Patent Description:
Pharmaceutical containers are known in the field, in the form of glass bottles, sealed by a rubber closure in the form of a disc and by a further safety cap which completely covers such rubber closure and which is removable, at least partially, by tearing.

In the case of containers 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.

In the field, containers for parenterally administrable drugs closed by caps made of metal, in particular aluminum, are known. 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.

In the field, containers for parenterally administrable drugs closed by plastic caps are known. Such an example is described in document <CIT> (A1), 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, this known container does not have sufficient space at the neck to be able to house further fixing elements of the rubber closure.

The object of the present invention is to provide a bottle for a container for parenterally administrable pharmaceutical products which solves the drawbacks of the prior art taking into account the needs of the field.

In particular, the object of the present invention is to provide a bottle with more space at the neck to house more than one fixing element of the rubber closure.

Another object of the invention is to provide a bottle which, together with the relative closing device, maintains reduced spaces and dimensions.

Another object of the invention is to provide a bottle which, together with the relative closing device, maintains reduced spaces and dimensions without resizing the inner diameter of the neck, intended for the withdrawal of the parenterally administrable pharmaceutical solution contained therein.

Another object of the invention is to provide a bottle which meets the above requirements and which may be made of glass.

Such object is achieved by a bottle for a container for parenterally administrable pharmaceutical products according to claim <NUM>, and by a relative container according to claim <NUM>. The dependent claims describe preferred embodiments of the invention.

The features and advantages of the bottle 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>.

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

The sealing element <NUM> 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.

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 internally protruding 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 at least one hook-like ridge 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>.

Advantageously, 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>. 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.

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 means of weakening <NUM> at an outer perimeter of the spread cover. Such weakenings <NUM> are suitable for being torn apart to separate the cover <NUM> from the band <NUM>, thus 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.

Preferably, the band <NUM> also has weakenings <NUM> which facilitate the complete removal of the outer cap <NUM> of the safety cap <NUM> from the container.

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 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>.

The sealing element <NUM> 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 <NUM> 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>.

With regard to the bottle <NUM> according to the present invention, unlike the known solutions shown in <FIG>, the entire neck <NUM> has been redesigned to create the space necessary to house more than one fixing element of the rubber closure, that is, to house a closing device <NUM> as described above, without resizing the inner diameter of the neck.

The neck <NUM> of bottle <NUM> has an inner diameter Di of between <NUM> and <NUM>, preferably <NUM>.

The ridge <NUM> of the bottle <NUM> defines the maximum outer diameter of the neck <NUM>, indicated by De. The maximum outer diameter De is between <NUM> and <NUM>, preferably <NUM>. As may be seen, the maximum outer diameter De of the bottle <NUM> according to the present invention has been considerably reduced with respect to that of a bottle of the prior art.

The thickness W of the bottle <NUM> at the neck <NUM> has also been considerably reduced with respect to that of a bottle of the prior art. The thickness W is between <NUM> and <NUM>, preferably <NUM>. The thickness W of the bottle <NUM> at the neck <NUM> is slightly greater than the thickness of the bottle in its lower part.

The height Hr of the ridge <NUM> has also been significantly reduced with respect to that of a bottle of the prior art. The height HR is preferably about <NUM>. Preferably, the height HR of the ridge <NUM> is approximately ¼ of the total height of the neck indicated with Hc. Such solution allows having a large space at the neck <NUM> to house the closing device <NUM>.

The maximum height L of the ridge <NUM> has also been significantly reduced with respect to that of a bottle of the prior art. The maximum width L is preferably less than <NUM>. Preferably, the maximum width L and the height Hr of the ridge <NUM> are substantially corresponding.

Preferably, the ridge <NUM> is provided with a specific profile specially designed to facilitate the assembly step of the closing device <NUM>.

Preferably, the ridge <NUM> is provided with an upper bevel <NUM> having an inclination angle α between <NUM>° and <NUM>°, preferably of <NUM>°.

Preferably, the ridge <NUM> is provided with a lower recess <NUM> having a rounded profile, which forms an annular seat which better accommodates the retaining means <NUM> of the closing device <NUM>. Preferably, the rounded profile of the lower recess <NUM> has a radius of <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.

Preferably, the bottle <NUM> is made of glass.

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

Innovatively, a bottle for a container for parenterally administrable drugs according to the present invention allows all the intended objects as described above to be achieved in a particularly effective manner.

Advantageously, a bottle for a container for parenterally administrable pharmaceutical products according to the present invention is provided with a completely redesigned neck and relative ridge to offer greater space for the closing device, while ensuring a sufficient fixing grip against any tampering, and while maintaining reduced dimensions without resizing the inner diameter Di.

Claim 1:
A bottle (<NUM>) for a container for parenterally administrable pharmaceutical products comprising a neck (<NUM>), having a neck height (Hc), and ending superiorly in an access mouth (<NUM>) defined by a radially protruding ridge (<NUM>), having a ridge height (Hr) and a maximum width (L);
characterized in that the ridge height (Hr) is about ¼ of the neck height (Hc) and the maximum width (L) of the ridge (<NUM>) substantially corresponds to the ridge height (Hr) .