EP1961668B1 - Tamper-proof storage assembly and single unit dispenser - Google Patents

Abstract

The assembly has a storage container (2) for storing bulk products, and a reclosable desiccant stopper (4) provided with a desiccant unit. A limiting device (3) limits distribution rate of the products, and has upper and lower surfaces (20, 21), where the device is made of thermoplastic material. The device has a breakable membrane (5) connected to a circumference of a distribution opening and provided with a tow ring (7). A passage allows gaseous exchange between the two surfaces and prevents the distribution of the products by restricted dimensions of the passage. An independent claim is also included for a method for conditioning a unitary product.

Description

FIELD OF THE INVENTION

The invention relates to a set of bulk storage and unit dispensing of oblong, cylindrical or spherical shaped objects of the tablet, pellet, capsule, dragée, pill, moisture-sensitive, in particular of the field type. pharmaceutical products, this storage and distribution assembly being formed of a sealed tubular container, equipped with a dispensing device and a desiccant plug associated with the dispensing device.

For obvious reasons, especially hygiene, but also to avoid any degradation and thus improve the shelf life of drugs or pharmaceutical products, they are protected from external pollution and / or physical damage. -chemicals resulting from the relative humidity level, light, in particular UV rays and other chemical substances, or degradation by mechanical effect.

For reasons also of hygiene, conservation and protection, many dispensing devices have been devised to allow dispensing, either unit by unit, or a distribution by at most a few units at a time of said compressed pharmaceutical products. , lozenge, capsule, dragee, pill, so as to avoid any pollution due to an involuntary exit of objects in large numbers which should then be reintroduced into the container.

Moreover, such a container assembly, desiccant stopper, flow restrictor must offer a tamper-proof function, more specifically a first-opening control function, in order to reassure the consumer as to the integrity of the product he is preparing. consume.

STATE OF THE ART

The first opening control function of a closed assembly, consisting of a container, a dispensing device of compressed pharmaceutical products, pellet, capsule, dragee, pill, and a cap type closure means desiccant is generally provided by a collaboration between the container and the closure means, that is to say the cap.

The pharmaceutical containers, for the most part, comprise a packaging envelope and a closure means of the cap type and are actually equipped with a first-opening indicator, positioned between the container and the closure means. This first-opening indicator, sometimes incorrectly called an inviolability indicator, generally consists, for example, of a multiplicity of micro-links connecting all or part of the lower peripheral surface of the closure means to all or part of the upper peripheral surface. a ring or a collar, or any fastening system such as ring, secured to the packaging envelope by any mechanical means such as for example press fitting without the possibility of disassembly.

These micro-links are micro-points of connection, independent of each other but forming a periphery or a simple toothed zone of connection between the closure means and the ring or the collar or more generally the system fixing said closure means to the packaging envelope.

These micro-points are broken during the first opening of the container by the user, by the application of a breaking force exerted on the closure means in the vertical direction, from bottom to top, if it is a simple connection microdots breakable between the ring or collar secured to the packaging envelope and the closure means, or in the horizontal direction by circular pulling movement if it is a double row of break points of one, for example, detachable intermediate link flange positioned between the ring or ring integral with the packaging envelope and the closure means.

The first user performs this destructive gesture and is thus assured that he is the first user, insofar as he can check whether the microdots link is still present or not, or if the collar is still present or not.

These well-known, proven, first-time tamper evident tamper-proof systems, however, require that the open end of the packaging casing and the integral ring of the closure means be connected permanently and without the possibility of disassembly. through micro-points breakable, the break micro-points of connection, operating at the time of opening.

These inviolability systems also require the user to exert a force from the bottom up, in order to break the breakable micro-points during the first opening. If it is relatively easy to deploy such a force with a closable closure-type closure hinge closures, especially equipped with a visor, it is much more difficult to exert such force with a single cap. A lever arm facilitating this breakage by the exercise of this force is indeed possible with such a cap lid, in particular equipped with a visor, while this is not possible with a single cap.

Finally, such a system of breakable micro-points positioned between a ring or collar and a plug-type closure means is nevertheless difficult to achieve on multi-cavity molds by molding injection techniques operating at higher rates. higher. The molds become complex in that they must incorporate movable elements leaving free the gap between upper surface of the ring or collar and lower surface of the closure means.

Therefore, consider that this function of first opening indicator integrated in the dispensing device / flow limiter unit products, positioned between the closure means and the packaging space of the envelope, and no longer integrated closure means operating in cooperation with the envelope, takes all its meaning and relevance.

Apparatus for dispensing objects of substantially oblong, cylindrical or spherical shape of the tablet, tablet, capsule, dragee and other medicaments or pharmaceuticals, in this physical form, packaged loose in a container, are amply described in FIG. technical literature, in particular in that constituted by patent applications and / or published patents.

The document US 6,142,337 discloses a pill dispenser comprising a container closed at its upper part by an indémontable lid, and at its lower part, a hollow cup-shaped base having an eccentric dispensing orifice, rotatable about the axis of symmetry of the container. The rotation of said cup, with eccentric dispensing orifice, conceals said orifice to the extent that a diaphragm secured to the container comes to cover the eccentric dispensing orifice during the rotation of the cup. Such an assembly does not have a cap and is not suitable for packaging products sensitive to moisture. The mechanical device for concealing the dispensing orifice by rotation of the cup after delivery of a pill does not ensure a seal of the assembly thus formed, with respect to the ambient environment. In addition, said pill dispenser does not have a first-opening control.

Other limited flow distribution devices, simpler in design, are also available on the market. In particular, there is an assembly comprising a tubular container, receiving at its open end a dispensing means, and a closure means plug-type fitting in the dispensing means and closing tightly.

Said dispensing means is in the form of a simple hollow cup having an outlet orifice, eccentric, adjusting by its outer cylindrical portion on the inner cylindrical portion of the open end of the tubular container.

The plug-type closure means has a cylindrical outer surface that fits tightly with the cylindrical inner surface of the cup. The closure means constituted by the cap may or may not comprise a desiccant device. It may also comprise fins partially obscuring the dispensing orifice during its introduction and regardless of the angular position taken by the closure means during its introduction into the dispensing means that is the hollow cup.

Pharmaceutical products of the tablet, lozenge, capsule, dragee or pill type are dispensed either unit by unit or by at most a few units at a time when the user reverses the assembly constituted by the container provided with its flow restrictor valve, once the closure means removed.

Such an assembly does not include a first-opening witness.

As can be seen, no prior art distribution device equipping containers gives satisfactory results, not in terms of the distribution of the products for which they are designed, but in terms of the integration of other functions, such as witnessing a first opening, while having the ability to allow an active plug to control the internal atmosphere of the container closing said container, for example its moisture content.

Document EP 0 337 484 A1 discloses a storage assembly comprising the elements of the preamble of claim 1.

Another document ( JP 07187218 A ) describes another device for storing and dispensing products, comprising desiccant means.

SUMMARY OF THE INVENTION

The problem posed and not yet solved by the state of the art appears to be, therefore, to achieve both a storage assembly, in a controlled atmosphere in moisture content and distribution of unitary solid products, packaged in bulk, together simultaneously equipped with a flow restrictor dispenser for preferentially distributing unit by unit said contained products, a means associated with said dispenser constituting the first opening control of said set.

Therefore, a first object of the invention is to create a flow limiting dispensing device that avoids the untimely exit of several unit products at a time, during use.

A second object of the invention is to create a flow-limiting dispensing device which makes it possible to maintain an internal and controlled atmosphere in the storage container, not only before the first opening of the container by the user. but also in use, by the presence of adsorbent capacity for in-situ treatment of the gaseous atmosphere of the container.

Another object of the invention is to create a storage and distribution assembly comprising a tubular container, a device for dispensing flow rate of unit products in the solid state comprising a first opening control, a resealable desiccant plug, said together being of simple design, inexpensive to produce and easy to use.

A final object of the invention is to create a flow-limiting dispensing device that makes it possible to check by the presence or absence of a particular witness of the first opening of said container by the user.

Therefore, the invention relates to a unitary storage and dispensing unit product set according to claim 1, a method according to claim 18 and a use according to claim 19.

DETAILED DESCRIPTION OF THE INVENTION

According to the invention, the storage and dispensing assembly is composed of a container of sensitive products to be conditioned, a flow rate limiter device with a first opening indicator and a resealable sealing means comprising a treatment of an internal atmosphere of the container, in particular its relative humidity, desiccant plug type.

The flow rate limiter device with first opening indicator has an upper face, a lower face and a cylindrical peripheral skirt, a dispensing orifice, a tearable membrane connected, on the one hand, to a gripping and traction means and on the other hand, around the dispensing orifice and completely obscuring the dispensing orifice and a passage allowing gaseous exchange between the closure means provided with its treatment means, desiccant plug type and products packaged in the container and preventing, by its restricted dimensions, the distribution of packaged products, said flow restricting device being inserted into the neck of the container with which it is associated. The inviolability of the storage and distribution assembly is proved by the presence of the membrane integral with the periphery of the dispensing orifice and the proof of a first early opening by a third party other than the user. The sealed closure of the container is, in turn, provided by a closure means equipped with means for treating the internal atmosphere of the container, this sealing being assured, before and after first opening, by the closing means.

The flow limiter device comprises an inlet opening located on its lower face, at least one guide surface with axis of symmetry or not whose surface may be developable or non-developable and an outlet opening which opens on the orifice of distribution in the case where a tubular connection exists between the outlet opening of the guide surface and the dispensing orifice, or which constitutes the dispensing orifice, when there is no tubular connection, this device having fastening means on the associated container.

The flow limiter device belonging to the assembly according to the invention can advantageously be architected in the form of a thin-walled structure, such as a hollow plug or a hollow cup, which can be obtained by the techniques of the plastics industry. .

This flow limiter device also comprises an outer peripheral surface, of peripheral type, preferably cylindrical, on which is placed the fixing means for assembling the device to the container permanently and sealed.

According to a particular architecture but very simple and often sufficient compared to the needs of users of tablet-type pharmaceutical products, lozenge, capsule, dragee, pill to be dispensed preferentially unit by unit or by at most a few units at a time, the upper face, the lower face, the guide surface, the dispensing orifice, and the tearable membrane connected to the periphery of the dispensing orifice and totally obscuring said dispensing orifice may be in the same plane perpendicular to the axis of the container and thus merge into one single wall. The shape of the device is then really that of a hollow cup with a substantially flat bottom.

Opening of entry:

The flow limiter device with a first-opening indicator belonging to the storage and distribution assembly, according to the invention, comprises an inlet opening on its lower face opening on the guiding surface.

The inlet opening of the guide surface may be, for example, of circular, elliptical or polygonal section depending on the section of the container. However, it is preferentially circular, for reasons of simplicity of machining. This section is at most equal to the internal section of the neck of the container on which the device is fixed in a sealed manner.

Guiding surface:

The flow limiter device with a first-opening indicator according to the invention, belonging to the storage and distribution assembly, comprises at least one guide surface of the products to be dispensed. A first guide surface is preferably located on the underside of the device, upstream of the orifice of distribution and is oriented towards the inside of the container in contact with the products to be dispensed.

A second guide surface may be located on the upper face of the device, downstream of the dispensing orifice and is oriented towards the opening of the container to return to the inside of the container the possible excess of products delivered by the dispensing orifice.

The first and second guide surfaces may be associated simultaneously in the flow restrictor device.

The guide surface is advantageously in the form of a wall delimiting a hollow volume with a spherical surface such as a cap or a spherical, frustoconical, cylindro-frustoconical, truncated parabolic or truncated hyperbolic zone, these surfaces being of straight or oblique revolution, c that is, generated by a straight line or a curvilinear line.

The hollow volume thus defined has a height and a base whose ratio between the height and the dimension of its base can be very low or even zero in the extreme case of a planar guide surface.

In the case of a conical type guide surface, the apex angle of the cone may be between 30 ° and 180 ° and preferably between 45 ° and 135 °.

The wall-forming guide surface is open at both ends. One of the openings, the largest, is oriented towards the inside of the container and constitutes the input of the device for the products to be distributed. The other opening opens on or constitutes the dispensing orifice and flow limitation of said products, because of its geometry created specifically.

Thus, all the geometric shapes of the guiding surfaces, making it possible to pass from the internal section of the neck of the container to the internal section of the main distribution orifice and to position this orifice in a manner possibly preferential with respect to the axis of the container, can to be considered.

In addition, one and / or the other of the guide surfaces can be, when viewed from inside the container, concave or convex. In a particular configuration, the upper face of the device may constitute a second guide surface, the first guide surface appearing as convex. This second guiding surface then operates as an aid not for the extraction of the unit products, but on their return to the container by an inverse path, via the dispensing orifice, thanks to this second guiding surface, and this in the case where several unit products were found distributed and therefore still present in the cavity between the upper face of the device and the open end of the container or the bottom of the closure means. This arrangement is more particularly indicated in the case where the unit products are spherical and have the ability to roll.

In a particularly simple and extreme design, as previously mentioned, the at least one surface of guidance may be a flat surface including the dispensing orifice.

Distribution port:

According to the invention, the storage and distribution assembly comprises a distribution orifice downstream of the guiding surface communicating the lower face and the upper face of the flow restricting device, and allowing the passage, from the inside towards the outside of the container, unit by unit, products to be distributed.

The guiding surface opens onto the dispensing orifice of the device or constitutes, by its small open end, the dispensing orifice.

The dispensing orifice may be of different sections, preferably circular, elliptical or polygonal or have any other geometry depending on the shape and size of the products to be dispensed. This orifice has dimensions that allow the passage of a single product at a time. Thus, in the case where the dispensing orifice is circular, its diameter is generally close to the length or the diameter of the product to be dispensed.

The dispensing orifice is set back, that is to say below the level of the plane constituted by the upper peripheral surface of the cylindrical skirt of the device.

The dispensing orifice may be positioned in the center, that is to say in the axis of the flow restrictor device. But in other designs, the main dispensing orifice may be positioned outside the axis of symmetry of the flow limiting device, such as for example at the periphery or at any other point on the upper face of the device.

Witness of first opening:

According to the invention the flow limiter device comprises a tearable membrane connected to the periphery of the dispensing orifice, said tearable membrane completely obscuring the dispensing orifice, and provided with a gripping and pulling means for tearing said membrane , this gripping and traction means being advantageously a ring.

The device belonging to the assembly according to the invention comprises a dispensing orifice positioned substantially recessed with respect to the plane of the upper peripheral surface of the cylindrical skirt of the device, thus freeing a space between the dispensing orifice and the bottom resealable closing means equipped with means for controlling the internal atmosphere of the container, of the desiccant plug type.

The user can thus, in a first step, remove the desiccant plug, ensure the presence of the first opening indicator that is to say the membrane obscuring the dispensing orifice, then tear, by pulling on the gripping and pulling means, that is to say on the ring, the tearable membrane, releasing thus the dispensing orifice. The device thus equipped with the tearable membrane and its gripping ring is made by injection and in mono-material.

This membrane is connected to the periphery of the dispensing orifice by a single continuous integral link of thin film type tear or a multiplicity of breakable micro-points.

Passage allowing gaseous exchange:

The device belonging to the assembly according to the invention comprises a passage allowing gas exchange between the closure means provided with its processing means, which is the desiccant plug type and the products packaged in the container, said limiter device flow rate being inserted into the neck of the container with which it is associated. This passage, because of its limited size, can not allow the distribution of packaged products.

This passage may be constituted by the remaining free intervals between the breakable micro-points connecting the first opening control membrane to the periphery of the dispensing orifice.

This passage may also consist of holes, slots, lights, perforated spaces positioned at any point on the lower surface or of the guide surface of the device or directly on the control membrane of first opening, and is of sufficient size restricted so that said packaged products can not pass through these holes, slits, lights, perforated spaces during the turning of the assembly in order to extract one of the packaged products.

Means for fastening the flow restrictor device in the neck of the container:

The flow limiter device belonging to the storage and distribution assembly, according to the invention, also comprises a fixing means on the inner surface of the container and / or on the neck of the container with which it is associated.

Preferably the fixing means is positioned on the outer peripheral surface of the device, that is to say on the peripheral skirt.

Various fastening means may be envisaged such as, for example, press fitting, clipping with groove and ring, on one or the other of the surfaces in the presence, differential thermal shrinkage, screwing, latching and the like. However, the preferred fastening means is constituted by a press fit between the preferentially outer cylindrical surface of the flow restricting device and the preferentially inner cylindrical surface of the neck of the container, that is to say its neck.

Said fastening means makes it possible to seal between the inside and outside of the container when the outer peripheral surface of said device is not cylindrical but having an olive-like bulge.

The fixing means also comprises means for positioning the device vertically relative to the neck of the associated container, preventing the vertical movement of the latter once in place, particularly in the case of a press fit.

Such means may be constituted for example by a collar abutting on the neck of the container or in a peripheral housing provided in the neck of the container.

The upper face of the flow restrictor device introduced into the neck of the container at most flush with the peripheral surface of the neck of the container or is supported on this surface, by means of the support means, which may be a preferably cylindrical collar of which the diameter is greater than the internal diameter of the neck of the container and at most equal to the outer diameter of the neck of the container. Said flange is located at the upper annular surface of the device.

Such a collar prevents too deep penetration of the device into the neck of the container and ensures precise vertical positioning.

Additional means of positioning and anti-return participating in the fixing means may also be constituted by a ring system adapted to a groove disposed on the inner cylindrical surface of the container and cooperating with the rod disposed on the outer cylindrical surface of the skirt of the flow limiter dispensing device.

Such means may also constitute an abutment against undercut, positioned at the lower surface of the device and preventing the device from leaving the neck of the container on which it is attached.

Several of the connecting means comprising fixing elements and positioning of the device relative to the neck of the container can be deployed concomitantly.

In a preferred configuration, the upper surface of the cylindrical skirt of the device comes to level the upper surface of the container, and this to avoid any possibility of extraction of the device by any protuberance that may exist, possibly facilitating its extraction and therefore ruining the first-opening witness function associated with said device, the device having been violated by simply removing said device.

Means for closing the flow-limiting device

The flow limiter device belonging to the storage and distribution assembly, according to the invention, is closed in a sealed manner, by a desiccant plug, thereby closing the container filled with conditioned sensitive products.

The seal is effected between the cylindrical internal surface of the skirt of the device and the cylindrical outer surface of the desiccant plug.

An olive shape with bulge positioned on the cylindrical outer surface of the desiccant plug and fitting a corresponding hollow shape existing on the inner surface of the cylindrical skirt of the device ensures the opening and sealing, the device, the opening and closing force being adapted to an employment facility for any user.

The desiccant plug is well known in the state of the art and comprises a storage chamber desiccant active products, which can be powder or monobloc. In the case of powdery products, this storage chamber is sealed by a porous sheet with moisture.

The upper periphery of the desiccant plug may comprise a means facilitating handling such as for example splines or a certain surface roughness.

The assembly consisting of a storage container and a dispensing flow limiter device according to the invention may be equipped with means for closing the open end of the body of said container, which may be also any cap / lid, for example with hinge and design to ensure a seal between the device and the cap / lid.

Operating mode :

According to the operating mode of the storage and distribution set, and during the distribution operation packaged products, the user first opens the desiccant plug, accesses the space released to the inviolate membrane, pulls by pulling on the gripping means the said membrane having thus guaranteed the non-opening prior to the set of storage and distribution. The user returns the storage and dispensing assembly such that the stock of products to be dispensed is placed above the dispensing device and in contact with its guide surface.

By the action of gravity, the products to be distributed successively come into contact with the guide surface, and then with the dispensing orifice whose adapted dimension allows the passage preferably of a single product at a time.

Realization of the device:

The flow restrictor device belonging to the storage and distribution assembly, according to the invention, is manufactured preferentially by molding injection techniques from thermoplastic materials.

Other production techniques can also be used such as single or multilayer extrusion and sheet cutting by any extrusion or calendering technique followed by thermoforming, then punching and cutting to obtain the said device. Blow injection can also be considered. However, the molding injection is preferably chosen.

Well known plastics can be used to form the device and include high and low density, free radical or linear polyethylenes, ethylene copolymers such as ethylenes vinyl acetate, ethylene ethyl acrylates, ethylene butyl acrylate, maleic anhydride ethylenes, ethylenes-alpha olefins, whatever the modes of polymerization or graft modification, polypropylene homo and copolymers, polybuten-1, polyisobutylene. The polyolefins are, for reasons of cost and ease of implementation, preferably chosen to produce the device.

Other polymeric materials may however be considered, such as polyvinyl chloride, vinyl chloride copolymers, polyvinylidene chlorides, polystyrenes, styrene copolymers, cellulose derivatives, polyamides, polycarbonates, polyvinylidene chlorides, oxy-methylenes, polyethylene terephthalates, polybutylene terephthalates, copolyesters, polyphenylene oxides, poly-methylmethacrylates, acrylate copolymers, fluorinated polymers, polyphenylene sulphides, polyarylsulphones poly-aryl-ether-ketones, poly-etherimides, polyimides, thermoplastic elastomers, polyurethanes, phenol resins, melamine resins, urea resins, epoxy resins and unsaturated polyester resins .

Biodegradable polymeric materials on, for example, starch bases are also possible such as, for example, poly lactic acid (PLA).

Combinations of these polymers may be employed. The polymer used to make the flow restricting device may also contain one or more additives such as elastomers, fibers, blowing agents, additives such as stabilizing agents and colorants, slip agents, agents and the like. demoulders, adhesion or reinforced adhesion agents, according to the imperatives of implementation.

Use of the various parts involved in the production of the assembly up to the packaging line:

According to a first preferred mode of use of the various parts involved in the production of the assembly, the cap-type closure means and the flow limiter are pre-assembled by the manufacturer in a subassembly, prior to their final assembly. on the packaging chain. The subassembly is delivered to the conditioner, which otherwise receives the containers separately. The unit products are introduced into the container on the packaging line, then said container is closed by the subassembly which is then permanently assembled to the filled container. The final assembly is done by the conditioner, in one operation, thus facilitating the packaging process, in particular allowing packaging on standard packaging machines, according to a simplified packaging method, as opposed to what would be an assembly of three components on a packaging line.

Once assembled the flow limiter is permanently and irreversibly locked in the upper part of the tubular container. The means for fixing between the container and the flow restrictor therefore appears as a combination of two separate means, a ring and groove connection and a press fit resulting in particular from the fact that the plug is introduced beforehand into the flow restrictor. In fact, the diameter of the outer cylindrical skirt of the flow limiter participating in the subassembly thus produced becomes slightly greater than the inside diameter of the neck of the container from which this mounting by press fitting. In addition, the presence of the plug in the flow restrictor, constituting the said subassembly makes it possible to ensure that, by creep over time, the ring and groove type fastening means is reinforced, that is to say that the ring present for example on the outer periphery of the cylindrical skirt of the device and the groove on the inner cylindrical wall of the neck of the container conform to one another.

According to a second mode of use on the packaging line, the container is filled beforehand with the products to be dispensed before receiving the flow limiting device. The filled container equipped with its flow limiter device is then permanently closed by the desiccant stopper resealable on the packaging line.

Thus, such a set of storage and distribution is used to distribute preferentially unit by unit a stock of sensitive products, to distribute, being stored in waiting for use and protected from the outside environment said storage and distribution assembly guaranteeing the user, by the fact that he finds the presence of the first opening indicator on the dispensing device, that the packaging was not opened prior to purchase.

FIGURES

• La figure 1 représente une vue en coupe de l'ensemble selon l'invention, comprenant le conteneur de stockage non représenté pour ce qui est de sa partie inférieure, équipé du dispositif limiteur de débit à témoin de première ouverture, associé à son conteneur, au niveau du col du dit conteneur et d'un bouchon déshydratant refermable. La membrane témoin de première ouverture n'a pas encore été déchirée.
• La figure 2 représente une vue de dessous, prise depuis l'intérieur du conteneur, de l'ensemble selon l'invention, comprenant le conteneur de stockage, le dispositif limiteur de débit à témoin de première ouverture et le bouchon déshydratant refermable. La membrane témoin de première ouverture n'a pas encore été déchirée. Le passage gazeux est rendu possible par la présence de deux trous effectués sur la membrane circulaire, témoin de première ouverture, qui n'a pas encore été déchirée.
• La figure 3 représente une vue en coupe de l'ensemble selon l'invention, comprenant le conteneur de stockage non représenté pour ce qui est de sa partie inférieure, équipé du dispositif limiteur de débit à témoin de première ouverture dans une variante mettant en évidence une surface de distribution tronconique désaxée. La membrane témoin de première ouverture n'a pas encore été déchirée.
• La figure 4 représente une vue de dessus en perspective du seul dispositif limiteur de débit séparé de sa membrane témoin de première ouverture solidaire de l'anneau de préhension utilisé pour son arrachage.

The invention will be better understood thanks to the numerical description of the figures below, these figures having only an illustrative non-limiting character of the set of storage and controlled distribution according to the invention.

• The figure 1 is a sectional view of the assembly according to the invention, comprising the storage container not shown in terms of its lower part, equipped with the flow rate limiter device with first opening, associated with its container, at the level of neck of said container and a resealable desiccant plug. The first opening control membrane has not yet been torn.
• The figure 2 represents a bottom view, taken from inside the container, of the assembly according to the invention, comprising the storage container, the first opening control flow restrictor device and the resealable desiccant plug. The first opening control membrane has not yet been torn. The gas passage is made possible by the presence of two holes made on the membrane circular, witness of first opening, which has not yet been torn.
• The figure 3 is a sectional view of the assembly according to the invention, comprising the storage container not shown in terms of its lower part, equipped with the flow limiter device with a first opening control in a variant highlighting a surface of truncated off-axis distribution. The first opening control membrane has not yet been torn.
• The figure 4 represents a top view in perspective of the single flow limiting device separated from its first opening control membrane integral with the gripping ring used for its tearing.

The figure 1 is a cross-sectional view of the assembly (1) comprising the storage container (2) and the flow restrictor device (3) with a first-opening indicator, according to the invention, as well as the resealable desiccant plug (4).

This flow limiter device (3) with a first-opening indicator comprises a breakable membrane (5), that is to say tearable, attached to the periphery of the dispensing orifice by a thin film-type continuous zone (6). The traction ring (7) integral with the membrane (5) allows tearing said breakable membrane (5), first opening indicator, by tearing the continuous thin zone (6) or breaking the plurality of bridges scored, ie micro-points, if it is micro-points (6).

This flow limiter device with a first-opening indicator is inserted into the neck of the container in such a way that its upper annular surface is flush with the peripheral surface of the neck of the container thus avoiding any risk of catching for possible dismantling.

Said device is associated with its container, at the neck of said container. Its vertical positioning is provided by a shoulder (8).

The force-fitting of the flow-limiting device (3) with a first-opening indicator in the neck of the container and the impossibility of its extraction is done by means of a rod system (9a) adapted to a groove (9b) disposed on the internal cylindrical surface of the container (2) and cooperating with the rod (9a) disposed on the outer cylindrical surface of the skirt (10) of the flow restrictor dispensing device (3).

In terms of its architecture, the flow restrictor device with a first-opening indicator (3) has an inlet opening (13) facing towards the inside of the container, which is, in this specific case, situated in the plane of the substantially convex guiding surface (12), which therefore merges with the dispensing orifice (15), an outlet opening (14) which opens onto the dispensing orifice (15), also in the plane of the guide surface (12), and which, therefore, also merges with the dispensing orifice (15). A second guiding surface (22) located on the upper face (20) of the device ensures the return of any surplus products having been distributed through the orifice.

The desiccant plug (4) comprises a desiccant means (16), retained by a porous sheet (17) itself retained by a crimping operated by turning a ferrule.

The seal between the resealable desiccant plug (4) and the dispensing device (3) with the first opening indicator is achieved by means of an olive bulge system (18a) disposed on the outer cylindrical surface of the closure means (4) adapted to a recess (18b) and cooperating with the said obviously disposed on the inner cylindrical surface of the skirt (10) of the device.

The resealable desiccant plug (4) is supported on the neck of the container (2) and on the upper end of the device (3) which are flush, that is to say forming the same plane, via a boss. The resealable desiccant plug (4) may comprise on the outer periphery of this boss, grooves (19) to facilitate gripping.

There remains an available space between the partition forming the back of the substantially convex distribution surface (12), that is to say the upper face of the device (20) and the bottom of the resealable desiccant plug (4) which makes it possible to accommodate the folded tear-off ring (7) for tearing off the tear-off control membrane (5).

The figure 2 highlights the gas passage (11) materialized by two holes made in the first opening control tear membrane (5) connected to the partition constituting the guide surface (12) of the device (3).

The control of the presence of the first opening control consisting of the tearable or breakable membrane (5) can only be done after opening the resealable desiccant plug (4). Tearing of the breakable membrane (5) is effected by pulling the ring (7), pulling which allows tearing of the bonding film or connection points (6) thus releasing the dispensing orifice (15).

The figure 3 is a cross-sectional view of the assembly (1) comprising the storage container (2) and the flow restrictor device (3) with a first-opening indicator, according to the invention, as well as the resealable desiccant plug (4).

This flow limiter device (3) with a first-opening indicator comprises a breakable membrane (5), that is to say tearable, attached to the periphery of the dispensing orifice by a thin film-type continuous zone (6) or by breakable micro-points (6). The traction ring (7) integral with the membrane (5) allows tearing said breakable membrane (5), first opening indicator, by tearing the continuous thin zone (6) or breaking the plurality of bridges scored, ie micro-points, if it is micro-points (6).

This figure 3 corresponds to a variant of the figure 1 highlighting a concave frustoconical distribution surface (12) which is off-axis and not substantially flat. The upper (20) and lower (21) faces of the device are also shown.

The figure 4 is a top view in perspective of the only flow restrictor device (3) separated from its first opening control membrane (5) integral with the gripping ring (7) used for its tearing.

The figure 4 also shows the gas passage (11) materialized by two holes made in the breakable first opening control membrane (5) connected to the partition constituting the guide surface (12) of the device.

It also highlights the dispensing orifice (15) of the packaged products, to distribute preferentially unit by unit and the back of the guide surface (12).

Such an assembly is used for the high speed packaging of pharmaceutical products such as tablets, lozenges, capsules, dragees, pills and other solid solid drugs, packaged in bulk in a sealed container whose atmosphere is controlled in terms of rate. moisture, by means of a resealable desiccant plug, during the storage and use phases of said pharmaceutical products, said products to be distributed to a final consumer user, unit by unit, or in a distribution by at most a few units at the same time, said end consumer user being able to be assured of the physical integrity of the assembly by the observed presence of a membrane acting as a first opening control remaining present on the device, and presence observed after opening the resealable desiccant plug .

Claims (19)

1. Assembly (1) for the storage and controlled distribution of individual products, comprising a container (2) for bulk storage of the said products, reclosable closure means (4) for the container (2), and a delivery-limiting device (3) for distribution of the products, provided with a top surface (20) and a lower surface (21), a peripheral cylindrical skirt (10), fixing means (9a, 9b) on the container (2), at least one guide surface (12) opening onto a distribution opening (15), a tearable membrane (5) which provides evidence of first opening connected to the perimeter of the distribution opening and wholly closing off the said opening and provided with means for gripping and traction (7), the distribution opening causing the lower surface (21) and the upper surface (20) to be in communication and allow the products for distribution to pass after the tearable membrane (5) has been torn, the assembly (1) comprising dehydrating means, characterised in that it is the closure means (4) which has the dehydrating means, and in that the delivery-limiting device (3) further comprises:

   a passage (11) allowing an exchange of gas between the lower surface (21) and the upper surface (20) but preventing distribution of the packed products because of its restricted dimensions, the passage (11) comprising

   a) holes, slots, windows or openings placed in any position on the lower surface or the guide surface (12) of the assembly (3) or directly on the tearable membrane (5), or

   b) free spaces between the cuttable micro-bridges connecting the tearable membrane (5) to the perimeter of the distribution orifice (15).
2. Assembly (1) according to claim 1, characterised in that the tearable membrane (5) connected to the perimeter of the distribution opening (15) is connected by an integral continuous thin connection (6) of the tearable film type, or by a multiplicity of cuttable micro-bridges (6).
3. Assembly (1) according to either of claims 1 and 2, characterised in that the gripping and pulling means (7) of one piece with the tearable membrane (5) is preferably a ring.
4. Assembly (1) according to any one of claims 1 to 3, characterised in that the entry opening to the delivery-limiting device (3) is of circular, elliptical or polygonal cross-section.
5. Assembly (1) according to any one of claims 1 to 4, characterised in that the entry opening to the delivery-limiting device (3) has a cross-section which is at the most of the same size as the internal cross-section of the neck of the container (2).
6. Assembly (1) according to any one of claims 1 to 5, characterised in that the guide surface (12, 22) of the delivery-limiting device (3) is a spherical, frustoconical, cylindrical/frustoconical, truncated parabolic, truncated hyperbolic surface, these surfaces being right or oblique concave or convex surfaces of revolution.
7. Assembly (1) according to any of claims 1 to 6, characterised in that the guide surface (12) of the delivery-limiting device (3) is a planar surface incorporating the distribution opening (15).
8. Assembly (1) according to any one of claims 1 to 7, characterised in that the distribution opening (15) is of preferably circular, elliptical or polygonal cross-section.
9. Assembly (1) according to any one of claims 1 to 8, characterised in that the distribution opening (15) lies outside the axis of symmetry of the device (3).
10. Assembly (1) according to any one of claims 1 to 9, characterised in that the distribution opening (15) is located in a position which is substantially set back in relation to the plane of the upper annular surface of the skirt of the device (3), thus freeing a space between the said opening and the bottom of the closure means (4).
11. Assembly (1) according to any one of claims 1 to 10, characterised in that the means (9a, 9b) for attachment of the delivery-limiting device (3) is positioned on the outer peripheral surface of the skirt (10) of the device (3).
12. Assembly (1) according to any one of claims 1 to 11, characterised in that the means for attachment of the delivery-limiting device (3) is of the force-fit sleeve, snap connection with groove and rib, differential thermal shrinkage, screwed or click-on type.
13. Assembly (1) according claim 12, characterised in that the means for attachment of the delivery-limiting device (3) comprises a rib system (9a) matching a groove (9b) located on the inner cylindrical surface of the container (2) and acting together with the rib on the external cylindrical surface of the skirt (10) of the delivery-limiting distribution device.
14. Assembly (1) according to any one of claims 1 to 13, characterised in that the attachment means for the delivery-limiting device (3) comprises a support whereby the device can be positioned vertically in relation to the neck of the associated container (2), this support being preferably a collar abutting the neck of the container (2) or placed in a circular housing of the shoulder type (8) provided in the neck of the container (2).
15. Assembly (1) according to any one of claims 1 to 14, characterised in that the upper annular surface of the cylindrical skirt (10) of the device (3) is flush with the upper surface of the container.
16. Assembly (1) according to any one of claims 1 to 15, characterised in that the delivery-limiting device (3) comprises a recess (18b) on the inner cylindrical surface of the skirt (10) acting together with the bulge (18a) located on the outer cylindrical surface of the closure means (4).
17. Assembly (1) according to any one of claims 1 to 16, characterised in that the delivery-limiting device (3) is manufactured through the injection of thermoplastic materials.
18. Process for the packaging of individual products in the assembly (1) according to any one of claims 1 to 17, characterised in that the closure means (4) of the cap type and the delivery-limiter (3) are pre-assembled by the manufacturer as a sub-assembly prior to final fitting in the packaging system in order to close the container.
19. Use of the storage and distribution assembly (1) according to any one of claims 1 to 17 for the storage and distribution of products packed in bulk which preferably have to be distributed one by one, in particular pharmaceutical products in the form of wafers, lozenges, pills, tablets, pastilles, granulates, hard capsules or capsules.

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