Container for the packaging, reconstitution, and dispensing of a liquid product
The container addresses sterility and waste issues in ophthalmic solution dispensing by integrating a deformable reservoir with filtration and a capsule for sterile reconstitution, offering a preservative-free and efficient solution.
Patent Information
- Authority / Receiving Office
- FR · FR
- Patent Type
- Applications
- Current Assignee / Owner
- LABORATOIRES THEA SAS
- Filing Date
- 2024-12-20
- Publication Date
- 2026-06-26
Smart Images
Figure 00000000_0000_ABST
Abstract
Description
Title of the invention: Container for the packaging, reconstitution of a liquid product, and distribution of the liquid product. TECHNICAL FIELD OF THE INVENTION
[0001] The invention relates to the field of conditioning and distribution of sterile liquids.
[0002] The present invention relates in particular to a bottle for the controlled distribution, notably drop by drop, of a sterile liquid product. The sterile liquid product is preferably an ophthalmic solution such as eye drops.
[0003] These products are used in small doses, one or a few drops from a bottle at each use, while the remaining product in the bottle must be kept for a certain period. The product in the bottle must generally be kept protected from contamination by bacteria or other agents from outside the bottle. STATE OF THE ART
[0004] Products commonly used as preservatives in liquid ophthalmic products to ensure the sterility of these products against bacteria and fungi can have significant adverse effects. It is therefore preferable to offer preservative-free ophthalmic products, although this still requires ensuring their sterility.
[0005] One known solution is to offer preservative-free products in single-dose containers. However, this has the disadvantage of generating a significant amount of waste after use and is costly. Single-dose bottles are also more likely than multi-dose bottles to be carelessly disposed of in the environment. Due to their small size (when the quantity of liquid to be dispensed is small), they are not very ergonomic.
[0006] Preservative-free multidose bottles (also designated by the acronym PFMD for "Preservative-free Multidose") have been developed in particular in response to this problem.
[0007] Document EP1765513 discloses a container for packaging a liquid to be dispensed drop by drop, which includes a membrane that is partially hydrophilic to allow the liquid to pass through for dispensing, under the effect of compression of the flexible container wall, and partially hydrophobic to allow air to return to the bottle to compensate for the volume of liquid dispensed. During this return, The air is filtered at the microbial level by the membrane, which guarantees the sterility of the product remaining in the container. This container proves to be entirely effective and satisfactory.
[0008] A particular problem arises, however, for extemporaneous medicinal products in solution form. Such a solution must be prepared shortly before use, because once dissolved, the active ingredient does not have sufficient stability to be stored for a long period. This is the case, for example, for a Tacrolimus solution, which must be reconstituted shortly before use, and constitutes one of the potential applications of the present invention.
[0009] This is also the case for products or medicinal products, known as biological products, which are derived, particularly isolated, from various natural sources. These medicinal products include certain proteins and peptides of interest for the treatment of certain ophthalmic pathologies.
[0010] Such a product, particularly when it comes to eye drops, is generally offered in single-dose packaging.
[0011] Some documents present multidose bottles or bottles of large capacity for a reconstituted product.
[0012] Document EP2576371 thus proposes a container for a beverage to be reconstituted. A powder is contained in an annular chamber formed in the cap. The cap has a nozzle, which is configured so that when pressed, lights formed laterally in the wall of the nozzle are brought into contact with the chamber containing the powder, allowing the powder to fall into the main reservoir of the bottle.
[0013] Document WO2017013550 describes a container for a reconstitutable medicinal product, which includes a cap with a chamber containing the active ingredient to be mixed with a liquid contained in the main reservoir. The active ingredient is released by screwing the cap completely onto the reservoir, thereby connecting the chamber of the cap to the main reservoir.
[0014] However, firstly, these containers do not guarantee the sterility of the product if it is not used all at once. Therefore, these containers cannot be used to hold an ophthalmic product.
[0015] Furthermore, the amount of active ingredient that can be stored in the cap before reconstitution of the liquid product is limited. Moreover, the active ingredient must be introduced into the cap during its manufacture. This results in a reservoir cap with a rather complex configuration, and a complex manufacturing process for the cap itself.
[0016] Generally speaking, there is currently no container on the market suitable for storage, reconstitution, and controlled distribution, particularly by drip, of an ophthalmic solution that must be reconstituted extemporaneously. In the current context, where certain unstable active ingredients in solution are of interest for the treatment of certain ophthalmic pathologies, particularly certain peptides, proteins, or other molecules, there is a need for such a container, in order to avoid, in particular, the drawbacks of single-dose vials. Description of the invention
[0017] The present invention aims to remedy all or part of the disadvantages of the prior art mentioned above.
[0018] To this end, the invention relates to a container for packaging, reconstituting a liquid product from a liquid and a product containing an active ingredient, and the controlled dispensing of the liquid product. The reservoir has a wall defining an internal volume and is adapted to deform under pressure exerted on the reservoir by a user of the bottle to dispense the liquid product, and to spontaneously return to its original shape after the pressure is released, causing air to enter the reservoir to compensate for the volume of liquid product dispensed. The reservoir contains one of the liquid and one of the product containing the active ingredient. The dispensing head is connected to a neck of the reservoir and is equipped with a nozzle for dispensing the liquid product and an air intake device comprising a sterilizing filter through which the air admitted into the reservoir passes.The reservoir has a base opposite, in a longitudinal direction, its neck. The container has a capsule containing, in a closed inner volume, liquid and the product containing the active ingredient, and said capsule is attached to the base of the reservoir. The inner volume of the capsule is closed by a lid fixed to its upper surface. The reservoir, the capsule, or the lid includes an activation element adapted to cause rupture by perforation or tearing of the lid under the effect of pressure exerted on a predefined area of the container.
[0019] Such a container allows the dispensing of sterile solutions without the use of preservatives, thanks to an integrated filtration system that ensures sterility is maintained within the container for applications such as extemporaneously reconstituted ophthalmic solutions. Sterility is maintained, in particular, by filtering the air returned to the reservoir to compensate for the volume of liquid product dispensed. Reconstitution is facilitated by the use of a capsule containing one of the elements necessary for reconstituting the liquid product, namely the liquid or the product containing the active ingredient. This allows for preparation just before use. The capsule can be manufactured and filled independently of the rest of the container, to which it is attached. This simplifies manufacturing and assembly. The container's function is to facilitate the simple preparation of the liquid product (resulting from a mixture of a liquid and a product containing the active ingredient). The product containing the active ingredient is advantageously in powder form, as the active ingredient generally remains stable in lyophilized form. In addition to the active ingredient, it may contain an excipient and / or other constituents. The invention helps reduce waste compared to single-dose packaging and minimizes the risk of contamination, thus offering a reliable solution while limiting environmental impact.
[0020] The container may include, in its reservoir, a hollow cylinder extending longitudinally from the neck to the base of the reservoir, said hollow cylinder having a free end opposite longitudinally to the neck, with a point forming the activation element, the container being configured so that a longitudinal pressure on the capsule, in the direction of the neck of the reservoir, presses the operculum on said point and causes the rupture of said operculum.
[0021] The capsule can be mounted sliding relative to the base, longitudinally, in the tank, so that the longitudinal pressure on the capsule moves the capsule towards the neck of the tank.
[0022] The capsule may include a sealing portion in contact with an internal surface of the reservoir, so as to seal the base of said reservoir tightly.
[0023] The container may include a tamper-evident ring interposed between a stop on the cap and the reservoir. The addition of a tamper-evident ring provides a visual indication of security that assures users that the product has not been tampered with before its first use.
[0024] The capsule can be made of a thermoplastic polymer, for example high-density polyethylene. Using a thermoplastic polymer to form the capsule offers good chemical and physical resistance, which helps to maintain the stability of the product under various storage conditions.
[0025] The capsule may include an outer wall connected to the base of the reservoir and a cup containing the product containing the active ingredient, said cup having an upper face bearing the lid, said cup being connected to the outer wall by a flexible skirt extending between a lower edge of said cup and the outer wall, at a longitudinally higher level than said lower edge of the cup.
[0026] The outer wall and one side wall of the cup may be made of a first material, and the skirt and one bottom of the cup may be made of a second material that is more flexible than the first material. The use of materials with different mechanical properties for the cup and the skirt allows for an optimal balance between rigidity to contain and protect a product, and flexibility to allow for easy actuation resulting in the reconstitution of the liquid product.
[0027] The first material can be a thermoplastic polymer, for example low-density polyethylene (LDPE), and the second material can be an elastomer, preferably a thermoplastic elastomer (TPE).
[0028] The capsule may include an outer wall connected to a deformable tank which contains the product containing the active ingredient in an internal volume of the tank, the tank may include an upper face bearing the lid, and the tank may include a point which extends in its internal volume from a bottom of the tank towards its upper face.
[0029] The capsule can be made of a thermoplastic polymer, for example high-density polyethylene (HDPE).
[0030] The reservoir may include a flap that seals its base, the flap having to be removed to access the cap, thus forming a tamper-evident seal. The addition of a flap that seals the base of the reservoir as a tamper-evident seal provides additional security, clearly indicating whether the product has been opened or whether attempts have been made to access it.
[0031] The activation element may include a local weakening of the configured lid so that a pressure rise in the tank, caused by pressure on a side wall of the tank, causes the lid to tear.
[0032] The local weakening may include one or more lines along which the thickness of the lid is less than on the rest of the lid. The reduction in specific thickness along certain lines of the lid allows for controlled and consistent tearing of the material, thus ensuring uniform and reliable reconstitution of the liquid product.
[0033] At least one base of the capsule may be translucent or transparent. This allows the user to easily check whether the reconstitution of the liquid product has taken place.
[0034] The sterilizing filter can be formed by a filter membrane located upstream of the nozzle. The filter membrane is hydrophilic on one part of its surface, positioned to allow the liquid product from the reservoir to pass through it for distribution, and hydrophobic on another part of its surface to allow the air entering the reservoir to be drawn in and filtered. The filter membrane, being hydrophilic and hydrophobic depending on the area, optimizes both the distribution of the product and protection against contamination.
[0035] The distribution head may include a microporous buffer disposed upstream of the filter membrane.
[0036] Alternatively, the sterilizing filter may include an air-permeable silicone membrane. Other return air filtration devices for the reservoir may be used, provided they ensure the sterility of this air. BRIEF DESCRIPTION OF THE FIGURES
[0037] Other advantages, purposes and particular features of the present invention will become apparent from the following non-limiting description of at least one particular embodiment of the devices and methods of the present invention, with reference to the accompanying drawings, in which: • [Fig.1] is a schematic perspective view of a container conforming to a first embodiment of the invention; • [Fig.2] is a schematic perspective view of the container of [Fig.1], without its cap; • [Fig.3] is a schematic cross-sectional view of the container in [Fig.1] and 2; • Fig. 4 is a schematic three-dimensional view of a capsule used in the first embodiment; • [Fig.5] is a schematic cross-sectional view of the container of [Fig.1] to 3 after reconstitution of the liquid product; • [Fig.6] is a schematic perspective view of a container according to a second embodiment of the invention; • [Fig.7] is a schematic perspective view of the container of [Fig.6], without its cap; • [Fig.8] is a schematic three-dimensional view of a capsule that can be used in the container shown in Figures 6 and 7; • [Fig.9] is a schematic cross-sectional view of the reservoir and capsule of the containers in Figures 6 and 7; • [Fig. 10] is a schematic cross-sectional view of a container according to a third embodiment of the invention; • [Fig. 11] is a schematic three-dimensional view of a capsule that can be used in the container of [Fig. 10]; • [Fig. 12] is a schematic cross-sectional view of a container according to a fourth embodiment of the invention; • [Fig. 13] is a schematic cross-sectional view of the container of [Fig. 12] after reconstitution of the liquid product; • [Fig. 14] is a schematic three-dimensional view of a capsule that can be used in the container shown in Figures 12 and 13; • [Fig. 15] is a schematic diagram illustrating the functions of a dispensing head that can be used in a container according to the invention. DETAILED DESCRIPTION OF THE INVENTION
[0038] The present description is given as a non-limiting example of an embodiment.
[0039] In the following description, it is assumed that before reconstitution of the liquid product, the capsule contains the product containing the active ingredient, and that the container contains the liquid. However, in all the following embodiments and more generally within the scope of the present invention, it is possible for the capsule to contain the liquid while the reservoir contains the product containing the active ingredient.
[0040] Fig. 1 represents a container 1, namely in the embodiment of the invention represented a bottle for a liquid product such as an ophthalmic product.
[0041] The container 1 extends along a so-called longitudinal direction L. The largest dimension of the bottle is thus measured in the longitudinal direction L.
[0042] The container 1 includes a reservoir 2 for receiving a liquid product. The reservoir 2 has a side wall 3. The side wall 3 is elastically deformable, meaning that after being pressed transversely (i.e., perpendicular to the longitudinal direction), it tends to return to its initial configuration. Such pressure on the side wall allows the liquid product contained in the reservoir to be distributed, and the return of the side wall to its original configuration results in air returning to the reservoir to compensate for the volume of product distributed, as will be detailed later.
[0043] Container 1 is in particular intended for a liquid product obtained extemporaneously, by mixing a liquid present in reservoir 2 from the initial filling of the bottle and a product comprising an active ingredient contained in a capsule described below.
[0044] The container 1 has, at the base 4 of the reservoir 2, which is at the longitudinal end opposite the neck 5 of the reservoir (visible in [Fig. 2]), a tamper-evident seal 6. The tamper-evident seal is a device whose presence guarantees to the user that the mixture between the liquid contained in the reservoir and the product containing the active ingredient has not yet occurred. This tamper-evident seal 6 is tearable. It can be torn and possibly removed from the rest of the container to allow the user to initiate the mixing between the liquid and the product containing the active ingredient.
[0045] In [Fig. 1], the container has a cap 7 screwed onto the neck 5 of the reservoir 2. The neck 5 is threaded for this purpose. Any other method of attaching the cap 7, for example by snapping it onto the neck 5, is of course possible as an alternative. Under the cap, a ring 8 fixed to the upper end of the reservoir 2 is connected to the cap 7 by breakable elements. The breakable elements break when the cap 7 is first opened. The ring 8 thus indicates to the user whether the cap of the container 1 has already been opened. Any other known system allowing this verification can be considered as an alternative to the ring 8, where the container has such a function.
[0046] Fig. 2 represents the container of Fig. 1 from which the cap 7 has been removed. With the cap removed, the neck 5 of the bottle is exposed. A dispensing head 9 (see [Fig. 3]) is mounted in the neck 5, the dispensing head having a nozzle 10 for delivering the liquid product from the reservoir 2. The nozzle 10 can be adapted for drop-by-drop dispensing. For this purpose, it can include a capillary channel 11 (see [Fig. 3]).
[0047] Throughout this document, the terms "upper" and "lower" applied to the container configuration are understood to mean the container being placed on its base, which then constitutes its lower part, while the distribution head is in its upper part.
[0048] Figure 3 is a cross-sectional view of the container in Figures 1 and 2. On the [Fig. 3], the container is shown in a storage configuration, such that the container is delivered before the mixing of the liquid 12 contained in the reservoir and the product containing the active ingredient 13, and before the first opening of the cap 7. In this configuration, a pin 14 of the cap 7 seals the capillary channel 11. The cap may include any other means of ensuring a liquid- and air-tight seal of the container 1.
[0049] The distribution head shown here comprises a main body 15 which is fixed in the neck 5. This fixing can be achieved, for example, by press fitting or snapping the main body 15 into place. A seal against liquids and air is provided between the neck 5 and the main body 15 of the distribution head 9.
[0050] The tip 10 is fixed to the main body 15.
[0051] A microporous filter membrane 16 is fixed between the main body 15 and the nozzle. This membrane 16 is considered to be positioned upstream of the nozzle 10. The terms upstream and downstream are understood throughout this document to refer to the direction of flow of the liquid product for its distribution, from the reservoir 2 to the outlet of the nozzle 10.
[0052] More particularly, the membrane 10 is supported against a base of the tip 10. In the shape of a disc, it is fixed on its periphery by thermal welding between a peripheral ring of this base and a cooperating bearing present on the main body 15.
[0053] The filter membrane 16 has pores whose small dimensions ensure bacterial filtration of the fluids passing through it. The membrane 16 may, for example, have a pore size of less than 0.45 pm and preferably less than or equal to 0.22 pm, for example between 0.1 pm and 0.2 pm.
[0054] In the example shown here, the filter membrane is of a bi-functional type, meaning that it allows the filtration of the liquid product during its dispensing, but also the filtration (and sterilization by filtration) of the air entering the reservoir in order to compensate for the volume of liquid product dispensed in the reservoir. This membrane 16 thus constitutes a sterilizing filter through which the air admitted into the reservoir passes.
[0055] In order to ensure the filtration of the liquid exiting the container and of the air entering it, the membrane advantageously comprises a part of its surface (the membrane being viewed as an essentially two-dimensional element due to its small thickness) which is hydrophilic so that this hydrophilic part can be traversed by the liquid product, and another part of its surface which is hydrophobic so that it is traversed by air.
[0056] Thus, during a product distribution, the user having inverted the bottle, with the nozzle 10 oriented towards the ground, as shown in [Fig.5], a transverse force on the lateral wall 3 of the reservoir 2 compresses the reservoir 2 and causes an increase in pressure in the reservoir 2, which drives the liquid product present in the reservoir 2 through the hydrophilic part of the membrane 16, the product then being distributed via the capillary channel 11.
[0057] When the force exerted by the user on the side wall 3 of the tank 2 ceases, the side wall 3 of the tank 2 tends to return to its initial configuration. This creates a vacuum in the tank, relative to the ambient pressure around the container, which causes air to enter the tank 2, via the nozzle 10 and through the membrane 16. The volume of air thus admitted, filtered and sterilized, compensates for the volume of product previously dispensed.
[0058] Such a membrane 16 provides so-called sterilizing filtration in that it prevents the passage of bacteria, fungi, and, depending on the porosity chosen, certain viruses. The membrane can be made of various materials, for example, polyethersulfone (PES), nylon, or polyvinylidene difluoride (PVDF). It prevents the passage of potential contaminants during product dispensing (although the product is normally packaged sterilely, so that no contaminants are normally present), but also guarantees the sterility of the product contained in the reservoir by preventing contaminants (bacteria, or even viruses) from entering the reservoir from outside the bottle. Therefore, no preservatives are necessary in the product.
[0059] It may be advantageous to impart an antibacterial effect to the container surfaces located downstream of the membrane 16 and liable to be wetted by the liquid product contained in the bottle. This can be achieved by treating these surfaces or by treating the material from which these surfaces are made. Such a treatment, based on silver or zinc ions, for example, prevents any bacterial growth on these surfaces. If a small amount of liquid product is retained in downstream of membrane 16 between two distributions, the treatment also prevents any bacterial proliferation in this small quantity of liquid product.
[0060] The antibacterial treatment thus concerns the internal surfaces of the tip 10, in particular the capillary channel 11. Advantageously, the downstream surface of the membrane 16 is also treated to prevent any bacterial growth.
[0061] The distribution head 9 used in the example shown further comprises a microporous buffer 17 upstream of the membrane 16.
[0062] The microporous buffer 17 advantageously comprises microchannels whose average pore diameter, which is greater than that of the membrane 16, is for example between 0.3 and 10 microns.
[0063] The microporous pad 17 upstream of the membrane 16 prevents the liquid in the reservoir 2 from coming into contact with the membrane before the first dispensing of the product. Before the first use, the liquid thus remains perfectly confined within the reservoir, and no drop of liquid risks passing through the membrane and ending up in an area, at the nozzle, where it is more difficult to guarantee sterility.
[0064] The microporous pad 17 also creates a pressure drop along the path of the liquid product during its dispensing, in conjunction with the membrane 16, which regulates the flow of liquid dispensed from the bottle. In other words, the pad 17 allows the user to more easily dose the desired number of drops by regulating the flow of liquid exiting the container 1.
[0065] The microporous pad 17 can in particular be made in the form of a felt pad of polyester or modified polyester resins, such as in particular low-density polyethylene resins or polyethersulfone resins.
[0066] Other dispensing heads can be used successfully, provided they guarantee the absence of contamination of the liquid product, and in particular the bacterial filtration of the air entering the reservoir to compensate for the dispensed liquid. Specifically, an air intake channel in which an air-permeable silicone membrane is interposed can be implemented for filtering the air admitted into reservoir 2.
[0067] Fig. 15 is a schematic diagram illustrating the functions sought in the distribution head of a container according to the present invention.
[0068] The dispensing head 9 includes a sterilizing filter 161. The sterilizing filter is configured to sterilize, by filtration, the air entering the reservoir of the bottle 1 to compensate for a volume of liquid product that has just been dispensed. Functionally, the sterilizing filter 161 corresponds, in the dispensing head described above, to the hydrophobic portion of the membrane 16. As illustrated in [Fig. 15], the sterilization function by filtration of the air entering the container This can be achieved by any suitable device, whether located in a conduit common to the distribution of the liquid product or in a dedicated conduit as shown in [Fig. 15]. Thus, any sterilizing filter 161 that provides sterilizing filtration of air can be considered. If this sterilizing filter 161 prevents the passage of a liquid, it can be used alone, as shown in [Fig. 15]. If this sterilizing filter also allows the passage of a liquid, it must be combined with a non-return valve that only allows fluid to pass from outside the container to inside it.
[0069] The distribution head 9 further comprises a valve 162. The valve 162 is a one-way valve, which only allows the passage of fluid from the inside of the container 1 to the outside of the container 1. Functionally, the valve 162 corresponds, in the distribution head described above, to the hydrophilic portion of the membrane 16. The valve 162 can be made in various ways (ball valve, lip valve, etc.), provided that it allows the liquid product to exit the reservoir 2, but prevents any air from entering the reservoir. The valve 162 can carry a bactericidal agent, for example, one based on silver ions.
[0070] The product containing the active ingredient 13 is contained in a capsule 18. The capsule 18 is visible in cross-section in [Fig. 3] and in more detail in [Fig. 4]. [Fig. 4] is a three-dimensional view of the capsule 18, in which a portion of the capsule has been truncated to show its interior.
[0071] The capsule 18 is hermetically sealed against air and liquids. The product containing the active ingredient 13 is often in powder form.
[0072] In the example shown here, the capsule comprises a container 19 which holds the product containing the active ingredient. The capsule is advantageously made of a rigid plastic material. The capsule 18 may, in particular, be made of a thermoplastic polymer such as high-density polyethylene.
[0073] The container 19 of the capsule has a side wall 20 and a bottom 21, which define an internal volume 22 of said container 19 and by extension of the capsule 18. The container is sealed, at the level of the upper face of the internal volume 22 by a lid 23. The lid 23 is sealed in an airtight and liquid-tight manner, it is preferably heat-sealed, so that the product containing the active ingredient 13 remains confined in the capsule 18 and does not come into contact with the liquid 12 present in the reservoir as long as the lid 23 is in place on the upper face of the internal volume 22 of the container, and is intact.
[0074] The capsule 18 is therefore a part which can be manufactured and filled with product containing the active ingredient independently of the rest of the container to which it is attached.
[0075] The capsule 18 is mounted in the base 4 of the reservoir 2. In particular, the capsule 18 has a sealing portion 24, which extends longitudinally. The portion The sealing portion 24 substantially extends the side wall 20 of the capsule 18. The sealing portion 24 is mounted in the base 4 of the tank 2, in contact with an internal surface of the tank 2. The length and configuration of the sealing portion 18 ensure sealing between said sealing portion 18 and the internal surface of the side wall 3 of the tank 2, at the level of its base 4.
[0076] The sealing portion and more generally the capsule 18 thus seal the base 4 of the reservoir in a hermetic manner.
[0077] The capsule 18 is nevertheless mounted to slide in the base 4 of the reservoir 2.
[0078] The capsule 18 has, at its base 21, a stop 25, here in the form of a peripheral part of the bottom 21.
[0079] The stop 25 rests on the tamper-evident ring 6, so that as long as the tamper-evident ring 6 is in place, at the level of the base 4 of the container 1, the capsule 18 is blocked in longitudinal translation and remains fixed with respect to the reservoir 2.
[0080] Once the tamper-evident ring 6 is torn and / or removed, longitudinal pressure exerted by the user on the capsule 18 causes the capsule to be pushed into the base 4 of the reservoir. The sealing portion 24 then slides along the inner surface of the wall 3 of the reservoir 2, maintaining the seal between the capsule 18 and this inner surface of the wall 3.
[0081] The purpose of this indentation is to cause the rupture of the seal 23 and the mixing of the product containing the active ingredient 13 initially contained in the capsule 18 and the liquid 12 initially contained in the reservoir 2, in order to form a liquid product. To this end, in the example shown here, the reservoir includes a hollow cylinder 26. The hollow cylinder 26 extends longitudinally from the neck 5 of the reservoir 2 towards the base of the reservoir 4. The hollow cylinder has a free end 27 opposite longitudinally to the neck 5 of the reservoir 2, which has a point 28.
[0082] It should be noted that the term "cylinder" here includes slightly flared shapes, close to a cylinder.
[0083] The hollow cylinder 26 can be formed in one piece with the reservoir 2.
[0084] The tip 28 is near the lid 23 when the container is in a storage configuration before use, as shown in [Fig.1] to 3.
[0085] When the capsule 18 is pushed into the reservoir 2 towards the neck 5, the seal 23 is pressed against the tip 28. The tip 28 then causes the seal 23 to rupture by piercing it. The hollow cylinder and its tip thus form an activation element of the container, that is to say, an element that allows for the immediate reconstitution of the liquid product.
[0086] The container then has the configuration shown in [Fig. 5]. The internal volume 22 of the capsule 18 is brought into contact with the internal volume of the reservoir 2. The product containing the active ingredient 13 and the liquid 12 mix. When The product containing the active ingredient is in powder form; it dissolves in liquid 12. The liquid product 29 to be dispensed, for example, an ophthalmic liquid, is thus formed. The user may advantageously shake the container 1 to promote mixing.
[0087] Fig. 5 represents the container 1 with its dispensing head 9 oriented towards the ground, in the position allowing the delivery of the liquid product 29. It is noted that lights 30 (visible in Fig. 3) allow the passage of the liquid product located around the hollow cylinder 26 towards the dispensing head.
[0088] Spontaneous flow of the liquid product in the position of [Fig.5] is prevented by the effects of the microporous buffer 17, the membrane 16, and where applicable the capillary nature of the capillary channel 11. As explained above, the distribution of the product is achieved by applying transverse pressure to the wall 3 of the reservoir 2.
[0089] Figure 6 represents a container according to a second embodiment of the invention. The container 1 of Figure 6 has the same purpose as that of the preceding figures. It allows for the separate storage of an active ingredient and a liquid, the mixing of the product containing the active ingredient and the liquid, and the distribution of the liquid product obtained by this mixture.
[0090] Container 1 of [Fig. 6] has many similarities with that of the preceding figures. Thus, container 1 extends along a longitudinal direction L. Container 1 includes a reservoir 2 initially intended to receive the liquid, and after mixing with the product containing the active ingredient, intended to receive the resulting liquid product. The lateral wall 3 is elastically deformable and therefore tends to return to its initial configuration after the release of a transverse pressure exerted on it. This results in air returning to the reservoir to compensate for the volume of product dispensed, just as in the first embodiment described above.
[0091] In [Fig. 6], the container 1 has a cap 7, which can be attached to the neck 5 of the reservoir 2 just as in the first embodiment. For example, it can be attached to a thread in the neck 5. Under the cap, the ring 8 is connected by breakable elements to the cap 7 and thus indicates to the user whether the cap 7 of the container 1 has already been opened.
[0092] Figure 7 shows the container of Figure 6 without the cap 7. With the cap 7 removed, the neck 5 of the bottle is visible. As in the previous embodiment described, the container 1 has a dispensing head with a nozzle 10 for delivering the liquid product from the reservoir 2.
[0093] The entire description given previously with reference to the first embodiment concerning the distribution head 9 is applicable to this embodiment. It is therefore possible to refer to the embodiment described previously for which relates to the distribution head 9 and the variants of this distribution head that can be used within the framework of the present invention.
[0094] As can be seen in figures 6 and 7, the second embodiment is distinguished by the absence of a tamper-evident ring 6 at the base 4 of the reservoir 2.
[0095] The capsule containing the product containing the active ingredient is brought back to the container in a different way.
[0096] A capsule 18 used in the embodiment shown here is visible in [Fig. 8]. This capsule 18 is in the form of a substantially cylindrical element, which has an outer wall 31. The outer wall 31 has a fixing element for the base 4 of the reservoir 2, here in the form of a capsule thread 32. The outer wall could be provided with other fixing elements, for example a snap-on element.
[0097] A lid 23 seals the upper face of the capsule 18. The lid 23 is preferably heat-sealed.
[0098] Figure 9 shows in cross-section the capsule 18 fixed on the reservoir 2. In order to constitute the container, the distribution head 9 is therefore missing from Figure 9. The liquid contained in the reservoir 2 and the product containing the active ingredient contained in the internal volume 22 of the capsule have been omitted.
[0099] As can be seen in [Fig.9], the reservoir 2 has at its base 4 a thread adapted to cooperate with the thread of capsule 32. The capsule 18 is thus screwed into the base 4 of the reservoir 2.
[0100] An upper portion of the capsule forms a sealing portion 24 vis-à-vis the wall 3 of the reservoir 2.
[0101] The capsule includes a reservoir 33, which defines the internal volume 22 which contains the product containing the active ingredient (before reconstitution of the liquid product).
[0102] The tank 33 is configured so that it is deformable. In particular, the tank 33 has a bottom 34, and the tank 33 is configured so that it can deform under the effect of a longitudinal pressure in the direction of the neck 5 of the tank so that the bottom 34 approaches the seal 23.
[0103] For this purpose, the shape and constituent material of the capsule (excluding the operculum) are adapted to allow this deformation.
[0104] The capsule may be made of a thermoplastic polymer, for example low-density polyethylene (LDPE), which has sufficient flexibility. Other materials, particularly more elastic ones, can be used successfully.
[0105] The tank also includes a tank wall 35, the lower part of which at least is distinct from the external wall 31 of the capsule 18, and extends essentially longitudinally at a distance from the external wall 31, the tank being able to be slightly frustoconical, being then wider at its upper face than at its bottom 34.
[0106] The tank 33 has a tip 36 which extends in its internal volume 22 from the bottom 34 towards the lid 23. The end of the tip 36 is located near the lid 23 when the container 1 is in storage configuration, before reconstitution of the liquid product.
[0107] When the user presses the bottom 34 upwards, towards the neck of the reservoir, the tank 33 deforms, and the tip of the nozzle 36 is pressed against the seal 23, which is then pierced or, more generally, broken. The nozzle thus forms an activation element, enabling the reconstitution of the liquid product.
[0108] The internal volume 22 of the capsule 18 is connected to the internal volume of the reservoir 2. The product containing the active ingredient 13 and the liquid 12 mix. When the product containing the active ingredient is in powder form, it dissolves in the liquid 12. The liquid product 29 to be dispensed, for example, an ophthalmic liquid product, is thus formed. The user can advantageously shake the container 1 to promote mixing.
[0109] The product can then be dispensed as described with reference to the first embodiment, by placing the container with the dispensing head facing the ground and pressing transversely on the wall 3 of the reservoir. Releasing the force exerted on the wall 3 causes it to return to its initial configuration, with air sterilized by bacterial filtration entering the dispensing head to compensate for the dispensed liquid.
[0110] When the container is in storage configuration it advantageously includes a foil which seals the base of the reservoir 2.
[0111] The sheet 37 may be in the form of a sheet or a thin plate, and may be made of plastic material.
[0112] The sheet 37 seals the base of the reservoir 4. The sheet 37 can be attached, for example heat-sealed, to the reservoir 4, or advantageously to the capsule 18. By attaching the sheet to the capsule 18, the risk of accidental perforation of the lid 23 before the capsule is attached to the reservoir 2 is reduced.
[0113] It is necessary to remove or break the foil 37 to press on the base 34 of the capsule. The foil 37 may have a tab to facilitate its removal. The foil 37 prevents accidental pressure on the base 34 of the capsule 18 and acts as a tamper-evident seal. Its presence and integrity guarantee that the liquid product has not yet been reconstituted.
[0114] Fig. 10 represents, in cross-section, a third embodiment of a container according to the present invention.
[0115] Externally, the bottle in [Fig. 10] is identical to that of the second embodiment. For this third embodiment, reference can be made to the description above in Figures 6 and 7.
[0116] The container of the third embodiment has the same purpose as that of the preceding figures. It allows for the separate storage of a product containing the active ingredient and a liquid, the mixing of the product containing the active ingredient and the liquid, and the distribution of the liquid product obtained from this mixture.
[0117] The entire description given above concerning the distribution head 9 is applicable to this embodiment. It is therefore possible to refer to the embodiments described above with regard to the distribution head 9 and the variants of this distribution head that may be used within the scope of the present invention.
[0118] The capsule 18 comprising the container 1 is fixed in the base 4 of the reservoir 2 as described with reference to the second embodiment.
[0119] Figure 11 illustrates the capsule 18 used in this third embodiment. The capsule 18 has an outer wall 31. The outer wall 31 has a fixing element for the base 4 of the reservoir 2, here in the form of a capsule thread 32. The outer wall could be provided with other fixing elements, for example a snap-on element.
[0120] The capsule 18 further comprises a cup 38, which forms an internal volume 22 containing the product containing the active ingredient 13. The cup can have various configurations. Here, it is cylindrical. The cup has a side wall 39, a base 40, and an upper face bearing a seal 23. The seal 23 can be of the same type as in the previous embodiments. The seal 23 is hermetically fixed, for example, heat-sealed to the cup 38 and closes its upper face. The product containing the active ingredient 13 is thus isolated from the liquid (not shown in [Fig. 10]) present in the reservoir 2.
[0121] The capsule 18 further comprises a skirt 4L The skirt 41 connects the cup 38 to the outer wall 31 of the capsule.
[0122] More particularly, the skirt 41 is a flexible piece which extends between a lower edge 42 of the cup 38 and the outer wall at a level higher than the lower edge 42 of the cup.
[0123] The skirt can for example be formed from elastomer, preferably a thermoplastic elastomer (TPE).
[0124] When the user presses longitudinally, towards the neck 5, on the bottom 40 of the cup 38, the skirt deforms and allows a longitudinal movement of the cup 38.
[0125] The skirt 41 can be made of a different material than the rest of the capsule. Advantageously, the skirt 41 and the base 40 are formed, possibly as a single unit, of a different material than the rest of the capsule. Thus, the outer wall 31 and the side wall 39 can be made of a thermoplastic polymer, for example the low-density polyethylene (LDPE), and skirt 41 is made of a more flexible material, such as an elastomer, preferably a thermoplastic elastomer (TPE).
[0126] The capsule can be formed, for example, by a bi-injection process.
[0127] As in the first embodiment, the reservoir 2 comprises a cylinder hollow 26 similar to that previously described. The hollow cylinder 26 therefore extends longitudinally from the neck 5 of the reservoir 2 towards the base of the reservoir 4. The hollow cylinder has a free end 27 opposite longitudinally to the neck 5 of the reservoir 2 which has a point 28.
[0128] The term "cylinder" here includes slightly flared shapes, close to a cylinder.
[0129] The hollow cylinder 26 can be formed in one piece with the reservoir 2.
[0130] The tip 28 is near the lid 23 when the container is in a storage configuration prior to use, as shown in [Fig. 10].
[0131] When the user presses longitudinally on the bottom 40 of the cup 38, causing its movement towards the neck 5 while the skirt 41 deforms, and the lid 23 is pressed onto the tip 28.
[0132] The tip 28 then causes the lid 23 to rupture by piercing it. The hollow cylinder and its tip thus form an activation element of the container, just as in the first embodiment.
[0133] The internal volume 22 of the cup 38 and the capsule 18 is brought into communication with the internal volume of the reservoir 2. The product containing the active ingredient 13 and the liquid mix to form the liquid product, as explained with reference to the previous embodiments.
[0134] A fourth embodiment is shown in Figures 12 to 14.
[0135] Externally, the bottle in [Fig. 12] is identical to that of the second embodiment. For this fourth embodiment, reference can be made to the description above in Figures 6 and 7.
[0136] The container of the fourth embodiment has the same purpose as that of the preceding figures. It allows for the storage of a product containing the active ingredient and a liquid, separately, the mixing of the product containing the active ingredient and the liquid, and the distribution of the liquid product obtained by this mixture.
[0137] The entire description given above concerning the distribution head 9 is applicable to this embodiment. It is therefore possible to refer to the embodiments described above with regard to the distribution head 9 and the variants of this distribution head that may be used within the scope of the present invention.
[0138] An example of a capsule 18 that can be used in this embodiment is shown in [Fig. 14]. The capsule 18 here comprises a cylinder defining the internal volume 22 which contains the product comprising the active ingredient 13.
[0139] The capsule 18 has a base 21. The capsule has, at its base 21, a stop 25, here in the form of a peripheral portion. The stop 25 is designed to bear longitudinally against the wall 3 of the reservoir 2, at its base 4. The stop 25 thus ensures the correct longitudinal positioning of the capsule 18 in the base 4 of the reservoir 2.
[0140] The capsule 18 has a sealing lip 43 adapted to hold the capsule 18 in the base 4 of the reservoir by friction and / or snap-fit. Thus, in the example shown, the capsule 18 is inserted into the base 4 of the reservoir 2 until its stop 25 comes to rest against the wall 3 of the reservoir 2. The sealing lip 43 ensures the longitudinal retention of the capsule, which can no longer be extracted from the reservoir once it has come to rest against the longitudinal stop on the wall 3.
[0141] The capsule 18 includes a lid 23 which closes the upper face of the capsule 18. The lid 23 has, in this embodiment, a local weakening 44. The local weakening refers to an area of the lid, for example one or more lines, curves, etc., which may break when a mechanical stress is applied to the lid 23 and tends to deform it.
[0142] The local weakening is here achieved in the form of two intersecting lines.
[0143] Local weakening may consist, for example, of a limitation of the thickness of the lid, continuous or not. For example, the thickness limitation can be achieved in the form of one or more "dotted" lines, with a discontinuous thickness limitation along the line or lines.
[0144] In order to reconstitute the liquid product, the user applies a transverse force by pressing on the wall 3 of the reservoir 2, while the cap 7 is in place and closes the nozzle 10. This force causes a rise in pressure in the reservoir 2.
[0145] Since the internal volume 22 of the capsule 18 is not completely filled by the product containing the active ingredient 13, it contains a pocket of air (or another gas). As the pressure rises in the reservoir 2, the lid 23 deforms to transmit this pressure to the internal volume 22 of the capsule 18. Under the effect of the pressure in the reservoir, the lid 23 ruptures at its local weakening point 44. The internal volume 22 of the capsule 18 is then brought into contact with the internal volume of the reservoir 2. The product containing the active ingredient 13 and the liquid 12 then mix to form the liquid product 29, as described in the preceding embodiments.
[0146] The capsule 18 is advantageously constructed, at least with regard to its base 21, of a transparent or translucent material. The capsule may be constructed of a transparent or translucent material. The transparent or translucent base 21 allows the user to verify whether the product has been reconstituted. For example, if the product containing the active ingredient 13 is a powder, it is easy to see whether the liquid 12 has reached the base 21 of the capsule 18. If the product containing the active ingredient is a liquid, using a colored liquid 12 or a colored product containing the active ingredient 13 allows the user to observe a color change visible through the base 41 during reconstitution of the liquid product.
[0147] The transparent or translucent nature of the base 41 therefore serves as an indicator of inviolability with regard to the reconstitution of the liquid product 29.
[0148] Fig. 13 represents the container 1, with the nozzle 10 oriented towards the ground, in a configuration allowing the distribution of the liquid product 29.
[0149] The distribution of the product is carried out as described above with reference to [Fig.5].
[0150] The container proposed within the framework of the present invention presents a solution for the conditioning and controlled distribution, for example drop by drop, of sterile liquid products which must be reconstituted shortly before their use (extemporaneous products).
[0151] The container configuration allows for reconstitution of the liquid product by a simple action of the user.
[0152] This container ensures the sterility required for liquid products such as ophthalmic solutions prepared extemporaneously, by maintaining the sterility of the liquid product through the filtration of the air admitted back into the reservoir after distribution of a dose of liquid product.
[0153] A capsule containing the product with the active ingredient, which can be manufactured and filled independently of the rest of the container, simplifies container manufacturing and associated logistics. The container proposed in the invention significantly reduces waste compared to unit-dose packaging, while minimizing the risk of contamination of the liquid product.
[0154] Nomenclature of reference signs: • 1. Container • 2. Reservoir • 3. Side wall • 4. Base • 5. Col • 6. Tamper-evident ring • 7. Cap • 8. Ring • 9. Distribution head • 10. Nozzle • 11. Capillary canal • 12. Liquid • 13. Product containing the active ingredient • 14. Pawn • 15. Main body • 16. Membrane (filter) • 161. Sterilizing filter • 162. Valve • 17. Microporous buffer • 18. Capsule • 19. Bac • 20. Side wall of the tray • 21. Background • 22. Interior volume • 23. Operculum • 24. Sealing portion • 25. Stop • 26. Hollow cylinder • 27. Free end of the cylinder • 28. Point • 29. Liquid product (after reconstitution) • 30. Lights • 31. External wall • 32. Capsule threading • 33. Tank • 34. Bottom of the tank • 35. Tank wall • 36. Tip (in the tank) • 37. Sheet • 38. Cup • 39. Side wall of the cup • 40. Bottom of the cup • 4L Skirt • 42. Lower edge of the cup • 43. Sealing lip • 44. Local weakening (of the operculum)
Claims
1.
2. Demands Container (1) for packaging, reconstituting a liquid product (29) from a liquid (12) and a product containing an active ingredient (13), and controlled dispensing of the liquid product (29), comprising: - a reservoir (2) having a wall (3) defining an internal volume and adapted to deform under the effect of pressure exerted on the reservoir (2) by a user of the bottle to cause a distribution of liquid product (29) and to spontaneously return to its original shape after release of said pressure, causing an admission of air into the reservoir (2) in compensation of the volume of liquid product (29) distributed, the reservoir (2) containing one of the liquid (12) and of the product comprising the active ingredient (13); - a distribution head (9) linked to a neck (5) of the reservoir (2) and equipped with a nozzle (10) for delivering the liquid product (29) and a device for the admission of air comprising a sterilizing filter (161) through which the air admitted into the reservoir (2) passes; characterized in that, the reservoir (2) has a base (4) opposite, in a so-called longitudinal direction, to its neck (5), and the container (1) has a capsule (18) containing in a closed internal volume (22) the other of the liquid and of the product comprising the active ingredient, said capsule (18) being attached to the level of the base (4) of the reservoir (2), the internal volume (22) of the capsule being closed by a lid (23) fixed on an upper face of the internal volume (22), the reservoir (2), the capsule (18) or the lid (23) having an activation element (26, 28, 36) adapted to cause a rupture by perforation or tearing of the lid (23) under the effect of pressure exerted on a predefined area of the container (1). A container according to claim 1, wherein the container (1) comprises, in its reservoir (2), a hollow cylinder (26) extending longitudinally from the neck (5) of the reservoir (2) to the base (4) of the reservoir (2), said hollow cylinder (26) having one end free (27) longitudinally opposed to the neck (5) of the reservoir (2) which has a tip (28) forming the activation element, the container (1) being configured so that a longitudinal pressure on the capsule (18), in the direction of the neck (5) of the reservoir (2), presses the lid (23) on said tip (28) and causes the said lid (23) to break.
3. Container according to claim 2, in which the capsule (18) is mounted slidably vis-à-vis the base (4), longitudinally, in said reservoir (2), such that the longitudinal pressure on the capsule (18) moves the capsule (18) towards the neck (5) of the reservoir (2).
4. Container according to claim 3, in which the capsule (18) has a sealing portion (24) in contact with an inner surface of the reservoir (2), so as to hermetically seal the base (4) of said reservoir (2).
5. Container according to claim 3 or claim 4, comprising a tearable tamper-evident ring (6) interposed between a stop (25) of the cap (18) and the reservoir (2).
6. Container according to any one of claims 3 to 5, wherein the capsule (18) is formed of a thermoplastic polymer, for example high-density polyethylene.
7. Container according to claim 2, wherein the capsule (18) comprises an outer wall (31) connected to the base (4) of the reservoir (2) and a cup (38) containing the product comprising the active ingredient (13), said cup (38) comprising an upper face bearing the lid (23), said cup (38) being connected to the outer wall (31) by a flexible skirt (41) which extends between a lower edge (42) of said cup (38) and the outer wall (31), at a longitudinally higher level than said lower edge (42) of the cup (38).
8. Container according to claim 7, wherein the outer wall (31) and a side wall (39) of the cup (38) are made of a first material, and the skirt (41) and a bottom (40) of the cup (38) are made of a second material more flexible than the first material.
9. Container according to claim 8, wherein the first material is a thermoplastic polymer, for example low-density polyethylene (LDPE), and the second material is an elastomer, preferably a thermoplastic elastomer (TPE)
10. Container according to claim 1, in which the capsule (18) has an outer wall (31) connected to a deformable tank (33) which contains the product comprising the active ingredient (13) in an internal volume (22) of the tank (33), the tank (33) has an upper face carrying the lid (23), and the tank (33) has a point (36) which extends in its internal volume (22) from a bottom (34) of the tank (33) towards its upper face.
11. Container according to claim 10 in which the capsule (18) is made of a thermoplastic polymer for example low-density polyethylene (LDPE).
12. Container according to any one of claims 7 to 11, wherein the reservoir (2) has a foil (37) which seals its base (4), the foil (37) having to be removed to access the cap (18), so that it forms a tamper-evident seal.
13. Container according to claim 1, wherein the activation element comprises a local weakening (44) of the lid (23) configured such that a pressure rise in the tank (2), caused by pressure on a side wall (3) of the tank (2), causes the lid (23) to tear.
14. Container according to claim 13, wherein the local weakening (44) comprises one or more lines along which the thickness of the lid (23) is less than on the rest of the lid (23).
15. Container according to claim 13 or claim 14, wherein at least one bottom (41) of the capsule (18) is translucent or transparent.
16. Container according to any one of the preceding claims, wherein the sterilizing filter (161) is formed by a filter membrane (16) which is disposed upstream of the nozzle (10), the filter membrane (16) being hydrophilic on one part of its surface and disposed so as to be passed through by the liquid product (29) from the reservoir (2) for its distribution, and hydrophobic on another part of its surface so as to allow the admission and filtration of the air admitted into the reservoir (2).
17. Container according to claim 16, in which the distribution head (9) comprises a microporous buffer (17) disposed upstream of the filter membrane (16).
18. Container according to any one of claims 1 to 15 in which the sterilizing filter comprises an air-permeable silicone membrane.