 1', 1”) the squeezing - / spacer element (8) is compressed, wherein the break-open element (7) is moved in the direction of the dissolvable or breakable element (5).

7. Primary packaging means (4) for introduction into a container closure device (1, 1 ', 1 ”) comprising

- A primary packaging material housing which defines at least one primary packaging material chamber (4a),

- The at least one primary packaging material chamber (4a) being delimited at a first end by a breakable and / or dissolvable element (5);

- The breakable and / or dissolvable element being designed as a breakable and / or dissolvable section of the primary packaging material housing or a breakable and / or dissolvable element which is firmly connected to the primary packaging material housing on a wall section of the primary packaging material housing.

8. Primary packaging (4) according to claim 7, wherein the at least one primary packaging chamber (4a) is delimited at a second end by a second breakable and / or dissolvable element, which is different or identical in terms of its design and / or composition of element (5) is.

9. Primary packaging (4) according to one of claims 7 or 8, wherein an external cross-sectional view of the primary packaging housing corresponds to an internal cross-sectional view of the area for receiving the primary packaging of the container closure device (1, 1 ', 1 ”), wherein the

Primary packaging (4) is in particular cylindrical.

10. primary packaging means (4) according to any one of claims 7 to 9, wherein the primary packaging means (4) further comprises a deformable by pressurization Quetscl spacer element (8) which is arranged and designed to a break-open element (7) or at least its cutting element (7a ) and / or mandrel (s) from the breakable element (5) or at least from its breakable area.

11. Kit containing at least one primary packaging means (4) as defined in one of claims 7 to 10 and a container closure device (1, 1 ', 1 ”) as defined in one of claims 1 to 6, wherein an outer cross section of the primary packaging means and an inner cross section of the Container closure device (1, 1 ', 1 ”) are designed and arranged to enable the primary packaging material to be picked up in the container closure device (1, 1', 1”).

12. Kit containing at least one container closure device (1, 1 ’, 1”) as defined in one of claims 1 to 6 and at least one container (B) which can be releasably connected / closed with the closure device.

13. Kit according to claim 11, further comprising at least one primary packaging means (4) according to one of claims 7 to 10.

14. Container comprising at least two primary packaging means (4) as defined in one of claims 7 to 10.

15. Container according to claim 14, wherein the container is a medical product, wherein the at least two primary packaging means (4) each contain a drug to be dissolved, dispersed or suspended in the contents of the container (B) in solid, liquid or thixotropic form, in which the at least two primary packaging means (4) contain the medicament in a different amount, in which the amount contained in a primary packaging means (4) results in a dosage specific to the patient group.

16. Container according to claim 14, wherein the container is a food product, wherein the at least two primary packaging means (4) each contain a substance to be dissolved, dispersed or suspended in the contents of the container (B) in solid, liquid or thixotropic form, in which the Substance is selected from electrolyte compositions, food supplements, flavorings / aromatic substances or combinations thereof, in which the chamber contents of the at least two primary packaging means (4) are different in terms of type and / or amount.