U.S. patent application number 14/185402 was filed with the patent office on 2015-08-20 for gas-tight pharmaceutical bottle closure.
The applicant listed for this patent is William Eugene LLOYD. Invention is credited to William Eugene LLOYD.
Application Number | 20150232235 14/185402 |
Document ID | / |
Family ID | 53797442 |
Filed Date | 2015-08-20 |
United States Patent
Application |
20150232235 |
Kind Code |
A1 |
LLOYD; William Eugene |
August 20, 2015 |
Gas-Tight Pharmaceutical Bottle Closure
Abstract
A gas-tight pharmaceutical container includes a pharmaceutical
bottle defining a main enclosure and an upper neck forming a top
opening. The upper neck includes an upper rim forming a planar
engagement surface. A screw-on closure cap seals the top opening,
and includes a circular top member and a circumferential flange. In
one embodiment, the closure cap is metal and includes an annular
pliable gasket secured to a peripheral portion thereof and a layer
of lacquer applied interiorly of the gasket. In another embodiment,
the closure cap is plastic and includes a circular inner liner
formed by a base layer, a foil layer adjacent to the base layer,
and an annular pliable gasket secured to the foil layer. With
either embodiment, threaded engagement of the screw-on closure cap
with the pharmaceutical bottle under pressure causes the pliable
gasket to sealingly engage the upper rim to provide a gas-tight
seal.
Inventors: |
LLOYD; William Eugene; (Fort
Meyers, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LLOYD; William Eugene |
Fort Meyers |
FL |
US |
|
|
Family ID: |
53797442 |
Appl. No.: |
14/185402 |
Filed: |
February 20, 2014 |
Current U.S.
Class: |
220/304 ;
215/344 |
Current CPC
Class: |
A61K 31/198 20130101;
B65D 50/00 20130101; B65D 51/18 20130101; B65D 41/0442 20130101;
B65D 41/045 20130101; A61J 1/03 20130101 |
International
Class: |
B65D 41/04 20060101
B65D041/04 |
Claims
1. A gas-tight pharmaceutical container comprising: a
pharmaceutical bottle including a main enclosure, an upper neck
extending from said main enclosure and forming a top opening for
said main enclosure, said upper neck including external screw
threads, and an upper rim of said upper neck forming a planar
engagement surface of said upper neck about said top opening of
said upper neck; a metal screw-on closure cap which is used to seal
said top opening of said bottle and to repeatedly re-seal said top
opening after a removal of said closure cap, said closure cap
including a circular top member, and a circumferential flange
depending downwardly from said top member and defining an interior
area of said top member, said flange having internal screw threads
which mate with said external screws of said upper neck to secure
said closure cap under pressure to said planar engagement surface
of said upper neck of said main enclosure, and an annular pliable
gasket secured to a peripheral portion of said interior area of
said top member; whereby threaded engagement of said screw-on
closure cap with said pharmaceutical bottle under pressure causes
said pliable gasket to sealingly engage said upper rim of said
pharmaceutical bottle to provide a gas-tight seal.
2. A pharmaceutical container as claimed in claim 1, wherein said
closure cap is aluminum.
3. A pharmaceutical container as claimed in claim 1, wherein said
closure cap is steel, and further including a layer of lacquer
applied to said interior area of said top member inside of said
gasket.
4. A pharmaceutical container as claimed in claim 1, wherein a
material of said pliable gasket is one of butyl, silicone, nitrile
or fluoroelastomer.
5. A pharmaceutical container as claimed in claim 1, wherein said
pharmaceutical bottle is made of a plastics material.
6. A pharmaceutical container as claimed in claim 1, further
including a layer of lacquer applied to said interior area of said
top member inside of said gasket.
7. A pharmaceutical container as claimed in claim 1, wherein said
gasket is adhered to said interior area of said top member.
8. A pharmaceutical container as claimed in claim 1, wherein said
gasket is resiliently held in place by said circumferential flange
in a position immediately adjacent said interior area of said top
member.
9. A gas-tight pharmaceutical container comprising: a
pharmaceutical bottle including a main enclosure, an upper neck
extending from said main enclosure and forming a top opening for
said main enclosure, said upper neck including external screw
threads, and an upper rim of said upper neck forming a planar
engagement surface of said upper neck about said top opening of
said upper neck; a screw-on closure cap which is used to seal said
top opening of said bottle and to repeatedly re-seal said top
opening after a removal of said closure cap, said closure cap
including a circular top member, and a circumferential flange
depending downwardly from said top member and defining an interior
area of said top member, said flange having internal screw threads
which mate with said external screws of said upper neck to secure
said closure cap under pressure to said planar engagement surface
of said upper neck of said main enclosure; and a circular inner
liner which extends over said interior area of said top member of
said closure cap, said inner liner including a base layer which is
secured to said interior area of said top member at the top of said
flange, a foil layer adjacent to said base layer, and an annular
pliable gasket secured to a peripheral area of said foil layer;
whereby threaded engagement of said screw-on closure cap with said
pharmaceutical bottle under pressure causes said pliable gasket to
sealingly engage said upper rim of said pharmaceutical bottle to
provide a gas-tight seal.
10. A pharmaceutical container as claimed in claim 6, wherein said
foil layer is adhered to said base layer.
11. A pharmaceutical container as claimed in claim 6, wherein a
material of said pliable gasket is one of butyl, silicone, nitrile
or fluoroelastomer.
12. A pharmaceutical container as claimed in claim 6, wherein said
pharmaceutical bottle is made of a plastics material, and wherein
said closure cape is made of a plastics material.
13. A pharmaceutical container as claimed in claim 9, wherein said
gasket is resiliently held in place by said circumferential flange
in a position immediately adjacent said foil layer.
14. A pharmaceutical container as claimed in claim 9, wherein said
gasket is adhered in held in place to said foil layer.
15. A pharmaceutical container as claimed in claim 9, wherein said
base layer is made of wax cardboard.
16. A pharmaceutical container as claimed in claim 9, wherein said
base layer is made of a pulp material.
17. A pharmaceutical container as claimed in claim 9, wherein said
closure cap is child-resistant and further includes an outer cap
about said top member and flange.
Description
BACKGROUND OF THE INVENTION
[0001] Various products are provided in sealed containers in order
to preserve the products in the container and prevent degradation.
Pharmaceuticals, especially pharmaceuticals which are
oxygen-sensitive or highly oxygen-sensitive, such as
ultra-oxygen-sensitive levothyroxine sodium tablets, capsules or
the like, are one type of product where a good and reliable seal at
the open top of the pharmaceutical bottle is important to prevent
oxygen in the atmosphere as well as moisture from any source from
coming in contact with the pharmaceuticals in the bottle and
unnecessarily degrading the pharmaceuticals. For that reason,
pharmaceutical containers often include an oxygen scavenger
therein, in addition (typically) to a foil seal attached by
induction heat sealing to the open top of the bottle and underneath
a removable cap provided for the bottle. This foil seal is used
after manufacture of the filled bottle, during shipping and prior
to opening by the user, at which time the foil seal is removed or
destroyed. However, the provision of such a foil seal has proven to
be difficult and complex, posing more problems than the closing of
the containers themselves.
[0002] In the prior art, a very common foil seal for a
pharmaceutical bottle at the open top thereof is a heat-sealed foil
laminate thermo-adhered to the upper rim or finish of the top of
the pharmaceutical bottle. Such a foil laminate is typically used
together with a) a metal cap having a pulp liner and a layer of
foil adhered to the pulp liner, or b) a plastic cap with a foil
laminate liner under a thermo-plastic coating of the cap top.
However, the effectiveness of such thermo-adhered foil laminates to
the open top of the bottle is dependent on the seal between the
bottle and the thermo-adhered foil laminate since heat-sealing
(especially polyethylene) bottles, even when done properly, is a
difficult operation. This heat-sealing of the thermo-adhered foil
laminate to the open top is difficult or undesirable because:
[0003] the heat-sealing equipment is complex, and dependent on
temperature and dwell time; [0004] the heat-sealed bottles
typically need a "re-torqueing" operation after the sealed
containers and applied caps have cooled; [0005] the heat-sealing
process itself exposes the contents to thermo-degradation and
possibly detrimental degradation, such as from the glue fumes;
[0006] the heat-sealing is difficult or ineffective if the tops or
finishes of the bottles have irregularities (probably the main
cause of failure before opening by the user); [0007] the removal of
the thermo-adhered foil laminate from the tops of the bottles is an
irritation to users; and [0008] after removal (or more typically
partial removal) of the thermo-adhered foil laminate, re-sealing is
practically impossible with the remaining top (having only a
pulp/foil liner or foil laminate) and the uneven surface of the
open top of the bottle.
[0009] Thus, there is a need in the art for an alternative to the
thermo-adhered foil laminate for sealing and resealing of a
pharmaceutical bottle or the like.
BRIEF SUMMARY OF THE INVENTION
[0010] Thus, in accordance with the present invention, a gas-tight
pharmaceutical container is provided including a pharmaceutical
bottle defining a main enclosure and an upper neck extending from
the main enclosure and forming a top opening for the main enclosure
as well as having external screw threads thereabout. The upper neck
also includes an upper rim forming a planar engagement surface
about the top opening. The pharmaceutical container also includes a
metal screw-on closure cap used to seal the top opening of the
bottle. This closure cap includes a circular top member and a
circumferential flange depending downwardly from the top member and
defining an interior area of the top member. The flange has
internal screw threads which mate with the external screws of the
upper neck to secure the closure cap under pressure to the planar
engagement surface of the upper neck of the main enclosure. The
closure cap also includes an annular pliable gasket secured to a
peripheral portion of the interior area of the top member and a
layer of lacquer applied to the interior area of the top member
inside of the gasket. With this construction, threaded engagement
of the screw-on closure cap with the pharmaceutical bottle under
pressure causes the pliable gasket to sealingly engage the upper
rim of the pharmaceutical bottle to provide a gas-tight seal.
[0011] The material of the closure cap is preferably either
aluminum or steel, while the pharmaceutical bottle is preferably a
plastics material. The material of the pliable gasket is preferably
one of butyl, silicone, nitrile or fluoroelastomer.
[0012] Also in accordance with the present invention a second
embodiment of a gas-tight pharmaceutical container is provided
including a pharmaceutical bottle as described above. The
pharmaceutical container also includes a screw-on closure cap much
as noted above, except that this second embodiment includes a
circular inner liner which extends over the interior area of the
top member of the closure cap. This inner liner includes a base
layer which is secured to the interior area of the top member at
the top of the flange, a foil layer adjacent to the base layer, and
an annular pliable gasket secured to a peripheral area of the foil
layer. Then, as with the first-mentioned pharmaceutical container,
threaded engagement of the screw-on closure cap with the
pharmaceutical bottle under pressure causes the pliable gasket to
sealingly engage the upper rim of the pharmaceutical bottle to
provide a gas-tight seal.
[0013] In this second embodiment, the foil layer is preferably
adhered to the base layer. In addition, the material of the pliable
gasket is preferably one of butyl, silicone, nitrile or
fluoroelastomer. Also preferably, the material of the
pharmaceutical bottle is a plastics material and the material of
the closure cap is a plastics material.
[0014] It is thus a feature of the present invention that an
effective seal is provided between a cap and bottle which seals the
bottle after manufacture and before use by the user, as well as
after the first use and each subsequent use by the user.
[0015] It is also a feature of the present invention that an
effective seal is provided which is simple and reliable, as well as
being effectively resealable after each use.
[0016] Other features and advantages of the present invention are
stated in or apparent from detailed descriptions of presently
preferred embodiments of the invention found hereinbelow.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0017] FIG. 1 is a cross sectional elevation view of a top portion
of a gas-tight pharmaceutical bottle of the present invention
including a closure cap.
[0018] FIG. 2 is a bottom view of the closure cap for the gas-tight
pharmaceutical bottle depicted in FIG. 1.
[0019] FIG. 3 is cross-sectional elevation view of a portion of the
closure cap identified by the broken line 3 in FIG. 1.
[0020] FIG. 4 is a cross sectional elevation view of a top portion
of a second embodiment of a gas-tight pharmaceutical bottle of the
present invention including another closure cap.
[0021] FIG. 5 is a bottom view of the closure cap for a gas-tight
pharmaceutical bottle depicted in FIG. 4.
[0022] FIG. 6 is cross-sectional elevation view similar to FIG. 3
but of a portion of still another closure cap.
DETAILED DESCRIPTION OF THE INVENTION
[0023] With reference now to the drawings in which like numerals
represent like elements throughout the views, there is disclosed in
FIG. 1 a pharmaceutical container 10 according to a first
embodiment of the present invention. In FIG. 1, only a top portion
of a gas-tight (and hence liquid-tight) pharmaceutical bottle 12 of
pharmaceutical container 10 is schematically shown. Pharmaceutical
bottle 12 is made of a suitable material in order to prevent any
transfer of oxygen (or other gases, or moisture) in the atmosphere
or environment through the walls thereof, as the oxygen (or other
gases or liquids) would potentially damage pharmaceuticals inside,
such as oxygen-sensitive pharmaceuticals or the like in any form
(tablets, capsules, coated tablets, etc.), and especially
ultra-oxygen-sensitive levothyroxine sodium tablets, capsules or
the like. In this embodiment, pharmaceutical bottle 12 is designed
for use by pharmacists, and thus holds large quantities (e.g.,
1000) of tablets, capsules, or the like. Bottle 12 is thus made of
a suitable plastics material such as high density polyethylene or
polypropylene which are well known in the art for preventing oxygen
ingress or which is well-known for preventing oxygen ingress
together with a suitable lining layer; but pharmaceutical bottle 12
could also be glass or other like materials which prevent gas or
liquid transfer therethrough if desired.
[0024] Pharmaceutical bottle 12 is only partially shown, but is
typical of such bottles known in the art and is thus only
schematically depicted in FIG. 1. Pharmaceutical bottle 12 includes
a main enclosure 14 (only partially shown) with an upper neck 16
extending vertically therefrom. Upper neck 16 includes external
screw threads 18, and upper neck 16 forms a top opening 20 for main
enclosure 14 by which the pharmaceuticals in bottle 12 can be
accessed (dispensed, spooned, shaken or poured out) by the user. An
upper rim 22 is presented at the topmost part of upper neck 16,
with upper rim 22 forming a planar engagement surface about top
opening 20.
[0025] In order to provide a gas-tight closing of top opening 20 of
main enclosure 14, pharmaceutical bottle 12 additionally includes a
metal screw-on closure cap 26 as additionally shown in FIGS. 2 and
3. Closure cap 26 is not of the child-resistant type in view of its
intended use by pharmacists (or alternatively by those not desiring
a child-resistant cap with a regular sized pharmaceutical bottle).
Conveniently, closure cap 26 is made of a suitable metal such as
aluminum or steel as desired. Closure cap 26 includes a circular
top member 28 having a circumferential flange 30 extending
downwardly from a periphery thereof so as to define an interior
area 32 of top member 28. Flange 30 has internal screw threads 34
which mate with external screw threads 18 of upper neck 16 to
secure closure cap 26 under pressure (torqueing of the closure cap)
to planar engagement surface of upper rim 22 of main enclosure
14.
[0026] The gas-tight closing supplied by closure cap 26 is provided
by an annular pliable gasket 36 which is held in place or secured
to a peripheral portion of interior area 32 of top member 28.
Gasket 36 preferably has an outer convex shape and an inner flat
shape as shown, whereby the convex shape can be suitably compressed
to provide the gas-tight seal against upper rim 22 while the flat
shape maintains its shape as it is pressed against the flat inside
surface of top member 28. Gasket 36 is suitably made of butyl,
silicone, nitrile or fluoroelastomer (such as VITON), or other
acceptable pliant materials as known in the art, and it is sized to
fit snuggly inside of flange 30 in order to be elastically held in
place or in order to be adhered in place to the peripheral portion
of interior area 32. In order to protect the pharmaceuticals from
the metal of closure cap 26, and vice versa, a layer of lacquer 38
(whose size is exaggerated in FIG. 3 in order to be easily seen) is
applied to interior area 32 of top member 28 at least inside of
gasket 36. In operation then, the torqueing threaded engagement of
screw-on closure cap 26 with pharmaceutical bottle 10 under
pressure causes pliable gasket 36 to be compressed and thus to
sealingly engage upper rim 22 of pharmaceutical bottle 12 to
provide a gas-tight seal for top opening 20.
[0027] Depicted in FIGS. 4 and 5 is a pharmaceutical container 50
according to a second embodiment of the present invention. In FIG.
4, a top portion of a gas-tight pharmaceutical bottle 52 of
pharmaceutical container 50 is schematically shown. Pharmaceutical
bottle 52 in this embodiment is designed for consumer use to hold a
single prescription (e.g., 10-100+, as desired). Bottle 52 is made
of a suitable plastics material such as high density polyethylene
or polypropylene, or a suitable plastics material coated with a
suitable layer such as various resins or fluoride compounds, in
order to prevent any transfer of oxygen in the atmosphere (or other
gases or liquids) through the walls thereof in the same manner as
pharmaceutical bottle 12. Pharmaceutical bottle 52 includes a main
enclosure 54 with an upper neck 56 extending therefrom. Upper neck
56 includes external screw threads 58, and upper neck 56 forms a
top opening 60 for main enclosure 54 by which the pharmaceuticals
in bottle 52 can be accessed by the user. An upper rim 62 is
presented at the topmost part of upper neck 56, with upper rim 62
forming a planar engagement surface about top opening 60.
[0028] In order to provide a gas-tight closing of top opening 60 of
main enclosure 54, pharmaceutical bottle 52 additionally includes a
plastic screw-on closure cap 66 as additionally shown in FIG. 5.
Closure cap 66 is conveniently made of a suitable plastics material
as known in the art such as polypropylene in order to be
sufficiently strong or robust. Closure cap 66 includes a circular
top member 68 having a circumferential flange 70 extending
downwardly from a periphery thereof so as to define an interior
area 72 of top member 68. Flange 70 has internal screw threads 74
which mate with external screw threads 58 of upper neck 56 to
secure closure cap 66 under torqueing pressure to planar engagement
surface upper rim 62 of main enclosure 54. Since bottle 52 is
designed for consumer use, surrounding closure cap 66 to make
closure cap 66 child-resistant as well known in the art is a
floating outer cap 86 (only partially shown in FIG. 5). Outer cap
86 is held loosely to closure cap 66 by a foot 88 at the bottom
thereof, as well known in the art. Finally, pressing down on outer
cap 86 allows screwing and unscrewing of closure cap 66 by virtue
of mating engagements 90 as also well known in the art.
[0029] The gas-tight closing supplied by closure cap 66 is provided
by a circular inner liner or backer 76 which extends over interior
area 72 of top member 68. This inner liner 76 includes an uppermost
(wax cardboard, pulp, plastic, foam or the like) base layer 78
which is fittingly held in place or lightly secured to interior
area 72 of top member 68 at the top of flange 70. Inner liner 76
also includes, below base layer 78 and hence facing the
pharmaceutical in bottle 52, an aluminum foil layer 80, or any
other suitable layer which provides an oxygen (or other gas and
liquid) impermeable layer to prevent ingress of oxygen through the
plastic material of top member 68 of closure cap 66. Finally, as
shown, an annular pliable gasket is secured, either adhered or
elastically held in place, to a peripheral area of foil layer 80 to
provide a gas-tight seal in the same manner as gasket 36 discussed
above. Foil layer 80 can either be adhered to base layer 78, or be
free floating and instead adhered to gasket 82 which is held
elastically in place similar to gasket 36. In operation then,
threaded engagement of screw-on closure cap 66 (through pressing
engagement on outer cap 86) with pharmaceutical bottle 50 under
torqueing pressure causes pliable gasket 82 (together with base
layer 78) to sealingly engage upper rim 62 of pharmaceutical bottle
52 to provide a gas-tight seal for top opening 60.
[0030] Depicted in FIG. 6 is a cross section (similar to that of
FIG. 3) of a top portion of an alternative closure cap 96. Closure
cap 86 is much like closure cap 26 or closure cap 66, and includes
an annular pliable gasket 36 adjacent thereto, either secured
thereto by adhering or the like or floating but held in place by a
resilient fit with the circumferential flange of closure cap 86. It
will be appreciated that closure cap 86 is made of a suitable
material, either metal or plastic, which by itself is satisfactory
for preventing oxygen or other egress. A suitable plastic material
would be the same as that (and with a like coating, if any) of the
bottle, or a suitable metal (not requiring a coating) such as
aluminum.
[0031] With any of the constructions described above, it will be
appreciated that the following is achieved with both disclosed
embodiments: [0032] a simple gas-resistant annual ring gasket is
employed; [0033] the simple ring gasket can be used with
child-resistant as well as non child resistance containers; [0034]
the complications of heat sealing a foil laminate are avoided;
[0035] no re-torqueing of the closure cap after cooling of a seal
is needed; [0036] the temperature of the pharmaceutical bottle
contents is not raised when the seal is provided; [0037] the use of
a pliant annular gasket helps to provide a good and reliable seal,
even where there are some minor surface irregularities on the upper
rim around the open top; [0038] the opening and closing of the
bottle using the closure cap is simple; [0039] re-sealing of the
main closure and then re-opening at the next use is easy and
reliable, requires little effort, and can be easily accomplished by
most users; [0040] the closure cap can be used on a variety of
pharmaceutical bottles, including glass as well as plastic; and
[0041] the gasket remains in the closure cap at all times, so a new
seal is always reliably provided after each use.
[0042] It is an advantage of the present invention that the use of
the rubber gasket eliminates the need for the induction heating and
sealing of the prior art glue/seal provided on the foil disk, which
prior art foil disc was adhered to the lips of the mouth of the
container and formed a seal therewith. However, it will be
appreciated that the peeling of the prior art foil disc also acted
as a tamper-evident feature, which tamper-evidence is not part of
the present invention since the foil disc remains in the closure
cap to effect a good barrier together with the gasket each time the
cap is re-applied. Thus, it is contemplated that a different
tamper-evident seal would be employed with the present invention,
such as a shrink wrap around the cap or the like as well known in
the art.
[0043] The present invention has been described as being applicable
to pharmaceutical containers or the like. However, it will be
appreciated that the invention would also be applicable to other
products requiring sealing from the environment, such as
nutritional products like rapidly-oxidized nuts or other foods.
[0044] While the present invention has been described with respect
to exemplary embodiments thereof, it will be understood by those of
ordinary skill in the art that variations and modifications can be
effected within the scope and spirit of the invention.
* * * * *