Multi-dose anti-contamination capping device

Abstract

Multi-dose anti-contamination capping device. A capping device for withdrawing a composition from a container using a syringe, comprising: A base portion (10) including: a mounting skirt (11) for attachment to a container neck, an upper wall (12) having an opening (52), an upper portion (20) including a tip (22) for connection to the syringe, a non-return valve (50) configured to open to allow the composition to pass through in case of aspiration of the container contents with the syringe, an antibacterial filter (70), at least one air return path (100) connecting the exterior to the interior of the container through the filter (70), this path opening laterally onto the capping device. Figure for the abbreviation: Fig. 3

Description

Title of the invention: Multi-dose anti-contamination capping device Technical field

[0001] The present invention relates to a capping device enabling the withdrawal for administration, in particular by enteral or nasal route, or for external use, of compositions in the pharmaceutical, cosmetic or food fields, preferably pharmaceutical.

[0002] The invention also relates to a packaging assembly comprising such a capping device. Previous technique

[0003] Oral syrups or solutions packaged in multi-dose bottles with screw caps are known. As soon as the bottle is opened, outside air enters the container and can contaminate the contents.

[0004] It is therefore necessary that antimicrobial preservatives be added to the liquid solutions thus packaged.

[0005] There is therefore a need to remove or reduce the preservative(s) from compositions in the pharmaceutical, food or cosmetic fields.

[0006] To achieve this, it is known to produce single-dose containers for the distribution of compositions. However, this solution generates more waste and requires more labor and packaging.

[0007] International application WO2016 / 166197 discloses a closure device for withdrawing a composition intended for enteral or nasal administration, or for external use, contained in a container, this closure device comprising: - a nozzle defining an internal passage leading to an opening, configured to allow connection to a collection device such as an enteral syringe, - a non-return valve associated with said nozzle, configured to open when the contents of the container are withdrawn using the sampling device, - a plurality of air intake vents opening onto the upper surface of the device, and - an antibacterial filter associated with the air intake orifice.

[0008] Such a device has the disadvantage that there is a risk of clogging the air intake orifices or of the filter becoming blocked if the composition spills onto the top of the device.

[0009] Consequently, there is a need to remedy this drawback. Summary of the invention

[0010] The invention aims to meet this need and achieves this, according to one of its aspects, by means of a capping device allowing the withdrawal, in particular by means of a syringe, of a composition contained in a container, comprising: - A basic section comprising: - a mounting skirt for attaching to the neck of the container, - an upper wall with an opening, - an upper part fixed to the base part, comprising a connection nozzle, in particular for a syringe, communicating with the opening of the base part, - a non-return valve fitted to the opening of the base part, configured to close it in the absence of sampling, and to open to allow the composition to pass through in the event of aspiration, particularly with the syringe, of the contents of the container, - an air-permeable antibacterial filter, - at least one air return path connecting the outside with the inside of the container through the filter, this path being formed at least partially between the base and the top part, this path opening laterally onto the sealing device.

[0011] The invention makes it possible to reduce the risk that the composition will enter the air intake path in the event of dripping on the top of the device, and clog the antibacterial filter.

[0012] The term "composition" means any liquid solution, emulsion, semi-liquid solution, colloidal solution, or semi-pasty product, in particular a gel, intended for pharmaceutical, food, or cosmetic use. Preferably, the composition is a liquid solution.

[0013] When the piston of the syringe or other sampling means is pulled, the vacuum created in the bottle attracts the air which passes through the filter.

[0014] The air return path preferably includes at least one baffle formed between a rib carried by one of the upper and lower portions and a corresponding groove formed on the other of the upper and lower portions, in which the rib is engaged. Such a baffle allows air to pass through easily but liquid to pass through with greater difficulty, and therefore constitutes an effective barrier to liquid flow towards the filter. The rib is preferably stepped, with a shoulder located above the filter. It may also include at least one slot allowing air to flow radially.

[0015] One of the base and upper portions, preferably the base portion, may comprise a succession of annular ribs, and the other portion a succession of corresponding annular grooves into which the ribs are engaged. The innermost radial ribs may define between them a groove into which a corresponding rib from the other portion is received, this rib being ultrasonically welded into the groove so as to create an airtight barrier.

[0016] The filter preferably has an annular shape, being positioned flat between the base and the upper part so as to allow air flowing through it in the air return path. Preferably, the filter is hydrophobic, and preferably also the material(s) constituting it are pharmaceutical grade and inert with respect to the other raw material(s) constituting the base and upper parts. This filter is preferably resistant to the sterilization methods that may be used to sterilize the closure device and / or the container when sterilization is performed, in particular sterilization by gamma radiation, autoclave, or ethylene oxide.

[0017] The base part preferably comprises a plurality of orifices passing through the upper wall of the base part and opening opposite the filter. These orifices allow air to enter the container.

[0018] The filter is preferably held in place by ultrasonic welding, which improves its mechanical strength and can facilitate obtaining an aseptic barrier between the inside of the bottle and the ambient air.

[0019] The base part may include an annular rib defining a receiving housing for the valve.

[0020] The valve may comprise an annular peripheral frame and an annular lip extending obliquely inwards, the opening of the base portion comprising a plurality of orifices arranged around a central seat. The lip bears against this central seat at rest.

[0021] The valve preferably comprises at least one annular groove, and better two annular grooves, applying to the annular rib defining the valve receiving housing, to oppose the passage of the composition between the valve and said rib.

[0022] The nozzle may have at least a partially conical shape, in particular of the "standard locking screw-on cone" or "En-Fit cone" type. The nozzle may include an external locking skirt, internally threaded, and a central conduit.

[0023] The filter can be made of a hydrophobic material, having an average pore diameter of less than 0.3 µm. The filter material is preferably chosen to allow ultrasonic welding with the base material, being advantageously assembled by ultrasonic welding to the base part, as mentioned above.

[0024] The invention further relates to a packaging assembly for a composition intended for enteral administration or external use, comprising a container for packaging said composition, secured with a closure device according to the invention, as defined above. Brief description of the drawings

[0025] The invention will be better understood upon reading the detailed description that follows, a non-limiting example of its embodiment, and upon examination of the accompanying drawing, in which:

[0026] [Fig-1] [Fig.1] schematically represents, in perspective, an example of conditioning device according to the invention, in the closed state,

[0027] [Fig.2] [Fig.2] represents the device of [Fig.1] in the open state,

[0028] [Fig.3] [Fig.3] is a schematic and partial axial cross-section of the sealing device fitted to the container,

[0029] [Fig.4] [Fig.4] shows in isolation, in exploded view, the sealing device of [Fig.1], and

[0030] [Fig.5] [Fig.5] represents in isolation, in perspective, the base part and the filter before mounting the latter on the base part. Detailed description

[0031] Figures 1 and 2 show a packaging device 1 comprising a container 2, for example made of glass or thermoplastic material, and a sealing device 3.

[0032] Container 2 contains a composition P to be taken using a syringe, not shown.

[0033] The capacity of container 2 ranges for example from 5 mL to IL. Preferably, the diameter of the neck of the bottle conforms to the standard DIN ISO 11418-2 Containers and accessories for pharmaceutical preparations - Part 2: Glass bottles with screw caps for syrups.

[0034] The capping device can be adapted for mounting on other types of containers, such as bags or jerrycans, without departing from the scope of the present invention.

[0035] The capping device 3 comprises a base part 10 and an upper part 20, assembled together, the upper part being connected by a hinge 21 to a closing cap 30. The base part 10 and upper part 20 are, for example, both made by injection molding of a thermoplastic material.

[0036] The base part 10 comprises, as can be seen in particular in Figures 3 and 4, an internally threaded mounting skirt 11, arranged to screw onto a threaded neck of the container 2. A ring seal 5 can be mounted between the edge of the neck and the base part 10, as seen in [Fig.3].

[0037] The mounting skirt 11 is extended below by a tamper-evident ring 40, which must be removed in order to unscrew the base part. This ring 40 is known per se, and has teeth 6 which engage with a ridge at the base of the neck after the base part has been screwed onto the neck.

[0038] The base part 10 has a transverse wall 12 which connects at its periphery to the upper end of the mounting skirt 11, and which extends perpendicularly to the longitudinal axis X of the skirt 11.

[0039] The wall 12 has on its upper face three concentric annular ribs with axis X, namely a radially external rib 14, a radially internal rib 16 and an intermediate rib 15, located between the other two.

[0040] The rib 16 defines a housing 51 in which a non-return valve 50 made of an elastomeric material is disposed.

[0041] The ribs 14 and 15 define between them an annular groove 105 in which an antibacterial filter 70 is disposed, as can be seen in particular in Figures 3 and 5. A plurality of orifices 110 open into the bottom of the groove 105, as illustrated in [Fig. 5].

[0042] The filter 70 can be fixed to the base part 10 in the bottom of the groove 105 by ultrasonic welding, for example at fixing points far from the orifices 105.

[0043] A plurality of orifices 52 open into the bottom of the housing 51 around a central seat 53 against which a flexible lip 55 of the valve 50 is applied at rest.

[0044] The upper part 20 includes an end piece 22 for example of the En-Fit cone type, surmounting a plate 23, the latter having at its periphery a notch 25 defining a peripheral rim on which the hinge 21 is connected, as seen in [Fig.4].

[0045] The upper part 20 has on its lower face opposite the base part 10 three concentric annular grooves 80, 81, 82 with axis X, arranged to receive respectively the ribs 14, 15 and 16.

[0046] The grooves 81 and 82 are separated by an annular rib 84 which is inserted between bosses 87 and 88 of the ribs 15 and 16, which together form a groove 89, as seen in [Fig.4].

[0047] Parts 10 and 20 are preferably joined together by ultrasonic welding, which avoids the need for different raw materials, and in particular the need for an adhesive that could interact with the raw materials of the upper part 20 and the base part 10. The welds between parts 10 and 20 can be carried out using levels of bosses 87, 88 and rib 84, which allow the fusion of material by ultrasound, thus creating a watertight barrier in relation to the throat receiving the filter 70.

[0048] The upper part 20 has between the ribs 14 and 15 a stepped rib 90, having a shoulder 107 which is located above the filter and the slots 106.

[0049] The portions of this rib 90 away from the base part 10 provide spaces which promote air circulation on the side of the upper face of the filter, in the groove formed between the ribs 15 and 16, and make it possible to limit potential external pollution and / or dust which could hinder, or even block, the operation of the filter.

[0050] Radial channels 93 are formed between the base 10 and upper 20 parts, these channels opening through orifices 94 on the lateral surface of the plugging device, as seen in [Fig.2].

[0051] A very slight play 57, visible on [Fig.3], may be present between the rib 16 and an annular upright 56 ​​of the flap 50, to which the lip 54 is connected.

[0052] The flap 50 preferably has on the outer surface of the upright 56 ​​two annular grooves 111, 112 which apply to the surface opposite the annular rib 16.

[0053] These grooves 111, 112 allow for a watertight assembly of the valve 50 in its housing 51.

[0054] An air recovery path 100 is defined between the base part 10 and the upper part 20, the air entering under the effect of a depression created in the container by the orifices 94, running along the radial channels 93, circulating in the gap between the groove 80 and the rib 14, passing through the antibacterial filter 70 and then the orifices 110.

[0055] To collect the composition present in the container, the user can place the container upside down after screwing the syringe onto the cone 22.

[0056] When the container is upside down, without action from the operator, there are no leaks, the valve 50 being closed.

[0057] By pulling on the syringe piston, the vacuum that is created deforms the lip 54 of the valve which allows the composition to flow through the orifices 52. It is thus the physical action of lifting the membrane by the operator during aspiration that allows the composition to flow.

[0058] The depression which is created in the container is compensated by an influx of air circulating through the air return path 100, through the filter 70 which opposes the entry of pathogenic organisms.

[0059] When the pressure drop ceases, the valve 50 closes and the composition cannot escape. Air cannot enter the container without passing through the filter 70.

[0060] It is possible thanks to the invention to carry out successive sampling without contamination of the composition.

[0061] If a spillage of the composition occurs on the outer surface of the capping device during syringe handling, the liquid cannot reach the filter 70 due to the complexity of the air intake path. This complex air path ensures that multiple samples can be taken without clogging the filter.

[0062] Preferably, at least one of the base part 10 and the upper part 20 is made at least partially of a thermoplastic material containing a biocidal agent, so as to prevent the development of undesirable organisms in the dead volume defined by the inner channel 8 of the nozzle 22 and the volume of the chamber 9 containing the valve 50 and communicating with this inner channel 8. The biocidal agent is for example integrated into the thermoplastic material and may be that marketed under the brand name Pylote® by the company Pylote.

[0063] Of course the invention is not limited to the example just described; the base and upper part can in particular be made with different shapes.

Claims

Demands

1. A closure device (1) allowing the withdrawal, in particular by means of a syringe, of a composition (P) contained in a container, comprising: - A base part (10) comprising: i. a mounting skirt (11) for fixing onto a neck of the container, ii.an upper wall (12) having an opening (52), - an upper part (20) fixed to the base part, having a connection tip (22), in particular to the syringe, communicating with the opening (52), - a non-return valve (50) equipping the opening (52), configured to close it in the absence of sampling, to open to allow the composition to pass through in the event of aspiration, in particular with the syringe, of the contents of the container, - an air-permeable antibacterial filter (70), - at least one air return path (100) communicating the outside with the inside of the container through the filter (70), this path (100) being formed at least partially between the base part (10) and the upper part (20) and opening laterally onto the closure device.

2. Device according to claim 1, the air return path (100) comprising at least one baffle formed between a rib (14) carried by one of the upper part and the base part and a corresponding groove (80) formed on the other of the upper part and the base part, in which the rib is engaged.

3. Device according to claim 2, said rib (14) being stepped, with a shoulder (107) located above the filter (70), and preferably at least one slot (106) allowing air to flow radially

4. Device according to any one of claims 11 3, one of the base part (10) and the upper part (20) comprising a succession of annular ribs (14, 15, 16), and the other part (20) a succession of corresponding annular grooves (80, 81, 82) in which the ribs (14, 15, 16) are engaged.

5. Device according to claim 4, the innermost radially ribs (15, 16) defining between them a groove (89) into which is received a corresponding rib (84) of the other part (20), this rib (84) being ultrasonically welded into the groove (89) so as to create an airtight barrier.

6. Device according to any one of the preceding claims, the antibacterial filter (70) having an annular shape and being arranged flat between the base part (10) and the upper part (20), so as to be traversed by the air circulating in the air return path (100).

7. Device according to any one of the preceding claims, the base part (10) comprising an annular rib (16) defining a receiving housing for the valve (50).

8. Device according to claim 7, the valve (50) comprising at least one annular groove (111, 112), and preferably two annular grooves (111, 112), applying to the annular rib (16) to oppose the passage of the composition between the valve and said rib (16).

9. Device according to any one of the preceding claims, the valve (50) comprising an annular peripheral post (56), and an annular lip (54) extending obliquely inwards, the opening of the base part comprising a plurality of orifices (52) arranged around a central seat (53) against which the annular lip (54) of the valve is applied at rest.

10. Device according to any one of the preceding claims, the tip (22) having at least partially a substantially conical shape, in particular of the type "standard lockable screw-on cone" or "En-Fit cone".

11. Device according to any one of the preceding claims, wherein the filter (70) is made of a hydrophobic material, having an average pore diameter of less than 0.3qm.

12. Device according to any one of the preceding claims, the upper (20) and base (10) parts being assembled by ultrasonic welding.

13. Device according to any one of the preceding claims, the filter (70) being assembled by ultrasonic welding to the base part (10).

14. Device according to any one of the preceding claims, the base part (10) comprising a plurality of orifices (110) passing through a transverse wall (12) of the base part and opening opposite the filter (70).

15. Assembly (1) of packaging for a composition intended for enteral administration or external use, comprising a container (2) for packaging said composition, secured with a closure device (3) according to any one of the preceding claims.

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