Description

A Process for Packing and a Package for Substances to be mixed immediately prior to Use.

Technical Field

The invention relates to a process for packing and a package for substances which are to be mixed at moment of use. Background Art

For packing substances to be mixed at moment of use, in particular for mixing an active substance internally of a solvent in order to obtain a solution immediately before use of the solution, the prior art includes a system for inserting a solvent in one container and to close that container with a capsule, generally made in two parts which are assemblable to one another, which are made of a plastic material by injection moulding or the like, in which capsule there is an active substance which at moment of use is introduced into the container following a laceration of a part of the closing capsule. To actuate this process, the prior art includes packages, single- or multi-dose, which comprise a container (generally a liquid) on which a capsule is mounted, of various types; in known packages, internally of the capsule there is a reservoir, having a breakable bottom, internally of which there is a cutting element that following a pressure exerted thereon causes the laceration of the breakable bottom. An active substance is contained in the reservoir, generally in powder or granule form, which when the bottom of the reservoir is lacerated drops into the container and dissolves in the liquid contained in the container.

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The substances contained in the reservoir, which are soluble in the liquid contained in the container and are in fact dissolved therein at moment of use, are generally sensitive to humidity, both due to their physical characteristics (they can form undesired lumps) and due to their chemical nature (they may undergo changes in their properties); the susceptibility to chemical change is very often the reason why these preparations are dropped into the solution only a few moments before they are to be used.

The materials the reservoirs containing the active substance are made of are, by their very nature, permeable to humidity, even if to a modest degree; this permeability leads to certain consequences of small entity in the thickest parts of the reservoir, as the time needed for humidity to migrate to those zones is very long; however the phenomenon of humidity migration is much more relevant in proximity of the circumferential line of the reservoir along which the cut is made as the thickness of the line is very small and the humidity migration time through the line is considerably less.

This phenomenon leads to deterioration, in relatively short times, of the chemical-physical characteristics of the active substance contained in the reservoir, or at least a part of it.

In attempts to obviate the drawback which is inherent in the process in which the capsules used are such as the one described above, less permeable plastic materials have been used to make the reservoirs. This solution does not in fact solve the problem, though it slows down the process, but a further problem is indeed created, because the less permeable plastic materials are much more difficult to lacerate with the cutting elements normally used. For this reason this possible solution has mostly been abandoned.

Another solution has been to insert a quantity of active substance in the reservoir which is more than is necessary; in this way, as the deterioration of

the substance is progressive, even if a part of it deteriorates enough will remain, and for long enough, for the aims of the package. This is however an expensive solution, and is also lacking in precision as concerns the formulation of the final product.

A further solution has been to indicate a use-by date on the package, which takes into account the humidity absoiption time, which is normally much shorter than the time limit for true active life of the active substance. This solution too is rather expensive.

A further solution has been to add preservatives to the active substance. This solution is not much preferred, and could indeed become impracticable if and when new norms and standards become effective.

The main aim of the present invention is to obviate the drawbacks in the prior art, by providing a process for packing and a package, which are easy to apply and use and which afford very long humidity permeability times.

An advantage of the present invention is to provide a process and a package which can be realised by simple tried and tested manufacturing methods.

A further advantage of the invention is that it provides a process and a package which are more economical with respect to known processes and packages.

Disclosure of Invention

Further characteristics and advantages of the present invention will better emerge from the detailed description that follows of the various stages of the process of the invention, as well as various preferred embodiments of the package of the invention, illustrated by way of non-limiting example in the accompanying figures of the drawings, in which:

Figure 1 is a vertical elevation, with some parts in section and others represented only partially, of a first embodiment of the package of the invention;

Figure 2 is a vertical elevation, with some parts in section and others represented only partially, of a second embodiment of the package of the invention;

Figure 3 is a vertical elevation, with some parts in section and others represented only partially, of a third embodiment of the package of the invention;

Figure 4 is an enlarged-scale representation of a section in vertical elevation of a part of the package of the invention.

The packaging process of the invention is used to obtain packages which, in two different environments, contain substances that are to be mixed at point of use; this type of package is especially used to obtain single-dose containers for medicinal substances and the like. A further possible use of the packages is to enable an extempore preparation of drinks, syrups and other products of that kind. These would not be single-dose packages but, once the solution had been made up, the package could be reclosed for further use on separate occasions.

These packages are provided with a container 1, normally a flagon or a bottle made of glass or plastic, which contains a solvent, normally a liquid, in which an active substance 5 is introduced at moment of use.

In the process of the invention, the active substance is inserted internally of a hermetically-closed blister 4, which is the usual English term for a bubble- like container of the type of the invention.

Preferably, though not of necessity, the active substance 5 is packaged in a pastille form; however it could also be a powder or even a gas. The blisters,

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made by coupling materials which are impermeable to humidity, are of known type, and the production process for them is widely known; they are normally used, among other things, for containing medicines in pill form, or the like. The blisters have a breakable wall which following a pressure exerted on an opposite wall thereof breaks and lets the contents of the blister exit.

The blister 4 is then coupled to the container 1 in such a way that when the blister is broken open following a simple pressure on the upper surface thereof, the active substance falls internally of the container. This coupling is realised in such a way as to guarantee the seal between the inside of the container and the outside environment.

In particular, the blister 4 is arranged with its breakable wall 4a facing the mouth 2 , i.e. the inside of the container.

The coupling between the container and the blister can be realised either directly, by gluing, using known systems, the blister to the mouth of the container, and by interpositioning, between the container and the blister, a capsule 3, which can be of various shapes, which is connected to the neck of the container and which, according to its shape and the system of coupling used between blister and capsule, can have the function of guaranteeing or not the container hermetic seal, proof of its having been opened before, the possibility of re-closure, and so on.

The package for realising the described process comprises: as with known- type packages, a container 1 provided with an open mouth 2, which contains the solvent, and which is closed by a closure element internally of which the active substance 5 is inserted.

In the package of the invention the closure element comprises a blister 4 of known type, hermetically closed and containing the active substance 5. The

blister 4 is made with a lacerable wall 4a which is arranged at the mouth 2 of the container, and with a deformable wall 4b which is solidly constrained to the lacerable wall 4a and which is arranged facing the outside of the container. The lacerable wall 4a of the blister 4 is realised according to a known process, with a multi-layer material containing at least a layer of aluminium and a layer of plastic material; this type of material is practically impermeable to humidity. The deformable wall 4b of the blister is made of a heat-formable material, preferably a polypropylene, a PVC or multi-layer polylaminates, impermeable to humidity and deformable by simple pressure. If the material the container is made of allows it, the lacerable walls 4a of the blister 4 can be heat-welded directly on the neck of the container 1 so as to close it hermetically. This solution, which is an easy step to imagine, is therefore not illustrated in the figures of the drawings. This solution however has the difficulty of accessing the inside of the container once the wall 4a has be lacerated; the drawback could be limited by use of a gripping tab, connected to the lacerable wall, which facilitates the removal of the blister from the neck of the bottle.

In other cases, such as for example what is illustrated in figures 1 , 2 and 3, the closure element can comprise a capsule 3 which is provided with an opening 3a and is connected to the neck of the container 1 in such a way that the opening 3a is arranged at the mouth 2 of the container. The coupling between the capsule 3 and the container is preferably realised by means of a threaded coupling. The capsule 3 constitutes a soil of "second neck" of the container 1, and the opening 3a guarantees accessibility to the inside of the container 1. In this case the coupling between the container 1 and the blister 4 is achieved by coupling the blister 4 to the capsule 3 and coupling the capsule 3 to the container 1.

The capsule can be of various types. For example the capsule of figure 1 includes an annular recess 10 in which the blister 4 can be gripped, and also includes a plurality of annular protuberances 11 which, once the capsule containing the blister 4 has been inserted on the container 1 , guarantee the seal on the package.

The capsule of figure 2 comprises a flat annular surface 12 on which the lacerable wall 4a of the blister is heat- welded. A ring 13 is included in the capsule which guarantees the container 1 seal. If it is considered important to protect the blister, the capsule can be fitted with a lid 14, as shown in figure 3. All the capsules illustrated and described herein are further provided with a security strip 15 which evidences a first unthreading of the capsule from the container 1.

The process and the package of the invention can obviously also be realised using capsules of a different nature to the ones illustrated and described herein.

The process and package described and claimed represent a considerable improvement on the processes and packages contained in the prior art, which use breakable reservoirs made by injection-moulding of plastic material. The realisation of the blisters is very much easier, more rapid and more economical than the manufacturing of the breakable reservoirs used up to now for these packages. Furthermore, to make the blister material can be used, such as aluminium, polypropylene and PVC, which are impermeable to humidity but which cannot be used for making breakable reservoirs. This high level of impermeability to humidity means that over-provision of active substance can be avoided; nor is it necessaiy to indicate shorter use-by dates than those really applicable. The use of preservatives is also obviated. Finally, the use of these packages is much easier for the final user.