OF WATER VAPOR AND OXYGEN

FIELD OF THE INVENTION

[0001] The present disclosure relates to a broad field of cold form laminateswith barrier to cross migration in a blister pack. More particularly the present disclosure relates to a cold form laminate with high barrier to cross migration of water vaporandoxygen through sealed area or seam of a blister pack.

BACKGROUND OF THE INVENTION

[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the present invention, or that any publication specifically or implicitly referenced is prior art.

[0003] Cold forming packaging materials with effective barrier properties still remains challenge for pharmaceutical packaging. Over the time migration of water vapors from environment into the pack and eventually into the product can adversely influence the product like pharmaceutical formulation, more specifically active pharmaceutical ingredient (API). To reduce the influence of environment and migration of water vapors and oxygen many approaches have been tried. For moisture sensitive products such as solid formulations of pharmaceutical products, laminates with aluminium as barrier layer are used mainly. When such laminates with aluminium layer are used for blister packaging, one of the risks still remains that renders such packaging ineffective is migration of water vapors through the sealed seam (Figure 1) of the final pack. In order to improve barrier properties laminates with multiple layers are provided comprising of polymeric layers in addition to the aluminium film. With a view to increase barrier, sealing layers are used to provide a better barrier compared with PVC film of 60 or 100 pm (standard for cold form laminate). In such cases increase inthe thickness of barrier layer is considered responsible to get a better barrier. However, despite the use of such multilayer laminatefor cold form blisterpack it is generally observed that after packaging, over a period of time these laminates do not offer adequate barrier to the water vapor and oxygen cross migration. Other approaches attemptedto provide high barrier to humidity and oxygen include incorporating chemical desiccant like calcium carbonate in one of the cavitiesof the blister pack commonly known as “fish bone blister” or integrating desiccant in the sealing layer. However, such approaches require additional machinery, more materials and complex processing making the laminate highly costly.

[0004] Cold form laminatesto overcome such challenges are generally used with much thicker polymeric layer, for example the base laminate comprises of 25 pmof oriented polyamide (oPA)film, 40 to 80 pmaluminium, adhesive about 4 pm, 60 or 100 pm PVC and the same is sealed with lid foil of hard or soft temper aluminiumwith lacquer coating with minimum total thickness of about 28 pm for push through and peel/peel-push with 91 - 96 pm thickness, and 5.6pm heat seal lacquer. Such cold form laminates are provided with a view to prevent failure or deformities during sealing and forming, such as pinholes or crack in the formed cold form film laminate.

[0005] However, such cold form laminate is notfound to ensure protection against migration of humidity and oxygenthrough the land areathat is adistance from edge of blister pack to beginning of cavity, or in case of no secure sealing could be afforded during the sealing with such cold form laminateallowing entry of humidity and oxygen into the cavity and therebyadversely impacting shelf life of the packed product. Thus, there exists an unmet demand to provide packaging materials like cold form laminates with high barrier to cross migration of water vapor and reduced ingress of oxygen through sealed seam of an Alu- Alublister pack.

OBJECTS OF THE INVENTION

[0006] It is an object of the present disclosure to provide a cold form laminate with high barrier to cross migration of water vapor and reduced ingress of oxygen through sealed seam of a blister pack.

[0007] It is a further object of the present disclosure to provide a cold form laminate comprising an oriented polymeric film;double layers ofaluminium foils ;and a heat seal layer to provide a cold form laminate withhigh barrier to cross migration of water vapor and oxygen through sealed area into cavities when formed into a blister pack.

[0008] It is a further object of the present disclosure to provide a cold form laminate comprising of an oriented polymeric film; twoaluminium foils; and a heat seal layer to provide barrier to cross migration of water vapor and ingress of oxygen through sealed area into cavities when formed into a blister pack.

[0009] It is a further object of the present disclosure to provide a cold form laminate comprising of an oriented polymeric film; a first aluminium foil; a secondaluminium foil; a heat seal layer; and optionally a polymeric film between one or both of, the oriented polymeric filmand the first aluminium foil, and the first aluminium foil and the second aluminium foil.

SUMMARY OF THE INVENTION'

[0010] Accordingly, in a general aspect the present disclosure provides a cold form laminate with high barrier to cross migration of water vapor and oxygen through sealed seam and sealed area when formed into a blister pack.

[0011] In an aspect the present disclosure provides a cold form laminate comprising an additional aluminium foil to the standard cold form laminate known in the art (Fig. 1) and with reduced overall thicknessof the sealing layerto provide high barrier to cross migration of water vapor and oxygen through sealed seam and sealed area into cavities when formed into a blister pack.

[0012] In one aspect the present disclosure provides a cold form laminate comprising of an oriented polymeric film; two aluminium foils; and a heat seal layerto provide high barrier to cross migration of water vapor and oxygen through sealed seam and sealed area into cavities when formed into a blister pack.

[0013] In one aspect the present disclosure provides a cold form laminate with high barrier to cross migration of water vapor and oxygen, said cold form laminate comprising an oriented polymeric film; a first aluminium foil; a second aluminium foil; and a heat seal layer.

[0014] In one aspect the present disclosure provides a cold form laminate comprising an oriented polymeric film; a first aluminium foil; a second aluminium foil; a heat seal layer;and one or more layer(s)of an adhesive layer, a coating layer, a tie layer anda lacquer layer disposed in between each of the oriented polymeric film, the first aluminium foil, and the second aluminium foil.

[0015] In one aspect the present disclosure provides a cold form laminate comprising an oriented polymeric film; a first aluminium foil; a second aluminium foil; a heat seal layer; and an optional polymeric film(s) positioned between the oriented polymeric film and the first aluminium foil, or the first aluminium foil and the second aluminium foil, or at both the positions.

[0016] In one aspect the present disclosure provides a cold form laminate comprising an oriented polymeric film; a first aluminium foil; a second aluminium foil; a heat seal layer;optional polymeric film(s); and one or more layer(s)of an adhesive layer, a coating layer, a tie layer anda lacquer layer disposed in between each of the oriented polymeric film, the first aluminium foil, the second aluminium foil, and optional polymeric film(s).

[0017] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments.

BRIEF DESCRIPTION OF DRAWINGS THE INVENTION

[0018] The following drawings form part of the present specification and are included to further illustrate aspects of the present disclosure. The disclosure may be better understood by reference to the drawings in combination with the detailed description of the specific embodiments presented herein.

[0019] Figure 1: It is representative cross-sectional view of a conventional blister pack 100 showing a passage or cross migration of water vapor and ingress of oxygen through the laminate in the cavity area 120, over the cavity area 130, and across the sealed seam 140 when the blister pack is made froma conventional cold form laminate 110.

[0020] Figure 2 is Table 1 showing exemplary construction of cold form laminate with high barrier to cross migration of water vapor and oxygen in accordance with the present disclosure comprisingtwo aluminium foils.

[0021] Figure 3: Figures 3a-3f are Tables 2-7 showing exemplary constructions of cold form laminate with high barrier to cross migration of water vapor and oxygen in accordance with the present disclosure with two aluminium foils; and a single coating layer (Fig. 3a), two coating layers in combination with different arrangements of adhesive and lacquer layers(Fig. 3b-3d), two coating layers in combination with different arrangements of tie layers, an adhesive layer and a lacquer layer.

[0022] Figure 4: Figures 4a-4c are Tables 8-10 showing exemplary constructions of cold form laminate with high barrier to cross migration of water vapor and oxygen in accordance with the present disclosure with two layers of aluminium foil; and a single polymeric layer in combination with different arrangements of a polymeric layer, adhesive layers and a lacquer layer (Fig. 4a-4b), and two polymeric layers in combination with adhesive layers and a lacquer layer (Fig. 4c).

[0023] Figure 5: Is a graph showing water vapor transmission rate in gram per cavity per day through a conventional cold form laminate as per Fig. 1 and the cold form laminate as per one of the exemplaryembodiments of the present disclosure. [0024] Figure 6: Is a graph showing oxygen transmission rate in gram per cavity per day through a conventional cold form laminate as per Fig 1 and the cold form laminate as per one of the exemplary embodiments of the present disclosure.

DETAILED DESCRIPTION

[0025] The following is a detailed description of embodiments of the disclosure. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

[0026] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply. [0027] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0028] In some embodiments, the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term “about.”Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment.In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable.The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

[0029] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.

[0030] Unless the context requires otherwise, throughout the specification which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense that is as “including, but not limited to.”

[0031] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein.All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context.The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain embodiments herein is intended merely to better illustrate the invention and does not pose a limitation on the scope of the invention otherwise claimed.No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[0032] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability.

[0033] The description that follows, and the embodiments described therein, is provided by way of illustration of an example, or examples, of particular embodiments of the principles and aspects of the present disclosure. These examples are provided for the purposes of explanation, and not of limitation, of those principles and of the disclosure.

[0034] It should also be appreciated that the present disclosure can be implementedin numerous ways, including as a system, a method or a device. In this specification, these implementations, or any other form that the invention may take, may be referred to as processes. In general, the order of the steps of the disclosed processes may be altered within the scope of the invention. [0035] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.

[0036] The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus, if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.

[0037] Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.

[0038] The term, “water vapors”, “moisture” and “humidity” as used herein interchangeably refers to the moisture content which can be in the surrounding atmosphere on the outside and inside of the cavity/cavities of a blister pack.

[0039] The terms, “oxygen”, “air”, and “gas” are used interchangeably herein and refers to the air, gas or oxygen in the atmosphere as well as inside the cavity/cavities of a blister pack.

[0040] The present disclosure relates to a cold form laminate with high barrier to cross migration of water vapor and reduced ingress of oxygen through sealed seam or sealed area into cavitiesof a formed blister pack.

[0041] The standard known cold forming laminate used conventionally includes 25 pm oriented polyamide (oPA) film, 45 to 80 pmaluminium foil, sealing layer usually made of 60pm or 100 pm PVC film. A1 foil and PVC films are laminated with each other with the help of adhesive usually 3 to 5 pm thick layer. The standard laminate usually has total thickness of sealing layer aboutl08 to 185pm sealed with 5.6 pm thick heat seal lacquer applied on the aluminium of lid foil.Despite such construction, conventional cold forming laminates do not provide desired effective barrierto cross migration to humidity and oxygen. [0042] Accordingly, the present disclosure provides a cold form laminate comprising an additional aluminium foil as compared to the standard cold form laminate known in the art (Fig. 1). The present disclosure provides a cold form laminate with the reduced thickness of sealing layer and with two aluminium foilsto provide high barrier to cross migration of water vapor and oxygen through sealed areasinto cavities when formed into a blister. Such construction is provided to minimize or avoid likelihood of failure during the sealing and cross migration of water vapor or oxygen through sealed seam and sealed areas. The construction of the cold form laminate in accordance with the present disclosure is provided to afford high barrier to cross migration of water vapor and oxygen through pin holes present in the aluminium foil and any cracks that may be formed either during the forming or storage. [0043] In one embodiment the present disclosure provides a cold form laminate comprising of an oriented polymeric film; two aluminium foils; and a heat seal layerto provide high barrier to cross migration of water vapor and oxygen through sealed seam and sealed area into cavities when formed into a blister pack.

[0044] In one embodiment the present disclosure provides a cold form laminate with high barrier to cross migration of water vapor and oxygen, said cold form laminate comprising an oriented polymeric film; a first aluminium foil; a second aluminium foil; and a heat seal layer.

[0045] In one embodiment the present disclosure provides a cold form laminate comprising an oriented polymeric film; a first aluminium foil; a second aluminium foil; a heat seal layer;and one or more layer(s)of an adhesive layer, a coating layer, a tie layer anda lacquer layer disposed in between each of the oriented polymeric film, the first aluminium foil, and the second aluminium foil.

[0046] In one embodiment the present disclosure provides a cold form laminate comprising an oriented polymeric film; a first aluminium foil; a second aluminium foil; a heat seal layer; and an optional polymeric film(s) positioned between the oriented polymeric film and the first aluminium foil, or the first aluminium foil and the second aluminium foil, or at both the positions.

[0047] In one embodiment the present disclosure provides a cold form laminate comprising an oriented polymeric film; a first aluminium foil; a second aluminium foil; a heat seal layer;optional polymeric film(s); and one or more layer(s)of an adhesive layer, a coating layer, a tie layer anda lacquer layer disposed in between each of the oriented polymeric film, the first aluminium foil, the second aluminium foil, and optional polymeric film(s).

[0048] An oriented polymeric film to form the cold form laminate can be selected from oriented film of polyamide, polyester, polypropylene, polyethylene, or the like or the combination thereof. In one embodiment the oriented film used is oriented film of polyamide (oPA). An oriented polymeric film can be biaxial oriented or monoaxial oriented. The biaxially oriented film for example can be biaxially oriented polyamide (BOPA) film, biaxially oriented polypropylene film (BOPP), polyethylene terephthalate (PET), or the like, or combination thereof.

[0049] The cold form laminate with high barrier to cross migration of water vapor and reduced ingress of oxygen comprises the oriented polymeric film, for example, anoriented film of polyamide (oPA) with the thickness of about 15 pm to about 40 pm. In certain embodiments, the oriented film of polyamide (oPA) can be of the thickness of about 15 pm to about 30 pm.

[0050] The aluminium foil used is of aluminium alloy selected from grade 8011, 8111, and 8021 and 8079. The aluminium foil layer used can be of the thickness of from about 4 pm to about 150 pm. The first and second aluminium layer can be from different or the same alloy. The first layer of aluminium foil can be of the thickness ranging from about 20 pm to about 100 pm. In certain embodiments, the first layer of aluminium foil can be of the thickness ranging from about 30 pm to about 80 pm. The second layer of aluminium foil can be of the thickness ranging from about 8 pm to about 80 pm. In certain embodiments, the second layer of aluminium foil can be ofthe thickness ranging from about 10 pm to about 60 pm.

[0051] In one embodiment, the polymeric film can be cast, biaxial oriented or monoaxial oriented, said polymeric film can be selected from the group consisting of polyethylene film, polyethylene terephthalate, cyclic olefin copolymer film, polyacrylonitrile, polylactic acid, polyamide, cyclo-olefinic polymer, cyclo-olefinic copolymer, polyvinyl chloride, polypropylene, polyester, polyvinylidene chloride, poly-chloro-tri-fluoro-ethylene, polylactic acid or the like. The polymeric film can be of the thickness ranging from about6 pm to about 100 pm. In certain embodiments the polymeric film can be of the thickness ranging from about 8pm to about 60 pm.

[0052] The adhesive is used to bond or laminate the two layers of similar or different materials. The adhesive for the adhesive layer isselected from polyethylene-based resin, urethane -based adhesives, olefin-based adhesives, butyl rubber-based adhesives, acrylic resin-based adhesives, polyester resin-based adhesives, epoxy resin-based adhesives and silicone resin-based. The adhesive that may be used in the adhesive layer include polyethylene-based resins in the case of adhering by sandwich lamination, or urethane-based adhesives, olefin-based adhesives, butyl rubber-based adhesives, acrylic resin-based adhesives, polyester resin-based adhesives, epoxy resin-based adhesives and silicone resin- based adhesives in the case of adhering by dry lamination. The adhesive layer can be of the thickness ranging from about 0.4 gsm to about 7 gsm. In certain embodiments, the adhesive layer can be of the thickness ranging from about 2 gsm to about 6 gsm.

[0053] The lacquer can be based on nitro cellulose-, vinyl-, acrylate-, epoxy-, acetate-, polyurethane-, polyester-, latices- resins, or mixture thereof. The lacquer used can be selected from the group consisting of the lacquer is selected from the group consisting of phenoxy resins; blends of copolymers of methacrylic ester, olefins and ethylidennorbornen as binder; blends of polybutylmetacrylate, polybutyl-ethacrylate and acrylic resins as binder; tackifier based on alphamethylstyrene, maleic acid anhydride modified copolymers of vinylacetat and vinylchloride; water-based dispersions based on ethylenevinylacetate, polyvinylidene- chloride, ethylene acrylic acid and metacrylic acid and salts thereof. The lacquer layer can be of the thickness ranging from about 0.2 gsm to about 10 gsm. In certain embodiments, the lacquer layer can be of the thickness ranging from about 0.3 gsm to about 5.0 gsm.

[0054] The coating material may bea layer of a resin or polymeric film. The resin may be for example an ionomer, a thermoplastic resin, an easy peelable resin such as a polyolefin- based polymers or any other resinused to adhere to the aluminium foil to form a laminate, or itcan be in a form adopted in which the aluminium foil is coated with an easy peeling resin. The resin that may be used include polyethylene-based resin, polypropylene -based resin, saturated or unsaturated polyester, ionomers, polyvinyl chloride (PVC), polystyrene, derivatives thereof and mixtures thereof. The polymeric film that may be used as a coating material may include for example polyethylene, polyvinylidene chloride, a polyvinylidene fluoride coating film. The coating film or layer can be of the thickness ranging from about 2 gsm to about 50 gsm. In certain embodiments, the coating layer can be of the thickness ranging from about 5 gsm to about 50gsm. In certain embodiments, the coating layer can be of the thickness ranging from about 10 gsm to about 30 gsm.

[0055] The tie layer is the layer which is applied in between two layers to increase the adhesion between said two layers, especially two layers of dissimilar materials that otherwise would have poor adhesion to each other. The tie layer in accordance with the present disclosurecan be of an ionomer resin, or ethylene-acrylic acid copolymer, in combination with polyethylene. In certain embodiments, the tie layer can be an adhesive layer of polymeric composition for example ethylene/butyl acrylate copolymer composition, or ethylene-butylene -propylene terpolymer layer, ethylene propylene copolymer layer, medium density polyethylene layer. The tie layer can be of the thickness ranging from about 1 gsm to about 50 gsm. In certain embodiments, the coating layer can be of the thickness ranging from about 3 gsm to about 30 gsm. [0056] The heat seal layercan be based on water or organic solvent, solution, suspension, emulsion, dispersion; based on vinyl chloride, vinylidene dichloride, vinyl acetate, acrylate, compatible with the sealing layer of lid foil. The heat seal layer can be a coating of resins, based on poly olefins, ionomers, polyester, vinyl acetate, cyclo-olefinic polymer, with or without a tie layer.The heat seal layer can be a film, based on poly vinyl chloride, poly vinylidene chloride, poly-olefins, polyester, cyclo-olefinic polymer, ionomers, as cast film or oriented film, bonded by adhesive. The combination of heat seal layer from cold form laminate and lid foil can allow opening of the produced blister pack by push through, tearing, peel-push or peel. The heat seal layer can preferably bea heat seal lacqueror coating or filmin the thickness ranging from about 2 gsm to about 45 gsm. In certain embodiments, the heat seal lacquer or coating or film can be in the thickness ranging from about 3 gsm to about30 gsm.

[0057] The cold form laminate may be formed by connecting individual layers for example oriented polymeric layer, aluminium foils, polymeric layer by laminating with solvent-based, solvent-free or aqueous adhesives and/or by extrusion lamination or coated to the other films, foils, and layers with the help of suitable adhesive, lacquer, coating or tie layer to provide the minimum bonding strength of film to foil and film to film (inner and outer side).

[0058] The oriented polymeric film (oPA), the first and second aluminium foils and optional polymeric foils are laminated to each other by means of an application of a layer of an adhesive between the film and foil, or foil and foil, or film and film. In certain embodiment, prior to applying the adhesive on the aluminium foil, a thin layer of lacquer can be applied to bond the aluminium foil with the oriented polymeric film or optional polymeric film to reduce the tendency of delamination of film(s) during and/or after forming. In few embodiments, a layer of a coating material may be applied to the aluminium foil before or after applying the layer of the adhesive or the lacquer to bond the aluminium foil with another aluminium foil or the oriented polymeric film. In certain embodiments two aluminium foils can be bonded together by application of a layer of a coating material and a tie layer. The tie layer can be required for laminating the aluminium foil with the film, especially certain type of film such as non-polar polymeric films.

[0059] In certain embodiments the cold form laminate comprises an oPA, the first aluminium foil; the second aluminium foil; and the heat seal layer; wherein the oriented polymeric film, the first aluminium foil and the second aluminium foil are laminated with each other by application of one or more layers of an adhesive, lacquer, coating material and tie layer. Such cold form laminate can comprise of following construction:

- oPA/adhesive/first aluminium foil/adhesive/second aluminium foil/heat seal layer.

- oPA/adhesive/lacquer/first aluminium foil/adhesive/second aluminium foil/heat seal layer.

- oPA/adhesive/lacquer/first aluminium foil/coating/adhesive/second aluminium foil/heat seal layer.

- oPA/adhesive/coating/first aluminium foil/lacquer/coating/second aluminium foil/heat seal layer.

- oPA/adhesive/coating/lacquer/first aluminium foil/lacquer/coating/second aluminium foil/heat seal layer.

- oPA/adhesive/coating/lacquer/first aluminium foil/coating/adhesive/second aluminium foil/heat seal layer.

- oPA/adhesive/coating/tie/first aluminium foil/tie/coating/second aluminium foil/heat seal layer.

- oPA/adhesive/coating/lacquer/first aluminium foil/tie/coating/second aluminium foil/heat seal layer.

[0060] In certain other embodiments the cold form laminate comprises an oPA, the first aluminium foil; the polymeric film in between the oPA and the first aluminium foil, the first and second aluminium foils, or both; and the heat seal layer; wherein the oriented polymeric film, the first aluminium foil, the second aluminium foil, and polymeric film(s) are laminated with each other by application of one or more layers of an adhesive, and lacquer. Such cold form laminate can comprise of following construction:

- oPA/adhesive/lacquer/first aluminium foil/adhesive/polymeric layer/adhesive/second aluminium foil/heat seal layer.

- oPA/adhesive/polymeric film/adhesive/lacquer/first aluminium foil/adhesive/second aluminium foil/heat seal layer.

- oPA/adhesive/polymeric film/adhesive/lacquer/first aluminium foil/adhesive/polymeric film/adhesive/second aluminium foil/heat seal layer.

[0061] The exemplary constructions of the cold form laminate with specific thickness of individual layers to provide high barrier to cross migration of water vapor and oxygen are shown in Fig. 2, Figs. 3a-3f, and Figs. 4a-4c as represented in Tables 1-10.

[0062] The cold form laminate in accordance with the present disclosure can be usedas a blister base part that may be produced in the known manner. [0063] The cold form laminate in accordance with the present disclosure can be used on flat forming flat sealing machine, rotary forming and flat sealing, rotary forming and rotary sealing, as well as on flat forming rotary sealing machines.

[0064] In some embodiments the present disclosure provides a blister pack formed from the cold form laminate provided in accordance with the present disclosure as a base part for packing of the product, especially those requiring protection from longer exposure of humidity/moisture and gas/air/oxygen, more particularly requiring cross barrier to water vapor and ingress of oxygen. The blister pack further includes lid layer comprising aluminium and a sealing layer. The lid layer comprises of for example aluminium foil with the thickness of about 6 pm to about 60 pm, preferably about 15 pm to 38 pm with minimum 0.5 pm thick heat seal layer of lacquer. Lid foil can be configured to open by tear, push through, rupture, peel, peel push or any suitable mechanism.

[0065] Such blister pack with the cold form laminates provide multifold better cross diffusion barrier to water vapor and also reduce ingress of gases or oxygen, or both as compared to the blister packs with the standard cold form laminateshaving much thicker constructions. At the same time such a blister construction drastically reduces a fast-gaseous migration of substances out of the blisteras needed in some of the products.

[0066] The invention is described in the following by way of examples and with reference to the accompanying drawing.

Example 1A

Blister pack with base made from convention cold form laminate

[0067] A standard blister pack was formed from the typical cold form laminate as a base laminate comprising of 25 pm of oriented polyamide (oPA) film, 40pm aluminium, adhesive about 4 pm, 60 pm PVC and the same was sealed with a lid foil of hard temper proofaluminium28pm with lacquer coating for push through blisterpack with sealing layer of 5.6pm heat seal lacquer. The totalthickness of the blister pack was about 162.6pm Example 1

Blister pack with base made from the cold form laminate in accordance with the present disclosure comprising double layers of aluminium foil

[0068] A blister pack was formed from the cold form laminate in accordance with the present disclosure as per Table 11 as a base laminate and the same was sealed with a lid foil of hard temper proofaluminium28 pm with lacquer coating for push through blisterpack with sealing layer of 5.6pm heat seal lacquer.

Table 11

Example 2

Determination of Water vapor transmission rate and Oxygen transmission rate of cold form laminates of Example 1A and Example 1 [0069] The water vapor transmission rate (WVTR) and oxygen transmission rate (OTR) were studies of the blister packs made from the conventional cold form laminate as per Example 1A and the cold form laminate in accordance with the present disclosure as per Example 1. The WVTR and OTR were determined of the blister packs middle cavities and the edge cavities having distance of 4mm from the edge after 1 year, 2 years, 3 years and 4 years of packaging by calculating the values with a specially developed software. The input data for the transmission of oxygen and humidity were measured with standard test equipment, e.g. from company MOCON and the data were used for the calculation. The results of the WVTR and OTR determination studies are provided in below Table 12 and Table 13 as well as Figure 5 and Figure 6 respectively: Table 12: WVTR results (g/cavity)

Table 13: OTR results (g/cavity)

[0070] As can be seen from the above Tables 12 and 13 and Figs. 5 and 6, it is very clear that the cold form laminate according to the present disclosure was unexpectedly able to provide significantly much higher barrier to the cross migration of the water vapor transmission and ingress of oxygen over longer duration of over four years as compared to the conventional cold form laminate.

[0071] While the foregoing describes various embodiments of the disclosure, other and further embodiments of the disclosure may be devised without departing from the basic scope thereof. The scope of the disclosure is determined by the claims that follow. The disclosure is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.