Method of packaging pharmaceuticals

Package making – Methods – Forming a cover adjunct or application of a cover adjunct to...

Reexamination Certificate

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Details

C053S422000, C053S489000, C053S490000

Reexamination Certificate

active

06240708

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates to pharmaceutical containers. In the pharmaceutical industry, containers have been used to store medication for prescription medicine and over-the-counter medicine.
Heretofore, a typical pill container typically included a wad of cotton inserted into the opening of the container because the pills in a typical pill container will not take up all of the space inside of the container. The cotton acts to keep the contents of the container from shifting during shipping and handling of the container, thereby avoiding product disintegration.
After the cotton is inserted into the bottle, a flat top seal is then typically attached to the top rim of the container. The flat top seal serves several functions: it keeps the cotton in the container, it helps keep the contents of the container fresh, and it serves as a security seal. A cap is then placed on the container.
In order to further protect the contents of the container from contamination, either from the environment or from people opening the container to add unwanted substances, a plastic band is typically shrink-wrapped around the cap and the top of the container. The plastic band provides the consumer with a visually perceptible inspection means to determine whether the seal of the container has been broken and the contents of the container have been tainted. The three-step process of filling the empty space in the container with cotton, and adding the two seals, namely the flat top seal and the shrink-wrapped band, is an expensive and relatively lengthy process.
Polymeric bladder type head space fillers have been proposed for pharmaceutical containers for many years, e.g. as in French Patents 1,488,306 and 1,339,263, and U.S. Pat. Nos. 2,880,900, 3,169,654, 3,863,795, 4,215,786, 4,279,351 and 5,096,078. Foil tops with safety seals tabs have been proposed for many years, see e.g. U.S. Pat. Nos. 5,119,964, 5,103,990, 4,697,719 and 4,872,571. However, none of these proposed packaging systems has achieved any common usage in the pharmaceutical packaging field.
Accordingly, a practical, economical packaging system solving the aforementioned disadvantages and having the aforementioned advantages is desired.
SUMMARY OF THE INVENTION
The present invention comprises a method for packaging pharmaceuticals and a container used therein comprising a head space filler with an integral safety seal device. The insert is located in the opening in the top of the container and is formed of a thin sheet of material. The insert includes an annular lip engaging the rim of the container, a body projecting downwardly from the lip into the container and a tab projecting laterally from the lip away from the body of the insert. The body of the insert has a downwardly extending sidewall which diverges away from the sidewall of the container as it progresses downwardly with the sidewall of the body terminating at a bottom wall. The lip of the insert is sealed to the rim of the container. The cap for the container seats over the opening and includes a downwardly depending skirt. The tab of the insert has a first portion that projects downwardly from the rim of the container, between the sidewall of the container and the skirt of the cap.
The principle objects of the present invention are to provide an integral insert for a container assembly that will take the place of cotton in the container. The container assembly also provides evidence of tampering with the seal of the container. Therefore, in one sealing operation, the manufacturer not only seals the top of the filled container, but also provides a space filler which replaces the normal cotton wad. The container is efficient in use, economical to manufacture, capable of a long operable life, and particularly adapted for the proposed use.


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