Capsule for a container for packaging and reconstituting a liquid product, and corresponding container

Abstract

The invention relates to a capsule (100) intended to be fitted to a container for packaging and reconstituting a liquid product by mixing a first product and a second product. The capsule forms a housing (110) suitable for receiving the first product, the housing (110) being delimited by a cylindrical or frustoconical side wall (120) extending around a longitudinal axis (L), this wall having an upper edge (121) closed by a seal (140) and a lower edge (122). The housing comprises a bottom (130) connected to the side wall (120) by a bistable annular wall (150), which deforms between an initial position and an activated position in order to bring the bottom (130) closer to the upper face of the capsule (100). The invention also relates to a container comprising such a capsule.

Description

[0001] Capsule for a container for packaging and reconstituting a liquid product, and corresponding container

[0002] TECHNICAL FIELD OF THE INVENTION

[0003]

[0001] The invention relates to the field of reconstitution, packaging and distribution of sterile liquids.

[0004]

[0002] The present invention relates in particular to a capsule adapted to be attached to a bottle for the controlled distribution, in particular drop by drop, of a liquid product.

[0005]

[0003] The liquid product is preferably an ophthalmic solution such as eye drops.

[0004] 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 of time. The product in the bottle must generally be kept protected from contamination by bacteria or other agents from outside the bottle.

[0006] STATE OF THE ART

[0007]

[0005] 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.

[0008]

[0006] 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.

[0009]

[0007] Preservative-free multidose bottles (also designated by the acronym PFMD for "Preservative-free Multidose") have been developed in particular in response to this problem.

[0010]

[0008] Document EP1765513, also published under reference US2008067194, discloses a container for packaging a liquid to be dispensed drop by drop. The container has a membrane that is partially hydrophilic, allowing the liquid to pass through for dispensing under the effect of compression of the flexible container wall, and partially hydrophobic, allowing 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, thus ensuring the sterility of the product remaining in the container. This container proves to be highly effective and satisfactory.

[0011]

[0009] A particular problem arises, however, for extemporaneous medications in solution form. Such a solution must be prepared shortly before use, because once dissolved, the active ingredient lacks sufficient stability for long-term storage. This is the case, for example, with a Tacrolimus solution, which must be reconstituted shortly before use and constitutes one of the potential applications of the present invention.

[0012]

[0010] 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.

[0013]

[0011] Such a product, particularly when it comes to eye drops, is generally offered in single-dose packaging.

[0014]

[0012] Some documents present multidose vials or large capacity for a reconstituted product.

[0015]

[0013] 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, openings formed laterally in the nozzle wall are aligned with the chamber containing the powder, allowing the powder to fall into the main reservoir of the bottle.

[0016]

[0014] Document KR20180134504 describes a dropper bottle for reconstituting a product by mixing two components. A first component is present in the bottle's reservoir. During bottle manufacturing, a compartment is formed at the base of the reservoir and filled with a second component. The bottle includes a pushable element, via a dome made of elastic material, to detach a locking plate located between the compartment and the reservoir. When the plate is detached, the two components can mix.

[0017]

[0015] 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.

[0016] 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.

[0018]

[0017] 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.

[0019]

[0018] Generally speaking, no container currently exists on the market suitable for the storage, reconstitution, and controlled dispensing, particularly drop by drop, 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 conditions, 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.

[0020] DESCRIPTION OF THE INVENTION

[0021]

[0019] The present invention aims to remedy all or part of the disadvantages of the prior art mentioned above.

[0022]

[0020] To this end, the invention relates to a capsule intended to equip a container for the packaging and reconstitution of a liquid product by mixing a first product and a second product, said capsule forming a housing adapted to receive said first product;the capsule comprising a cylindrical or truncated conical side wall extending around a longitudinal axis, the side wall comprising a lower edge and an upper edge longitudinally opposite the lower edge, the housing being closed by a lid fixed on an upper face of the housing defined by said upper edge, the housing comprising a bottom longitudinally opposite its upper face, the bottom being connected to the side wall by an annular wall, the annular wall being configured so as to be deformable between two stable positions, namely an initial position and an activated position, the bottom being displaced longitudinally when the annular wall is deformed from the initial position to the activated position, the bottom being closer to the upper face of the capsule when the annular wall is in the activated position than when it is in the initial position.;

[0023]

[0021] A capsule is thus proposed for use in a container for reconstituting a liquid product, such as an ophthalmic solution, which can be manufactured and filled independently of the container it is intended to equip.

[0022] The fact that the annular wall, and more generally the capsule, has two stable positions offers the user great ease of use because when pressure is applied to activate the capsule (and cause the reconstitution of the liquid product in the container equipped with the capsule), the annular wall spontaneously assumes its activated position, which ultimately ensures reliable rupture of the capsule's seal and reconstitution of the liquid product by mixing the first product contained in the capsule with a second product contained in a reservoir of the container equipped with the capsule.

[0024]

[0023] The bi-stability of the capsule also allows direct visualization of whether it has been activated or not.

[0025]

[0024] The annular wall and the bottom forming a concavity, said concavity is reversed when the annular wall passes from the initial position to the activated position.

[0026]

[0025] The annular wall may include at least one annular undulation allowing deformation of the annular wall from its initial position to its activated position.

[0027]

[0026] The annular wall may include at least one annular thinning at which the wall deforms when it moves from its initial position to its activated position.

[0027] The capsule may include a first part and a second part, the first part forming all or part of the lateral wall and the second part forming the annular wall and the capsule housing, the first part being formed of a first material, the second part being formed of a second material, the second material being more flexible than the first material.

[0028]

[0028] The first material can be high-density polyethylene and the second material can be low-density polyethylene.

[0029]

[0029] The capsule may include a pusher adapted to transmit longitudinal pressure to the bottom of the housing.

[0030]

[0030] The invention also relates to a capsule as described above, containing said first product, said first product being a powder or a liquid containing an active ingredient.

[0031]

[0031] The capsule may include a point which extends into the housing from the bottom and towards its upper face.

[0032]

[0032] The present invention also relates to a container for packaging, reconstituting a liquid product by mixing a first product and a second product, and the controlled dispensing of the liquid product, said container comprising:

[0033] • a tank having a wall defining an internal volume and adapted to deform under the effect of pressure exerted on the tank by a user to cause a distribution of liquid product and to spontaneously return to its original shape after release of said pressure, causing an admission of air into the tank to compensate for the volume of liquid product distributed, the tank containing the second product, the tank further having a base opposite, in a direction of extension of the tank, to its neck;

[0034] • a dispensing head linked to a neck of the reservoir and equipped with a nozzle for delivering the liquid product and a device for the admission of air comprising a sterilizing filter through which the air admitted into the reservoir passes;

[0035] • a capsule as described above, containing the first product, attached and fixed to the base of the tank; the container being configured so that when the bottom of the capsule is moved longitudinally so that the annular wall is deformed from the initial position to the activated position, the capsule seal is broken and the capsule housing is brought into communication with the internal volume of the tank, which allows mixing between the first product and the second product.

[0036]

[0033] 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 a product containing the active ingredient or a liquid. This allows for preparation just before use. The capsule is manufactured and filled independently of the rest of the container, to which it is attached. This simplifies the manufacturing and implementation of the container. Thus, the capsule can be manufactured on a separate line or even at a different site than the reservoir.It is possible to produce reservoirs of containers according to the present invention without necessarily knowing beforehand which product will be reconstituted in the container. In particular, a large number of reservoirs can be produced, and then it can be decided which capsule, containing a given liquid or a product containing a given active ingredient, is subsequently assembled into the reservoir. Furthermore, the container allows for simple preparation of the liquid product (resulting from the mixture of a liquid and a product containing the active ingredient). The product containing the active ingredient is advantageously in powder form, the active ingredient generally remaining 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 unit-dose packaging and minimizes the risk of contamination, thus offering a reliable solution while limiting environmental impact.

[0037]

[0034] The tank may consist of a main part and a base, the base being formed of a first material and the main part being formed of a second material, the first material being more rigid than the second material.

[0035] The base may be made of high-density polyethylene (HDPE) and the main part may be made of low-density polyethylene (LDPE).

[0038]

[0036] This allows for a main part of the reservoir that is easily deformable and has good elastic return to its initial configuration. The base of the reservoir, on the other hand, is more rigid, which ensures good support for the capsule and allows it to withstand the pressure exerted, if necessary, on the capsule to cause the reconstitution of the liquid product.

[0039]

[0037] For the record, low-density polyethylene (often abbreviated as LDPE) is distinguished not only from high-density polyethylene (often abbreviated as HDPE) by its density, but also by its structure.

[0040]

[0038] LDPE consists of highly branched chains. This architecture creates less regular stacking between the chains, resulting in lower crystallinity and density than HDPE. LDPE is a fairly flexible, elastic material with a moderate melting point (approximately 105-115 °C).

[0041]

[0039] Conversely, HDPE has more linear and less branched chains, allowing for tighter packing. This results in a material with higher crystallinity and density than LDPE. HDPE is rigid, abrasion-resistant, and exhibits better mechanical strength (tensile, creep), as well as a higher melting point (130-137 °C) than LDPE.

[0042]

[0040] The base can be overmolded onto the main part or the tank can be formed by bi-injection or co-injection of the main part and the base.

[0043]

[0041] Overmolding or bi-injection (or co-injection) allows for perfect bonding and perfect sealing between the base and the main part.

[0044]

[0042] The second part of the capsule may include a sealing portion in contact with an internal surface of the base of the reservoir, so as to seal said base of the reservoir tightly.

[0045]

[0043] The container may include, in its reservoir, a hollow cylinder extending longitudinally from the neck of the reservoir to the base, said hollow cylinder having a free end opposite longitudinally to the neck of the reservoir which has a point adapted to cause the seal to break.

[0046]

[0044] The sterilizing filter can be formed by a filter membrane which is disposed upstream of the nozzle, the filter membrane being hydrophilic on one part of its surface and disposed so as to be crossed by the liquid product from the reservoir 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.

[0047]

[0045] The dispensing head may include a microporous pad disposed upstream of the filter membrane.

[0046] The sterilizing filter may include an air-permeable silicone membrane.

[0048]

[0047] Other air filtration devices returning to the tank may be used, provided that they guarantee the sterility of this air.

[0049] BRIEF DESCRIPTION OF THE FIGURES

[0050]

[0048] 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: Figure 1 is a schematic cross-sectional view of an example of a capsule according to one embodiment of the invention, the capsule being in an initial configuration; Figure 2 is a schematic cross-sectional view of the capsule of Figure 1, the capsule having been moved to an activated configuration; Figure 3 is a schematic cross-sectional view of a capsule according to another embodiment of the invention; Figure 4 is a schematic cross-sectional view of a capsule according to another embodiment of the invention; Figure 5 is a schematic cross-sectional view of a capsule according to another embodiment of the invention;Figure 6 is a schematic cross-sectional view of a capsule installed in the base of a container, according to another embodiment of the invention; Figure 7 is a schematic cross-sectional view of a capsule illustrating yet another aspect of certain embodiments; Figure 8 is a schematic cross-sectional view of the capsule of Figure 7 fixed to the base of a reservoir of a container; Figure 9 is a three-dimensional schematic view of a container, in this case a bottle, according to an embodiment of the invention; Figure 10 represents the bottle of Figure 9 without its cap; Figure 11 is a schematic cross-sectional view of the container of Figure 9; Figure 12 is a schematic diagram illustrating the functions of a dispensing head that can be used in a container according to certain embodiments of the invention;Figure 13 is a schematic three-dimensional view of a container according to an embodiment of the invention, viewed from below; Figure 14 shows the container of Figure 13 when the capsule it contains has been activated. DETAILED DESCRIPTION OF THE INVENTION;

[0051]

[0049] The present description is given as a non-limiting example of an embodiment.

[0052]

[0050] Figure 1 shows a capsule according to an embodiment of the present invention. The capsule 100 is intended to be fitted to a container for the packaging and reconstitution of a liquid product by mixing a first product and a second product. According to a preferred application of the invention, the capsule 100 is intended to be fitted to a bottle such as a multi-dose bottle of a liquid ophthalmic product.

[0053]

[0051] The capsule 100 forms a compartment 110. The compartment 110 is a volume adapted to contain a first product. The first product may be, for example, a powder or a liquid. The first product may, in particular, contain an active ingredient for a liquid product, especially an ophthalmic product, prepared extemporaneously.

[0054]

[0052] The capsule has a lateral wall 120. The lateral wall 120 is substantially cylindrical or frustoconical. The concept of cylinder and frustocone includes cylinders and frustocones with a circular base, but also cylinders and frustocones with a polygonal base.

[0055]

[0053] The side wall 120 gives the capsule its general shape. The side wall 120 has an upper edge 121 and a lower edge 122.

[0056]

[0054] Considering that the main axis of the cylinder or truncated cone formed by the lateral wall 120 defines a so-called longitudinal direction L, the upper edge 121 and the lower edge 122 are longitudinally opposed to each other.

[0057]

[0055] Housing 110 is closed in its lower part by a bottom 130.

[0058]

[0056] The housing 110 is closed at the top by a lid 140. In particular, the lid 140 covers an upper face of the housing 110 delimited by the upper edge 121. The lid 140 is a film which can be made of plastic material, metallic, or formed of several plastic and / or metallic plies.

[0059]

[0057] The lid 140 is preferably heat-sealed, so that the product contained in the housing 110 remains confined in the capsule 100 as long as the lid 140 is in place on the upper face of the housing 110.

[0060]

[0058] The lid 140 is liquid- and airtight to maintain sterility and ensure proper preservation of the product (referred to as the "first product") contained in the capsule. However, the thinness and composition of the lid mean that it can be broken, by perforation or tearing, under moderate mechanical stress, sufficiently weak to be applied manually by a user, for example, by means of a pointed or sharp object, or simply by applying a localized force to the lid.

[0059] The lid may have a localized weakening that allows for controlled and reproducible breakage from one capsule to another. The weakening may consist, for example, of one or more lines where the lid is thinned.For example, the lid may have a thickness limitation which may be achieved in the form of one or more "dotted" lines, with a discontinuous thickness limitation along the line or lines.

[0061]

[0060] The bottom 130 of the housing is connected to the side wall 120 by an annular wall 150.

[0062]

[0061] In the example of embodiment shown here, the side wall of the housing is formed by the side wall 120 of the capsule.

[0063]

[0062] The base 130 and the annular wall 150 can be one piece. Similarly, the annular wall 150 and the side wall 120 can be one piece.

[0064]

[0063] The annular wall 150 is configured to be deformed and to be able to pass from an initial stable state, associated with an initial position of the annular wall 150, to another stable state, called the activated state, associated with an activated position of the annular wall 150. When the wall is between the initial stable state and the activated stable state, it tends to return to the stable state of which it is closest.

[0065]

[0064] The initial state of the annular wall 150 is associated with an initial state of the capsule, and the activated state of the annular wall 150 with an activated state of the capsule. In other words, the capsule is said to be activated when the annular wall 150 has entered the activated state. The initial state of the capsule corresponds in particular to the state in which it is stored before its use.

[0066]

[0065] The position of the annular wall is correlated with the longitudinal position of the bottom 130. Thus, when the annular wall is in the activated position, the bottom 130 is closer to the upper face of the capsule, and therefore to the operculum 140, than when the annular wall is in the initial position.

[0067]

[0066] Thus, with the annular wall 150 and the capsule 100 in their initial position, a longitudinal force on the base 130, in the direction of the operculum, sufficient to cause the annular wall to leave its initial state, allows the annular wall to be moved towards its activated position. The base 130 is thus brought closer to the operculum 140.

[0068]

[0067] In the example shown here, maintaining the annular wall and the capsule in their initial state is not guaranteed solely by the stability of the initial position of the annular wall. Indeed, the lateral wall 120 has on its inner surface 123 a bulge 124, which is here an annular bulge.

[0069]

[0068] The pusher 160 is initially against the bulge 124. Sufficient longitudinal force must be applied to the pusher 160 to move it beyond said bulge 124. The bulge 124 and the pusher 160 are also configured so that the pusher 160 cannot spontaneously return to its original position once it has passed the bulge 124.

[0070]

[0069] The thrust on the bottom 130 can be exerted directly on it, or, as in the example shown here via a pusher 160.

[0071]

[0070] The pusher 160 is an element bearing on the bottom 130 of the housing 110.

[0072]

[0071] The pusher 160 is advantageously connected to the base 130. In the example shown, the pusher 160 is connected to the base 130 by snap-fitting. In particular, the pusher here comprises a longitudinal extension 161, which is cylindrical and into which a connecting element 131 of the base 130 is inserted. The longitudinal extension 161 has a bead 162 which snaps into place in a groove 132 of the connecting element 131.

[0073]

[0072] In all embodiments of the capsule comprising a pusher 160, this pusher can be made in one piece with the base 130.

[0074]

[0073] The pusher 160 has a bearing surface. The bearing surface can be substantially transverse (i.e., perpendicular to the longitudinal direction L). The pusher 160 is configured so that it can be pushed longitudinally, for example by a user's thumb. This force is then applied to the bottom 130 of the housing 110. This force causes the bottom 130 to move by deforming the annular wall 150.

[0075]

[0074] The push button 160 thus makes it easier for the user to apply pressure to activate the capsule.

[0076]

[0075] In fact, in the end, the capsule or the container which contains the capsule is configured so that the passage of the capsule into the activated position, by pressure on the bottom of the housing 110, causes the rupture of the seal 140, as explained below.

[0077]

[0076] Figure 2 represents the capsule of Figure 1 once it has been activated.

[0078]

[0077] In the embodiment shown here, the capsule has a point 170. When the capsule 100 is in its initial position, the point 170 extends into the housing from the base 130 towards the lid 140. The point 170 can thus extend longitudinally. The point 170 can have various cross-sections such as circular, square, etc. In the example shown here, the point 170 has a cross-section. The dimensions of the cross-section of the point 170 decrease from the base to one end 171 of the point 170. This gives the point 170 its pointed shape, allowing it to easily break the lid 140 when the end 171 is pressed against the lid 140.

[0079]

[0078] Thus, in the example shown and as can be seen in Figure 2, when the capsule is activated, i.e. when the bottom 130 has been pressed via the pusher 160, the bottom 130 is close to the level of the lid 140 and the lid 140 (which is omitted in Figure 2) is pierced by the tip 170.

[0080]

[0079] Rupture of the operculum releases the product contained in the housing 110.

[0080] The bistable nature of the annular wall 150 can be achieved in various ways. Generally, the annular wall initially forms a concavity, the base of which is formed by the base 130 of the housing 110. When longitudinal pressure is applied to the base, it is possible to cause this concavity to invert. In other words, in the initial position, the annular wall and the base form a concavity, viewed from inside the housing 110, and after inverting, the annular wall 150 and the base 130 form a convexity, viewed from inside the housing 110.

[0081]

[0081] Various arrangements allow for the bistable deformation of the annular wall. In the example shown in Figures 1 and 2, the annular wall has, in its initial position, a corrugation 151. The corrugation 151 corresponds to an annular fold of the annular wall 150, which, in the example shown, is located near the lateral wall 120. When the bottom 130 is pushed longitudinally towards the operculum 140, the annular wall gradually unfolds from the corrugation 151, until a point where it flips over to adopt the activated position shown in Figure 2. In this activated position, the corrugation 151 of the annular wall is then near the bottom 130.

[0082]

[0082] At the point of the connection between the annular wall 150 and the bottom 130, the annular wall may have a thinning 152. The thinning 152 has the effect that the annular wall will fold preferentially at the point of the thinning and allows the annular wall to be turned over in this area.

[0083]

[0083] Figure 3 shows a capsule that differs from the capsule in Figure 1 by the configuration of its annular wall. In particular, the annular wall 150 has, in an intermediate zone between the base 130 and the lateral wall 120, a large undulation 151. The undulation 151 has a thinning 152. When the base 130 is pushed towards the operculum 140, the annular wall begins to deform at the thinning 152, the undulation 151 allowing the annular wall to move laterally and eventually turn inside out.

[0084]

[0084] According to another optional aspect shown in Figure 3, the capsule 100 is formed in two parts, namely a first part 101 and a second part 102.

[0085]

[0085] The first part 101 is intended to be in contact with the base of the container on which the capsule will be mounted, and thus forms, in whole or in part, the outer surface 125 of the side wall 120. The second part 102 forms the housing 110 of the capsule 100. The second part 102 thus comprises the bottom 130 and the annular wall 150. In the embodiment shown here, the second part forms, in part, the inner surface 123 of the side wall 120.

[0086]

[0086] The first part 101 may be formed of a first material and the second part may be formed of a second material. The second material is advantageously more flexible than the first material. In particular, the first material may be HDPE. The second material may be LDPE.

[0087]

[0087] The first part 101 and the second part 102 can be formed, for example, by bi-injection or co-injection. It should be noted that bi-injection involves injecting two materials into a mold, while co-injection further requires that the injections of the two materials be simultaneous. Other means of joining the first part and the second part are nevertheless conceivable.

[0088]

[0088] With the capsule 100 thus constituted, the first part ensures good overall rigidity of the capsule. The capsule can therefore withstand the thrust exerted for its activation without risk of external deformation. However, the second part 102, being more flexible, will deform first when a thrust is exerted on the base 130, thus allowing the annular wall 150 (and consequently the capsule) to move into the activated position.

[0089]

[0089] Figure 4 shows a capsule whose annular wall 150 has yet another configuration to allow its deformation and bistable nature. In this embodiment, the annular wall 150 has a succession of undulations 151.

[0090]

[0090] The series of undulations 151 allows for a certain radial compression of the annular wall as it moves from its initial position to the activated position. In particular, the annular wall can be compressed radially up to the longitudinal level at which it is connected to the lateral wall 120. Once this level is passed, the annular wall relaxes and brings the capsule into the activated position.

[0091]

[0091] To amplify this phenomenon, which tends to spontaneously bring the annular wall 150 and the capsule 100 into the activated position, the capsule 100 is typically manufactured by molding with the annular wall 150 in the activated position. The capsule 100 is then brought to its initial position before being filled. By "shape memory," the annular wall 150 will tend to spontaneously return to the activated position when it leaves its initial stable position, which tends to bring the capsule into the activated position. Thus, when the user presses the base 130 of the capsule longitudinally, either directly or via a pusher 160, the capsule 100 quickly tends to adopt the activated position. Activating the capsule is therefore simple, quick, and reliable (in that it is thus guaranteed that the capsule moves perfectly into the activated position).

[0092]

[0092] Just like the capsule in Figure 3, the capsule in Figure 4 is here made in two parts, according to the optional feature described above.

[0093]

[0093] Figure 5 represents a capsule 100 according to an embodiment close to that of Figures 1 and 2, in which the turning of the annular wall 150 and the housing 110 is facilitated and guided simply by a thinning 152. The thinning 152 of the annular wall 150 is located at the boundary between said annular wall 150 and the bottom 130.

[0094] Figure 6 shows a capsule according to an embodiment in which the annular wall 150 is reversed as in the embodiment of Figure 5, by means of a thinning 152. Other annular wall configurations, which use one or more corrugations 151, can also be used. The distinctive feature of the capsule 100 shown in Figure 6 is that the housing 110 is not laterally delimited by the lateral wall of the capsule, but by a peripheral wall 180 that extends substantially longitudinally from the bottom 130. The peripheral wall 180 could alternatively extend in a flared manner.

[0094]

[0095] In the embodiment of figure 6, the entire housing 110 is thus displaced when the bottom 130 is pushed longitudinally and the annular wall 150 is deformed.

[0095]

[0096] The capsule 100 is shown in Figure 6 installed in the base 210 of a reservoir 200 of a container. In order to allow the seal 140 to break when the base 130 is pushed longitudinally so as to displace the housing 110, in the example shown here, the reservoir includes a hollow cylinder 220. The hollow cylinder 220 extends longitudinally from a neck of the reservoir 200 towards its base 210. The hollow cylinder 220 has a free end 221 which has a point 222.

[0096]

[0097] It should be noted that the term "cylinder" here includes slightly flared shapes, close to a cylinder.

[0097]

[0098] The hollow cylinder 220 can be formed in one piece with the tank 200.

[0098]

[0099] The tip 222 is close to the lid 140 when the capsule is in its initial position, that is, in practice, when the container with the reservoir 200 and the capsule 100 is in a storage configuration before use.

[0099]

[0100] When the base 130, and consequently the housing 110, are pushed longitudinally, the operculum 140 is pressed onto the point 222. The point 222 then causes the operculum 140 to break, by piercing it.

[0100]

[0101] Figure 7 shows a capsule 100 according to another embodiment. With regard to the activation of the capsule and its general configuration, the capsule 100 in Figure 7 is similar to those in Figures 1 and 2.

[0101]

[0102] Capsule 100 here comprises a first part 101 and a second part 102.

[0102]

[0103] As explained above, the first part 101 can be formed from a first material and the second part can be formed from a second material. The second material is advantageously more flexible than the first material. In particular, the first material can be HDPE. The second material can be LDPE. The first part 101 and the second part 102 can be formed, for example, by bi-injection or co-injection.

[0104] Other materials are of course conceivable, for example the second part 102 can be made of an elastomer, such as natural rubber or a synthetic elastomer.

[0103]

[0105] The second part 102 comprises the base 130 and the annular wall 150. In the embodiment shown here, the first part 101 and the second part 102 of the capsule 100 are joined longitudinally, with possibly a junction zone 103 between said first part 101 and said second part 102. Thus, overall, the lateral wall 120 and more particularly its outer surface 125 is formed successively, in the longitudinal direction, by the first part 101 and then by the second part 102.

[0104]

[0106] Surface 125 is flared, specifically frustoconical, according to a characteristic applicable to all embodiments of the capsule. This shape facilitates the placement of the capsule in the base 210 of a reservoir 200, as illustrated in particular in Figures 8 and 12 below. It also improves the seal.

[0105]

[0107] The first part 101 forms an annular groove 104 for attachment to a reservoir.

[0106]

[0108] Figure 8 represents the capsule of figure 7 attached to the base 210 of a reservoir 200.

[0107]

[0109] The reservoir 200 of the container in Figure 8 consists of two parts, namely the base 210 and a main part 220. The main part 220 forms the bulk of the reservoir 200, and in particular the area in which the user squeezes the reservoir 200 to cause the distribution of the product contained in said reservoir.

[0108]

[0110] According to the aspect illustrated here, the base 210 is formed from a different material than the material that forms the main part 220. More specifically, the base 210 of the tank 200 is formed from a first material and the main part is formed from a second material, and the first material is more rigid than the second material.

[0109]

[0111] For example, base 210 is made of high-density polyethylene (HDPE), and main part 220 is made of low-density polyethylene (LDPE).

[0110]

[0112] Thus, while the main part 220 is made of a flexible material allowing elastic compression of the reservoir for the distribution of the product it contains, the base 210 is sufficiently rigid to avoid any significant deformation when the capsule 100 is activated by pushing on the bottom 130.

[0111]

[0113] Regarding the assembly and sealing between the main part 220 and the base 210, the base 210 can be connected to the main part 220 in various ways. Advantageously, the base 210 and the main part 220 are produced by bi-injection or co-injection.

[0112]

[0114] Forming the base 210 from a more rigid material than that forming the main part 220 of the reservoir 200 is applicable and advantageous in all embodiments of the invention. In particular, it provides advantages with regard to the seal between the capsule 100 and the reservoir 200.

[0113]

[0115] When base 210 is made of a rigid material, it is advantageous for a portion of the capsule, made of a more flexible material, to be in contact with said base. Thus, the interaction between the relatively flexible material of capsule 100 and the relatively rigid material of base 210 ensures a good seal between capsule 100 and base 210.

[0114]

[0116] In the example in Figure 8, advantageously, the main part 220 is in LDPE, the base is in HDPE, the first part 101 is in HDPE and the second part 102 is in LDPE.

[0115]

[0117] The first part 101 is attached to the lower part of the base 210. Specifically, the lower part of the base is inserted into the annular groove 104 where it is snapped into place. This snapping can be achieved by inserting a first protruding element 105 into a first groove 211. The first protruding element 105 is supported here by the capsule and the first groove 211 is supported by the base, but a reversed configuration would be possible.

[0116]

[0118] The assembly between two rigid materials (the first part 101 and the base 210 being for example both in HDPE) guarantees good mechanical support.

[0117]

[0119] The second part 102 also interacts with the base 210. In particular, the second part 102 is in contact with the base 210 and ensures a seal between these parts. Specifically, in addition to the seal achieved by surface contact between the capsule and the base, a second protruding element 106 is inserted into a second groove 212 within a sealing portion. Furthermore, the seal between the capsule 100 and the base 210 is improved by the fact that the second part 102 is made of a flexible material (e.g., LDPE) while the base 210 is made of a more rigid material (e.g., HDPE).

[0118]

[0120] Figure 9 represents a container, namely in the embodiment of the invention represented a bottle for a liquid product such as an ophthalmic product.

[0119]

[0121] In the following description, it is assumed that before reconstitution of the liquid product, the capsule (containing the first product) contains the product containing the active ingredient, and that the reservoir (containing the second product) contains a liquid in which the first product is mixed to form the liquid product to be dispensed. However, in all the embodiments that follow, and more generally within the scope of the present invention, it is possible for the capsule to contain the liquid (which would then be the first product) while the reservoir contains the product containing the active ingredient (which would then be the second product).

[0120]

[0122] With the capsule 100 placed in the reservoir 200, in the example shown the reservoir and the capsule extend along the longitudinal direction L. The largest dimension of the bottle is thus measured in the longitudinal direction L.

[0123] The tank 200 initially contains the second product and is intended to receive a liquid product obtained by reconstitution, through the mixing of the first and second products. The tank 200 has a side wall 230. The side wall 230 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 distribution of the liquid product contained in the tank, and the return of the side wall to its original configuration results in air returning to the tank to compensate for the volume of product distributed, as will be detailed later.

[0121]

[0124] The container is in particular intended for a liquid product obtained extemporaneously, by mixing a liquid present in reservoir 200 from the initial filling of the bottle and a product containing an active ingredient contained in capsule 100.

[0122]

[0125] In Figure 9, the container has a cap 300 screwed onto the neck 240 of the reservoir 200. The neck 240 is threaded for this purpose. Any other method of attaching the cap 300, for example, by snapping it onto the neck 240, is of course possible as an alternative. Below the cap, a ring 400, fixed to the upper end of the reservoir 200, is connected to the cap 300 by breakable elements. The breakable elements break the first time the cap 300 is opened. The ring 400 thus indicates to the user whether the container's cap has already been opened. Any other known system allowing this verification can be considered as an alternative to the ring 400, where the container has such a function.

[0123]

[0126] Figure 10 shows the container of Figure 9 with the cap 300 removed. With the cap 300 removed, the neck 240 of the bottle is exposed. A dispensing head 500 (see Figure 11, for example) is mounted in the neck 240. The dispensing head has a nozzle 510 for delivering the liquid product from the reservoir 200. The nozzle 510 can be adapted for drop-by-drop dispensing. For this purpose, the nozzle 510 may include a capillary channel 511.

[0124]

[0127] 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 dispensing head is in its upper part.

[0125]

[0128] Figure 11 is a cross-sectional view of the container of Figures 9 and 10. In Figure 11, the container is shown in a storage configuration, such that the container is delivered before the mixing between the liquid 600 contained in the tank and the product containing the active ingredient 700 (here contained in the capsule 100), and before the first opening of the cap 300.

[0129] In this configuration, a pin 310 of the cap 300 seals the capillary channel 511. The cap may include any other means of ensuring a liquid- and air-tight seal of the container.

[0126]

[0130] The distribution head 500 shown here comprises a main body 520 which is fixed within the neck 240. This fixing can be achieved, for example, by press fitting or snap-fitting. A seal against liquids and air is provided between the neck 240 and the main body 520 of the distribution head 500.

[0127]

[0131] The 510 tip is fixed to the 520 main body.

[0128]

[0132] A microporous filter membrane 530 is fixed between the main body 520 and the nozzle. This membrane 530 is considered to be positioned upstream of the nozzle 510. The terms upstream and downstream throughout this document refer to the direction of flow of the liquid product for its distribution, from the reservoir 200 to the nozzle outlet.

[0129]

[0133] More specifically, the membrane 530 is supported against a base of the tip 510. 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 520.

[0130]

[0134] The 530 filter membrane has pores with small dimensions that ensure bacterial filtration of the fluids passing through it. For example, the 530 membrane can have a pore size of less than 0.45 µm and preferably less than or equal to 0.22 µm, for example, between 0.1 µm and 0.2 µm.

[0131]

[0135] In the example shown here, the filter membrane is of a dual-function type, meaning that it filters the liquid product during dispensing and also filters (and sterilizes by filtration) the air entering the reservoir to compensate for the volume of liquid product dispensed. This membrane 530 thus acts as a sterilizing filter through which the air entering the reservoir passes.

[0132]

[0136] In order to ensure the filtration of the liquid exiting the container and 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.

[0133]

[0137] Thus, during product dispensing, the user having inverted the bottle, with the nozzle 510 oriented downwards (approximately towards the ground), a transverse force on the lateral wall 230 of the reservoir 200 compresses the reservoir and causes an increase in pressure in the reservoir, which drives the liquid product present in the reservoir 200 through the hydrophilic part of the membrane 530, the product then being dispensed via the capillary channel 511.

[0138] When the force exerted by the user on the side wall 230 of the tank 200 ceases, the side wall 230 of the tank 200 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 200 through the nozzle 510 and the membrane 530. The volume of air thus admitted, filtered and sterilized, compensates for the volume of product previously dispensed.

[0134]

[0139] Such a 530 membrane provides sterilizing filtration by preventing the passage of bacteria, fungi, and, depending on the chosen porosity, certain viruses. The membrane can be made of various materials, such as 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 no contaminants are typically present), but it also guarantees the sterility of the product in the reservoir by preventing contaminants (bacteria, or even viruses) from entering the reservoir from outside the bottle. Therefore, no preservatives are required in the product.

[0135]

[0140] It may be beneficial to impart an antibacterial effect to the container surfaces located downstream of membrane 530, which are susceptible to being wetted by the liquid product in the bottle. This can be achieved by treating these surfaces or the material from which they are made. Such a treatment, based on silver or zinc ions, for example, prevents bacterial growth on these surfaces. If a small amount of liquid product is retained downstream of membrane 530 between dispensings, the treatment also prevents bacterial growth in this small amount of liquid product.

[0136]

[0141] The antibacterial treatment thus concerns the internal surfaces of the tip 510, in particular the capillary channel 511. Advantageously, the downstream surface of the membrane 530 is also treated to prevent any bacterial growth.

[0137]

[0142] The distribution head 500 used in the example shown also includes a microporous buffer 540 upstream of the membrane 530.

[0138]

[0143] The microporous buffer 540 advantageously includes microchannels whose average pore diameter, which is greater than that of the membrane 530, is for example between 0.3 and 10 microns.

[0139]

[0144] The microporous pad 540, located upstream of the membrane 530, prevents the liquid in the reservoir 200 from coming into contact with the membrane before the first dispensing of the product. Before the first use, the liquid remains perfectly contained within the reservoir, and no droplets risk passing through the membrane and ending up in an area, at the nozzle, where sterility is more difficult to guarantee.

[0145] The 540 microporous pad also creates a pressure drop along the liquid product's path during dispensing, in conjunction with the 530 membrane, which regulates the liquid flow from the bottle. In other words, the 540 pad allows the user to more easily dispense the desired number of drops by regulating the liquid flow exiting the container.

[0140]

[0146] The microporous pad 540 can notably be made in the form of a felt pellet of polyester or modified polyester resins, such as in particular low-density polyethylene resins or polyethersulfone resins.

[0141]

[0147] Other dispensing heads can be used successfully, provided they guarantee the absence of contamination of the liquid product, and in particular, bacterial filtration of the air entering the reservoir to compensate for the dispensed liquid. Specifically, an air intake channel with an air-permeable silicone membrane can be implemented to filter the air entering the reservoir.

[0142]

[0148] Figure 12 is a schematic diagram illustrating the functions sought in the distribution head of a container according to the present invention.

[0143]

[0149] The dispensing head 500 includes a sterilizing filter 501. The sterilizing filter is configured to sterilize, by filtration, the air entering the container's reservoir to compensate for the volume of liquid product that has just been dispensed. Functionally, the sterilizing filter 501 corresponds, in the dispensing head described above, to the hydrophobic portion of the membrane 530. As illustrated in Figure 12, the sterilization function by filtration of the air entering the container can be performed by any suitable device, whether located in a common duct for dispensing the liquid product or in a dedicated duct as shown in Figure 12. Thus, any sterilizing filter 501 that allows for sterilizing filtration of the air can be considered. If this sterilizing filter 501 prevents the passage of a liquid, it can be used alone, as shown in Figure 12.If this sterilizing filter also allows the passage of a liquid, it can be associated with a non-return valve that only allows the passage of fluid from outside the container to inside said container.

[0144]

[0150] The dispensing head 500 also includes a valve 502. Valve 502 is a one-way valve, allowing fluid to flow only from the inside of the container to the outside. Functionally, valve 502 corresponds, in the dispensing head described above, to the hydrophilic portion of the membrane 530. Valve 502 can be designed in various ways (ball valve, lip valve, etc.), provided that it allows the liquid product to exit the reservoir 200 while preventing any air from entering the reservoir. Valve 502 can carry a bactericidal agent, for example, one based on silver ions.

[0145]

[0151] The product containing the active ingredient 700 is contained in capsule 100.

[0152] Capsule 100 seals the base 210 of the reservoir airtight as explained above.

[0146]

[0153] Figures 13 and 14 show the container of Figures 9 to 11 viewed from below. Figure 13 shows the container before any use and before reconstitution of the liquid product in the container. The plunger 160 is aligned (or substantially aligned) with the lower edge 122 of the side wall of the cap, which is also more generally the lower edge of the cap 100.

[0147]

[0154] Optionally, a sheet attached to the lower edge 122 can cover the pusher 160 and prevent its actuation. It is then necessary to remove this sheet in order to press the pusher 160 (or, depending on the embodiment considered, directly on the base 130 of the capsule 100, in the absence of a pusher).

[0148]

[0155] The sheet may include a tab to facilitate its removal.

[0149]

[0156] Figure 14 shows the container of Figure 13 after the capsule has been activated. In Figure 14, a user has pushed the plunger 160 lengthwise. This has caused the seal 140 to break, which has connected the housing 110 with the inside of the reservoir 200 for the reconstitution of the liquid product.

[0150]

[0157] Activating the annular wall 150 and the capsule 100 by pushing on the pusher 160 places the annular wall in the activated, stable position. The pusher 160 then remains depressed beyond the lower edge 122. Depending on the embodiment considered, the bulge 124, when present, further ensures that the pusher 160 or the base 130 cannot return to its original position.

[0151]

[0158] The position of the pusher 160 (or of the bottom 130 in the absence of a pusher) thus constitutes a visual indicator which allows the user to know whether the reconstitution of the product has been carried out or not.

[0152]

[0159] In addition, the base 130 and, where applicable, the pusher 160 can be transparent or translucent in order to be able to visually observe the reconstitution of the liquid product (either, for example, simply because liquid is visible through the base and no longer powder, or by coloring the liquid present in the reservoir so that it is perfectly visible through the base).

[0153]

[0160] 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).

[0154]

[0161] The container configuration allows for reconstitution of the liquid product through a simple action by the user.

[0155]

[0162] 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.

[0156]

[0163] Since the capsule containing one of the products necessary for reconstituting the liquid product is manufactured and filled independently of the rest of the container, the manufacturing of the container and the associated logistics are simplified. The container proposed in the invention significantly reduces waste compared to single-dose packaging, while minimizing the risk of contamination of the liquid product.

Claims

Demands 1. Capsule intended to equip a container for the conditioning and reconstitution of a liquid product (600) by mixing a first product (700) and a second product (600), the capsule (100) forming a housing (110) adapted to receive said first product (700); the capsule (100) comprising a cylindrical or frustoconical side wall (120) extending around a longitudinal axis (L), the side wall (120) comprising an upper edge (121) and a lower edge (122) longitudinally opposite the upper edge (121), the housing (110) being closed by a lid (140) fixed on an upper face of the housing (110) defined by said upper edge (121), the housing (110) comprising a bottom (130) longitudinally opposite its upper face, the bottom (130) being connected to the side wall (120) by an annular wall (150), the annular wall (150) being configured so as to be deformable between two stable positions,namely an initial position and an activated position, the bottom (130) being displaced longitudinally when the annular wall (150) is deformed from the initial position to the activated position, the bottom (130) being closer to the upper face of the capsule (100) when the annular wall (150) is in the activated position than when it is in the initial position.

2. Capsule according to claim 1, in which the annular wall (150) and the bottom (130) form a concavity, said concavity being reversed when the annular wall (150) passes from the initial position to the activated position.

3. Capsule according to claim 1 or claim 2, wherein the annular wall (150) has at least one annular undulation (151) allowing deformation of the annular wall (150) from its initial position to its activated position.

4. Capsule according to any one of the preceding claims, wherein the annular wall (150) has at least one annular thinning (152) at which the wall deforms when it moves from its initial position to its activated position.

5. Capsule according to any one of the preceding claims, wherein the capsule (100) comprises a first part (101) and a second part (102), the first part (101) forming all or part of the side wall (120) and the second part (102) forming the annular wall (150) and the housing (110) of the capsule (100), the first part (101) being formed of a first material, the second part (102) being formed of a second material, the second material being more flexible than the first material.

6. Capsule according to claim 5, wherein the first material is high-density polyethylene and the second material is low-density polyethylene.

7. Capsule according to any one of the preceding claims comprising a pusher (160) adapted to transmit longitudinal pressure to the bottom (130) of the housing (110).

8. Capsule according to any one of the preceding claims containing said first product (700), said first product (700) being a powder or liquid containing an active ingredient.

9. Capsule according to any one of the preceding claims, the capsule (100) comprising a point (170) which extends into the housing (110) from the bottom (130) and towards its upper face.

10. Container for the packaging, reconstitution of a liquid product (600) by mixing a first product and a second product, and controlled dispensing of the liquid product (600), said container comprising: • a tank (200) having a wall (230) defining an internal volume and adapted to deform under the effect of pressure exerted on the tank (200) by a user to cause a distribution of liquid product (600) and to spontaneously return to its original shape after release of said pressure, causing an admission of air into the tank (200) in compensation of the volume of liquid product (600) distributed, the tank (200) containing the second product (600), the tank (200) further having a base (210) opposite, in an extension direction of the tank (200), to its neck (240); • a dispensing head (500) linked to a neck (240) of the reservoir (200) and equipped with a nozzle (510) for delivering the liquid product (600) and a device for air intake comprising a sterilizing filter (501) through which the air admitted into the reservoir (200) passes; • a capsule (100) according to any one of the preceding claims, containing the first product, attached and fixed to the base (210) of the tank (200); the container being configured so that when the bottom (130) of the capsule (100) is moved longitudinally so that the annular wall (150) is deformed from the initial position to the activated position, the lid (140) of the capsule (100) is broken and the housing (110) of the capsule (100) is brought into communication with the internal volume of the tank (200), which allows the mixing between the first product (700) and the second product (600).

11. Container according to claim 10, in which the reservoir (200) is made up of a main part (220) and the base (210), the base (210) being formed of a first material and the main part (220) being formed of a second material, the first material being more rigid than the second material.

12. Container according to claim 11, wherein the base (210) is formed of high-density polyethylene (HDPE) and the main part (220) is formed of low-density polyethylene (LDPE).

13. Container according to claim 11 or claim 12, in which the base (210) is overmolded onto the main part (220) or in which the reservoir (200) is formed by bi-injection or co-injection of the main part (220) and the base (210) 14. Container according to claims 5 and 11, wherein the second part (102) of the capsule (100) has a sealing portion in contact with an inner surface of the base (210) of the reservoir (200), so as to hermetically close said base (210) of the reservoir (200).

15. Container according to any one of claims 10 to 14 in which said container comprises, in its reservoir (200), a hollow cylinder (220) which extends longitudinally from the neck (240) of the reservoir (200) to the base (210), said hollow cylinder (220) comprising a free end (221) opposite longitudinally to the neck (240) of the reservoir (200) which comprises a point (222) adapted to cause rupture of the seal (140).

16. Container according to any one of claims 10 to 15, wherein the sterilizing filter (501) is formed by a filter membrane (530) which is disposed upstream of the nozzle (510), the filter membrane (530) being hydrophilic on one part of its surface and disposed so as to be passed through by the liquid product (600) from the reservoir (200) 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 (200).

17. Container according to claim 16, in which the distribution head (500) comprises a microporous buffer (540) disposed upstream of the filter membrane (530).

18. Container according to any one of claims 10 to 17 in which the sterilizing filter (501) comprises an air-permeable silicone membrane.

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