Patent Publication Number: US-2019177057-A1

Title: Packaging for extemporaneous preparation products, particularly medicinal, pharmaceutical, cosmetic products or the like

Description:
TECHNICAL FIELD 
     The present invention relates to a packaging for extemporaneous preparation products, particularly medicinal, pharmaceutical, cosmetic products or the like. 
     BACKGROUND ART 
     In the medicinal, pharmaceutical and cosmetic sectors, extemporaneous preparation products are known, i.e. products consisting of the solution or the mixture of at least two different substances, of which one is e.g. in the liquid state and the other in the powdery state, which are kept separate from each other until the time of use. 
     For the packaging of such extemporaneous preparation products, the use is known of a packaging that essentially consists of a container which is closed at the bottom and extends superiorly into a neck at the top of which a mouth is defined; inside the container there is a first substance, generally in the liquid state. 
     In the mouth of the container is accommodated a tank of a second substance which consists of a cylindrical hollow body, inferiorly closed by a frangible bottom and superiorly open; the bottom of the tank, until it remains intact, separates the second substance from the first one. 
     Inside the tank is hermetically inserted a cutting element, which consists of a tubular body, the lower ending part of which is sectioned according to an oblique plane or shaped like a flute spout, and the upper ending part of which extends beyond the upper opening of the tank. 
     The cutting element is axially sliding with respect to the tank between a non-interference configuration, in which it is placed above the intact bottom of the tank itself, and a cutting configuration in which, pushed towards the bottom of the tank itself, it cuts the latter along the perimeter edge by placing the tank, thus opened, in communication with the container. 
     Known packaging is also provided with a cover cap which is associated with the neck of the container; the lower edge of the cap is temporarily bound, along a breaking line, to a sealing ring bound to the neck of the container and provided with a weakened axial line at which it opens. 
     At the time of using the product the cap is pushed towards the neck of the container thus causing the cutting element to slide inside the tank until the bottom of the latter is cut off; the second substance then pours from the tank to the container, within which it blends with the first substance thus forming the product. 
     To dispense the product so formed, it is enough to remove the cap. 
     Examples of similar packaging for extemporaneous preparation products are described in patent documents EP 0561322 and IT 1287425. 
     These known types of packaging are susceptible to upgrading specifically aimed at improving the isolation and separation of the substances prior to their mixing. 
     In particular, the vapors released by the liquid substance present in the container permeate, in part, inside the tank where there is generally a powdery, often hygroscopic, substance. 
     Before the preparation of the product, when the two substances are still separate, the powdery substance absorbs the vapors released by the liquid one impregnating with them and thickening into agglomerates. 
     When, at the time of preparing the product, the tank is opened and placed in communication with the container, the agglomerates that are formed tend to remain inside the tank and, even when poured into the container, they hardly dissolve and disperse completely into the liquid substance. 
     The composition of the product so formed does not correspond to that for which it is intended; in the event of the product being a drug or a medicinal product, this causes an indeterminable alteration in the content of its active ingredients as well as in the dosage established for it and, consequently, a disadvantageous modification of the therapy studied for a patient. 
     This drawback is accentuated by the fact that the tanks of known packaging are generally made of polymeric materials having a certain degree of vapor permeability. Vapor permeability is also increased at the bottom of the tank which, being of the breakable type, generally has small thickness and/or is bound to the tank body along weakening lines of even smaller thickness. 
     To overcome at least partly these drawbacks, bottles are known such as those disclosed in the documents EP 1 186 548 and EP 1 858 774, wherein the container containing the second substance defines an insulating interspace to hinder the passage of the vapors released by the liquid substance. 
     However, also these bottles are not free from drawbacks. 
     Recent studies in fact have shown that the presence of an insulating interspace can only delay the spread of the vapors released by the liquid substance and, therefore, cannot prevent any absorption by the powdery substance and the formation of improper agglomerates. 
     DESCRIPTION OF THE INVENTION 
     The main aim of the present invention is to provide a packaging for extemporaneous preparation products, particularly medicinal, pharmaceutical, cosmetic products or the like, which allows to effectively keep the substances composing the product perfectly separated and isolated from one another until the time of product preparation. 
     One object of the present invention is to provide a packaging which permits, in particular, to prevent the absorption by a substance, generally the powdery and hygroscopic one, of the vapors released by another, generally liquid, substance, and hence the formation of unwanted thickenings and agglomerates. 
     It is a further object of the present invention to provide a packaging that allows preparing a product of desired composition and, therefore, in the particular case of medicinal or pharmaceutical products, with a predetermined content of active ingredients, thus permitting compliance with the dosage established for the therapy of a patient. 
     Another object of the present invention is to provide a packaging that can be used and opened in a simple, practical and easy manner by the users, without requiring any special effort. 
     Not the last object of the present invention is to provide a packaging with reduced costs and production times, that is easy to assemble and which allows limiting the quantities of construction materials used for its production. 
     Another object of the present invention is to provide a packaging for extemporaneous preparation products, particularly medicinal, pharmaceutical, cosmetic products or the like, which allows to overcome the aforementioned drawbacks of the prior art within the ambit of a simple, rational, easy, efficient to use and cost-effective solution. 
     The aforementioned objects are achieved by the present packaging for extemporaneous preparation products, particularly medicinal, pharmaceutical, cosmetic products or the like having the characteristics of claim  1 . 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Other characteristics and advantages of the present invention will become more evident from the description of a preferred, but not exclusive, embodiment of a packaging for extemporaneous preparation products, particularly medicinal, pharmaceutical, cosmetic products or the like, illustrated by way of an indicative, but non-limiting example, in the attached drawings in which: 
         FIG. 1  is an exploded and partially broken view of the packaging according to the invention; 
         FIG. 2  is an axonometric and broken view of the packaging according to the invention in an idle configuration; 
         FIG. 3  is an axonometric and partially broken view of the packaging according to the invention in a breakthrough configuration; 
         FIG. 4  is an axonometric view of the packaging according to the invention in the dispensing phase of the product. 
     
    
    
     EMBODIMENTS OF THE INVENTION 
     With particular reference to these figures, reference numeral  1  globally indicates a packaging for extemporaneous preparation products, particularly medicinal, pharmaceutical, cosmetic products or the like. 
     The packaging  1  comprises at least one container  2 ,  3 , at least in part internally hollow and containing a first substance S 1 , the container  2 ,  3  comprising a container body  2  and a mouth  3  formed on the container body  2 . 
     The container body  2 , e.g., is made of flexible and deformable plastic to push the first substance S 1  to exit through the mouth  3 . 
     The packaging  1  also comprises at least one tank  4 ,  5 , at least in part internally hollow and containing a second substance S 2  mixable with the first substance S 1  to obtain a product P. 
     The first substance S 1 , the second substance S 2  and the product P obtained from mixing the two are fluid products. 
     In this regard, it is specified that in the present discussion with the term fluid products are not only meant liquid products but also viscous products, e.g. in the paste and gel state, and powdery products, in particular very fine powders with high smoothness. 
     The first substance S 1 , for example, is present in the liquid state while the second substance S 2  is present in the powdery state. 
     The tank  4 ,  5  is associated with the container  2 ,  3  and comprises:
         at least one tank body  4  substantially tubular that extends between a first ending part  4   a,  arranged towards the inside of the container body  2  through the mouth  3 , and a second ending part  4   b,  arranged on the opposite side of the first ending part  4   a;  and   at least one frangible separation partition  5 , arranged inside the tank body  4  between the first ending part  4   a  and the second ending part  4   b,  in which the frangible separation partition  5  divides the tank body  4  into a first sector  4   c , which extends between the first ending part  4   a  and the frangible separation partition  5 , and into a second sector  4   d,  which extends between the frangible separation partition  5  and the second ending part  4   b.          

     Usually, the tank body  4  and the frangible separation partition  5  are made in a single monolithic body and joined along a weakened section connection line  6 . 
     The weakened section connection line  6  can be broken, thus allowing the separation of the frangible separation partition  5  from the tank body  4 . 
     The tank  4 ,  5  is joinable to the container  2 ,  3  by means of first interlocking means  7 . 
     The packaging  1  also comprises at least one closure body  8  which is associated with the first ending part  4   a.    
     In particular the closure body  8  closes the first ending part  4   a  to obtain an internal volume in the first sector  4   c  of the tank  4 ,  5  that contains the second substance S 2  and which is temporarily separated from the internal volume of the container  2 ,  3  which contains, on the contrary, the first substance S 1 . 
     The closure body  8  has at least one barrier layer. 
     In this regard it should be noticed that, as part of the present discussion, with “barrier layer” is meant a layer of the closure body  8  which is made of a barrier material, i.e. a material which is resistant to the crossing of agents such as oxygen, gas and/or water vapor. 
     Barrier materials can be of both metallic and plastic type. 
     Some examples of barrier materials are the following:
         aluminum, which performs the function of an obstacle to the crossing by oxygen, air, moisture and light;   EVOH (ethylene vinyl alcohol), which performs the function of an obstacle to the crossing by oxygen and other gases;   LDPE (low density polyethylene), HDPE (high density polyethylene), LLDPE (linear low density polyethylene), all performing the function of an obstacle to the crossing by water vapor.       

     Preferably, the barrier layer in the closure body  8  is made of aluminum and the closure body  8  consists, e.g. of a polyethylene and aluminum poly-laminate sheet (PE/ALU). 
     The joining of the closure body  8  at the first ending part  4   a  occurs, for example, by induction sealing. 
     Alternative embodiments of the present invention cannot however be ruled out wherein a different type of barrier layers is used and the joining of the closure body  8  at the first ending part  4   a  occurs in a different manner, e.g. by bonding, interlocking or the like. 
     The packaging  1  also comprises at least one perforating body  9  fitted inside the second sector  4   d  in a sliding manner along a direction of sliding A. 
     The perforating body  9  is movable between an idle configuration spaced apart from the frangible separation partition  5  and a breakthrough configuration in which the frangible separation partition  5  and the closure body  8  are broken through by the perforating body  9  to allow the mixing of the first substance S 1  and of the second substance S 2  and the formation of the product P. 
     In this respect it should be emphasized that, within the scope of this discussion, by breakthrough of the closure body  8  can be meant indifferently one of the following circumstances:
         the closure body  8 , under the thrust of the perforating body  9 , detaches at least partially from the first ending part  4   a  without breaking;   the closure body  8 , under the thrust of the perforating body  9 , breaks without detaching completely from the first ending part  4   a;      the closure body  8 , under the thrust of the perforating body  9 , breaks and detaches from the first ending part  4   a.          

     In any case, it is easy to understand that the breakthrough of the frangible separation partition  5  and the closure body  8  is intended to place the internal volume of the first sector  4   c,  initially closed and isolated when the perforating body  9  is in the idle configuration, in communication with the internal volume of the container  2 ,  3 , when the perforating body  9  passes to the breakthrough configuration. 
     The perforating body  9  comprises:
         a first extremal stretch  9   a  turned towards the inside of the container body  2  and having an edge  10  at least partially inclined relative to the direction of sliding A which facilitates the breakthrough of the frangible separation partition  5  and of the closure body  8 ; and   a second extremal stretch  9   b  opposite to the first extremal stretch  9   a.          

     Advantageously, the perforating body  9  has a substantially tubular shape and the second extremal stretch  9   b  has a transit opening  11  for the outflow of the product P. 
     Preferably, the second extremal stretch  9   b  is a dropper, i.e. it is provided with a very tight transit opening  11  having a predetermined diameter depending on the rheological properties of the product P, so as to permit the crossing of product P only in the form of drops. 
     The packaging  1  also comprises at least a push cap  12  arranged at least partially around the perforating body  9 , the push cap  12  being operable to push the perforating body  9  from the idle configuration to the breakthrough configuration. 
     The push cap  12  is screwable on the outer surface of the tank body  4 . 
     In other words, the push cap  12  has an inner thread  13 , while the tank body  4  has an outer thread  14  onto which the inner thread  13  of the push cap  12  can be screwed. 
     The activation of the push cap  12  occurs therefore by screwing-in and not by simple pressure, which facilitates the operator thus reducing the force that the latter has to apply for the opening of the packaging  1 . 
     The push cap  12  comprises a blockage internal portion  15  adapted to close the transit opening  11  formed on the second extremal stretch  9   b,  in the breakthrough configuration the push cap  12  being removable to release the transit opening  11 . 
     The packaging  1  also comprises a closing plug  16 ,  17  having:
         a first portion  16  substantially tubular, which is associated with at least one of the container  2 ,  3  and the tank  4 ,  5 ; and   a second portion  17 , defining the push cap  12  and joined to the first portion  16  by interposition of frangible joining means  18 .       

     The first portion  16  and the second portion  17  are implemented in a single monolithic body and the frangible joining means  18  comprise a weakened section joining line. 
     At the time of use, the screwing-in of the second portion  17  or push cap  12  on the tank  4 ,  5  causes the breakage of the frangible joining means  18 , which performs the function of a tamper-evident element since it indicates that the packaging  1  has been opened beforehand. 
     In the particular embodiment shown in the figures, the closing plug  16 ,  17  is joinable to the tank  4 ,  5  by means of second interlocking means  19 . 
     Alternative embodiments cannot however be ruled out wherein the closing plug  16 ,  17  can be directly joined to the container  2 ,  3 . 
     It is pointed out that the closing plug  16 ,  17  is devoid of openings and, when fitted onto the tank  4 ,  5 , it protects the tank body  4  and the perforating body  9  (in particular the second extremal stretch  9   b  which performs the function of a dropper) from the external environment, preventing the passage of liquids, powders and other contaminants. 
     The operation of the packaging  1  is as follows. 
     The packaging  1  is manufactured as five separate components ( FIG. 1 ): container  2 ,  3 , tank  4 ,  5 , closure body  8 , perforating body  9  and closing plug  16 ,  17 , which integrates the push cap  12 . 
     At the time of the packaging operation, the container  2 ,  3  is filled with the first substance S 1  and the tank  4 ,  5  is filled with the second substance S 2 , which is poured through the first ending part  4   a,  then closed by means of the closure body  8 . 
     At this point, the packaging  1  is assembled by interlocking the tank  4 ,  5  into the mouth  3 , by inserting the perforating body  9  into the second sector of the tank  4 ,  5  and finally fitting the closing plug  16 ,  17  around the perforating body  9  and the tank  4 ,  5  until the first portion  16  is interlocked with the tank  4 ,  5  ( FIG. 2 ). 
     At the time of use, the push cap  12  is screwed onto the tank  4 ,  5 , causing the breaking of the frangible joining means  18  and the displacement of the perforating body  9  from the idle configuration to the breakthrough configuration. 
     The second substance S 2  can then pour into the container  2 ,  3  to form the product P ( FIG. 3 ). 
     To dispense the product P so prepared, it is sufficient to unscrew the push cap  12 , which releases the transit opening  11  through which the product P can be administered ( FIG. 4 ). 
     It has in practice been found that the disclosed invention achieves the intended objects. 
     In fact, the present packaging allows keeping the substances making up the product separate and perfectly isolated from one another until the time the product has to be prepared. 
     The use of a closure body having at least one barrier layer allows in fact isolating perfectly the second substance from the first one, thus avoiding that the second substance absorbs the vapors released from the first substance, thus preventing the formation of thickenings and agglomerates and ensuring the complete dissolution of one into the other. 
     The packaging according to the invention thus ensures the preparation of a product with desired composition, in the particular case of medicinal or pharmaceutical products, with a predetermined content of active ingredients, thus permitting compliance with the established dosage for a patient&#39;s therapy. 
     Finally, the packaging according to the invention is practical and easy to use by the users and does not require any particular effort to be applied.