System for long-term storage of pharmaceutical composition comprising adapter for connecting needle to syringe barrel

Abstract

To provide an adapter for connecting a needle to a syringe barrel including a Lure Lock connector having a thread, and a system for long-term storage of a pharmaceutical composition comprising the adapter.SOLUTION: An adapter 1 for connecting a needle to a syringe barrel having a thread and a cone includes: a first part 4 to support a needle 3; a second part 5 including a counter thread to form a screwing connection with the thread of a Lure Lock connector 2; and at least one deformable locking element 6 arranged within a region of the counter thread and protruding radially beyond a minor outer diameter of the counter thread, such that the at least one deformable locking element is to be deformed by the thread of the Lure Lock connector when the adapter is screwed to the syringe barrel.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to an adapter for connecting a needle to a syringe barrel having a threaded Luer lock connector, and a system for long-term storage of a pharmaceutical composition comprising the same. [Background technology]

[0002] Pharmaceutical or cosmetic compositions are often provided in a convenient, ready-to-use form in a prefilled syringe.Typically, such a syringe comprises a syringe barrel filled with the composition, a plunger, a needle hub, and a needle that is typically covered by a needle shield.One method for connecting the needle hub to the syringe barrel is to use a standardized luer lock connector that includes a screw thread and a cone.

[0003] The integrity of the closure of a prefilled syringe is of paramount importance to avoid leakage and / or contamination of the pharmaceutical or cosmetic composition stored therein. A particularly critical area for leakage is the threaded screw connector of the luer lock. The needle hub that secures the needle to the syringe barrel is screwed and therefore may constitute a weak connection spot under storage and transport conditions. The connection between the cone of the luer lock and the needle hub is sealed by a form-fit between the surfaces of their respective cone surfaces and may additionally be sealed by an elastomeric sealing member compressed by the screwed parts. During transport of the prefilled syringe, vibrations may loosen the screw connection, resulting in an insufficient seal. In the worst case, the needle may even be completely removed from the container.

[0004] Furthermore, in situations where pre-filled syringes are stored at reduced temperatures, the threaded connections may loosen. The lower the storage temperature or the greater the difference between the filling, storage, and application temperatures, the greater the risk of the threaded connections loosening and losing integrity.

[0005] Luer lock connectors are specially designed with a single cone plus a threaded connector known as a Luer slip connector to avoid needle popping out when higher pressures need to be applied during injection due to small needle gauges and / or high viscosity injection media. Basically, this design achieves this goal well. However, improvements are still needed, especially for connections of automatic injection devices, where small amounts have to be administered over a long period of time and, as a result, pressure has to be maintained for a long time. In these cases, the threaded connection can also start to drift and become loose.

[0006] SUMMARY OF THE PRESENT EMBODIMENT It is therefore an object of the present invention to overcome at least some of the above-mentioned drawbacks, and in particular to improve the sealing integrity of the luer lock connection between a syringe barrel and a needle hub.

[0007] Summary of the Invention definition The "crown" of a screw thread refers to the protruding top of the thread.

[0008] The "valley" of a thread refers to the bottom of the groove between two thread flanks.

[0009] The "pitch" of a thread refers to the distance between two adjacent crests along the thread.

[0010] The "major outer diameter" of a thread refers to the larger of the two terminal diameters that define the height of the thread profile. It is the diameter of the thread measured between the opposed top surfaces and is equal to the major outer diameter of the thread.

[0011] The "minor outer diameter" of a thread refers to the smaller of the two terminal diameters that define the height of the thread profile. It is the diameter of the thread measured between the opposing root surfaces and is equal to the diameter of the core of the thread.

[0012] The "depth" of a thread refers to the distance between a crest and its adjacent root, and is equal to the difference between the nominal and root diameters of the thread.

[0013] A "cylindrical shape" can be understood in the context of the present application as a shape in the form of a general cylinder of mathematical definition, in particular a general right circular cylinder, this definition explicitly including the special shapes of prisms, in particular right rectangular prisms and hexahedrons. Preferably, this is a right circular cylinder or right rectangular prism with a base area of ​​hexagonal to icosahedral.

[0014] A "form-locking" connection may refer to a joining technique in which the joint is produced by geometric elements that prevent the relative movement of the components with respect to each other. A form-locking connection is produced by the interlocking of at least two connection partners. The connection partners cannot come loose even if the force transmission is uninterrupted or interrupted. When an operating load is applied, a compressive force acts perpendicular to the surface of the connection partners. Examples are dovetail joints, tongue and groove joints, key joints, or interlocking joints.

[0015] "Material bond" connections may refer to joining techniques that hold the connection partners together by atomic or molecular forces. At the same time, these are non-removable connections that can only be separated by destroying the connection means. Examples are welding, soldering, gluing, or vulcanization.

[0016] "Matching thread" refers to a second thread suitable for engaging with a first thread. It can therefore be defined as the possibility of screwing two threads together. It does not necessarily define the thread as an internal or external thread. Both versions are equally encompassed by this definition and are selected depending on the design of the first thread.

[0017] When a part is said to be "disposed" at a certain location, this may mean that the part is positioned there or that the part is provided with another part at the location, i.e., including the alternative of an assembly of two parts and the formation of an integrated part.

[0018] Aspects In a first aspect, the present invention provides an adapter for connecting a needle to a syringe barrel having a thread and a cone, comprising: - a first part supporting the needle; - a second part having a corresponding thread for threaded connection to the thread of the Luer lock connector; - at least one deformable locking element arranged in the region of the corresponding thread and protruding radially beyond the root diameter of the corresponding thread so as to be deformed by the thread of the luer lock connector when the adapter is screwed onto the syringe barrel; The present invention relates to an adapter comprising:

[0019] The at least one deformable locking element may have the form of a ridge or protrusion.

[0020] "Protruding radially beyond the root diameter of the corresponding thread" means in this context that at least one deformable locking element extends radially from the core of the thread, i.e. its root diameter, towards its crest.

[0021] Preferably, the deformation of the at least one deformable locking element comprises axial and / or radial compression.

[0022] "Area of ​​the mating thread" in this context refers to essentially the entire surface of the thread, meaning that the deformable locking element should be suitably positioned for engagement with the threads of the luer lock connector of the syringe barrel.

[0023] The adapter may also be referred to as a "needle hub." The needle hub is removable and replaceable from the syringe barrel. It has two structural parts, the first part is a needle base that holds the needle, and the second part is a gripping base with a threaded connector. To assemble the adapter with the syringe, it is held by the gripping base and screwed together.

[0024] In a second aspect, the present invention provides an adapter for connecting a needle to a syringe barrel comprising a luer lock connector having a thread and a cone, comprising: - a first part supporting the needle; - a second part having a corresponding thread for threaded connection to the thread of the Luer lock connector; - at least one deformable locking element arranged in the region of the corresponding thread and protruding radially beyond the root diameter of the corresponding thread so as to be deformed by the thread of the luer lock connector when the adapter is screwed onto the syringe barrel; The present invention relates to an adapter comprising:

[0025] The luer lock connector is preferably an ISO 80369-7:2021 compliant connector.

[0026] In a preferred embodiment, the at least one deformable locking element is elastic and / or comprises, preferably consists of, an elastomeric material. Preferably, the at least one deformable locking element is made of an elastomeric material. Examples of preferred materials are silicone rubber, butyl rubber and bromobutyl rubber, each optionally containing an inorganic filler, in particular silica.

[0027] The inventors have discovered that the integrity of the pre-filled syringe can be increased by securing the threaded connection between the needle adapter and the Luer lock connector with at least one additional deformable locking element.

[0028] The deformable locking element may be part of the needle adapter and may be positioned in or on the threads of the luer lock connector such that the needle adapter can engage the threads of the luer lock connector. When the two parts are threaded together, the deformable locking element may bend or compress, and the frictional engagement between the two threads counteracts torsional forces caused by tension induced by vibration or temperature. Depending on the size, shape, and diameter, the deformable locking element engages the flanks and / or roots of the threads of the luer lock connector.

[0029] In particular, if the deformable locking element is made of an elastomeric material, an increase in friction can be produced by the material itself and on the basis of the fact that the deformable locking element can adapt to the shape of the space between the threads. Such an embodiment can be advantageously provided, for example, by two-component injection molding of the second part and the deformable locking element using a thermoplastic elastomer (TPE).

[0030] In further preferred embodiments, the at least one deformable locking element may be at least one of a cam, a bulge, a raised rim, a raised lip, or a bead, and / or the adapter comprises a plurality of deformable locking elements. The plurality of deformable locking elements may be 2, 3, 4, 5, 6, or more deformable locking elements. Two, three, or four deformable locking elements are preferred, with two or three being particularly preferred. For example, the deformable locking elements may be 10 or less, since dimensioning and positioning too many deformable locking elements may become impractical or uneconomical. As a result, the embodiment may preferably have 2-10 deformable locking elements, more preferably 2-6 deformable locking elements, 2-5 deformable locking elements, or 2-4 deformable locking elements.

[0031] Preferably, at least one deformable locking element may project radially beyond the nominal diameter of the corresponding thread. If the deformable locking element projects beyond the thread, it is possible to compress the deformable locking element more when the thread is screwed together. Furthermore, the tips of the deformable locking elements can more easily reach and engage the thread roots of the luer lock connector, since the crowns of these threads generally do not extend to the roots of the mating thread. Thus, if the deformable locking element does not extend beyond the crowns, i.e. the nominal diameter, in its initial state, it can only engage the roots if it is sufficiently compressed by the mating thread to extend beyond the thread. Otherwise, the deformable locking element would only engage the flanks of the thread.

[0032] In a third aspect of the invention, the adapter may comprise a third part including at least one deformable locking element and one or more inner surfaces for contacting the cone of the luer lock connector, the second part having at least one opening formed in the area of ​​the corresponding thread, the third part being at least partially disposed inside the second part, and the at least one deformable locking element engaging and extending through the at least one opening. Such an embodiment provides the advantage that the third part can be made of a different material than the second part. In particular, the third part can be made of a material that provides tailored properties for locking function and good sealing against the cone of the luer lock connector, while the second part is optimized for adapter stability.

[0033] At least one opening formed in the region of the corresponding thread may extend radially through the entire wall thickness of the second part in the region of the thread, most preferably including the thread.

[0034] In a preferred embodiment, the third component comprises, preferably consists of, a polymer, preferably an elastomer, more preferably a thermoplastic elastomer. Examples of preferred materials are silicone rubber, butyl rubber, and bromobutyl rubber, each optionally containing an inorganic filler, in particular silica. Preferably, the material is the same material as the material of the at least one deformable locking element.

[0035] Preferably, at least one deformable locking element is arranged substantially perpendicular to the central axis of the corresponding thread of the second part when assembled. This is advantageous because compression of the threaded connection can be subjected to an axial force by the thread root acting on the entire length of the deformable locking element in addition to the radial force caused by the thread flank. If the orientation is not perpendicular, a bending moment is introduced, which reduces the compression.

[0036] In preferred embodiments, the first and second parts form a form- or material-bonded integral part, in which the two parts are fixed to each other by a locking mechanism or material bond to prevent unintended separation of the parts, which may result in a complete loss of integrity of the prefilled syringe with the adapter according to the invention and leakage of the contents.

[0037] In a further preferred embodiment, the first and second parts are irreversibly connected, preferably by a click or snap mechanism. The connection may be rotatable about the central axis of the needle, especially in the case of a click or snap mechanism. An irreversible connection is preferred due to the fact that not only is the aforementioned unintended separation prevented, but also tempering by the adapter parts is prevented. The user of the adapter generally does not need to disassemble the adapter, since the needle is replaced together with the entire adapter to maintain sterility of the assembly. The click or snap mechanism may be achieved, for example, by a notch, a latch and / or an undercut.

[0038] In a preferred variant of this embodiment, in which the first part and the second part are irreversibly connected by a click mechanism, the set force to reach the click point of the click mechanism is 10N to 300N, preferably 20N to 200N, more preferably 80N to 150N. In an embodiment, the set force may be at least 10N, preferably at least 20N, or at least 80N. The set force may be up to 300N, preferably up to 200N, or up to 150N.

[0039] Preferably, the at least one deformable locking element has an oval or rectangular cross-sectional shape, preferably a circular or square cross-sectional shape. These cross-sectional shapes have proven to be particularly suitable for adjusting the locking effect and ensuring good contact with the thread. Adjustment of the locking effect is necessary in order to adjust the holding force and the screwing torque, since it is expected not only to hold the adapter safely in place and ensure its integrity, but also to still be conveniently screwable by the user.

[0040] Moreover, in a preferred embodiment, the distal end of at least one deformable locking element has, in an undeformed, preferably uncompressed, shape of a cylinder, in particular a prism or hexahedron, preferably a cube, a truncated cone, a truncated pyramid, and / or a semi-ellipse, in particular a hemisphere. These forms of the tip of the deformable locking element are advantageous for contact with the root of the thread and also for adjusting the locking effect. The option "and" in the list refers in particular to a combination of one of the first three shapes with the fourth shape, resulting in a rounded tip. However, other combinations are also useful and are considered as well, for example a cylinder with a truncated cone, which can help to better match the shape of the root of the thread.

[0041] In some preferred embodiments, the ratio between the diameter or width of the at least one deformable locking element extending in the direction of the central axis of the corresponding thread and the pitch of the corresponding thread of the second part is 0.3-0.5 mm / mm. This ratio characterizes the amount by which the deformable locking element extends laterally beyond the thread, in other words, how much wider the deformable locking element is than the thread. Since the thread matches the thread of the luer lock, this is the same as indicating the amount of compression the deformable locking element experiences from the thread of the luer lock. It has been found that configurations within the ratio range of 0.3-0.5 mm / mm provide optimal contact and compression forces to securely fasten the adapter with a convenient required screw-in torque. The ratio may preferably be at least 0.3 [mm / mm], at least 0.31 [mm / mm], at least 0.32 [mm / mm], at least 0.33 [mm / mm], at least 0.34 [mm / mm], or at least 0.35 [mm / mm]. The ratio may preferably be at most 0.5 [mm / mm], at most 0.49 [mm / mm], at most 0.48 [mm / mm], at most 0.47 [mm / mm], at most 0.46 [mm / mm], or at most 0.45 [mm / mm]. The ratio may preferably be within a ratio range of 0.3 to 0.5 [mm / mm], a ratio range of 0.31 to 0.49 [mm / mm], a ratio range of 0.32 to 0.48 [mm / mm], a ratio range of 0.33 to 0.47 [mm / mm], a ratio range of 0.34 to 0.46 [mm / mm], or a ratio range of 0.35 to 0.45 [mm / mm].

[0042] Another ratio that can be observed for the same purpose is the ratio between the diameter or width of the at least one deformable locking element extending in the direction of the central axis of the corresponding thread and the crest of the corresponding thread of the second part. However, this crest ratio does not contain any information about the size of the roots of the thread and therefore is less informative than the aforementioned pitch ratio. Preferably, the ratio is between 1 and 8 [mm / mm], more preferably between 1.1 and 7.7 [mm / mm].

[0043] In a preferred embodiment, the at least one deformable locking element extends 0.0 mm to 1.5 mm, preferably 0.1 mm to 0.5 mm beyond the nominal diameter of the corresponding thread of the second part. Preferably, the at least one deformable locking element may extend at least 0.0 mm, at least 0.025 mm, at least 0.05 mm, at least 0.075 mm or at least 0.1 mm beyond the nominal diameter of the corresponding thread of the second part. Preferably, the at least one deformable locking element may extend up to 1.5 mm, up to 1.25 mm, up to 1.0 mm, up to 0.75 mm or up to 0.5 mm beyond the nominal diameter of the corresponding thread of the second part. Preferably, the at least one deformable locking element may extend beyond the nominal diameter of the corresponding thread of the second component by 0.0 mm to 1.5 mm, 0.025 mm to 1.25 mm, 0.05 mm to 1.0 mm, 0.075 mm to 0.75 mm, or 0.1 mm to 0.5 mm. This length range over which the deformable locking element exceeds the height of the corresponding thread represents the axial compression exerted by the thread flanks, in particular the thread roots of the Luer lock, and has been found to provide optimal contact and compression forces to securely fasten the adapter at a convenient required threading torque.

[0044] In a preferred embodiment, at least the at least one deformable locking element, preferably the entire third part, has a Shore A hardness of 20 to 80, preferably 30 to 70, more preferably 45 to 65, more preferably 50 to 60, measured at 10 seconds according to ASTM D2240:2021. The Shore A hardness may preferably be at least 20, at least 30, at least 45, or at least 50. The Shore A hardness may preferably be up to 80, up to 70, up to 65, or up to 60.

[0045] In a preferred embodiment, the Young's modulus of the at least one deformable locking element and / or the third part is 0.1 MPa to 5 MPa, preferably 1 MPa to 4 MPa, more preferably 1.5 MPa to 3 MPa, determined in accordance with ISO 527-1 / -2:2019. The Young's modulus is preferably at least 0.1 MPa, at least 0.5 MPa, at least 1 MPa, at least 1.25 MPa, or at least 1.5 MPa. The Young's modulus may preferably be at most 5 MPa, at most 4.5 MPa, at most 4 MPa, at most 3.5 MPa, or at most 3 MPa. The Young's modulus may preferably be at most 0.1 MPa to 5 MPa, at most 0.5 MPa to 4.5 MPa, at least 1 MPa to 4 MPa, at most 1.25 MPa to 3.5 MPa, or at most 1.5 MPa to 3 MPa.

[0046] In an embodiment, the adapter, when assembled to a Luer lock connector with the cone removed, has a frictional torque resistance of 0.9 Ncm to 4 Ncm, preferably 1 Ncm to 3.5 Ncm, measured in accordance with Annex G.4 of ISO 11040-4:2015. The frictional torque resistance is preferably at least 0.9 Ncm, at least 0.92 Ncm, at least 0.94 Ncm, at least 0.96 Ncm, at least 0.98 Ncm, or at least 1 Ncm. The frictional torque resistance is preferably up to 4 Ncm, up to 3.9 Ncm, up to 3.8 Ncm, up to 3.7 Ncm, up to 3.6 Ncm, or up to 3.5 Ncm. The friction torque resistance is preferably 0.9 Ncm to 4 Ncm, 0.92 Ncm to 3.9 Ncm, 0.94 Ncm to 3.8 Ncm, 0.96 Ncm to 3.7 Ncm, 0.98 Ncm to 3.6 Ncm, or 1 Ncm to 3.5 Ncm. In order to be able to measure the friction torque resistance imparted by the at least one deformable locking element, the cone of the luer lock connector of the test syringe must be removed before the measurement. The rest of the measurement conditions can then be used as in the ISO standard. The inventors have found that a friction torque resistance within this range provides a secure fixation and comfortable operation of the adapter.

[0047] In a preferred embodiment, the at least one opening for the at least one deformable locking element of the region of the corresponding thread of the second part is located at a position along the length of the region of the corresponding thread, when viewed from the distal end to the proximal end of the second part, within 20% to 100% of the length, preferably within 75% to 100% of the length. The position is preferably at least 20% of the length, at least 30% of the length, at least 40% of the length, at least 50% of the length, at least 60% of the length, at least 70% of the length, or at least 75% of the length. The position is preferably within 20% to 100% of the length, within 30% to 100% of the length, within 40% to 100% of the length, within 50% to 100% of the length, within 60% to 100% of the length, within 70% to 100% of the length, or within 75% to 100% of the length. It has been found that the closer the position of the at least one deformable locking element is to the end of the corresponding thread of the second part, i.e., the closer it is to the syringe body in its assembled position, the greater the effect it has on the torque, providing the user with a more uniform screwing experience.

[0048] In a preferred embodiment, the at least one deformable locking element has a deformation width of 1.5 mm in an undeformed, preferably uncompressed, state. 2 ~4.0mm 2 , preferably 2.5 mm 2 ~3.5mm 2 The luer lock connector has a surface area that contacts the threads of the luer lock connector. The surface area is preferably at least 1.5 mm 2 , at least 1.75mm 2 , at least 2.0 mm 2 , at least 2.25mm 2 , or at least 2.5 mm 2 The surface area is preferably up to 4.0 mm 2 , up to 3.9mm 2 , up to 3.8mm 2 , up to 3.7mm 2 , up to 3.6mm 2 , or up to 3.5 mm 2 The surface area is preferably 1.5 mm 2 ~4.0mm2 , 1.75mm 2 ~3.9mm 2 , 2.0mm 2 ~3.8mm 2 , 2.25mm 2 ~3.7mm 2 , 2.5mm 2 ~3.6mm 2 , or 2.5 mm 2 ~3.5mm 2 Within this range, the contact surface of the deformable locking element is ideally suited for the locking function: the surface is large enough to provide sufficient friction for the threads, but small enough to avoid creating too high a frictional torque resistance and excessive compression by the threads.

[0049] Most preferably, the material of the first component and / or the second component comprises, preferably consists of, a polymer preferably selected from the group comprising polyamide (PA), polypropylene (PE), polycarbonate (PC), polyvinylidene fluoride (PVDF), cyclic olefin copolymer (COC), cyclic olefin polymer (COP), and polyethylene terephthalate (PET).

[0050] In a preferred embodiment, the needle and the first part are an integrated part, and preferably the needle is overmolded by injection molding together with the first part, i.e. surrounded by the material of the first part. The integration of the needle into the first part can be achieved by different mechanisms. The needle can be fixed to the first part by means of an adhesive or by a press-fit connection. The preferred approach is the fixation by overmolding the needle in an injection molding process, since this avoids further assembly steps and achieves an excellent fixation with optimal sealing.

[0051] In an embodiment, the adapter is configured such that the fluid injected from the syringe barrel into the needle only contacts the first and / or third parts of the adapter after leaving the cone and before entering the needle. Such design variations have the advantage that not all parts of the adapter need to be made of expensive medical grade polymers. In general, the first part will be smaller in size than the second part, since the former only needs to be large enough to fix the needle in the second part, while the latter needs to be large enough for convenient handling by the user. Also, the third part will be smaller in size since it is positioned within the second part. Thus, if the design of the adapter is such that the fluid of the syringe does not contact the second part on its way into the needle, only the first and / or third parts need to be made of medical grade polymers. Even if the three parts are approximately the same in size, costs can still be reduced because only one or two of them require expensive materials. For example, if the fluid enters the first part directly from the cone of the Luer lock connector, the first part may be made of medical grade COC, while the second part is made of standard grade PA or PC.

[0052] In a further embodiment, the adapter is configured such that the ratio between the hardness of the at least one deformable locking element, determined as Shore A at 3 seconds according to DIN ISO 7619-1:2012-02, and the hardness of the thread of the luer lock of the container, determined as Shore D at 3 seconds according to DIN ISO 7619-1:2012-02, is between 1:1.1 and 1:2.0, preferably between 1:1.2 and 1:1.6. The inventors have found that the effect of the deformable locking element can be improved if the hardness of the deformable locking element is selected within a certain ratio to the hardness of the thread of the luer lock of the container against which it abuts.

[0053] In a fourth aspect, the present invention provides a system for long-term storage of a pharmaceutical composition, comprising: - a syringe barrel, · Front end; a Luer lock connector, preferably according to ISO 80369-7:2021, at the front end, including a thread and a cone; and Opposite rear end a syringe barrel comprising: - a plunger inserted into the rear end; - an adapter according to the invention connected at its front end to a Luer lock connector; - Optionally, a needle shield to cover the needle; The present invention relates to a system comprising:

[0054] Such a system with an adapter according to the invention improves the integrity of the pre-filled syringe, especially during long-term storage at reduced temperatures and during transport. The deformable locking element secures the adapter to the luer lock connector of the syringe, preventing it from loosening or dislodging.

[0055] In a preferred embodiment, the syringe barrel comprises, preferably consists of, glass, preferably borosilicate glass or aluminosilicate glass, or a polymer, preferably polyethylene (PE), polypropylene (PP), cyclic olefin copolymer (COC), or cyclic olefin polymer (COP).

[0056] In a preferred embodiment, the syringe barrel is filled with a solid or liquid composition, preferably a pharmaceutical composition. [Brief description of the drawings]

[0057] [Figure 1] FIG. 2 is a side view of the front end of a syringe barrel having a threaded Luer lock connector and a two-piece embodiment adapter according to the present invention for connecting a needle to the syringe barrel. [Diagram 2] FIG. 2 is a cross-sectional view of the front end of a syringe barrel having a threaded Luer lock connector and a three-piece embodiment adapter according to the present invention for connecting a needle to the syringe barrel. [Diagram 3]FIG. 13 is an enlarged perspective view of a threaded luer lock connector and the inserted third part.

[0058] Detailed Description A first example of an adapter 1 according to the invention for connecting a needle 3 to a syringe barrel having a threaded luer lock connector 2 is shown in Fig. 1. This is an example of an adapter 1 of two-part design with a deformable locking element 6 in the form of an elastomeric hemispherical cam bonded to the valley of a corresponding thread in a second part 5. For this purpose, part of the corresponding thread has been removed. The figure shows only the front end of the syringe barrel having the luer lock connector 2. The rest of the syringe barrel and the plunger, which complete the diagram of the system according to the invention, are not shown.

[0059] The first part 4 is made of cyclic olefin copolymer (COC) by injection molding, and the needle 3 is overmolded to fix the needle 3 to the first part 4. The first part 4 and the second part 5 made of polycarbonate (PC) are glued to form an integrated part. The second part 5 is then screwed onto the threads of the luer lock connector 2, and the second part 5 is fixed by a deformable locking element 6.

[0060] A second example of an adapter 1 according to the invention is shown in Figure 2. This time the adapter 1 comprises three parts. From the outside it looks almost identical to the example of Figure 1, but a cross-section makes the differences clear. Again, the figure does not show the complete syringe barrel and plunger of the system, but shows the first part 4 and an optional needle shield 8 covering the needle 3.

[0061] As in the example of FIG. 1, the first part 4 is made of cyclic olefin copolymer (COC) by injection molding and the needle 3 is overmolded to fix it to the first part 4. However, the part of the first part 4 inside the second part 5 is formed with a raised ring (see the protrusion of the lower cylindrical part in FIG. 2). The second part 5 is also made of cyclic olefin copolymer (COC) and has a corresponding undercut on its inner circumference to interlock with the raised ring when the first part 4 and the second part 5 are pressed together for assembly. This irreversible connection can be designed to be rotatable or non-rotatable by adjusting the distance between the raised ring at the top end of the second part 5 and the flange, relative to the distance between the corresponding undercut and the rim against which the flange abuts.

[0062] The third part 7 is made of bromobutyl rubber with a hardness of 50 Shore A (measured according to ASTM D2240:2021, 10 seconds) and is positioned inside the second part 5. In contrast to the first example, the third part 7 has two raised cams arranged opposite each other with hemispherical tips. These raised cams extend through corresponding holes in the second part 5 so as to form the deformable locking element 6. The holes are positioned at 75% along the length of the area of ​​the corresponding thread when viewed from the distal end to the proximal end of the second part 5. The deformable locking element 6 extends 0.6 mm beyond the nominal diameter of the corresponding thread of the second part 5. The surface area for contacting the thread of the Luer lock connector 2 in the uncompressed state is 3.2 mm. 2 From the outside, the deformable locking element 6 looks like the first example in Fig. 1, the only difference being that the gap of the corresponding thread of the second part 5 does not stop at the root of the thread but continues in a hole through the wall of the second part 5. The third part 7 abuts with its inner surface on the surface of the cone of the luer lock connector 2 and the lower end of the first part 4, providing an additional seal of the system.

[0063] Only an enlarged perspective view of the threaded luer lock connector 2 and the inserted third part 7 of the second example shown in Fig. 2 is shown in Fig. 3 for better visibility. In this view it can be clearly seen how the deformable locking element 6 moves within the thread of the luer lock connector 2 and creates a frictional force for locking the threaded connection.

[0064] Torque measurements were carried out in accordance with Annex G.4 of ISO 11040-4:2015 with an adapter as shown in Figure 2, where the cone of the Luer lock connector 2 was removed so that the effect of the deformable locking element 6 could be measured without the additional contact surface of the third part 7 with the cone. 11 samples were measured to calculate the average. For comparison, adapters 1 with the deformable locking element 6 disconnected from the third part 7 were tested respectively.

[0065] [Table 1]

[0066] As can be seen from the table, the deformable locking element 6 increases the frictional torque resistance when the adapter 1 of Example 2 is screwed onto the luer lock connector 2 by approximately 30%. [Explanation of symbols]

[0067] 1 Adapter 2 Luer lock connector 3 needles 4. First Part 5 Second Part 6 Deformable locking element 7. Third Part 8 Needle Shield

Claims

1. An adapter (1) for connecting a needle (3) to a syringe barrel having a luer lock connector (2) with a thread and a cone, a first part (4) supporting said needle (3); a second part (5) having a corresponding thread for threaded connection to the thread of the luer lock connector (2); - at least one deformable locking element (6) arranged in the region of the corresponding thread and projecting radially beyond the root diameter of the corresponding thread so as to be deformed by the thread of the luer lock connector (2) when the adapter (1) is screwed onto the syringe barrel; An adapter (1).

2. - said at least one deformable locking element (6) is elastic and / or comprises an elastomeric material, and / or - said at least one deformable locking element (6) is at least one of a cam, a bulge, a raised rim, a raised lip or a bead; and / or - said adapter (1) comprises a plurality of deformable locking elements (6); The adapter of claim 1 .

3. 2. The adapter (1) according to claim 1, wherein the at least one deformable locking element (6) also projects radially beyond the nominal diameter of the corresponding thread.

4. a third part (7) comprising said at least one deformable locking element (6) and one or more inner surfaces for contacting said cone of said luer lock connector (2); Equipped with - said second part (5) has at least one opening formed in said region of said corresponding thread, - said third part (7) is arranged at least partially inside said second part (5), said at least one deformable locking element (6) engaging in and extending through said at least one opening; The adapter (1) according to claim 1.

5. The adapter (1) of claim 4, wherein the third part (7) comprises a polymer.

6. 2. The adapter (1) according to claim 1, wherein the at least one deformable locking element (6) is arranged substantially perpendicular to the central axis of the corresponding thread of the second part (5) when assembled.

7. 2. The adapter (1) according to claim 1, wherein the first part (4) and the second part (5) form a form- or material-bonded integral part and / or are irreversibly connected.

8. The adapter (1) according to claim 7, wherein the first part (4) and the second part (5) are irreversibly connected by a click mechanism, and a set force for reaching a click point of the click mechanism is 10N to 300N.

9. The at least one deformable locking element (6) - have an oval or rectangular cross-sectional shape, and / or - extending 0.0 mm to 1.5 mm beyond the nominal diameter of the corresponding thread of the second part (5), and / or - has a Shore A hardness of 20 to 80, measured in 10 seconds according to ASTM D2240:2021; and / or - 1.5 mm in the undeformed state ２ and / or has a surface area in contact with the threads of the luer lock connector (2) of 4.0 mm 2 . - have a Young's modulus of 0.1 MPa to 5 MPa, determined in accordance with ISO 527-1 / -2:2019, The adapter (1) according to claim 1.

10. 2. The adapter (1) according to claim 1, wherein the ratio between the diameter or width of the at least one deformable locking element (6) extending in the direction of the central axis of the corresponding thread and the pitch of the corresponding thread of the second part (5) is between 0.3 and 0.5 mm / mm.

11. 2. The adapter (1) according to claim 1, wherein the adapter (1) when assembled to a luer lock connector (2) from which the cone has been removed has a friction torque resistance of 0.9 Ncm to 4 Ncm when measured in accordance with Annex G.4 of ISO 11040-4:2015.

12. 2. The adapter (1) according to claim 1, wherein the at least one opening for the at least one deformable locking element (6) in the region of the corresponding thread of the second part (5) is arranged at a position along the length of the region of the corresponding thread within 20% to 100% of the length when viewed from the distal end to the proximal end of the second part (5).

13. The distal end of said at least one deformable locking element (6), in an undeformed state, - cylinder, - truncated cone, - a truncated pyramid, and / or - semi-elliptical 2. The adapter (1) according to claim 1, having the shape of:

14. 1. A system for long-term storage of a pharmaceutical composition, comprising: a syringe barrel, ・ Front end, a luer lock connector (2) at said front end, said luer lock connector including a thread and a cone; - Rear end on the opposite side a syringe barrel comprising: a plunger inserted into said rear end; - an adapter (1) according to any one of claims 1 to 13, connected at its front end to the luer lock connector (2); - optionally a needle shield (8) covering the needle (3); A system comprising:

15. The syringe barrel comprises: - containing glass or polymers and / or - filled with a solid or liquid composition, 15. The system of claim 14.

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