US20110056948A1

US20110056948A1 - Pharmaceutical Container Having Non-Child-Resistant Closure

Info

Publication number: US20110056948A1
Application number: US12/554,198
Authority: US
Inventors: Sean M. Brennan
Original assignee: Pacific Management Holding LLC
Current assignee: Pacific Management Holding LLC
Priority date: 2009-09-04
Filing date: 2009-09-04
Publication date: 2011-03-10

Abstract

A non-child-resistant closure and container system for a pharmaceuticals comprises a cap configured to cooperate with a2 container. The container has at least one bayonet structure that includes a leading taper, a recess, and a backstop. The cap has an outer shell that includes a skirt and at least one lug formed thereon. The lug is configured to cooperate with the bayonet structure such that one of an audible signal and a tactile sensation is produced upon closing the cap onto the container. The cap is closed onto the container by rotating the cap until a portion of the lug enters the recess. The lug is further configured to be released from the recess by reverse rotation of the cap causing the lug to move axially relative to the recess.

Description

BACKGROUND OF THE INVENTION

This invention relates in general to pharmaceutical containers. In particular, this invention relates to non-child-resistant closures for pharmaceutical containers.
Pharmaceutical containers are used to dispense drugs and other medicines from a pharmacist to patients. Because of the potential for children to gain access to these medicines with potentially dangerous effects, closure devices have been provided with various mechanisms to prevent or deter small children from gaining access to the contents. One popular type of child-resistant (CR) closure and container system is a push and turn type system that includes a cap having an outer shell and an inner seal. While this closure configuration has the intended result of hampering or preventing small children from gaining unauthorized access to medicines, it also has the unintended result of hampering access to medicines by the elderly or physically challenged patients. The difficulty lies in certain users having a lack of manual dexterity and strength to both compress and twist the cap. For this reason, non-child-resistant caps are still in substantial use.
Previous non-child-resistant closures, such as traditional snap caps, are easy to open but may not provide adequate sealing to contain liquids or may be inadvertently opened, such as when carried in a purse or pocket. Other non-child-resistant cap configurations may include external threads that engage threads formed on the inner diameter of the container. However, forming threads on containers, particularly on the inner diameter of the containers, increases the cost of manufacture. Other non-child-resistant closure configurations do not provide any indication that they are truly in a closed position. Thus, it would be desirable to provide an improved non-child-resistant closure for pharmaceutical containers.

SUMMARY OF THE INVENTION

This invention relates to a non-child-resistant closure and container system for a pharmaceuticals. The system comprises a container and a cap configured to cooperate with the container. The container has at least one bayonet structure that includes a leading taper, a recess, and a backstop. The cap has an outer shell that includes a skirt and at least one lug formed thereon. The lug is configured to cooperate with the bayonet structure such that one of an audible signal and a tactile sensation is produced upon closing the cap onto the container. The cap is closed onto the container by rotating the cap until a portion of the lug enters the recess. The lug is further configured to be released from the recess by reverse rotation of the cap causing the lug to move axially relative to the recess.
The lug of the cap includes a primary profile and a secondary profile. The primary profile engages the recess and the secondary profile controls the amount of engagement of the lug into the recess. The secondary profile further controls the compression of a resilient inner seal having a spring force characteristic and a spring rate. The amount of engagement of the primary profile into the recess compresses the resilient inner seal. Compression of the resilient inner seal is such that the lug is permitted to be released from the recess by rotation of the cap. Rotation of the cap causes the lug to move axially relative to the recess.
Various aspects of this invention will become apparent to those skilled in the art from the following detailed description of the preferred embodiment, when read in light of the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded, perspective view of a closure and container system for pharmaceuticals.

FIG. 2 is an enlarged view, in partial cross-section, of the closure and container system of FIG. 1.

FIG. 3 is an exploded view of an embodiment of a cap of the closure and container system of FIG. 1.

FIG. 4A is an enlarged view, in cross-section, of the closure and container system of FIG. 1 shown in a closed and unlocked orientation.

FIG. 4B is the closure and container system of FIG. 4A shown in a closed and locked orientation.

FIG. 4C is an enlarged view, in cross-section, of an embodiment of a closure positioned on the container of FIG. 1 shown in a closed and locked orientation.

FIG. 5A is a first embodiment of a bayonet and lug closure structure.

FIG. 5B is a second embodiment of a bayonet and lug closure structure.

FIG. 5C is a third embodiment of a bayonet and lug closure structure.

FIG. 5D is a fourth embodiment of a bayonet and lug closure structure.

FIG. 5E is a fifth embodiment of a bayonet and lug closure structure.

FIG. 6 is a prior art child-resistant bayonet and lug closure structure.

FIG. 7 is a prior art non-child-resistant bayonet and lug closure structure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawings, there is illustrated in FIGS. 1 and 2 a closure and container system, shown generally at 10, that includes a non-child-resistant cap 12 and a container 14. The container 14 includes a plurality of bayonets 16 spaced around an open end 18 of the container 14 and may be suitable for both child-resistant and non-child resistant closures. The bayonets 16 include a leading taper 20, a recess 22, and a backstop 24. The bayonets 16 are configured to cooperate with a lug 26 that is part of the cap 12. As shown in FIG. 3, the cap 12 includes an outer shell 28 having a skirt 30 that extends from a back portion 32 of the outer shell 28. The lugs 26, the skirt 30, and the back portion 32 are integrally molded to form the outer shell 28. The lugs 26 are shown spaced around an inner surface of the skirt 30. The cap 12 further includes a resilient inner seal, shown generally at 34. Though illustrated as a separate member, the inner seal 34, or any portions of the inner seal 34, may be integrally formed with the outer shell 28.
Referring now to FIGS. 4A and 4B, the inner seal 34 is illustrated having a sealing bead 36 and an edge seal 38, though any resilient sealing geometry may be used. The resilient characteristic of the inner seal 34 applies a spring force between the outer shell 28 and the container 14 that causes the two structures to separate. The sealing bead 36 is shown in the form of a general “U” or “V” shape, though such a geometry is not required. The sealing bead 36 extends into the opening 18 and seals against the leading edge of the container 14 and may produce a fluid tight seal arrangement. The edge seal 38 may be shaped in a in a “U” or “V” geometry or any other contacting shape such as flat, rounded, “C”-shaped, or any other suitable sealing geometry. The sealing bead 36 and the edge seal 38 may produce the spring force as they are compressed between the outer shell 28 and the container 14, as shown in FIG. 4B. Either structure, alone or in cooperation, may generate the separating spring force between the outer shell 28 and the container 14. In order to generate a spring force, the resilient inner seal 34 is made from an elastomeric material such as, for example, synthetic rubber, urethane, poly vinyl chloride, polyethylene, and the like.
Referring now to FIG. 4C, there is illustrated another embodiment of a closure, shown generally at 12 a, which is similar to the closure 12 described previously. Similar reference numbers will be used to describe features of closure 12 a that are similar to closure 12. The closure 12 a includes an outer shell 28 a having a skirt 30 a that extends from a back portion 32 a of the outer shell 28 a. A plurality of lugs 26 a, similar to lugs 26 or any other lug embodiment described herein, are formed on the inner surface of the skirt 30 a. The lugs 26 a, the skirt 30 a, and the back portion 32 a are integrally molded to form the outer shell 28 a. The outer shell 28 a includes an inner seal 34 a that is also formed integrally with the back portion 32 a. The inner seal 34 a is shown having a tapered outer surface 36 a which may also be applied as a taper on the inner surface, though such is not required. The tapered outer surface 36 a includes an edge seal portion 38 a that seals against the container 14. The edge seal portion 38 a may have either a smooth surface finish or a matte or satin textured finish in order to adjust the coefficient of friction between portions of the container 14 and the closure 12.
The integral inner seal 34 a includes an anchor section 37 a that is formed integrally with the outer shell 28 a. The anchor section 37 a extends from an inner surface of the back portion 32 a of the outer shell 28 a. In the illustrated embodiment, the anchor section 37 a is thicker than the edge seal 38 a. The tapered surface 36 a may extend from the anchor portion 37 a and provide the inner seal 34 a with a gradually decreasing cross section. The gradually decreasing cross section of the inner seal 34 a has a spring rate that applies a sealing force against the container 14 as the closure 12 a is moved to the closed position of FIG. 4C. The inner seal 34 a may be deflected at the edge seal portion 38 a to create a fluid tight seal.
Referring now to FIG. 5A, in a first embodiment, the lug 26 includes a primary profile 40 and a secondary profile 42. The primary profile 40 engages the recess 22 of the bayonet 16. The secondary profile 42 contacts another portion of the bayonet 16 such as the leading taper 20, near the intersection with the recess 22 shown in FIG. 5A. Referring again to FIGS. 4A and 4B, the cap 12 is moved from an unclosed position shown in FIG. 4A to a closed and secured position of FIG. 4B by twisting the cap 12 relative to the container 14. As the outer shell 28 is twisted, the lug 26 makes contact with the leading taper 20 of the bayonet 16. The lug 26 moves along the leading taper 20 which draws the outer shell 28 onto the container 14. As the outer shell 28 is rotated and drawn onto the container 14, the inner seal 34 is compressed between the back portion 32 of the outer shell 28 and a portion of the container 14, such as the rim. As the outer shell 28 is twisted further, the primary profile 40 of the lug 26 enters the recess 22 of the bayonet 16. The depth of engagement between the primary profile 40 and the recess 22 is controlled by contact between the secondary profile 42 and a portion of the bayonet 16. As shown in FIGS. 4B and 5A, the end of the leading taper 20 contacts the secondary profile 42. Upon closing, the contact of the secondary profile 42 with the bayonet 16 produces at least one of an audible signal or a tactile sensation that indicates the cap 12 is engaged in a closed and secure condition with the container 14. The audible signal may sound like a “click” and a corresponding “tap” or impulse input to the cap may be felt by the user's finger tips or palm.
To open the cap 12 from the container 14, the outer shell 28 is twisted relative to the container 14 in the opposite direction of the closing movement. The depth of engagement between the primary profile 40 and the recess 22 is controlled by the secondary profile 42 such that added compression of the inner seal 34 required to disengage the primary profile 40 from the recess 22 can be achieved without requiring the application of a secondary axial force to the outer shell 28. In other words, the secondary profile 42 limits the spring force generated by the inner seal 34 so that when the cap is unscrewed, the lug 26 disengages from the recess 22. The lug 26 disengages from the recess 22 without an additional axial force being applied by the user to urge the lug 26 away from engagement with the recess 22. As shown in FIG. 6, such a secondary axial force and deflection, A, is required to disengage a lug 526 of a conventional child-resistant cap from the recess 22 of the container 14, as will be explained in detail below. Only after the lug 526 of the child-resistant cap of FIG. 6 is disengaged from the recess 22 by the axial deflection “A” can the lug 526 be rotated to permit removal of the child-resistant closure from the container. In contrast, rotating the non-child-resistant cap 12 provides a sufficient axial compression of the inner seal 34 to permit the lug 26 to disengage the recess 22 without requiring the application of a secondary axial force.
The primary profile 40 is offset or spaced apart from the secondary profile such that a depth of engagement “B”, as shown in FIG. 5A, of the lug 26 with the recess 22 is limited. The depth of engagement of the lug 26 with the recess 22 is a function of the stiffness of the resilient inner seal 34. As the spring rate (measured, for example, in pounds per inch) of the inner seal 34 becomes higher (i.e., stiffer), the depth of engagement is smaller. This inverse proportion of stiffness to depth of engagement provides a force to compress the seal, with the force being achievable by rotation alone of the outer shell 28. In one embodiment, the primary profile is offset to permit the lug 22 to project approximately 0.005 inch into the recess 22. The offset however may be any depth such as within the range of 0.003 to 0.060 inches if desired.
Referring now to FIGS. 5B-5E, there are illustrated various alternative embodiments of lugs where the primary and secondary profiles are engaged with the recess 22 of the bayonet 16. As shown in FIG. 5B, a lug 126 has a primary profile 140 that may be a projection extending into the recess 22, such as a rounded bump. Such a projection may permit a stiffer inner seal member to be used with a greater depth of engagement “B” by providing a less abrupt transition between the primary profile 140 and a secondary profile 142. FIG. 5C shows an alternative primary profile 240 that is a double sided ramp having a lead-in surface 240 a with a longer length and shallow inclination angle and a retaining surface 240 b having a steep inclination angle. Such a primary profile may allow for a wider range of seal spring rates to be used while still permitting the cap to be removed by the user only rotating the outer shell.
FIGS. 5D and 5E illustrate alternative embodiments of secondary profiles. As shown in FIG. 5D, a secondary profile 342 that extends from a lug 326 adjacent to the leading taper 20 of the bayonet 16. A primary profile 340 abuts the bayonet 16 in a similar manner as the lug 26 of FIG. 5A. FIG. 5E shows another embodiment of a lug 426 having a secondary profile 442 that engages a portion of the backstop 24. A primary profile 440 abuts the bayonet 16 in a similar manner as depicted in FIG. 5A. Alternatively, the secondary profile 442 may be combined with any primary profile shape desired.
Referring now to FIG. 6 there is illustrated a cooperating bayonet 16 and lug 526 of a conventional push and turn type child-resistant (CR) closure and container system that includes a cap having an outer shell and an inner seal. The outer shell includes a skirt having lugs formed thereon, similar to the outer shell described above. The lugs 526 are adapted to cooperate with the bayonet structure 16 formed on an outer surface of the container. The bayonet structure includes a leading edge taper or cam surface, a back stop portion, and a recess 22 as previously described above.
The cap is aligned on the container so that the lugs may pass vertically between adjacent bayonet structures. Rotating the cap on the container causes the lugs to contact the leading taper of the bayonet structure. As the cap continues to be rotated, the lugs 526 move along the leading taper which draws the outer shell toward the container. The outer shell compresses the inner seal into the opening of the container. The lugs 526 are rotated beyond the taper toward the back stop portion. The lugs 526 are then drawn into the recess 22 by the spring force of the compressed inner seal to lock the cap onto the container. If the cap is rotated relative to the container, without a secondary axial force applied to the cap, the seating of the lug 526 into the recess 22 provides both of an audible signal and a tactile sensation to indicate the lid has been properly secured. The seating of the lug into the recess may also provide one of the audible and tactile indicators to the user in certain instances. Rotating the cap without compressing the cap against the container provides an added confirmation that the cap is properly closed. The inner seal maintains a residual compression to provide a liquid and/or air tight seal.
To release the child-resistant cap from the container, a downward force is applied to the cap causing the inner seal to be further compressed from the closed seal state. The lugs 526 are then axially disengaged from the recesses 22 of the bayonet structure 16. A rotational force is required to slide the lugs around the cam surface on the bayonets and back to the spaces between adjacent bayonets. The torque to rotate the container lid increases with the amount of axial force applied to compress the seal. The axial force is high enough to prevent or frustrate a child's attempts to open the container. By way of the coefficient of friction between the inner seal and one of the outer shell of the child-resistant cap or the container 14, the torque to rotate the cap to a removable position also increases while compressing the inner seal. As previously mentioned, certain of the elderly or physically challenged patients may be hampered or even prevented from accessing their medications with these child-resistant closure systems. The difficulty lies in certain users having a lack of manual dexterity and strength to both compress and twist the cap. Depending upon the materials selected for the container and the inner seal and outer shell of the cap, the different coefficients of friction of the contacting materials may add to the difficulties in opening these pharmaceutical containers.
Referring now to FIG. 7, there is illustrated a cooperating lug 626 and bayonet structure 16 of a prior art non-child-resistant closure and container system. The closure is similar to the CR cap described above and shown in FIG. 6. The main difference is that the lug 626 is sized to be larger than the recess 22 to prevent engagement therewith. The lug 626 engages and is moved along the leading taper or cam of the bayonet 16 as described above. However, the lug 626 completely spans the recess 22 when the edge of the lug 626 contacts the back stop. While these closures are more easily twisted to remove, they do not provide any indication that they are completely seated. As such, they may be more susceptible to inadvertent opening in a purse or pocket. Additionally, because of a lack of confidence in closing these containers, users may twist the closure so hard that the lugs 626 are permanently deformed and the cap is no longer operable or fluid tight.
The principle and mode of operation of this invention have been explained and illustrated in its preferred embodiment. However, it must be understood that this invention may be practiced otherwise than as specifically explained and illustrated without departing from its spirit or scope.

Claims

What is claimed is:

1. A non-child-resistant closure and container system for a pharmaceutical comprising:

a container having at least one bayonet structure that includes a leading taper, a recess, and a backstop; and

a cap configured to cooperate with the container and having an outer shell that includes a skirt and at least one lug formed thereon, the lug configured to cooperate with the bayonet structure such that one of an audible signal and a tactile sensation is produced upon closing the cap onto the container and rotating the cap until a portion of the lug enters the recess, and the lug being further configured to be released from the recess by reverse rotation of the cap causing the lug to move axially relative to the recess.

2. The non-child-resistant closure and container system of claim 1 wherein the cap includes a resilient portion having a spring rate and the resilient portion being configured to engage the portion of the lug into the recess when the cap is moved to a closed position.

3. The non-child-resistant closure and container system of claim 1 wherein the rotation of the cap from a closed and latched position to an unlatched position causes the lug to move axially out of engagement with the recess in response to compression of a resilient inner seal that is disposed between the container and the outer shell.

4. The non-child-resistant closure and container system of claim 3 wherein the resilient inner seal provides a fluid tight engagement with the container.

5. A non-child-resistant closure and container system for a pharmaceutical comprising:

a cap having at least one lug configured to cooperate with the bayonet structure, the lug having a primary profile that engages the recess and a secondary profile that controls the amount of engagement of the lug into the recess.

6. The non-child-resistant closure and container system of claim 5 wherein the primary and secondary lug profiles are primary and secondary lug upper surface profiles.

7. The non-child-resistant closure and container system of claim 5 wherein the primary and secondary lug profiles cooperate with the bayonet structure to provide at least one of an audible signal and a tactile sensation when the cap engages the container in a closed and axially retained position.

8. The non-child-resistant closure and container system of claim 5 wherein the primary profile is a step.

9. The non-child-resistant closure and container system of claim 5 wherein the primary profile is one of a bump, a ramp, and a pin.

10. The non-child-resistant closure and container system of claim 5 wherein the cap includes a separate resilient inner seal.

11. The non-child-resistant closure and container system of claim 5 wherein the cap includes an integral inner seal.

12. The non-child-resistant closure and container system of claim 5 wherein the primary profile is a pin and the pin contacts a portion of the backstop in the closed position.

13. The non-child-resistant closure and container system of claim 12 wherein the pin is positioned on the lug in a manner that will result in contact with the leading taper of the bayonet structure as the cap is moved to a closed position.

14. The non-child-resistant closure and container system of claim 9 wherein the cap includes a resilient inner seal.

15. The non-child-resistant closure and container system of claim 14 wherein the resilient inner seal is compressed between the outer shell and the container, the inner seal having a spring rate such that compression of the inner seal causes the primary profile to engage the recess and the secondary profile to engage another portion of the bayonet structure.

16. The non-child-resistant closure and container system of claim 7 wherein the cap includes a resilient inner seal that is compressed as the lug engages the leading taper of the bayonet structure, the at least one of the audible signal and the tactile sensation being produced in response to the compression of the resilient inner seal.

17. A non-child-resistant closure and container system for a pharmaceutical comprising:

a cap having an outer shell, a resilient inner seal having a spring force characteristic, and at least one lug formed onto a portion of the outer shell and further configured to cooperate with the bayonet structure, the lug having a profile that controls compression of the resilient inner seal such that the spring force characteristic permits the lug to be released from the recess by rotation of the cap causing the lug to move axially relative to the recess.

18. The non-child-resistant closure and container system of claim 17 wherein the spring force characteristic is an inversely proportional function of a spring rate of the resilient inner seal and a depth of engagement between a primary profile of the lug and the recess.

19. The non-child-resistant closure and container system of claim 18 wherein a secondary profile of the lug is configured to engage another portion of the bayonet structure and thus limit the depth of engagement of the primary profile.

20. The non-child-resistant closure and container system of claim 19 wherein the primary and secondary lug profiles cooperate with the bayonet structure to provide at least one of an audible signal and a tactile sensation when the cap engages the container in a closed and axially retained position.