EP3082707B1 - Protective cap for a dispenser, and dispenser for discharging pharmaceutical and/or cosmetic liquids - Google Patents

Description

The invention relates to a discharge device for the discharge of pharmaceutical and / or cosmetic liquids. Such a device is out WO2013140069 and 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 DE 10 2011 086 755 A1 known. The dispenser comprises an outlet channel connecting the liquid reservoir to the outlet opening 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 allow a quick drying of the residual liquid even when placing a protective cap on the dispenser, it is off DE 10 2011 086 755 A1 It is known to provide the protective cap of the dispenser with ventilation openings which create a permanent connection between the area where a residual liquid can remain and an external environment. The vents, however, may in turn cause contamination.

According to DE 10 2011 086 755 A1 is provided to prevent contamination, that surfaces of the outlet channel downstream of the exhaust valve, as viewed in the discharge direction, and / or an outer surface of the outlet opening surrounding housing are made antibacterial, the antibacterial training is limited exclusively to these surfaces.

Task and solution

The object of the invention is to provide a discharge device which allows rapid drying and in which the problem of microorganisms entering the protective cap is alleviated.
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 of the disclosure, 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 the protective cap has at least one ventilation opening for communicating an interior space with an external environment, and a sterile filter covering the at least one ventilation opening is arranged on the protective cap in order to reduce or prevent germination via the at least one ventilation opening into the interior of the protective cap.

According to a second aspect of the disclosure, 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 which is at least a ventilation opening for communicating an interior with an external environment wherein a sterile filter covering the at least one ventilation opening is arranged on the protective cap in order to reduce or prevent germ introduction via the at least one ventilation opening into the interior of the protective cap.

Through the sterile filter, germ introduction into an interior of the protective cap via the at least one ventilation opening is prevented or at least reduced. As germs or microorganisms in the context of the present invention, all microbial pathogens, especially bacteria and viruses, understood.

The dispenser is particularly suitable for unpreserved ophthalmics. In advantageous embodiments, the dispenser comprises an outlet channel which connects the liquid reservoir to the outlet opening, and a pressure-dependent opening or manually operable outlet valve which is arranged in the outlet channel and which 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 taken from it 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 causes a rapid drying of this residual liquid.

The sterile filter preferably has an average pore diameter or a separation limit of at most about 0.1 .mu.m to about 0.3 .mu.m, preferably at most about 0.2 .mu.m. The separation limit describes the size at which particles are retained by the sterile filter. The sterile filter is preferably designed as a membrane filter. A membrane filter with a separation limit between about 0.1 .mu.m to about 0.3 .mu.m is also referred to as microfiltration membrane. Bacteria have a size of about 0.2 to about 5 microns and can be filtered out efficiently by means of a microfiltration membrane. Depending on the application, stricter requirements may also be imposed on the sterile filter. In particular, sterilization filters having an average pore diameter or a separation limit of approximately 10 nm are provided in one embodiment. Such membrane filters are also referred to as ultrafiltration membrane. With an ultrafiltration membrane also viruses with a size of 15 nm can be filtered out. In one embodiment, the sterile filter is fabricated from a polymer or from an inorganic material, for example a ceramic. In advantageous embodiments, the sterile filter is formed as a microporous polymer membrane from a membrane polymer from the group comprising polysulfone, polyethersulfone, cellulose, cellulose derivatives, polyvinylidene fluoride, polyamide, polyester, and polyacrylonitrile and / or combinations thereof.

Preferably, the sterile filter also serves as an absorber surface, whereby liquid is transported away from the outlet opening via the sterile filter and the sterile filter thus advantageously assists in rapid drying of the dispenser. The sterile filter is designed for this purpose as a hydrophilic polymer membrane. The design of the protective cap with an absorber surface contacting the outlet opening is also advantageous in embodiments without a sterile filter. In one embodiment, two membranes are provided, which act as a sterile filter or absorber surface. In yet other embodiments, a multilayer membrane is provided in the protective cap, wherein a first layer facing the outlet opening of the dispenser has absorbent properties and a second layer facing the ventilation opening has filter properties.

The sterile filter is designed in one embodiment as an insert, which is connected to the protective cap by molding. In other embodiments, the sterile filter is locked with a wall of the protective cap.

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 lid portion. In one embodiment, radially inwardly directed latching projections or a circumferential latching projection are provided on an inner wall of the cylindrical portion, through which (n) the sterile filter is received. In advantageous embodiments, protruding latching arms for fastening the sterile filter are provided by an inner side of the lid section. Such locking arms allow reliable, error-free installation.

In advantageous embodiments of the sterile filter is made of a material which has a sufficient mechanical strength, so that the sterile filter can be engaged in the latching arms or locking projections. In other embodiments, the sterile filter is applied to a carrier layer. In one embodiment, the carrier layer has material properties deviating from the sterile filter. Preferably, a gas-permeable, hydrophilic carrier layer is provided, so that the carrier layer is a drying of the dispenser also supported. The carrier layer and the sterile filter are preferably fixed, in particular materially connected to one another, for example adhesively bonded or welded. In one embodiment, the sterile filter is vapor-deposited or sputtered onto the carrier layer.

The sterile filter is preferably arranged such that in use it contacts an outlet opening of the dispenser, wherein in particular the protective cap has a stop which forces the sterile filter into contact with the outlet opening during use. As a result, an advantageous use of the sterile filter as an absorber is possible.

Brief description of the drawings

Fig. 1

einen Spender zum Austrag von pharmazeutischen und/oder kosmetischen Flüssigkeiten in einer Schnittdarstellung,

Fig. 2

die Auslassbaugruppe gemäß Fig. 1 mit einer Schutzkappe gemäß einem ersten Ausführungsbeispiel;

Fig. 3

eine Austragvorrichtung umfassend einen Spender und eine Schutzkappe in einer perspektivischen Gesamtdarstellung,

Fig. 4

die Austragvorrichtung gemäß Fig. 3 in einer Schnittdarstellung,

Fig. 5

eine alternative Ausgestaltung einer Austragvorrichtung umfassend einen Spender und eine Schutzkappe in einer perspektivischen Gesamtdarstellung und

Fig. 6

die Austragvorrichtung gemäß Fig. 6 in einer Schnittdarstellung.

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:

Fig. 1

a dispenser for dispensing pharmaceutical and / or cosmetic liquids in a sectional view,

Fig. 2

the outlet assembly according to Fig. 1 with a protective cap according to a first embodiment;

Fig. 3

a discharge device comprising a dispenser and a protective cap in a perspective overall view,

Fig. 4

the discharge according to Fig. 3 in a sectional view,

Fig. 5

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

Fig. 6

the discharge according to Fig. 6 in a sectional view.

Detailed description of the embodiments

FIG. 1 first shows a dispenser 2 for the discharge of pharmaceutical and / or cosmetic liquids, which is particularly suitable for unpreserved ophthalmic.

This dispenser 2 has a liquid reservoir 21 delimited by a container body 20. The liquid 4 is stored in the liquid reservoir 21. 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 presentation of the Fig. 1 is only a final portion 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 via a filter element 29. The filter element 29 comprises in advantageous embodiments, a pointing to the liquid reservoir 21 and a liquid-side facing away from the liquid reservoir 21 bacterial filter with a separation limit of about 0.2 .mu.m so that bacteria with a size of about 0.2 to about 5 microns are safely retained by the bacteria filter.

The illustrated dispenser 2 is designed as a so-called squeeze bottle. 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.

The Fig. 2 shows the outlet assembly 22 with a protective cap 3 placed thereon. The illustrated protective cap 3 has a plurality of ventilation openings 30 for communicating an interior space 31 with an external environment. The protective cap 3 comprises a substantially cylindrical portion 32 and a cover portion 33 connected thereto. In the protective cap 3 according to FIG Fig. 2 the ventilation openings 30 are provided on the lid portion 33. The number of ventilation openings 30 can be suitably selected by the person skilled in the art. In the embodiment according to Fig. 2 the protective cap 3 has three uniformly distributed ventilation openings 30, of which in Fig. 1 only one is visible. The protective cap 3 is manufactured as an injection-molded part and has a tamper-evident seal 34 which is to be removed when it is used for the first time. On an inner wall locking elements 35 for locking with the dispenser 2 according to Fig. 1 intended. The locking elements 35 are designed such that they prevent removal of the protective cap 3 and / or removal of the outlet assembly 22 of 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, the protective cap 3 has a sterile filter 5 covering the ventilation openings 30, by means of which germ introduction into an interior 31 of the protective cap 3 via the ventilation openings 30 is prevented or at least reduced. The sterile filter 5 has a separation limit of a maximum of 0.2 .mu.m, so that bacteria with a size of about 0.2 to about 5 microns are securely retained.

The sterile filter 5 is arranged in the illustrated embodiment parallel to the lid portion 33 of the protective cap 3 on an inner side of the lid portion 33, the ventilation openings 30 covering. For attachment of the sterile filter 5 33 locking arms 37 are provided in the illustrated embodiment on the cap 3 on the inside of the lid portion. The latching arms 37 protrude in the longitudinal direction of the protective cap 3 from the lid portion 33. For attaching the sterile filter 5, the latching arms 37 are elastically deformed.

As in FIG. 2 a material of the sterile filter 5 is selected such that the sterile filter 5 as absorber surface for a rapid distribution of the in the region of the outlet opening 24th remaining residual drop and thus a quick drying is available. In one embodiment, the sterile filter 5 is designed for this purpose as a hydrophilic polymer membrane of a membrane polymer from the group comprising polysulfone, polyethersulfone, cellulose, cellulose derivatives, polyvinylidene fluoride, polyamide, polyester, and polyacrylonitrile and / or combinations thereof. The illustrated sterile filter 5 is made of a material which has a sufficient rigidity, so that the sterile filter 5 can be engaged in the latching arms 37.

The FIGS. 3 and 4 show a discharge device 1 comprising a dispenser 2 according to Fig. 1 and a protective cap 3 similar Fig. 2 in a perspective overall view or a sectional view. For a description of the dispenser 2, see above. The protective cap 3 according to 3 and 4 also essentially corresponds to the protective cap 3 according to Fig. 2 and for the same or similar components, the same reference numerals are used.

Unlike the embodiment according to Fig. 2 is the sterile filter 5 according to 3 and 4 attached to a carrier layer 50. A material of the carrier layer 50 is chosen such that the carrier layer 50 gives the associated sterile filter 5 a higher mechanical strength. The carrier layer 50 is also made in advantageous embodiments of a hydrophilic material, so that a sufficient moisture release over the carrier layer 50 is ensured to the environment. In the illustrated embodiment, the carrier layer 50 is disposed on an outer side of the sterile filter 5 facing the environment. In other embodiments, the carrier layer 50 is arranged on an inner side 31 of the protective cap 3 facing inside of the sterile filter 5.

The FIGS. 5 and 6 show a discharge device 1 comprising a dispenser 2 according to Fig. 1 and a further embodiment of a protective cap 3 similar Fig. 2 in a perspective overall view or a sectional view. For a description of the dispenser 2, see above. The protective cap 3 according to FIGS. 5 and 6 also essentially corresponds to the protective cap 3 according to Fig. 2 and for the same or similar components, the same reference numerals are used.

Unlike the embodiment according to Fig. 2 the protective cap 3 has four ventilation openings 30.

As described above, it is provided in advantageous embodiments that the sterile filter 5 in the attached state of the protective cap 3 touches a tip of the dispenser 2 assigned to the outlet opening 24. In order to force the sterile filter 5 in contact with the tip, the protective cap 3 according to the FIGS. 5 and 6 a protruding from the inside of the lid portion 33 stop 38. By attaching the sterile filter 5 by means of the latching arms 37 and the stop 38, a free surface of the sterile filter 5 is maximized. As a result, an absorber effect and a drying of the dispenser by means of the sterile filter 5 is optimized.

In order to reduce a microbial entry and thus a load on the membrane in the case of long-term storage, storage in a germ-rich environment and / or prior to first use, it is provided in one embodiment that an additional overcap (not shown) is attached over the protective cap 3. For a fastening of this cap, not shown, the cap 3 according to the FIGS. 5 and 6 Receiving openings 39.

Claims (10)

1. Discharging device, comprising

   - a dispenser (2) for discharging pharmaceutical and/or cosmetic liquids (4), having

   - a liquid reservoir (21) and

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

   - a protective cap (3) for repeatedly removing the protective cap (3) from the dispenser (2) and placing it thereon, which protective cap has at least one ventilation opening (30) in order for an interior to communicate with exterior surroundings,

   characterized in that
   the protective cap (3) has arranged on it a sterile filter (5), which covers the at least one ventilation opening (30) so as to reduce, or to prevent, the introduction of germs into the interior of the protective cap (3) via the at least one ventilation opening (30).
2. Discharging device according to Claim 1, characterized in that the sterile filter (5) has an average pore diameter or a cutoff of at most approximately 0.1 µm to approximately 0.3 µm, preferably at most approximately 0.2 µm.
3. Discharging device according to Claim 2, characterized in that the sterile filter (5) is designed in the form of a microporous polymer membrane, preferably in the form of a microporous hydrophilic polymer membrane, made of a membrane polymer from the group comprising polysulfone, polyethersulfone, cellulose, cellulose derivatives, polyvinylidene fluoride, polyamide, polyester and polyacrylonitrile and/or combinations thereof.
4. Discharging device according to one of Claims 1, 2 and 3, characterized in that the sterile filter (5) is latched to a wall of the protective cap (3) .
5. Discharging device according to one of Claims 1 to 4, characterized in that the protective cap (3) comprises a cylindrical portion (32) and a cover portion (33) connected thereto, wherein the at least one ventilation opening (30) is provided on the cover portion (33).
6. Discharging device according to Claim 5, characterized in that latching arms (37), which project from an inner side of the cover portion, are provided for fastening the sterile filter (5).
7. Discharging device according to one of Claims 1 to 6, characterized in that the sterile filter (5) is applied to a carrier layer (50).
8. Discharging device according to Claim 7, characterized in that a gas-permeable, hydrophilic carrier layer (50) is provided.
9. Discharging device according to one of Claims 1 to 8, characterized in that the sterile filter (5) is arranged such that, during use, it is in contact with an exit opening (24) of the dispenser (2), wherein in particular the protective cap (3) has a stop (38), which forces the sterile filter (5) into contact with the exit opening (24) during use.
10. Discharging device according to one of the preceding claims, wherein the dispenser (2) has an outlet channel (23), which connects the liquid reservoir (21) to the exit opening (24), and an outlet valve (25), which opens in a pressure-dependent manner or is manually actuable, is arranged in the outlet channel (23) and, in a closed state, closes the outlet channel (23).

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