Special receptacle or package – For ampule – capsule – pellet – or granule – With indicia or indicator
Reexamination Certificate
2001-09-13
2004-06-22
Fidei, David T. (Department: 3728)
Special receptacle or package
For ampule, capsule, pellet, or granule
With indicia or indicator
C206S528000, C206S232000
Reexamination Certificate
active
06752272
ABSTRACT:
The invention relates to a paperboard package for containing unit dose materials, the unit doses being encapsulated on an internal slide card within an outer sleeve. In its broadest aspect, the package blank is formed with an extra panel which, when folded, forms a pocket for holding a loose insert. The construction allows the insert to be placed within the pocket during machine folding of the package. The package may also include features that render it suitable for packaging unit doses while meeting regulatory criteria for child resistance by the inclusion of a pull-out mechanism comprised of offset notches for withdrawing the internal slide card from the outer sleeve, in combination with a false bottom that provides additional support to the outer sleeve, and tear resistant lamination of at least a portion of the sleeve.
BACKGROUND OF THE INVENTION
Unit dose packaging is an attractive packaging format for certain pharmaceutical applications because it is convenient, yet sturdy enough to be opened and closed numerous times until the course of medication is completed, and also enables the user to track the consumption of doses according to the prescribed schedule. Examples of such packaging are described in U.S. Pat. No. 6,047,829 (Johnstone), which is commonly assigned with the invention described herein. The Johnstone patent relates to a unit dose paperboard package that includes an outer paperboard sleeve, an inner paperboard slide card that is lockably retained within the sleeve. The sleeve includes a plurality of side panels operatively connected to each other such that one of said plurality of side panels includes a first inner slide card releasing means, and another of said side panels includes a second inner slide card releasing means, such that the inner slide card retaining and releasing means are located substantially adjacent to said unit dose dispensing means.
It is also desirable for a unit dose package to carry product information, dosing instructions or other information. The package surfaces often do not provide enough space that can be printed with all the necessary information. In traditional packaging formats, therefore, a product insert is often included in the package interior or otherwise attached to the package exterior as an outsert.
U.S. Pat. No. 5,820,165 (Verenski) discloses a folding carton with an extension panel, which may be detachable or non-detachable, attached at the edge of the front panel. A brochure or pad is attached, such as by gluing or stapling, between the front panel and this extension panel. The extension panel and the underlying brochure are then held closed by wafer seals adhesively attached to the outside of the extension panel and the box body. In a similar fashion, U.S. Pat. No. 5,433,317 (Roser) discloses a box with an integrated multi-page booklet that is glued, stapled or sewn, and thus protected, beneath an auxiliary flap on the outside of the box. The rear panel of the booklet serves as the point of attachment to the box. U.S. Pat. No. 4,643,301 alternatively discloses a plastic videocassette storage container in which a booklet is inserted inside a pocket exterior to the main compartment of the box. The pocket is formed by a flat plate of stiff plastic material having outwardly projecting flanges along three of its sides. This plate snap-fits onto the bottom wall of the video cassette container and is held in place by a pair of clips.
The foregoing patents demonstrate means for externally attaching a booklet to boxes. However, a means for incorporating literature material into a unit dose package using an external attachment has not previously been contemplated. Such a package should desirably accommodate one or more sheets of printed material, but should also be disposed for folding and forming in a completely automated process. This capacity for automation is favorable because a fully machine-compatible process decreases production costs and increases production efficiency and capacity. In this respect, a package that necessitates gluing, stapling, sewing or any additional steps to fasten the literature material to one or more surfaces of the package, as demonstrated by the prior art patents discussed above, is not preferred.
The invention described herein is an improvement over that described and claimed in U.S. Pat. No. 6,047,829, in that the package is rendered less susceptible to unintentional opening and has improved structural stability. Child resistance is a feature particularly desired for pharmaceutical packaging, and is mandated by the Poison Prevention Packaging Act of 1970. For a desired child resistance (CR) rating of F=1, a random sampling of the subject packages may not be compromised by an age specific test pool of children at a failure rate of greater than 10%. This general guideline is designed to ensure that the package has sufficient integrity against tampering by children. In view of this desired requirement, it is an object of the invention to provide a unit dose packaging system with improved child resistance, which prevents unauthorized access to the package contents.
In addition to child resistance, however, it is also desirable that the unit dose packaging system be senior friendly to permit easy withdrawal of the package contents with minimum manipulation. Such a withdrawal means should be easy to use even if the patient's manual dexterity or strength is reduced. Accordingly, another object of the present invention is to provide a senior friendly package that can be easily manipulated by the user.
The aforementioned objectives and the recognized deficiencies in the prior art with respect to the incorporation of literature materials and the recognized need for a machine-friendly unit dose package having greater capacity to accommodate printed information are met by the packaging system, articles and methods of the present invention, which are described and claimed below.
SUMMARY OF THE INVENTION
The invention broadly comprises an outer paperboard sleeve and an inner paperboard slide card lockably retained within said outer sleeve; the outer sleeve further comprising an external panel having a pocket therein for accommodating a loose insert. The need for greater storage space to house inserts and other printed material such as coupons or promotional materials is also met by the inclusion of this external panel. Advantageously, the exterior panel may be folded to provide the package with a rectangular profile that allows efficient stacking for storage or transport.
In another aspect, the invention additionally meets the needs for child resistance and senior friendliness by providing a unit dose paperboard package having a locking feature that permits the package to be opened and closed during repeat usage, then disposed of when all the unit doses have been consumed. The package comprises an outer sleeve, which may be at least partially laminated to provide tear resistance, said sleeve further comprising an internal structural support formed from a panel extension thereof; an internal slide card, and a foldover panel, which when folded, forms a pocket for housing an insert. In this latter aspect, therefore, the invention comprises:
a) an outer sleeve including a plurality of side panels, a plurality of hinge panels, said side panels and hinge panels being operatively connected to each other; and wherein at least one side panel includes a foldable extension thereof, said extension being folded toward the interior of the sleeve to form a false bottom; and further wherein one of the side panels includes an internal slide card retaining element and a first inner slide card releasing element, and another of said plurality of side panels includes a second inner slide card releasing element; wherein the outer sleeve includes a pair of offset notches for grasping and removing an internal slide card; and wherein the outer sleeve is at least partially laminated with a polymeric film material;
b) a foldable exterior panel hingedly attached to one edge of the outer sleeve, said exterior panel be
Jones Brad A.
Karow Meredith M.
Sasthav Mohan
Drew, Esq. Michael V.
Fidei David T.
Mead Westvaco Corporation
MeadWestvaco Corporation
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