Patent Description:
It is an object of this invention to provide a plastic closure device, partially removable by tearing, able to guarantee the authenticity of the container, highlighting any tampering thereof.

Caps are known in the art for further sealing a container, generally a vial in the form of a glass bottle, which is already sealed by a rubber closure. In such known solutions, the cap entirely covers the rubber closure.

In the case of orally administrable drugs, which therefore require intestinal absorption, the cap is completely removed to allow the removal of the rubber closure and therefore access to the container.

An example of said known solutions for orally administrable drugs is described in prior art document <CIT>), directed to a cap entirely made of metal, specifically made of aluminum. One of the advantages of aluminum lies in the deformability of the material which allows the cap to be easily fixed in position by folding a lower end thereof under the edge of the container neck. Furthermore, a cap entirely made of metal allows very reduced thickness and dimensions to be maintained. However, the metal cap has a number of disadvantages, linked precisely to the material. A thin metal cap may in fact deform undesirably during the filling and cleaning steps of the containers. A further drawback lies in the fact that minute metal particles may detach during the tear-open step and come into contact with the rubber closure, contaminating it. Moreover, this type of cap does not guarantee the authenticity and integrity of the contents of the container. In fact, the fixing of the cap by folding the edge is easily tampered with using suitable tools.

Solutions of plastic caps for orally administrable drugs are known in the art. An example is described in <CIT>), in which the cap comprises a tear-off removable outer cap and an easily removable inner cage to allow subsequent removal of the rubber closure. In such solution, the outer cap is required to hold the inner cage firmly in place below the edge of the container neck. Although such a cap allows the problems related to the use of metal to be solved, it still has a major drawback. In fact, this type of cap does not guarantee the authenticity and integrity of the contents of the container, since the outer cap is easily tampered with using suitable tools.

In summary, in caps for orally administrable drugs it is essential that the cap is completely removed to allow the subsequent removal of the rubber closure. Furthermore, the caps known for this type of drug are easily tampered with by acting on the lower edge of the cap itself.

In caps for parenterally administrable drugs, it is essential that the rubber closure remains firmly pressed into the container neck. In the case of parenterally administrable drugs, in fact, only the upper portion of the cap may be opened, for example by tearing, to allow exposure of the upper part of the rubber closure intended to be pierced by the needle of a syringe, used to withdraw the pharmacological solution contained inside the container.

Solutions of plastic caps for parenterally administrable drugs are known in the art. Such an example is described in document <CIT>), in which the cap comprises an upper portion which may be opened to expose the pierceable area of the rubber closure, and a fixed lower portion to keep the rubber closure firmly in the sealing position. In this solution, the fixed portion is snap-engaged to the edge of the container neck and extends to cover the entire neck. While this solution reduces the risks of tampering, given that it is difficult to access under the cap to try to tamper with it, it still has some drawbacks. In fact, in the event of accidental blows at the lower edge or tampering attempts, there is in any case the risk that the fixed portion is released from the neck of the container, making the pressure force on the rubber closure disappear and compromising the hermetic closure thereof. Furthermore, the presence of a deliberately elongated fixed portion causes a problem of visibility of the container neck when, during the final withdrawal of the pharmacological solution by means of a syringe, the container is turned upside down and the residual solution collects right at the neck. Furthermore, this known cap does not have any adaptation mechanism for compensating different heights of the glass containers in the case of simultaneous filling, nor mechanisms for compensating the dimensional tolerances typical of glass and rubber components.

The object of the present invention is to provide a plastic closure device for parenterally administrable drugs, partially tear-off, which solves the problems of the prior art taking into account the needs of the field.

In particular, an object of this invention is to provide a plastic closure device for parenterally administrable drugs, partially removable by tearing, able to guarantee the authenticity of the container, highlighting any tampering thereof.

Another object of the invention is to provide a plastic safety cap capable of guaranteeing the authenticity of the container while allowing correct visibility of the neck of the container during the final withdrawal of the pharmacological solution by means of a syringe.

Another object of the invention is to provide a plastic safety cap which keeps the rubber element firmly sealingly fixed to the container even after the cap has been partially torn-off.

Another object of the invention is to provide a plastic safety cap which, even in the event of undesirable partial deformations during the filling and cleaning of the containers, still maintains the hermetic closure thereof.

Another object of the invention is to provide a plastic safety cap provided with at least one adaptation mechanism to compensate for different heights of the glass bottles in the case of simultaneous filling.

Another object of the invention is to provide a plastic safety cap provided with at least one mechanism for compensating the dimensional tolerances typical of glass and rubber components.

Another object of the invention is to provide a plastic safety cap consisting of only two components which are easy to manufacture by injection molding.

Such object is achieved by a partially tear-off plastic closure device and a container for parenterally administrable drugs, as claimed herein. Preferred embodiments of the invention are also described.

The features and advantages of the closure device according to the present invention will appear more clearly from the following description, made by way of an indicative and non-limiting example with reference to the accompanying figures, in which:.

In the accompanying figures, the reference numeral <NUM> indicates a container for parenterally administrable pharmaceutical products comprising a bottle <NUM> closed by a closing device <NUM> made of a sealing element <NUM>, for example made of rubber, and a safety cap <NUM>, for example made of plastic, partially tear-off and adapted to guarantee the authenticity of the container, highlighting any tampering.

The safety cap <NUM> completely covers the sealing element <NUM> and may be removed at least partially in order to expose a pierceable portion <NUM> of such sealing element <NUM> intended to be pierced by the needle of a syringe in order to be able to withdraw the pharmacological solution S contained in the bottle <NUM>.

The bottle <NUM>, shown in detail in <FIG>, is intended to contain a parenterally administrable pharmacological solution S and is provided with a neck <NUM> ending superiorly in an edge <NUM> which defines the mouth <NUM> of the bottle itself. The edge <NUM> is provided with a ridge <NUM> protruding radially from the neck <NUM> and having an outer diameter greater than the outer diameter of the neck <NUM>. The neck <NUM> of the bottle ends at the beginning of the shoulder of the bottle.

In the container <NUM>, the mouth <NUM> of the bottle <NUM> is closed by a sealing element <NUM>.

The sealing element <NUM>, shown in detail in <FIG> and described below, is a rubber cap which seals in a sterile manner the contents of the bottle <NUM> from the environment, and which may be pierced by a hypodermic needle, not shown in the drawings, to remove the pharmacological solution S from the container <NUM>.

The sealing element <NUM> is covered by the safety cap <NUM> which, in addition to contributing to the sealing of the container <NUM>, also has a "tamper evident" function, highlighting any tampering with the container itself.

The safety cap <NUM> comprises two elements and is made entirely of plastic. Preferably, the safety cap <NUM> consists of only two elements.

<FIG> show the inner cage <NUM> of the safety cap <NUM> according to the present invention, in two possible embodiment variants.

The inner cage <NUM> comprises a head <NUM>, provided with a central opening <NUM> which allows access to the pierceable portion <NUM> of the sealing element <NUM>, below which a cylindrical skirt <NUM> extends, ending in a lower edge <NUM> at which retaining means <NUM> are provided.

The head <NUM> of the inner cage <NUM> is provided with an outer head surface <NUM> and an inner head surface <NUM>.

The skirt <NUM> has a certain height, adapted to the dimensions of the ridge <NUM> of the bottle <NUM> and of the sealing element <NUM>.

The skirt <NUM> of the inner cage <NUM> is provided with an outer skirt surface <NUM> and an inner skirt surface <NUM>.

The skirt <NUM> ends in a lower edge <NUM> at which internally projecting retaining means <NUM> are provided. In fact, the inner cage <NUM> of the safety cap <NUM> snap-engages below the ridge <NUM> of the neck <NUM> of the bottle <NUM> by means of said retaining means <NUM>.

The retaining means <NUM> are made in one piece with the skirt <NUM>.

The retaining means <NUM> are at least one hook-shaped protrusion facing towards the inside of the inner cage <NUM>, that is to say facing towards the inner surface of the skirt <NUM>.

Preferably, the retaining means <NUM> are connected to the skirt <NUM> through the lower edge <NUM>, which preferably has a curvilinear profile to further increase the flexibility of the retaining means <NUM>.

The retaining means <NUM> are provided with a bearing space <NUM> defined between the retaining means itself and the inner surface of the skirt <NUM>. As may be seen in <FIG>, during the positioning of the inner cage <NUM> on the neck <NUM> of the bottle <NUM>, the retaining means <NUM> compress, approaching the inner surface of the skirt <NUM> and occupying the bearing space <NUM>, without deforming the inner cage <NUM>. This solution facilitates the sliding of the retaining means <NUM> at the ridge <NUM> of the bottle <NUM>, until the snap engagement underneath said ridge <NUM> is obtained. Advantageously, the high flexibility of the retaining means <NUM> reduces the fitting loads of the safety caps <NUM> on the bottles <NUM> in the case of simultaneous filling.

Therefore, the retaining means <NUM> are preferably hook-folded projections, capable of bending during assembly on the neck <NUM> of the bottle <NUM> (<FIG>), and of jamming under said neck <NUM> in case of removal attempts (<FIG>). This solution provides a low fitting force, by virtue of the bearing space <NUM>, and a high removal force, by virtue of the folded hook shape. In summary, therefore, the inner cage <NUM> of the safety cap <NUM> is provided with highly flexible retaining means <NUM>, to facilitate the assembly steps of the container <NUM>, and with a high clamping force, to best retain the inner cage <NUM> on the neck <NUM> of the bottle <NUM>. Advantageously, therefore, by virtue of the retaining means <NUM> of the inner cage <NUM>, once the snap coupling on the neck <NUM> of the bottle <NUM> has been obtained, no further fixing or retaining element will be required to keep the sealing element <NUM> firmly in the closed sealing position of the mouth <NUM> of the bottle <NUM> even if the outer cap <NUM> is completely removed by tearing. Therefore, even in the event of attempts to tamper with the outer cap <NUM> and breakage of the relative band <NUM>, the sealing element <NUM> remains firmly in the sealing position of the mouth <NUM> by means of the inner cage <NUM>.

An embodiment example of an inner cage <NUM> is shown in <FIG>. In this example, the retaining means <NUM> are a single, annular and continuous fold of the lower edge <NUM> of the skirt <NUM>. In such solution, the fold is obtained by folding the lower edge <NUM> towards the inside of the skirt <NUM>.

A further embodiment example of an inner cage <NUM> is shown in <FIG>. In this example, the retaining means <NUM> are a plurality of folds, arranged uniformly on the lower edge <NUM> of the skirt <NUM>. In such solution, the folds are obtained by molding. To facilitate the extraction of the mold inserts and the entire molding step, the inner cage <NUM> has, for each fold, an upper access window <NUM> at the head <NUM>.

Preferably, the inner cage <NUM> is provided with thrust means <NUM> of the sealing element <NUM>, arranged below the head <NUM> and shown in <FIG>.

Preferably, the thrust means <NUM> comprise at least one continuous annular protrusion <NUM> at the inner head surface <NUM>. The thrust means <NUM> are shaped to provide a compensation mechanism for the coupling tolerances between the sealing element <NUM>, the inner cage <NUM> and the ridge <NUM> of the neck <NUM> of the bottle <NUM>. In fact, the rubber sealing element <NUM> and the glass ridge <NUM> are elements characterized by high variations in the dimensional tolerances that the inner cage <NUM> should compensate for to ensure the correct pulling force below the ridge <NUM> against any tampering. In the case of minimum tolerances of the rubber and the glass, in fact, the pull may be insufficient to guarantee the correct tightening on the bottle <NUM>, and on the contrary in the case of maximum tolerances of the rubber and the glass, the pull may be too high so as to prevent the tightening on the bottle <NUM>.

With reference to <FIG>, the following dimensional features of the elements involved in the tightening on the bottle neck have been indicated:.

It should be noted that the technical solution of the thrust means <NUM> having a certain height W, and the related condition to be satisfied above, is independent of the presence or absence of the outer cap <NUM>, of specific features of the sealing element <NUM>, such as for example the elevation <NUM>, or of the inner cage <NUM>, as the specific shape of the thrust means <NUM>. Therefore, such technical solution may also be applied to other types of closure devices and containers.

In an embodiment example, shown in <FIG>, the thrust means <NUM> have a triangular profile ending in a tip <NUM> suitable for sinking at least partially into the sealing element <NUM>. In such embodiment examples, the thrust means <NUM> comprise a plurality of shaped protrusions.

In a further embodiment example, shown in <FIG>, the thrust means <NUM> have a stepped profile, with a larger section above which a reduced section tip <NUM> protrudes.

The thrust means <NUM> of the inner cage <NUM> will be able to exert, through the tip <NUM>, a minimum thrust on the sealing element <NUM> even in the case of minimum tolerances of the glass and the rubber, as in <FIG>. At the same time, the maximum thrust exerted towards the sealing element <NUM> in the case of maximum tolerances of the glass and the rubber, shown in <FIG>, will not be excessive since the tip <NUM>, having a very small section, will sink more into the sealing element <NUM>. Advantageously, therefore, also by virtue of the thrust means <NUM> of the inner cage <NUM>, once the snap coupling on the neck <NUM> of the bottle <NUM> has been obtained, no further fixing or retaining element will be required to keep the sealing element <NUM> firmly in the closed sealing position of the mouth <NUM> of the bottle <NUM> even if the outer cap <NUM> is completely removed by tearing.

<FIG> shows the outer cap <NUM> of the safety cap <NUM> according to the present invention.

The outer cap <NUM> is provided with tear-open means by means of which it may be opened to expose the sealing element <NUM>.

The outer cap <NUM> is formed by a band <NUM>, preferably cylindrical, closed at the top by a cover <NUM>, preferably disc-shaped.

Preferably, the band <NUM> is elongated, i.e. it extends to cover the entire neck <NUM> of the bottle <NUM>, as seen in <FIG>. This solution considerably reduces the risks of tampering as it is more difficult to access underneath the safety cap <NUM> to try to tamper with it.

The cover <NUM> is connected to the band <NUM> by weakenings <NUM> at an outer perimeter <NUM> of the cover. Such weakenings <NUM> are suitable for being torn apart to separate the cover <NUM> from the band <NUM>, opening the outer cap <NUM> at the top to allow access to the sealing element <NUM>.

The weakenings <NUM> are a plurality of uniformly distributed thin bridges, as shown in <FIG>, or necking lines of the material, or pre-cuts, or grooves.

In an embodiment example, the cover <NUM> is completely separable from the band <NUM>.

In a further embodiment example, the cover <NUM> is partially separable from the band <NUM>, as seen in <FIG>. In this example, the cover <NUM> remains connected to the band <NUM> by means of a connecting portion <NUM>, which may not be torn apart, placed at the outer perimeter <NUM> of the cover itself.

Preferably, also the band <NUM> has at least one line <NUM> of weakenings <NUM>. Such line <NUM> may be whole and extend for the entire length of the band <NUM>, or interrupted and therefore interrupt before the lower edge <NUM>.

Preferably, the band <NUM> has an entire line <NUM> of weakenings <NUM> which allows the longitudinal opening of the band itself, and a parallel interrupted line <NUM> of weakenings <NUM> which allows the removal of the entire outer cap <NUM> at once, that is to say without the formation of separate pieces.

Preferably, the at least one line <NUM> of weakening <NUM> extends from one end of the connecting portion <NUM> between the cover <NUM> and the band <NUM>.

The presence of the weakenings <NUM> also on the band <NUM> facilitates the complete removal of the outer cap <NUM> of the safety cap <NUM> from the container. Advantageously, by virtue of a completely removable outer cap <NUM>, even in the presence of a deliberately elongated band <NUM> covering the entire neck <NUM> of the bottle <NUM>, it is possible to maintain full visibility of the neck itself, as may be seen in <FIG>, useful when the bottle <NUM> is turned upside down during the final withdrawal of the pharmacological solution by means of a syringe and the residual solution is collected precisely at said neck.

Preferably, the outer cap <NUM> is also provided, at the band <NUM>, with a gripping depression <NUM> to facilitate gripping and removal of the cover <NUM>. The user may thus more easily insert a nail under the outer perimeter <NUM> of the cover <NUM> and lift it, causing the tearing of the weakenings <NUM>.

The cover <NUM> of the outer cap <NUM> is provided with an outer cover surface <NUM> and an inner cover surface <NUM>.

Preferably, the outer cap <NUM> is provided with means <NUM> for protecting the sealing element <NUM>, arranged under the cover <NUM>. Preferably, the protection means <NUM> are a protrusion <NUM>, preferably annular and continuous, at the inner covering surface <NUM>. Such protrusion <NUM> delimits a chamber <NUM>, visible in <FIG>. When the closing device <NUM> is assembled, the protection means <NUM> are arranged in such a way that the protrusion <NUM> abuts against the sealing element <NUM> about the pierceable portion <NUM>, which is therefore arranged inside the chamber <NUM>. Therefore, the inner covering surface <NUM> of the outer cap <NUM> is always raised with respect to the pierceable portion <NUM> of the sealing element <NUM> to avoid the contamination thereof.

Preferably, the outer cap <NUM> is provided with cushioning means <NUM> arranged at the cover <NUM>, and shown in <FIG>. Preferably, the cushioning means <NUM> form a linear spring and are obtained by folds in the cover <NUM>. In particular, the cover <NUM> comprises a pair of inclined walls <NUM>, facing each other, between which a bottom wall <NUM> is arranged, so as to provide an annular depression <NUM>. As may be seen in <FIG>, when the closure device <NUM> is assembled, the bottom wall <NUM> abuts against the head <NUM> of the inner cage <NUM>. Advantageously, the cushioning means <NUM> provide a mechanism for adapting the closure device <NUM> to compensate for different heights of the bottle <NUM> in the case of simultaneous filling.

As shown in <FIG>, the band <NUM> of the outer cap <NUM> has a height adapted to completely cover the inner cage <NUM> and the entire neck <NUM> of the bottle <NUM>.

The band <NUM> of the outer cap <NUM> is provided with an outer band surface <NUM> and an inner band surface <NUM>.

The outer cap <NUM> is fixed to the bottle <NUM> by means of the interposition of the inner cage <NUM>. The outer cap <NUM> of the safety cap <NUM> is in fact snap-engaged under the lower edge <NUM> of the inner cage <NUM> by means of coupling means <NUM>.

The coupling means <NUM> are made in one piece with the band.

The coupling means <NUM> are at least one relief protruding inside the band <NUM>. Preferably, the coupling means <NUM> are in the form of a continuous annular relief, protruding from the inner surface of the band <NUM>.

Preferably, the coupling means <NUM> are arranged more internally, that is to say upstream, with respect to the lower edge <NUM> of the band <NUM>.

The sealing element <NUM>, shown in two embodiment variants in <FIG>, is a rubber cap having a cap head <NUM>, preferably disc-shaped, below which the cap body <NUM>, preferably cylindrical, extends.

The cap body <NUM> is intended to fit inside the neck <NUM> of the bottle <NUM>, while the cap head is intended to rest against the edge <NUM> to close the mouth <NUM> of the bottle itself.

The sealing element <NUM> is provided with a pierceable disc-shaped portion <NUM>, arranged centrally to the cap head <NUM> and defined inside an annular edge <NUM>.

Preferably, the pierceable portion <NUM> is made on a disc-like elevation <NUM> of the cap head <NUM>. That is to say that the cap head <NUM> defines a head plane, and that the pierceable portion <NUM> is arranged on a raised plane with respect to the head plane and defined by the elevation <NUM>. As may be seen in <FIG>, when the closing device <NUM> is assembled, the elevation <NUM> is inserted and retained inside the central opening <NUM> of the head <NUM> of the inner cage <NUM>. Advantageously, in this way the sealing element <NUM> is engaged with the inner cage <NUM> and this facilitates the handling thereof during the assembly step of the closure device <NUM>. Advantageously, the elevation <NUM> allows the pierceable portion <NUM> to be positioned higher, which is more easily accessible and disinfectable when using the container <NUM>.

Preferably, the pierceable portion <NUM> is arranged flush with the head <NUM> of the inner cage <NUM>. Preferably, the annular edge <NUM> which defines the pierceable portion <NUM> projects above the head <NUM> of the inner cage <NUM>.

In an embodiment, shown in <FIG>, the sealing element <NUM> is provided with a plurality of thrust reliefs <NUM> arranged radially on the cap head <NUM>, uniformly distributed about the pierceable portion <NUM>. For example, the sealing element <NUM> is provided with four thrust reliefs <NUM>. The thrust reliefs <NUM> of the sealing element <NUM> are adapted to collaborate with the thrust means <NUM> of the inner cage <NUM>.

The present invention also relates to a container <NUM> for parenterally administrable pharmaceutical products comprising a bottle <NUM> closed by a closing device <NUM> as described above, i.e. made of a sealing element <NUM>, for example made of rubber, and a safety cap <NUM>, for example made of plastic, partially tear-off and adapted to guarantee the authenticity of the container, highlighting any tampering.

Advantageously, a container <NUM> thus made is provided with a particularly effective anti-tampering system, while maintaining reduced overall dimensions. As may be seen in <FIG>, in fact, the closing device <NUM> according to the present invention has an outer diameter which is smaller than or at most corresponding to the outer diameter of the bottle <NUM>. Even more advantageously, in the case of a closing device <NUM> with an outer diameter corresponding to the outer diameter of the bottle <NUM>, the container <NUM> has an overall cylindrical shape which considerably facilitates the handling thereof, especially in the case of simultaneous filling of several containers in completely automated systems.

As far as the materials are concerned, the technical solutions described above are applied to plastic closing devices <NUM>, to glass or plastic bottles <NUM>, to sealing elements <NUM> in thermosetting rubber or thermoplastic rubber.

Innovatively, a plastic closure device for parenterally administrable drugs, partially tear-off, and a relative container according to the present invention allow all the intended objects as described above to be achieved in a particularly effective manner.

Advantageously, a closure device according to the present invention not only guarantees the authenticity of the container, but is also capable of guaranteeing the tightness of the container even in the event of tampering attempts.

In summary, a closure device according to the present invention has the following innovative and advantageous features:.

Claim 1:
A plastic closure device (<NUM>) for a container for parenteral pharmaceutical products in the form of a bottle (<NUM>) provided with a neck (<NUM>), said closure device (<NUM>) comprising a removable outer cap (<NUM>), formed by a cylindrical band (<NUM>) closed at the top by a cover (<NUM>), said outer cap (<NUM>) being provided with tearable weakenings (<NUM>) to allow it to be removed by tearing, and snap-coupling means (<NUM>) protruding inside the band (<NUM>); characterized in that it comprises an inner cage (<NUM>) provided with a head (<NUM>) having a central opening (<NUM>) and below which a skirt (<NUM>) extends ending in a lower edge (<NUM>) at which retaining means (<NUM>) are provided for permanently engaging the neck (<NUM>) of the bottle (<NUM>) by snapping, and wherein said outer cap (<NUM>) is engaged by snapping below the lower edge (<NUM>) of the inner cage (<NUM>) by means of said coupling means (<NUM>).