EP3083434A1

EP3083434A1 - Protective cap for a dispenser and dispenser for discharging pharmaceutical and/or cosmetic liquids

Info

Publication number: EP3083434A1
Application number: EP14814843.0A
Authority: EP
Inventors: Matthias Wochele
Original assignee: Aptar Radolfzell GmbH
Current assignee: Aptar Radolfzell GmbH
Priority date: 2013-12-17
Filing date: 2014-12-16
Publication date: 2016-10-26
Anticipated expiration: 2034-12-16
Also published as: JP2016540697A; DE102013226250A1; US20160311589A1; DE102013226250B4; JP6526002B2; BR112016013106A2; CN105813951B; WO2015091536A1; CN105813951A; EP3083434B1; BR112016013106B1; US9889978B2

Abstract

The invention relates to a protective cap for a dispenser (2) for discharging pharmaceutical and/or cosmetic liquids (4), wherein the dispenser (2) has a liquid reservoir (21) and an outlet opening (24) through which the liquid (4) can be dispensed into a surrounding atmosphere, and wherein the protective cap (3) has at least one ventilation opening (30) to allow communication between an interior and an external surroundings, and an irreversibly removable sealing element (5, 6, 7) which covers the at least one ventilation opening is arranged on the protective cap, by means of which sealing element the at least one ventilation opening is closed in an airtight and germproof manner before a first use. The invention further relates to a discharge device (1) comprising a dispenser (2) and a protective cap (3).

Description

Protective cap for a dispenser and dispenser for dispensing pharmaceutical and / or cosmetic liquids

Field of application and state of the art

The invention relates to a protective cap for a dispenser and a dispenser for dispensing pharmaceutical and / or cosmetic liquids. Such a dispenser comprises a liquid reservoir and an outlet opening through which the liquid can be discharged into a surrounding atmosphere.

A stored in the liquid reservoir liquid will be promoted for discharge in the direction of the outlet opening, which can be done via many different mechanisms. Thus, the liquid reservoir may be formed as a squeeze bottle, the content of which can be pressurized by deformation of the walls. Also, a separate pumping device is used.

Generic dispensers are known from the prior art, for example from DE 10 201 1 086 755 A1. The dispenser comprises an outlet channel and a pressure-dependent opening or manually operable outlet valve arranged in the outlet channel, the outlet valve closing the outlet channel in the closed state. In this case, the outlet valve divides the outlet channel into a first partial section and a second partial section, wherein the second partial section extends adjacent to the outlet opening in the direction of the liquid reservoir. In other embodiments, the second portion corresponds to a drop formation surface at the exit opening.

In any case, the exhaust valve results in that after closing it no liquid, which has passed into a portion of the outlet channel on a side facing away from the liquid reservoir side of the outlet valve or which is left in the vicinity of the outlet opening outside the outlet channel, sucked back into the dispenser can be. A possible contamination of the contents of the liquid reservoir by liquid residues that have been sucked back is thereby prevented. The residual liquid therefore remains in an externally accessible area. Upon contact with the atmosphere, the residual liquid dries quickly.

In order to enable a rapid drying of the residual liquid even when placing a protective cap on the dispenser, it is known from DE 10 201 1 086 755 A1, to provide the protective cap of the dispenser with ventilation openings, which provide a permanent connection between the area where residual liquid can remain and an external environment. The vents, however, may in turn cause contamination.

According to DE 10 201 1 086 755 A1, in order to avoid contamination, it is provided that surfaces of the outlet channel downstream of the outlet valve, viewed in the discharge direction, and / or an outer surface of a housing surrounding the outlet opening are made antibacterial, the antibacterial formation being limited exclusively to these surfaces is.

Task and solution

The object of the invention is to provide a protective cap for a dispenser, which allows rapid drying and in which the problem of penetration of microorganisms is mitigated into the protective cap. The object of the invention is further to provide a dispenser with a corresponding protective cap available.

This object is solved by the objects with the features of claims 1 and 10. Further advantages of the invention will become apparent from the dependent claims.

According to a first aspect, there is provided a protective cap for a dispenser for dispensing pharmaceutical and / or cosmetic liquids, the dispenser having a liquid reservoir and an outlet opening through which the liquid can be dispensed into a surrounding atmosphere, and wherein the protective cap is at least a vent opening for communicating an interior with an external environment, and on the cap an irreversibly removable, the at least one vent opening covering the sealing element is arranged, through which the at least one vent opening before a first use air and is sealed germ-tight.

According to a second aspect, there is provided a dispensing apparatus comprising a dispenser for dispensing pharmaceutical and / or cosmetic liquids having a liquid reservoir and an outlet opening through which the liquid can be dispensed into a surrounding atmosphere, and a protective cap having at least one ventilation opening for Communicating an interior with an external environment, wherein on the cap an irreversibly removable, the at least one vent opening covering the sealing element is arranged, through which at least one ventilation opening is closed air and germ-tight before first use.

By means of the sealing element, germ introduction into an interior of the protective cap via the at least one ventilation opening is prevented from being used for the first time, without having to take special precautions for storage, transport, etc. for this purpose. In other words, it is prevented by the sealing element that deposit before the first use during storage, during transport, etc. over time on the dispenser and in the interior of the cap germs. Before or after a first use, the sealing element is removed to allow for a subsequent use, a rapid drying of the residual liquid. Due to a short time of use of the donor is a possible possible germ entry after receiving the first use usually not critical.

As germs in the context of the present invention, all microbial pathogens, especially bacteria and viruses, understood. As germ and airtight seal in connection with the application, a seal is referred to in which the leak rate is less than or equal to 10 ^"6 mbar l / s during storage of the dispenser under normal or standard conditions. A review of the microbial barrier properties takes place for example according to DIN 58953 In other embodiments, the sealing element is designed such that the requirements of the standards DIN EN ISO 1 1607 and / or DIN EN ISO 1 1868 are met.

The dispenser is particularly suitable for unpreserved ophthalmics. In advantageous embodiments, the dispenser has an outlet channel, which connects the liquid reservoir to the outlet opening, and a pressure-dependent opening or manually operable outlet valve, wherein the outlet valve is arranged in the outlet channel and closes the outlet channel in a closed state. The outlet valve prevents penetration of germs into the liquid reservoir. The outlet valve is preferably a pressure-dependent opening outlet valve, which is opened by pressurizing the liquid in the liquid reservoir or a partial charge removed therefrom and automatically closes again as soon as the corresponding overpressure relative to the environment is eliminated. In principle, however, other types of valves can be used here. Thus, for example, be provided that the liquid in the liquid reservoir is permanently under pressure and the handling of the dispenser via a handle, whose manual operation opens the outlet valve. The outlet valve prevents a sucked back liquid in the liquid reservoir. The at least one ventilation opening on the protective cap causes a rapid drying of this residual liquid.

In advantageous embodiments, it is provided that the protective cap comprises a cylindrical portion and a lid portion connected thereto, wherein the at least one ventilation opening is provided on the cylindrical portion and / or on the lid portion. The cylindrical portion has in one embodiment on its inner wall a latching geometry for latching with the dispenser and / or a clamping area contacting the dispenser. If the at least one ventilation opening is provided on the cylindrical section, the area of the ventilation opening preferably does not coincide with the area of the latching geometry or the clamping area. Preferably, the ventilation openings are arranged in a region which is arranged in use of the protective cap substantially in the region of the outlet opening of the dispenser.

In one embodiment, it is provided that the sealing element is designed as a peelable, air and germ-proof adhesive label. As an adhesive label or adhesive label is referred to in connection with the application, a single-layer or multi-layer element with a non-adhesive top and an adhesive bottom. In order to avoid contamination, the adhesive label is removable without residue in advantageous embodiments. An adhesive for the adhesive label is suitably selectable by the person skilled in the art, whereby legal regulations are to be observed due to a liquid stored in the dispenser or the like. Preferably, an adhesive is chosen such that a re-adhesion of the adhesive label is not possible. In connection with the application, however, an adhesive label, which is again intended to cover the ventilation opening, is referred to as an irreversibly removable sealing element. In one embodiment, a region of the adhesive label, which is arranged directly in the region of the outlet opening when adhering, has no adhesive.

The adhesive label is arranged on an inner and / or an outer side of the protective cap in the region of the at least one ventilation opening. The adhesive label extends in one embodiment over an area surrounding the ventilation opening (s). In other embodiments, the adhesive label extends over other areas. The adhesive label preferably has a label with usage instructions or the like. In order to allow a good legibility of the label, the adhesive label is preferably sufficiently large dimensions. In one embodiment, the adhesive label is associated with a tamper-evident seal such that the adhesive label is removed upon removal of the tamper-evident seal. Alternatively or additionally, the adhesive label in advantageous embodiments, a tear tab, by means of which a user grips the adhesive label for removal.

In another embodiment, the sealing element is designed as air and germ-proof Folienumhüllung. In one embodiment, the film envelope only covers the protective cap. The film wrapping is thus attachable to the cap before snapping the cap on the dispenser. In other embodiments, the foil wrap covers the protective cap and the dispenser. The film wrapping is formed in one embodiment as a banderole, which is wound around the protective cap or to the protective cap and the dispenser.

In advantageous embodiments, the film wrapping is formed as a closed-end or sleeve-shaped wrap-around label film on one side. As wrap-around label film, in connection with the application, a tubular film is designated into which the protective cap or the dispenser with the protective cap is inserted. After insertion, shrinkage takes place in advantageous embodiments.

Alternatively or in addition to a shrinking, the film wrapping is welded in advantageous embodiments with the protective cap. The weld ensures air and germ impermeability. A weld is arranged separately from a ventilation opening. Therefore, it is harmless if residues remain on the protective cap after a tearing of the film wrapping.

In yet another embodiment, the sealing element is designed as a molded on the protective cap Abziehlasche. The pull tab is an integral part of the protective cap with this produced. Additional assembly or other manufacturing steps can thus be omitted. The pull tab is coupled in one embodiment with a tamper-evident seal, so that a particularly simple handling for a user is given.

After removal of the sealing element, the at least one ventilation opening serves for quick drying. In order to alleviate the problem of germ introduction via this ventilation opening, in one embodiment an antibacterial design of the surfaces is provided, as known from DE 10 201 1 086 755 A1. The content of DE 10 201 1 086 755 A1 is hereby fully incorporated by reference. Alternatively or additionally, an absorber element, in particular an absorber element with filter properties, such as a microfiltration membrane or an ultrafiltration membrane, is provided on an inner side of the protective cap in the region of the at least one ventilation opening. The absorber element helps to dry the dispenser by taking up and distributing the residual drop. In one embodiment, the absorber element additionally has filter properties, in particular a microfiltration membrane or an ultrafiltration membrane is provided. This reduces germination via the vents after removal of the sealing element. As a microfiltration membrane is referred to in connection with the application, a microporous membrane having a mean pore diameter or a separation limit of about 0.1 μηη to about 0.3 μηη, preferably about 0.2μηΊ. Bacteria have a size of about 0.2 to about 5 μηη and can therefore be filtered out efficiently by means of a microfiltration membrane. In the context of the application, the term "ultrafiltration membrane" refers to a microporous membrane which has an average pore diameter or a separation limit of about 10 nm. This also filters out viruses with a size of 15 nm. The absorber element is designed, for example, as a sponge-like element, fabric or membrane. In one embodiment, the absorber element is made of a material from the group comprising polysulfone, polyethersulfone, cellulose, cellulose derivatives, polyvinylidene fluoride, polyamide, polyester, and polyacrylonitrile and / or combinations thereof.

Brief description of the drawings

Other advantages and aspects of the invention will become apparent from the claims and from the following description of preferred embodiments of the invention, which are explained below with reference to the figures. For identical or similar components, the same reference numbers are used in the drawings. Features described or illustrated as part of one embodiment may also be used in another embodiment to obtain a further embodiment of the invention. Show it:

1 shows a dispenser for the discharge of pharmaceutical and / or cosmetic liquids in a sectional view,

FIG. 2 shows a first exemplary embodiment of a protective cap for the dispenser according to FIG. 1; FIG.

3 shows a second embodiment of a protective cap for the dispenser according to FIG. 1; 4 shows a discharge device comprising a dispenser and a protective cap in an overall perspective view,

5 shows the discharge device according to FIG. 4 in a sectional view, FIG.

6 shows an alternative embodiment of a discharge device comprising a dispenser and a protective cap in an overall perspective view,

7 shows the discharge device according to FIG. 6 in a sectional representation, FIG.

Fig. 8 shows another embodiment of a protective cap for the dispenser according to FIGS. 1 and

9 shows an embodiment of a protective cap for the dispenser according to FIG. 1.

Detailed description of the embodiments

FIG. 1 initially shows a dispenser 2 for dispensing pharmaceutical and / or cosmetic liquids, which is particularly suitable for unpreserved ophthalmics.

This dispenser 2 has a liquid reservoir 21 delimited by a container body 20. In the liquid reservoir 21, the liquid 4 is stored. An outlet assembly 22 is placed on the container body 20 and fastened by means of a latching connection. This outlet assembly 22 serves the purpose of passing liquid through an outlet channel 23 from the liquid reservoir 21 to an outlet opening 24. The illustrated outlet opening 24 is designed as a drop formation surface and widens conically in the discharge direction.

In the illustration of FIG. 1, only a last section of the outlet channel 23 is shown due to the sectional plane. In the outlet channel 23, an outlet valve 25 is arranged, which closes the outlet channel 23 in a closed state, so that in the discharge direction downstream of the outlet valve 25 located liquid can not get back into the liquid reservoir 21. The outlet valve 25 shown comprises a valve body 27 which can be adjusted against the force of a restoring spring 26 and which cooperates with a valve seat 28 formed on a housing wall. An inflow of air into the liquid reservoir 21 for pressure equalization takes place via a filter element 29. The filter element 29 comprises in advantageous embodiments a liquid filter pointing towards the liquid reservoir 21 and a liquid reservoir pointing away from the liquid reservoir 21 Bacteria filter with a separation limit of about 0.2μη "ΐ, so that bacteria with a size of about 0.2 to about 5 μηη are safely retained by the bacterial filter.

The illustrated dispenser 2 is designed as a so-called pressure bottle (Engl. Squeeze Bottie). The use of this dispenser 2 takes place in such a way that it is brought into an overhead position with the outlet opening 24 facing downwards. Subsequently, walls of the container body 20 are compressed to pressurize the liquid 4 in the liquid reservoir 21 with a pressure. This pressure causes opening of the exhaust valve 25. More specifically, as soon as the fluid pressure in a portion of the exhaust passage 23 upstream of the exhaust valve 25 is sufficiently high, the valve body 27 is displaced by this pressure against the force of the return spring 26 and provides the path for the liquid in Direction of the outlet opening 24 free.

After a discharge, the outlet valve 25 is closed again. As a rule, a remainder of the liquid, the so-called residual drop, remains at the outlet opening 24 designed as a droplet formation surface and in a partial section of the outlet channel 23 assigned to the outlet opening 24 downstream of the outlet valve 25 in the discharge direction. A backflow into the liquid reservoir 12 is not possible due to the pressure-dependent opening exhaust valve 25.

Without putting on a protective cap, the residual droplet can dry quickly. In order to allow a quick drying even when attached protective cap, have generic protective caps on at least one vent opening.

2 and 3 show a first and a second embodiment of a protective cap 3 for the dispenser 2 according to FIG. 1. The illustrated protective caps 3 each have a plurality of ventilation openings 30 for communicating an interior space 31 with an external environment. The protective caps 3 each comprise a cylindrical portion 32 and a cover portion 33 connected thereto. In the protective cap 3 according to FIG. 2, the ventilation openings 30 are provided on the cylindrical portion 32. In the protective cap 3 according to FIG. 3, the ventilation openings 30 are provided on the lid section 33. The number of ventilation openings 30 can be suitably selected by the person skilled in the art. In preferred embodiments, the protective caps 3 according to FIGS. 2 and 3 each have four evenly distributed ventilation openings 30. The protective caps 3 are each manufactured as an injection molded part and have a tamper-evident seal 34 which is to be removed when used for the first time. On an inner wall locking elements 35 are also provided for locking with the dispenser 2 shown in FIG. The locking elements 35 are such designed to prevent removal of the protective cap 3 and / or removal of the outlet assembly 22 from the container body 20 without removing the tamper evident seal 34. The protective cap 3 is also designed such that a repeated removal and clamping of the protective cap 3 on the dispenser 2 is possible. For this purpose, the protective cap 3 is slightly deformed when placed, so that the elastic restoring forces of a protective cap 3 made of plastic produce a clamping action. In other embodiments locking elements are provided for this purpose.

According to the application, an irreversibly removable sealing element which covers the ventilation openings is arranged on the protective cap 3, by means of which the ventilation openings 30 are sealed in an airtight and germ-proof manner before being used for the first time. In other words, a germ introduction into an interior 31 of the protective cap 3 is prevented by the sealing element via the ventilation openings 30 before a first use.

In the embodiments according to FIGS. 2 and 3, the sealing element is designed as an air-tight and germ-proof foil sheath 5.

The film envelope 5 according to FIG. 2 is designed as a sleeve-shaped wrap-around label film, which is provided on the cylindrical section 32 in the region of the ventilation openings 30. The film envelope 5 shown is welded in at the edge regions 50 with the protective cap 3. The film wrapping 5 preferably has a tab, not shown, or the like, which can be taken to remove the film wrapping 5.

The film wrapping 5 according to FIG. 3 is designed as a closed wrap-around label film and essentially covers the entire protective cap 3. The film envelope 5 shown is connected to the tamper-evident seal 34, for example, welded or glued and thus removable therewith.

Figures 4 to 7 show two embodiments of a discharge device 1 comprising a dispenser 2 according to FIG. 1 and a protective cap 3 in a perspective overall view (Figures 4 and 6) and a sectional view (Figures 5 and 7). For a description of the dispenser 2, see above. The protective cap 3 according to FIGS. 4 to 7 also essentially corresponds to the protective cap 3 according to FIGS. 2 and 3, and identical reference symbols are used for identical or similar components.

FIG. 8 shows a protective cap 2 similar to FIG. 3 with ventilation openings 30 provided on the lid section 33. In the embodiments according to FIGS. 4 to 8, the sealing element is designed as an air-tight and germ-proof adhesive label 6.

The adhesive label 6 is arranged according to the embodiments of Figures 4 to 7 on an outer side of the protective cap 3 in the region of the ventilation openings 30. In the embodiment according to FIG. 8, the adhesive label 6 is arranged on an inner side of the protective cap 3 in the region of the ventilation openings 30.

In the protective cap 3 according to FIGS. 4 and 5, the ventilation openings 30 are provided in the lid section 33 and the strip-shaped adhesive label 6 extends from an area surrounding the ventilation openings 30 in the lid section 33 over a region extending parallel to the longitudinal axis of the protective cap 3 up to the area Tamper-evident seal 34. The adhesive label 6 according to FIGS. 4 and 5 is thus dimensioned sufficiently large to permit a label with not shown usage instructions or the like. The adhesive label 6 is further connected to the tamper-evident seal 34, so that the adhesive label 6 can be released upon removal of the tamper-evident seal and thus easily removed by a user. In addition, the adhesive label 6 has a tear tab 60, by means of which a user can take the adhesive label 6 for removal.

In the protective cap 3 according to FIGS. 6 and 7, the ventilation openings 30 are likewise provided in the lid section 33. The strip-shaped adhesive label 6, however, extends only over an area surrounding the ventilation openings 30 in the lid portion 33 and not to the tamper-evident seal 34. To remove the adhesive label 6, a tear-open tab 60 is provided. The lid surface 33 has a recess 330, by which a simple gripping the tear tab 60 is ensured.

Also in the protective cap 3 according to Figure 8, the ventilation openings 30 are provided in the lid portion 33. The strip-shaped adhesive label 6 is attached to an inside of the lid portion 33 and has a tear tab 60 for removal. It is ensured due to the complex handling that a user after removing the adhesive label 6 this does not reinstall on the inside. In advantageous embodiments, the adhesive label 6 is attached in such a way that when the protective cap 3 is removed for initial use it is automatically removed, ie without additional measures by the user, or at least detached completely. 9 shows a protective cap 2 similar to FIGS. 3 and 8 with ventilation openings 30 provided on the lid section 33, wherein the sealing element is designed as a pull-tab 7 molded onto the protective cap 3. The protective cap 3 and the pull tab 7 can be produced as a common component, in particular as an injection-molded part. In a predetermined breaking region between the pull tab 7 and the protective cap 3, predetermined breaking points in the form of material weakenings or the like are preferably provided. The pull-tab 7 shown here has a protruding end to be gripped by the user. In another embodiment, the pull-tab 7 is coupled to the tamper-evident seal 34 so that removal of the tamper-evident seal causes removal of the pull tab. As a result, a particularly simple handling for a user is given.

After removal of the sealing element 5, 6, 7, the ventilation openings assist in quick drying. In addition, as shown by way of example in FIGS. 4 to 7, in one embodiment, an absorber element 8, which assists rapid drying of the dispenser 2 by removal of the liquid, is provided on an inner side of the protective cap 3 in the region of the ventilation openings. The absorber element 8 has hydrophilic properties. The residual drop is absorbed by the absorber element and distributed, so that a quick drying is guaranteed. The absorber element 8 is arranged in the illustrated embodiment, parallel to the cover portion 33, the ventilation openings 30 covering. For attachment of the absorber element 8 33 locking arms 37 are provided in the illustrated embodiment on the cap 3 on an inner side of the lid portion. As can be seen in FIGS. 5 and 7, the absorber element 8 contacts a tip of the dispenser 2 assigned to the outlet opening 24 in the latched state of the protective cap 3.

After removal of the sealing element 5, 6, 7, a generally tolerable germ introduction via the ventilation openings 30 is conceivable. In order to mitigate the problem of germ introduction via this ventilation opening 30 in critical applications, the absorber element 8 is designed in one embodiment as a microfiltration membrane. The microfiltration membrane has a separation limit of about 0.2μηΊ, so that bacteria with a size of about 0.2 to about 5 μηη be safely retained. Alternatively or additionally, in one embodiment, an antibacterial design of the surfaces on which residual drops collect downstream of the outlet valve 25 is provided.

Claims

claims

1 . Protective cap for a dispenser (2) for dispensing pharmaceutical and / or cosmetic liquids (4), the dispenser (2)

a liquid reservoir (21),

- An outlet opening (24) through which the liquid (4) can be discharged into a surrounding atmosphere, and

has, and

the protective cap (3) having at least one ventilation opening (30) for communicating an interior space with an external environment, characterized in that

on the cap an irreversibly removable, the at least one vent opening covering the sealing element (5, 6, 7) is arranged, through which the at least one ventilation opening is closed air and germ-tight before first use.

2. Protection cap according to claim 1, characterized in that the protective cap (3) comprises a cylindrical portion (32) and an associated cover portion (33), wherein the at least one ventilation opening (30) on the cylindrical portion (32) and / is provided on the lid portion (33).

3. Protection cap according to claim 1 or 2, characterized in that the sealing element is designed as a peelable, air and germ-proof adhesive label (6).

4. A protective cap according to claim 3, characterized in that the adhesive label (6) with a tamper-evident seal (34) is connected to release the adhesive label (6) upon removal of the tamper-evident seal (34), and / or the adhesive label (6) Tear tab (60).

5. Protective cap according to claim 1 or 2, characterized in that the sealing element is designed as an air-tight and germ-proof film wrapping (5).

6. Protective cap according to claim 5, characterized in that the film envelope (5) is designed as a closed-end or sleeve-shaped wrap-around label film on one side.

7. Protective cap according to claim 5 or 6, characterized in that the film envelope (5) is welded to the protective cap.

8. Protection cap according to claim 1 or 2, characterized in that the sealing element is formed as molded on the protective cap Abziehlasche (7).

9. Protective cap according to one of claims 1 to 8, characterized in that on an inner side of the protective cap (3) in the region of the at least one ventilation opening an absorber element (8), in particular an absorber element (8) with filter properties, such as a microfiltration membrane or an ultrafiltration membrane , is provided.

10. Discharge device comprising a dispenser (2) for the discharge of pharmaceutical and / or cosmetic liquids (4) with

- A liquid reservoir (21) and

a protective cap (3) according to any one of claims 1 to 9, comprising at least one ventilation opening (30) for communicating an interior with an external environment, wherein on the protective cap (3) an irreversibly removable, the at least one ventilation opening (30) covering the sealing element (5, 6, 7) is arranged, through which the at least one ventilation opening (30) before a first use is sealed air and germ-tight.

1 1. Discharge device according to claim 10, characterized in that the dispenser an outlet channel (23) which connects the liquid reservoir (21) with the outlet opening (24), and a pressure-dependent opening or manually operable outlet valve (26) arranged in the outlet channel (22) is and which in a closed state, the exhaust passage (23) closes.