FIELD OF THE INVENTION

The present invention relates to a pharmaceutical container for holding a pharmaceutical product, a method of providing a pharmaceutical container, and a kit comprising a pharmaceutical container and a syringe. More specifically, the present invention relates to a pharmaceutical container having a container body, a plug seal for sealing off an opening of the container body, a seal cap for retaining the plug seal relative to the container body, an outer cap covering a portion of the seal cap and a gripping member for separating the outer cap from the seal cap.

BACKGROUND OF THE INVENTION

Liquid pharmaceutical products for application to a patient by a syringe are typically packaged in containers which are sealed with a stopper inserted into a neck of the container. Such containers may either be provided filled with the liquid medication or filled with a powdered drug that is to be reconstituted with a diluent prior to administration. A metallic seal cap is typically applied over the exterior opening of the neck to cover the end of the rubber stopper. The seal cap is secured to the neck by crimping the cap seal around a shoulder of the neck. The seal cap includes a small diameter hole at its centre, facilitating the insertion of a needle of the syringe into the container. Fig. 1 a represents a prior art solution (disclosed in WO 2006/041965 A2) of a closure 10 for a pharmaceutical container wherein a removable outer cap 17 is attached over the seal cap 1 1 . The mechanism for attaching the outer cap 17 to the seal cap 1 1 is expressly designed to be altered when the outer cap is removed from the seal cap, thus preventing replacement of the outer cap on the seal cap. Consequently, the absence of the outer cap 17 on a container is a positive indication that access to the medicament has been attempted or tampering of the container has been made. Such an outer cap is. The outer cap 17 is attached to the seal cap 1 1 and subsequently the seal cap/outer cap assembly is secured to the container body 12 by means of a crimping operation. From a manufacturing perspective, this type of outer cap is generally attractive. In addition it also provides a reliable and effective tamper evidence. However, in pharmaceutical containers of the above kind, due to the outer cap being somewhat diminutive, inexperienced users may by mistake attempt to penetrate the closure of the container with the needle while the outer cap is still being attached to the container. Such attempt may lead to the needle becoming bent and not suitable for the subsequent injection. In addition, the diminutive nature of the outer cap does not offer an ergonomic grip. This may be a problem to some users. In particular, when the contents of the pharmaceutical container is to be used in an emergency situation, such as when a diabetic patient suffers from a severe hypoglycaemic incidence and requires an immediate injection of glucagon, conventional pharmaceutical containers such as the one described in WO 2006/041965 does not enable a sufficiently effective and fail-safe administration.

Fig. 1 b represents another prior art solution originally disclosed in US 5,334,178 wherein a container closure includes an outer cap (seal 80) that is provided with a laterally extending tab portion 82 to facilitate removal of the outer cap 80. A seal cap 30 is secured to the container body, but in this reference the outer cap 80 is attached to the seal cap 30 by means of a ridge 84 protruding radially inwards from a side wall of the outer cap that engages a groove 35 formed in a sidewall of the seal cap 30. Although the outer cap 80 provides an improved grip, a similar or larger extending grip portion cannot be readily formed in the type of closure disclosed in fig. 1 a without interfering with the crimping operation for securing the seal cap to the container body. A similar structure of a pharmaceutical container is disclosed in US 4,482,071 wherein it is mentioned that the seal cap and the outer cap may be coupled with each other into an integral body by means of a conventional heating treatment prior to securing the caps to the container. However, in the Ό71 reference, no information is given as to how this could be realized in a real-life manufacturing process. Further related prior art pharmaceutical containers are disclosed in US 5,405,031 and US 5,447,247. In addition, a bottle opener for beverage bottles is disclosed in US 2010/078404 A1 .

BRIEF DESCRIPTION OF THE INVENTION

Having regard to the above-identified prior art, it is an object of the present invention to provide an improved pharmaceutical container which enable more easy operation compared to pharmaceutical containers of the prior art, which reduces the risk of wrong use of the pharmaceutical container and which enables a cost effective process for its manufacture. In a first aspect the present invention relates to a pharmaceutical container for accommodating a pharmaceutical product. The pharmaceutical container comprises: a container body having a wall section and a flange section defining an opening, a pierceable seal cooperating with the flange section of the container body to seal off the opening of the container body, the pierceable seal being adapted to be pierced by a needle cannula to gain access to the pharmaceutical product, a seal cap cooperating with the flange section of the container body and securing the pierceable seal relative to the flange section of the container body, the seal cap defining a seal cap opening through which access to the pierceable seal is enabled, an outer cap removably connected relative to the seal cap to seal the seal cap opening and enabling, upon removal of the outer cap relative to the seal cap, access to the pierceable seal through the seal cap opening, and a gripping member, the gripping member being formed separately from the outer cap but relatively connectable thereto, the gripping member defining first and second portions, the first portion being adapted for being mounted relative to the outer cap and the second portion being adapted to be manually gripped by a user, the gripping member being so formed that upon a user moving the second portion of the gripping member relative to the container body, the gripping member removes the outer cap relative to the seal cap to enable access to the pierceable seal.

By providing a pharmaceutical container according to the first aspect a particular user- friendly and ergonomic solution is provided which at the same time visually indicates the need of operating the gripping member relative to the container body as an initial step. In this way, even first-time users of such pharmaceutical containers will be able to correctly gain access to the contents of the container. Hence, confusion and erroneous usage of the pharmaceutical container may be avoided.

In the present application, when specifying that the gripping member removes the outer cap relative to the seal cap, it implies that the outer cap is at least partially separated from the seal cap to enable needle access to the plug seal. In some embodiments the outer cap may be removed from the seal cap even though the outer cap will still be loosely connected relative to the seal cap after operation of the gripping member but allowing a syringe needle to directly penetrate the pierceable seal. In other embodiments, the outer cap is fully separated from the cap seal.

The gripping member may be a member non-integrally formed relative to the outer cap but which is subsequently mounted onto or relative to the outer cap.

The pierceable seal may be provided as a plug having a section that enters into the opening of the flange section of the container body. Alternatively, in other embodiments, the pierceable seal may be generally disc shaped having a surface adapted to make sealing contact with the upper surface of the flange section of the container body.

In the pharmaceutical container, the seal cap may be beaded onto the flange section of the container body to secure the pierceable seal relative to the flange section of the container body. In some embodiments the seal cap is non-removably attached to the flange section. In some further embodiments the seal cap is beaded onto the flange section of the container body through 360 degrees of rotation to secure the pierceable seal relative to the flange section of the container body.

In some embodiments, the outer cap may be fastened relative to the seal cap to thereby form an assembly that is subsequently secured relative to the flange section of the container. The outer cap may be fastened relative to the seal cap by any suitable methods such as by a thermoforming process.

The means for fastening the outer cap relative to the seal cap may include retaining elements extending from the outer cap and engaging the seal cap and/or vice versa. Said retaining elements may be adapted to fracture during initial use of the container for preparing the container for needle penetration, i.e. during the initial procedure where the outer cap is removed from the seal cap, this procedure being carried out by operation of the gripping member.

In some embodiments the gripping member, prior to being operated to remove the outer cap relative to the seal cap, is adapted to extend from the outer cap and at least partly along the container body towards an end of the container body distant from said opening of the container body. The container may define a total height in the upright position, wherein the gripping member, prior to being operated to remove the outer cap relative to the seal cap, is adapted to extend from the outer cap and generally parallel with the container body along a substantial height of the container body, such as more than 25% of the height of the container, such as more than 40% of the height of the container, such as more than 50% of the height of the container, such as more than 75% of the height of the container and such as more than 90% of the total height of the container.

The container body may be of the kind having a main wall section and a reduced neck portion connecting the main wall section with the flange section. The gripping member, prior to being operated to remove the outer cap relative to the seal cap, may in some embodiments be adapted to extend from the outer cap and at least partly overlapping said reduced neck portion towards an end of the container body distant from said opening of the container body. In a storage state of the container, the gripping member may be arranged generally parallel to a central axis of the container body. The second portion of the gripping member may define an open loop section adapted to receive a finger of a user. Other embodiments may define a pull tab having serrated profile for increasing grip when grabbed between two fingers and pulled.

The first portion of the gripping member may be mounted relative to the outer cap by means of a mechanical engagement. Exemplary embodiments include a snap fit engagement, a friction fit engagement, a threaded engagement and a bayonet coupling engagement. Alternative engagements between the first portion of the gripping member and the outer cap may be provided by the gripping member being adhered, glued or fused relative to the outer cap.

In a second aspect, the present invention relates to a pharmaceutical kit comprising a pharmaceutical container according to the first aspect. In such kit, the base part of the container (a) may be arranged to form a first entity including the container body, the seal, the seal cap and the outer cap. The gripping member (b) forms a second entity that may be arranged either pre-mounted relative to the outer cap or arranged separated therefrom.

In other embodiments the pharmaceutical kit further comprises a syringe (c) having a needle cannula attached at one end to cooperate with the pierceable seal of the pharmaceutical container, and d) a casing accommodating the pharmaceutical container and the syringe. In some embodiments of the pharmaceutical kit, the syringe has a removable needle cap covering the needle cannula. The gripping member of the container comprises a first indicia and the needle cap of the syringe comprises a second indicia wherein the first and second indicia indicates an operating sequence of firstly removal of the outer cap of the pharmaceutical container by means of operating the gripping member relative to the container body to enable access to the pierceable seal and subsequent removal of the needle cap from the syringe to expose the needle cannula. Hence the necessary steps for preparing the container and the needle may be safely performed enabling the penetration of the pierceable seal of the container by the needle cannula.

The syringe of the kit may be of the prefilled kind, such as being prefilled with a diluent or a pharmaceutical composition for mixing with the contents of the container.

In further embodiments, the kit comprises first and second containers where each container is provided in accordance with the first aspect. Also, such kit may be provided with different indicia to indicate proper operating sequence.

In a third aspect, the present invention relates to a method of manufacturing a pharmaceutical container according to the first aspect.

The method of providing a pharmaceutical container may comprise the steps of: a) providing a container body, the container body having a wall section and a flange section defining an opening, b) providing a pierceable seal and arranging the pierceable seal relative to the flange section of the container body, c) providing a seal cap for cooperating with the flange section of the container body and for securing the pierceable seal relative to the flange section of the container body, the seal cap defining a seal cap opening through which access to the pierceable seal is enabled, d) providing an outer cap and connecting the outer cap relative to the seal cap to seal the seal cap opening, e) securing the seal cap to the flange section to secure the pierceable seal relative to the flange section, and f) providing a gripping member, the gripping member and the outer cap being adapted to be relatively connected, the gripping member defining first and second portions, the first portion being adapted to be mounted relative to the outer cap, the second portion adapted to be manually gripped by a user, the gripping member being so formed that upon a user moving the second portion of the gripping member relative to the container body, the gripping member removes the outer cap relative to the seal cap to enable access to the pierceable seal, and g) subsequent to step e) mounting the gripping member relative to the outer cap.

In the method of providing a pharmaceutical container according to the third aspect, in step e) the step of securing the seal cap to the flange section includes the step of beading the outer cap onto the flange section of the container body.

The method step d) may be carried out prior to the method step e).

The method may further include the step of operating the second portion of the gripping member by manually operating the gripping member relative to the container body to thereby remove the outer cap relative to the seal cap to enable access to the pierceable seal.

DETAILED DESCRIPTION OF THE INVENTION

The invention will now be described in further detail with reference to the drawings in which:

Fig. 1 a and 1 b show two different prior art pharmaceutical containers,

Fig. 2 is a cross sectional view of an embodiment of a pharmaceutical container in accordance with the present invention comprising a container assembly including an outer cap and a gripping member attached to the outer cap,

Fig. 3 is a perspective view of the pharmaceutical container shown in fig. 2, but prior to the subsequent assembling operation between the container assembly and the gripping member, Fig. 4a is a perspective view of the pharmaceutical container shown in fig. 3, after the assembling operation between the container assembly and the gripping member,

Fig. 4b is a perspective view of the pharmaceutical container shown in fig. 4a, wherein the gripping member has been initially lifted for removing the outer cap of the container assembly,

Fig. 5 is a side view of a syringe adapted for cooperation with the pharmaceutical container shown in figs. 3, 4a and 4b, and

Fig. 6 is a side view of a pharmaceutical kit according to the second aspect of the invention comprising a pharmaceutical container as shown in figs. 3, 4a and 4b, a syringe as shown in fig. 5 and a casing holding the container and the syringe.

Turning now to the drawings relating to the present invention, fig. 2 shows a cross sectional view of an embodiment of a pharmaceutical container 100 in accordance with the present invention comprising a container assembly 200 including an outer cap 240 and a gripping member 300 attached to the outer cap 240.

The container body generally designated with reference numeral 210 has a longitudinally extending cylindrical wall integrally formed with a base portion to provide an internal volume for containing a liquid medication. Wall structure and base may be fabricated from any suitable material, such as glass, polycarbonate plastic material or any other relatively inert material which is non-reactive with the medication to be contained. A reduced diameter neck portion 212 connects the cylindrical wall with an outwardly extending flange section 21 1 . At the central portion of flange section 21 1 the flange forms an opening leading into an interior cavity of the container body 210. Outwardly, the flange section 21 1 provides a lower abutment edge for engagement with the lower inwardly extending edge portion 232 of a seal cap 230. In the shown embodiment, seal cap 230 is fabricated from soft aluminium that is beaded onto the flange section 21 1 all the way around the circumferential edge. In the embodiment of fig. 2, seal cap 230 has a central seal cap opening 231 that enable access to the container interior.

Positioned between the flange section 21 1 and the seal cap 230 is the top section of a pierceable seal 220. In the embodiment shown, the lower section of pierceable seal cap 220 forms a plug section that extends into the opening formed in flange section 21 1 . Pierceable seal 220 may be fabricated by any suitable material capable of providing a tight fluid seal with the container body 210 while being penetrable by an injection needle or other fluid communication means such as a spike. Suitable materials for use in fabricating pierceable seal 220 are butyl rubber, latex and silicone, but other materials may be used as well. Also composite seal members may be used, for example provided as a layered product. Furthermore, container assembly 200 comprises a cylindrical outer cap 240 which serves as a lid for sealing off the upper part of seal cap 230 until the container assembly 200 is put into initial use. In the shown embodiment, the outer cap 240 includes a round going external ridge 241 . As discussed above in connection with the pharmaceutical container shown in fig. 1 a, the outer cap 240 may be attached relative to the seal cap 230 so that removal of outer cap 240 from seal cap 230 prevents the outer cap 240 to be refitted relative to seal cap 230. Hence, outer cap 240 serves additionally as a tamper indicating means. In the embodiment shown in fig. 2, the outer cap 240 includes a one or more retaining elements 242 each of which, in the storage state of the container, grips beneath the seal cap opening 231 so as to retain the outer cap 240 relative to the seal cap 230. Alternatively, the one or more retaining elements may be provided by means of a disc shaped member that extends beneath the rim of seal cap opening 231 to thereby facilitate retaining of the outer cap 240 relative to the seal cap 230. Hence, removal of outer cap 240 from the container assembly 200 requires a deliberate action by a user so that the retaining elements frees the outer cap 240 from seal cap 230 so to enable access to pierceable seal 220 though the seal cap opening 231 . In the shown embodiment, the retaining elements 242 may be designed to break off from outer cap 240. In other embodiments the retaining elements and the seal cap may be designed so that the retaining element(s) slips free from seal cap 230 once a predetermined force has been applied on the outer cap relative to the container body 210.

The container assembly 200, in the embodiment shown in fig. 2, generally corresponds to pharmaceutical containers that are commercially available. Apart from the container assembly 200, as noted above, the pharmaceutical container 100 further comprises a grip member 300 that is assembled relative to the outer cap 240 of container assembly 200 once the outer cap 240 and the seal cap 230 has been attached relative to the container body 210. Fig. 3 shows the container assembly 200 and the gripping member 300 during the assembly process. Gripping member 300 includes a first portion 310 defining a cylindrical opening that is adapted to receive the top portion of the outer cap 240. The first portion 310 further comprises a first set of protrusions 312 and a second set of protrusions 31 1 both sets of protrusions extending radially inwards from the cylindrical opening of first portion 310.

The gripping member 300, at an end opposite to the first portion 310, includes a second portion 320 that is formed as a gripping tab that may easily be gripped and manipulated by the fingers of a user's hand. In the shown embodiment, the tab forms an open loop 321 which permits a finger of the user to be received into the loop 321.

During assembly of container assembly 200 and gripping member 300, when the outer cap 240 of the container assembly 200 is inserted into the cylindrical opening of the first portion 310 of the gripping member 300, the external ridge 241 of the outer cap 240 is snapped into engagement between the two sets of protrusions 31 1 and 312 (see fig. 2 and fig. 4a). Hence, the first portion 310 of the gripping member 300 is attached permanently to the outer cap 240, i.e. with a sufficient holding engagement that permits the movements of gripping member to be transferred to the outer cap 240. When the gripping member 300 has been attached to the container assembly 200, i.e. in the storage state of container 100, the gripping member extends from the outer cap 240 along the side of the container body 210 towards the bottom part along a substantial part of the total height of the container 100. Hence, an easily grabbed finger tab is formed which at the same time visually indicates that the gripping member 300 is to be operated before attempting to penetrate the liquid seal forming the top of the container 100. Gripping member 300 may be made of a relatively soft plastic material or other material offering a suitable flexibility for the gripping member to bend as it is operated. In other embodiments, the gripping member may be made of a relatively stiff material offering only limited flexure.

In the shown embodiment, as shown in fig. 4a, the gripping member 300 includes a reduced width section 315 that bridges the first 310 and the second portion 320. The reduced width section 315 enables the second portion 320 to be pulled sideways/upwards away from the sidewall of the container body 210 into the intermediate position shown in fig. 4b, while the outer cap 240 still remaining attached to the seal cap 230. Upon further pulling of loop section 320/321 of the gripping member 300 in an upwards direction relative to the container assembly 200 the outer cap 240 is pulled away from seal cap 230 upon fracturing of the retaining members 242 relative to the seal cap 230. Hence, as the outer cap 240 is removed from seal cap 230, the pierceable seal 222 is exposed through the seal cap opening 231 enabling a needle of a syringe to penetrate through the pierceable seal. Thus, the container 100 is made ready for use.

Due to the fracture of the retaining members 242 the outer cap 240 cannot be replaced on the seal cap 230 once outer cap has been removed. It is to be noted that instead of the shown configuration of the retaining members 242 and the seal cap 230 alternative constructions similar in function as the retaining mechanism 242/230 may be provided such as the one that is shown on fig. 1 a (see description of reference WO 2006/041965 A2). Again, other constructions are also feasible such as the type having a central disc that is designed to break off during detachment of the outer cap relative to the seal cap. The process of preparing pharmaceutical containers accommodating a pharmaceutical product of the above described kind for shipment to a distributor may in some embodiments include the steps of: (1 ) sterilizing an empty container, (2) filling the container with a medicament, (3) placing the pierceable seal in or on the neck of the container, (4) attaching the outer cap to the seal cap, (5) sealing the end of the container with the seal cap/outer cap assembly, (6) sterilizing the sealed container, (7) labeling the container with the contents of the container and other information related to the manufacturing history and (8) attaching a gripping member relative to the outer cap.

Turning now to fig. 5, a conventional syringe 400 is shown which includes a barrel 410, a plunger 420 a needle connected to the barrel and a needle cap 440 sealing off and protecting the needle. The syringe 400 and a pharmaceutical container 100 may be arranged as a kit including a casing 500 or other receptacle suitable for storing or carrying the kit. Such a kit is shown in fig. 6 which shows a casing having a base and a lid and supporting members holding the syringe 400 separate but aligned relative to the container 100 so that the needle end of the syringe points towards the container closure. In the shown kit, the syringe 400 may be prefilled with a diluent while the container 100 may accommodate a lyophilized product. Hence, the kit includes all the necessary elements for reconstituting a pharmaceutical product and subsequently injecting the reconstituted product into a patient.

As shown in figs 4a, 5 and 6, the gripping member 300 may include an first indicia 316 such as the number "1 ", the letter "A", Roman letter Ί" or similar The needle cap 440 may include a second indicia 446 such as the number "2", the letter "B", roman letter "M" or similar. The first indicia 316 and second indicia 446 indicates the proper sequence order for preparing the contents of the kit once the casing 500 has been opened. Hence the risk of human errors in preparing the injection or the risk of the user becoming confused will to a large degree be avoided.

Some preferred embodiments have been shown in the foregoing, but it should be stressed that the invention is not limited to these, but may be embodied in other ways within the subject matter defined in the following claims.