Tamper resistant package

A tamper-resistant package for articles such as pharmaceuticals and medicine which are themselves first enclosed within a first closed and sealed container. The first container is then enclosed within a second container, there being a void between the two containers. The second container includes a lid which is secured over its opening. Positioned between the lid and the opening of the second container is a permanently adhered thin sheet of elastic material or membrane which is impermeable to gas or liquid. This membrane is permanently adhered to the opening of the second container after the sealed first container and a portion of solid chemical material possessing the physical property of sublimation is placed into the void. In conjunction with the expansion into gas of the solid sublimation material at atmospheric pressure and normal ambient temperature subsequent to the permanent adhesion of the lid to the membrane and over the opening of the second container, the membrane stretches and expands outwardly from an aperture in the lid to produce visible and touchable positive evidence that the package has not been tampered with. The membrane is permanently destroyed when the lid is removed or when the membrane is punctured, cut or otherwise ruptured in any manner. This physical indicia remains in tact for at least the shelf life of the article, unless tampering occurs. A transparent protective cover releasably connected over the lid is also provided.

BACKGROUND OF THE INVENTION 
This invention relates generally to tamper-resistant packages, and more 
particularly to a dual container package and method for packaging articles 
such as pharmaceuticals and medicines within the smaller inner container. 
With the recent rash of deaths and serious illness as a result of tampering 
with over-the-counter pharmaceuticals and drugs, considerable emphasis has 
been directed to the inadequacy of existing tamper-resistant and 
tamper-proof packages and methods of constructing same. Most of the prior 
art devices are not truly tamper-proof, in that tampering with the 
articles therein is possible. Alternately, prior art discloses 
tamper-resistant packages and packaging devices which are intended to 
provide some indicia or physical evidence that tampering has occured 
therewith. 
An example of a claimed tamper-proof package is disclosed in U.S. Pat. No. 
4,449,632, directed to a dual container arrangement having a pressurized 
void therebetween, the outer container or enclosure creating the 
pressurization as it is sealed about the inner container. Additional 
elastic layers are also provided around the second container to enhance 
the tamper-proof features. Other prior art which discloses air pressurized 
protective packaging are shown in U.S. Pat. No. 2,835,596 directed to a 
method for packaging marshmellows which uses an air pressurizing bag to 
provide protective packaging. U.S. Pat. No. 2,833,398 discloses an 
inflation cushioned sealed container wherein a pressurized bag is placed 
within a container above the article to be protected in order to provide 
protective packaging in a tamper-resistant closure for the article. U.S. 
Pat. No. 4,434,893 is, likewise, directed to a tamper-evident packaging 
device which includes an inner and an outer gas tight container each 
having flexible walls and pressurization with gas above atmospheric 
pressure to inflate their flexible walls. However, none of these have 
received any substantial degree of commercial acceptance. 
With respect to tamper-resistance and tamper-evidence type packages, U.S. 
Pat. No. 2,880,900 discloses an outer sealed cushion or container 
employing a vacuum to provide packaging protection of the articles in the 
inner container. Likewise, the packaging device disclosed in U.S. Pat. No. 
4,436,203 is directed to a dual inner and outer packaging device wherein 
tampering is rendered obvious by the change in the physical shape of the 
inner container which is pressurized while the void between the inner and 
outer layers is at a vacuum or less than atmospheric pressure. Other 
patents which include a variation of this theme wherein loss of the vacuum 
within a vacuum sealed package provides the resistive and indicative 
tampering virtues are disclosed in U.S. Pat. Nos. 2,040,798, 3,152,711, 
3,160,302, 2,197,004, 3,736,899, 3,443,711, and 2,034,739. 
Still other tamper-resistant seals are disclosed in U.S. Pat. Nos. 681,774 
and 1,039,843 which are directed to tamper-resistant seals. 
The present invention, although not providing tamper proof features, does 
provide a packaging which is virtually fool proof with respect to its 
tamper evident novel features. The method of construction is convenient 
and economical, as well as reliable and provides a tamper-evident seal 
which cannot be disrupted, disturbed, or be otherwise penetrated without 
the potential user or purchaser having clear and convincing evidence of 
the tampering. 
SUMMARY OF THE INVENTION 
The present invention relates generally to a tamper-resistant package for 
articles such as pharmaceuticals, drugs and medicine which are themselves 
first enclosed within a first closed and sealed container. The first 
container is then enclosed within a second container, there being a void 
between the two containers. The second container includes a lid or closure 
which is secured over its opening. Positioned between the lid and the 
opening of the second container is a permanently adhered thin sheet of 
elastic material or membrane which is impermeable to gas or liquid. This 
membrane is permanently adhered to the opening of the second container 
after the sealed first container and a portion of solid chemical material 
possessing the physical property of sublimation at ambient temperature and 
atmospheric pressure is placed into the void. In conjunction with the 
expansion into gas of the solid sublimation material at atmospheric 
pressure and normal ambient temperature subsequent to the permanent 
adhesion of the lid to the membrane and over the opening of the second 
container, the membrane stretches and expands outwardly from an aperture 
in the lid to produce visible and touchable positive evidence that the 
package has not been tampered with. The membrane is permanently destroyed 
when the lid is removed or when the membrane is punctured, cut or 
otherwise ruptured in any manner. This physical indicia remains in tact 
for at least the shelf life of the article, unless tampering occurs. A 
releasably attachable clear cover may also be provided over the lid to 
provide resistance against mischievous destruction of the membrane. 
It is therefore an object of this invention to provide a package for 
articles which will give clear, quick and reliable evidence of intrusion 
into the package even by small objects such as extremely fine hypodermic 
needles. 
It is another object of this invention to provide a package for drugs, 
medicines, pills, capsules and the like which is inexpensive and reliable 
to manufacture. 
It is another object of this invention to provide a package which will 
indicate by both touch and sight in virtually total reliable fashion that 
tampering with the contents has occurred. 
It is another object of this invention to provide a package which will have 
a useful shelf life for the tamper-evident features which will reliably 
last at least as long as that of the articles contained therein. 
It is another object of this invention to provide a package which includes 
means for resisting mischievous destruction of the tamper-evident features 
.

DETAILED DESCRIPTION OF THE INVENTION 
Referring now to the drawings, the invention is designated generally by 
numeral 10 and includes an outer container 12 and an inner container 34. 
This inner container 34 includes articles to be protected therein, here 
shown in FIG. 1 as pharmaceutical capsules P. The articles P to be 
protected may also be medicines, pills, and various other articles. Inner 
container 34 includes cap 36 which has been secured thereunto to provide a 
sealed environment for the articles P. Both inner and outer containers 34 
and 12 have circular cross sections in the preferred embodiment. 
The inner and outer containers 34 and 12 may be fabricated of a suitable 
molded plastic material and the cap 36, in addition to having a 
conventional mechanical sealable attachment thereto, may also include 
means for hermetic sealing of the entire inner container 34. 
The outer container 12 is sized such that a void 32 exists between the 
outer walls of the inner container 34 and the inner walls of the outer 
container 12. This void is necessary to provide an air or gas space which 
will be pressurized as herebelow described. 
The outer container 12 includes a continuous circular perimeter or opening 
margin 22 having an extended portion 20 and forming an opening 36 for 
container 12. Lid 16 is also provided which is mateable over the opening 
margin 22 and extended portion 20 by flexible snap portion 26. By this 
arrangement then, the cap 16 in a well known manner may be snapped into 
place over the opening margin 22 of container 12. Alternately, cap 12 may 
be engagable onto the opening margin 22 and the adjacent side walls by 
mating threaded portion or the like. 
Positioned between the cap 16 and the open margin 22 of outer container 12 
is an elastic membrane 14. This membrane 14 is fabricated preferrably of 
thin elastomeric material which is totally impervious to the transmittal 
of gas or liquid therethrough. 
After the inner container 34 is placed through opening 36 and into the 
outer container 12, a portion of solid chemical material 18 which 
possesses the physical characteristics of sublimation is deposited into 
the void 32. The property of sublimation as herein described refers to any 
solid material which can pass directly from a solid to a gaseous state at 
ambient temperatures and atmospheric pressure without becoming a liquid. 
The preferred choice for such a solid material is carbon dioxide or "dry 
ice" which sublimates into carbon dioxide, an inert gas with respect to 
the article P and other components of this invention 10. 
After the solid sublimation material 18 is dropped into the void 32, the 
membrane 14 is then, by an adhesive substance applied to the container 
margin 22, permanently adhered over the opening 36 of outer container 12. 
The lid 16 is, then, likewise snapped or screwed over the membrane 14 and 
interlocked over the extended portion 20 of container 12 after an 
additional layer of adhesive is applied along the surface 28. Once the 
membrane 14 and cap 16 are permanently adhered in assembled position as 
shown in FIG. 2, the solid sublimation material 18, then becoming a gas as 
shown at numeral 18', expands to produce a positive pressure in the void 
32. Because the void 32 is now a completely sealed and gas impervious 
volume, pressure rapidly builds within the void 32. 
Lid 16 includes aperture 24, which is, preferrably, centrally located in 
and through the circular lid 16 and, as the expanding solid sublimation 
material 18 becomes a gas 18', pressure is exerted on the inside of 
membrane 14 in the direction of arrows B, producing a bubble or raised 
portion 30 of membrane 14. The amount of the solid sublimation material 18 
is of a predetermined size to produce a suitable amount of gas 18' and 
pressure B such that the membrane 14 will expand at bubble portion 30 out 
of the aperture 24 in cap 16 beyond the outer surface of the cap 16 but 
will not rupture the membrane 14. 
Once the entire package, including the expanded gas 18' has stablized, the 
existence of positive pressure B within the void 32 may be tested or 
evidenced in two ways. First, the bubble portion 30 is viewable as it 
extends through aperture 24. Second, by finger pressure in the direction 
of arrow A as shown, the internal pressure in the void can be increased by 
collapsing the bubble portion 30, as well as providing a positive touch 
response with respect to evidence of tampering. 
This increased pressure caused by the compressure of bubble portion 30, 
provides an additional margin of assurance that tampering has not occured. 
By this increased pressurization means, then, if a devious mind and 
devices not now known to the inventor have penetrated the membrane 14 and 
contaminated the article P, but have somehow done so without leaving a 
hole therethrough sufficient for the pressurized gas 18' to escape, then, 
by increasing that pressure through compression of bubble portion 30, the 
increased pressure should serve to force gas 18' out of the intrusion 
caused breach of the membrane 14, thereby decreasing the size of the 
bubble portion 30 during or after finger pressure release. 
Because lid 16 has been permanently adhered at 28 to the membrane 14, and 
because the membrane 14 has been permanently adhered to the container 
opening margin 22, should a would-be intruder attempt to remove same in 
order to tamper with the articles P, the membrane 14 will be destroyed and 
rendered unuseable, even though the lid 16 may be reattached and appear in 
tact. Nonetheless, the bubble portion 30 caused by the gas pressure at B 
by gas 18' will have been destroyed or released, and no bubble portion 30 
will any longer be viewable or touchable through aperture 24 thereafter. 
To protect the membrane 14 as it protrudes through aperture 24 as the 
bubble portion 30, a clear, disposable cover 38 may also be provided which 
releasably snaps into position over lid 16 in any well known manner. By 
this means, then the visible evidence of tampering remains readily 
available while the feel or touch mode of evidence is also available by 
the simple removal of the cover 38 for finger testing as previously 
described. However, mischievous random distruction of the membrane 14 by 
poking or cutting with a sharp object after the package 10 is placed on 
retail shelves is somewhat thwarted. 
The preferred method for constructing the packaging 10 is as follows. After 
the article has been placed within the first container, that container is 
closed and inserted into a second larger container through its opening. 
The two containers are sized such that there exists a void therebetween. 
Next a portion of solid chemical of predetermined size and possessing the 
physical property of sublimation is placed into the void. The opening of 
the second container is then sealed over by permanent adhesion means with 
an elastic membrane which is impermeable to gas and water. This is 
followed by the releasable attachment of a lid over the opening of the 
second container and the membrane. This releasable interengagement between 
lid and second container opening is by conventional well known mechanical 
means. Additionally, in conjunction with the assembly of the lid onto the 
second container, a second permanent adhesion means is placed between the 
surface of the lid and the membrane. The entire package is then allowed to 
stand for a time sufficient for the solid material to change state into 
gas. This change of state causes a pressurization within the void and, 
thus the membrane expands elastically out through an aperature provided in 
the lid. 
While the instant invention has been shown and described herein in what is 
conceived to be the most practical and preferred embodiment, it is 
recognized that depatures may be made therefrom within the scope of this 
invention, which is therefore not to be limited to the details disclosed 
herein, but is to be accorded the full scope of the claims so as to 
embrace any and all equivalent apparatus and articles.