DESC:FIELD
The present disclosure relates to packaging material, particularly multilayered laminate for making cold formed blister films.
DEFINITIONS
As used in the present disclosure, the following terms are generally intended to have the meaning as set forth below, except to the extent that the context in which they are used indicates otherwise.
MVTR: Moisture vapor transmission rate (MVTR), also water vapor transmission rate (WVTR), is a measure of the passage of water vapor through a substance.
Ingress: The term “ingress” refers to the action or fact of going in or entering; the capacity or right of entrance.
Cold formed foil blisters: Cold formed foil blisters refer to a process of obtaining blisters at ambient temperature. The base comprises a metal layer sandwiched between two polymeric layers. Usually, an aluminum-based laminate film is simply pressed into a mold by means of a stamp. The aluminum layer will be elongated and maintains the formed shape.
BACKGROUND
Blister packaging includes several types of pre-formed plastic packaging used for small consumer goods, foods, and for pharmaceuticals. The blister packaging typically comprises a formable web in which blisters or cavities are formed, and a lidding, which provides a seal once the product to be sealed is placed in the blisters.
Developments in blister packaging material and technology have led to various material and ways of sealing, depending on the required barrier resistance and protection against light. The use of aluminium foil has grown over the past few years, as aluminium provides good protection against vapors as well as light as compared to polymeric based packaging.
Typically, aluminium is laminated as a sandwich between two polymer layers to make it usable for packing unit solid doses in cavities formed in the sandwich laminate. However, the polymer layer coming in contact with the product allows moisture and gas ingress, particularly along the edges, resulting in deterioration of the product. Delamination of the different layers is another problem associated with cold formed blister films.
Therefore, there is felt a need for a film for making cold formed blistered packaging material that overcomes the drawbacks mentioned herein above.
OBJECTS
Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:
An object of the present disclosure is to ameliorate one or more problems of the prior art or to at least provide a useful alternative.
An object of the present disclosure is to provide a multilayered laminate for making cold formed blistered packaging articles.
Another object of the disclosure is to provide a process for preparing a multilayered laminate for making cold formed blistered packaging material.
Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

SUMMARY
The present disclosure relates to a multilayered laminate. The multilayered laminate comprises a barrier polymeric base layer having a thickness in the range of 5 microns to 40 microns, a polymeric support layer having a thickness in the range of 50 microns to 60 microns, a first metallic layer having a thickness in the range of 40 microns to 60 microns, and a second metallic layer having a thickness in the range of 20 microns to 30 microns. Typically, the barrier polymeric base layer is formed on the polymeric support layer, the first metallic layer is formed on the polymeric support layer, and the second metallic layer is formed on the first metallic layer. In one embodiment, the water vapor transmission rate of the multilayered laminate is less than 0.005 mg/day.
The present disclosure further provides a process for preparing a multilayered laminate for making cold formed blistered film. The process comprises coating a barrier polymeric base layer having a thickness in the range of 5 microns to 40 microns to a polymeric support layer having a thickness in the range of 50 microns to 60 microns. A first metallic layer having a thickness in the range of 40 microns to 60 microns is laminated to the polymeric support layer using an acrylic adhesive, and a second metallic layer having a thickness in the range of 20 microns to 30 microns is laminated to the first metallic layer, using an acrylic adhesive, to obtain the multilayered laminate. Typically, acrylic adhesive layers are formed between the first metallic layer and the polymeric support layer, and between the first metallic layer and the second metallic layer, having a thickness in the range of 1 GSM to 15 GSM.
The multilayered laminate of the present disclosure can be used to prepare packages that require high barrier contact layer.

BRIEF DESCRIPTION OF ACCOMPANYING DRAWING
The process of the present disclosure will now be described with the help of the accompanying drawing, in which:
Figures 1a and 2 illustrate the physical appearance of a blister package (containing Orofer tablet) prepared using the multilayered laminate of the present disclosure, after 6M of stability study;
Figure 1b illustrates the physical appearance of Orofer tablet, packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 6M of stability study;
Figure 3 illustrates the physical appearance of a blister package (containing Orofer tablet) prepared using the commercially available Alu Alu pack, after 6M of stability study;
Figures 4a and 5a illustrate the physical appearance of a blister package (containing Orofer tablet) prepared using the multilayered laminate of the present disclosure, after 12M of stability study;
Figure 4b and 5b illustrate the physical appearance of Orofer tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 12M of stability study;
Figure 6a illustrates the physical appearance of a blister package (containing Orofer tablet) prepared using the commercially available Alu Alu pack, after 12M of stability study;
Figure 6b illustrates the physical appearance of Orofer tablet packaged inside a blister package prepared using commercially available Alu Alu pack, after 12M of stability study;
Figures 7a and 8a illustrate the physical appearance of a blister package (containing Ferium tablet) prepared using the multilayered laminate of the present disclosure, after 6M of stability study;
Figures 7b and 8b illustrate the physical appearance of Ferium tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 6M of stability study;
Figures 9a and 10a illustrate the physical appearance of a blister package (containing Ferium tablet) prepared using multilayered laminate without the coating of PVdC, after 6M of stability study;
Figures 9b and 10b illustrate the physical appearance of Ferium tablet packaged inside a blister package prepared using the multilayered laminate multilayered laminate without the coating of PVdC, after 6M of stability study;
Figures 11a and 12a illustrate the physical appearance of a blister package (containing Korandil tablet) prepared using the multilayered laminate of the present disclosure, after 6M of stability study;
Figures 11b and 12b illustrate the physical appearance of Korandil tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 6M of stability study;
Figures 11c and 12c illustrate the graphical representation of the % weight gain of the blister packages (containing Korandil tablet) prepared using the multilayered laminate of the present disclosure, after 6M of stability study;
Figure 13a illustrates the physical appearance of a blister package (containing Korandil tablet) prepared using the commercially available desiccant blister pack, after 6M of stability study;
Figure 13b illustrates the physical appearance of Korandil tablet packaged inside a blister package prepared using commercially available desiccant blister pack, after 6M of stability study;
Figure 13c illustrates the graphical representation of the % weight gain of the blister package (containing Korandil tablet) prepared using commercially available desiccant blister pack, after 6M of stability study;
Figures 14a and 15a illustrate the physical appearance of a blister package (containing Korandil tablet) prepared using the multilayered laminate of the present disclosure, after 12M of stability study;
Figures 14b and 15b illustrate the physical appearance of Korandil tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 6M of stability study;
Figures 14c and 15c illustrate the graphical representation of the % weight gain of the blister packages (containing Korandil tablet) prepared using the multilayered laminate of the present disclosure, after 12M of stability study;
Figure 16a illustrates the physical appearance of a blister package (containing Korandil tablet) prepared using the commercially available desiccant blister pack, after 12M of stability study;
Figure 16b illustrates the physical appearance of Korandil tablet packaged inside a blister package prepared using commercially available desiccant blister pack, after 12M of stability study;
Figure 16c illustrates the graphical representation of the % weight gain of the blister package (containing Korandil tablet) prepared using commercially available desiccant blister pack, after 6M of stability study;
Figure 17a illustrates the physical appearance of a blister package (containing Olmesartan + Amlodipine + Hydrochlorthiazide tablet) prepared using the multilayered laminate of the present disclosure, after 6M of stability study;
Figures 17b and 17c illustrate the physical appearance of Olmesartan + Amlodipine + Hydrochlorthiazide tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 6M of stability study;
Figure 18a illustrates the physical appearance of a blister package (containing Olmesartan + Amlodipine + Hydrochlorthiazide tablet) prepared using the multilayered laminate of the present disclosure, after 12M of stability study;
Figures 18b and 18c illustrate the physical appearance of Olmesartan + Amlodipine + Hydrochlorthiazide tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 12M of stability study;
Figures 19a and 19b illustrate the physical appearance of the Becusule capsule powder packaged inside blister packages prepared using the multilayered laminate of the present disclosure, after 6M of stability study;
Figure 19c illustrates the physical appearance of the Becusule capsule powder in a commercially available pack, after 6M of stability study;
Figures 20a and 20b illustrate the physical appearance of the Becusule capsule powder packaged inside blister packages prepared using the multilayered laminate of the present disclosure, after 12M of stability study;
Figure 20c illustrates the physical appearance of the Becusule capsule powder in a commercially available pack, after 12M of stability study;
Figures 21a and 22a illustrate the physical appearance of a blister package (containing of Amoxicillin + Potassium Clavulanate tablet) prepared using the commercially available desiccant blister pack, after 6M of stability study;
Figures 21b and 22b illustrate the physical appearance of Amoxicillin + Potassium Clavulanate tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 6M of stability study;
Figures 23a and 24a illustrate the physical appearance of a blister package (containing Clavulanic Acid) prepared using the commercially available desiccant blister pack, after 6M of stability study;
Figures 23b and 24b illustrate the physical appearance of Clavulanic Acid tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 6M of stability study;
Figures 25a and 26a illustrate the physical appearance of a blister package (containing Clavulanic Acid) prepared using the commercially available desiccant blister pack, after 12M of stability study;
Figures 25b and 26b illustrate the physical appearance of Clavulanic Acid tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 12M of stability study;
Figure 27a illustrates the physical appearance of a blister package (containing Pulmocef CV 500 tablet) prepared using the commercially available desiccant blister pack, after 6M of stability study; and
Figure 27b illustrates the physical appearance of Pulmocef CV 500 tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 6M of stability study.
DETAILED DESCRIPTION
Typically, the aluminium foil for making cold formed blistered packaging material comprises three layers: an inner layer in contact with the product, made of polyvinyl chloride (PVC) having a thickness in the range of 50 microns to 60 microns, an intermediate sandwiched layer of aluminium having a thickness in the range of 40 microns to 60 microns and an outer layer made of nylon having a thickness in the range of 20 microns to 30 microns.
In case of cold forming, an aluminum-based laminate film is simply pressed into a blister forming mold by means of a stamp. The aluminum layer will be elongated and maintains the formed blister shape. In the industry these blisters are called cold formed foil (CFF) blisters.
The principal advantage of cold formed foil blisters is that the use of aluminum offers a near complete barrier for water and oxygen, allowing an extended product expiry date. Further, as aluminium is fully opaque, the packaging material provides good light shielding properties.
However, when aluminium is sandwiched between two polymers, to make it suitable for packing unit sold dose in cavity form, the polymer layer that comes in contact with the product allows moisture and gas ingress, particularly along the edges. The ingress causes deterioration of the sensitive formulation present inside. One way to prevent moisture absorption by the sensitive formulation is to use a desiccant, which will absorb the moisture. The desiccant can be used either in embedded form or in the form of capsules. However, the desiccants are capable of absorbing moisture only till their saturation level.
Another problem associated with the use of the aluminium foil used in packaging is the delamination of the oriented polyamide (OPA) layer and the aluminium layer, due to the poor moisture barrier of OPA.
The present disclosure envisages a multilayered laminate for making cold formed blistered film that mitigates the aforestated drawbacks. The present disclosure, in an aspect provides a multilayered laminate having a high barrier contact layer by using a coating of polyvinylidene chloride (PVdC) on the PVC layer, such that the PVdC coated surface is in contact with the product. Further, the moisture barrier of the OPA has been enhanced by depositing metal particles.
In an aspect of the present disclosure, there is provided a multilayered laminate for making cold formed blistered film. The multilayered laminate provides absolute barrier against light, moisture and gases and hence can be used to pack sensitive formulations. The multilayered laminate comprises a barrier polymeric base layer, a polymeric support layer, a first metallic layer, and a second metallic layer. The water vapor transmission rate of the multilayered laminate is less than 0.005 mg/day.
The polymeric support layer has a thickness in the range of 5 microns to 40 microns. In one embodiment, the barrier polymeric base layer is polyvinylidene chloride layer. The PVdC layer is in contact with the product.
The barrier polymeric base layer is formed on the polymeric support layer. The polymeric support layer has a thickness in the range of 50 microns to 60 microns. In one embodiment, the polymeric support layer is polyvinyl chloride layer.
The first metallic layer is formed on the polymeric support layer. The first metallic layer has a thickness in the range of 50 microns to 60 microns. In one embodiment, the first metallic layer is aluminum layer.
The second metallic layer is formed on the first metallic layer. The second metallic layer has a thickness in the range of 20 microns to 30 microns. In one embodiment, the second metallic layer is metallized oriented polyamide layer (OPA) made up of aluminium particles. Typically, the average particle size of the aluminium particles is in the range of 0.02 microns to 1 microns. In one embodiment, the metals particles are deposited on the OPA layer before the lamination steps.
Typically, acrylic adhesive layers are formed between the first metallic layer and the polymeric support layer, and between the first metallic layer and the second metallic layer.
In another aspect of the present disclosure there is provided a process for preparing a multilayered laminate for making cold formed blistered film. The multilayered laminate for making cold formed blistered film of the present disclosure is prepared by sequential lamination of the different layers. Typically, two layers of the film of the present disclosure can be laminated using an adhesive. In one embodiment, the adhesive is acrylic based adhesives, such as, pure acrylic adhesives, ester acrylic adhesives, and the like. The process is described hereinafter.
A barrier polymeric base layer having a thickness in the range of 5 microns to 40 microns is coated to a polymeric support layer having a thickness in the range of 50 microns to 60 microns. A first metallic layer having a thickness in the range of 40 microns to 60 microns is laminated to the polymeric support layer. A second metallic layer having a thickness in the range of 20 microns to 30 microns is laminated to the first metallic layer, to obtain the multilayered laminate.
In one embodiment, the barrier polymeric base layer is polyvinylidene chloride layer, the polymeric support layer is polyvinyl chloride layer, the first metallic layer is aluminum layer, and the second metallic layer is metallized oriented polyamide layer (OPA) made up of aluminium particles.
In one embodiment, the step of coating the barrier polymeric base layer to the polymeric support layer is carried out before the laminating steps.
In one embodiment, the step of coating the barrier polymeric base layer to the polymeric support layer is carried out after the laminating steps.
Typically, the PVdC layer is coated on to the PVC layer before forming the cavity in the blister foil.
Adhesives, such as acrylic based adhesives are used to laminate the layers. Typically, acrylic adhesive layers are formed between the first metallic layer and the polymeric support layer, and between the first metallic layer and the second metallic layer, having a thickness in the range of 1 GSM to 15 GSM.
The lamination of the layers can be carried out using dry lamination or wet lamination. A lacquer, containing a color pigment, may be added when dry lamination is carried out.
Typically, during dry lamination the substrate (PVC/ aluminium/ OPA) comes in contact with a gravure roller through an un-winder and then the gravure roller picks up the adhesive/ lacquer from the tray and deposits it on the substrate. The doctoring technique is applied prior to deposition in order to ensure uniform deposition. The lacquered substrate travels through a controlled heating tunnel with a passage length of 5 m to 10 m where it is dried. Typically, a pressure in the range of 5 kg to 8 kg is maintained during the lamination process. The temperature of the nip roller is in the range of 65 °C to 75 °C and the oven temperature is maintained in the range of 140 °C to 180 °C.
The multilayered laminate having a high barrier of the present disclosure can be used to pack sensitive formulations and provides absolute barrier against light, moisture and gases. When moisture sensitive formulations, such as, ferrous fumarate tablets and potassium clavulanate tablets are stored in conventional aluminium foil blister pack, they exhibit blackening of the tablet, also the blister pack are found to be swollen (bulgy), due to reactions taking place as a result of moisture absorption. However, these problems are avoided if the formulations are stored in the multilayered laminate of the present disclosure, due its absolute barrier against moisture.
Use of metallized OPA is effective in stopping the delamination of the OPA layer and the aluminium layer. Further, the metallized OPA adds brightness to the cold formed blistered film and increases the aesthetic value of the finished product and can also help in arresting counterfeiting issues.
The present disclosure further provides a package comprising a blister formed from the multilayered laminate, a product contained within the blister, and a lid sealed on to the blister. The multilayered laminate of the present disclosure can be used to as a packing material for food and pharmaceutical industries to provide absolute barrier against moisture, light and gas, over the shelf life of the product.
The present disclosure is further described in light of the following laboratory scale experiments which are set forth for illustration purpose only and not to be construed for limiting the scope of the disclosure. These laboratory scale experiments can be scaled up to industrial/commercial scale and the results obtained can be extrapolated to industrial/commercial scale.
Experimental details:
The multilayered laminate prepared in accordance with the process of the present disclosure (Nutra Venus), multilayered laminate without the PVdC coating (Venus), and conventional laminate were used for the studies.
Experiment 1: Determination of WVTR of blisters
The WVTR of blisters was determined in accordance with USP <671> containers-Performance Testing, Single Unit containers & Unit dose containers for Capsule & Tablets-Method II.
Methodology: Desiccant tablets were dried at 110 °C for 1 hour in an oven. Blisters were formed by cold forming with Zero size Alu cavity. Sealed blisters were checked for leak test. Sealed 10 desiccant tablets per blister in Nutra Venus with different lid foils (Test pack). Blisters without tablet was sealed and used as control pack. Total 10 blisters, each of test and control pack was sealed. Test pack was weighed individually and control pack as a unit and recorded as initial weights. The test and control packs were stored at 23 ºC (± 2ºC) and 75% Rh (± 3%). After 24 hours, and at each multiple thereof, the packs were removed from the chamber and allowed to equilibrate for about 45 minutes. The weights were recorded for individual packs and returned to the chamber (Test pack). The control packs were weighed as a unit, divided the total weight by the number of control packs to obtain the average weight of the empty packs (Control pack). The procedure was continued up to 28 days from the initial 24-hour equilibration period. The average rate of moisture permeation in mg per day, for each blister in each pack was determined by the formula:
(1 / NX)[(WF – WI) – (CF – CI)]
wherein,
N=Number of days expired in the test period (beginning after the initial 24-hour equilibration period), X=Number of separately sealed units per pack, (WF-WI)=Difference in mg between the final & initial weights of each test pack and(CF-CI)=Difference in mg between the average final & average initial weights of the control packs. The results obtained are summarized in Table-1.
Table-1: WVTR of different Packing Materials exposed to normal environment for three months
S. No. Packing Materials
(Exposed to normal environment for three months) WVTR (mg/day)
1 Commercially available Desiccant Film / Desiccant lid foil 0.15
2 Bilcare Nutra Venus/ Bilcare Zeon C lid foil 0.001
3 Bilcare Nutra Venus / Bilcare Aqua Zeon lid foil 0.002
4 Regular Venus / Bilcare Zeon C lid foil 0.031
5 Regular Venus / Bilcare Zeon C lid foil 0.063
6 Bilcare Vento Venus/ Bilcare Zita lid foil 0.005

It is seen from Table-1 that the WVTR of the mulilayered laminate of the present disclosure is significantly lower that the WVTR of commercially available desiccant film.
value of different cold formed cold form blister (CFB) material with their respective lidding foils. To validate this, commercially available samples from market were selected and compared with the multilayered laminate of the present disclosure.
Experiment 2: Stability study of packages prepared by the multilayered laminate of the present disclosure and conventionally available films
Methodology: Stability study of the pharmaceutical formulation was carried out in accordance with ICH guideline. Pharmaceutical Formulations were packed in required packing materials with optimum sealing temperature and then tested for leak test.
After passing the leak test the packed formulation along with market sample were exposed to International Conference On Harmonisation (ICH) 40 °C / 75% RH (6 months) and LHM 25 °C / 75% RH (12 months) as summarized in Table-2.
Table-2: Testing frequency and conditions
Exposed conditions
ICH Accelerated 40 °C / 75% RH LHM 25 °C / 75% RH
Testing Frequency (Months) 0, 1, 2, 3, 4, 5, 6 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

The formulations were then tested for physical tests, such as appearance, colour, odour, weight gain/loss, disintegration time, hardness, powder flow ability (in case of powder in capsules), gas bulging, and % water content.
Comparative studies of all above applicable tests with market formulation were done for the above time period at the desired frequency, using different formulations. The results obtained are summarized in Tables 3 to 18.
Study of the multilayered laminate of the present disclosure using different lidding materials
a) Orofer XT

Composition:
Ferrous Ascorbate equivalent to elemental iron 100 mg
Folic Acid IP 1.1 mg

The stability study of Orofer tablet in package prepared using the multilayered laminate (Nutra Venus) of the present disclosure with different lidding materials, i.e., Zeon C and Aqua Zeon, and commercially available samples were carried out as per the methodology mentioned above. The results obtained are summarized in Figures 1 to 6, and Tables 3 and 4.
Table-3: Comparison of 6M stability study of Orofer XT
ICH (40°C/75%) Nutra Venus/ Zeon C Nutra Venus/ Aqua Zeon Market sample CFB/Lidding foil
1 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 2
2 Month PC 0, GB 1 PC 0, GB 1 PC 0, GB 2
3 Month PC 0, GB 1 PC 0, GB 1 PC 0, GB 2
4 Month PC 0, GB 1 PC 0, GB 1 PC 0, GB 3
5 Month PC 0, GB 1 PC 0, GB 1 PC 0, GB 3
6 Month PC 0, GB 1 PC 0, GB 1 PC 0, GB 3
PC: Physical change, GB: Gas bulging, 0:No change, 1: Nominal change, 2: Considerable change, 3:Severe change
Table-4: Comparison of 12M stability study of Orofer XT
LHM (25°C/75%) Nutra Venus/ Zeon C Nutra Venus/ Aqua Zeon Market Alu Alu blister
1 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 1
2 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 1
3 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 1
4 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 1
5 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 1
6 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 1
7 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 1
8 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 1
9 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 1
10 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 1
11 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 1
12 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 1

Figures 1a and 2 illustrate the physical appearance of a blister package (containing Orofer tablet) prepared using the multilayered laminate of the present disclosure, after 6M of stability study. Figure 1b illustrates the physical appearance of Orofer tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 6M of stability study. Figure 3 illustrates the physical appearance of a blister package (containing Orofer tablet) prepared using the commercially available Alu Alu pack, after 6M of stability study. Figures 4a and 5a illustrate the physical appearance of a blister package (containing Orofer tablet) prepared using the multilayered laminate of the present disclosure, after 12M of stability study. Figure 4b and 5b illustrate the physical appearance of Orofer tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 12M of stability study. Figure 6a illustrates the physical appearance of a blister package (containing Orofer tablet) prepared using the commercially available Alu Alu pack, after 12M of stability study, and Figure 6b illustrates the physical appearance of Orofer tablet packaged inside a blister package prepared using commercially available Alu Alu pack, after 12M of stability study. It is seen from the Figures 1 to 6 and Tables 3 and 4 that when the multilayered laminate is used, there is no physical change and also the gas bulging is less as compared to the gas bulging observed when commercially available Alu Alu pack was used.
b) Ferium XT
Composition:
Ferrous Ascorbate equivalent to elemental iron 100 mg
Folic Acid IP 1.5 mg

The stability study of Ferium XT tablet in package prepared using the multilayered laminate (Nutra Venus) of the present disclosure with different lidding materials, i.e., Zeon C and Aqua Zeon, and commercially available samples were carried out as per the methodology mentioned above. The results obtained are summarized in Figures 7 to 10 and Tables 5 and 6.
Table-5: Comparison of 6M stability study of Ferium XT
ICH (40°C/75%) Nutra Venus/ Zeon C Nutra Venus/ Aqua Zeon Venus / Zeon C Venus/Zeon (25/7)
1 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 0 PC 0, GB 0
2 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 0 PC 0, GB 0
3 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 0 PC 0, GB 1
4 Month PC 0, GB 1 PC 0, GB 1 PC 2, GB 0 PC 0, GB 1
5 Month PC 0, GB 1 PC 0, GB 1 PC 2, GB 0 PC 0, GB 2
6 Month PC 0, GB 1 PC 0, GB 1 PC 2, GB 0 PC 0, GB 2

Table-6: Comparison of 12M stability study of Ferium XT
LHM (25ºC/75%) Nutra Venus/ Zeon C Nutra Venus/ Aqua Zeon Venus/
Zeon C Venus/Zeon (25/7)
1 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 0 PC 0, GB 0
2 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 0 PC 0, GB 0
3 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 0 PC 0, GB 0
4 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 0 PC 0, GB 0
5 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 0 PC 0, GB 0
6 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 0 PC 0, GB 0
7 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 0 PC 0, GB 0
8 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 0 PC 0, GB 0
9 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 0 PC 0, GB 0
10 Month PC 0, GB 0 PC 0, GB 0 PC 0, GB 0 PC 0, GB 0
11 Month PC 0, GB 0 PC 0, GB 0 PC 1, GB 0 PC 0, GB 0
12 Month PC 0, GB 0 PC 0, GB 0 PC 1, GB 0 PC 0, GB 0

Figures 7a and 8a illustrate the physical appearance of a blister package (containing Ferium tablet) prepared using the multilayered laminate of the present disclosure, after 6M of stability study, and Figures 7b and 8b illustrate the physical appearance of Ferium tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 6M of stability study. Figures 9a and 10a illustrate the physical appearance of a blister package (containing Ferium tablet) prepared using multilayered laminate without the coating of PVdC, after 6M of stability study, and Figures 9b and 10b illustrate the physical appearance of Ferium tablet packaged inside a blister package prepared using the multilayered laminate multilayered laminate without the coating of PVdC, after 6M of stability study. It is seen from Figures 7 to 10 and Tables 5 and 6 that there is no change in the physical appearance in the blister pack when the multilayered laminate of the present disclosure is used.
c) Korandil tablet
Composition:
Nicorandil IP 5 mg
The stability study of Korandil tablet in package prepared using the multilayered laminate (Nutra Venus) of the present disclosure with different lidding materials, i.e., Zeon C and Aqua Zeon, and commercially available samples were carried out as per the methodology mentioned above. The results obtained are summarized in Figures 11 to 16 and Tables 7 and 8.
Table-7: Comparison of 6M stability study of Korandil tablet
ICH (40°C/75%) Nutra Venus/ Zeon C Nutra Venus/ AQUA ZEON (25/5) Market Desiccant blister
Initial Wt of blister: 2.0003 g
Wt of tablet: 94.4 mg Wt of blister: 1.9932 g
Wt of tablet: 94.4 mg Wt of blister: 0.8572 g
Wt of tablet: 94.4 mg
1 Month PC 0, GB 0
Wt of blister: 2.0022 g
Wt of tablet: 94.0 mg PC 0, GB 0
Wt of blister: 1.9941 g
Wt of tablet: 94.3 mg PC 0, GB 0
Wt of blister: 0.8583 g
Wt of tablet: 94.5 mg
2 Month PC 0, GB 0,
Wt of blister: 2.0031 g
Wt of tablet: 94.4 mg PC 0, GB 0
Wt of blister: 1.9953 g
Wt of tablet: 93.0 mg PC 0, GB 0
Wt of blister: 0.8585 g
Wt of tablet: 93.4 mg
3 Month PC 0, GB 0,
Wt of blister: 2.0045 g
Wt of tablet: 94.6 mg PC 0, GB 0
Wt of blister: 1.9969 g
Wt of tablet: 95.0 mg PC 0, GB 0
Wt of blister: 0.8595 g
Wt of tablet: 93.9 mg
4 Month PC 0, GB 0
Wt of blister: 2.0047 g
Wt of tablet: 94.1 mg PC 0, GB 0
Wt of blister: 1.9971 g
Wt of tablet: 94.9 mg PC 0, GB 0
Wt of blister: 0.8597 g
Wt of tablet: 91.8 mg
5 Month PC 0, GB 0
Wt of blister: 2.0039 g
Wt of tablet: 95.4 mg PC 0, GB 0
Wt of blister: 1.9966 g
Wt of tablet: 94.5 mg PC 0, GB 0
Wt of blister: 0.8600 g
Wt of tablet: 95.0 mg
6 Month PC 0, GB 0
Wt of blister: 2.0046 g
Wt of tablet: 96.0 mg PC 0, GB 0
Wt of blister: 1.9970 g
Wt of tablet: 95.4 mg PC 0, GB 0
Wt of blister: 0.8605 g
Wt of tablet: 95.3mg

Table-8: Comparison of 12M stability study of Korandil tablet

LHM (25°C/75%) Nutra Venus/ Zeon C Nutra Venus/ AQUA ZEON (25/5) Market Desiccant blister
Initial Wt of blister: 2.0228 g
Wt of tablet: 94.4 mg Wt of blister: 2.0097 g
Wt of tablet: 94.4 mg Wt of blister: 0.8368 g
Wt of tablet: 94.4 mg
1 Month PC 0, GB 0
Wt of blister: 2.0232 g
Wt of tablet: 94.6 mg PC 0, GB 0
Wt of blister: 2.0105 g
Wt of tablet: 94.9 mg PC 0, GB 0
Wt of blister: 0.8371 g
Wt of tablet: 94.8 mg
2 Month PC 0, GB 0
Wt of blister: 2.0258 g
Wt of tablet: 96.5 mg PC 0, GB 0
Wt of blister: 2.0122 g
Wt of tablet: 95.2 mg PC 0, GB 0
Wt of blister: 0.8380 g
Wt of tablet: 94.2 mg
3 Month PC 0, GB 0
Wt of blister: 2.0251 g
Wt of tablet: 96.6 mg PC 0, GB 0
Wt of blister: 2.0111 g
Wt of tablet: 94.7 mg PC 0, GB 0
Wt of blister: 0.8382 g
Wt of tablet: 94.6 mg
4 Month PC 0, GB 0
Wt of blister: 2.0255 g
Wt of tablet: 94.7 mg PC 0, GB 0
Wt of blister: 2.0119 g
Wt of tablet: 94.0 mg PC 0, GB 0
Wt of blister: 0.8387 g
Wt of tablet: 92.6 mg
5 Month PC 0, GB 0
Wt of blister: 2.0255 g
Wt of tablet: 96.4 mg PC 0, GB 0
Wt of blister: 2.0117 g
Wt of tablet: 95.5 mg PC 0, GB 0
Wt of blister: 0.8388 g
Wt of tablet: 95.2 mg
6 Month PC 0, GB 0
Wt of blister: 2.0259 g
Wt of tablet: 96.2 mg PC 0, GB 0
Wt of blister: 2.0119 g
Wt of tablet: 94.6 mg PC 0, GB 0
Wt of blister: 0.8389 g
Wt of tablet: 96.4 mg
7 Month PC 0, GB 0
Wt of blister: 2.0257 g
Wt of tablet: 93.0 mg PC 0, GB 0
Wt of blister: 2.0120 g
Wt of tablet: 95.4 mg PC 0, GB 0
Wt of blister: 0.8391 g
Wt of tablet: 94.0 mg
8 Month PC 0, GB 0
Wt of blister: 2.0253 g
Wt of tablet: 94.9 mg PC 0, GB 0
Wt of blister: 2.0116 g
Wt of tablet: 95.9 mg PC 0, GB 0
Wt of blister: 0.8392 g
Wt of tablet: 94.9 mg
9 Month PC 0, GB 0
Wt of blister: 2.0254 g
Wt of tablet: 95.8 mg PC 0, GB 0
Wt of blister: 2.0116 g
Wt of tablet: 94.3 mg PC 0, GB 0
Wt of blister: 0.8391 g
Wt of tablet: 94.7 mg
10 Month PC 0, GB 0
Wt of blister: 2.0254 g
Wt of tablet: 95.8 mg PC 0, GB 0
Wt of blister: 2.0115 g
Wt of tablet: 93.3 mg P PC 0, GB 0
Wt of blister: 0.8393 g
Wt of tablet: 94.2 mg
11 Month PC 0, GB 0
Wt of blister: 2.0256 g
Wt of tablet: 95.0 mg PC 0, GB 0
Wt of blister: 2.0115 g
Wt of tablet: 95.0 mg PC 0, GB 0
Wt of blister: 0.8394 g
Wt of tablet: 94.9 mg
12 Month PC 0, GB 0
Wt of blister: 2.0257 g
Wt of tablet: 95.5 mg PC 0, GB 0
Wt of blister: 2.0118 g
Wt of tablet: 94.0 mg PC 0, GB 0
Wt of blister: 0.8395 g
Wt of tablet: 94.0 mg

Figures 11a and 12a illustrate the physical appearance of a blister package (containing Korandil tablet) prepared using the multilayered laminate of the present disclosure, after 6M of stability study. Figures 11b and 12b illustrate the physical appearance of Korandil tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 6M of stability study. Figures 11c and 12c illustrate the graphical representation of the % weight gain of the blister packages (containing Korandil tablet) prepared using the multilayered laminate of the present disclosure, after 6M of stability study. Figure 13a illustrates the physical appearance of a blister package (containing Korandil tablet) prepared using the commercially available desiccant blister pack, after 6M of stability study. Figure 13b illustrates the physical appearance of Korandil tablet packaged inside a blister package prepared using commercially available desiccant blister pack, after 6M of stability study. Figure 13c illustrates the graphical representation of the % weight gain of the blister package (containing Korandil tablet) prepared using commercially available desiccant blister pack, after 6M of stability study. Figures 14a and 15a illustrate the physical appearance of a blister package (containing Korandil tablet) prepared using the multilayered laminate of the present disclosure, after 12M of stability study. Figures 14b and 15b illustrate the physical appearance of Korandil tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 6M of stability study. Figures 14c and 15c illustrate the graphical representation of the % weight gain of the blister packages (containing Korandil tablet) prepared using the multilayered laminate of the present disclosure, after 12M of stability study. Figure 16a illustrates the physical appearance of a blister package (containing Korandil tablet) prepared using the commercially available desiccant blister pack, after 12M of stability study. Figure 16b illustrates the physical appearance of Korandil tablet packaged inside a blister package prepared using commercially available desiccant blister pack, after 12M of stability study. Figure 16c illustrates the graphical representation of the % weight gain of the blister package (containing Korandil tablet) prepared using commercially available desiccant blister pack, after 6M of stability study. It is seen from Figures 11 to 16 and Tables 7 and 8, that % weight gain of the blister pack prepared using the multilayered laminate of the present disclosure is lower compared to that of the blister pack prepared from commercially available desiccant blister pack.
d) Olmesartan + Amlodipine+ Hydrochlorthiazide
The stability study of Olmesartan + Amlodipine+ Hydrochlorthiazide tablet in package prepared using the multilayered laminate (Nutra Venus) of the present disclosure with the lidding material, i.e., Zeon C, and commercially available samples were carried out as per the methodology mentioned above. The results obtained are summarized in Figures 17 to 18 and Tables 9 to 10.
Table-9: 6M stability study of Olmesartan + Amlodipine+ Hydrochlorthiazide tablet
ICH (40°C/75%) Nutra Venus/ Zeon C
1 Month PC 0, GB 0
2 Month PC 0, GB 0
3 Month PC 0, GB 0
4 Month PC 0, GB 0
5 Month PC 0, GB 0
6 Month PC 0, GB 0

Table-10: 12M stability study of Olmesartan + Amlodipine+ Hydrochlorthiazide tablet

LHM (25°C/75%) Nutra Venus/ Zeon C
1 Month PC 0, GB 0
2 Month PC 0, GB 0
3 Month PC 0, GB 1
4 Month PC 0, GB 1
5 Month PC 0, GB 1
6 Month PC 0, GB 1
7 Month PC 0, GB 1
8 Month PC 0, GB 1
9 Month PC 0, GB 1
10 Month PC 0, GB 1
11 Month PC 0, GB 1
12 Month PC 0, GB 1

Figure 17a illustrates the physical appearance of a blister package (containing Olmesartan + Amlodipine + Hydrochlorthiazide tablet) prepared using the multilayered laminate of the present disclosure, after 6M of stability study. Figures 17b and 17c illustrate the physical appearance of Olmesartan + Amlodipine + Hydrochlorthiazide tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 6M of stability study. Figure 18a illustrates the physical appearance of a blister package (containing Olmesartan + Amlodipine + Hydrochlorthiazide tablet) prepared using the multilayered laminate of the present disclosure, after 12M of stability study. Figures 18b and 18c illustrate the physical appearance of Olmesartan + Amlodipine + Hydrochlorthiazide tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 12M of stability study. It is seen from Figures 17 to 18 and Tables 9 to 10 that there is no change in the physical appearance of blister package prepared using the multilayered laminate of the present disclosure, and also only nominal gas bulging was observed.
e) Becosule Capsule
Composition:
Thiamine Mononitrate IP 10 mg
Riboflavine IP 10 mg
Pyridoxine Hydrochloride IP 3 mg
Vitamin B12 IP (as stablets 1:100) 15 mcg
Niacinamide IP 100 mg
Calcium PaZeon Cothenate IP 50 mg
Foilc Acid IP 1.5 mg
Biotin USP 100 mcg
Ascorbic Acid IP (as coated) 150 mg

The stability study of Becosule Capsule in package prepared using the multilayered laminate (Nutra Venus) of the present disclosure with the lidding material, i.e., Zeon C, and commercially available samples were carried out as per the methodology mentioned above. The results obtained are summarized in Figures 19 to 20 and Tables 11 and 12.
Table-11: 6M stability study of Becosule Capsules
6M ICH
40 °C/75% Rh Becosule Capsule's physical parameters
Sr. No. Physical Parameters? Packing Material? Odor Colour Melting/ Sticking Size Brittleness/ cracking Wt gain/loss Initial single dose wt = 477 mg Bulging
1 Nutra/ Aqua Zeon lid
1 2 1 0 1 471 mg 1
2 Nutra/ Zeon C
1 2 1 0 0 479 mg 1
3 Market pack (Strip)
2 3 3 1 1 490 mg 0

Table-12: 12M stability study of Becosule Capsules
12M LHM 25 °C/75% Rh Becosule Capsule's physical parameters
Sr. No. Physical Parameters? Packing Material? Odour Colour Melting/ Sticking Size Brittleness/ cracking Wt gain/loss Initial single dose wt.= 477 mg Bulging
1 Nutra/ Aqua Zeon lid 0 0 0 0 0 476 0
2 Nutra/ Zeon C 0 0 0 0 0 472 0
3 Market pack (Strip) 0 0 0 0 0 495 0

Figures 19a and 19b illustrate the physical appearance of the Becusule capsule powder packaged inside blister packages prepared using the multilayered laminate of the present disclosure, after 6M of stability study. Figure 19c illustrates the physical appearance of the Becusule capsule powder in a commercially available pack, after 6M of stability study. Figures 20a and 20b illustrate the physical appearance of the Becusule capsule powder packaged inside blister packages prepared using the multilayered laminate of the present disclosure, after 12M of stability study. Figure 20c illustrates the physical appearance of the Becusule capsule powder in a commercially available pack, after 12M of stability study. It is seen from Figures 19 to 20 and Tables 11 and 12 that the changes in the physical parameters of the Becusule capsule powder packaged inside blister packages prepared using the multilayered laminate of the present disclosure, are significantly lower as comapres to that of the commercially available pack.
f) Amoxicillin + Potassium Clavulanate
Composition:
Amoxicillin 500 mg
Potassium Clavulanate 125 mg

The stability study of Amoxicillin + Potassium Clavulanate tablet in package prepared using the multilayered laminate (Nutra Venus) of the present disclosure with the lidding material, i.e., Zeon C, and commercially available samples were carried out as per the methodology mentioned above. The results obtained are summarized in Figures 21 to 22 and Tables 13 and 14.
Table-13: 6M stability study of Amoxicillin + Potassium Clavulanate tablet

ICH (40°C/75%) Nutra Venus/ ZEON C Nutra Venus/ AQUA ZEON (25/5)
1 Month PC 1, GB 1 PC 1, GB 1
2 Month PC 1, GB 1 PC 2, GB 1
3 Month PC 1, GB 1 PC 2, GB 1
4 Month PC 1, GB 1 PC 2, GB 1
5 Month PC 1, GB 1 PC 2, GB 1
6 Month PC 1, GB 1 PC 2, GB 1

Table-14: 12M stability study of Amoxicillin + Potassium Clavulanate tablet
LHM (25°C/75%) Nutra Venus/ ZEON C Nutra Venus/ AQUA ZEON (25/5)
1 Month PC 0, GB 0 PC 0, GB 0
2 Month PC 0, GB 0 PC 0, GB 0
3 Month PC 0, GB 0 PC 0, GB 0
4 Month PC 0, GB 0 PC 0, GB 1
5 Month PC 0, GB 0 PC 0, GB 1
6 Month PC 0, GB 1 PC 0, GB 1
7 Month PC 0, GB 1 PC 0, GB 1
8 Month PC 0, GB 1 PC 0, GB 1
9 Month PC 1, GB 1 PC 0, GB 1
10 Month PC 1, GB 1 PC 1, GB 1
11 Month PC 1, GB 1 PC 1, GB 1
12 Month PC 1, GB 1 PC 1, GB 1

Figures 21a and 22a illustrate the physical appearance of a blister package (containing of Amoxicillin + Potassium Clavulanate tablet) prepared using the commercially available desiccant blister pack, after 6M of stability study. Figures 21b and 22b illustrate the physical appearance of Amoxicillin + Potassium Clavulanate tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 6M of stability study. It is seen from Figures 21 to 22 and Tables 13 and 14 that the physical changes and gas bulging are lower for the Clavulanate tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure.
g) Clavulanic Acid combinations
Gramocef CV 200
Composition:
Cefixime 200 mg
Clavulanic Acid 125 mg

The stability study of Clavulanic Acid tablet in package prepared using the multilayered laminate (Nutra Venus) of the present disclosure with the lidding material, i.e., Zeon C, and commercially available samples were carried out as per the methodology mentioned above. The results obtained are summarized in Figures 23 to 26 and Tables 15 and 16.
Table-15: 6M stability study of Clavulanic Acid tablet
ICH (40°C/75%) Nutra Venus/ ZEON C Nutra Venus/ AQUA ZEON (25/5)
1 Month PC 0, GB 0 PC 0, GB 2
2 Month PC 1, GB 0 PC 1, GB 3
3 Month PC 1, GB 1 PC 1, GB 3
4 Month PC 1, GB 1 PC 1, GB 3
5 Month PC 1, GB 1 PC 1, GB 3
6 Month PC 2, GB 1 PC 2, GB 3

Table-16: 12M stability study of Clavulanic Acid tablet
LHM (25°C/75%) Nutra Venus/ ZEON C Nutra Venus/ AQUA ZEON (25/5)
1 Month PC 0, GB 0 PC 0, GB 1
2 Month PC 0, GB 0 PC 0, GB 1
3 Month PC 1, GB 0 PC 0, GB 1
4 Month PC 1, GB 0 PC 1, GB 1
5 Month PC 1, GB 0 PC 1, GB 1
6 Month PC 1, GB 0 PC 1, GB 1
7 Month PC 1, GB 0 PC 1, GB 1
8 Month PC 1, GB 0 PC 1, GB 2
9 Month PC 1, GB 0 PC 1, GB 2
10 Month PC 1, GB 0 PC 1, GB 2
11 Month PC 1, GB 0 PC 1, GB 2
12 Month PC 1, GB 0 PC 1, GB 2

Figures 23a and 24a illustrate the physical appearance of a blister package (containing Clavulanic Acid) prepared using the commercially available desiccant blister pack, after 6M of stability study. Figures 23b and 24b illustrate the physical appearance of Clavulanic Acid tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 6M of stability study. Figures 25a and 26a illustrate the physical appearance of a blister package (containing Clavulanic Acid) prepared using the commercially available desiccant blister pack, after 12M of stability study. Figures 25b and 26b illustrate the physical appearance of Clavulanic Acid tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 12M of stability study. It is seen from Figures 23 to 26 and Tables 15 and 16 that the blister package prepared using the multilayered laminate of the present disclosure, and using Zeon C as the lidding material are more stable, as compared to use of Aqua Zeon as the lidding material.
h) Pulmocef CV 500
Composition:
Cefuroxime 500 mg
Clavulanic Acid 125 mg
The stability study of Pulmocef CV 500 tablet in package prepared using the multilayered laminate (Nutra Venus) of the present disclosure with the lidding material, i.e., Zeon C, and commercially available samples were carried out as per the methodology mentioned above. The results obtained are summarized in Figure 27 and Tables 17 and 18.

Table-17: 6M stability study of Pulmocef CV 500 tablet
ICH (40°C/75%) Nutra Venus/ ZEON C MSV/ ZEON C
1 Month PC 0, GB 0 PC 0, GB 0
2 Month PC 0, GB 0 PC 0, GB 0
3 Month PC 0, GB 1 PC 0, GB 1
4 Month PC 0, GB 1 PC 2, GB 1
5 Month PC 1, GB 1 PC 2, GB 2
6 Month PC 1, GB 1 PC 2, GB 2

Table-18: 12M stability study of Pulmocef CV 500 tablet
LHM (25°C/75%) Nutra Venus/ ZEON C MSV/ ZEON C
1 Month PC 0, GB 0 PC 0, GB 0
2 Month PC 0, GB 0 PC 0, GB 0
3 Month PC 0, GB 0 PC 0, GB 0
4 Month PC 0, GB 0 PC 0, GB 0
5 Month PC 0, GB 0 PC 0, GB 0
6 Month PC 0, GB 0 PC 0, GB 0
7 Month PC 0, GB 0 PC 1, GB 0
8 Month PC 0, GB 0 PC 1, GB 0
9 Month PC 0, GB 0 PC 1, GB 0
10 Month PC 0, GB 0 PC 1, GB 0
11 Month PC 0, GB 0 PC 1, GB 0
12 Month PC 0, GB 0 PC 1, GB 0

Figure 27a illustrates the physical appearance of a blister package (containing Pulmocef CV 500 tablet) prepared using the commercially available desiccant blister pack, after 6M of stability study. Figure 27b illustrates the physical appearance of Pulmocef CV 500 tablet packaged inside a blister package prepared using the multilayered laminate of the present disclosure, after 6M of stability study. It is seen from Figures 27 and Tables 17 and 18 that there is a nominal change in the physical appearance and gas bulging, when the blister package was prepared using the multilayered laminate of the present disclosure.
TECHNICAL ADVANCEMENTS
The present disclosure described herein above has several technical advantages including, but not limited to, the realization of a cold, formal aluminium film having high barrier against moisture, light and gas.
Throughout this specification the word “comprise”, or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.
The use of the expression “at least” or “at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the invention to achieve one or more of the desired objects or results. While certain embodiments of the inventions have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the inventions. Variations or modifications to the formulation of this invention, within the scope of the invention, may occur to those skilled in the art upon reviewing the disclosure herein. Such variations or modifications are well within the spirit of this invention.
The numerical values given for various physical parameters, dimensions and quantities are only approximate values and it is envisaged that the values higher than the numerical value assigned to the physical parameters, dimensions and quantities fall within the scope of the invention unless there is a statement in the specification to the contrary.
While considerable emphasis has been placed herein on the specific features of the preferred embodiment, it will be appreciated that many additional features can be added and that many changes can be made in the preferred embodiment without departing from the principles of the disclosure. These and other changes in the preferred embodiment of the disclosure 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 disclosure and not as a limitation.
,CLAIMS:1. A multilayered laminate comprising:
- a barrier polymeric base layer having a thickness in the range of 5 microns to 40 microns;
- a polymeric support layer having a thickness in the range of 50 microns to 60 microns;
- a first metallic layer having a thickness in the range of 40 microns to 60 microns; and
- a second metallic layer having a thickness in the range of 20 microns to 30 microns.
2. The multilayered laminate as claimed in claim 1, wherein said barrier polymeric base layer is formed on said polymeric support layer, said first metallic layer is formed on said polymeric support layer, and said second metallic layer is formed on said first metallic layer.
3. The multilayered laminate as claimed in claim 1, wherein said barrier polymeric base layer is polyvinylidene chloride layer, said polymeric support layer is polyvinyl chloride layer, said first metallic layer is aluminum layer, and said second metallic layer is metallized oriented polyamide layer made up of aluminium particles, wherein the average particle size of said aluminium particles is in the range of 0.02 microns to 1 microns.
4. The multilayered laminate as claimed in claim 1, wherein the water vapor transmission rate of said multilayered laminate is less than 0.005 mg/day.
5. The multilayered laminate as claimed in claim 1, wherein acrylic adhesive layers are formed between said first metallic layer and said polymeric support layer, and between said first metallic layer and said second metallic layer.
6. A process for preparing a multilayered laminate for making cold formed blistered film, said process comprising the following steps:
- coating a barrier polymeric base layer having a thickness in the range of 5 microns to 40 microns to a polymeric support layer having a thickness in the range of 50 microns to 60 microns;
- laminating a first metallic layer having a thickness in the range of 40 microns to 60 microns to said polymeric support layer using an acrylic adhesive; and
- laminating a second metallic layer having a thickness in the range of 20 microns to 30 microns to said first metallic layer, using an acrylic adhesive, to obtain said multilayered laminate.
7. The process as claimed in claim 6, wherein acrylic adhesive layers are formed between said first metallic layer and said polymeric support layer, and between said first metallic layer and said second metallic layer, having a thickness in the range of 1 GSM to 15 GSM.
8. The process as claimed in claim 6, wherein said step of coating said barrier polymeric base layer to said polymeric support layer is carried out before the laminating steps.
9. The process as claimed in claim 6, wherein said step of coating said barrier polymeric base layer to said polymeric support layer is carried out after the laminating steps.
10. A package comprising a blister formed from said multilayered laminate as claimed in claim 1, a product contained within said blister, and a lid sealed on to said blister.