WO2016207918A1

WO2016207918A1 - A laminate structure for blister packaging and a blister package made therefrom

Info

Publication number: WO2016207918A1
Application number: PCT/IN2016/050202
Authority: WO
Inventors: Ashok Chaturvedi
Original assignee: Ashok Chaturvedi
Priority date: 2015-06-26
Filing date: 2016-06-25
Publication date: 2016-12-29

Abstract

A laminate structure for making a blister laminate of a blister package is provided herein. The laminate structure includes a first layer, a second layer and a third layer. Each of the first layer and the third layer include a metallized PET film. The second layer is a multi-layer barrier film including a metallized surface. A lidding is provided to cover the blister laminate to form the blister package.

Description

A LAMINATE STRUCTURE FOR BLISTER PACKAGING AND A BLISTER PACKAGE MADE THEREFROM

Field of the Invention

The present invention relates, in general, to blister packaging of products, and, in particular, to a laminate structure for making such blister packages for pharmaceutical and other products.

Background of the Invention

In packaging of pharmaceutical products such as medicine tablets / capsules for distribution to consumers, blister packages are generally used. One of the important features that the blister packages require is high barrier properties. The products i.e. medicinal tablets / capsules / eatables stored therein are highly sensitive to direct exposure with atmosphere, moisture, sunlight etc. and may get spoiled therefore the blister packages require a high barrier strength.

Generally, these blister packages are formed by thermoforming a resiliently deformable film or laminate structure of polymers or polymers and aluminium. However, cost of making such blister packages is very high because of expensive aluminium foil. Conventionally, Polyvinyl chloride (PVC) sheets, Polyvinylidene chloride (PVDC), APET, PETG sheets were used in forming the blister packages. However, these materials provide limited barrier properties.

Therefore, there exists a need for an improved laminate structure for making blister packages that is easy to manufacture, cost effective and still provide efficient barrier and other desired properties.

Brief Description of the Drawings

The advantages and features of the present invention shall be better understood with reference to the following detailed description taken in conjunction with the accompanying drawings, wherein like elements are identified with like symbols and in which:

FIG. 1 illustrates an exemplary blister package, according to an embodiment of the present invention;

FIG. 2 illustrates an exploded cross sectional view of a formed blister laminate of the blister package of FIG. 1 , according to an exemplary embodiment of the present invention; and

FIG. 3 illustrates a cross sectional view of a lidding for the blister package, according to an embodiment of the present invention.

Like reference numerals refer to like parts throughout the description of several views of the drawings.

Detailed Description of the Invention

For a thorough understanding of the present invention, reference is made to the following detailed description in connection with the above- mentioned drawings. Although the present invention is described with reference to exemplary embodiments, the present invention is not intended to be limited to the specific forms set forth herein. It is understood that various omissions and substitutions of equivalents are contemplated as circumstances may suggest or render expedient, but these are intended to cover the application or implementation without departing from the spirit or scope of the present invention. Further, it will nevertheless be understood that no limitation in the scope of the invention is thereby intended, such alterations and further modifications in the figures and such further applications of the principles of the invention as illustrated herein being contemplated as would normally occur to one skilled in the art to which the invention relates. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. Further, reference herein to "one embodiment" or "an embodiment" means that a particular feature, characteristic, or function described in connection with the embodiment is included in at least one embodiment of the invention. Furthermore, the appearances of such phrase at various places herein are not necessarily all referring to the same embodiment. The terms "a" and "an" herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item.

The present invention relates to a blister package and a laminate structure for making the blister package. FIG. 1 illustrates an exemplary blister package (100) for packaging for example, pharmaceutical products such as medicinal tablets / capsules (106). In various exemplary embodiments, other products that could be stored in the blister package (100) may include chewing gums, jellies, softules or any other product that could be in a tablet form.

The term "blister package" as used herein refers to a pre-formed or pre-configured packaging laminate sheet(s), for example configured as a shallow tray, pre-profiled with multiple localized deep drawn recesses also referred to as compartments or pockets or wells. The individual compartment profile conveniently accommodates the intended content. The rigid / semi rigid pocket walls offer some resistance to impact, but is typically deformable to allow content access by pushing and ejection usually through the lidding.

The term "tablet / capsule" as used herein refers to a solid composition made by compressing and / or moulding a mixture or filling in a preformed enclosure of compositions in a form convenient for swallowing.

According to an embodiment of the present disclosure, the blister package (100) includes a blister laminate (102) having thermoformed recesses (104) for retaining the tablets (106). The blister laminate (102) is further covered with a lidding film (108), hereinafter referred to as the lidding (108). It may be contemplated that the lidding (108) may be attached to the blister laminate (102) by using an adhesive layer (1 10) there between or by heat sealing or by ultrasonic sealing etc.

The blister package (100) may be obtained by thermoforming a thin sheet of multi-layer laminate structure, which is formed to have pre- configured array of multiple discrete recesses (104). The tablets (106) are restrained within the recesses (104) by releasable, removable or tearable lidding (108). In various embodiments of the present invention, the recesses (104) may be 3mm to 10mm deep blister laminated on the size of the tablets (106) to be stored therein.

It may be contemplated that the method of making, shape and size of the blister package (100) is merely exemplary and is not to be construed in a limiting manner. Any other method of manufacturing and / or shape and size of the blister packages (100) known in the art may be used without deviating from the scope of the subject matter. The laminate structure of the blister laminate (102) and the lidding (108) is further described in detail with reference to FIGS. 2 and 3.

FIG. 2 illustrates a cross sectional view of the blister laminate (102) of the blister package (100), according to an embodiment of the present disclosure. The blister laminate (102) is a multi-layer laminate structure including a first polymeric layer (202), a second polymeric film (204) and a third polymeric layer (206). For example, the multi-layer laminate structure of the blister laminate (102) is a metallized polymeric laminate structure.

The first polymeric layer (202), hereinafter referred to as the first layer (202), includes a first surface (208) and a second surface (210). In an exemplary embodiment, the first layer (202) is a polymeric layer comprising a Polyethylene Terephthalate (PET) film (209). It may be contemplated that the PET used as the first layer (202) may be both oriented and / or non-oriented type. In an exemplary embodiment, the thickness of the first layer (202) is within a range of about 18μ to 30μ. Furthermore, the exemplary thickness of the PET film (209) may be within a range of about 22-23μ.

The second surface (210) of the first layer (202) may be metalized (21 1 ) using a metal oxide, such as Aluminium Oxide which is transparent. The metallized surface (21 1 ) of the Polyethylene Terephthalate (PET) film (209) may be reverse printed with text, holographic images, latent images or any other security feature to provide authenticity check of the blister package (100). The transparency of Aluminium oxide metallization (21 1 ) allows clear visibility of reverse printing etc.

According to various other embodiments of the present invention, the first surface (208) of the first layer (202) may be surface printed using one or a combination of the processes such as rotogravure printing, or Flexographic printing or offset printing or screen printing or laser printing or digital printing. It may be contemplated that the surface printing may be done using any other known methods of printing.

Additionally holograms or latent images may be configured with or over the printed surface by cold transfer or hot foil stamping or direct embossing or by cast & cure method or any other method known in the art.

Furthermore, a coating of clear lacquer, or UV or electron beam cured coating may be applied to protect the surface printing on the first surface (208) of the first layer (202).

In case of surface printing on first surface (208), the second surface (210) of the first layer (202) may be metalized (21 1 ) using one of or a combination of metal such as Aluminum, Silver, Gold, Copper, Chrome or opaque metal blister laminated compound such as Magnesium Fluoride, Titanium Dioxide, Tin Tungsten Oxide, Zinc Sulphide and Indium Tin Oxide or any other suitable metal, or its compounds.

The metallized layer (21 1 ) may be formed on the first layer (202) by any known method of metallization such as vacuum deposition, indirect metallization, electro-less plating, electrolytic plating, etc. The metalized PET is inert to water, serves as a moisture barrier and is unaffected by oils, gases, and most aromatics.

According to an embodiment of the present invention, the second polymeric film (204), hereinafter referred to as the second layer (204), is a multi-layer barrier film, essentially comprising a layer of Ethylene vinyl alcohol (EVOH) (213). For example, the second layer (204) may include a 5-layers, 7 layers, or a 9 layers structure. The thickness of the second layer (204) may be within a range of about 40μ to 65μ. In an embodiment of the present invention, the thickness of the second layer (204) is 55μ.

According to an embodiment of the present invention, the second layer (204) is a 9-layer structure having the EVOH layer in the middle. The EVOH in the second layer (204) provides very high barrier properties against moisture, gases, and aroma. The second layer (204) may further include a layer of polyamides (PA) placed on each side of the EVOH layer. Furthermore, the second layer (204) includes a number of layers of Polyethylene (PE) disposed on each sides of the EVOH layer and after the PA layer respectively. The multi-layered structure of the second layer (204) provides strength, increases barrier properties significantly, and subsequently decreases the cost of manufacturing the blister laminate (102) of blister package by eliminating expensive metal foil from the laminate structure, as used conventionally and by reduction in overall laminate thickness without compromising the desired properties of the blister package (100). Although, the second layer (204) is disclosed to be a 9-layer structure comprising EVOH, PA and PE layers, it may be well understood that the total number of layers, the thickness and the materials of the various layers and sequence and configuration may be varied, without deviating from the scope of the present invention. It may be contemplated, that the second layer (204) may further include a number of suitable tie layers provided between the layers of various polymers where the adjacent layers are not compatible for adhesion together.

In a further embodiment of the present invention, the second layer (204) may also include a first surface (212) and a second surface (214). The first surface (212) of the second layer (204) is laminated with the second surface (210) of the first layer (202). In an embodiment of the present invention, the first surface (212) of the second layer (204) is metallized

(215) using one of or a combination of metal such as Aluminum, Silver, Gold, Copper, Chrome or metal blister laminated compound such as Magnesium Fluoride, Titanium Dioxide, Aluminium Oxide, Tin Tungsten Oxide, Zinc Sulphide and Indium Tin Oxide or any other suitable metal, or its compounds.

The blister laminate (102) further includes the third layer (206) configured to be sealed with the lidding (108). The third layer (206) again includes a metallized PET film (217). The PET film (217) is heat sealable and is therefore, capable of getting sealed with the lidding (108) when the blister laminate (102) is covered with lidding (108) to retain the tablet within the recesses (106). In an exemplary embodiment, the third layer (206) further includes a first surface (216) and a second surface (218). The first surface

(216) is metallized (219) using one of or a combination of metal such as Aluminum, Silver, Gold, Copper, Chrome or metal blister laminated compound such as Magnesium Fluoride, Titanium Dioxide, Aluminium Oxide, Tin Tungsten Oxide, Zinc Sulphide and Indium Tin Oxide or any other suitable metal, or its compounds. The metalized surface (219) is laminated with the second surface (214) of the second layer (204).

In an alternative embodiment of the present invention, the second surface (218) of the third layer (206) is not heat sealable and is coated with a VMCH solution vinyl resin, so that the blister laminate (102) becomes sealable with the lidding being presently used in the industry. In various alternative embodiments of the present invention, the VMCH coating may be replaced by any other sealable coating approved for food / medical application. The thickness of the third layer (206) may be within a range of about 35μ to 60μ. In an embodiment of the present disclosure, the thickness of the third layer (206) is 50μ.

Since, the laminate structure of the blister laminate (102) includes metallization, it eliminates usage of pure metal foil, thereby significantly reducing the cost of manufacturing of such laminates. Furthermore, the laminate structure of the blister laminate (102) sufficiently meets the desired WVTR (Water Vapour Transmission Rate) and OTR (Oxygen Transmission Rate) values for pharmaceutical and other products. The laminate structure of the blister laminate (102) of the present invention also has an increased yield as compared to the currently used aluminium foil based blister laminate since density of second layer (204) is much less than the density of Aluminium foil. Furthermore, the metalized laminate structure is easy to recycle compared to the laminate having Aluminium or any other metal foil, thereby making it environment friendly.

According to various alternative embodiments, the PET films (209 and 217) used in the blister laminate (102) may be suitably replaced with one of Oriented or Non-oriented Poly Amide (PA), Poly-vinyl Chloride (PVC), Polypropylene (PP), Polyethylene (PE) or any other suitable polymer. Various examples of the metallized laminate structures of the blister laminate (102) may be as given below where the thickness of each layer is given in numbers as microns and may be varied according to the need without deviating from the scope of the present invention:

PET 25 / multilayer barrier film 55 / PET 50

PA 25 / multilayer barrier film 55 / PVC 60

PA 25 / multilayer barrier film 55 / PA 25

PA 25 / multilayer barrier film 55 / PE 50

PA 25 / multilayer barrier film 55 / PP 60

PA 25 / multilayer barrier film 55 / PVC 100

PA 25 / multilayer barrier film 55 / PA 25

PA 25 / multilayer barrier film 55 / PVC 30

PET 25 / multilayer barrier film 55 / PVC 30

PA 25 / multilayer barrier film 55 / PET 25

PET 25 / multilayer barrier film 55 / PET 25

FIG. 3 illustrates an enlarged cross-sectional view of the lidding (108) configured to be sealed with the blister laminate (102) for covering the blister package (100) and retaining the tablets (106) within.

In an embodiment of the present invention, the lidding (108) includes a metal foil, such as an aluminium foil (302) in desired thickness. The outer surface (304) of the lidding (108) may be surface printed to provide various details of the product packaged therein. For example, the medicine name, composition, manufacturing and expiry dates, warning etc., may be printed on the outer surface of the lidding (108). Further, security features such as holograms, latent images, may also be configured on the outer surface (304) of the lidding (108). In a further embodiment, the surface printing could be protected by applying a transparent coating of clear lacquer, UV or E-beam cured coating, etc.

Furthermore, the lidding (108) may include an inner surface (305) configured to be sealed with the second surface (218) of the third layer (206) of the blister laminate (102). In an exemplary embodiment, a layer of sealable coating (306) such as VMCH, may be applied on the inner surface (305) of the lidding (108). Therefore, the VMCH coating of the lidding (108) is sealable with the VMCH coating on the third layer (206) of the blister laminate (102). In an alternative embodiment, the layer of VMCH coating (306) may be replaced by any other food / medical grade material that may be sealable to the second surface (218) of the third layer (206) of the blister laminate (102). It may be contemplated, that the sealable coating (306) on the inner surface (305) of the lidding (108) may be compatible with the heat sealable PET film (217) or the sealable coating provided on the surface (218) of the blister laminate (102) so as to enable sealing of the lidding (108) with the blister laminate (102) to retain the tablets (106) within the recesses (104).

The foregoing description of specific embodiments of the present invention has been presented for the purposes of illustration and description only. They are not intended to be exhaustive or to limit the present invention to the precise forms disclosed and obviously many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the present invention and its practical application, to thereby enable others skilled in the art to best utilize the present invention and various embodiments with various modifications as are suited to the particular use contemplated. It is understood that various omission and substitutions of equivalents are contemplated as circumstance may suggest or render expedient, but such are intended to cover the application or implementation without departing from the spirit or scope of the present invention.

Claims

I Claim:

1 . A laminate structure for making a blister package, the laminate structure comprising:

a first polymeric layer having at least one metallized surface;

a second polymeric film having a plurality of layers, the second polymeric film having at least one layer of Ethylene vinyl alcohol (EVOH); and

a third polymeric layer having at least one sealable outer surface, such that the sealable outer surface is configured to be attached to a lidding film of the blister package.

2. The laminate structure as claimed in claim 1 , wherein the first polymeric layer includes a Polyethylene Terephthalate (PET) layer.

3. The laminate structure as claimed in claim 1 , wherein the first polymeric layer further comprising:

a. a first surface; and

b. a second metalized surface.

4. The laminate structure as claimed in claim 1 , wherein a thickness of the first polymeric layer is within a range of 18μ to 30μ.

5. The laminate structure as claimed in claim 1 , wherein the metallization of the first polymeric layer is done using aluminium oxide.

6. The laminate structure as claimed in claim 5, wherein the metallized surface of the first polymeric layer is reverse printed.

7. The laminate structure as claimed in claim 1 , wherein a first surface of the first polymeric layer is surface printed and coated with at least one of a clear lacquer coating or UV cured coating or an Electron beam cured coating.

8. The laminate structure as claimed in claim 1 , wherein the second surface (210) of the first layer (202) is metalized (21 1 ) using one of or a combination of metal such as Aluminum, Silver, Gold, Copper, Chrome or opaque metal blister laminated compound such as Magnesium Fluoride, Titanium Dioxide, Tin Tungsten Oxide, Zinc Sulphide and Indium Tin Oxide or any other suitable metal, or its compounds in case of surface printing on first surface (208).

9. The laminate structure as claimed in any of claims 6 or 7, the reverse printing and the surface printing includes at least one of text, latent image, and holograms.

10. The laminate structure as claimed in claim 1 , wherein the second polymeric film includes at least one layer of Poly Amide (PA) provided on each sides of the EVOH layer and at least one layer of Poly Ethylene (PE) provided on the opposite sides of the EVOH layer after the PA layers.

1 1 . The laminate structure as claimed in claim 1 , wherein the second polymeric film is at least one of a 5 layered, 7 layered and 9 layered barrier film structure.

12. The laminate structure as claimed in claim 1 , wherein a thickness of the second polymeric film is within a range of 40μ to 65μ.

13. The laminate structure as claimed in claim 1 , wherein the second polymeric film further includes a first metalized surface configured to be attached to the metallized surface of the first polymeric layer and a second surface.

14. The laminate structure as claimed in claim 1 , wherein the third polymeric layer includes a Polyethylene Terephthalate (PET) layer having an inner metalized surface and the outer surface.

15. The laminate structure as claimed in one of the claims 13 or 14, wherein metallization is done using one of or a combination of metal such as Aluminum, Silver, Gold, Copper, Chrome or opaque metal blister laminated compound such as Magnesium Fluoride, Titanium Dioxide, Tin Tungsten Oxide, Zinc Sulphide and Indium Tin Oxide or any other suitable metal, or its compounds.

16. The laminate structure as claimed in claim 1 , wherein the outer surface of the third polymeric layer is coated with at least one of a VMCH coating and a food / medical grade sealable coating.

17. A blister package comprising:

a base having a plurality of recesses configured to retain a tablet, the base including a laminate structure, the laminate structure including: a first polymeric layer having at least one metallized surface;

a second polymeric film having a plurality of layers, the second polymeric film having at least one layer of Ethylene vinyl alcohol

(EVOH);

a third polymeric layer having at least one sealable outer surface; and a lidding film configured to close the blister package for retaining the tablets within the recesses, wherein the lidding includes an inner surface attached to the sealable outer surface of the third polymeric layer.