Field of the Invention
[0001] The invention relates to a tamper-evident single-use container for holding unitary
dose products and a system of a tamper-evident single-use container and a closure.
Prior Art
[0002] Single-use containers for pharmaceutical products are especially known from single-dose
containers for holding a vaccine. Vaccine or other types of serum are often stored
in single-use containers made of glass which are provided with a breakable head.
[0003] Such containers are not useful for holding unitary dose products like loose pills
or capsules, lozenges or granules. Such unitary dose products are usually packaged
in tubular containers which are closed with a conventional openable cover. However,
such prior art containers are not tamper-evident because the cover can be repeatedly
opened and closed.
Summary of the Invention
[0004] Accordingly, there is a need for a single-use container which is specifically adapted
for holding unitary dose products, especially solid pharmaceutical products and which
is tamper-evident.
[0005] This object is solved by a tamper-evident single-use container for holding unitary
dose products with the features of claim 1, a system of such a tamper-evident single-use
container and a cover therefore with the features of claim 16, and the use of such
a container according to claim 18. Preferred embodiments follow from the other claims.
[0006] An inventive tamper-evident single-use container for holding unitary dose products,
especially solid pharmaceutical products, comprises a container body made of plastic
material with a bottom end and a tubular top end and a head section closing the top
end, wherein the head section is integrally connected to the container body at a connecting
region. The thickness of the plastic material at the connecting region is reduced
by at least 50% as compared to the wall thickness of the container body.
[0007] Such container made of plastic material is advantageous over single-use containers
made of glass in that, when removing the head section from the container body and
the material of the connecting region is broken, no sharp-edged chips will be generated.
Further, the inventive container is handled in a straightforward way in that it is
the perceived top end of the container which is removed. The container is inviolable
apart from the connecting region integrally connecting the head section to the container
body. Once the head section has been removed, the container can no longer be closed
again so that any tampering with the container will immediately become evident.
[0008] The body of the container can be of any shape including a cylindrical shape with
a round, oval or polygonal base. However, apart from cylindrical shapes, the container
body can be of any geometry including irregular shapes.
[0009] The head section is provided with protrusions and/or depressions which promote a
firm grip. This feature helps the user to apply the required force to break the container.
[0010] The protrusions and/or depressions can be molded as a part of the head section or
can be provided using a further separate part which can be manufactured by bi-injection
molding, overmolding or which can be molded in a separate manufacturing step before
it is mounted to the container.
[0011] In case that the protrusions and/or depressions are integrally molded as a part of
the head section, the container and its head section are molded using a sliding splitmould
in order to demould the container.
[0012] In case of the provision of a separate part with the protrusions and/or depressions,
this simplifies the moulding of the container and increases the production rate. Further,
the separate part can be customized depending on the user or the specific product
intended to be contained. To this end, the separate part can be individualized as
regards the shape, color, material or texture just to mention some examples.
[0013] The plastic material according to the invention is preferably made of a suitable
plastic material which is preferably selected from the group comprising radical or
linear high and low density polyethylenes, copolymers of ethylene such as for example
ethylene vinyl acetates, ethylene ethyl acrylates, ethylene butyl acrylates, ethylene
maleic anhydrides, ethylene alpha olefines, regard-less of the methods of polymerisation
or modification by grafting, homo polypropylene and copolymers, polybutene-1, polyisobutylene.
Polyolefines are preferably selected to make the single-use container for cost reasons
and because they are easy to use.
[0014] Other polymer materials can be considered however such as polyvinyl chloride, copolymers
of vinyl chloride, polyvinylidene chlorides, polystyrenes, copolymers of styrene,
derivatives of cellulose, polyamides, polycarbonates, polyoxymethylenes, polyethylene
terephthalates, polybutylene terephthalates, copolyesters, polyphenylene oxides, polymethyl
methacrylates, copolymers of acrylate, fluoride polymers, polyphenylene sulphides,
polyarylsulphones, polyaryletherketones, polyetherimides, polyimides, polyurethanes,
phenol resins, melamine resins, urea resins, epoxy resins and unsaturated polyester
resins.
[0015] Biodegradable polymer materials, with for example a starch base, are also possible
such as polylactic acids (PLA).
[0016] Combinations of these polymers can be used, if desired. The polymer used to produce
the single-use container can also contain one or more additives such as fibers, expanding
agents, additives such as stabilizers and colorants, sliding agents, demolding agents,
adhesion agents or reinforced catching agents and/or any others according to the requirements
of usage.
[0017] The single-use container can also be made from injectable materials made in such
a way that they are capable of absorbing various different pollutants such as humidity,
oxygen, odour and other possible pollutants. The thermoplastic materials are thus
themselves formulated with active agents belonging to a group of humidity absorbers,
oxygen scavengers, odour absorbers and/or emitters of humidity or volatile olfactory
organic compounds.
[0018] Suitable dehydrating agents are selected from a group comprising silica gels, dehydrating
clays, activated alumina, calcium oxide, barium oxide, natural or synthetic zeolites,
molecular or similar sieves, or deliquescent salts such as magnesium sulfide, calcium
chloride, aluminum chloride, lithium chloride, calcium bromide, zink chloride or the
like. Preferably the dehydrating agent is a molecular sieve and/or a silica gel.
[0019] A suitable oxygen collecting agent is selected from a group comprising metal powders
having a reducing capacity, in particular iron, zinc, tin powders, metal oxides still
having the ability to oxidize, in particular ferrous oxide, as well as compounds of
iron such as carbides, carbonyls, hydroxides, used alone or in the presence of an
activator such as hydroxides, carbonates, sulfites, thiosulfates, phosphates, organic
acid salts, or hydrogen salts of alkaline metals or alkaline earth metals, activated
carbon, activated alumina or activated clays.
[0020] Other agents for collecting oxygen can also be chosen from specific reactive polymers
such as those described for example in the patents
US 5,736,616,
WO 99/48963 and
WO 98/051758. These specific reactive polymers can be mixed with a thermoplastic polymer used
to produce the single-use container according to the present invention.
[0021] The amount of treatment agent introduced into the thermoplastic polymer to produce
the single-use container according to the present invention expressed in percentage
by weight can advantageously vary from 5% to 70%, preferably from 5% to 55% of the
thermoplastic material used to produce the single-use container.
[0022] By reducing the thickness of the plastic material at the connecting region by at
least 50% as compared to the wall thickness of the container body, the container will
be opened at a well-defined position.
[0023] Preferably, the plastic material of the container comprises a plastic polymer composition
including an active substance, the active substance preferably being a desiccant.
This is an especially advantageous embodiment because unlike multi-use containers
which are opened and closed several times with an accompanying at least partial change
of the inner atmosphere of the container, a single-use container only will have to
maintain a certain inner atmosphere up to its single use. Since a plastic container
always shows a residual amount of permeation based on its material properties (transmission
rate), undesired gases might penetrate the walls of the container, such substances
can already become trapped before reaching the inside of the container. In such a
way, the unitary dose products packaged inside the single-use container can be best
protected against an undesired contact with harmful substances, like water vapor or
oxygen. The active substance, however, can be a desiccant or can be different from
a desiccant. It can be any substance or mixture of substances which trap and/or release
certain compounds. It is possible, just to give some examples, to hold the unitary
dose products inside the container free of oxygen or free of volatile organic compounds
such as for example formaldehydes or other aldehydes.
[0024] Preferably, the head section has a round outer shape, preferably generally spherical
outer shape. This makes the head section easy to grip by a user when a certain force
will have to be applied in order to break the frangible connecting region between
the head section and the container body.
[0025] Preferably, the tamper-evident single-use container further comprises a gorge on
the head section. Such design has various advantages. Firstly, a gorge provides some
protection of the thin-walled connecting region against an inadvertent mechanical
impact. Further, a gorge has the advantage that the circumferential length of the
connecting region is reduced. For breaking the single-use container along the connecting
region, the overall area of the connecting region, i.e. the product of the wall thickness
and the length of the connecting region, is decisive. The provision of a gorge reduces
the circumferential length of the connecting region and facilitates the breaking of
the connecting region or, when this is not required, makes it possible to increase
the wall thickness as compared to a container without a gorge on the head section
in the region between the container body and the head section.
[0026] Preferably, the angle A between the wall section of the container body and the wall
section of the head section at the connecting region is at least 10°. The angle A
corresponds to the maximum possible tilting of the head section around an axis perpendicular
to the longitudinal axis of the container relative to the container body before the
head section contacts the container body and prevents a further relative tilting motion
of the head section. Such minimum angle of at least 10° is sufficient to tilt the
head section to a sufficient degree so that the container will break at the connecting
region.
[0027] According to a preferred embodiment, the connecting region bridges a distance between
the container body and the head section, the length 1 of the connecting region in
the direction of the distance being defined by 0 ≤ 1 ≤ 1mm, more preferably 0 ≤ 1
≤ 0,5mm. The connecting region is preferably arranged and dimensioned such that the
connecting region can be broken by tilting the head section relative to the container
body around an axis which is perpendicular to the longitudinal axis of the container.
Examples in the prior art in which the connecting region can be broken by a relative
rotation around the longitudinal axis of the tubular container body between the head
section and the tubular container body requires a high force so that the wall thickness
of the connecting region has to be made very small. This, however, makes the connecting
region vulnerable against any inadvertent impacts.
[0028] According to a preferred embodiment, the maximum outer dimensions of the head section
are such that the head section does not protrude beyond the outer extension of the
tubular container body. In other words, the maximum outer dimensions of the head section
is preferably smaller than the outer diameter of the tubular container body. This
characteristic feature helps to maintain the integrity of the container because any
force acting on a container lying on its side will not generate a force which could
break the container. This is especially the case when a high number of containers
are stored in a way such that many containers are lying on their side and being stacked
in multiple rows in top of each other.
[0029] Furthermore, according to a preferred embodiment, the maximum outer dimensions of
the head section are preferably larger than the inner diameter of the tubular container
body. In this manner, the head section, once it has been broken, cannot be used to
reclose the container body.
[0030] Preferably, the head section is shaped so that the head section, once removed from
the container body, cannot be turned upside down and used to reclose the container
body. This can be achieved e.g. by providing the upper part of the head section which
is aligned with the fictitious extension of the inner wall surface of the cylindrical
container body with a shape which cannot be inserted into the container body and become
engaged therein. Specifically, the tangent to that upper part of the head section
which is aligned with the fictitious extension of the inner wall surface of the cylindrical
container body should form an angle B to the longitudinal axis of the container body
which exceeds 30°, preferably 45°.
[0031] According to a most preferred embodiment, the cylindrical container body has an inner
diameter d
in and an outer diameter d
out, and wherein a maximum outer outer diameter d
head of the head section is selected to satisfy the equation d
in < d
head < d
out.
[0032] Preferably, the wall thickness of the container body at the tubular top end thereof
is at least 0.5mm, more preferred 0,8mm. This makes the plastic material of the container
body sufficiently rigid in the region of the tubular top end such that the head can
be easily broken while the container body maintains its basic shape without deforming
or bending during breakage.
[0033] According to a preferred embodiment, the thickness of the plastic material at the
connecting region is less than 0.5mm, preferably between 0.1mm and 0.5mm and more
preferably between 0.1mm and 0.3mm. As outlined above, it is not the thickness alone
of the plastic material of the connecting region, but also the length of the connecting
region which determines the resistance of the single-use container against breaking
at the contact region. However, single-use containers are usually of relatively small
dimensions especially when storing pharmaceutical products. Therefore, on the basis
of common sizes for such single-use containers for pharmaceutical substances, the
above-mentioned range of the thickness of the plastic material was found to provide
a sufficient stability to the container and, at the same time, to make it possible
for an average adult to open the container by breaking the connecting region.
[0034] Furthermore, according to a preferred embodiment, the length of the connecting region
is less than 0.3mm.
[0035] Preferably, the container body is provided with an interior annular shoulder close
to its bottom end. The provision of an annular shoulder close to the bottom end provides
a stop for receiving and positioning a cover for closing the container at its bottom
end, especially if the cover is integrated in the container body without protruding
beyond the bottom end.
[0036] According to an alternative preferred embodiment of the invention, the bottom end
of the container is closed by (heat) welding together the lower end of the container
body. This is an easy-to-perform process step for closing the container once the unitary
dose products to be stored inside the container have been inserted into the container.
Further, no extra part for closing the container is required.
[0037] In such an embodiment, the wall thickness at the open end of the container body shall
not exceed preferably 0,5mm, most preferably 0,3mm. In such an embodiment, the thickness
of the container wall is not constant: the open end of the container wall has preferably
a wall thickness of 0,5mm or less to allow for the welding operation, whereas the
top end of the container has a wall thickness of 0,5mm or more to be sufficiently
rigid to allow for breaking the connecting region.
[0038] Preferably, the tamper-evident single-use container comprises a cover closing the
bottom end of the container body. The provision of a cover is the easiest option for
closing the single-use container after the product to be stored therein has been inserted.
Once the single-use container has been closed by means of a cover, it must no longer
be possible to reopen the container by removing the cover again. Therefore, according
a preferred embodiment of the invention, the cover is received in the bottom end of
the container body such that it does not protrude beyond the bottom end in a longitudinal
direction of the container body. In this manner, the cover cannot be easily removed
and the container cannot be openend unless the user breaks the connecting region to
the head section. The container can be filled by placing it on a conveying surface,
upside down. After filling, a cover is assembled by e.g. placing the cover above the
container opening and pressing the cover onto the container body.
[0039] Preferably, the cover is provided with a recess which, in the assembled state, faces
toward the outside of the container. This recess is used to grip the cover in the
process of placing the cover above the container opening and pushing the cover when
closing the container.
[0040] As an alternative, the cover has a flat surface facing, in the assembled state, the
outside of the container. The assembly of such cover can use a vacuum holder.
[0041] The container and the cover can be provided with interlocking form-fit elements like
a circumferential groove on the container body and a corresponding shaped and arranged
circumferential rib on the cover. The form-fit connection of the rib and the groove
additionally provides a sealing contact between the container body and the cover.
The position of the rib and the groove can be exchanged. A further advantage of the
form-fit connection is the high resistance of the cover against being removed again
from the container body. This increases the safety that the container cannot be opened
and tampered with by unauthorized persons.
[0042] According to another preferred embodiment, the cover can be provided with a flexible
skirt or a deformable lip around its circumference which further improves the sealing
relationship between the cover and the container body because the skirt compensates
because of its flexibility manufacturing tolerances as well as unevenness of either
the cover or the container body.
[0043] Preferably, the cover is attached to the container body by welding, crimping or a
force fit, more preferably by welding or crimping.
[0044] The invention also relates to a system of a tamper-evident single-use container and
a cover which is adapted to close the bottom end of the container. The production
and the delivery of the basic structure of the container and the provision and delivery
of the cover can be carried out separately because the cover will only be attached
to the bottom end of the container once the unitary dose product will have been introduced
into the interior of the container.
[0045] According to a preferred embodiment of the invention, the cover comprises gas treating
agent. In an embodiment the cover comprises a chamber filled with a gas treating agent
or holds a tablet, a canister, a packet filled with a gas treating agent, preferably
a gas releasing agent or gas adsorbing agent. In another embodiment, the gas treating
agent is entrained within the resin forming the cover. Thus, after the unitary dose
product has been inserted into the container, the container will be closed by means
of the cover. After this, the closed inner atmosphere of the container will be appropriately
treated and maintained by means of the gas treating agent filled into the canister
or chamber. in one embodiment, the gas treating agent is an oxygen scavenger so that,
once the single-use container has been closed by means of the cover, the inner atmosphere
of the container can be brought to and maintained at a reduced oxygen level. In another
embodiment, the gas treating agent is a desiccant so that, once the single-use container
has been closed by means of the cover, the inner atmosphere of the container can be
brought to and maintained at a controlled humidity level. The gas treating agent can
be any substance or mixture of substances which trap and/or release component from/into
the container headspace.
[0046] Because of its convenient use, the tamper-evident feature and the possibility to
tailor the inner atmosphere of the container, it has a specific use for storing a
pharmaceutical solid substance, preferably loose pills, pellets, globules, granules,
powder or capsules.
Brief Description of the Drawings
[0047] In the following, some preferred embodiments of the invention will be described with
reference to the accompanying drawings, in which
- Figs. 1 and 2
- show a three dimensional view and a cross-sectional view of a first embodiment of
the inventive container without a cover;
- Figs. 3 and 4
- show a three dimensional view and a cross-sectional view of the container according
to Figs. 1 and 2 but with a cover 24;
- Fig. 5
- shows a cross-sectional view of an alternative container similar to that according
to Fig. 4 but with a co-moulded head section;
- Fig. 6
- shows a cross-sectional view of a further embodiment of the inventive container with
a different shape of the head section;
- Figs. 7 and 8
- show a three dimensional view and a cross-sectional view of a further embodiment of
the inventive container without a cover;
- Figs. 9 and 10
- show a three dimensional view and a cross-sectional view of the container according
to Figs. 7 and 8 but with a cover 24 heat crimped after filling of the unitary dose
product (not shown)
- Fig. 11
- shows a side view of a further embodiment of an inventive container;
- Fig. 12
- shows another side view of the container according to Fig. 11;
- Fig. 13
- shows a three dimensional view of the container as shown in Figs. 11 and 12; and
- Figs. 14 and 15
- show schematic half-cuts of the upper part of the single-use container with different
orientations of the connecting region.
Description of Specific Embodiments
[0048] Throughout the description the same or similar elements will be denoted by the same
reference numerals.
[0049] Fig. 1 shows a single-use container 10 in a three dimensional view. Fig. 2 is the
corresponding cross-sectional view. The container 10 consists of a tubular container
body 12 with a bottom end or open end 14 and a top end 16. A head section 18 is integrally
formed with the container body 12 at the top end 16 of the container body. Between
the top end 16 of the container body and the head section 18, there is a connecting
region 20 having a wall thickness d
2 which is less than 50% of the thickness d
1 of the tubular container body. Specifically, the thickness d
2 of the material at the connecting region is between 0.1mm and 0.5mm and preferably
between 0.1mm and 0.25mm.
[0050] Throughout the embodiments, the connecting region 20, which is the frangible region
of the inventive container, is on the inner side of the wall of the container. In
other words, it starts from the inner side 28 of the wall forming the container body
12 which faces the interior 30 of the container. This serves the purpose that, when
the connecting region is broken, the broken section faces towards the inside of the
container so that a user grasping the opened container does not contact possible sharp
edges of the broken connecting region. Further, such broken container is suitable
for direct oral supply of the medication contained therein.
[0051] The container body is provided close to its bottom end 14 with a shoulder 26 which,
as can be seen in Figs. 3 and 4, serves to receive a cover 24 in order to close the
container after the unitary dose product or products to be filled into the container
have been introduced into the interior 30 of the container. In the specific embodiment
as shown in Figs. 3 and 4, the cover 24 is fixed to the container body 12 by means
of a press fit. As can be seen from Figs. 3 and 4, the cover 24 does not protrude
beyond the bottom end 14 of the container body.
[0052] The head section 18 of the container has a spherical shape forming an annular protrusion
38 to promote a firm grip of the head section 18 by a user. At the lower part of the
head section 18, there is a gorge or peripheral depression 22. Further, an angle A
is formed between the wall sections of the container body and the head section adjacent
to the connecting region 20. This angle is at least 10°.
[0053] According to the invention, the container body 12, the head section 18 as well as
the connecting region 20 are made of plastic material, here in a single piece. The
same preferably applies to the cover 24.
[0054] As an alternative or in addition to the provision of a plastic polymer composition
including an active substance, the cover 24 can hold a gas treating agent. The gas
treating agent could be embedded into the composition of the cover and/or container
body 12. Further, the gas treating agent could be provided by means of a canister
or by means of an active tablet which can for example be made of compressed desiccant
or desiccant entrained polymer. Such canister 32 is schematically shown in Fig. 5.
The cover 24 is provided with a ring-shaped holding structure 34 which, when the cover
24 is press fit in the container body 12, firmly holds the canister 32.
[0055] In alternative embodiments, the cover comprises a gas treating agent. In an embodiment
the cover comprises a chamber filled with a gas treating agent or holding a tablet,
a canister, a packet filled with a gas treating agent, preferably a gas releasing
agent or gas adsorbing agent. In another embodiment, the gas treating agent is entrained
within the resin forming the cover.
[0056] The container 10 as shown in Fig. 5 differs from that as shown in Fig. 4 by the additional
provision of a head section 18 which has a further part 36 that can be bi-injected,
overmolded or simply attached onto the head section 18 in order to provide another
part of a different color or a different material. Different colors can e.g. be used
to distinguish different products contained in the container, like different homeopathic
products or different medication dosing or strength. A further advantage is that a
container with a simple shape can be used before it is later on customized by the
further part 36. Such a simple shape of the container can be naturally demoulded.
[0057] The container as shown in Fig. 6 has a head section 18 with a different shape. Unlike
the head section as shown in the embodiments of Figs. 1 to 5, the head section according
to Fig. 6 does not have a spherical shape. It is provided with protrusions 38 which
enable a user to firmly grip the head section of the container before breaking the
connecting region 20 in the process of opening the container.
[0058] Throughout the embodiments as shown in Figs. 1 to 6, the bottom end 14 of the container
body 12 is provided with a shoulder 26. However, this is not necessarily the case.
The container body 12 can also have the same thickness over its interior length without
forming a shoulder close to the bottom end 14.
[0059] The embodiment of Figs. 7 to 10 corresponds to that as shown and explained above
with reference to Figs. 1 to 4. The only difference, however, is the way in which
the cover 24 is fixed to the container body 12. In the embodiment as shown in Figs.
7 to 10, the cover 24 is secured to the bottom end 14 of the container body by "crimping".
The term "crimping" is supposed to describe that the cover 24 is inserted into the
lower part of the container body and resting against the shoulder 26. After this,
it is secured to the container body 12 by applying heat and pressure on the bottom
end 14 of the container body 12 so that the bottom end 14 is bent towards the interior
of the container body 12 and generates a form fit which prevents the remove of the
cover 24 from the container 10. In order to enable the bending of the section 40 of
the container body close to its bottom end 14, it is preferably made longer in the
longitudinal direction of the container as compared to the corresponding lower part
40 as shown e.g. in Fig. 2 such that it can be conveniently bent over a sufficient
distance so as to firmly hold the cover 24 resting against the shoulder 26 of the
container body.
[0060] Throughout the embodiments as shown in Figs. 1 to 10, the container body, once it
has been filled with the unitary dose product or products, is closed using a cover
24. Besides the specific embodiments as shown, in which the cover is either press
fit into the container body or affixed to the container body by crimping, it could
also be fixed to the container body by welding or glueing.
[0061] The embodiment as shown in Figs. 11 to 13 differs from that according to the preceding
embodiments in that the container is not closed by means of a cover but by welding
the lower end of the container body. Further, the head section 18 has additional depressions
48 to promote a firm grip of the head section by a user. As can be seen in Figs. 11
to 13, a section 42 starting from the bottom end 14 of the container is welded onto
itself in order to close the container. In such a way, no additional cover is necessary.
For sealing the bottom section 42, the container body should have a certain flexibility.
In order to achieve this, the wall thickness d1 of the container body at its bottom
end can be made smaller than the wall thickness at the tubular top end of the container.
Furthermore, or alternatively, the container body at the tubular top end can be made
with a material that is different from the remaining part of the tubular container
body, the last being made of a more flexible material. Such a container can be molded
in one single shot or in two shots depending on the overall size of the container.
For example, the tubular part of the container body can be made by extrusion (for
example in LDPE with a constant wall thickness d1a) and then be provided by overmolding
with an integrally molded top end and head section (for example in another material
such as polypropylene or HDPE and with a wall thickness at the top end d1b which is
larger than d1a). It is also possible to manufacture the top end and head section,
and to combine it with the extruded tubular part of the container body by welding
and especially heat fusing or ultrasonic welding.
[0062] The embodiments according to Figs. 14 and 15 serve to illustrate general principles
of the invention and are not limited to any geometries shown in addition to those
as described below. As can be seen from Figs. 14 and 15, the connecting region 20
has a distinct length 1 which is at most 0.3 mm and can be oriented in a longitudinal
direction parallel to the rotational axis O or in a radial direction. The embodiment
according to Fig. 14 is advantageous over that according to Fig. 15 in that a broken
connecting region which might have sharp edges seems to be not problematic as long
as the connecting region extends towards the interior of the container body. In such
a case, the opened container can be brought to the mouth of the user for direct oral
supply of medication or single dose product.
[0063] In the embodiment according to Fig. 14, the connecting region 20 is in a radial direction
and bridges a distance between the lower end of the head section 18 and the upper
end of the tubular container body 12. The maximum diameter of the head section d
head is smaller than the outer diameter d
out of the container body 12 but smaller than the inner diameter d
in of the container body 12. Once broken, the head section cannot be used to reclose
the container body.
[0064] When tilting the head section 18 relative to the container body 12, the force F applied
by the user will act at the apex position of the head section with the greatest diameter
of the head section d
head, which forms the protrusion 38 or in the embodiment according to Fig. 15, will act
in the middle of the longitudinal extension of the protrusion 38, i.e. the region
with the greatest diameter of the head section. In both cases, there is a considerable
longitudinal distance between force F, which is the center of the force applied, and
the connecting region 20 which generates a sufficient bending moment on the frangible
connecting region. This momentum reduces the effort to open the single-use container.
[0065] The tamper-evident single-use container according to the invention cannot be closed
in a way such that a user will immediately recognize if the container has been tampered
with.
1. Tamper-evident single-use container for holding unitary dose products, especially
solid pharmaceutical products, comprising:
- a container body (12) made of a plastic material with a bottom end (14) and a tubular
top end (16); and
- a head section (18) closing the top end (16); wherein the head section (18) is integrally
connected to the container body (12) at a connecting region (20); wherein
- the thickness of the plastic material at the connecting region (20) is reduced by
at least 50% as compared to the wall thickness of the container body (12); and wherein
- the head section (18) is provided with protrusions (38) and/or depressions (48).
2. Tamper-evident single-use container according to claim 1, characterized in that the plastic material of the container (10) comprises a plastic polymer composition
including an active substance, the active substance preferably being a desiccant.
3. Tamper-evident single-use container according to claim 1 or 2, characterized in that the head section (18) has a round outer shape, preferably a generally spherical outer
shape.
4. Tamper-evident single-use container according to any of the preceding claims, further
comprising a gorge (22) on the head section (18).
5. Tamper-evident single-use container according to claim 4, wherein the angle (A) between
the wall section of the container body (12) and the wall section of the head section
(18) at the connecting region is at least 10°.
6. Tamper-evident single-use container according to any of the preceding claims, wherein
the connecting region bridges a distance between the container body and the head section,
the length 1 of the connecting region in the direction of the distance being defined
by
7. Tamper-evident single-use container according to any of the preceding claims, characterized in that the maximum outer dimensions of the head section (18) are such that the head section
(18) does not protrude beyond the outer extension of the tubular container body (12).
8. Tamper-evident single-use container according to any of the preceding claims, wherein
the cylindrical container body has an inner diameter d
in and an outer diameter d
out, and wherein a maximum outer outer diameter d
head of the head section is selected to satisfy the equation
9. Tamper-evident single-use container according to any of the preceding claims, characterized in that the thickness of the plastic material at the connecting region (20) is less than
0.5mm. Preferably is between 0.1 mm and 0.5 mm and more preferably between 0.1 mm
and 0.3 mm.
10. Tamper-evident single-use container according to any of the preceding claims, characterized in that the container body (12) is provided with an interior annular shoulder (26) close
to the bottom end (14).
11. Tamper-evident single-use container according to any of claims 1 to 8, characterized in that the bottom end (14) of the container (10) is closed by welding.
12. Tamper-evident single-use container according to any of the claims 1 to 9, further
comprising a cover (24) closing the bottom end (14) of the container body (12).
13. Tamper-evident single-use container according to claim 11, characterized in that the cover (24) does not protrude beyond the bottom end (14) in a longitudinal direction
of the container body (12).
14. Tamper-evident single-use container according to claim 11 or 12, wherein the cover
(24) is attached to the container body (12) by welding, crimping or a force fit.
15. System of a tamper-evident single-use container (10) according to any of the claims
1 to 10 and a cover (24) which is adapted to close the bottom end (14) of the container
(10).
16. System of a tamper-evident single-use container and a cover according to claim 14,
wherein the cover (24) holds a canister or an active tablet (22) comprising a gas
treating agent, preferably a gas releasing agent or gas adsorbing agent.
17. System of a tamper-evident single-use container and a cover according to claim 16,
the gas treating agent being an oxygen scavenger or a desiccant.
18. Use of the tamper-evident single-use container according to any of the claims 1 to
14, for storing a pharmaceutical or nutraceutical substance, preferably loose pills,
pellets, globules, granules, powder or capsules.