Stopper for a medicament container and medicament container

Abstract

In one aspect the present disclosure relates to a stopper (20) for a medicament container (10), wherein the medicament container comprises a barrel (11) with a cylindrically-shaped sidewall (12), the stopper (20) comprising: - a stopper body (21) of generally cylindrical geometry and comprising an elastomeric material, the stopper body (21) further comprising a first end surface (24) at a first longitudinal end (22) and a second end surface (25) at a second longitudinal end (23) and a sidewall (26) extending between the first longitudinal end (22) and the second longitudinal end (23), wherein the first end surface (24) and the second end surface (25) each comprise a closed end surface, - a first sealing rib (31) extending in circumferential direction and protruding radially outwardly from the sidewall (26) by a first radial extent (r1), - a second sealing rib (41) separated from the first sealing rib in longitudinal direction, extending in circumferential direction and protruding radially outwardly from the sidewall (26) by a second radial extent (r2), and - - a circumferentially extending trim edge portion (60), which is located longitudinally between the first sealing rib (31) and the second sealing rib (41).

Description

[0001] Stopper for a Medicament Container and Medicament Container

[0002] Description

[0003] Field

[0004] The present disclosure relates to the field of medical devices, particularly to injection devices, such as syringes and in particular to prefilled syringes. Specifically, the present disclosure relates to stoppers for sealing a medicament container, such as cartridges or prefilled syringes.

[0005] Background

[0006] Drug delivery devices for setting and dispensing a single or multiple doses of a liquid medicament are as such well-known in the art. Generally, such devices have substantially a similar purpose as that of an ordinary syringe.

[0007] Drug delivery devices, such as pen-type injectors, have to meet a number of user-specific requirements. For instance, with patients suffering chronic diseases, such as diabetes, the patient may be physically infirm and may also have impaired vision. Suitable drug delivery devices especially intended for home medication therefore need to be robust in construction and should be easy to use. Furthermore, manipulation and general handling of the device and its components should be intelligible and easy understandable. Such injection devices should provide setting and subsequent dispensing of a dose of a medicament of equal or variable size. Moreover, a dose setting as well as a dose dispensing procedure must be easy to operate and has to be unambiguous.

[0008] Some drug delivery or injection devices provide selecting of a dose of a medicament of variable size and subsequent injecting of the dose previously set. Other injection devices provide setting and dispensing of a fixed dose. Here, the amount of medicament that should be injected in accordance to a given prescription schedule is always the same and does not change or cannot be changed over time.

[0009] Some injection devices are implemented as reusable injection devices offering a user to replace a medicament container, such as a cartridge. Other injection devices are implemented as a disposable injection device. With disposable injection devices it is intended to discard the i device when the content, i.e. the medicament, has been used up. Disposable injection devices may be prefilled with the injectable medicament.

[0010] Concentrated and highly efficient drug products, such as LI300 Insulin formulations, require precise dosing by pen devices to ensure safe administration of the medication by the patient. Dosing precision requirements are determined by pharmacopeias (e.g. PhEur, USP) and by ISO 11608. Specifically, for high-concentrated insulin formulations like LI300 (300U / mL), the administration of a minimum dose of 11I correlates to a very low volume of 3.33 pL that must be precisely delivered, as well as the last dose volume at the transition point with the requirement on its tolerance of only + / - 11I. Variability in performance of the cartridge system as functional element of pen devices may jeopardize dosing precision and needs to be under control.

[0011] It is therefore desirable to provide improvements to elastomeric stoppers for sealing medicament containers, such as cartridges or prefilled syringes.

[0012] Summary

[0013] In one aspect there is provided a stopper for a medicament container. The medicament container comprises a barrel with a cylindrically-shaped sidewall. The stopper is configured to be movably disposed inside the barrel. It may seal the interior of the barrel. Typically, the stopper is configured to seal a proximal longitudinal end of the interior of the barrel. The stopper comprises a stopper body of a generally cylindrical geometry. The stopper body comprises an elastomeric material, such as natural or synthetic rubber. The stopper body further comprises a first end surface at a first longitudinal end and a second end surface at a second longitudinal end. The first longitudinal end is opposite to the second longitudinal end.

[0014] The first longitudinal end may be also denoted or considered as a distal longitudinal end, e.g. facing in distal direction and hence towards an outlet of the medicament container when duly arranged inside the barrel of the medicament container. The second longitudinal end may be also denoted or considered as a proximal end of the stopper or stopper body.

[0015] The stopper body further comprises a sidewall. The sidewall extends between the first longitudinal end and a second longitudinal end. The sidewall may be of a generally cylindrical shape. Typically, the outer dimensions of the sidewall match or correspond to an inside diameter of the sidewall of the barrel in order to seal the barrel.

[0016] At least one of the first and the second and surfaces is a closed end surface. With some 1 surface of the stopper body is a closed end surface and the second end surface of the stopper body is also a closed end surface. A closed end surface is void or free of a recess or insert opening, e.g., to mechanically connect to a plunger. Rather, one of the first end surface and the second end surface may be particularly configured for a longitudinal abutment with a plunger or piston rod of an injection mechanism. The other one of the first end surface and the second end surface may be configured for confining the interior of the barrel. At least one of the first end surface and the second end surface may be a planar - shaped end surface, it may comprise a planar shape and may define or may extend in a transverse plane, which is substantially perpendicular to the longitudinal direction extending from the second end surface to the first end surface.

[0017] The stopper comprises a first sealing rib extending in circumferential direction and protruding radially outwardly from the sidewall by a first radial extent.

[0018] The stopper further comprises a second sealing rib, which is separated from the first sealing rib in longitudinal direction. Also, the second sealing rib extends in circumferential direction and protrudes radially outwardly from the sidewall by a second radial extent.

[0019] The stopper further comprises a circumferentially extending trim edge portion. The trim edge portion may be provided as a result of a trimming or cutting operation and hence a result of a mechanical separation of the stopper from an intermediate product during stopper manufacturing, wherein the intermediate product comprises a planar mat or a sheet of the rubber material. Here, the individual stoppers may partially protrude from a planar surface of the intermediate product, e.g. from a planar surface of the sheet and may have to be separated by a punching or cutting or trimming operation from the sheet. As a result, a circumferential portion of the sidewall of the stopper body will be provided with a circumferential trim edge portion.

[0020] Due to the trimming or cutting operation the trim edge portion may not qualify as a sealing rib. The geometric precision of a trimming or cutting operation is typically less than the geometric precision at which the sealing rib or sealing lip can be formed and / or manufactured. Typically, the geometric size of the sealing rib is defined by the geometric size of a cavity of a respective mold used for manufacturing or molding of the stoppers.

[0021] The trim edge portion is located longitudinally between the first sealing rib and the second sealing rib. In this way, the trim edge portion may not get in contact with the medicament because it is effectively shielded by at least one of the first sealing rib and the second sealing ' provide a sufficient seal between an outside surface of the stopper and the inside surface of the sidewall of the barrel.

[0022] With a trim edge portion located longitudinally between the first sealing rib and the second sealing rib there can be provided a rather symmetric stopper, which can be inserted into the barrel in two different orientations. In one orientation, the first sealing rib may be a front rib and the second sealing rib may be a rear rib. In another configuration the first sealing rib may be a rear rib, e.g. facing in proximal direction and the second sealing rib may be a front rib, e.g. facing in distal direction, hence towards the outlet of the barrel of the medicament container.

[0023] Providing the circumferentially extending trim edge portion longitudinally between the first sealing rib and the second sealing rib may not have an influence on the stopper orientation. In either orientation, the stopper may provide identical or substantially identical sealing capabilities as well as static and dynamic friction forces when moved relative to the barrel.

[0024] According to a further example the trim edge portion is located midway between the first longitudinal end and the second longitudinal end of the stopper body. Here, the first sealing rib may be arranged longitudinally offset from the trim edge portion along a first longitudinal direction and the second sealing rib may be located longitudinally offset from the trim edge portion along a second longitudinal direction, wherein first and second longitudinal directions point in opposite directions.

[0025] With the trim edge portion located midway between the first longitudinal end and the second longitudinal end of the stopper body there can be provided a substantially symmetric stopper profile as seen in longitudinal direction, wherein the trim edge portion may coincide or may be located at a longitudinal position, which is intersected by a transverse plane of symmetry of the stopper or stopper body. Such a stopper design is beneficial to use the stopper in either one of the two conceivable oppositely oriented configurations for insertion into the barrel. According to a further example the first sealing rib comprises a convex profile with a first apex section as seen in longitudinal direction. The apex section forms or constitutes a radially outermost section of the convex profile of the first sealing rib. At the apex section the sealing rib and / or in the sidewall of the stopper or stopper body comprises a maximum cross-section or a maximum diameter.

[0026] According to a further example, the second sealing rib comprises a convex profile with a second apex section as seen in longitudinal direction. Like the first apex section also the second apex section forms or constitutes a portion of the second sealing rib that defines or constitutes a •n or maximum diameter of the second sealing rib of the sidewall of the stopper body.

[0027] According to a further example, the stopper comprises a third sealing rib, which is separated from the first sealing rib and which is separated from the second sealing rib in longitudinal direction. The third sealing rib extends in circumferential direction and protrudes radially outwardly from the sidewall by a third radial extent by way of the third sealing rib, the sealing capability and hence the container closure integrity of a respective medicament container equipped with such a stopper can be improved.

[0028] According to a further example the third sealing rib comprises a convex profile with a third apex section as seen in longitudinal direction. Like any one of the first apex section and the second apex section, also the third apex section forms or constitutes a portion of the third sealing rib that defines or constitutes a maximum cross-section or maximum diameter of the third rib of the sidewall of the stopper body.

[0029] Generally, a convex profile of such apex sections is of particular benefit to provide a sufficient sealing with respect to a sidewall of the barrel of the medicament container while supporting and allowing a sliding motion of the stopper relative to the barrel at comparatively low friction forces between the stopper and the sidewall of the barrel of the container.

[0030] According to another example the trim edge portion comprises a maximum diameter, which is smaller than, equal to or larger than a maximum rib diameter of at least one of the first sealing rib, the second sealing and the optional third sealing rib. In some examples and for ease of manufacturing the trim edge portion may be slightly larger than any or each of the first sealing rib, the second sealing rib and the third sealing rib.

[0031] Here, a punching or cutting or trimming operation may be implemented by making use of a hollow cutting tool configured to receive the entirety of the outside surface of the stopper. Here and when the maximum diameter of the trim edge portion is larger than a maximum rib diameter of at least one of the first sealing rib, the second sealing rib and an optional third sealing rib, a punching, trimming or cutting operation can be conducted without touching or otherwise deteriorating or affecting the mechanical integrity of any one of the first sealing rib, the second sealing rib or the optional third sealing rib.

[0032] In other examples the trim edge portion may comprise a maximum diameter that is smaller than or equal to a maximum rib diameter of at least one of the first sealing rib, the second sealing rib sealing rib. Here, the maximum diameter of the trim edge portion may be smaller than or equal to each or any of a diameter of the first sealing rib, the second sealing rib and the optional third sealing rib.

[0033] Here, a respective cutting, trimming or punching may be obtained by laterally and / or radially outwardly extending or stretching the intermediate product, e.g. the rubber sheet containing or including numerous stoppers to become separated therefrom. Hence, a sheet of rubber material comprising numerous stoppers protruding from a planar surface of the sheet may be expanded or stretched radially outwardly with regard to the stopper geometry. In the stretched configuration the trimming or cutting operation can be conducted, which may then lead to a maximum diameter of the trim edge portion that is substantially smaller than a maximum rib diameter of at least one of the first sealing rib, the second sealing rib and the optional third sealing rib when the stopper relaxes into an unbiased or non-stretched configuration.

[0034] According to a further example the maximum diameter of the trim edge portion is smaller than the inner diameter of the sidewall of the barrel. In this way, the trim edge portion may not have an influence neither on the sealing capability nor to the static and / or dynamic friction forces that arise during or for moving the stopper relative to the barrel.

[0035] In another example the maximum diameter of the trim edge portion may be larger than the inner diameter of the sidewall of the barrel. However, the shape of the trim edge portion as well as the contact width of the trim edge portion may be in a range that has only a minimum influence on the container closure integrity and / or on the gliding or friction forces for moving the stopper relative to the barrel.

[0036] According to a further example, at least one of a first rib ratio R1 and a second rib ratio R2 is between 0.5 - 4. The first rib ratio R1 is defined by a radius of curvature rc1 of the first apex section divided by the first radial extent r1. The second rib ratio R2 is defined by a radius of curvature rc2 of the second apex section divided by the second radial extent r2.

[0037] With a rib ratio between 0.5 and 3 there can be provided improved sealing between the respective first or second sealing rib and the inside surface of the sidewall of the barrel. At the same time there can be provided comparatively low static and dynamic friction forces for moving the stopper in longitudinal direction relative to the barrel or barrel sidewall. Specifically, and by way of a convex profile of the first sealing rib and / or of the second sealing rib there can be provided a comparatively small contact width as seen in longitudinal direction between the first or second sealing rib and an inside surface of the sidewall of the barrel. Dntact surface and / or contact width may also reflect in a respective reduction of a contact pressure between the first sealing rib or second sealing rib and the inside surface of the sidewall of the barrel. With a comparatively low contact pressure there can be provided comparatively low friction forces for moving the stopper relative to the barrel, e.g. in the course of expelling the liquid medicament from the medicament container.

[0038] At the same time a convex shape of the first rib and / or of the second rib provides a sufficient and excellent sealing between the respective ribs and the inside of the sidewall of the barrel.

[0039] The specific stopper design as defined and described herein is beneficial to provide low friction forces and hence a good or excellent gliding effect between the stopper and the barrel of the medicament container. At the same time the sealing capability and specifically a container closure integrity as provided by the stopper body effectively sealing the medicament container can be provided and maintained over a comparatively long storage time or shelf life.

[0040] According to a further example at least one of the first rib ratio R1 and the second rib ratio R2 is between 1.5 - 2, between 1 - 1.5, between 1.25 - 1.4 or between 1.3 and 1.35.

[0041] In some examples the radius of curvature of at least one of the first sealing rib and the second sealing rib is in the region of the radial extent of the respective sealing rib by way of which the sealing rib protrudes radially outwardly from a longitudinally adjacent portion of the sidewall of the stopper body.

[0042] With a rib ratio R1 and / or R2 between 1 - 1.5 or between 1.25 - 1.4 there can be provided further improvements with regards to the sealing capability, with regards to the container closure integrity as well as with regards to a reduction of gliding forces or friction forces for moving the stopper relative to the barrel.

[0043] According to a further example a diameter body ratio of at least one of the first sealing rib and the second sealing rib is between 0.03 - 0.1. Here, the diameter ratio DR of a sealing rib may be defined by the radial extent of the respective sealing rib divided by a diameter of the stopper body sidewall. Hence, the diameter body ratio of the first sealing rib may be defined by the radial extent of the first sealing rib divided by the diameter of the body sidewall, e.g., by a minimum diameter of the sidewall. A diameter body ratio of the second sealing rib may be accordingly defined by the radial extent of the second sealing rib divided by the radial extent of the body side wall. ) of at least one of the sealing rib between 0.03 - 0.1 there can be provided a sufficient elasticity of the respective sealing rib, which may provide improved sealing capabilities in combination with low gliding forces and / or friction forces for moving the stopper relative to the barrel.

[0044] The diameter Ratio DR of a sealing rib may be also defined by the radial extent of the respective sealing rib divided by a diameter of the stopper body at a foot portion of a sealing rib. Accordingly, the diameter body ratio of the first sealing rib may be defined by the radial extent of the first sealing rib divided by a diameter of the sidewall of the body at the location of a foot or foot portion of the first sealing rib, e.g. a diameter of a sidewall portion of the body in direct longitudinal vicinity to the first rib. the same may be valid for the second sealing rib. Hence, the diameter body ratio of the second sealing rib may be defined by the radial extent of the second sealing rib divided by a diameter of the sidewall of the body at the location opposition of a foot or foot portion of the second sealing rib, e.g. by a diameter of a sidewall portion of the body, which is in direct longitudinal vicinity to the second rib.

[0045] Hene, the alternative definition of diameter body ratio DR may be also expressed by a ratio between a maximum diameter of a sealing rib minus a minimum diameter of the sealing rib divided by the minimum diameter of the sealing rib. Here, the minimum diameter of the sealing rib may coincide or may be defined by a minimum diameter of the sidewall of the stopper body. The minimum diameter of the sealing rib may be defined as a local minimum diameter of the sidewall of the stopper body longitudinally adjacent to the respective sealing rib.

[0046] According to another example, a maximum rib diameter may be about 7.1 mm and a diameter of the sidewall of the stopper body may be about 6.5 mm. Then, the differences in diameters between the maximum diameter of a sealing rib and the minimum diameter of the sealing rib or the (minimum) diameter of the sidewall is about 0.6 mm. Accordingly, the radial extent of the respective sealing rib is half of the diameter difference between the sealing rib and the sidewall and may be about 0.3 mm. With a diameter of the sidewall of about 6.5 mm the diameter body ratio may be about 0.046.

[0047] According to a further example the diameter body ratio DR of at least one of the first sealing rib and the second sealing rib is between 0.04 - 0.06. A sealing rib featuring a diameter body ratio DR between 0.04 - 0.06 exhibits comparatively low friction forces and comparatively low gliding forces while simultaneously providing a comparatively good container closure integrity.

[0048] In some examples, the first sealing rib and the second sealing rib may be substantially sy may comprise identical profiles. In other examples, the first sealing rib and the second sealing rib may distinguish from each other with regards to their geometric profile or geometric shape.

[0049] According to a further example a maximum rib diameter MRD of at least one of the first sealing rib and the second sealing rib in an uncompressed state of the stopper exceeds an inner diameter ID of the sidewall of the barrel by more than or equal to 0.1 than or equal to 0.4 mm. Of course, and since the stopper is made of an elastomeric material the stopper or stopper body as well as the sealing rib are compressible in radial direction to a particular extent so as to fit into the barrel only for a well-defined radial compression by way of which the sealing ribs sealingly engage with the inside surface of the sidewall of the barrel.

[0050] Specifically, the maximum rib diameter, i.e. the diameter of the sealing ribs in the region of the respective apex section exceeds the diameter of the inside surface of the sidewall of the barrel when in the uncompressed or initial state. The geometric radial oversize of the stopper body, in particular the radial geometrical oversize of the sealing ribs in radial direction compared to the inner diameter of the sidewall of the barrel defines the degree of radial compression of the sealing rib or stopper body that is required to arrange or to urge the stopper inside the barrel of the medicament container.

[0051] An oversize between 0.1 mm and 0.4mm provides an excellent container closure integrity between the stopper and the barrel of the medicament container. At the same time gliding forces as well as static and / or dynamic friction forces for moving the stopper relative to the barrel can be kept in a moderate or particularly low range.

[0052] According to a further example a maximum rib diameter MRD of at least one of the first sealing rib and the second sealing rib in an uncompressed state of the stopper exceeds an inner diameter ID of the sidewall of the barrel by more than or equal to 0.2 mm and less than or equal to 0.3 mm. In this parameter range for a radial geometric oversize there can be provided an improved container closure integrity and / or an improved sealing effect. At the same time and compared to a radial oversize of 0.4 mm there can be provided a reduction of gliding or friction forces for moving the stopper relative to the barrel of the sidewall.

[0053] In still another embodiment the radial oversize between the maximum rib diameter MRD of at least one of the first sealing rib and the second sealing rib in an uncompressed state of the stopper exceeds an inner diameter ID of the sidewall of the barrel by more than or equal to 0.25 mm and less than or equal to 0.3 mm. In this parameter range for the radial geometric oversize aling ribs the container closure integrity and hence the sealing capability of the stopper can be improved. Simultaneously, the gliding or friction forces can be reduced.

[0054] According to a further example a maximum rib diameter MRD of at least one of the first sealing rib and the second sealing rib in an uncompressed state of the stopper exceeds an inner diameter of the sidewall of the barrel by more than or equal to 0.2 mm and less than or equal to 0.25 mm.

[0055] Also here, improvements with regards to the container closure integrity as well as with regards to a reduction of gliding or friction forces can be provided and obtained.

[0056] In some examples the radial oversize of at least one of the first and the second sealing rib is in a region of 0.25 mm, wherein the sealing rib comprises a maximum diameter of 7.1 mm and wherein an inner diameter of the sidewall of the barrel is about 6.85 mm.

[0057] The radial sizes as mentioned herein are nominal sizes and may be subject to manufacturing tolerances. Here, and in some examples, the rib diameter of the stopper may be subject to tolerances of + / - 0.1 mm. With this example, or with further examples, the diameter of the barrel may be subject to tolerances not exceeding 0.05 mm.

[0058] According to a further example the sidewall of the stopper body comprises a first recessed sidewall portion extending in circumferential direction, adjoining the first sealing rib in longitudinal direction and comprising a concave profile as seen in longitudinal direction. The first recessed sidewall portion may be provided directly longitudinally adjacent to the first sealing rib. A radial extent of the sealing rib may be defined by the radial distance between the largest or maximum rib diameter and a minimum sidewall diameter at a bottom section of the recessed sidewall portion that adjoins longitudinally the respective sealing rib.

[0059] In some examples, the diameter of a bottom of the recessed sidewall portion is smaller than the inner diameter of the sidewall of the barrel. In this way, it can be guaranteed, that only the first sealing rib and / or the second sealing rib gets in direct mechanical contact with the inside surface of the cylindrically-shaped sidewall of the barrel. In this way there can be provided well- defined and comparatively low friction forces in combination with a sufficient sealing effect and a respective container closure integrity.

[0060] According to a further example the concave profile of the first recessed sidewall portion comprises a bottom section with a radius of curvature brc, which is 2 - 6 times larger than the :he first apex section of the first sealing rib. Such a radius of curvature of the bottom section of the recessed sidewall portion is of particular benefit to provide a well- defined profile directly adjacent to the sealing rib, which allows and supports a well-defined elastic deformation of the sealing rib when the sealing rib engages with the inside surface of the cylindrically-shaped sidewall of the barrel.

[0061] According to a further example the first recessed sidewall portion comprises a bottom section with a radius of curvature brc, which is 2.5 - 4 times larger than the radius of curvature of the first apex section.

[0062] In some examples a radius of curvature of the first apex section is smaller than 1 mm, smaller than 0.6 mm, smaller than 0.5 mm or smaller than or equal to 0.4mm. The radius of curvature of the first apex section is typically larger than 0.22 mm, larger 0.25 mm, larger than 0.3 mm or larger than 0.35 mm.

[0063] In some examples, the radius of curvature of the bottom section of a recessed sidewall portion is larger than 1 mm, 1.2 mm, larger 1.3 mm, larger than 1.5 mm or even larger than 2 mm.

[0064] In some examples the shape of the recessed sidewall portion may be symmetric as seen in longitudinal direction. In other examples the shape or profile of the recessed sidewall portion is asymmetric as seen in longitudinal direction.

[0065] According to a further example the first radial extent is defined by a radial distance between the first apex section of the first sealing rib and a bottom section of the first recessed sidewall portion and / or wherein the second radial extent is defined by a radial distance between the second apex section of the second sealing rib and the bottom section of the first recessed sidewall portion. In other examples and when the sidewall comprises also a second recessed sidewall portion longitudinally adjacent to the second sealing rib the second radial extent may be also defined by a radial distance between the second apex section of the second sealing rib and the bottom section of the second recessed sidewall portion.

[0066] For determining the radial extent of at least one of the first sealing rib and the second sealing rib those sidewall portions of the sidewall of the stopper body are regarded that comprises a maximum diameter in the region of the apex of the respective sealing rib and such sidewall portions of the sidewall that comprise a minimum diameter in a recessed portion longitudinally adjacent to the respective sealing rib. example the first recessed sidewall portion adjoins the first sealing rib along a first longitudinal direction. The first recessed sidewall portion adjoins the second sealing rib or adjoins a third sealing rib along a second longitudinal direction, which is opposite to the first longitudinal direction.

[0067] In other words, the first recessed sidewall portion may be located longitudinally between the first sealing rib and the second sealing rib or it may be located between the first sealing rib and an optional third sealing rib, which is located longitudinally between the first sealing rib and the second sealing rib.

[0068] In some examples, the sidewall of the stopper body may comprise an alternating arrangement of sealing ribs and recessed portions as seen in longitudinal direction.

[0069] In some examples, the first sealing rib may be arranged near or adjacent the first longitudinal end of the stopper body. Towards the second longitudinal end, the first sealing rib may transition into a first recessed sidewall portion. The first recessed sidewall portion may transition towards the proximal or second longitudinal end into or towards the second sealing rib.

[0070] Alternatively, and with other examples, wherein the stopper body comprises a first sealing rib, a second sealing rib and a third sealing rib, the third sealing rib is arranged longitudinally between the first sealing rib and the second sealing rib. Then, the first recessed sidewall portion is located between the first sealing rib and the third sealing rib. Between the third sealing rib and the second sealing rib there may be provided an optional second recessed sidewall portion.

[0071] According to another example the sidewall of the stopper body comprises a second recessed sidewall portion extending in circumferential direction. The second recessed sidewall portion adjoins the second sealing rib in longitudinal direction and comprises a concave profile as seen in longitudinal direction. In some examples, the second recessed sidewall portion may be somewhat identically or equivalently shaped compared to the first recessed sidewall portion.

[0072] According to a further example the first recessed sidewall portion adjoins the second sealing rib along the first longitudinal direction. The second recessed sidewall portion adjoins the second sealing rib along the second longitudinal direction, which is opposite to the first longitudinal direction. The same may apply to a third sealing rib. Here, the first recessed sidewall portion may adjoin the third sealing rib along the first longitudinal direction and the second recessed sidewall portion may adjoin the third sealing rib along the second longitudinal direction, which is opposite to the first longitudinal direction. jitudinal end of the first recessed sidewall portion may adjoin the first sealing rib and an opposite longitudinal end of the second recessed sidewall portion may adjoin or extend into the second sealing rib.

[0073] According to a further example the stopper comprises a third sealing rib extending in circumferential direction and protruding radially outwardly from the sidewall by a third radial extent. The third sealing rib comprises a convex profile with a third apex section as seen in longitudinal direction. The third sealing rib may be identically or correspondingly shaped compared to at least one of the first sealing rib and the second sealing rib.

[0074] In some examples, the first sealing rib, the second sealing rib and the third sealing rib are of substantial identical shape and / or structure. They may be separated from each other along the longitudinal direction of the sidewall of the stopper body.

[0075] According to another example the third sealing rib comprises a third rib ratio R3 defined by a radius of curvature of the third apex section divided by the third radial extent r3, wherein the third rib ratio R3 is between 0.5 - 4, between 1.5 - 2, between 1 - 1.5, between 1.25 - 1.4 or between 1.3 - 1.35.

[0076] In some examples, at least two of the rib ratios R1, R2, R3 are substantially identical. In other examples all three rib ratios R1, R2, R3 are identical.

[0077] According to a further example the first rib ratio R1 and the second rib ratio are identical. In a further example at least two of the first rib ratio, the second rib ratio and the third rib ratio are identical.

[0078] According to another example the stopper body is an individually injection molded stopper body. Hence, the entirety of the stopper body is directly produced and provided by injection molding. Here, the stopper body conforms the shape of a respective injection mold. Injection molding of individual stopper bodies, hence an individual injection molding of separate or individual stopper bodies does not require a manual separation of a stopper from an intermediate product, such as a rubber sheet comprising a large number of stopper bodies, which may be molded in a cavity sized to receive or to form a large number of such stopper bodies. A mold for producing injection moldable stoppers may comprise numerous wells or recesses, each of which being sized to form an individual stopper. Hence, in the present context and with individual injection molding it is meant that the demolded article does not have to be separated from other articles produced in the same injection molding process by way of a trimming or punching operation. nolded, in particular, individually injection molded stopper bodies, may be void of a trim edge portion.

[0079] Conventionally, stoppers for medicament containers are manufactured by filling a rubber material into a large number of cavities in a compression molding tool such that the rubber material entering the individual cavities and remains connected across the entirety of a row or array of molding cavities. Upon demolding and hence after removal of the intermediate product, e.g. in form of a sheet comprising stopper preforms, the individual stoppers as formed in individual cavities are mutually connected across the rubber sheet, which extends all over the area of the individual stopper cavities of the mold or molding tool.

[0080] After removing of the stopper sheet from a respective molding tool the individual stoppers have to be punched, cut or trimmed out of or from the rubber sheet.

[0081] With individually injection molded bodies such a separation can be avoided and the outside, specifically the sidewall of the stoppers can be void of a trim edge, which is otherwise compulsory for compression-molded stoppers initially provided as a part of a rubber sheet comprising a large number of such stoppers.

[0082] According to a further example the stopper comprises a spacer protruding from at least one of the first end surface and the second end surface. The spacer is formed by or coincides with an injection point of the injection molded stopper body. Typically, there may be provided at least two, three or even more spacers regularly or irregularly arranged on a planar end surface at at least one of the first longitudinal end and the second longitudinal end of the stopper body. Such spacers typically comprise a nipple-shaped protrusion of limited size and serve to prevent mutual adhesion of e.g. planar-shaped end faces of numerous stopper bodies when provided as bulk material in a mass manufacturing or mass assembly process.

[0083] Since the spacer protrudes from at least one of the first end surface and the second end surface they can be used to provide an injection point of the injection molded body for the injection molding process. Hence, the spacer and the injection point of the stopper body may be integrally formed or may be mutually integrated thereby avoiding generation of an injection point, e.g. at a sidewall of the stopper body, which may otherwise harm or alter the sealing capability and / or the static and / or dynamic friction between the stopper and the barrel.

[0084] According to a further example the trim edge portion is located at or near the first longitudinal end or the second longitudinal end. Here, it is preferred, that the longitudinal end, which is void n is oriented towards the distal end of the barrel and hence towards the outlet of the barrel of the medicament container. In this way it can be provided that the trim edge portion is furthest away from the liquid product located inside the barrel of the medicament container. The trim edge portion may be effectively sealed with respect to the liquid content of the medicament container by at least the first sealing rib and the second sealing rib.

[0085] According to some examples the trim edge portion comprises a planar profile, a concave profile or a convex profile as seen in longitudinal direction. The longitudinal profile of the trim edge portion may strongly depend on the trimming operation and / or the trimming process.

[0086] In some examples the trim edge portion may comprise a slanted profile or a skewed profile, which when oriented towards the medicament located inside the medicament container may be prone to ingress of air or other gaseous substances prior to or during a filling process of the medicament container. A trim edge portion oriented towards the distal end of the barrel of the medicament container may favor entrapment of air or other gaseous substances into the interior of the barrel before or during a filling process of the medicament container. Therefore, it is beneficial to arrange the trim edge portion at or near a proximal end of the stopper or to arrange the stopper with the trim edge portion proximally and hence away from the contained of the medicament container when inserting the stopper into the barrel of the medicament container.

[0087] In other examples and when the trim edge portion is located longitudinally between the first sealing rib and the second sealing rib, the trim edge portion can be effectively separated from a potential contact with the medicament.

[0088] According to a further example the stopper body comprises a symmetric profile in longitudinal direction with regards to a transverse plane located midway between the first longitudinal end and the second longitudinal end. The transverse plane may form or constitute a mirror axis with regards to which the stopper body is mirror symmetric.

[0089] Such a profile of the stopper body is suitable for an arbitrary insertion into the barrel of the medicament container. Here, any one of the first and second longitudinal ends of the stopper body can be used as a leading edge or trailing edge in view of the longitudinal movement of the stopper relative to the sidewall of the barrel in the course of expelling the liquid medicament from the medicament container.

[0090] According to a further example the first sealing rib is located at, located near or adjoins the first longitudinal end. The second sealing rib is located at, located near or adjoins the second an arrangement of first and second sealing ribs may be also beneficial for a symmetric stopper design, which is suitable for an arbitrarily oriented stopper insertion into the barrel of the medicament container.

[0091] According to a further example the first sealing rib adjoins the first longitudinal end by a first beveled sidewall section. Additionally or alternatively, the second sealing rib adjoins the second longitudinal end by a second beveled sidewall section. Beveled sidewall sections extending at a well-defined beveled angle relative to the longitudinal extent of the sidewall or relative to the longitudinal direction of the cylindrically-shaped stopper may facilitate insertion of the stopper into the barrel of the medicament container upon assembly of preparation of the medicament container. The beveled section may provide a radial self-centering of the stopper relative to the barrel sidewall upon insertion of the stopper into the barrel.

[0092] In some examples, wherein the stopper body comprises only one beveled sidewall section at one of the two longitudinal ends, the beveled sidewall section may provide a symmetry breaking feature and may therefore define a distal end of the stopper body. Here, the distal end of the stopper body may be that longitudinal end of the stopper, which is provided with the beveled sidewall section. The distal longitudinal end of the stopper body is typically configured to get in contact with the medicament located inside the barrel. It may face towards the distal end of the barrel, which may be provided with an outlet for the medicament. Providing of the distal end of the stopper body with a beveled sidewall section towards the distal end may facilitate insertion of the stopper into the barrel from a proximal open end of the barrel towards the distal direction. Here, the beveled sidewall section provides a kind of a radial and / or self-centering guiding function.

[0093] According to a further example at least one of the first beveled sidewall section and the second beveled sidewall section extends at a beveled angle (a) relative to the longitudinal direction, wherein 15° < a < 65°, or wherein 15° < a < 45°, or wherein 20° < a < 40°.

[0094] According to another example the stopper body comprises a shore A hardness between 45-65, between 45-55, or between 47-50. In some examples the shore A hardness is below 50. Accordingly, the stopper material is comparatively soft and elastically deformable rather easily. Such a rather soft material in combination with the specific profile of the at least first and second sealing ribs provides an improved container closure integrity together with low gliding or friction forces for a stopper movement relative to the barrel of the medicament container.

[0095] According to some examples, an outside surface of the stopper may be lubricated and / or may ricant, e.g., a lubricant coating, such as silicone oil or the like lubricants.

[0096] According to further examples the inside surface of the sidewall of the barrel may be likewise lubricated and / or may be provided with a lubricant, e.g., a lubricant coating, which may comprise silicone oil or the like lubricants.

[0097] According to a further example the stopper body comprises butyl rubber or is entirely made of butyl rubber. In some examples the stopper body may be made of a single and / or homogeneous rubber material. The stopper body and hence the entire stopper may be integrally formed or constituted by the stopper body. The first and second sealing ribs may be integral portions of the stopper body. The stopper and / or the stopper body is a single part of single component of the medicament container.

[0098] According to a further example the stopper body comprises at least one of a bromobutyl rubber and a chlorobutyl rubber or is almost entirely made of a bromobutyl rubber or a chlorobutyl rubber. Both rubber materials provide excellent sealing capabilities as well as sufficient and well-defined gliding and friction forces with regards to the cylindrically-shaped sidewall of the barrel.

[0099] According to a further example the sidewall of the stopper as described herein is provided with a lubricant, such as a silicone oil, an x-linked silicone oil or any other lubricant coating or lubricant layer, e.g. comprising a flouroresin film, such as PTFE. Hence, an outermost surface of at least one of the first sealing rib and the second sealing rib may be provided with a lubricant or lubricating structure to reduce friction with the inside sidewall of the barrel.

[0100] In another example at least one of the longitudinal end faces of the stopper body may comprise a barrier layer of barrier membrane provided on the rubber material of the bulk of the stopper body. Typically, a contact side of the stopper body may be provided with such a barrier layer or barrier membrane. The barrier layer or barrier membrane may comprise a fluororesin film, e.g. a ethylene - tetraflouroethylene (ETFE) layer or ETFE membrane.

[0101] In some examples, only the distal end face of the stopper body may be provided with a barrier layer or barrier membrane. In further examples, both, the distal end face and the proximal end face of the stopper body may be provided with a barrier layer of barrier membrane.

[0102] According to another aspect the present disclosure further relates to a medicament container.

[0103] The medicament container comprises a barrel with a cylindrically-shaped sidewall and a stopper he stopper is arranged inside the barrel and is movable relative to the sidewall along the longitudinal direction of the barrel. The stopper seals the interior of the barrel in a fluid-tight manner.

[0104] Insofar, all features, effects and benefits as described above in connection with the stopper equally apply to the medicament container; and vice versa.

[0105] According to a further example the barrel is made of glass or the barrel comprises one of a cyclic olefin polymer (COP) or a cyclic olefin copolymer (COC). These materials exhibit and provide excellent sealing capabilities in combination with a rubber stopper. They can be manufactured with sufficient precision. Furthermore, these materials are substantially chemically or pharmaceutically inert with regard to the medicament, e.g. the liquid medicament to be stored inside the barrel of the medicament container.

[0106] According to a further example production tolerances of an inner diameter of the sidewall of the barrel are smaller than or equal to + / - 0.05 mm or smaller than or equal to + / - 0.02 mm. These rather small tolerances in combination with the geometric oversize of the sealing rib(s) of the stopper compared to the inner diameter of the sidewall of the barrel provide and guarantee sufficient sealing capability and hence a sufficient container closure integrity in combination with comparatively small gliding or friction forces for moving the stopper relative to the barrel, e.g. in the course of expelling the medicament from the medicament container.

[0107] According to another example a contact surface between an inside of the sidewall of the barrel and at least one of the first sealing rib and the second sealing rib of the stopper is less than 10 mm2, less than 9 mm2or less than 8 mm2per sealing rib. Such comparatively small contact surfaces are of particular benefit to provide low gliding forces as well as comparatively low static and dynamic friction forces for moving the stopper relative to the barrel.

[0108] According to a further example a contact surface between an inside of the sidewall of the barrel and the sum of all sealing ribs and an optional trim edge of the stopper is less than 55 mm2, less than 50 mm2, less than 45 mm2, less than 35 mm2, less than 30 mm2or less than 26 mm2. Accordingly, and with such a small contact surface between that portions or sections of the sidewall of the stopper body that get in contact with the inside of the sidewall of the barrel there can be provided improvements with regard to comparatively low friction forces and gliding forces for moving the stopper relative to the barrel.

[0109] According to a further example a contact width between an inside of the sidewall of the barrel first sealing rib and the second sealing rib as seen in longitudinal direction is less than 0.45 mm, less than 0.42 mm, less than 0.4 mm, less than 0.38 mm or less than 0.37 mm. The contact width may be larger than 0.3 mm or larger than 0.35 mm. A comparatively short or small contact width between the inside of the sidewall of the barrel and the outside of at least one of the first, the second and optional third sealing ribs is beneficial to provide comparatively low friction forces or gliding forces for moving the stopper relative to the barrel, e.g. in the course of expelling of the medicament from the medicament container.

[0110] According to a further example a contact pressure between an inside of the sidewall of the barrel and at least one of the first sealing rib and a second sealing rib of the stopper is larger than or equal to 0.10 MPa and smaller than or equal to 0.70 MPa per sealing rib. The contact pressure can be defined or obtained via a finite element analysis and / or by respective finite element models configured to simulate friction forces and / or contact pressure between the sidewall of the stopper body and the sidewall of the barrel.

[0111] In further examples, the contact pressure between the inside of the sidewall of the barrel and at least one of the first sealing rib and the second sealing rib of the stopper is larger than or equal to 0.13 MPa, larger than or equal to 0.20 MPa, larger than or equal to 0.30 MPa, larger than or equal to 0.40 MPa, or larger than or equal to 0.45 MPa per sealing rib.

[0112] According to a further example the contact pressure between an inside of the sidewall of the barrel and at least one of the first sealing rib and the second sealing rib of the stopper is larger than or equal to 0.46 MPa and smaller than or equal to 0.66 MPa per sealing rib A contact pressure in this range is beneficial to provide a sufficient container closure integrity between the stopper and the barrel of the medicament container in combination with low gliding and / or friction forces.

[0113] According to a further example a total contact force between an inside of the sidewall of the barrel and the sum of all sealing ribs and an optional trim edge of the stopper is less than 20 N, less than 16 N, less than 13 N, less than 10 N or less than 9 N. Such a comparatively small total contact force is beneficial to provide an easy gliding at low friction forces between the stopper and the barrel.

[0114] Moreover, with reduced contact forces the demand with respect to a mechanical stability of the barrel can be also reduced, which may allow to reduce the thickness of the sidewall of the barrel in order to reduce costs and weight of the medicament container. example of the medicament container barrel comprises an outlet at a longitudinal distal end. The stopper seals the interior of the barrel towards a longitudinal proximal direction or towards a longitudinal proximal end. For expelling a dose or the entirety of the medicament from the medicament container the stopper has to be displaced, i.e. longitudinally displaced relative to the barrel from a proximal start position towards a distal end position and hence towards the outlet at the longitudinal distal end of the barrel.

[0115] In some examples of the medicament container the outlet of the medicament container comprises a pierceable seal. The pierceable seal may be provided at a radially narrowed neck or head portion of the barrel. The pierceable seal may comprise a septum, e.g. a rubber septum pierceable by an injection needle or the like cannula. The pierceable seal may be held in place at the outlet of the barrel by way of a fastener, such as a crimped metal cap. The medicament container may be implemented as a medicament cartridge, e.g. for use with a pen-type injector.

[0116] According to a further example the outlet of the medicament container is provided with or comprises an injection needle. The injection needle may be non-detachably or detachably fastened to the outlet or may be integrated into the outlet of the medicament container. Here, the medicament container may be implemented as a pre-filled syringe.

[0117] The stopper of the medicament container may be readily attached with a plunger or may be attachable to a plunger or may be simply engageable with a plunger by way of which a user may apply a distally directed pressure or force effect onto the stopper relative to the barrel in order to move the stopper towards the outlet of the medicament container.

[0118] In a further example the medicament container is filled with an injectable medicament. It may be filled with a liquid medicament.

[0119] The present disclosure relates to a specific design of the plunger stopper in consideration of the requirements for low glide force, manufacturability, and processing, but maintaining container closure integrity for the sealing function of the stopper. Specifically, the plunger stopper design provides a reduced contact area, a contact pressure of 0.1 - 1.0 MPa, and a radial force of 3 - 20 N to the barrel. From standard square-shaped sealing ribs the design is changed to smaller round-shaped sealing ribs. Further, the position of the trim-edge is moved from a standard onesided design to a centered design and with an improved control of the dimension of the trim diameter, not to extend the diameter of the sealing ribs.

[0120] Furthermore, the geometric overlap of the sealing ribs with the glass barrel is tightened to a nm - 0.20 mm and the allowed variation of inner diameter of the cartridge is limited to + / - 0.05mm. As a result, the cartridge or barrel system shows enlarged tolerance to variability in lubrication of the glass barrel, low and constant dosing forces, and matches with the required high precision of dosing according to ISO 11608 and pharmacopeial requirements

[0121] It is to be noted that the present disclosure is in no way limited by the claims or by the above and below described examples. Moreover, numerous variations of the stopper and / or of the medicament container that are within the present disclosure will be defined and will be apparent by the following clauses and their mutual combinations.

[0122] Clause 1 A stopper (20) for a medicament container (10), wherein the medicament container comprises barrel (11) with a cylindrically-shaped sidewall (12), the stopper (20) comprising: a stopper body (21) of generally cylindrical geometry and comprising an elastomeric material, the stopper body (21) further comprising a first end surface (24) at a first longitudinal end (22) and a second end surface (25) at a second longitudinal end (23) and a sidewall (26) extending between the first longitudinal end (22) and the second longitudinal end (23), a first sealing rib (31) extending in circumferential direction and protruding radially outwardly from the sidewall (26) by a first radial extent (r1), a second sealing rib (41) separated from the first sealing rib in longitudinal direction, extending in circumferential direction and protruding radially outwardly from the sidewall (26) by a second radial extent (r2),

[0123] Clause 2 The stopper (20) according to clause 1 , wherein the first end surface (24) and the second end surface (25) each comprise a closed end surface.

[0124] Clause 3 The stopper (20) according to any one of the preceding clauses, wherein the first sealing rib (31) comprises a convex profile (32) with a first apex section (33) as seen in longitudinal direction (z).

[0125] Clause 4 The stopper (20) according to any one of the preceding clauses, wherein the second sealing rib (41) comprises a convex profile (42) with a second apex section (43) as seen in longitudinal direction (z).

[0126] Clause 5 The stopper (20) according to any one of the preceding clauses, wherein at least one of a first rib ratio (R1) and a second rib ratio (R2) is between 0.5 - 4, wherein the first rib ratio (R1) is defined by a radius of curvature (rc1) of the first apex section (33) divided by the and wherein the second rib ratio (R2) is defined by a radius of curvature (rc2) of the second apex section (43) divided by the second radial extent (r2).

[0127] Clause 6 The stopper according to any one of the preceding clauses, wherein at least one of the first rib ratio (R1) and the second rib ratio (R2) is between 1 - 1.5, between 1.25 - 1.4 or between 1.3 and 1.35.

[0128] Clause 7. The stopper (20) according to any one of the preceding clauses, wherein a diameter body ratio (DR) of at least one of the first sealing rib (31) and the second sealing rib (41) is between 0.03 - 0.1 , wherein the diameter body ratio (DR) is defined by the radial extent (r1, r2) of the first or second sealing rib (31 , 41) divided by the diameter (D) of the sidewall (26).

[0129] Clause 8 The stopper (20) according to clause 7, wherein the diameter body ratio (DR) of at least one of the first sealing rib (31) and the second sealing rib (41) is between 0.04 - 0.06.

[0130] Clause 9. The stopper (20) according to any one of the preceding clauses, wherein a maximum rib diameter (MRD) of at least one of the first sealing rib (31) and the second sealing rib (41) in an uncompressed state of the stopper (20) exceeds an inner diameter (ID) of the sidewall (12) of the barrel (11) by more than or equal to 0.1 mm and less than or equal to 0.4 mm.

[0131] Clause 10. The stopper (20) according to any one of the preceding clauses, wherein a maximum rib diameter (MRD) of at least one of the first sealing rib (31) and the second sealing rib (41) in an uncompressed state of the stopper (20) exceeds an inner diameter (ID) of the sidewall (12) of the barrel (11) by more than or equal to 0.2 mm and less than or equal to 0.3 mm.

[0132] Clause 11. The stopper (20) according to any one of the preceding clauses, wherein a maximum rib diameter (MRD) of at least one of the first sealing rib (31) and the second sealing rib (41) in an uncompressed state of the stopper (20) exceeds an inner diameter (ID) of the sidewall (12) of the barrel (11) by more than or equal to 0.25 mm and less than or equal to 0.3 mm.

[0133] Clause 12 The stopper (20) according to any one of the preceding clauses, wherein a maximum rib diameter (MRD) of at least one of the first sealing rib (31) and the second sealing rib (41) in an uncompressed state of the stopper (20) exceeds an inner diameter (ID) of the rrel (11) by more than or equal to 0.2 mm and less than or equal to 0.25 mm.

[0134] Clause 13 The stopper (20) according to any one of the preceding clauses, wherein the sidewall (26) comprises a first recessed sidewall portion (34) extending in circumferential direction, adjoining the first sealing rib (31) in longitudinal direction (z) and comprising a concave profile (35) as seen in longitudinal direction (z).

[0135] Clause 14 The stopper (20) according to clause 13, wherein the concave profile (35) of the first recessed sidewall portion (34) comprises a bottom section (36) with a radius of curvature (brc), which is 2 - 6 times larger than the radius of curvature (rc1) of the first apex section (33).

[0136] Clause 15 The stopper (20) according to clause 13 or 14, wherein the concave profile (35) of the first recessed sidewall portion (34) comprises a bottom section (36) with a radius of curvature (brc), which is 2.5 - 4 times larger than the radius of curvature (rc1) of the first apex section (33).

[0137] Clause 16. The stopper (20) according to any one of the clauses 13 - 15, wherein the first radial extent (r1) is defined by a radial distance between the first apex section (33) of the first sealing rib (31) and the bottom section (36) of the first recessed sidewall portion (34) and / or wherein the second radial extent (r2) is defined by a radial distance between the second apex section (43) of the second sealing rib (41) and the bottom section (36) of the first recessed sidewall portion (34).

[0138] Clause 17 The stopper (20) according to any one of the clauses 13 - 16, wherein the first recessed sidewall portion (34) adjoins the first sealing rib (31) along a first longitudinal direction (2) and adjoins one of the second sealing rib (41) and the optional third sealing rib (51) along a second longitudinal direction (3), which is opposite to the first longitudinal direction (2).

[0139] Clause 18 The stopper (20) according to any one of the clauses 13 - 17, wherein the sidewall (26) comprises a second recessed sidewall portion (44) extending in circumferential direction, adjoining the second sealing rib (41) in longitudinal direction (z) and comprising a concave profile (45) as seen in longitudinal direction (z).

[0140] Clause 19 The stopper (20) according to clause 18, wherein the first recessed sidewall portion (34) adjoins the second sealing rib (41) along the first longitudinal direction (2) and cessed sidewall portion (44) adjoins the second sealing rib (41) along the second longitudinal direction (3), which is opposite to the first longitudinal direction (2).

[0141] Clause 20 The stopper (20) according to any one of the preceding clauses, wherein the stopper (20) comprises a third sealing rib (51) extending in circumferential direction and protruding radially outwardly from the sidewall (26) by a third radial extent (r3) and comprising a convex profile (52) with a third apex section (53) as seen in longitudinal direction (z).

[0142] Clause 21 The stopper (20) according to clause 20, wherein the third sealing rib (51) comprises a third rib ratio (R3) defined by a radius of curvature of the third apex section (53) divided by the third radial extent (r3), wherein the third rib ratio (R3) is between 0.5 - 4, between 1.5 - 2, between 1 - 1.5, between 1.25 - 1.4 or between 1.3 and 1.35.

[0143] Clause 22 The stopper (20) according to any one of the preceding clauses, wherein the first rib ratio R1 and the second rib ratio R2 are identical.

[0144] Clause 23 The stopper (20) according to any one of the clause 5, wherein at least two of the first rib ratio (R1), the second rib ratio (R2) and the third rib ratio (R3) are identical.

[0145] Clause 24 The stopper (20) according to any one of the preceding clauses, wherein the stopper body (21) is an individually injection molded body (21).

[0146] Clause 25 The stopper (20) according to clause 24, wherein the stopper body (21) is void of a trim edge portion (60).

[0147] Clause 26 The stopper (20) according to clause 24 or 25, further comprising a spacer (29) protruding from at least one of the first end surface (24) and the second end surface (25) and wherein the spacer (29) is formed by or coincides with an injection point of the injection molded body (21).

[0148] Clause 27 The stopper (20) according to any one of the preceding clauses 1 - 23, wherein the sidewall (26) comprises a circumferentially extending trim edge portion (60).

[0149] Clause 28 The stopper (20) according to clause 27, wherein the trim edge portion (60) is located longitudinally between the first sealing rib (31) and the second sealing rib (41). pper (20) according to clause 27 or 28, wherein the trim edge portion (60) is located midway between the first longitudinal end (22) and the second longitudinal end (23) of the stopper body (21).

[0150] Clause 30 The stopper (20) according to any of the clauses 27 - 29, wherein the trim edge portion (60) is located at or near the first longitudinal end (22) or the second longitudinal end (23).

[0151] Clause 31 The stopper (20) according to any one of the clauses 27 - 30, wherein the trim edge portion (60) comprises a maximum diameter (TMD), which is smaller than, equal to or larger than a maximum rib diameter (MRD) of at least one of the first sealing rib (31), the second sealing rib (41) and an optional third sealing rib (51).

[0152] Clause 32 The stopper (20) according to any one of the preceding clauses 27 - 30, wherein the maximum diameter (TMD) of the trim edge portion (60) is smaller than the inner diameter (ID) of the sidewall (12) of the barrel (11).

[0153] Clause 33 The stopper (20) according to any one of the preceding clauses, wherein the stopper body (21) comprises a symmetric profile in longitudinal direction (z) with regards to a transverse plane located midway between the first longitudinal end (22) and the second longitudinal end (23).

[0154] Clause 34 The stopper (20) according to any one of the preceding clauses, wherein the first sealing rib (31) is located at, is located near or adjoins the first longitudinal end (22) and wherein the second sealing rib (41) is located at, is located near or adjoins the second longitudinal end (23).

[0155] Clause 35 The stopper (20) according to clause 30, wherein the first sealing rib (31) adjoins the first longitudinal end (22) via a first beveled side wall section (27) and / or wherein the second sealing rib (41) adjoins the second longitudinal end (23) via a second beveled sidewall section (28).

[0156] Clause 36 The stopper (20) according to clause 35, wherein at least one of the first beveled sidewall section (27) and the second beveled sidewall section (28) extends at a beveled angle (a) relative to the longitudinal direction (z), wherein 15° < a < 65°, or wherein 15° < a < 45°, or wherein 20° < a < 40°. pper (20) according to any one of the preceding clauses, wherein the stopper body (21) comprises a shore A hardness between 45-65, between 45-55, or between 47-50.

[0157] Clause 38 The stopper (20) according to any one of the preceding clauses, wherein the stopper body (21) comprises butyl rubber or is entirely made of a butyl rubber.

[0158] Clause 39 The stopper (20) according to clause 38, wherein the stopper body (21) comprises at least one of a bromobutyl rubber and a chlorobutyl rubber or is entirely made of one of a bromobutyl rubber or a chlorobutyl rubber.

[0159] Clause 40 The stopper (20) according to any one of the preceding clauses, wherein the sidewall (26) comprises a friction reducing coating or friction reducing laminate.

[0160] Clause 41 A medicament container (10) comprising: a barrel (11) with a cylindrically-shaped sidewall (12), and a stopper (20) according to any one of the preceding clauses arranged inside the barrel (11) and movable relative to the sidewall (12) along the longitudinal direction of the barrel (11).

[0161] Clause 42 The medicament container (10) according to clause 41 , wherein the barrel (11) is made of glass or wherein the barrel (11) is made of a cyclic olefin polymer (COP) or a cyclic olefin copolymer (COC).

[0162] Clause 43 The medicament container (10) according to clause 41 or 42, wherein production tolerances of an inner diameter (ID) of the sidewall (12) of the barrel (11) are smaller than or equal to + / - 0.05 mm or smaller than or equal to + / - 0.02 mm.

[0163] Clause 44 The medicament container (10) according to any one of the preceding clauses 41

[0164] - 43, wherein a contact surface between an inside of the sidewall (12) of the barrel (11) and at least one of the first sealing rib (31) and the second sealing rib (41) of the stopper (20) is less than 10 mm2, less than 9 mm2, or less than 8 mm2per sealing rib (31 , 41).

[0165] Clause 45 The medicament container (10) according to any one of the preceding clauses 41

[0166] - 44, wherein a contact surface between an inside of the sidewall (12) of the barrel (11) and the sum of all sealing ribs (31 , 41 , 51) and an optional trim edge (60) of the stopper (20) is less than 55 mm2, less than 50 mm2, less than 45 mm2, less than 35 mm2, less than 30 mm2or less than dicament container (10) according to any one of the preceding clauses 41

[0167] - 45, wherein a contact width between an inside of the sidewall (12) of the barrel (11) and at least one of the first sealing rib (31) and the second sealing rib (41) as seen in longitudinal direction (z) is less than 0.45 mm, less than 0.42 mm, less than 0.40 mm, less than 0.38 mm or less than 0.37 mm.

[0168] Clause 47 The medicament container (10) according to any one of the preceding clauses 41

[0169] - 46, wherein a contact pressure between an inside of the sidewall (12) of the barrel (11) and at least one of the first sealing rib (31) and the second sealing rib (41) of the stopper (20) is larger than or equal to 0.10 MPa and smaller than or equal to 0.70 MPa per sealing rib (31 , 41).

[0170] Clause 48 The medicament container (10) according to any one of the preceding clauses 41

[0171] - 47, wherein the contact pressure between an inside of the sidewall (12) of the barrel (11) and at least one of the first sealing rib (31) and the second sealing rib (41) of the stopper (20) is larger than or equal to 0.46 MPa and smaller than or equal to 0.66 MPa per sealing rib (31 , 41).

[0172] Clause 49 The medicament container (10) according to any one of the preceding clauses 41

[0173] - 48, wherein a total contact force between an inside of the sidewall (12) of the barrel (11) and the sum of all sealing ribs (31 , 41 , 51) and an optional trim edge (60) of the stopper (20) is less than 20 N, less than 16 N, less than 13 N, less than 10 N or less than 9 N.

[0174] Clause 50 The medicament container (10) according to any one of the preceding clauses 41

[0175] - 49, wherein the barrel (11) comprises an outlet (14) at a longitudinal distal end (15) and wherein the stopper (20) seals an interior (13) of the barrel (11) towards a longitudinal proximal direction (3).

[0176] Clause 51 The medicament container (10) according to clause 46, wherein the outlet (14) comprises a pierceable seal (19).

[0177] Clause 52 The medicament container (10) according to clause 50, wherein the outlet (14) is provided with or comprises an injection needle (6).

[0178] Clause 53 The medicament container (10) according to any one of the preceding clauses 41

[0179] - 52, wherein the barrel is filled with an injectable medicament (5). er (20) for a medicament container (10), wherein the medicament container comprises barrel (11) with a cylindrically-shaped sidewall (12), the stopper (20) comprising: a stopper body (21) of generally cylindrical geometry and comprising an elastomeric material, the stopper body (21) further comprising a first end surface (24) at a first longitudinal end (22) and a second end surface (25) at a second longitudinal end (23) and a sidewall (26) extending between the first longitudinal end (22) and the second longitudinal end (23), a first sealing rib (31) extending in circumferential direction and protruding radially outwardly from the sidewall (26), a second sealing rib (41) separated from the first sealing rib in longitudinal direction, extending in circumferential direction and protruding radially outwardly from the sidewall (26), a circumferentially extending trim edge portion (60) located longitudinally between the first sealing rib (31) and the second sealing rib (41).

[0180] Clause 55 The stopper (20) according to clause 54, wherein the trim edge portion (60) comprises a maximum diameter (TMD), which is smaller than, equal to or larger than a maximum rib diameter (MRD) of at least one of the first sealing rib (31), the second sealing rib (41) and an optional third sealing rib (51)

[0181] Clause 56 The stopper (20) according to clause 54 or 55, wherein the maximum diameter (TMD) of the trim edge portion (60) is smaller than the inner diameter (ID) of the sidewall (12) of the barrel (11).

[0182] Clause 57 The stopper (20) according to clause 54 or 55, wherein the stopper (20) comprises a third sealing rib (51) extending in circumferential direction and protruding radially outwardly from the sidewall (26).

[0183] Clause 58 The stopper (20) according to clause 57, wherein the third sealing rib (31) is located longitudinally between the first sealing rib (31) and the second sealing rib (41).

[0184] Clause 59 The stopper (20) according to clause 57 or 58, wherein the trim edge portion (60) is located longitudinally between the first sealing rib (31) and the third sealing rib (51) or wherein the trim edge portion (60) is located longitudinally between the second sealing rib (41) and the third sealing rib (51).

[0185] Clause 60 A medicament container (10) comprising: a barrel (11) with a cylindrically-shaped sidewall (12), and arranged inside the barrel (11) and movable relative to the sidewall (12) along the longitudinal direction of the barrel (11), wherein the stopper comprises: a stopper body (21) of generally cylindrical geometry and comprising an elastomeric material, the stopper body (21) further comprising a first end surface (24) at a first longitudinal end (22) and a second end surface (25) at a second longitudinal end (23) and a sidewall (26) extending between the first longitudinal end (22) and the second longitudinal end (23), a first sealing rib (31) extending in circumferential direction and protruding radially outwardly from the sidewall (26), a second sealing rib (41) separated from the first sealing rib in longitudinal direction, extending in circumferential direction and protruding radially outwardly from the sidewall (26), wherein a maximum rib diameter (MRD) of at least one of the first sealing rib (31) and the second sealing rib (41) in an uncompressed state of the stopper (20) exceeds an inner diameter (ID) of the sidewall (12) of the barrel (11) by more than or equal to 0.25 mm and less than or equal to 0.3 mm.

[0186] Clause 61 The medicament container (10) according to clause 60, wherein the maximum rib diameter (MRD) of at least one of the first sealing rib (31) and the second sealing rib (41) in an uncompressed state of the stopper (20) exceeds an inner diameter (ID) of the sidewall (12) of the barrel (11) by more than or equal to 0.2 mm and less than or equal to 0.25 mm.

[0187] Clause 62 The medicament container (10) according to any one of the clauses 60 - 61 , wherein a maximum rib diameter (MRD) of at least one of the first sealing rib (31) and the second sealing rib (41) in an uncompressed state of the stopper (20) exceeds an inner diameter (ID) of the sidewall (12) of the barrel (11) by more than or equal to 0.25 mm and less than or equal to 0.3 mm.

[0188] Clause 63 The medicament container (10) according to any one of the clauses 60- 62, wherein a maximum rib diameter (MRD) of at least one of the first sealing rib (31) and the second sealing rib (41) in an uncompressed state of the stopper (20) exceeds an inner diameter (ID) of the sidewall (12) of the barrel (11) by more than or equal to 0.2 mm and less than or equal to 0.25 mm.

[0189] Clause 64 The medicament container (10) according to any one of the clauses 60 - 63, wherein production tolerances of an inner diameter (ID) of the sidewall (12) of the barrel (11) are smaller than or equal to + / - 0.05 mm or smaller than or equal to + / - 0.02 mm. :ament container (10) comprising: a barrel (11) with a cylindrically-shaped sidewall (12), and a stopper (20) arranged inside the barrel (11) and movable relative to the sidewall (12) along the longitudinal direction of the barrel (11), wherein the stopper comprises: a stopper body (21) of generally cylindrical geometry and comprising an elastomeric material, the stopper body (21) further comprising a first end surface (24) at a first longitudinal end (22) and a second end surface (25) at a second longitudinal end (23) and a sidewall (26) extending between the first longitudinal end (22) and the second longitudinal end (23), a first sealing rib (31) extending in circumferential direction and protruding radially outwardly from the sidewall (26), a second sealing rib (41) separated from the first sealing rib in longitudinal direction, extending in circumferential direction and protruding radially outwardly from the sidewall (26), wherein: a) a contact surface between an inside of the sidewall (12) of the barrel (11) and at least one of the first sealing rib (31) and the second sealing rib (41) of the stopper (20) is less than 10 mm2, less than 9 mm2, or less than 8 mm2per sealing rib (31 , 41), and / or b) a contact surface between an inside of the sidewall (12) of the barrel (11) and the sum of all sealing ribs (31 , 41 , 51) and an optional trim edge (60) of the stopper (20) is less than 55 mm2, less than 50 mm2, less than 45 mm2, less than 35 mm2, less than 30 mm2or less than 26 mm2and / or c) a contact width between an inside of the sidewall (12) of the barrel (11) and at least one of the first sealing rib (31) and the second sealing rib (41) as seen in longitudinal direction (z) is less than 0.45 mm, less than 0.42 mm, less than 0.40 mm, less than 0.38 mm or less than 0.37 mm and / or d) a contact pressure between an inside of the sidewall (12) of the barrel (11) and at least one of the first sealing rib (31) and the second sealing rib (41) of the stopper (20) is larger than or equal to 0.10 MPa and smaller than or equal to 0.70 MPa per sealing rib (31 , 41) and / or e) a contact pressure between an inside of the sidewall (12) of the barrel (11) and at least one of the first sealing rib (31) and the second sealing rib (41) of the stopper (20) is larger than or equal to 0.46 MPa and smaller than or equal to 0.66 MPa per sealing rib (31 , 41) and / or ;ontact force between an inside of the sidewall (12) of the barrel (11) and the sum of all sealing ribs (31, 41 , 51) and an optional trim edge (60) of the stopper (20) is less than 20 N, less than 16 N, less than 13 N, less than 10 N or less than 9 N.

[0190] Generally, the scope of the present disclosure is defined by the content of the claims. The disclosure is not limited to specific embodiments or examples but comprises any combination of elements of different embodiments or examples. Insofar, the present disclosure covers any combination of claims and any technically feasible combination of the features disclosed in connection with different examples or embodiments.

[0191] In the present context the term ‘distal’ or ‘distal end’ relates to an end of the injection device that faces towards an injection site of a person or of an animal. The term ‘proximal’ or ‘proximal end’ relates to an opposite end of the injection device, which is furthest away from an injection site of a person or of an animal.

[0192] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0193] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0194] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- Df one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0195] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0196] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the > to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

[0197] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0198] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega- carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0199] Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1 , ZYD-1, GSK-2374697, DA-3091 , MAR-701 , MAR709, ZP- 2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA- 15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide- XTEN and Glucagon-Xten. Dnucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom. Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0200] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0201] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0202] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0203] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, specific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0204] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0205] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0206] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0207] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0208] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0209] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated liner. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

[0210] As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0211] Brief description of the drawings

[0212] In the following, numerous examples of stoppers for medicament containers in various scenarios of use are shown and described in greater detail by making reference to the drawings, in which:

[0213] Fig. 1 schematically shows one example of a medicament container, e.g. implemented as a prefilled syringe,

[0214] Fig. 2 shows a further example of a medicament container implemented as a medicament cartridge,

[0215] Fig. 3 shows an example of a stopper for a medicament container,

[0216] Fig. 4 shows another example of a stopper,

[0217] Fig. 5 shows a further example of a stopper,

[0218] Fig. 6 shows another example of a stopper,

[0219] Fig. 7 shows a further example of a stopper and

[0220] Fig. 8 shows another example of a stopper for use and for receiving a medicament container.

[0221] Detailed description

[0222] Fig. 1 schematically illustrates an injection device 1 implemented as a prefilled syringe 4. The injection device 1 comprises a medicament container 10 to receive, to hold and / or to expel a liquid medicament 5. The medicament container 10 comprises an elongated barrel 11. The cylindrically-shaped sidewall 12. The barrel 11 extends in a longitudinal direction (z). Towards a distal longitudinal direction 2 the medicament container 10 is provided with an outlet 14. Hence, at a distal end 15 of the barrel 11 there is provided a radially narrowing shoulder portion extending into a needle mount 8. There protrudes an injection needle 6 from the needle mount 8 in distal direction 2. The needle mount 8 and / or the injection needle 6 is fluidically connected to the interior 13 of the barrel 11.

[0223] Towards the proximal end and hence in proximal direction 3 the barrel 11 is sealed by a movable stopper 20, which may be also denoted as a bung or as a piston. The movable stopper 20 is in a sealing engagement with an inside surface of the sidewall 12 of the barrel 11. The stopper 20 comprises a cylindrical geometry and one or more sealing ribs that are in fluid tight engagement with the inside surface of the barrel 11.

[0224] The stopper 20 is movable e.g. by a plunger 18. The plunger 18 may be fastened to the stopper 20. It may be also separated from the stopper 20. For expelling a portion, e.g. a dose of the medicament 5 from the interior 13 of the barrel 11 the stopper 20 has to be moved in distal direction 2 relative to the barrel 11. In this way there can be expelled an amount, e.g. a dose, of the medicament 5 from the barrel through the injection needle 6. The injection needle 6 comprises a tipped distal end 7, which is configured for piercing biological tissue, such as the skin of a patient.

[0225] Before use and upon delivery to patients or consumers the tipped end 7 of the injection needle 6 is covered by a protective cap, e.g. by a needle cap 9. The needle cap 9 is detachably connected to at least one of the needle mount 8 and the distal end 15 of the barrel 11.

[0226] Towards a proximal end the barrel 11 comprises a radially outwardly extending barrel flange 17. The barrel flange 17 is useful for holding the injection device 1 and hence the prefilled syringe 4 e.g. by an index finger and by a middle finger of a hand of a user while the user uses his thumb to apply a distally directed pressure to a plunger flange at the proximal end of the plunger 18 to exert a distally directed driving force onto the plunger 18, thereby moving the stopper 20 in distal direction 2.

[0227] In a further example as illustrated in Fig. 2 the medicament container 10 is implemented as a cartridge. It may be filled with a liquid medicament 5. The medicament container 10 also comprises an elongated barrel 11 with a cylindrically or tubular-shaped sidewall 12. Towards the distal end 15 the barrel 11 is also provided with an outlet 14. Here, the outlet 14 is provided with a pierceable seal 19, such as a septum. The septum may be held in position at a radially k section of the barrel 11 by way of a fastener 16. The fastener 16 may comprise a crimped metal cap having a centrally located through opening for piercing the seal 19, e.g. with a proximally tipped injection needle.

[0228] Here, the injection needle may be fastened to a pen-type injection device, such as a pen-type injector. Such injection devices typically comprise a cartridge holder to accommodate the medicament container 10, e.g. in form of the cartridge. At a distal injection end such injection devices comprise a through opening to receive a proximally extending tipped end of the double -tipped injection needle. The proximally extending portion of the injection needle may be inserted through the through opening of the cartridge holder so as to pierce and to penetrate the seal 19 of the cartridge or medicament container 10.

[0229] The injection needle may be detachably fastenable to a cartridge holder, e.g. by way of a needle hub. The needle hub may comprise a standardized fastener complementary shaped to a standardized counter fastener provided at the distal end of the cartridge holder of the injection device. In some examples the standardized fastener comprises a thread and the standardized counter fastener comprises a complementary shaped counter threaded portion to detachably mount and / or to detachably fasten the needle to the cartridge holder of the respective injection device.

[0230] In order to provide a sufficient container closure integrity as well as to provide comparatively low friction and / or stiction forces between the stopper 20 and the barrel there is provided a specific stopper design as will be described in connection with the numerous examples according to Figs. 3-8.

[0231] The stopper 20 as illustrated in Figs. 3-8 comprises a unitary stopper body 21 comprising or made of an elastomeric material, such as a natural or synthetic rubber. The stopper body 21 comprises a first longitudinal end 22, e.g. a distal end, and a opposite second longitudinal end 23, e.g. a proximal end. At the distal or first longitudinal end 22 there is provided a rather planar shaped first end surface 24. At the opposite longitudinal end 23 there is provided another rather planar shape second end surface 25.

[0232] In some examples at least one of the first end surface 24 and the second end surface 25 is a closed end surface. Such a closed end surface may be free or void of a recess, e.g., to mechanically connect to a plunger. Rather, at least the proximal end surface, e.g., the second end surface 25, may be configured and implemented as a thrust receiving surface, which may get in longitudinal abutment with a plunger or piston rod or with a radially widened pressure ;tal end of a piston rod to make a mechanical contact with the plunger or piston rod of an injection device. In some examples, the second end surface 25 may be particularly configured and designed to make or to establish a planar surface contact with a piston rod, a plunger or with a radially widened pressure piece of an injection device.

[0233] In some examples both end surfaces 24, 25 are provided with distance spacers 29. The spacers 29 may be regularly or irregularly distributed and arranged on or across the end surfaces 24, 25. The spacers 29 may protrude in longitudinal direction from the respective end surfaces. They may comprise a nipple-like shape. They may protrude from the respective end surfaces 24, 25 by about 0.1 - 0.4 mm. The spacers 29 serve to prevent mutual adhesion of the end surfaces 24, 25 of numerous stoppers 20, when provided by a stopper manufacturer and when provided as bulk material to a pharmaceutical manufacturer.

[0234] Between the first longitudinal end 22 and the second longitudinal end 23 the stopper body 21 comprises a generally tubular shaped sidewall 26. The sidewall 26 is configured to slidably engage with the inside surface of the sidewall 12 of the barrel 11. In order to improve the container closure integrity as well as to provide a well-defined gliding or friction force for moving the stopper 20 relative to the barrel 11 the sidewall 26 comprises a first sealing rib 31 and a second sealing rib 41. Both sealing ribs 31, 41 protrude radially outwardly from the sidewall 26. They may define a maximum rib diameter MRD and hence a maximum diameter portion of the sidewall 26.

[0235] The sealing ribs 31, 41 extend all around the circumference of the tubular shaped stopper body 21 or sidewall 26. Hence, they may comprise a closed annular structure in circumferential direction.

[0236] In some of the presently illustrated examples the sealing rib 31 , 41 comprise a convex profile 32, 42 as seen in longitudinal direction. The convex profile 32, 42, and hence the respective sealing ribs 31, 41 comprise an apex section 33, 43, which is characterized by a first radial of curvature rc1 and by a second radius of curvature rc2, respectively. The first sealing rib 31 comprises a first apex section 33 forming or constituting a maximum diameter MD of the sealing rib 31. At the first apex section 33 the first sealing rib 31 comprises a first radius of curvature rc1. Likewise, the second sealing rib 41 comprises a second apex section 43 with a second radius of curvature rc2.

[0237] The first sealing rib 31 and the second sealing rib 41 are further characterized by a radial extent, e.g. by a first radial extent r1 and by a second radial extent r2, respectively. The radial 1 by the radial distance between the apex section 33, 43 and a bottom section 36, 46 of an adjacently located recessed sidewall portion 34, 44, which longitudinally adjoins the respective first sealing rib 31 or second sealing rib 41 , respectively.

[0238] In the example of Fig. 3 the first sealing rib 31 is provided at or near the first longitudinal end 22. Hence, the first sealing rib 31 is provided at or near a distal end of the stopper body 21.

[0239] Towards the proximal direction 3 the first sealing rib 31 extends into the first recessed sidewall portion 34. The first sidewall portion 34 comprises a concave profile 35. The concave profile 35 and / or the recessed sidewall portion 34 comprises a bottom section 36 defining a minimum or a local minimum diameter of the sidewall 26 of the stopper body 21. The radial distance between the bottom section 36 and the apex section 33 in the natural or uncompressed state of the stopper body 21 defines the first radial extent r1 of the first sealing rib 31.

[0240] Likewise, the second sealing rib 41 is provided at or near a proximal longitudinal end 23 of the stopper body 21. The second recessed portion 44 with a respective second concave profile 45 extends in distal direction 2 and adjoins the second sealing rib 41 in distal direction 2. The second recessed sidewall portion 44 comprises a bottom section 46. Also here, the second radial extent r2 of the second sealing rib 41 is defined by the radial distance between the bottom section 46 and the second apex section 43.

[0241] The first sealing rib 31 and the second sealing rib 41 may be characterized by a specific rib ratio, e.g. by a first rib ratio R1 and by a second rib ratio R2, respectively. The first rib ratio R1 and / or the second rib ratio R2 is between 0.5 - 4. In some examples the rib ratios R1, R2 are between 1 - 1.5, between 1.5 - 2, between 1.25 - 1.4, or between 1.3 and 1.35. The rib ratio R1, R2 is defined by the radius of curvature rc1 or rc2 divided by the respective first radial extent r1 or r2. Hence, the first rib ratio R1 of the first sealing rib 31 is defined by the first radius of curvature rc1 divided by the first radial extent r1. The second rib ratio R2 is defined by the second radius of curvature rc2 divided by the second radial extent r2.

[0242] The rib ratios as defined and disclosed herein are beneficial in terms of providing a comparatively good container closure integrity in combination with comparatively low friction forces. The rib ratios R1, R2 provide an easy and smooth sliding of the stopper 20 relative to the barrel 11.

[0243] The first rib 31 adjoins the first end surface 24 by a beveled sidewall section 27. Likewise, the second rib 41 adjoins the second end surface 25 by a second beveled sidewall section 28. The sidewall sections 27, 28 extend at a well-defined beveled angle relative to the longitudinal mples, the beveled angle is between 15° and 65°. It may range between 15° and 45° or may range between 20° and 40°. The beveled sidewall sections 27, 28 provide an effective guiding and self-centering of the stopper 20 during insertion into the barrel 11.

[0244] The stopper 20 and hence the stopper body 21 further comprises a trim edge portion 60, which is a result of the production process of the stopper 20. The trim edge is obtained by cutting or trimming the stopper 20 from an intermediate product, e.g. from a sheet obtained by a molding process of the elastomeric stoppers. Typically, a molding cavity comprising numerous wells or numerous individual molding cavities for individual stoppers is filled with an elastomeric stopper material, which under the application of heat and / or or pressure is vulcanized. After the molding or compression molding process the entire sheet is demolded and released from the mold. The individual stoppers 20 may then protrude from one or from both sides of the molded sheet and may have to be separated from the sheet e.g. by trimming, cutting or punching.

[0245] Accordingly, and due to the trim operation for individualizing individual stoppers 20 from the intermediate product, e.g. from a rubber sheet, there is provided a trim edge portion 60.

[0246] In the example of Fig. 3, the trim edge portion 60 is located between, e.g. midway between, the first sealing rib 31 and the second sealing rib 41. The trim edge portion 60 may comprise a profile section 61. The profile section 61 of the trim edge portion 60 may be of rather planar shape. The trim edge portion cannot be used as a well-defined sealing rib. The geometric tolerances of the trim edge portion 60 are comparatively large due to the trimming or cutting process. Also, the trimming tool, e.g. a knife or a punching tool may be subject to significant wear after execution of numerous cutting, punching or trimming operations.

[0247] In some examples the maximum diameter TMD of the trim edge portion 60 may be larger than the maximum rib diameter MRD of the sealing rib(s) 31, 41. With a maximum diameter TMD of the trim edge portion 60 exceeding the maximum rib diameter MRD of at least one of the first sealing rib 31 and the second sealing rib 41 there may be provided a rather straightforward punching or trimming of the stopper from the intermediate product. Here, a respective hollow cutting or punching tool may comprise an inner diameter that exceeds the maximum rib diameter MRD. Thus, the sealing ribs 31 , 41 may not be harmed or affected during or due to the trimming operation.

[0248] However, in other examples the maximum diameter TMD of the trim edge portion 60 may be smaller than the maximum rib diameter MRD. Here, a specific cutting tool may be used for cutting or punching the rubber sheet. Specifically, the intermediate product, e.g. in form of the subject to a transverse or radial stretching for or during the cutting operation.

[0249] The stopper 20 and the stopper body 21 of the example according to Fig. 3 is symmetric in longitudinal direction. This way, the stopper may 20 may be inserted into the barrel 11 in either orientation. Any of the end surfaces 24, 25 may be oriented in distal direction 2 and may get in contact with the medicament 5. Insofar, any of the end surfaces 24, 25 may be used as a leading or as a trailing edge upon insertion of the stopper 20 into the barrel 11. The symmetric profile facilitates the stopper assembly into the barrel 11.

[0250] With the example of Fig. 3 opposite end surfaces 24, 25 are of planar shape. The sealing ribs 31, 41 exhibit a reduced contact surface with the barrel 11 as compared to known solutions.

[0251] The stopper body 21 may be made of bromobutyl rubber and may exhibit a shore A hardness of about 50. A static simulation by using a finite element analysis provides the following results of contact area per rib, contact width per rib and contact pressure per rib as well as a total contact force:

[0252] Compared to a standard design of a stopper the contact surface of the stopper with regards to the surface of the sidewall 12 of the barrel 11 can be reduced by about 39%. The contact force can be reduced by about 40%. The average contact pressure of the sealing ribs 31, 41 may be increased compared to a reference example by about 20%.

[0253] In the example according to Fig. 3 the inner diameter ID of the barrel 11 is about 6.85 mm. The diameter D or the minimum diameter DM of the recessed sidewall portions 34, 44 is about 6.5 mm and the maximum rib diameter MRD of the first sealing rib 31 and the second sealing rib 41 is about 7.1 mm. The maximum diameter TMD of the trim edge portion 60 may be about 7.3 mm.

[0254] Accordingly, the radial extent R1 , R2 of the first sealing rib 31 and of the second sealing rib 41 is about 0.3 mm and the difference between the maximum rib diameter MRD and the minimum diameter MD is about 0.6 mm. ' be useful or may be used for medicament containers 10 configured to hold 1.5 ml of a liquid medicament.

[0255] In the further example of a stopper 20 as shown in Fig. 4 there is provided a likewise stopper design. The dimensions of the maximum rib diameter MRD, the inner diameter ID of the barrel 11 and the maximum diameter TMD of the trim edge portion 60 as well as the minimum diameter MD of the recessed sidewall portion 34, 44, 54 may be in the same range as described above in connection with the example of Fig. 3. The stopper 20 according to Fig. 4 distinguishes from the stopper according to Fig. 3 in that the sidewall 26 is provided with three sealing ribs 31, 41 , 51.

[0256] Here, a third sealing rib 51 is located midway between the longitudinal distance between the first sealing rib 31 and the second sealing rib 41. Also here, the first sealing rib 31 is located near or adjacent to the first longitudinal end 22. The second sealing rib 41 is provided at or near the second longitudinal end 23 of the stopper body 21. Both end surfaces 24, 25 are of planar shape. They are both provided with spaces 29. The sealing ribs 31, 41 , 51 may be separated in longitudinal direction equidistantly. The sealing ribs 31 , 41, 51 may be characterized by a convex profile 32, 42, 52 with an apex section 33, 43, 53 comprising a well-defined radius of curvature rc1 , rc2, rc3, respectively.

[0257] In the presently illustrated example the radius of curvature rc1 , rc2, rc3 is about 0.4 mm. Longitudinally adjacent to the sealing ribs 31, 41 , 51 there are provided two recessed sidewall portions 34, 44. The first recessed sidewall portion 34 is longitudinally located between the first sealing rib 31 and the third sealing rib 51. The second recessed sidewall portion 44 is provided longitudinally between the third sealing rib 51 and the second sealing rib 41. The recessed sidewall portions 34, 44 each comprise a radially symmetric concave profile 35, 45 with a respective bottom section 36, 46.

[0258] Also here, the radial extent r1 , r2, r3 of the individual sealing ribs 31 , 41 , 51 is defined by the radial distance between the respective apex section 33, 43, 53 of the respective sealing rib 31 , 41, 51 and the bottom section 36, 46 of the longitudinally adjoining recessed sidewall portion 34, 44.

[0259] The radial extent of the sealing ribs 31 , 41, 51 may be also characterized by a diameter body ratio DR. The diameter body ratio DR is defined by the radial extent r1 , r2, r3 of one of the first, the second or third sealing rib 31 , 41, 51 divided by the diameter D of the sidewall 26. The diameter D of the sidewall 26 may be defined as the minimum diameter MD of the sidewall 26 om sections 36, 46 of the first recessed sidewall portion 34 and / or of the second recessed sidewall portion 44. In some examples the diameter body ratio DR is between 0.03 - 0.1. In the presently illustrated example the diameter body ratio is between 0.04 - 0.06.

[0260] Hence, the minimum diameter MD or the diameter D of the sidewall 26 may be about 6.5 and the maximum rib diameter MRD may be about 7.1. Hence, the radial extent of the sealing ribs 31, 41 , 51 may be about 0.3 mm. Such a diameter body ratio of the sealing ribs 31 , 41, 51 may be beneficial to provide a good container closure integrity in combination with comparatively low friction, stiction or gliding forces for moving the stopper 20 relative to the barrel 11.

[0261] In the example of Fig. 4, the trim edge portion 60 is located between the first sealing rib 31 and the first end surface 24 of the stopper body 21. Here, the trim edge portion 60 comprises a concave profile 61. The maximum diameter TMD of the trim edge portion 60 may be smaller than the maximum rib diameter MRD of any of the sealing ribs 31, 41 , 51. Here, the trim edge portion 60 is provided at the first longitudinal end 22. The trim edge portion 60 may adjoin the first end surface 24, which may be a trailing surface facing in proximal direction 3 when the stopper 20 or stopper body 21 is inserted into the barrel 20.

[0262] The sealing ribs 31, 41 , 51 exhibit a reduced contact surface with the barrel 11 as compared to known solutions. The stopper body 21 may be made of bromobutyl rubber and may exhibit a shore A hardness of about 50. A static simulation by using a finite element analysis provides the following results of contact area per rib, contact width per rib and contact pressure per rib as well as a total contact force:

[0263] Compared to a standard design of a stopper the contact surface of the stopper with regards to the surface of the sidewall 12 of the barrel 11 can be reduced by about 30%. The contact force can be reduced by about 61%. Due to its comparatively small diameter the trim edge portion does not make contact with the inside of the sidewall 12 of the barrel 11 and has therefore no impact on the friction between the stopper 20 and the sidewall 12.

[0264] The longitudinally symmetrically shaped first and second recessed sidewall portions 34, 44 may symmetric or longitudinally symmetric concave profile 35, 35. The concave profile may be characterized by a radius of curvature brc, which is 2.5 - 4 times larger than the radius of curvature rc1 , rc2, rc3 of any of the first sealing rib 31 , the second sealing rib 41 or the third sealing rib 51. In the example as shown in Fig. 4, the radius of curvature brc of the recessed sidewall portions 34, 44 is about 1.25 mm.

[0265] Generally, all stoppers 20 as shown herein may be also provided with at least one tapered structure on one of the first end surface 24 and the second end surface 25. A tapered structure e.g. at a distal end may be beneficial to completely empty the barrel 11 since the tapered shape of the distal end surface of the stopper 20 may be somewhat complementary shaped to a radially narrowing shoulder portion at or near the distally located outlet of the barrel 11.

[0266] The stopper 20 according to the example of Fig. 5 is somewhat similar to the example as shown in Fig. 3. Here and in comparison to the stopper 20 as shown in Fig. 3 the stopper 20 of Fig. 5 is provided with a third sealing rib 51 , which is located between the first sealing rib 31 and the trim edge portion 60. The maximum diameter TMD of the trim edge portion 60, the diameter body ratio DR, the rib ratios R1 , R2, R3 as well as the minimum diameter MD and the maximum rib diameter MRD of the example of Fig. 5 are somewhat identical or similar to the respective parameters as described above in connection with the example of Fig. 3.

[0267] The static simulation of an interaction between the stopper 20 according to Fig. 5 with a barrel 11 on the basis of a finite element analysis provides the following results:

[0268] Compared to a standard design of a stopper the contact surface of the stopper with regards to the surface of the sidewall 12 of the barrel 11 can be reduced by about 51%. The contact force can be reduced by about 25%. The average contact pressure of the sealing ribs 31, 41 may be increased compared to a reference example by about 12%.

[0269] The further example according to Fig. 6 is somewhat equivalent or similar to the example as shown in Fig. 5. Here, the trim edge portion 60 comprises an asymmetric profile 51 as seen in longitudinal direction. Here, and in comparison to the examples as shown in Figs. 3-5, the • body 21 comprises a shore A hardness of 47. Moreover, the maximum diameter TMD of the trim edge portion 60 is smaller than the maximum rib diameter MRD of any of the sealing ribs 31, 41 , 51. Accordingly, the following static simulation results as obtained by a finite element analysis are as follows:

[0270] Compared to a standard design of a stopper the contact surface of the stopper with regards to the surface of the sidewall 12 of the barrel 11 can be reduced by about 59%. The contact force can be reduced by about 48%. The average contact pressure of the sealing ribs 31, 41 may be reduced compared to a reference example by about 10%. The contact pressure of the trim edge portion may be reduced by about 42 % compared to a standard design.

[0271] In Figs. 7 and 8 there are shown two further examples of stopper 20 that are obtained by individual injection molding. Here, the sidewall 26 of the stopper 20 is void of a trim edge portion 60. The stopper 20 according to Fig. 7 is individually injection molded. Here, one of the spacers 29 forms or constitutes an injection point of the injection molded stopper body 21.

[0272] The stopper 20 according to Fig. 7 is of the biplanar design. Hence, the oppositely located first and second end surfaces 24, 25 are planar shaped.

[0273] With the stopper according to Fig. 8, the first end surface 24 is of a tapered design. The taper angle as shown in Fig. 8 may be in a range between 10° - 35°. In some examples it may be in a range between 15° - 20°.

[0274] The tapered longitudinal end surface 24 may provide a complete or nearly complete emptying of the barrel 11 when the stopper 20 reaches a distal end position inside the barrel 11 at the end of an injection procedure. The tapered section at the longitudinal end may be also beneficial for introducing or urging the stopper 20 into the barrel 11, specifically, when the tapered sidewall section faces in distal direction 2. The tapered section also provides a symmetry breaking feature by way of which the stopper 20 can be easily pre-oriented for an introduction into the barrel. igs. 7 and 8, the radius of curvature brc of the recessed sidewall portions 34, 44 may be in a range of 1.6 mm with the example of Fig. 7 and may be in the range of about 2.15 mm in the example of Fig. 8. The radius of curvature rc1 , rc2, rc3 of the respective apex sections 33, 43, 53 of the individual sealing ribs 31, 41 , 51 may be in a range as described above in connection with the examples of Figs. 3 - 6. It may be in a range between 0.3 mm - 0.6 mm. It may be about 0.4 mm. The convex profile 32, 42, 52 of the individual sealing ribs 31 , 41, 51 may likewise provide a reduced longitudinal contact width, which provides a correspondingly reduced contact pressure or contact force, thus providing excellent and beneficial sliding capabilities for the stopper 20 relative to the barrel 11.

[0275] 1 injection device

[0276] 2 distal direction

[0277] 3 proximal direction

[0278] 4 pre-filled syringe

[0279] 5 medicament

[0280] 6 injection needle

[0281] 7 tipped end

[0282] 8 needle mount

[0283] 9 needle cap

[0284] 10 medicament container

[0285] 11 barrel

[0286] 12 barrel sidewall

[0287] 13 interior

[0288] 14 outlet

[0289] 15 distal end

[0290] 16 fastener

[0291] 17 barrel flange

[0292] 18 plunger

[0293] 19 seal

[0294] 20 stopper

[0295] 21 stopper body

[0296] 22 longitudinal end

[0297] 23 longitudinal end

[0298] 24 end surface

[0299] 25 end surface

[0300] 26 sidewall

[0301] 27 beveled sidewall section

[0302] 28 beveled sidewall section

[0303] 29 spacer

[0304] 31 sealing rib

[0305] 32 convex profile

[0306] 33 apex section

[0307] 34 recessed sidewall portion

[0308] 35 concave profile

[0309] 36 bottom section 42 convex profile

[0310] 43 apex section

[0311] 44 recessed sidewall portion

[0312] 45 concave profile

[0313] 46 bottom section

[0314] 51 sealing rib

[0315] 52 convex profile

[0316] 53 apex section

[0317] 54 recessed sidewall portion

[0318] 55 concave profile

[0319] 56 bottom section

[0320] 60 trim edge portion

[0321] 61 profile section brc radius of curvature rc1 , rc2, rc3 radius of curvature r1 , r2, r3 radial extent

[0322] R1 , R2, R3 rib ratio

[0323] DR diameter body ratio

[0324] MRD maximum rib diameter

[0325] ID inner diameter

[0326] TMD trim maximum diameter

[0327] MD minimum diameter

Claims

Claims1. A stopper (20) for a medicament container (10), wherein the medicament container comprises a barrel (11) with a cylindrically-shaped sidewall (12), the stopper (20) comprising: a stopper body (21) of generally cylindrical geometry and comprising an elastomeric material, the stopper body (21) further comprising a first end surface (24) at a first longitudinal end (22) and a second end surface (25) at a second longitudinal end (23) and a sidewall (26) extending between the first longitudinal end (22) and the second longitudinal end (23), wherein the first end surface (24) and the second end surface (25) each comprise a closed end surface, a first sealing rib (31) extending in circumferential direction and protruding radially outwardly from the sidewall (26) by a first radial extent (r1), a second sealing rib (41) separated from the first sealing rib in longitudinal direction, extending in circumferential direction and protruding radially outwardly from the sidewall (26) by a second radial extent (r2), and a circumferentially extending trim edge portion (60), which is located longitudinally between the first sealing rib (31) and the second sealing rib (41).

2. The stopper (20) according to claim 1 , wherein the first sealing rib (31) comprises a convex profile (32) with a first apex section (33) as seen in longitudinal direction (z) and / or wherein the second sealing rib (41) comprises a convex profile (42) with a second apex section (43) as seen in the longitudinal direction (z).

3. The stopper (20) according to claim 1 or 2, further comprising a third sealing rib (51) separated from the first sealing rib (31) and separated from the second sealing rib (41) in longitudinal direction, extending in circumferential direction and protruding radially outwardly from the sidewall (26) by a third radial extent (r3).

4. The stopper (20) according to claim 3, wherein the third sealing rib (51) comprises a convex profile (52) with a third apex section (53) as seen in longitudinal direction (z).

5. The stopper (20) according to any one of the preceding claims, wherein the trim edge portion (60) comprises a maximum diameter (TMD), which is smaller than, equal to or larger than a maximum rib diameter (MRD) of at least one of the first sealing rib (31), the second sealing rib (41) and the third sealing rib (51).0) according to any one of the preceding claims, wherein a maximum diameter (TMD) of the trim edge portion (60) is smaller than an inner diameter (ID) of the sidewall (12) of the barrel (11).

7. The stopper (20) according to any one of the preceding claims, wherein at least one of a first rib ratio (R1) and a second rib ratio (R2) is between 0.5 - 4, wherein the first rib ratio (R1) is defined by a radius of curvature (rc1) of the first apex section (33) divided by the first radial extent (r1), and wherein the second rib ratio (R2) is defined by a radius of curvature (rc2) of the second apex section (43) divided by the second radial extent (r2).

8. The stopper (20) according to any one of the preceding claims, wherein a diameter body ratio (DR) of at least one of the first sealing rib (31) and the second sealing rib (41) is between 0.03 - 0.1 , wherein the diameter body ratio (DR) is defined by the radial extent (r1, r2) of the first or second sealing rib (31 , 41) divided by the diameter (D) of the sidewall (26).

9. The stopper (20) according to any one of the preceding claims, wherein a maximum rib diameter (MRD) of at least one of the first sealing rib (31) and the second sealing rib (41) in an uncompressed state of the stopper (20) exceeds an inner diameter (ID) of the sidewall (12) of the barrel (11) by more than or equal to 0.1 mm and less than or equal to 0.4 mm.

10. The stopper (20) according to any one of the preceding claims, wherein the sidewall (26) comprises a first recessed sidewall portion (34) extending in circumferential direction, adjoining the first sealing rib (31) in longitudinal direction (z) and comprising a concave profile (35) as seen in longitudinal direction (z).

11. The stopper (20) according to claims 2 and 10, wherein the concave profile (35) of the first recessed sidewall portion (34) comprises a bottom section (36) with a radius of curvature (brc), which is 2 - 6 times larger than the radius of curvature (rc1) of the first apex section (33).

12. The stopper (20) according to claim 10 or 11, wherein the first recessed sidewall portion (34) adjoins the first sealing rib (31) along a first longitudinal direction (2) and adjoins one of the second sealing rib (41) and the optional third sealing rib (51) along a second longitudinal direction (3), which is opposite to the first longitudinal direction (2).

13. The stopper (20) according to any one of the preceding claims, wherein the stopper body (21) is an individually injection molded body (21).0) according to any one of the preceding claims, wherein the stopper body (21) comprises a symmetric profile in longitudinal direction (z) with regards to a transverse plane located midway between the first longitudinal end (22) and the second longitudinal end (23).

15. The stopper (20) according to any one of the preceding claims, wherein the first sealing rib (31) is located at, is located near or adjoins the first longitudinal end (22) and wherein the second sealing rib (41) is located at, is located near or adjoins the second longitudinal end (23).

16. The stopper (20) according to any one of the preceding claims, wherein the stopper body (21) comprises a shore A hardness between 45-65, between 45-55, or between 47-50.

17. A medicament container (10) comprising: a barrel (11) with a cylindrically-shaped sidewall (12), and a stopper (20) according to any one of the preceding claims arranged inside the barrel (11) and movable relative to the sidewall (12) along the longitudinal direction of the barrel (11).

18. The medicament container according to claim 17, wherein the barrel (11) comprises a distal barrel end (15) sealed with a penetrable seal (19).

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