ES2241965T3 - PACKING SYSTEM FOR UNIT DOSE WITH A MOLDED LOCK COMPONENT. - Google Patents

Abstract

A molded locking element for a package having a flexible paperboard or plastic portion.The locking element is composed of a frame (81), a slidable locking tongue (61), a locking flap (13) and a lock release element (33) and provides a child resistant trigger release mechanism.

Description

Packaging system for unit doses with a molded locking component.

The invention relates to a packaging system reusable, which can be blocked, of unit dose that is Composed of a cardboard part and a molded locking element. The packaging is easy to use although it is made proof child handling, and therefore it is suitable for packaging pharmaceutical preparations It is also strong enough to withstand repeated use, including opening and closing of the blocking component.

The concept of unit dose packaging is attractive for certain pharmaceutical applications because it allows convenient way to administer individual doses systematic, and also allows the user to take control of the dose consumption according to the prescribed program. A feature of such a container is that it is robust enough to open and close numerous times until the medication treatment is completed. Examples of such a container are described in the patent of the United States ordinarily assigned number 6,047,829 (Johnstone). Johnstone's patent refers to a container of unit dose cardboard that includes an outer cardboard sheath and an inner cardboard sliding card that is contained inside the case so that it can be locked. The cover includes a plurality of side panels operatively connected between yes so that one of said plurality of side panels includes a first means of releasing the sliding card interior, and another one of said side panels includes a second means of releasing the inner sliding card, so that the means of retention and release of the sliding card interior are located substantially adjacent to said means of unit dose administration.

A particularly desired feature for the packaging of pharmaceutical unit dose preparations is that it is proof of child handling, and is required by the Poison Prevention Packaging Act of 1970. Guidelines are prescribed by law for packaging to meet the criteria to be child tamper proof. For example, a classification for the tamper-proof container (CR) of F = 1 requires that a random sample of the packages studied is not compromised by a group of age-specific tests of children with a failure rate greater than the 10% This general guideline is designed to ensure that the package maintains sufficient integrity against handling by children.

An object of the present invention is provide a unit dose reinforced container that has, in particular, a durable component of blocking. Another objective of the invention is to provide a unit dose packaging system which is easy to open while reaching and maintaining the Desired criteria of being tested for child manipulation during All his life of use. These and other objectives, including improvement of the aesthetic enhancement and the stability of shipping and packaging are reach with the different embodiments of the present invention.

United States patents 5267650 and 6047829 disclose both the packaging of drug-proof child manipulation Other United States Patent Number 4007828 discloses a suitable container for, among others things, drugs.

Summary of the invention

The present invention provides a system of unit dose packaging according to claim 1. Additionally, the invention also provides a method of package unit doses according to claim 7.

The unit dose packaging system of the invention comprises a combination of elements that form a Robust container, child manipulation proof. In this regard, The elements of the package include a flexible part composed of a series of adjoining panels; and a rigid plastic element lock molding. Unit doses may be contained in a structure inside the inner container, such as a card, a distributor container or other structural element.

The flexible part can be formed of cardboard or of a flexible and foldable plastic material; be preferably use cardboard. This part of the package acts together with the molded locking element to form a rigid structure surrounded by an outer layer. In this regard, one or more panels of the cardboard part are normally attached at least partially to the molded locking element to form the rigid structure, and additional cardboard panels are extended over the upper and lower parts of the structure to form the outer cover. The panels are cut to fit into the structure provided by the plastic part, and they can include one or more indentations, cuts, notches, grooves or similar to ensure a precise fit of the panels cardboard in the plastic part. In this regard, for example, cardboard panels that form the top of the container can include slots to allow the passage of the locking mechanism formed to the plastic part. The cardboard panel that forms the part Bottom of the container may also include means of depression, such as grooves, cuts, notches, to allow manipulation of the elements of the locking mechanism inside the container.

The cardboard part can be formed from of any C1S or C2S bleached or unbleached, coated or Uncoated, suitable for packaging applications. The paperboard It can also be laminated with polymeric or other materials materials to provide additional stiffness and resistance to breaks, if desired. Such laminated materials are described in the U.S. application number 09 / 951.035 recognized in a manner ordinary processing together with this. Alternatively, the cardboard part can be replaced by another base material that It can bend, like plastic. It can also be formed from of a single piece of the base material and folded to form the respective panels of the container or, alternatively, may cut individual panels from the base material and be attached to the blocking element as needed to form the container.

The molded locking element comprises, as basic elements, a blocking element and an element of lock release. Some non-limiting embodiments of a suitable locking element are described in detail in the US provisional application number 60 / 305,851 in processing together with this, which has at least one inventor common with this request. In such an embodiment, the molded container lock element includes parts rigid molding of the structure described above in this document, and the locking element is molded to form a structure, a sliding tongue and a locking flap.

The frame part of the locking element is composed of panels connected perpendicularly to form a polygonal container structure and a frame base that is cut partially to accommodate the elements of the sliding tongue of blocking. In addition to housing the sliding slide tab, the frame base additionally provides support and rigidity to the container. However, it is not necessary that the frame base be formed as an entire contiguous panel, however, can be molded to provide only the framing elements, removing from this container weight mode and reducing material cost while providing the necessary support to the elements more flexible container. The frame base is fastened with a medium adhesive, mechanical or other to at least one panel of the part of paperboard. In one embodiment, the molded polygonal structure is rectangular, in which case it includes two end panels that are more Short in height and shorter than the two side panels remaining. One of the panels of shorter height and shorter length it is preferably located at one end of the structure and provides support and attachment point for the locking flap, while the other is located at the other end of the frame opposite the locking flap. The two side panels that complete the rectangular structure are subject so that they can be molded perpendicular to the end panels. Every side panel end extends slightly above from the point of attachment to the corresponding end panel, so that each end of the side panel forms a protrusion to hold the end panels of the cardboard part that overlap. Additional side panels or ends may be included in the structure to provide additional structural support.

In addition to the end panels and panels lateral, a panel is placed that houses a slot between the side panels and on the basis of the structure. This panel includes a slot to receive and hook a dependent notch of the locking flap and is molded with sufficient thickness to raise it above the base of the structure and allow this way the locking tongue hitch on its side lower. The height of the panel that houses the slot provides I also support the locking flap when the container is closing.

A sliding slide tab is housed within the base of the structure, and works in conjunction with the locking flap and the panel that houses the slot to close and Protect the container. The locking tab is terminated in a end with a closing ring. The other end of the tongue of lock is fully connected to a curved spike that has a prominent edge up from which a notch extends lateral located in the outermost part of the curved spike. This lateral notch can be hooked with the dependent notch part of the locking flap when inserted into the panel that houses the groove. The curved spike is preferably held in place. by a pair of molded stops in the panel that houses a groove.  In the molded position, the curved spike and the notch are housed under the panel that houses a slot. The sliding tongue of lock can be molded as an individual unit from a plastic material that can bend, however the spike curve, which works to enhance the movement of the rod during manipulation of the closure ring, it may be formed preferably from a plastic that is more flexible than the material used to form the structure or other elements of the element lock

A trigger mechanism is used to disable the locking mechanism, which adopts a configuration locked in molded position, not tensioned. In this regard, the trigger mechanism can be a locking ring, a lever or a roller, for example a T-shaped lever. In a preferred embodiment, the trigger mechanism is a ring closing circular When the ring is pulled, the tongue moves to remove the curved spike and the side notch from under the slot housing. The movement of the locking tongue in the direction of shooting is intentionally limited by a pair of stops located at the base of the structure at a separate distance of the closing ring, and by a stop projection located so horizontal through the rod to engage the stops. He butt overhang is additionally configured to extend to through and beyond the width of the rod, keeping from this way the rod and the closing ring located in it plane than the base of the structure.

The locking flap is connected to a panel end of the container structure molded by a mechanism of hinge. Preferably, this mechanism is in the form of a hinge. live that is molded together with the locking flap. From Optional way, the locking flap can include flanges for fingers to allow easy access by the user. A dependent notch is attached to one end of the flap of blockage, preferably near its central area. Notch dependent includes a corresponding slot with the notch side attached to the locking tab. Locking mechanism is protected when the dependent notch is hooked inside of the slot housing and the side notch engages with the groove inside the dependent notch.

The cardboard part of the package is fixed to the plastic part molded by any suitable means. When he container of the invention is used to contain dose matters unit such as pharmaceutical preparations, medications, food supplements, etc., a unit dose may be included which contains the element inside the package. Other goods consumables and a wide range of materials can also be packaged using this type of container if administration is required of discrete quantities. Such items can be selected from blisters, bags, pillows, leaf inserts and other containers of containment, all formed by conventional means, and can be attached to the part of cardboard that forms the container or in a card inserted as a separate storage item inside the bowl For example, when a blister card It is incorporated in the container, the blister card can be formed as one or more extensions of the cardboard panel that forms the upper, lower and lateral parts of the container.

A tamper proof container is provided infantile, in part, by activating the component of security lock described in this document. To close the container, the cardboard part extends on the basis of the structure and pressure applied in the area of the dependent notch of the locking flap to engage the notch with the groove in The accommodation panel. When the dependent notch is hooked inside the groove, it slides past the notch protruding side to snap on site. In position fully locked, the lateral notch exerts a positive force against the side of the dependent notch, doing so difficult to extract the dependent notch without applying an amount moderate pressure to disengage the lateral notch. The fully locked position represents the position in which you are molded locking element.

A more skillful method is required to open the container. The side notch must be disengaged to remove the notch dependent on slot housing panel. In this regard, the user's finger hooks the locking ring on the bottom of the container, pulling the sealing ring in the opposite direction to the locking flap. The ring pulls the locking tab and, to in turn, the pin curves out of the slot housing panel. Positive contact between the lateral notch and the notch dependent is removed, and thus the dependent notch can loosen freely from the slot housing panel. The flap lock can then be turned around the live hinge to release the cover or top panel of the container. In several embodiments, the closure ring may be hidden on the outside of the container through the lower cardboard panel. In this configuration, a groove is provided in the lower cardboard panel to allow the operation of the closing ring. In others embodiments, a cut can be provided on the side panel bottom that provides unrestricted access to the ring of closing. Once the locking flap is released, the part that contains the unit dose, for example, a blister card, It can be unfolded to allow doses to be withdrawn.

As an additional security feature during opening, the locking flap may be partially trifurcated into three segments using a pair of slits near the innermost edge of the locking flap. Each segment formed in this way it is capable of some limited movement with respect to adjacent segment. To open the container, at least one segment must be caught and pulled out of the container while the tongue lock is removed from the slot housing panel to open Successfully blocking flap.

The invention further comprises a method for packaging unit dose materials comprising:

a) form a blocking element from a rigid plastic material and a flexible plastic material; the locking element comprising a sliding tongue of blocking, a structure base and a locking flap;

b) cut a blank from a flexible cardboard or plastic material;

c) fold the blank to form a container and secure it to the blocking element; Y

d) insert one or more doses of a material of unit dose inside the container.

Figure 1 is an isometric view of a container of partially open unit dose according to the invention.

Figure 2 is a fully extended view of the blank that forms the cardboard part of the package.

Figure 3 is an isometric view from above. of the closed container.

Figure 4 is a plan view of the part external rear of the container showing the situation of the mechanism Release under the outer cardboard panel.

Figure 5 is an isometric view of the part external rear of the container with a cut on the mechanism release trigger.

Figure 6 is a cross section through of a closed unit dose container according to the invention.

Figure 7 is a plan view of a container open with the top panel removed to show the items of the molded plastic locking mechanism.

Figure 8 is an isometric view of the container which shows an alternative configuration of the structure of the container.

Figure 9 is an isometric view of the container with the top panel removed to display the locking flap in the locked, closed position.

Figure 10 represents a cross section of the locking mechanism that shows the flap hitch of lock with the lock tab.

Figure 11 is an isometric view of the container which shows the operation of the locking mechanism in a container partially open according to the invention.

As shown in Figure 1, a container of unit dose of a combination of cardboard / plastic according to the invention in one embodiment comprises a cardboard part 2 which at in turn it comprises a top panel 3 and an extension 4 that houses 16 unit dose blisters in it. The upper panel 3 is connected so that it can bend to an end panel 5, which form the spine of the fully formed container. A bottom panel 6 It is attached to a molded locking element 12. Panel 6 includes, in this embodiment, a slot 11 cut for provide a moving area on a part of the molded part. In other embodiments, exposed cutting elements of the part of plastic can replace slot 11. The cardboard part 2 is fastened by glue or hot melt adhesive to one part 12 molded plastic. Other fastening means may be used. The  plastic part 12 comprises a locking flap 13, a tongue 14 lock, and a structure base 15. Structure base 15 it also comprises end panels 22 and side panels 23, which are connected perpendicularly to form a structure rectangular defining the shape of the container 1, and a panel 18 of slot housing that has a slot 21 to engage the locking flap 13 and having a hollow area under it (no shown), in which a curved shank part 27 of the locking tab 14. Alternatively, they may not be used. double panels, and instead the blister pack material is directly attached, by sealing or other known means to an individual panel of the blank. In one embodiment alternative, exemplified in figure 8, frame base 15 can include a series of end panels at the end of the container 1 opposite the locking flap.

As shown in figure 2, part 2 of cardboard is formed as a top panel 3 and a panel 4 of extension. As shown, top panel 3 and panel 4 extension are formed from bent panels of the base material chosen. Double panels provide support additional physical to the container. In addition, the packaging material of blisters such as a laminate or a sheet of metal can stand between the folded panels 4 to form blisters of unit dose In use, extension 4 opens out moving away from the upper panel 3. Consequently, both the interior surface as the exterior of the upper panel 3 and the extension 4 can be printed with text or graphics, for example, with dosage instructions. Panels 3, 4 also include slots 9 and 10, which are located and sized to correspond when the double panels fold together. The grooves formed in this way allow notch 19 dependent on the locking mechanism pass through panel 3 upper and extension 4 when container 1 is closed. As it mentioned above, the blank can be modified to eliminate the use of double panels, or it may be provided in multiple pieces, for example, a two blank piece pieces.

A top view of the closed container is shown in figure 3. When the container is completely closed, the upper panel 3 is folded into the container and is fold under the locking flap 13. Panel 3 remains in position by protrusions 28 located near the edges of the side panels 23. When panel 3 is pressed down, their edges are pressed down and positively hooked by the projections 28 and are thus retained in the position. The lock flap 13 is trifurcated by a pair of slits 37, which divide the lock flap 13 into segments each having a limited range of movement with respect to the adjacent segment.  In this preferred embodiment, at each end of the flap 13 handles 34, 36 for ovoid fingers for fingers are molded. In other embodiments, the handles may be curved, crooked or striated The division of the flap 13 into segments can improve the safety feature in which to open the container, the user must pull at least one segment while hooking the locking ring 17 to move the locking tab 14 from the unstressed position. If ring 17 is not engaged, when the user grabs only one finger grip 34 without pulling the other finger grip 36 or flap edge 35, the segment in the area of the handle moves slightly, the applied tension is keeps located around handle 34 instead of propelling against the edge 35 of the flap, as necessary to disengage  the lock flap 13 of the slot housing 18, and the container It will not open easily. A slot 20 in the central segment of the locking flap 13 is placed directly on the notch 19 dependent, protruding down under the flap panel 13 lock to engage the locking tab 14.

The bottom or bottom of the container 1, such as shown in figure 4, it presents a cardboard panel 6 in the outer surface. Panel 6 borders the lower plane of the base 15 of the structure and is held in place by means adhesives, or by hooking with protrusions on the panels 23 laterals, as described above, or both. A medium of depression is included in panel 6 to allow Trigger mechanism operation below. In the realization shown, a crooked slit is cut to form a node 11 in panel 6 on closing ring 17. In node 11 not subject can be lowered, thus allowing the user to grab and move the sealing ring 17 from the outside of the container 1. In another embodiment, shown in Figure 5, node 11 can remove and form a cut 41 to partially expose or totally closing ring 17. The concealment of the ring of closure can be added incrementally to the characteristics of the child tamper-proof packaging, however, because the Opening medium is less obvious.

Figure 6 is a cross section of the container closed showing the internal position of blisters 16 which They contain unit doses with respect to the blocking mechanism. Preferably, the dimensions of the package are such that the blister packs 16 can be stored internally without being compressed by the elements of the locking mechanism, in particular the base 15 of the structure, stops 30, projections 31 of stopper and closure ring 17, which protrudes to a certain extent on the plane of the lower panel 6.

The open container with panels 3 and 4 removed to reveal the blocking element is shown in figure 7. The blocking element is composed of a locking flap 13, a base 15 of the structure, a closure ring 17, which is formed entirely with and attached to a locking tab 14, and a panel 18 slot housing. The closing ring 17 is sized to accommodate a normal finger of a user and is located within a cut 32 that is spaced to allow movement of the closing ring 17. Locking tab 14 it ends in a 27 spike curve made of a flexible material, which is fixedly attached to the base 15 of the structure in the clamping points 33. Oriented towards the central area of the spike 27 curve is located a lateral notch 25, which protrudes towards outside from the end of the locking tongue 14 parallel to the base 15 of the structure. The locking tab 14 acts together with a pair of stops 30 and a shoulder boss 31, which can be caught with stops 30 to limit the movement of the tab 14 and to prevent its displacement out of the plane of the base 15 of the structure.

The locking flap 13 is composed of a notch 19 dependent, which is placed perpendicularly with with respect to the flap 13, and a groove 20 located on the notch 19. The flap 13 is further divided into segments by slits 37. The flap 13 is attached to the base of the structure by a live hinge 26, which is molded together with the others elements of the locking mechanism, and is arranged towards the closed position The dependent notch 19 corresponds to a slot 21 located in a slot housing panel 18, which is adjacent and is partially connected to the end panel 22 inside of the structure of the container.

Figure 8 shows an alternative embodiment of the molded structure of the container 1, in which multiple panels 22, 24 ends of approximately the same dimensions can placed in parallel but spaced apart from each other in the end that forms the spine of the container. These multiple panels They provide additional support for the container structure. The Figure 8 also describes the pin 27 curve of the tongue 14 of lock that, as shown, is molded to include the 25 side notch. The spike 27 curve is in turn subject to fixed way to the base 15 of the molded structure at points 33 clamping The flexibility of the curved spike facilitates movement of the locking tongue 14 with respect to the supports 38 and base 15 of the structure. The flexible part of the spike 27 curve is formed as sections 42 that have edges 40 molded therein to provide reinforcement and areas 43 reduced that facilitate the curvature of sections 42 with with respect to the locking tongue 14.

Figures 9 to 11 show the operation of the locking mechanism In Figure 9, the container is closed (panel upper removed) and the locking mechanism is in the state molded, not tensioned. The spike 27 curve is housed inside the panel 18 (not shown) slot housing and notch 25 side protrudes outward towards groove 35 of notch 19 dependent. The slits 37 trifurcate the locking flap 13 in three segments, the two end segments having handles 34 and 36 for fingers, respectively, located therein. To open the locking flap, the user must first hook the closure ring 17 and pull it out into the opening 32 out of the locking flap to remove the tongue 14 from blocking, normally until the shoulder projection 31 engages with the stops 30. Removing the locking tab 14, the pin 27 curve is removed from inside the housing panel 18 of groove.

Figure 10 shows the notch hitch 19 dependent, more particularly slot 38 formed therein, with the lateral notch 25 of the spike 27 curve, in section cross.

Figure 11 shows the closing ring 17 activated and partially shifted out in opening 32 to remove the locking tab 14. The closing ring can activated by grasping the upper and lower parts of the container and inserting a finger to operate the closing ring 17. When the locking tab 14 is removed, the lateral notch 25 extending from the end of it is removed from the slot 39 within the dependent notch. While closing ring 17 is hooked, the user simultaneously pulls one or both handholds 34 and 36 for fingers to remove dependent notch 19 of slot 20. If any of the handholds 34, 36 for fingers or the central segment is pulled without lifting the other section, it is not transfers enough tension to release the dependent notch 19 to the central segment of the locking flap 13 and the container is not will open easily. The ease of manipulating this aspect of mechanism can be modulated by shortening or lengthening the slits 37.

The combination package of the invention is normally formed in a machine operation in which the pre-cut, pre-folded blanks are glued or heat sealed to the fastening points at the bottom of the base 15 of the structure , panels 5, 22 ends and side panels 23. The projections present along the length of the panels 23 can allow the cardboard part to snap into the molded structure formed by these side and end panels. The material for forming the blister packs and unit doses can be inserted before the cardboard part is attached to the plastic frame, but preferably, this stage is carried out after the parts of the package are
unite

The containers of the invention are suitable for a wide range of applications, and are particularly useful in the medication packaging or pharmaceutical dosage preparations units where being tamper-proof is important to avoid unwanted manipulation.

It is believed that the present invention includes many other embodiments that may not be described in detail in this document, but that nonetheless would be appreciated by specialists in the technique from the descriptions made. Consequently, this description should not be read as being limited only to the previous examples or only to designated designated embodiments.

Claims (12)

1. Unit dose container comprising a part (2) of cardboard or plastic formed as a series of adjacent panels, a rigid blocking element (12), and a structure to accommodate unit doses inside the package, characterized in that: The flexible part of cardboard or plastic comprises an upper panel (3) having an extension (4) that can be folded with respect to the upper panel, the extension (4) having within it one or more blisters (16) to contain the unit dose matters, the upper panel (3) and the extension panel (4) each having one or more grooves (10, 9) near one edge thereof, a lower panel (6) having a means (11) of depression located therein, and an end panel (5) connected so that it can be bent to the upper panel (3) and the lower panel (6); the rigid blocking element (12) is a molded plastic blocking element, said blocking element comprising a pair of side panels (23) and a pair of panels (22) forming a rectangular rigid container structure, a base (15 ) of the structure located parallel to and against the lower panel (6) of the cardboard part to form a rigid tray, a sliding tongue (14) locking inside the tray, said locking tongue located at one end of the same a trigger mechanism and having at its other end a curved spike (27), and a locking flap (13) attached to an end panel (22) of the container structure, said flap (13) comprising blocking a dependent notch (19) that protrudes downwards and perpendicularly thereto and that can be engaged with the curved spike (27); and wherein the depression means (11) of the cardboard part (2) corresponds to the trigger mechanism (17) of the molded plastic element (12); and the grooves (9) in the upper panel (3) and the extension panel (4) of the cardboard part (2) act together to form a groove for the passage of the groove (19) dependent on the locking mechanism. 2. Unit dose container according to claim 1, wherein the curved spike (27) comprises a lateral notch (25) protruding perpendicularly thereto, and the notch (19) dependent on the locking flap (13) comprises furthermore a groove (39) within said notch for engaging the lateral notch (25). 3. Unit dose container according to claim 1 or 2, wherein the depression means (11) is a button, slit, notch or cut. 4. Unit dose container according to claim 1, 2 or 3, wherein the trigger mechanism (17) is a closing ring 5. Unit dose container according to any of claims 1 to 4, wherein the cardboard part is formed from C1S or C2S cardboard bleached or not bleached. 6. Unit dose container according to any of claims 1 to 5, wherein the cardboard part is laminated with a polymer material. 7. Method of packaging dose material units in a unit dose container according to any of the claims 1 to 6, the method comprising the following stages: a) forming a locking element (12) comprising a sliding slide tab (14), a structure base (15) and a block flap (13)
queo; b) cut a blank from a flexible cardboard or plastic material; c) fold the blank to form a container (2) and secure it to the blocking element (12); and d) insert one or more doses of a material of unit dose inside the container. 8. Method according to claim 7, which comprises forming the blocking element (12) from a material rigid plastic and a flexible plastic material. 9. Method according to claim 7 or 8, in the that the blank is formed to include a panel (6) bottom that has a groove or cut (11) therein; a pair of end panels (5, 7), each connected so that it can bend at opposite ends of lower panel (6); and a panel (3) superior that includes one or more extensions (4) of the same. 10. Method according to any of the claims 7 to 9, wherein the unit dose matters are inserted into one or more blisters (16) mounted on part (2) of paperboard. 11. Method according to claim 10, wherein the blisters (16) are mounted on the one or more extensions (4) of the top panel (3). 12. Method according to any of the claims 7 to 11, wherein the unit dose matters they are contained in individual container containers inside of the container.