FORM - 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
PROVISIONAL
Specification
(See section 10 and rule 13) PHARMACEUTICAL PACKAGING FILMS
BILCARE LIMITED
an Indian Company
of 1028, Shiroli, Rajgurunagar, (Taluka Khed), Pune 411505,
Maharashtra, India

THE FOLLOWING SPEC IFICATION DESCRIBES THE INVENTION.

Field of the invention
This invention relates to pharmaceutical packaging films.
Description of the invention
This invention envisages a pharmaceutical packaging film having a light refractive outer surface, typically a holographic surface.
The use of the film of this invention is to provide a unique identity to the product eventually packed in the package made from the film particularly, a Blister pack, which not only protects the pharmaceutical product from the environment i.e. it acts as a gas and a moisture barrier but, at the same time it also acts as an anti-counterfeit measure. The film envisaged in accordance with this invention is a multi-laminate film having a plurality of layers.
In accordance with one embodiment of the film, the film consists of a
substrate bonded to an upper laminate bearing a refractive surface. The
substrate is typically of a thermo formable polymeric material i.e. one or more
resins selected from the following thermo polymeric resins:
ABS (Acrylonitrile-Butadiene-Styrene), Acrylates (methyl methacrylate,
polymethyl methacrylate), Ethylene Vinyl Alcohol (EVOH), Ethylene-Vinyl
Acetate (EVA), Fluoroplastics (polytetrafluoroethylene (teflon), fluorinated
ethylene-propylene, ethylene tetrafluoroethylene, ethylene
chlorotrifluoroethylne, Polyvinyl fluoride, polyvinylidene fluoride, perfluoroalkoxy tetrafluoroethylene, trifluoroacetaldehyde), Liquid Crystal Polymer (LCP, polyester polymers), polyoxymethylene (POM),
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Polyacrylonitrile (PAN Or Acrylonitrile), Polyamide (PA or Nylon), Polyamide-Imide (PAI, Polyetheretherketone (PEEK)), Polybutylene terephthalate (PBT), Polyethylene Terephthalate (PET), Polycyclohexylene Dimethylene Terephthalate, Polycarbonate (PC), Polyhydroxyalkanoates (PHAs), Polyketone (PK), Polyester, Polyethylene (PE), High density polyethylene (HDPE), Low density polyethylene (LDPE), Linear low density polyethylene (LLDPE), Polyethylene Naphthalate (PEN), Kydex (A Trademarked Acrylic/PVC Alloy), Polyetherimide (PEI), Polyethersulfone (PES), Polyethylenechlorinates (PEC) , Polyimide (PI), Polylactic Acid (PLA), Polymethylpentene (PMP), Polyphenylene Oxide (PPO), Polyphenylene Sulfide (PPS), Polyphthalamide (PPA), Polypropylene (PP), Polypropylene terephthalate (PPT), Polystyrene (PS) , Polyvinyl Chloride (PVC), Polyaryletherketone (PAEK), Polybutadiene (PBD), Polybutylene (PB), Polybutylene naphthalate (PBN), Polyvinyl Fluoride, Polyvinylidene Chloride (PVDC), Polyvinylidene Fluoride, PP+EVA, MMA+styrene, PC+PET, PC+ABS, Ethylene +vinyl acetate, Fluorinated Ethylene-Propylene and the like.
The typical thickness of this substrate layer is between 100 to 1,000 microns.
In accordance with preferred embodiment of the invention, one of the surfaces of the substrate is provided optionally with a metallised layer typically of aluminum or silver. The thickness of the metallised layer is typically between 0.01 micron to 0.5 micron. This substrate layer is joined to the refractive surface bearing layer.
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The refractive surface bearing layer is again of a polymeric material being singly or in combination of resin or resins selected from PVC, CPP, OPP, PET, HDPE, LDPE, MLDPE, LLDPE, and the like. The typical thickness of this polymeric layer is between 15 to 150 microns. On the surface of this polymeric layer, the refractive surface is formed either in the surface itself or on a metallised layer on the surface. The metallised layer formed on this surface for forming the refractive surface is typically in the range of 0.001 to 0.1 micron. The refractive surface is formed typically by any one of the following processes:
Laser treatment, thermal treatment, electron beam treatment, gravure treatment, doctoring, reverse doctoring, and any other suitable process typically used for giving holographic effect on films.
The holographic effect is described hereinafter at the end of the specification.
The two films are joined together by an adhesive system. The typical
adhesive used for joining includes:
1. Hot melt adhesive: Hot melt adhesive compositions contain low molecular
weight thermoplastic resins, mostly ethylene/vinyl acetate copolymer-based
hot melt compositions.
However, the use of these hot melt compositions is limited to a narrow
temperature range, they lose their strength at temperatures as low as about 80
degree C. Hot melt adhesives are based on polyurethane, acrylic, -rubber,
ethylene vinyl acetate, epoxy, polyvinyl acetate and starch and dextrin
chemistry.
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2. Reactive adhesives: Reactive adhesives works by chemical bonding with the surface material. They are applied in thin films; these are less effective as there is a secondary goal of filling gaps between the surfaces.
3. Polyurethane adhesives: Polyurethane adhesives based on polyurethane dispersions are for example, used for the lamination of furniture front panels and automotive interior trim parts, and for the bonding of shoe soles. In these applications, a strong and reliable initial bond strength is essential as the finished parts are often processed further immediately after the bonding process.
4. Acrylic adhesive: Acrylic adhesives have exceptional bonding properties; and new economical pressure sensitive adhesive for films. This adhesive offers excellent starting tack level, high clarity, and medium-high shear: resistance. It also permits initial repositionability, while still developing a strong bond over time.
Soft aluminum foil, coated with aggressive solvent-based acrylic adhesive, provides high peel adhesion and quick stick. It is designed for sealing joints! and seams of foil jacket facings in air conditioning duct work and for fixing1 copper tubing in refrigerators. Acrylic Adhesive bond variety of prepared or unprepared aluminum materials
5. Ethylene vinyl acetate: Ethylene copolymer based hot-melts will present a
very good adhesion on various substrates (such as paper, wood, plastics,
metals) and a broad operating window.
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2,2-bis[4-(amino- phenoxy)phenyl]hexafluropropane lower [alkyl diester of benzophenone tetracarboxylic acid] are excellent adhesives for bonding polyimide films to various substrates including metals, films and the like.
6. Pressure sensitive additives:
Raw materials used for coatings and prostate-specific antigens (PSA) in food
packaging are:
polyvinyl chloride
polyester
acrylic acid copolymers
ethylene vinylacetate copolymers
atactic polypropylene
mineral oil
hydrocarbon resins
styrene isoprene styrene
polyethylene
polyvinlacetate
The adhesive system is applied on the metallised surface of the substrate and, either the refractive surface bearing layer is bonded directly or an intermediate layer of LDPE or MLLDPE or PPE is first adhered on to the metallised surface and the refractive bearing surface is joined thereto. The thickness of the adhesive system may vary between 1 to 40 g/sq.m.
In accordance with the preferred embodiment of the invention, the adhesive system may include a primer coat of urethane or acrylate applied on the metallised surface or a pre-corona treatment of the surface to improve the
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bonding of the adhesive system with the metallised film surface by creating cohesive bonds. The adhesive system is typically applied or provided by gravure processes, doctoring, reverse doctoring or extrusion. The entire coating and joining process of this invention may preferably be carried out in an environment having temperature of about 80 to 175° C and the joining is done by passing a substrate and the refractive surface bearing laminate through pressure rollers of typically 6 kg pressure.
The typical film so formed can be thermoformed to form blister pack having discrete blisters thereon or cold formed with pockets.
The refractive surface may be provided either on the entire surface of the film or specific areas may be masked, particularly, the areas which are required for the blister formation or for the joints between blister packs.
In experiments conducted till date, it has been found that in the process of thermoforming, the refractive surface remains refractive even after the thermoforming and there is no de-lamination. The film so produced is translucent in itself, in its flat as well as thermoformed state.
In a further embodiment, additional barrier layers may be provided on the non-metallised substrate surface for improving gas and moisture barrier properties.
Hologram (Holography)
Method of producing three-dimensional (3-D) images, called holograms, by means of coherent (laser) light. Holography uses a photographic technique
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(involving the splitting of a laser beam into two beams) to produce a picture, or hologram, that contains 3-D information about the object photographed. Some holograms show meaningless patterns in ordinary light and produce a 3-D image only when laser light is projected through them, but reflection holograms produce images when ordinary light is reflected from them (as found on credit cards).
> Types and how to make hologram
1. Transmission hologram
To make a hologram, two coherent light waves and laser light is required. One beam is reflected from the object and carries information about the object (object beam). The other one is a plane wave without information (reference beam). The object and reference beams generate an interference pattern which is recorded in the form of a hologram on a film emulsion. Absolutely stable conditions are required during the exposure of the film. This type of hologram is called transmission hologram because the light passes through the holographic plate. Another characteristic of transmission holograms is that the object beam and the reference beam come in from the same side of the holographic film plate during the exposure.
To reconstruct the holographic image, the hologram is developed and placed in its original position in the reference beam as during recording. If one looks along the reconstructed object beam, a replica of the object can be seen, and as one shifts viewpoints, the object is seen from different perspectives. Thus the object appears to be three-dimensional (3D). The light does not actually pass
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through the image, but only generates a wavefront that makes it appear as though the light had been generated in the position of the object. This image is called virtual image.
In contrast to the virtual image, an image that light has actually passed through is called a real image. The difference between the real image and the virtual image is that the real image can be caught on a screen placed in its plane without additional lenses. The real image is used in the two-step process which really is a hologram of a hologram. The real image is focused just in front of the recorded film plate and so a reflection hologram can be produced.
To get a three dimensional image of the object, we have to recreate the original wavefront. That means that the hologram must be illuminated by a wave like one of the original waves which was used during the exposure.
When the developed film is illuminated, diffraction and interference will give rise to a new wavefront which is quite like the original wavefront. The result is that, it is difficult to see the difference between the object and the image. The image appears to us as though it is formed at a distance behind the film plate.
2. Reflection hologram
During the recording a reflection hologram, the reference beam and the object beam illuminate the film plate on opposite sides. As a consequence, the resolution of the film emulsion must be very high. The recording of reflection holograms needs about 10 to 100 times as much power as for a transmission
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hologram. The result is that the exposure time will be long, and we need an optical arrangement which is multi-stabile.
The interference fringes are formed by standing waves generated when two beams of coherent light traveling in opposite directions interact. The fringes formed are in layers more or less parallel to the surface of the emulsion, and these sheets are roughly one half-wavelength apart. Under these circumstances, Bragg diffraction is the controlling phenomenon in image formation. The diffraction efficiency can be very high and in certain types of hologram it can approach 100 %. In addition, we can replay the hologram using white light. A reflection hologram reflects light only within a narrow band of wavelength, so if we illuminate it with a highly directed beam of white light such as is given by a spotlight or light from the sun, the hologram will select the appropriate band of wavelengths to reconstruct the image, the remainder of the light passing straight through. In the work with the 3-D printer we concluded, however, that this one step method is not practical.
As already mentioned, another common method to make a reflection hologram is to use two steps in the production, called a two-step reflection hologram. First we make a transmission hologram called HI, because it is the first hologram or a master hologram. Sometimes the HI is the master hologram from which we make multiple copies. A high quality transmission hologram is often used as a master hologram. Transfer copies (making another hologram using the image on the master as the subject) can be made in quantity from the master. These transfer holograms can either be other laser-visible transmission holograms or reflection holograms H2.
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Historically, one of the big problems that holographers used to have was placing the object to be holographed exactly where they wanted it. For example, we want the object in the final hologram to appear half in front and half behind the recording plate. The way in which we have to do this is to first make a transmission hologram. We call this HI because it is our first hologram. Now, since we can make a hologram of the H1's image, we take; time to move the image around to wherever we want it positioned. In this case, we adjust the H2 recording plate so that the image of the object is half in front and half behind the plate and then make our H2. The problem of getting half the object in front of the plate, and half behind, is solved.
3. Rainbow hologram
The rainbow hologram separates out components wavelengths of white light and sends them in different directions, so that the viewer sees the image by light of only one wavelength, the actual wavelength being determined by the viewpoint. In order to achieve this, the hologram contains a plain diffraction grating which disperses the light into a vertical spectrum with red at the top and violet at the bottom. This diffraction grating is produced in the transfer process, and takes the place of the vertical parallax. So when we .view a rainbow hologram at average height the image appears yellow-green. If we stand a little higher, it changes to orange or red, and if we dip, it becomes blue or violet. In the horizontal plane the image has full parallax, and appears in three dimensions, as does any other type of hologram. We may mention that the concept of two-steps rainbow hologram is practical in the 3-D printer recording process.
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4. Embossed holograms
Embossed holograms are holograms which are mass-produced by taking a shim, or metal negative of the holographic image, and making impressions of the image onto a desired substrate. Foil is probably the most popular due to its low cost. The major drawback of embossed holograms is that they lack depth. It is difficult to obtain a depth of more than 1 inch. There are great advantages with embossed holograms, and there are tricks one can use to get around the problem of depth. For example, since a photograph is 2D and has no depth, it is an ideal subject. Furthermore, there is no reason why can not take several photographs, splice them together in extremely small strips and produce a three-dimensional effect for the viewer.
> Holographic materials
Photographic materials for holography must meet specific requirements. This is essential with very high resolving power, since the dimensions of the structure of the interference pattern to be recorded are usually of the order of magnitude of the wavelength of the light used for exposure. A high speed is also desirable to allow short exposure time. High resolving power and high speed are often incompatible properties, which makes it necessary to arrive at a compromise of the highest possible efficiency. The nature of the subject will determine whether the ideal solution of this problem will be slanted towards high speed or high resolving power. Typical commercially available films used in holography include AGFA-GEVAERT Holotest, and have the number 10 E 75 and 8 E 75 HD. Other materials such as special photo-polymers and photo-resists films may also be used.
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> Developing holography images
The holographic images are developed like any other image, except that the materials used are specials and the techniques vary to some extent. Typically, the silver-halide materials for holography are all of the fine grained type. Such materials require the application of special processing techniques to achieve the best possible results. Therefore, a great deal of research has gone into the problem of processing methods of holographic silver-halide emulsions. Special built holographic printers are also available for large-scale commercial printing. The advanced holography techniques involve preparation of stereogram.
While considerable emphasis has been placed herein on the specific structure of the preferred embodiment, it will be appreciated that many alterations can be made and that many modifications can be made in the preferred embodiment without departing from the principles of the invention. These and other changes in the preferred embodiment as well as other embodiments 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 12th day of April 2007.

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