WO2008049443A1

WO2008049443A1 - Container system for lyophilized active substances

Info

Publication number: WO2008049443A1
Application number: PCT/EP2006/010249
Authority: WO
Inventors: Patrice Aubert; Hervé LAUGERI; Guillaume Valenzuela; Caspar F. V. STÜRM; Volker Rosenberger
Original assignee: Cadorit Ag
Priority date: 2006-10-24
Filing date: 2006-10-24
Publication date: 2008-05-02

Abstract

The container system for active substances in the shape of a powder or a lyophilisate consists of a glass container for the substance and a plastic container for a solvent. A sleeve with an internal thread engages in a thread of a counterpart. By interaction of the thread arrangement a closure cap is displaced which in a first axial position seals and in a second axial position releases the opening of the glass container and establishes a connection between the two interior spaces.

Description

Container System for Lyophilized Active Substances .

The invention relates to a container system for active substances in the shape of a powder or a lyophilisate with a first container for the lyophilisate or powder and a second container connected therewith for a solvent, whereby the interior space of the two containers are separated from one another by a sealing element and are connected with one another prior to use for transferring the solvent to the lyophilisate or powder and prepare a fresh product.

In a known two chamber system having this function the lyophilisate is located in a glass container which is sealed by a membrane or a partially thin-walled stopper and is thus essentially protected. The solvent is contained in a separate plastic container provided with a dripper (stiligoutte) . For the preparation of the ready-for-use product the membrane or the stopper is perforated by the dripper and the solvent is filled into the glass container. After the lyophilisate is dissolved the product is transferred back into the solvent container for final use.

As the membrane or the stopper in this known system have to be very thin where the perforation takes place there is a risk that products with holes are manufactured. It is a further disadvantage of this known system that the membrane is very sensitive to great temperature and pressure variations like those occurring e.g. in airplanes. This may result in leakage or in the entrance of humidity into the lyophilisate chamber which may cause the lyophilisate to shrink or get brittle. Moreover, the activity of substances sensitive to humidity, like e.g. vitamins, decreases. A further disadvantage is the fact that during transfer of the solvent through the perforated membrane and the ready-to-use product back inaesthetic and unhygienic residues of the product remain at the dripper. The handling of the known system comprises six steps and is therefore also not optimal. After the transfer the ready-to-use product is contained in the plastic container, which means that the as such more valuable glass container is not used any more.

It is the object of the invention to provide a container system which is eliminating the disadvantages of the known system.

According to the invention this is achieved by a container system of the type mentioned at the outset, which is characterized by a sleeve with an internal thread which engages in a thread at the glass container, a closure cap guided in the sleeve, the closure cap in a first axial position sealing the opening of the glass container and in a second axial position releasing the opening, thereby establishing a connection between the two interior spaces.

In the following a preferred embodiment of the invention is described making reference to the accompanying drawings. It is shown in

Fig. 1 a sectional view of a container system with the closure cap closed

Fig . 2 a respective view with the closure cap open

Fig . 3 an explosion view of the individual parts of the container system

Fig . 4 a sectional view of an alternative embodiment of the container system with the closure cap closed

Fig . 5 a respective view of the alternative embodiment with the closure cap open

Fig . 6 an explosion view of the alternative embodiment. A glass container 1 serves to receive an active substance in the shape of a cake of lyophilisate 2. The active substance could as well be in another shape such as a powder, a powder mixture etc. The glass container has a narrowed intermediate part 3 provided with an external thread 4 and a further narrowed neck 5 with an annular groove 6 surrounding the neck for receiving a sealing ring 7.

The intermediate part 3 and the neck 5 of the glass container are surrounded by a sleeve 8 which at its lower end is provided with an internal thread 9 which engages with the thread 4 of the glass container and by turning changes its axial position relative to the glass container.

At its upper end the sleeve has an outer annular groove 10 followed by a surrounding flange 11. The groove and the flange serve the mechanical connection with a plastic container 12 arranged on top of it and containing a solvent.

Internally the sleeve has a cylindrical skirt 13 which is long enough to contact the sealing ring in every axial position. On top of the skirt 13 the inner surface of the sleeve is provided with several projections 14 distributed over the circumference and extending towards the interior.

The sleeve with its upper part encloses a sealing stopper 15 which consists of a narrower lower part 16 and a wider upper part 17. With its lower part the stopper fits into the neck of the glass container. The upper part of the stopper is provided with a circumferential annular groove 18 in which the projections 14 of the sleeve extend.

By the engagement of the projections 14 with the groove 18 the stopper 15 is fixed to the sleeve such that it follows the axial movement of the sleeve. This can be seen in the two states shown in Fig. 1 and 2. In Fig. 1 the sleeve is shown in its lower position. The sealing stopper 15 is placed in the neck of the glass container and seals it hermetically. In the state shown in Fig. 2 the sleeve by turning has moved into its upper position and has taken the stopper with it, i.e. withdrawn it from the neck of the glass container. Thereby a connection has been opened between the interior of the glass container to that of the plastic container 12.

The plastic container 12 has at its lower rim a surrounding collar 19 with an annular bulge 20 extending towards the interior, the bulge enclosing the flange of the sleeve and engaging with its groove 10. In addition the plastic container 12 is provided with a sealing edge 21 which is in contact with the outside of the upper end of the sleeve to guarantee the tightness to the exterior. The plastic container 12 has on its upper side a dripper 22 of the kind known as such and is covered by a decoration and protection cap 23.

The glass container holds either a lyophilisate, which contains active substances, like e.g. vitamins, and stabilizers, like e.g. monosaccharide, disaccharides and polyoles, or a powder consisting of one or more active substances, or a powder mixture consisting of one or more active substances as well as stabilizers like e.g. polysaccharides .

The plastic container holds a low-viscous liquid, which may be aqueous or an emulsion of the type nanoemulsion, microemulsion, oil in water, and water in oil, multiple emulsion of the type water-oil-water or oil-water-oil, or a gel. Water, active substances, thickening agents, oil, emulgators, preservation agents, UV filters, fragrances etc. may be contained. When by turning of the sleeve relative to the glass container the stopper is removed from the neck of the glass container, the liquid contained in the plastic bottle can reach and dissolve the powder, powder mixture or lyophilisate. In this way a cosmetic ready-to-use product is freshly prepared.

In the system according to the invention lyophilisate which are sensitive to humidity, like e.g. vitamins, can be used in cosmetic ready-to-use products without any loss of quality even under extreme climatic conditions. The useful amount of ready-to-use product is in the range of 1 and 50 ml, preferably between 2 and 8 ml.

In the alternative embodiment shown in Fig. 4 - 6 the height of the glass container 31 is reduced in that it has no threaded neck portion but a neck 32 which is reduced in two steps defining a first annular groove 34 surrounding the wider neck portion 33 and a second annular groove 36 surrounding the narrower neck portion 35. A stopper 52 has a narrower lower portion 53 fitting into the neck of the glass container and a wider upper portion 54 with a circumferential annular groove 55.

The wider neck portion 33 is surrounded by the lower end of a first cylindrical sleeve 37 which at its lower edge is provided with an inwardly protruding flange 38 which engages with the first annular groove 34, thereby fixing the axial position of the first cylindrical sleeve relative to the glass container. The upper portion 39 of the first cylindrical sleeve 37 features a reduced diameter to fit into a downwardly directed skirt portion 41 of a plastic bottle 40 arranged on top of the first cylindrical sleeve. The plastic bottle and the first cylindrical sleeve are fixedly connected to each other, such as by welding. The first cylindrical sleeve 37 is closed at its upper end by a cover plate 42 which has a central threaded opening 43 arranged coaxial with the containers and a second opening 44 radially displaced from the threaded opening 43.

A second cylindrical sleeve 45 is arranged coaxially inside the first cylindrical sleeve 37. At its lower edge the second cylindrical sleeve 45 is provided with flange-like projection 46 engaging the second annular groove 36 surrounding the narrower neck portion 35, thereby fixing the annular position of the second cylindrical sleeve relative to the glass container. A further inwardly directed flange 47 is arranged at a distance above the lower end, this distance corresponding to the height of the narrower neck portion of the glass container. A flat sealing ring is located between the further flange and the upper edge of the glass container.

Towards the upper portion of its outer surface the second cylindrical sleeve 45 is provided with two outwardly directed flanges 48, 49 defining an annular groove 50 between them. An O-ring seal 51 is arranged in this annular groove, sealing the outside of the second cylindrical sleeve 45 against the inside of the first cylindrical sleeve 37.

Furthermore, the inner surface of second cylindrical sleeve 45 is provided with axially extending ribs 59, the function of which will be evident from as follows.

The second cylindrical sleeve houses a gripping member 56 with three claws 57 engaging in the annular groove 55 of the stopper 52. In radial direction the claws 57 extend to the inner surface of second cylindrical sleeve 45. The upper portion of gripping member 56 is a threaded rod 58 guided in the threaded opening 43 of the cover plate 42 of the first cylindrical sleeve 37. The remainder of the plastic container is identical to the first embodiment.

By turning the first cylindrical sleeve relative to the glass container the interaction of the threaded opening 43 and rod 58 is causing the gripping member 56 to be displaced in axial direction away from the glass container. Rotation of the gripping member is prevented by the ribs 59 blocking the claws from rotational movement. The claws 57 of the gripping member 56 are removing the stopper from its seat in the neck of the glass container thereby opening a connection between the glass container 31 and the plastic bottle 40. Liquid contained in the plastic bottle can pass through the second opening 44 in the cover plate and by the stopper into the glass container to dissolve the active substance preserved therein.

Claims

1. Container system for active substances in the shape of a powder or a lyophilisate with a glass container for the lyophilisate or powder and a plastic container connected therewith for a solvent, whereby the interior space of the two containers are separated from one another by a sealing element and are connected with one another prior to use for transferring the solvent to the lyophilisate or powder and prepare a fresh product, characterized by a sleeve with an internal thread which engages in a threaded counterpart and by rotation causes a relative axial displacement between the sleeve and the counterpart, a closure cap which in a first axial position seals the opening of the glass container and by the said relative axial displacement is brought in a second axial position releasing the opening, thereby establishing a connection between the two interior spaces.

2. Container system according to claim 1, characterized in that the threaded counterpart is a threaded rod of a gripping member located inside the sleeve and being connected to the closure cap for removing it from the opening of the glass container.

3. Container system according to claim 1, characterized in that the threaded counterpart is a threaded portion on the outside of the neck portion of the glass container, causing axial displacement of the sleeve upon rotation.