FORM-2 THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
PROVISIONAL
Specification
(See section 10 and rule 13)


COLD FORMABLE FILMS
BILCARE LIMITED
an Indian Company
of 1028, Shiroli, Rajgurunagar (Taluka Khed), Pune 410 505,
Maharashtra, India

THE FOLLOWING SPEC IFICATION DESCRIBES THE INVENTION.


This invention relates to cold formable films.
Cold forming process is a manufacturing process in which metal is shaped at ambient temperature to produce metal components with a close tolerance and net shape. Techniques include bending, cold drawing, cold heading, coining extrusion (forward or backward), thread rolling and others, all without removal of material, thus cold forming the component.
A blank of metal is placed within a die and a punch is pressed into the blank to cold" form the part. The blank then takes on the form of the punch and the die. Under extreme pressure, many metals can be formed into new shapes without he;at or cutting. Energy consumption involved in the process is low. Furthermore, it produces little or no waste.
Following are the main types of extrusion that are used.
Forward Extrusion, where the stock piece or billet is pressed into the die by pressure from the punch. The geometries produced range from basic 'T' shapes to conical and stepped radius parts.
Backward Extrusion, where the billet is extruded through the cavity between the punch and die to create a cup or cylindrical shape. These can be single radius shapes or feature stepped or shouldered radii.
Above process is explained for basic metal cold forming process while in case of blister forming process same principle is used with some modifications in the process. In the case of cold forming for blister packaging, an aluminum-based laminate film is simply pressed into a mold by means of a stamp. The aluminum gets elongated and maintains the formed shape. In the industry, these blisters are called cold form foil (CFF)
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blisters. The principal advantage of cold form foil blisters is that the use of aluminum is offering a near complete barrier for water and oxygen, allowing an extended product expiry date.
The principal disadvantages of cold form foil blisters are: the slower speed of production compared to thermoforming; the lack of transparency of the package (a therapy compliance disadvantage); and the larger size of the blister card (aluminum can not be formed with near 90 degree angles).
Because cold-formable foil (CFF) has an elongation percentage of only 15 to 18%, monolayer CFF cannot be formed without cracking. Consequently, the foil is laminated in a sandwich between two polymers. One commonly used structure is OPA/adhesive/aluminum/adhesive/PVC. The structure can be customized to meet specific forming or product contact layer requirements. OPA is used primarily for its forming capabilities.
The OPA enhances the forming process due to its elasticity. As it stretches, it brings the aluminum with it to create the cold-formed cavity. Special grades of aluminum have been developed for cold forming. These are designed to stretch and form more easily than conventional grades. PVC is used for two reasons. First, it has been commonly used as the contact layer and seal-to layer on pharmaceutical blisters. The second reason is that PVC is very stiff, and does not tend to shrink or spring back during cold forming. Once the cold-forming process is complete, the PVC helps the cavity hold its shape.
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Despite the addition of OPA, CFF still has forming limitations. The CFF structure doesn't form easily, so blister cavity designs can't be too sharp or great because the foil will break.
Because curves must be gradual, there is a significant increase in package size when comparing CFF packages with thermoformed packages. The typical draft for the side walls is 50% of the depth at 30° and 50% at 45°. (Thermoformed materials can form well with as little as 3° to 4° drafts on the side walls of the cavities.) As a rule of thumb, the width of the cavities for CFF is three times the depth for the formed part. These requirements may increase material usage by more than 60% in some cases.
In general creation of nonuniform embossed images on cold formable film
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is difficult as film requires typical characteristics that can withstand sudden impact arising during cold forming process and draw along with aluminum foil without breaking the nonuniformed embossed images on the film.
Description of Invention
In the present invention a CFF is produced from Alu-Alu laminates consisting of aluminum foil of thickness between 25-100 microns, preferably 45-65 microns which is sandwiched between two polymeric layer such as oriented polyamide layer (OPA) of thickness between 20-60microns and polyvinyl chloride film of thickness between 20-100 microns. Sandwiching polymeric layers can be replaced by suitable grades of polypropylene (PP), polyester, co-polymers of polyesters, polyethylene (PE), co-polymeb of polystyrene, EVOH, copolymers of nylon. Further, nonuniform embossed image is created on the CFF by laminating existing
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CFF with a nonuniform embossed metallized polymeric film by applying a
special type of tie layer. This tie layer ensure not only proper fixing of
nonuniform embossed polymeric film with CFF, but also helps to withstand
the force arising during the cold forming process.
Nonuniform metallized polymeric film: The structure consist of a polymeric
film consisting of a group of polymers like Polyvinyl Chloride (PVC),
polypropylene (PP), polyethylene (PE), copolymer of polyester, polystyrene
in the thickness between 10-100 microns upon which aluminum metal or
zinc sulphide or silicon dioxide was deposited by vacuum deposition
technique in presence or absence of plasma to achieve thickness of 0.02 to 2
microns. Metallization process is then followed by nonunoformly embossing
a specific image pattern thereon. But before metallization, a special primer
j of thickness 1 -5 microns is applied for ensuring proper bonding of metal
layer on polymeric layer. _
Nonuniform embossed metallized laminate can be formed in two ways. In
one of the methods metallized polymeric film is first laminated to the CFF
with the help of a special adhesive and then the nonuniform embossing
process is; carried out above the metal layer. The process can be called as
i pre-laminate nonuniform metallized polymeric laminate process while in
other process first the metallized polymeric film was underwent the process of nonuniform embossing and then this nonuniform embossed metallized polymeric |film laminated with the CFF. The process can be called as post-laminate nonuniform metallized polymeric laminate process.
A special type of adhesive that has been used for lamination of nonuniform embossed i metallized polymeric film with CFF in the present invention is
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selected form a group of polymers like polyurethane, acrylic polymer, isocyanides and having thickness between 2-8 microns. This special adhesive can also be called as tie layer. Further, CFF structure is also formed by applying adhesives in between OPA and aluminum and aluminum and PVC layers. These adhesives were selected from a group of polymers like polyurethane, isocyanides, and acrylic polymers having thickness between
2-8 microns.
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In one of the embodiments of this invention, an anti-scuffing layer of thickness between 2-8 microns is applied over the nonuniform embossed metal layer.
Further, a coloured multilayered nonuniformed embossed metallized CFF can be prepared by
1) applying colored lacquer on top of the polymeric layer of CFF
2) Applying coloured lacquer on the top of the nonuniform embossed polymeric layer
3) Applying coloured lacquer prior to metallization
4) Selecting a pigmented top polymeric layer of CFF
In yet another embodiment of the invention printed CFF was laminated to nonuniform embossed metallized polymeric layer.
This film is an answer to the current counterfeiting problem in the world. After extensive experimentation and studies the inventors of the present invention have come up with a new innovative packaging solution in the form of cod formable multilayer holographic polymeric film for packaging of pharmaceutical products.
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While considerable emphasis has been placed herein on the specific ingredients of the preferred embodiment, it will be appreciated that many further ingredients can be added and that many changes can be made in the preferred composition without departing from the principles of the invention. These and other changes in the preferred composition of the invention will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation.
Dated this 24th day of June, 2008.

Mohan Dewan
of R.K. Dewan & Co
Applicants' Patent Attorneys
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