Protective enclosure to protect fragile vessels

The present invention concerns a protective enclosure for protecting vessels for liquids, particularly liquid medicaments, against breakage.

The accommodation of a liquid medicament in a vessel (e.g. a bottle, phial or ampoule) is known. Such vessels typically consist of a medicament glass, which is brittle by its very nature. This means that the vessel can break very easily if it is dropped. This may lead to contamination of individuals, working areas and equipment. This problem is exacerbated by the possibility that the medicament may be toxic (e.g. cytostatica) and its spillage may constitute a health hazard. In particular, glass vessels containing pharmaceutical products for injection or infusion and especially toxic substances, such as e.g. cytostatica, must be protected from breakage during carriage or use. At the same time, possible contamination of the user by residues of the substance, which may be present on the surface of the glass vessel, must be prevented.

The corresponding vessels made from a fragile material are usually accommodated in a protective enclosure for the aforementioned reasons.

For example, US 1,063,351 describes a protective casing for glass bottles. The protective casing consists of sheet metal or wood and has a plurality of internal

concavities formed so that they hold or support the bottle accommodated. These internal concavities are present in the cover, side walls and base of the protective casing.

US 2,575,283 describes a jacket for accommodating ajar inside, which jar may contain cosmetic preparations such as salves, but also pharmaceutical compositions such as powders, liquids and pastes. The inner jar is a vessel with a screw cap having a flexible flange at its lower extremity which can be screwed on to the internal thread of the jacket and which is held by screwing on an outer cap with an external thread into the final convolution of the internal thread of the j acket. The j acket disclosed in US patent 2,575,283 is not configured as a protective enclosure, but primarily serves as a high-quality permanent container for an inner one-way jar, i.e. the jacket serves primarily as packaging offering scope for design.

EP 0 303 781 describes a safety container characterised in that the open end is located at the bottom of the container and an aperture with a frangible sealing means is located at the opposite end of the container, whereby, if the glass vial is inserted in the container and the annular base (i.e. the base of the container) is snapped into the container, the vial or ampoule is protected from breakage or crushing, but the content of the vial is accessible by removing said frangible sealing means and inserting a syringe through the aperture and a stopper disposed in the top of the vial. This secure safety container thus has a base and a hollow, generally cylindrical body which snap together to hold the vial securely within. A plurality of spaced ribs or webs are disposed longitudinally along the inner surface of the container. They act as spacers and create, or act as, an air cushion around the side of the vial. The base has a floor having a raised centre area on which the bottom of the vial rests, and thus also a surrounding annular air cushion. The upper wall of the body has a central depression in which an aperture is disposed which is closed by a frangible sealing means. The depression produces an annular air cushion formed around the top of the vial.

EP 1 412 253 describes a further development of the above-mentioned protective container. The protective container is characterised in that, in addition to the characteristics stated in EP 0 303 781, it has wing-shaped outer surfaces at the top and bottom of the container so that impact energy will be absorbed by these side walls if the protective container lands sideways on these side walls if it falls on a flat surface (e.g. a floor).

US 4,245,685 describes a protective carrier for fragile containers. Said protective carrier has a generally cylindrical body, closed at the bottom and open at the top, whereby the open end can be closed by a snap-fitting lid. Ribs extend axially at intervals across the inside surface of the cylindrical body and are continued across the bottom, meeting in its centre. The ribs are primarily intended to create a type of air cushion for the fragile internal container.

The protective enclosure described in US 6,793,076 is characterised in that sensors are located in the base of the generally cylindrically- formed body, which can display the escape of the content, e.g. a liquid, toxic medicament by a visible or acoustic signal, following breakage of the internal container. A water-soluble substance, e.g. a dye tablet or capsule, which produces a visible colour on contact with the liquid escaping from the internal container, may be used as a sensor for a visible signal. In order to render this colour signal visible externally, a protective carrier is described in a preferred embodiment, the body of which consists of a transparent material such as polycarbonate.

WO 2006/066736 describes a drug or a chemical composition packaged in an interior packaging and an exterior packaging. According to the invention, the interior packaging is contained in an exterior packaging which is at least partially transparent, whereby blister packs, phials, ampoules, tubes and the like may be used

- A -

as interior packaging. In particular, plastics, cellophane, PVC without fillers, polystyrene, polymethylmethacrylate (PMMA) or polycarbonate may be used as materials for the exterior packaging. A bottle may also be used as interior packaging, which is particularly suitable for liquid dosage forms of medicaments or chemical compositions. The packaging disclosed in WO 2006/066736 serves primarily to make information on the medicament or chemical composition inside the exterior packaging discernable through the at least partially transparent exterior packaging. However, there is no information on whether the transparent exterior packaging may also be used to make any leaks in the interior packaging or particulate impurities disadvantageous to the user visible from the outside or whether it can serve as a protective container for fragile interior packaging. Neither does the prior art disclose a container having a receiving device for machine-readable data media (e.g. an RPID chip).

A fundamental disadvantage of the protective containers described in the prior art is that they are only suitable for one size of phial and that they lose their protective effect as soon as phials of sizes other than those intended are to be used. The object of the present invention is therefore to provide a protective enclosure for a phial made from a fragile material to accommodate a medicament, which, firstly, protects the phial from breakage, e.g. in the case of impact of the container and the phial against a flat surface (floor) or contact, e.g. with the edge of a table, and, secondly, which is suitable for different sizes of phial.

This problem is solved by the protective enclosure described in the claims. The inventive protective enclosure which is suitable for accommodating a phial made from a fragile material comprises a generally cylindrical body with an open end for insertion of a phial, the open end being closeable by a screw cap and being located at the upper end of the body, and a plurality of axial webs at intervals inside and at the lower end of the body for ensuring radial retention of the phial. The inventive

protective enclosure is characterised in that a retaining ring is inserted at the upper end of the body, so that a collar of the phial presses on it after the screw cap has been screwed on. The retaining ring is used to ensure radial and downward axial retention of the phial, whilst the screw cap ensures upward axial retention of the phial. The enclosure is also characterised in that the base of the phial is at an interval from the closed end of the body, i.e. the base of the protective container, and not resting upon it. The major features and embodiments of the invention are explained in more detail below, using Figs. 1-4.

Figure 1 shows a first embodiment of the inventive protective enclosure, consisting of a cylindrical body (1), a screw cap (2), a plurality of axial webs (3) at intervals and a retaining ring (4). The plurality of axial webs is located at the lower end of the cylindrical body, preferably extending from the base or closed end of the body along the side wall to the approximate centre of the body.

Figure 4 shows a preferred embodiment (Illustration A) of the inventive retaining ring (4) with flexible elements (6) and another view (Illustration B) of the generally cylindrical body (1). In a preferred embodiment of the inventive protective enclosure, the phial made from a fragile material is accommodated by flexible elements (6) on the retaining ring (4). Phials of different sizes, i.e. different widths (diameters) and heights, and thus also of different volumes, can thus be located by one size of retaining ring in the uniformly standardised neck. The flexible elements (6) are also used to absorb impact energy to protect the phials. The retaining ring (4) is inserted at the upper end of the body (1), preferably sealed to the body (1) by a snap ring fitting. This enables different sizes of container, the length of the body (1) of which differs, to be combined with one and the same retaining ring (same size, same shape).

Protective enclosures which differ only in their length are shown in Fig, 1 , Illustrations A and B. The axial webs (3) in the lower part of the cylindrical body (1)

for lateral retention of the phials are preferably arranged tangentially (see Fig. 4, Illustration B). In this case, tangentially means any arrangement of the axial webs in which the axial webs do not point radially towards the centre of the cylindrical body (1). With this geometry, the webs (3) can deform under the influence of force from the side and thus absorb impact energy to protect the phials. Moreover, this geometry facilitates the accommodation of phials which are of different width. The protective enclosures (A) and (B) shown in Fig. 1 have the same screw cap size and width of the body (1). Protective enclosure (A) emphasises the accommodation of relatively narrow phials, whereby the axial webs (3) approximate to a radial orientation. Protective enclosure (B) emphasises the accommodation of relatively wide phials, whereby the tangentially-aligned webs (3) approach the internal wall of the body (1).

The smallest size of phial in terms of length (height) for the respective protective enclosure is that at which the phial is just held or retained by the upper end of the axial webs (3). The smallest phial size in terms of width (diameter of the phial) which is suitable for a given protective enclosure is defined firstly by the width of the axial webs (3), i.e. the wider the axial webs (3), the less wide phials (phials with a smaller diameter) may be used. Secondly, the geometrical arrangement of the axial webs (3) defines the possible phial sizes. The axial webs (3) are inventively preferably arranged tangentially and the more they approach a radial alignment with the centre of the body (1), the less wide phials can be used. In other words, the further the axial webs (3) extend into the enclosure in the unstressed state, the less wide phials (phials of a smaller diameter) may be used.

The largest phial size in terms of length for a given enclosure is that at which the phial does not quite touch, i.e. is not in contact with, the base. The maximum phial size in terms of width is that at which the axial webs (3) almost rest against the internal wall of the body (1) (in their stressed state) whilst retaining a spring effect after the introduction of the phial. If the phials are at a greater distance from the base,

the axial webs (3) are more flexible, in case, as shown in Fig. 1, Illustration A, or Fig. 3, the axial webs are linked at the base (8). However, should the axial webs (3) not be linked at the base, i.e. they can adapt to the respective phial size freely across the base, the space between the base of the phial and the base of the enclosure may be smaller accordingly.

The screw cap (2) and the moulded-on sealing lip (7) seal the protective enclosure closed. In use, the phial remains in the protective enclosure after the screw cap has been opened. After the screw cap (2) has been replaced, the system will be sealed closed again.

Fig. 2 shows a further embodiment of the protective enclosure described above. The protective enclosures (A) and (B) shown in Fig. 2 only differ in the length of the body (1). In the embodiment of the inventive protective enclosure shown in Fig. 2, the retaining ring (4) is designed so that it may be connected with a body (1) which is wider, i.e. which has a greater diameter than the diameter of the screw cap (2). In this embodiment, the retaining ring (4) is not only for retaining the phial and absorbing impact energy, but also simultaneously forms an outer wall in the shoulder area of the protective enclosure.

Fig. 3 shows a further embodiment of the inventive protective enclosure. In this embodiment, a gasket (5) made from a flexible material is inserted above the retaining ring (4), so that a collar of the phial presses upon the gasket (5) and the retaining ring (4) below after the screw cap (2) has been screwed on. The gasket (5) is clamped in between the retaining ring (4) and the body (1) around its periphery. A radial sealing effect thus arises between the two parts, so than no liquid can escape into the upper area, even if the screw cap (2) is open.

In a further embodiment, not shown, the gasket (5) may also be located below the retaining ring (4), so that a collar on the phial presses against the retaining ring (4) and the gasket (5) below after the screw cap (2) has been screwed on. The gasket firstly supports the retaining ring when absorbing impact energy and secondly has a triple sealing effect, namely extensive sealing to the neck of the phial, between the retaining ring and the container and between the screw cap and the container.

Preferably, the screw cap (2) has a spacer (9) being in contact with the cap (10) of the phial (see, e.g., Fig. 3). It should be noted that the assembly of the retaining ring (4), the gasket (5) if present, and the screw cap (2) optionally having a spacer (9) alone may provide for a radial as well as downward axial and upward axial retention of the phial. If, as show in Fig. 2, the retaining ring (4) is not only for retaining the phial and absorbing impact energy, but also simultaneously forms an outer wall in the shoulder area of the protective enclosure, it is possible to use the assembly as a holder to take the phial out of the body (1). Thus, the present invention also relates to a holder for a phial comprising the retaining ring (4), optionally the gasket (5), and the screw cap (2) optionally having a spacer (9).

Depending upon use and requirements, the following plastics are suitable for the body (1) and the screw cap (2), i.e. standard plastics, engineering plastics, thermoplastic elastomers and transparent plastics, e.g. selected from the groups of styropolymers (ABS, PS, MABS), polyvinyl chlorides (HPVC, WPVC), polyolefms (HDPE, PP), polyamides (PA), polyacetales C/H (POM), saturated polyesters (PET, PETG), acrylics (PMMA), olefin-based thermoplastic elastomers (TPE-O or TPO), cross-linked olefin-based thermoplastic elastomers (TPE-V or TPV), urethane-based thermoplastic elastomers (TPE-U or TPU), thermoplastic copolyesters (TPE-E or TPC), styrene block copolymers (TPE-S or TPS, SBS, SEBS, SEPS, SEEPS and MBS) and thermoplastic copolyamides (TPE-A or TPA) and polycarbonates.

The flexible material used inventively for the gasket (5) is preferably selected from the groups of thermoplastic elastomers (TPE), e.g. block copolymers (e.g. SBS, SIS) and elastomer alloys (polyblends) made from olefin-based thermoplastic elastomers (TPE-O or TPO), preferably PP/EPDM, e.g. Santoprene (AES/Monsanto); cross- linked olefin-based thermoplastic elastomers (TPE-V or TPV), preferably PP/EPDM, e.g. Sarlink (DSM); urethane-based thermoplastic elastomers (TPE-U or TPU), e.g. Desmopan (Bayer); thermoplastic copolyesters (TPE-E or TPC), e.g. Hytrel (DuPont); styrene block copolymers (TPE-S or TPS, SBS, SEBS, SEPS, SEEPS and MBS), e.g. Septon; and thermoplastic copolyamides (TPE-A or TPA), e.g. PEBA .

After the screw cap has been opened, the phial remains in the enclosure during use. When open, the enclosure volume is largely sealed closed by the seal formed by the gasket (5) around the neck of the phial.

The generally cylindrical body (1) preferably consists of a fracture-resistant plastic material or is, alternatively, coated with such a material. Depending upon use and requirements, the following plastics are suitable, i.e. standard plastics, engineering plastics and transparent plastics, e.g. selected from the groups of styropolymers (ABS, PS, MABS), polyvinyl chlorides (HPVC, WPVC), polyolefins (HDPE, PP), e.g. Purell 5037 L (Basell) or PP 1013 Hl (ExxonMobil), polyamides (PA), polyacetales C/H (POM), saturated polyesters (PET, PETG), acrylics (PMMA) and polycarbonates (PC).

In a particularly preferred embodiment, the body (1) consists of a transparent material, e.g. selected from the groups of polycarbonates (PC; Macrolon 2458,

Bayer), acrylic (PMMA), polyvinyl chlorides (HPVC, WPVC), polypropylenes (PP), saturated polyesters (PET, PETG) or styropolymers (ABS, PS, MABS; Terlux, BASF).

A person skilled in the art will understand that the present invention is not restricted to the specimen embodiments described herein and that many variations and modifications may be made within the protective scope of the appended claims. A reader acquainted with the art will understand that the present invention is not restricted to the object of a protective enclosure for liquid medicaments. The protective enclosure which is the object of the present invention may also be used for other vessels and contents to be dispensed, whether in liquid, powder or another form, and for the storage or carriage of fragile items in general, e.g. ceramic or glass structures.