Pharmaceutical packaging with separation means

Special receptacle or package – For ampule – capsule – pellet – or granule – With rupture means for access

Reexamination Certificate

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Details

C206S484000, C206S524200, C383S211000

Reexamination Certificate

active

06199698

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to improved packaging, more specifically improved pouches, for pharmaceutical, cosmetic and medical products.
2. Background Art
Currently, pouches on the market for pharmaceutical, cosmetic and medical products are constituted by a front and a back material sealed firmly together all around the perimeter of the pouch. The pouches are made out of laminates known to the art as laminates of metal foils and polymeric films, typically decorated with printing on one or both visible sides of the pouch.
Typical pouch laminate constructions are laminates of polyester films adhering to a metal foil, such as, an aluminum foil, adhering to a sealant layer, typically made out of a polyolefinic material, such as, polyethylene, polypropylene or copolymers thereof.
The polyester film is typically printed on one side. The printing may be buried between the polyester film and the adhesive, known as reverse printing, or may be on the surface of the polyester and exposed to the outside environment, known as surface printing. In many situations the surface printing would require an overlacquer, also known as an overprint varnish, to protect the ink from flaking or scuffing when exposed to the rigors or packaging lines, shipping stresses and consumer misuse.
The pouch constructions, as known in the art, are made out of multiple layers put together with an adhesive. The adhesive may be, although not necessarily, a urethane base or a polyolefinic type like polyethylene and its copolymers. The selection of the layers and the adhesive to adhere the layers together or the heat seal coatings to effect the seals, depend upon the product to be packaged, conditions of use, storage conditions and the barrier requirements needed to protect the product. Moisture, oxygen, light and sometimes other gases can be detrimental to the packaged product, and a protection to such environmental effects is required. In such applications, a metal foil as barrier is often used. In some applications, such barrier is not required, and more cost-effective structures can be used successfully. Such structures would, for instance, be constituted of biaxially oriented polypropylene with a polyolefinic sealant layer, such as, polyethylene, or a laminate of paper and a polymeric sealant could also be used.
The pouch embodiment is fabricated by welding the sealant layer together, thereby constituting an enclosed pocket containing the goods to be packaged. See FIG.
1
.
In certain pharmaceutical applications, such pouch laminate is realized so that the tear resistance of the material is high enough to prevent children from tearing them, and are thereby considered child-resistant. A typical mode of opening for adults is realized by providing the pouch with a notch in the seal area, this notch not extending to the extremity of the pouch. The sealed area needs to be folded over the notch and the pouch torn from the notch in the direction of said notch to tear the pouch open. See
FIGS. 2 and 3
. This sequence of movements is not achievable by children of age less than 51 months and, therefore, the pouch is considered child-resistant.
In the case of pouches used for pharmaceutical products, the United States Food and Drug Administration, as well as similar administrations in other countries, require that each unit or single dose have a complete disclosure of the product content, dosage, side-effects, etc., thereby constantly increasing the surface required to print such vast information with font size readily legible by consumers. Therefore, the pharmaceutical industry and consumers are afflicted by increasing costs of packaging, as the size of these packages increase simply to allow for sufficient print area.
BROAD DESCRIPTION OF THE INVENTION
An object of the invention is to provide improved child-resistant pouches for pharmaceutical, medical, cosmetic and similar products, which provide large surfaces for printing information on without extension of the size of the pouches. Other objects and advantages of the invention are set out herein or are obvious herefrom to those skilled in the art.
The objects and advantages of the invention are achieved by the improved pouches of the invention.
The invention involves a pouch for a pharmaceutical, cosmetic, medical or similar product. The pouch has a structure with a top laminate and a bottom laminate. A pouch enclosure for the product is formed in one portion of the structure. The top laminate and the bottom laminate of the pouch enclosure portion are strongly adhered together in the periphery around the pouch enclosure. A flap portion is formed by the remainder of the structure with a portion of the involved region of the top laminate and a portion of the involved region of the bottom laminate are weakly adhered together and are easily pulled apart. Means for separating the flap portion and the pouch enclosure portion is situated at the interface between the flap portion and the pouch enclosure portion. A notch or slot is located in the strongly adhered periphery of the pouch enclosure portion adjacent to the flap portion. The flap portion is larger than the pouch enclosure portion. Both sides of the top laminate and of the bottom laminate are capable of being printed on. For example, printing can be visibly contained on the inside and outside surfaces of both of the top laminate region and the bottom laminate region of the flap portion.
The invention can also increase the available outer surface for printing on by reducing the size of the pouch enclosure (as compared to the prior art pouch enclosures). In view of this approach, the outer surface area of the flap portion of the invention pouch can be increased up to 50 percent or more.
The invention pouches have the purpose to keep the packaging costs contained within the current situation, thus increasing the total printing surface significantly without increasing the cost of packaging nor adding a secondary package.
Other solutions to achieve the benefit of larger print surfaces are costly, as they involve as discussed above either a bigger package or by adding flaps to packages, including inserts or booklets or by adding expanded-content labels. These add-ons are invariably a source of increased raw material costs and process costs.
The invention achieves such increase in printing surface without adding material and process costs while still providing a child-resistant package.
The main benefit of the pouches of the invention is that it increases the area available for printing information without adding more materials. It takes a current pouch, such as, a sample unit dose pouch or sachet, reduces the size of the cavity while keeping the length and width as originally specified. The balance of the material is used for the information printing on both surfaces, front and back.
When the top and bottom laminate regions of the flap portion have been separated from each other, the top and bottom laminate regions can each individually be easily separated from the pouch enclosure portion.
The means for separating the flap portion from the pouch enclosure portion preferably is a line of perforations aligned along the intersection of the flap portion and the pouch enclosure portion. Preferably a notch or slot is located on each end of the line of perforations and aligned on the longitudinal axis of the line of perforations.
The means for separating the flap portion from the pouch enclosure portion can also be a groove located in the top surface of the top laminate and/or the bottom laminate and aligned along the intersection of the flap portion and the pouch enclosure portion. Preferably a notch or slot is located on each end of the groove line and aligned on the longitudinal axis of the groove or grooves.
The longitudinal axis of the notch or slot in the strongly adhered periphery of the pouch enclosure portion is aligned between 45 and 90 degrees, preferably between 75 and 90 degrees, most preferably 90 degrees, to the intersection between the pouch enclosure portion and

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