KR20210141501A - A system comprising a pre-fillable syringe and a package for the pre-fillable syringe. - Google Patents

Abstract

SUMMARY OF THE INVENTION The present invention is a system comprising a pre-fillable syringe having a syringe barrel and a syringe tip and a package suitable and intended to receive the pre-fillable syringe, the syringe tip having a tip cap, the system comprising: A system comprising a replacement cap for a fillable syringe, wherein said package is suitable and intended to receive said replacement cap.

Description

A system comprising a pre-fillable syringe and a package for the pre-fillable syringe.

The present invention is a package suitable and intended for receiving a pre-fillable syringe comprising a syringe barrel and a syringe tip, said syringe tip comprising a tip cap ( It relates to a package characterized in that it has a tip cap). The present invention also provides a system comprising a pre-fillable syringe having a syringe barrel and a syringe tip, and a package suitable and intended to receive the pre-fillable syringe, wherein the syringe tip has a tip cap. system and use of the system. Additionally, the present invention relates to a replacement cap for a pre-fillable syringe.

A pre-fillable syringe may be used as a kit with a medium to be administered or delivered to a user, wherein the pre-fillable syringe of the kit is filled with the medium.

In particular, these days, pre-filled syringes (prefilled syringes) have emerged as one of the fastest growing options for unit dose medications. The operation (handling) of such a syringe is easy because the medium to be administered does not need to be transferred to the syringe before use. The use of pre-filled syringes minimizes drug waste and increases product life.

Drug administration to patients rather than by injection is becoming more popular due to the development of new drugs. Possible modes of administration are, inter alia, oral, intranasal, topical, dermal, and further external application. For these applications, pre-filled syringes may be the best way to store (storage), transport, and administer drugs.

Also, for medium or drugs to be injected into the body, a pre-filled syringe is a convenient choice. In particular, modern vaccines are very sensitive to external influence factors, so they are safely stored in pre-filled syringes.

The pre-fillable syringe body includes a syringe barrel, a syringe tip, and optionally a finger flange. In some cases, the syringe tip already has a penetrating means. The penetrating means may be a needle, cannula, or similar element.

The syringe body is produced by the primary packaging producer under clean room conditions. After sterilization, the syringe body is equipped with a tip cap and placed in a so-called syringe nest. A tip cap is generally located on the syringe tip and may surround a needle arranged on the syringe tip.

The pre-fillable syringe is then delivered to the pharmaceutical company that provides the kit with the medium to be administered, or preferably fills (fills) the syringe with the medium.

In the latter case, after the filling process, a plunger or piston is introduced into the syringe barrel, whereby the barrel is closed on its proximal side. The filled syringe is then placed in the secondary packaging.

The tip cap may seal the tip and optionally the needle. Generally, the tip cap is at least partially made of an elastic material. Because space for syringes is limited in syringe nests, tip caps are generally designed to be as small as possible. However, such a small size tip cap may be inconvenient for a user to handle.

In some cases, the user must set a dose prior to the actual administration of the medium, which may be done later. For this purpose, the tip cap may have to be temporarily removed. Closing the syringe back with the tip cap may result in unwanted entry of some air into the syringe barrel. Some of this air can cause irritation to the patient. If the medium in the syringe barrel is a medium with high viscosity, some of the enclosed air may be difficult to remove.

WO 2018/038078 A1 discloses a medical device package having a plurality of syringe packaging bodies comprising a pre-filled syringe system and a packaging main body and an outer box containing the plurality of syringe packaging bodies. The needle unit of the pre-filled syringe system is for a needle unit case having the largest outer diameter portion provided at the tip end of the needle hub which engages the inner surface of the needle unit case. is supported In the outer box, a plurality of syringe packaging bodies are arranged such that the axial direction of the needle body is up and down of the outer box. The pre-filled syringe is sealed with a sealing cap, but no replacement cap is provided.

Summary of the Invention

It is therefore an object of the present invention to provide a pre-fillable syringe, a package for receiving the pre-fillable syringe, and a pre-fillable syringe and a system comprising the package, which overcome the above-mentioned disadvantages.

The invention also relates to a system of the invention wherein the syringe is prefilled with a ready-to-use pharmaceutical formulation.

The present invention also provides a kit comprising a pharmaceutical preparation in powder form, which is reconstituted in a ready-to-use aqueous solution or in a suitable vehicle, together with the system of the present invention, and instructions for administering the pharmaceutical preparation. (kit)

1 shows a pre-fillable syringe without a tip cap.
Figure 2a shows a pre-fillable syringe with a tip cap.
2b shows the replacement cap.
3 shows a pre-fillable syringe with a replacement cap.
4 shows a pre-fillable syringe with a replacement cap on a support surface.
FIG. 5A shows a pre-fillable syringe with a tip cap, as shown in FIG. 2A .
Fig. 5b shows a replacement cap as shown in Fig. 2b, with different foot portions.
6 shows a package body according to an embodiment of the present invention without a pre-fillable syringe.
7 shows a package body according to an embodiment of the present invention with a pre-fillable syringe and a replacement cap.
8 shows a package body according to one embodiment of the present invention with a pre-fillable syringe positioned in a replacement cap.
9 shows a bottom perspective view of a plunger in accordance with one or more embodiments.
10 shows a top perspective view of the plunger.
11 shows a bottom plan view of the plunger.
12 shows a top plan view of the plunger.
13 shows a side view of the plunger.

The problem is a system comprising a pre-fillable syringe having a syringe barrel and a syringe tip and a package suitable and intended to receive the pre-fillable syringe, the syringe tip having a tip cap, the system comprising: A system comprising a replacement cap for a pre-fillable syringe, wherein said package is suitable and intended to receive said replacement cap.

The system has the advantage that the package provided to the user includes a pre-fillable syringe for use and an appropriate replacement cap. The user can remove the pre-fillable syringe from the package, remove the tip cap, and optionally set the dose of the pre-fillable syringe. Replacement caps are already available to the user and do not need to be obtained separately. Also, replacement caps do not need to be taken out of the additional package. In order to take the replacement cap out of this add-on package, the user will probably have to put down the syringe that has already been opened. Laying down a pre-fillable syringe can contaminate the syringe tip and entail unnecessarily complicated manipulation.

In contrast, the system according to the present invention provides the user with a pre-fillable syringe and a replacement cap in one package. Therefore, replacement caps can always be used with pre-fillable syringes, and there is no need to obtain them separately even when the tip cap has probably already been removed. The mounting of the replacement cap can therefore be performed in an uncomplicated manner.

The further use of a replacement cap also has the advantage of easier syringe handling for the user, as it can be difficult to hold and remove the relatively small tip cap.

Hereinafter, the expressions "distal" and "proximal" are understood to mean that the distal end (distal end) of the syringe is the proximal end (proximal end), which is closer to the site of application. The expressions “distal direction” and “proximal direction” are understood similarly.

Hereinafter, the longitudinal axis (X), the horizontal axis (Y), and the vertical axis (Z) are used in relation to the package body. The longitudinal axis (X'), the horizontal axis (Y'), and the vertical axis (Z') are used in connection with the pre-fillable syringe. The longitudinal axis X'', the horizontal axis Y'', and the vertical axis Z'' are used in connection with the replacement cap.

According to a preferred embodiment, the package comprises a package body defining a first cavity defined by a side wall and a bottom wall. Preferably, a pre-fillable syringe is arrangeable in said first cavity. Preferably, the package body extends along a longitudinal axis (X), a horizontal axis (Y) and a vertical axis (Z) orthogonal to each other.

According to a preferred embodiment, at least one second receiving element in which the syringe barrel is receivable is provided in the first cavity of the package body. Preferably two second receiving elements are provided in the first cavity of the package body. Preferably, at least one second receiving element is arranged in the bottom wall. It is further advantageous that the at least one second receiving element comprises a semicircular upper section arranged in a base section. The semi-circular upper section preferably extends along a horizontal axis (Y) and a longitudinal axis (X) and opens in a vertical axis (Z). Also, the semi-circular upper section is suitable and intended to receive a syringe barrel. The semi-circular upper section includes two arms that at least partially surround the syringe barrel.

According to a further preferred embodiment, the distal end of the syringe barrel is supported by a first element of the second receiving element and the proximal end of the syringe barrel is supported by a second element of the second receiving element. The first element of the second receiving element is advantageously located in or close to the region where the syringe barrel joins into the syringe tip. Furthermore, the second element of the second receiving element is preferably located proximate to a finger flange of the syringe arranged on the package body. Preferably, the first and second elements of the second receiving element are separated along the longitudinal axis X' of the prefillable syringe. Thus, with the pre-fillable syringe being arranged in the package body and the syringe barrel being received by preferably two second receiving elements, the central axis of the pre-fillable syringe is preferably the bottom of the package body. extends parallel to the wall. Advantageously, the central axis extends to a height L2 above the bottom wall. The height L2 is dimensioned to enable easy gripping of the pre-fillable syringe.

According to a further preferred embodiment, at least one third receiving element in which a rod of the pre-fillable syringe can be received is provided in the first cavity of the package body. Preferably, the third receiving element comprises two walls extending along a vertical axis Z defining a cavity in which the rod is received. Preferably, the walls extend along the longitudinal axis (X). Advantageously, the at least one third receiving element is formed in a semicircular shape and has a bottom wall connecting the walls to each other.

It is further advantageous if a gap is provided between the second element of the second receiving element and the third receiving element. Preferably, a finger flange of the pre-fillable syringe projects through the gap such that the finger flange is sandwiched between the second and third receiving elements of the second receiving element. This gap allows the finger flange of the pre-fillable syringe to preferably protrude when the syringe is positioned inside the package body. Since the finger flange is preferably sandwiched between the second element and the third receiving element of the second receiving element, the pre-fillable syringe comprises the finger flange and the second and third receiving elements of the second receiving element and the finger flange. is fixed to the package body due to the engagement of The length of the walls is essentially determined by the length of the rod section protruding from the syringe barrel, without the length of the rod in the gap between the second and third receiving elements of the second receiving element.

According to a preferred embodiment, the pre-fillable syringe further comprises a plunger or piston connected to a rod projecting out of the syringe barrel. Advantageously, said pre-fillable syringe also comprises a finger flange. The finger flange may be formed on the syringe barrel. It is also possible for a separate finger flange element to be connected to the syringe barrel which provides a larger gripping surface. The syringe tip is preferably shaped like a cone. Advantageously, the syringe tip has a Luer-Cone. Currently ISO 80369 governs the Luer standard. The syringe tip may also preferably be equipped with a penetrating means, which may be a needle, cannula, or similar means.

However, since it is intended for sublingual administration to newborns, in order to avoid accidental harm to the newborn's mouth, preferably, the syringe can be used without a penetrating means at the tip.

The pre-fillable syringe advantageously has a tip cap, which is arranged on the syringe tip. The tip cap may be constructed, at least in part, from an elastomeric material. Advantageously, the pre-fillable syringe may be constructed of glass or plastic.

According to a preferred embodiment, the replacement cap is arranged in the package such that the replacement cap or an opening of the replacement cap is oriented along the vertical axis Z of the package body. Preferably, the opening area of the replacement cap is oriented parallel to the bottom wall of the package body. This arrangement allows for easy mounting of a replacement cap to the pre-fillable syringe. The replacement cap does not need to be removed from the package for the mounting process. The pre-fillable syringe may be inserted into the replacement cap while the replacement cap remains in the package. When the replacement cap is mounted on the pre-fillable syringe, the replacement cap is removed from the package along with the pre-fillable syringe. This allows operation of the syringe with only one hand. To obtain a separate replacement cap, two-handed operation may be required as the replacement cap must be removed from a separate package and oriented relative to the pre-fillable syringe for mounting.

According to a preferred embodiment, the replacement cap comprises an inner cap for engagement with the syringe tip. Advantageously, the replacement cap includes an outer collar that engages the syringe barrel for mounting the replacement cap to the syringe barrel. In addition, the replacement cap preferably includes a foot portion.

The inner cap is preferably arranged on the foot portion of the replacement cap. Advantageously, the inner cap may at least partially consist of an elastomeric material, thus enabling a sealing connection with the syringe tip. The syringe tip can preferably be introduced into the inner cap through an opening in the inner cap.

The outer collar is advantageously formed as a ring arranged along the longitudinal axis X'' over the opening of the inner cap. The ring is preferably supported by a strut arranged in the foot portion and radially surrounding the inner cap. Preferably, the three struts are arranged equidistant from one another along the circumference of the ring. The struts project radially inward from the ring and abut the syringe barrel when the replacement cap is placed on the prefillable syringe.

Preferably, the opening area of the replacement cap is defined by the ring and an opening in the inner cap disposed along the longitudinal axis X'' below the opening in the ring. The opening and the opening of the ring are advantageously parallel to each other and share the same central axis. Preferably, the opening area of the replacement cap is defined by the ring. Preferably, the opening region of the replacement cap formed by the ring, and the opening region of the inner cap are preferably oriented parallel to the bottom wall of the package body.

According to a preferred embodiment, a first receiving element is provided in the first cavity of the package body. Preferably, the replacement cap is received in the first receiving element. Advantageously, said foot portion of said replacement cap is received in said first receiving element. The replacement cap is thus placed upright on the package. Therefore, the opening area of the replacement cap formed by the ring and the opening area of the inner cap are preferably oriented parallel to the bottom wall of the package body.

According to a preferred embodiment, the foot portion is adapted to provide a stable upright positioning of the pre-fillable syringe with the replacement cap on the support surface. Preferably, the foot portion comprises a bearing area in contact with the support surface. Preferably, the bearing region comprises an edge surrounding the central axis of the replacement cap at an edge-distance.

For the user, the straight-line positioning is a very convenient and practical way to place a pre-fillable syringe from the package and then put it away. It is understood that in a straight-line positioning, the distal end of the pre-fillable syringe is placed on the support surface. This positioning has the advantage that the proximal end has a finger flange and the rod is easy to grip. Pre-fillable syringes generally have a much greater extensibility along the longitudinal axis (X') than along the horizontal axis (Y').

A stable positioning is possible as long as the center of gravity is within the area defined by the tilting edge of the bearing area. The bearing area may extend over a portion of the distal surface of the replacement cap constituting the distal end of the foot portion. It is also possible for the bearing area to extend over the entire distal surface. In addition, it is possible for the bearing area to extend along the edge of the distal face.

Movement of the center of gravity in the radial direction may not affect the standing stability, unless the center of gravity is located more radially outward than the tilting edge. Since a finger flange is provided at the proximal end of the pre-fillable syringe, the center of gravity is closer to the proximal end of the syringe. This means that a small shift in the center of gravity can cause the upright syringe to tip over.

Preferably, the edge distance between the edge of the bearing region and the central axis is at least twice the radius of the syringe barrel, more preferably, the edge distance is at least 3 times the radius of the syringe barrel. Preferably, the edge distance is at least four times the radius of the syringe barrel. Preferably, the edge distance is at least 5 times the radius of the syringe barrel. With this embodiment, the tilting edge is further away from the central axis. Thus, a greater shift in the center of gravity is possible before the upright syringe falls over. Therefore, the standing stability is improved.

Preferably, the distal face of the foot portion comprises an edge surrounding the central axis of the replacement cap at a specified distance. This edge may preferably be parallel to the edge of the bearing area, which is considered a tilting edge. The edge of the distal face forms the shape of the foot section, which may be arbitrary. Advantageously, the foot portion has a disc-like shape. Preferably, the foot portion is essentially circular. Optionally, the foot portion may be rectangular.

Due to the preferred placement and orientation of the replacement cap in the package after mounting the replacement cap into the syringe, which can be performed with only one hand as described, the syringe can be positioned upright and easily accessible by the user when needed. have.

According to a preferred embodiment, the bearing region and/or the edge surrounding the bearing face is at least partially coated with a rubberized material. This embodiment has the advantage that slippage of the foot portion on the support surface is suppressed or minimized.

According to a preferred embodiment, the foot part is designed as a suction cup. A suction cup is a device or article that is attached to a nonporous surface using the negative fluid pressure of air to create a partial vacuum. The working surface of the foot portion is preferably made of an elastic and flexible material and has a curved surface. When the center of the foot portion is pressed against the flat support surface, the volume of the space between the foot portion and the flat surface is reduced. Thus, air or water between the foot portion and the surface is expelled past the edge of the cup. Thereby, a pressure deficit occurs between the foot portion and the support surface. The pressure difference between the atmospheric pressure outside of the foot portion and the low pressure between the foot portion and the support surface keeps the foot portion attached to the surface.

Preferably, the replacement cap is manufactured by injection molding, preferably by multi-component injection molding.

According to a further preferred embodiment, the side walls of the package body extend along an essentially vertical axis Z. By essentially extending it is meant that the sidewall can have a relatively small angle α with respect to the vertical axis Z. This angle may range between 0° and 25°, preferably between 0° and 10°, preferably between 0° and 5°.

Advantageously, the side wall of the package body has a flange at its upper end, said flange extending essentially outward along the longitudinal (X) or horizontal (Y) axis. Preferably, the flange surrounds the package body.

According to a further preferred embodiment, the package comprises a closure element which at least partially covers the package body. Preferably, the closure element entirely covers the package body.

According to a further preferred embodiment, the closing element is arranged on the flange provided on the side wall. The closure element may be a foil or a dimensionally stable element. The closure element may be connected to the flange, preferably by means of a clamping connection, a snap connection, a welded connection, or an adhesion bond, or a similar connection. Preferably, prior to use, this connection is disconnected, preferably prior to use, to expose the pre-fillable syringe in the package body.

According to a further preferred embodiment, the closure element is slidably arranged on the package body. Preferably, the closure element is slidable along a sliding direction which is preferably oriented along the longitudinal direction (X). Advantageously, the closure element has a guidance element extending along the longitudinal direction X on each edge extending in the sliding direction, in particular in the direction of the closure element. Preferably, each flange of the two side walls extending in the sliding direction, in particular in the longitudinal direction, is accommodated in the guiding element.

According to a further preferred embodiment, the package may consist of plastic. Preferably, the package is produced in an injection molding process, preferably in a multicomponent injection molding process.

The object is also a package suitable and intended for receiving a pre-fillable syringe comprising a syringe barrel and a syringe tip, wherein the syringe tip has a tip cap, said package comprising a replacement cap for said pre-fillable syringe is addressed by a package that is suitable and intended to accommodate

The package may include a single feature or a combination of features described above for the system. Further, the system may include a single feature or a combination of features described for the package. Additionally, the same advantages described above for the system can be applied to the package.

According to a preferred embodiment, the package comprises a package body, defining a first cavity, formed by side walls and a bottom wall. Preferably, said pre-fillable syringe is arranged in said first cavity. Advantageously, at least one second receiving element in which the syringe barrel is received is provided in the first cavity of the package body.

According to a further preferred embodiment, the distal end of the syringe barrel may be supported by a first element of the second receiving element and the proximal end of the syringe barrel may be supported by a second element of the second receiving element have. Advantageously, the first element of the second receiving element can be located in or close to the region where the syringe barrel joins into the syringe tip. It is also preferred that the second element of the second receiving element can be positioned proximate to the finger flange of the syringe arranged on the package body. Preferably, the first and second elements of the second receiving element are separated along the longitudinal axis X' of the prefillable syringe. Thus, with the pre-fillable syringe being arranged in the package body and the syringe barrel being received by preferably two second receiving elements, the central axis of the pre-fillable syringe is preferably the bottom wall of the package body. extends parallel to Advantageously, the central axis extends to a height L2 above the bottom wall of the package body.

According to a preferred embodiment, the first receiving element is provided in the first cavity of the package body. Preferably, such that the replacement cap is oriented along a vertical axis (Z) of the package body, and an opening area of the replacement cap is oriented parallel to the bottom wall of the package body, the replacement cap is positioned on the first accommodated in the receiving element. Preferably, the foot portion of the replacement cap is received in the first receiving element. Preferably, the bearing area of the replacement cap is in contact with the bottom wall of the package body.

The object is also a replacement cap for a pre-fillable syringe, wherein the replacement cap comprises an inner cap for engagement with a syringe tip, an outer collar for engagement with the syringe barrel for mounting the replacement cap to the syringe barrel; and a foot portion replacement cap comprising a foot portion suitable for providing stable upright positioning of the syringe with the replacement cap on a surface thereof.

The replacement cap may comprise a single feature or a combination of features described above for the system. Further, the system may include a single feature or a combination of features described for the replacement cap. Additionally, the same advantages described above for the system can be applied to the replacement cap.

The inner cap is preferably arranged on the foot portion of the replacement cap. Advantageously, the inner cap may at least partially consist of an elastomeric material, thus enabling a sealing connection with the syringe tip. The syringe tip can preferably be introduced into the inner cap through an opening in the inner cap.

The outer collar is advantageously formed as a ring arranged along the vertical axis Z' above the opening of the inner cap. The ring is preferably supported by a strut arranged in the foot portion and radially surrounding the inner cap. Preferably, the three struts are arranged equidistant from one another along the circumference of the ring. The struts project radially inward from the ring and abut the syringe barrel when the replacement cap is placed on the prefillable syringe.

Preferably, the opening area of the replacement cap is defined by the ring and an opening in the inner cap disposed along the vertical axis Z below the opening in the ring. The opening and the opening of the ring are advantageously parallel to each other and share the same central axis. Preferably, the opening area of the replacement cap is defined by the ring. Preferably, the opening region of the replacement cap formed by the ring, and the opening region of the inner cap are preferably oriented parallel to the bottom wall of the package body.

According to a preferred embodiment, the foot portion is adapted to provide a stable upright positioning of the pre-fillable syringe with the replacement cap on the surface. For the user, the straight-line positioning is a very convenient and practical way to place the syringe. The straight line positioning may mean locating the distal end on the support surface to facilitate gripping the proximal end provided with the finger flange and the rod.

Advantageously, said foot portion comprises an edge surrounding a central axis of said replacement cap. This edge can be considered as the above-mentioned tilting edge. The edge forms the shape of the foot section, which may be arbitrary. Preferably, the foot portion has a disk shape. Advantageously, the foot portion has the form of a disc. Preferably, the foot portion has an essentially circular base area. Preferably, the foot portion has an essentially rectangular base area. Preferably, the distance between the edge and the central axis is at least twice the radius of the syringe barrel, more preferably, the distance between the edge and the central axis is at least three times the radius of the syringe barrel. Preferably, the distance between the edge and the central axis is at least four times the radius of the syringe barrel. Preferably, the distance between the edge and the central axis is at least 5 times the radius of the syringe barrel. With this embodiment, the tilting edge is further away from the central axis. Thus, a greater shift in the center of gravity is possible before the upright syringe falls over. Therefore, the standing stability is improved.

Due to the preferred placement and orientation of the replacement cap in the package after mounting the replacement cap into the syringe, which can be performed with only one hand as described, the syringe can be positioned upright and easily accessible by the user when needed. have.

According to a preferred embodiment, the bearing region and/or the edge surrounding the bearing face is at least partially coated with a rubbery material. This embodiment has the advantage that slipping of the foot portion on the support surface is suppressed.

According to a preferred embodiment, the foot part is designed as a suction cup. A suction cup is a device or article that is attached to a non-porous surface using the negative fluid pressure of air to create a partial vacuum. The working surface of the foot portion is preferably made of an elastic and flexible material and has a curved surface. When the center of the foot portion is pressed against the flat support surface, the volume of the space between the foot portion and the flat surface is reduced. Thus, air or water between the foot portion and the surface is expelled past the edge of the cup. Thereby, a pressure deficit occurs between the foot portion and the support surface. The pressure difference between the atmospheric pressure outside of the foot portion and the low pressure between the foot portion and the support surface keeps the foot portion attached to the surface.

Preferably, the replacement cap may be made of a plastic material. Preferably, the replacement cap is produced by injection molding, preferably by multi-component injection molding.

Said object is also solved by the use of a system according to any of the above-mentioned embodiments, comprising the steps of:

a) removing the pre-fillable syringe from the package;

b) removing the tip cap from the syringe tip;

c) positioning the syringe tip in a replacement cap arranged in the package; and

d) removing the pre-fillable syringe with the replacement cap attached from the package.

Use of the system may include a single feature or combination of features described above for the system or package. Further, the system or the package may include a single feature or combination of features described above for use. Additionally, the same advantages as described above for the system or the package may apply to the use of the system.

According to a preferred embodiment, said use comprises setting the dose of said pre-fillable syringe.

According to a preferred embodiment, said use may also comprise the step of removing said closure element.

According to a preferred embodiment, after removal of the syringe equipped with the replacement cap of the package, the syringe can be placed in an upright position on the support surface. Preferably, the foot portion of the replacement cap is adapted to provide stable upright positioning of the pre-fillable syringe with the replacement cap on the support surface. Preferably, the bearing area of the foot portion of the replacement cap is in contact with the support surface.

Hereinafter, the longitudinal axis X, the horizontal axis Y, and the vertical axis Z are used in relation to the package body 3 . The longitudinal axis (X'), the horizontal axis (Y'), and the vertical axis (Z') are used in connection with the prefillable syringe 100 . The longitudinal axis X'', the horizontal axis Y'', and the vertical axis Z'' are used in connection with the replacement cap 300 .

1 , 2A , 3 , 4 , and 5A , a pre-fillable syringe is shown. The pre-fillable syringe 100 includes a syringe barrel 101 and a syringe tip 102 . The syringe barrel 101 is cylindrical in shape and is open at its proximal end. At its distal end, the syringe barrel 101 merges into the syringe tip 102 along the distal direction X'1. The syringe tip 102 may have a conical shape. Advantageously, the syringe tip 102 is a luer cone. Although not necessarily preferred, it is also possible for a piercing means, in particular a needle, cannula, or similar means, to be arranged on the syringe tip 102 . In the syringe barrel 101, a medium for administration is stored. At its proximal end, the syringe barrel 101 is closed with a plunger or piston 500 , as shown in FIGS. 9-13 , movable within the syringe barrel 101 .

In a preferred embodiment, the plunger 500 may have a flat surface at its bottom 502 instead of a conical section as in a standard plunger, as shown in FIGS. 9-13 . The flat surface 502 of the bottom of the plunger 500 allows for better dose control. The sidewall of the plunger has an annular ridge 501 for sealing sliding within the syringe barrel 101 .

More preferably, the plunger may be completely coated with silicone, Teflon, or the like, and even more preferably, it may be completely coated with a film of polytetrafluoroethylene (PTFE).

The use of a standard plunger stopper and a siliconized barrel may increase the plunger stopper Break-Loose-Force (BLF) during storage of a filled syringe. This increase in Glide-Force (GF) may not be observed during storage. Thus, the difference ΔF between the two (2) forces may increase during storage. This can lead to the following user experience after storage: The user increases the force pushing the plunger rod until the plunger stopper moves. Due to the relatively large difference between the release force and the gliding force, the user may not be able to stop the force quickly enough to establish a small dose difference.

Furthermore, according to the present invention, the coating favors the easiest operation of the device of the present invention and the lowest level of subvisible particulate.

The plunger or piston (eg, as shown in FIGS. 9-13 ) may be attached to a rod 104 that protrudes in the proximal direction X′2 from the syringe barrel 101 . At the proximal end of the rod 104, a finger support 109 is arranged. The syringe barrel 101 also has a finger flange 105 . In this case, the finger flange 105 is a clip-on finger flange that can be clipped to the finger flange in the syringe barrel 101 . These clip-on finger flanges have the advantage of a larger area for the user to grip.

The pre-fillable syringe 100 has a tip cap 103 arranged on the syringe tip 102 . The tip cap 103 may be constructed, at least in part, of an elastomeric material.

2b and 5b, a replacement cap 300 is shown. 3 , 4 , and 8 , a pre-fillable syringe 100 with a replacement cap 300 is shown. 7 , 8 and 10 , a package 1 is shown in which a replacement cap 300 is arranged.

The replacement cap 300 includes an inner cap 301 for engagement with the syringe tip 102 . The inner cap 301 is arranged on the foot portion 303 of the replacement cap. Preferably, the inner cap 301 may be constructed, at least in part, of an elastomeric material to enable a sealing connection to the syringe tip 102 . The syringe tip 102 may be introduced into the inner cap 301 through the opening 304 of the inner cap 301 .

The replacement cap 300 also includes an outer collar 302 and a foot portion 303 that engage the syringe barrel 101 for mounting the replacement cap 300 .

The outer collar 300 includes a ring 305 arranged along the longitudinal axis X'' over the opening 304 of the inner cap 301 . The ring 305 is supported by a strut 306 . Preferably, the three struts 306 are arranged at the same radial distance relative to each other along the perimeter of the ring 305 . The strut 306 is arranged on the foot portion 303 and radially surrounds the inner cap 301 . Further, the strut 306 projects radially inward from the ring 305 and abuts the syringe barrel 101 when the replacement cap 300 is placed on the pre-fillable syringe 100 .

The replacement cap 300 includes an opening 309 and an opening region 309a defined by the ring 305 . The opening 304 of the inner cap 301 is disposed below the ring opening 309 along the longitudinal axis X''. Accordingly, the opening area 309a is oriented parallel to the opening area of the opening 304 of the inner cap 301 . The pre-fillable syringe 100 is first introduced through the opening 309 and then into the opening 304 of the inner cap 301 . The opening 309 and the opening 304 share the same central axis 307 . 7 and 8 a package 1 is shown in which a replacement cap 300 is arranged. And the opening area 309a is oriented parallel to the bottom wall 6 of the package body 3 .

The foot portion 303 is adapted to provide a stable upright positioning of the pre-fillable syringe 100 on the support surface 400 . This is shown in FIG. 4 . In the upright positioning, the distal end of the prefillable syringe 100 is placed on a support surface ( 400) is understood. The foot portion 303 includes a bearing area 311 abutting the support surface 400 . The bearing region 311 may extend over a portion of the distal surface 312 of the replacement cap 300 constituting the distal end of the foot portion. It is also possible for the bearing region 311 to extend to the entire distal surface 312 . Additionally, it is possible for the bearing region 311 to extend along the edge of the distal surface 312 .

The pre-fillable syringe 100 has a much greater extensibility along the longitudinal axis X' than along the horizontal axis Y'. A stable positioning is possible as long as the center of gravity is within the area defined by the edge of the bearing area 311 . Movement of the center of gravity in the radial direction (along the horizontal axis (Y') or the vertical axis (Z')) does not affect the standing stability, unless the center of gravity is located more radially outward than the tilting edge. it may not be Since the finger flange 105 is provided at the proximal end of the pre-fillable syringe 100 , the center of gravity is closer to the proximal end of the pre-fillable syringe 100 . This means that a small shift in the center of gravity can cause the upright syringe to tip over.

The bearing area 311 includes an edge 313 surrounding the central axis 307 of the replacement cap 300 at an edge distance 308 . The edge distance 308 is at least twice the radius 112 of the syringe barrel 101 , and more preferably at least three times the radius 112 of the syringe barrel 101 . Preferably, the edge distance 308 is at least four times the radius 112 of the syringe barrel 101 . Preferably, the edge distance 308 is at least 5 times the radius 112 of the syringe barrel 101 . With this embodiment, the tilting edge is further away from the central axis. Thus, a greater movement is required to topple the pre-fillable syringe 100 .

The distal surface 312 of the foot portion 303 includes an edge. The edge of the distal face 312 and the edge 313 of the bearing region 311 are parallel and adjacent to each other.

2B , 3 , 4 , 7 , and 8 , the replacement cap 300 has an essentially circular disc shape, except for a cut portion 314 . The edge distance 308 is thus essentially the radius of the disc-shaped foot portion 313 . The cut-out portion 314 extends along a secant line, which is a line crossing the circular replacement cap at two points in diameter, wherein the secant does not penetrate the center of the circular replacement cap. . The cut-out portion 314 abuts a side wall 5 extending along the longitudinal axis X.

The foot portion 303 according to the embodiment of FIG. 5B is rectangular. Thus, the edge distance 308 will be the distance from the central axis 307 to the closest edge.

The foot portion 303 is also a grip portion suitable for a user to grip the replacement cap 300 due to its dimensions. The foot portion 303 may also be designed as a suction cup, a device or object that is attached to a non-porous surface using the negative fluid pressure of air to create a partial vacuum.

6 to 8 , a package 1 and/or a system 200 is shown.

The system (200) comprises a pre-fillable syringe (100) having a syringe barrel (101) and a syringe tip (102) and a package (1) suitable and intended to receive the pre-fillable syringe (100); , the syringe tip 102 includes a tip cap 103 , the system 200 includes a replacement cap 300 for the pre-fillable syringe 100 , and the package 1 includes the It is suitable and intended to receive the replacement cap 300 .

The package (1) suitable and intended to receive a pre-fillable syringe (100) comprises a syringe barrel (101) and a syringe tip (102), the syringe tip (102) having a tip cap (103) and the package 1 is suitable and intended to receive a replacement cap 300 for the pre-fillable syringe 100 .

The package (1) comprises a package body (3), forming a first cavity (4), formed by a side wall (5) and a bottom wall (6), wherein the pre-fillable syringe (100) comprises the Arrangeable or arranged in the first cavity 4 . The package body 3 extends along a longitudinal axis X, a horizontal axis Y, and a vertical axis Z perpendicular to each other. In addition, the package body 3 has a rectangular shape.

At least one second receiving element ( 7 , 7a , 7b ) in which the syringe barrel ( 101 ) can be accommodated is provided in the first cavity ( 4 ) of the package body ( 3 ). The embodiments shown in the figures have two second receiving elements 7 , 7a , 7b arranged on the bottom wall 6 of the package body 3 .

The first element 7a of the second receiving element 7 comprises a semi-circular upper section 26 arranged in the base section 27 . The semi-circular upper section 26 is dimensioned to receive the syringe barrel 101 . According to the embodiments of FIGS. 6 to 8 , the second element 7b of the second receiving element 7 also comprises a semicircular upper section 26 arranged in the base section 27 .

The distal end 101a of the syringe barrel 101 is supported by the first element 7a of the second receiving element 7 , and the proximal end 101b of the syringe barrel 101 is the second receiving element supported by the second element 7b of (7).

When the prefillable syringe ( 100 ) is placed in the package ( 1 ), the first element ( 7a ) of the second receiving element ( 7 ) allows the syringe barrel ( 101 ) to enter the syringe tip ( 102 ). It is located at or close to the area 110 to be merged. Further, the second element 7b of the second receiving element 7 is positioned proximate to the finger flange 105 of the refillable syringe 100 arranged on the package body 3 .

The first cavity 4 of the package body 3 has a third receiving element 8 in which the rod 104 of the pre-fillable syringe 100 is accommodated or received. The third receiving element 8 comprises two walls 8a , 8b extending along the vertical axis Z, forming a cavity in which the rod 105 is received or received. The third receiving element 8 also has a bottom wall which is formed in a semicircular shape and connects the walls 8a, 8b. The third receiving element 8 terminates at its proximal end at a fastening element 30 in which the finger support 109 of the rod 104 is received.

A gap 29 is formed between the second element 7 , 7b of the second receiving element and the third receiving element 8 . When the pre-fillable syringe 100 is placed inside the package body 3 , the finger flange 105 of the pre-fillable syringe 100 may protrude through the gap 29 . Thus, the finger flange 105 is configured such that the second element 7b of the second receiving element 7 and the third receiving element are fixed such that the pre-fillable syringe 100 is fixed to the package body 3 . (8) is sandwiched between.

The third receiving element 8 extends essentially along the length of the section of the rod 104 protruding from the syringe barrel 101 after the gap 29 .

When the pre-fillable syringe 100 is placed in the package body 3 , it is carried by the first element 7a of the second receiving element 7 , preferably the second receiving element 7 . It is supported by the second element 7b of the , and preferably by the third receiving element 8 , in particular by the fastening element 30 . Thus, with the pre-fillable syringe 100 in the package body 3 , the central axis 111 of the pre-fillable syringe 100 is aligned with the bottom wall 6 of the package body 3 . extend parallel. The central axis 111 extends to a height L2 above the bottom wall 6 of the package body 3 . The height L2 makes it possible to easily hold the pre-fillable syringe 100 .

The replacement cap 300 is arranged in the package 1 such that the opening 309 of the replacement cap 300 is oriented along the vertical axis Z of the package body 3 . The opening area 309a of the replacement cap 300 is oriented parallel to the bottom wall 6 of the package body 3 . Preferably, the central axis 307 of the replacement cap 300 is parallel to the height extension of the side wall 5 of the package body 3 .

The sidewall(s) 5 of the package body 3 surround the package body 3 along a longitudinal axis X and a horizontal axis Y. Said sidewall(s) 5 extend along a vertical axis Z to a height L4. The height L4 is at least the height L2 plus the radius 112 of the syringe barrel 101 . A flange 31 is provided at the upper end (along the vertical axis Z) of the side wall(s) 5 . The flange 31 extends outwardly and surrounds the package body 3 along the longitudinal axis X and the horizontal axis Y, preferably without any spacing.

On said flange 31 , a closing element 15 can be arranged. Preferably, the closing element is connected with a suitable connection to the flange 31 . The closure element 15 is only partially shown in FIG. 6 and may be a foil or a slidable stable element.

6 to 8 , the first cavity 4 of the package body 3 is provided with a first receiving element 2 in which the replacement cap 300 is accommodated. In particular, here the foot part 303 of the replacement cap 300 is received in the first receiving element 2 . Thus, the first receiving element 2 is essentially in the shape of the outer perimeter of the foot portion 303 . 6-8, this shape would be essentially circular with a cutout extending along the secant.

The first receiving element 2 comprises a side wall 12 arranged on the bottom wall 6 of the package body 3 . The side wall 12 and the side wall 5 of the package body 3 form a cavity conforming to the shape of the foot portion 303 of the replacement cap 300 . 6 to 8 of the present case, this cavity and the foot portion 303 of the replacement cap 300 are essentially circular in shape. Accordingly, the bearing surface 311 of the replacement cap 300 is such that the opening 309 of the replacement cap 300 is located in the package body 3 so that the replacement cap 300 is disposed within the package 1 . It sits on the bottom wall 6 of the package body 3 so as to be oriented along the vertical axis Z. The opening area 309a of the replacement cap 300 is oriented parallel to the bottom wall 6 of the package body 3 .

The height 13 of the sidewall 12 along the vertical axis Z is essentially the height 310 at the outer edge of the replacement cap 300 .

1-8, the use of the system 200 is illustrated. Said use preferably comprises removing the closure element from said package body 3 . The pre-fillable syringe 100 is then removed from the package 1 . Then, the tip cap 103 is removed. Optionally, the dose of the pre-fillable syringe is set. The replacement cap 300 is then mounted on the pre-fillable syringe 100 . To this end, the syringe tip 102 is placed on a replacement cap 300 arranged on the package 1 . The syringe tip 102 is passed through an opening 309 of the replacement cap 300 and an opening 304 of the inner cap 301 . Eventually, the inner cap 301 is attached to the syringe tip 102 , and the ring 305 or strut 306 abuts the syringe barrel 101 . During mounting, the replacement cap 300 remains inside the package 1 . Because the opening 309 of the replacement cap 300 is oriented along the vertical axis Z of the package body 3 , the syringe tip 102 can be easily introduced into the replacement cap 300 . can Therefore, it is possible to operate the syringe 100 using only one hand. There is no need to put down the pre-fillable syringe 100 to obtain or align the replacement cap 300 with respect to the pre-fillable syringe 100 . The pre-fillable syringe 100 to which the replacement cap 300 is attached can then be taken out of the package 1 .

The pre-fillable syringe 100 can preferably be placed in an upright position on the support surface 400 . Preferably, the foot portion 303 of the replacement cap 300 provides a stable upright positioning of the pre-fillable syringe 100 with the replacement cap 300 on the support surface 400 . The bearing area 311 of the foot portion 303 of the replacement cap 300 abuts the support surface 400 .

Such a system 200 has the advantage that the user is provided with a package 1 comprising the pre-fillable syringe 100 and an appropriate replacement cap 300 for use. The replacement cap 300 is already available to the user, and there is no need to obtain it separately. Also, the replacement cap 300 does not need to be taken out of the additional package.

The present invention also relates to the system disclosed herein, wherein the syringe is prefilled with a ready-to-use pharmaceutical formulation.

Advantageously, the pharmaceutical preparation is in the form of a solution or emulsion and comprises one or more active ingredients suitable for oral, intramuscular or intravenous administration.

More advantageously, the agent is an aqueous solution or a hydroalcoholic solution.

Preferably, the pharmaceutical formulation is administered to a patient affected by opiate withdrawal syndrome (OWS), more preferably to a patient affected by neonatal OWS, sublingual and/or buccal For effective treatment by administration, it is an aqueous solution or a hydroalcoholic solution containing buprenorphine.

More preferably, said buprenorphine formulation in the form of an aqueous solution comprises:

i) 0.005 to 0.02% w/v of buprenorphine or a pharmaceutically acceptable salt thereof as the sole active ingredient;

ii) 0.5% to 10% w/v of a thickening agent; and

iii) a buffering agent in an amount to provide a pH of 5.0 - 7.0.

Buprenorphine as a base or hydrochloric acid, hydrobromic acid, sulfuric acid, phosphoric acid, nitric acid, acetic acid, glycolic acid, lactic acid, pyruvic acid, malonic acid, succinic acid, glutaric acid, fumaric acid, malic acid, mandelic acid, tartaric acid, citric acid, ascorbic acid pharmaceutically formed with inorganic or organic acids such as acid, palmitic acid, maleic acid, hydroxymaleic acid, benzoic acid, hydroxybenzoic acid, phenylacetic acid, cinnamic acid, salicylic acid, methanesulfonic acid, benzenesulfonic acid, and toluenesulfonic acid It can be utilized in the form of an acceptable salt.

Preferably, buprenorphine is present as the hydrochloride salt.

Advantageously, the concentration of buprenorphine will be comprised between 0.005 and 0.02% w/v expressed as free base, preferably between 0.006 and 0.01% w/v expressed as free base.

In a specific embodiment, the concentration of buprenorphine hydrochloride, expressed as free base, is 0.0075% w/v.

The concentration of thickener will be comprised between 0.5% and 10% w/v, preferably between 0.6% and 8.0% w/v. The type and amount of thickening agent will be appropriately selected to achieve sufficient viscosity to keep the formulation under the patient's tongue as far as possible, and to minimize absorption through the gastrointestinal tract.

At the same time, the viscosity should not be so high as to impede the release of the active ingredient from the matrix and thus its local absorption.

More preferably, the concentration of the thickener may be between 1.0 and 6.0% w/v.

In a specific embodiment, the concentration is 1.0% w/v, or 1.5% w/v, or 2.0% w/v, or 6.0% w/v.

Advantageously, the thickener comprises water-soluble polysaccharides such as alginate, carrageenan, pectin, water-soluble derivatives of cellulose: alkylcelluloses hydroxyalkylcelluloses and hydroxyalkylalkylcelluloses such as methyl Cellulose, hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxyethylmethylcellulose, hydroxypropylmethylcellulose, hydroxybutylmethylcellulose, cellulose esters, and hydroxyalkylcellulose esters such as cellulose acetate phthalate ( CAP), hydroxypropylmethylcellulose (HPMC); carboxyalkylcellulose, carboxyalkylalkylcellulose, carboxyalkylcellulose esters such as carboxymethylcellulose and alkali metal salts thereof; Water-soluble synthetic polymers such as polyacrylic acid and polyacrylic acid ester, polymethacrylic acid and polymethacrylic acid ester, polyvinylacetate, polyvinylalcohol, polyvinylacetate phthalate (PVAP), polyvinylpyrrolidone (PVP) and polycroton acid; phthalated gelatin, gelatin succinate, crosslinked gelatin, shellac, water-soluble chemical derivatives of starch, for example tertiary such as diethylaminoethyl group which can be quaternized if desired or cationically modified acrylates and methacrylates having quaternary amino groups are also suitable.

Preferably, the thickener is a water-soluble cellulose derivative selected from the group consisting of alkali metal salts of carboxymethylcellulose (CMC), such as hydroxyethylcellulose (HEC) or sodium salt.

Indeed, thickeners belonging to this class can provide adequate viscosity, whereas for other agents of the gum family, such as xanthan gum, the viscosity of the formulation has been found to be too high.

Advantageously, the viscosity of the formulation will be comprised between 500 and 2300 mPas at 25±2° C. (1 mPas corresponds to 1 centipoise), preferably between 700 and 2100 mPas. Viscosity can be measured using any known method, for example, a rheometer.

Advantageously, the pH of the formulations of the invention may be comprised between 5.0 and 7.0, more advantageously between 5.2 and 6.8, preferably between 5.5 and 6.5.

When a water-soluble cellulose derivative is used, the preferred formulation comprises a pH between 5.5 and 6.5 and an amount of thickener between 1.0% and 2.0% w/v, even more preferably 1.5% w/v. A preferred thickener of this class may be hydroxyethylcellulose. The excipient is commercially available as Natrosol 250 HX™.

Any buffer capable of providing the above pH may be used, for example a phosphate or citrate buffer as a sodium or potassium salt. A person skilled in the art will be able to determine the appropriate amount.

In a preferred embodiment, citric acid anhydride and sodium citrate anhydrous are used as buffers.

The formulations may also contain other excipients such as flavoring and/or sweeteners.

Flavoring agents may be selected from natural and synthetic flavor liquids. An exemplary list of such substances includes volatile oils, synthetic flavor oils, flavoring aromatics, oils, liquids, or oleoresin or extracts derived from plants, leaves, flowers, fruits, stems, and these includes a combination of A list of representative examples includes mint oil, cocoa, and citrus oils such as lemon, orange, grape, lime and grapefruit, and apple, pear, peach, grape, strawberry, raspberry, cherry, plum, pineapple, apricot or other fruit flavors ( fruit essences with fruit flavors).

Other useful flavoring agents include benzaldehyde (cherry, almond), citral, i.e. alpha-citral (lemon, lime), neral, i.e. beta-citral (lemon, lime), decanal. (orange, lemon), aldehyde C-8 (citrus fruit), aldehyde C-9 (citrus fruit), aldehyde C-12 (citrus fruit), tolyl aldehyde (cherry, almond), 2,6-dimethyloctanol ( aldehydes and esters, such as green fruit), and 2-dodecenal (citrus, mandarin), and combinations thereof.

The sweetener may be selected from the following non-limiting list: glucose (corn syrup), dextrose, invert sugar, fructose, and combinations thereof; saccharin and its various salts, such as the sodium salt; dipeptide sweeteners such as aspartame; dihydrochalcone compound, glycyrrhizin; Stevia rebaudiana (Stevioside); chloro derivatives of sucrose such as sucralose; Sugar alcohols such as sorbitol, mannitol, and xylitol, etc. Also hydrogenated starch hydrolyzate and synthetic sweetener 3,6-dihydro-6-methyl-1-1-1,2,3-oxathiazin-4-one-2,2-dioxide, especially its potassium salt ( cesulfame-K), and sodium and calcium salts are also contemplated. Other sweeteners may also be used.

In general, one of ordinary skill in the art would select a sweetening and/or flavoring agent from among those considered safe for neonatal administration.

The formulation may also contain permeation enhancers such as propylene glycol, and polyoxyl hydrogenated castor oil derivatives, such as polyoxyl 40 hydrogenated castor oil (commercially available as Kolliphor RH 40™). may contain.

In a preferred embodiment, the formulation has the following composition: 0.05-0.01% w/v buprenorphine hydrochloride expressed as a base, 1.5% w/v hydroxyethylcellulose, 0.12% w/v anhydrous Citric acid, 1.13% w/v anhydrous sodium citrate, water for injection and its pH 6.0±0.3.

In an optional embodiment, the formulation has the following composition: 0.05-0.01% w/v buprenorphine hydrochloride expressed as a base, 6.0% w/v sodium carboxymethylcellulose, 0.12% w/v Anhydrous citric acid, 1.13% w/v anhydrous sodium citrate, water for injection and its pH is 6.0 ± 0.3.

Further details are reported in International PCT Patent Application No. PCT/EP2018/078447 and U.S. Patent Application Serial No. 16/164,282, each of which is incorporated herein by reference in its entirety.

The pharmaceutical preparation may be prepared according to a known method.

In a preferred embodiment, the pharmaceutical formulation is sterile and the pre-filling is performed under aseptic conditions performed according to methods known in the art.

Although less preferred, the pharmaceutical formulation may be in the form of a dry powder that can be dissolved immediately prior to use.

Accordingly, the present invention also relates to a kit comprising a pharmaceutical preparation in powder form for reconstitution in a ready-to-use aqueous solution or in a suitable vehicle, together with the system disclosed herein, and instructions for administering the pharmaceutical preparation. it's about

1 package
2 first receiving element
3 package body
4 First cavity of package body
5 Sidewall of package body
6 Bottom wall of package body
7 second receiving element
7a first element of the second receiving element
7b second element of the second receiving element
8 Third Receiving Element
8a, 8b wall of the third receiving element
12 sidewall of the first receiving element
13 side wall height
15 closure element
26 Semicircular upper section of the second receiving element
27 Base section of the second receiving element
30 fastening elements
31 flange
100 pre-fillable syringes
101 syringe barrel
101a Distal end of syringe barrel
Proximal end of 101b syringe barrel
102 syringe tips
Outer diameter of 102a syringe tip
103 tip cap
Outer diameter of 103a tip cap
103b tip cap distal end face
104 rod
105 finger flange
106 length of pre-fillable syringes
107 width of finger flange
108 width of syringe barrel
109 finger support
110 Area where the syringe barrel merges into the syringe tip
111 Central axis of pre-fillable syringes
112 radius of syringe barrel
200 system
300 replacement cap
301 inner cap
302 outer collar
303 foot part
304 opening in inner cap
305 ring
306 strut
307 center shaft of replacement cap
308 edge distance
309 replacement cap opening
309a replacement cap opening area
310 height
311 bearing area
312 Fabric side of foot
313 Edge of bearing area
314 incision
400 support surface
500 plunger
Ridge of 501 plunger
502 bottom of plunger
Longitudinal axis of the X package body
Y package body horizontal axis
Vertical axis of the Z package body
X' longitudinal axis of the pre-fillable syringe
Y' Horizontal axis of pre-fillable syringe
Z' vertical axis of pre-fillable syringe
X'' longitudinal axis of replacement cap
Y'' horizontal axis of replacement cap
Vertical axis of Z'' replacement cap
X'1 distal direction
X'2 proximal direction
The height of the central axis of the syringe above the L2 bottom wall
The height of the side wall of the L4 package body

Claims (20)

A system ( 200 ) comprising a pre-fillable syringe ( 100 ) having a syringe barrel ( 101 ) and a syringe tip ( 102 ) and a package ( 1 ) suitable for receiving said pre-fillable syringe ( 100 ). ), wherein the syringe tip (102) has a tip cap (103), the system (200) includes a replacement cap (300) for the pre-fillable syringe (100), and the package (1) includes: A system (200) suitable for receiving the replacement cap (300). According to claim 1,
The package (1) comprises a package body (3), forming a first cavity (4), formed by a side wall (5) and a bottom wall (6), wherein the pre-fillable syringe (100) is At least one second receiving element ( 7 , 7a , 7b ) arranged in the first cavity ( 4 ) and receiving the syringe barrel ( 100 ) is provided in the first cavity ( 4 ) of the package body ( 4 ) The distal end 101a of the syringe barrel 101 is supported by the first element 7a of the second receiving element 7 , the proximal end 101b of the syringe barrel 101 being the second System (200), characterized in that it is supported by a second element (7a) of the receiving element (7). 3. The method of claim 1 or 2,
The replacement cap 300 is arranged in the package 1 such that the opening 309 of the replacement cap 300 is oriented along the vertical axis Z of the package body 3 , and the replacement cap 300 ) of the system ( 200 ), characterized in that the opening area ( 309a ) of the package body ( 3 ) is oriented parallel to the bottom wall ( 6 ) of the package body ( 3 ). 4. The method according to any one of claims 1 to 3,
At least one third receiving element (8) in which a rod (104) of the pre-fillable syringe (100) is received is provided in the first cavity (4) of the package body (3), A gap 29 is provided between the second element 7b of the receiving element 7 and the third receiving element 8 , the finger flange 105 of the pre-fillable syringe 100 being System (200), characterized in that the finger flange projects through the gap (29) such that the finger flange is sandwiched between the second element (7b) and the third receiving element (8) of the second receiving element (7). ). 5. The method according to any one of claims 1 to 4,
The replacement cap 300 includes an inner cap 301 for engagement with the syringe tip 102 and the syringe barrel 101 for mounting the replacement cap 300 to the syringe barrel 101 . A system (200) comprising: an outer collar (302) for engaging with the body; and a foot portion (303). 5. The method according to any one of claims 2 to 4,
A first accommodating element 2 is provided in the first cavity 4 of the package body 4 , the replacement cap 300 is accommodated in the first accommodating element 2 , the replacement cap 300 ), the foot portion (303) of which is received in the first receiving element (2). 5. The method of claim 4,
The foot portion 303 is suitable for providing a stable upright positioning of the pre-fillable syringe 100 with the replacement cap 300 on the support surface 400 , comprises a bearing area 311 abutting the support surface 400 , the bearing area 311 being the central axis of the replacement cap 300 at an edge-distance 308 ( 307 surrounding an edge 313 , the edge distance 308 being at least twice the radius 112 of the barrel 101 , the foot portion 303 having a disc-like shape System 200, characterized in that it has. 8. The method according to any one of claims 1 to 7,
The side wall 5 of the package body 3 has at its upper end a flange 31 , the package 1 comprising a closing element at least partially covering the package body 3 , the closure System (200) characterized in that an element is disposed on said flange (31). A package (1) suitable and intended to receive a pre-fillable syringe (100) comprising a syringe barrel (101) and a syringe tip (102), said syringe tip (102) having a tip cap (103) and , wherein said package (1) is suitable and intended to receive a replacement cap (300) for said pre-fillable syringe (100). 10. The method of claim 9,
The package (1) comprises a package body (3), forming a first cavity (4), formed by a side wall (5) and a bottom wall (6), wherein the pre-fillable syringe (100) is At least one second receiving element ( 7 , 7a , 7b ) arranged in the first cavity ( 4 ) and receiving the syringe barrel ( 100 ) is provided in the first cavity ( 4 ) of the package body ( 4 ) A package (1), characterized in that it becomes. 11. The method of claim 10,
A first receiving element (2) is provided in the first cavity (4) of the package body (4), and the replacement cap (300) is configured such that the replacement cap (300) is positioned in a vertical direction of the package body (3). oriented along the axis Z and received in the first receiving element 2 such that the opening area 309a of the replacement cap 300 is oriented parallel to the bottom wall 6 of the package body 3 . and the foot portion (303) of the replacement cap (300) is received in the first receiving element (2). 12. The method of claim 10 or 11,
At least one third receiving element ( 8 ) in which a rod ( 14 ) of the pre-fillable syringe ( 100 ) can be accommodated is provided in the first cavity ( 4 ) of the package body ( 3 ), the second receiving element A gap 29 is provided between the second element 7b of ( 7 ) and the third receiving element 8 , the finger flange 105 of the pre-fillable syringe 100 , the finger flange 105 . ) can project through the gap (29) so that it is sandwiched between the second element (7b) and the third receiving element (8) of the second receiving element (7). A replacement cap (300) for a pre-fillable syringe comprising:
The replacement cap 300 is an inner cap 301 for coupling with the syringe tip 102, and the syringe barrel 101 for mounting the replacement cap 300 to the syringe barrel 101. an outer collar (302) and a foot portion (30) suitable for providing stable upright positioning of the pre-fillable syringe (100) with the replacement cap (300) on a support surface (400); Replacement cap 300, characterized in that. 14. The method of claim 13,
The foot portion 303 includes a bearing region 311 abutting the support surface 400 , the bearing region 311 aligning the central axis 307 of the replacement cap 300 at an edge distance 308 . replacement cap comprising a surrounding edge (313), said edge distance (308) being at least twice the radius (112) of said syringe barrel (101), said foot portion (303) having the shape of a disc (300). 9. Use of a system (200) according to any one of the preceding claims, comprising:
a) taking out the pre-fillable syringe ( 100 ) from the package ( 1 );
b) removing the tip cap (103) from the syringe tip (102);
c) positioning the syringe tip (102) on the replacement cap (300) arranged in the package (1); and
d) removing the pre-fillable syringe (100) to which the replacement cap (300) is attached from the package (1). 9. The method according to any one of claims 1 to 8,
The system ( 200 ), wherein the syringe is pre-filled with a ready-to-use pharmaceutical formulation. 17. The method of claim 16,
The pharmaceutical formulation is in the form of a solution or emulsion, and comprises one or more active ingredients suitable for oral, intramuscular, or intravenous administration. 18. The method of claim 16 or 17,
The system (200) of any one of the preceding claims, wherein the agent is an aqueous solution or a hydroalcoholic solution. 19. The method according to any one of claims 16 to 18,
The pharmaceutical formulation is an aqueous solution or a hydroalcoholic solution for sublingual and/or buccal administration containing buprenorphine as an active ingredient (200). 20. A pharmaceutical preparation in the form of a ready-to-use aqueous solution or a powder for reconstitution in a suitable vehicle, and administration of the pharmaceutical preparation together with the system according to any one of claims 1 to 8 and 16 to 19. A kit with instructions for doing so.

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