WO2007072494A1

WO2007072494A1 - Metallized packaging blister container

Info

Publication number: WO2007072494A1
Application number: PCT/IN2006/000167
Authority: WO
Inventors: Naik Praful Ramchandra; Nair Ajit Sashidharan; Bhandari Mohan Harakchand; Bhardia Rahul; Tilak Ammanabrolu Balgangadhar; Itkar Sachin Chandrashekhar
Original assignee: Naik Praful Ramchandra; Nair Ajit Sashidharan; Bhandari Mohan Harakchand; Bhardia Rahul; Tilak Ammanabrolu Balgangadhar; Itkar Sachin Chandrashekhar
Priority date: 2005-12-23
Filing date: 2006-05-17
Publication date: 2007-06-28
Also published as: WO2007072505A2; WO2007072505A3; AR058743A1; EP1979244A2; MX2008006380A; EP1979244A4; TW200733950A; BRPI0621087A2

Abstract

A multi-layer thermoformed, translucent pharmaceutical and food packaging blister container consisting of a substrate of 100 to 1000 microns thickness of food grade poly vinyl chloride [PVC], and a metallized layer of thickness 0.02 to 0.2 microns provided at least on one side of the said substrate and at least one to 250 microns thick food and pharmaceutical grade polymeric layer provided at least on one side of the substrate, having opacity in the range of between 39 % to 100 % as compared to a non metallized container which allow better visual inspection abilities.

Description

FIELD OF INVENTION

The present invention relates to thermoformed containers.

In particular, this invention relates to a container, at least one of the components of which is thermoformed blister

INTRODUCTION

Articles for retail sale are frequently packaged in "blister pack" packaging. A blister pack consists of a flat backing sheet called as "lid", generally of cardboard, plastic or metal foil; and a plastic "bubble" or "blister" usually called "base", generally of transparent plastic, the backing sheet and blister being joined to form a sealed cavity in which the article for sale rests.

There are in general two kinds of blister packs. Push-through packs:

The lid is made of aluminium foil or an aluminium foil laminate. Aluminium foil is a material of choice for the lids on blister packs, as the thickness of the material used requires relatively little force for it to break. Consequently, the energy for rupture is low as the aluminium is a non-elastic material. As a rule the base of the blister pack is made of plastic, for example plastics such as PVC, polyamides, polyolefins, polyesters and laminates or multi-layered materials containing at least one of these materials and, if desired, may also contain an aluminium foil as one of the layers.

Pee I -off packs:

Other blister packs feature a base, which is covered by a lid foil. The lid foil may cover the whole of the base area and is usefully provided with a line of weakness in the region of each recess, or each recess may be covered with an individual lid segment. Within the line of weakness or on each lid segment may be a tab for gripping which enables the individual recess to be exposed by peeling back the lid segment. As a rule, the base and the lid are of the above-mentioned materials, whereby plastic laminates may also be employed for the lid materials. Blister packaging has been formed in one of three ways. In a first method, the blister package comprises a single moulded plastics sheet adapted to be folded along a central region. In one or each side of the folded region a blister (or recess or protrusion) is formed. Where such a blister is formed in each side, it is preferred that after folding of the plastics sheet the two blisters are aligned to form a single storage region. The plastics sheet is otherwise generally planar. The item or items to be sold are for convenience usually located within the blister prior to folding of the plastics sheet.

A second method, commonly known as captive blister packaging, comprises a planar sheet of plastics material into which a blister (or recess or protrusion) has been formed, held between a front and a back sheet of cardboard, the front sheet being provided with an opening through which the blister (but not the surrounding planar region of the plastics sheet) extends.

In a third method, the blister pack comprises a planar sheet of plastic material into which a blister has been formed by hot stamping, air force or vacuum suction method. The product being packed is inserted in the blister and the base having blister is then sealed by another planar sheet comprising of plastics, laminates or aluminium foil. Pharmaceutical blisters as packaging for pharmaceutical formulations serve to package tablets, capsules or other forms of pharmaceuticals; safely and protect them from external environmental influences which might in certain circumstances affect the pharmaceutical quality of the formulations. In this context, water or water vapour should be mentioned in particular. If water penetrates into the interior of a blister it may cause lasting changes to the pharmaceutical quality of the drug stored therein. There is also the danger that volatile substances will diffuse out of the material contained in the blister during storage and thereby alter the pharmaceutical formulation. In addition, the blisters must be so designed that the atmospheric conditions inside them remain constant, e.g., in respect of inhalable preparations, so as not to alter their particle size distribution.

The blister portion of the packaging may be formed by thermoforming a region of a planar plastic material to a desired shape, e.g., by placing the plastic material between a pair of male and female dies that are temperature controlled at a temperature sufficient to soften the plastic and pressing the male and female dies together to form an indentation or "blister" in the plastic.

A rolled web of PVC plastic supplies the blister material as the sheet is pulled by an Idler unwinding unit that is fed to a heating station via deviating rollers where the film is plasticized by contact heaters. The contact heaters can be adjusted for precise plasticization of the PVC film by controlling the temperature, contact pressure, and heating time. By directly monitoring energy consumption, only the film is heated and not the surrounding machine or environment. Once the critical plasticization temperature is reached, the PVC film web is fed along the conveyor rollers into the forming station. The web is then thermoformed in a pressurized diaphragm station where the edges of the web are gripped and pulled taunt. Compressed air is then injected at critical points along the web, which correspond to the respective cavity placement sites. The cavities are formed as the PVC web sheet is drawn into the cavity moulds of the thermoforming chambers by means of the compressed air. Precisely engineered molds create blister cavities that are uniform in size and thickness.

The multi-blistered web is then transferred to the filling station where the tablet to be packaged can either be manually deposited within each cavity or as is more often the case, automatically placed therein using automated feeder tubes. The filled yet open blister packs continue onward to a foil sealing station wherein the lidding foil is fed into the machine and sealed onto the thermoformed web. A sealing roller with bores corresponding to the cavities of the web, indexes and transports the PVC blister web through the sealing station at which point the heating roller fuses the lidding foil to the PVC web thereby sealing the cavities closed.

The filled and sealed web is embossed, perforated and then cut to the appropriate sized package so that unit doses can be removed from the main package without having to remove the tablet from the package until it is ready to be taken. Pressure is exerted against the PVC blister cavity and the tablet is pushed through the foil cover.

The movement of the PVC web through the cavity forming, heating and sealing stations is intermittent. Movement of the web through the filling station however, is continuous and therefore there is a chance that the tablets can either is improperly disposed within the cavity or more than one may be placed therein. Such aberrations are unacceptable in large-scale commercial operations and there is therefore a need to detect when improperly filled packages occur.

Pharmaceutical blisters as packaging for pharmaceutical formulations serve to package tablets, capsules or other forms of pharmaceuticals safely and protect them from external environmental influences, which might in certain circumstances affect the pharmaceutical quality of the formulations. In this context, water or water vapour should be mentioned in particular. If water penetrates into the interior of a blister it may cause lasting changes to the pharmaceutical quality of the drug stored therein. There is also the danger that volatile substances will diffuse out of the material contained in the blister during storage and thereby alter the pharmaceutical formulation. In addition, the blisters must be so designed that the atmospheric conditions inside them remain constant, e.g., in respect of inhalable preparations, so as not to alter their particle size distribution.

Typical blisters consist of at least two films or foils, which in turn may be made up of a number of layers of different or identical materials. On the one hand there is the base layer or base foil and on the other hand there is a cover layer or cover foil.

One or more wells may be formed in the base foil in which the pharmaceutical formulation, e.g., tablet(s), coated tablet(s) or capsule(s) can be placed.

The cover foil is placed on the base foil and attached thereto. The two layers are tightly joined together, e.g., by adhesive bonding, at least at the edges. The foils are generally made from plastics or metal or combinations thereof (so called laminates or composite foils). Other materials such as paper, for example, may also be used, possibly in addition.

United States Patent 4039080 indicates a tray having individual compartments for holding pills, capsules, or similar solid medication, each compartment being rectangular in plan view and arranged in a rectangular format or seven columns and a plurality of rows. The tray may be loaded with a week's medication for an individual patient with indicia adjacent each column indicating the day of the week, and indicia adjacent the rows indicating the time of day that the medication in each compartment is to be taken. A lid or cover cooperates with the wall means defining the individual compartments to mutually isolate the compartments when in the closed position. The inner surfaces of the compartments are preferably rounded in at least one plane of ease of withdrawing medication therefrom. This packaging system only gives a convenient way to pack but does not provide good moisture and gas barrier.

United States Patent 4068448 discloses a small article packaging apparatus and comprises a housing that is subdivided into six separate working areas. An elongated conveyor strip is fed sequentially through each of the six working areas while an elongated closure strip is fed through and covers the conveyor strip in the final three working areas. The first working area includes labeling means for imprinting desired indicia on the conveyor strip while indentation means at the second work area forms an indentation in the conveyor strip. The desired small article or articles are placed within the indentations formed in the conveyor strip at the third working area while the fourth working area includes means for sealing the conveyor strip to the closure strip in a closed loop encircling the indentation in the conveyor strip. The fifth working area includes means for simultaneously incrementally advancing the joined conveyor and closure strips through the respective work areas. The last work area includes means for cutting the joined conveyor and closure strip between adjacent indentations thereby forming individual packages from the conveyor and closure strips. The labeling, indenting, sealing, and cutting means are synchronized in their operation while the advancing means is asynchronous with these aforementioned means. This discloses a convenient and organised way of blister packing but does not provide any means of better barrier from moisture and gases.

Preferred blisters consist of transparent or at least translucent plastics or a base foil of transparent plastics and a cover foil of aluminium. Both foils may be laminates, i.e., they may consist of a number of foils of different materials. The blisters known from the prior art do not necessarily adequately protect a formulation embedded therein from the penetration of substances from outside such as, for example, gases or vapours, particularly oxygen, carbon dioxide, water vapour and solvents, even when they are mechanically intact. Theoretically, these substances may permeate or diffuse through the topside of the blister (cover foil), the underside (base foil) or through the seam between the cover foil and base foil.

To avoid this problem, it is preferable in the prior art to use blisters consisting only of aluminium foils or aluminium foil laminates. However, these blisters are then no longer transparent and make it virtually impossible to inspect the contents of the blister before opening, e.g., after the filling process. Therefore, special plastics with high barrier qualities are used for transparent blisters. In most cases, however, special plastics of this kind have only moderate barrier properties against certain gases, e.g., either against water vapour or against oxygen, which means that this measure is not satisfactory either.

United States Application 20050061705 relates to a new pharmaceutical blister with reduced permeability to water vapour and gas. It is proposed according to the invention to coat conventional blisters with a silicon oxide-containing functional layer to protect against gases, water vapour and organic molecules. This process is expensive and time consuming.

The use of electronic sensors as a means of detecting errors or problems in large-scale conveyor belt production has been used with limited success. U.S. Pat. No. 4,593,515 discloses the use of an electronic sensor, which is positioned under the conveyor belt of a wrapping machine. Articles dropped from the conveyor path fall upon the sensor, which not only catches the articles but also generates a stop signal, which stops the conveyor belt so the article may be retrieved and placed back on the belt.

U.S. Pat. No. 5,040,353 to Evans et. al. also discloses a blister packing process whereby a sensor apparatus includes a plurality of air valves for removing empty blister cavities prior to sealing. The cavities pass through a detection station, which sends a signal to the pneumatic air valves upon sensing an empty blister packet. This ignites a high-pressure airflow, which selectively separates the unfilled, empty blister cavities from the filled packs, which are ready for sealing.

U.S. Pat. No. 4,472,922 to Romagnoli ^■ teaches a system for monitoring a blister packaging machine comprising a photosensitive detector device, which scans the blister pack carrier strip, and upon sensing an empty blister cavity activates a perforator that punches a hole into the cover strip comprising the empty blisters. An error pulse simultaneously loaded into a shift register actuates, after a suitable delay, a sorter downstream of the cutting station that eliminates the defective blister package from the regular machine output.

U.S. Pat. No. 6,757,420 is concerned with the problem of providing an automatic inspection device, with which it is possible to determine, with little effort and without contact, whether packages, particularly sealed blister packages consisting of a blister container and a cover film, are free of defects. This problem is solved by the use of at least two light sources, which are arranged at a certain distance from one another and each emit a light bundle at a predetermined wavelength range, whereby the emission maxima of the two light sources are offset in relation to one another. The light sources are arranged such that the packages are vertically illuminated. A CCD camera records the light reflected by the packages and the digital images are stored in a computer, so that they are available in a computer-supported image-processing and documentation system.

U.S. Pat. No. 5,555,707 discloses a blister pack scanning device for detection and removal of overfilled or defective pharmaceutical blister packs is comprised of a photoelectric LED transmitter and sensor with a scanning beam channel bar disposed therebetween. The blister pack web is passed below the bar through a space precisely equivalent to the thickness of a properly filled blister. Overfilled or improperly molded blisters will contact a beveled edge of the bar as the web passes thereunder and the lateral movement forces the bar and its two end plates which are in juxtaposition to the transmitter and receiver respectively, to move upward, thereby interfering with the beams transmission. The interference created thereby shuts off the blister production machine and sounds an alarm for removal of the defective package.

BACKGROUND OF THE INVENTION

Poly vinyl chloride is a relatively inexpensive packaging material but has little use in the blister packaging of sensitive drugs because of its poor moisture barrier properties. Plain PVC has MVTR [moisture vapour transmission rate] of 3-4 g/m2/24 hr. Moreover the packing created by using normal PVC film can be copied easily by any manufacturer, as it is cheaply available and therefore can be counterfeited.

Again, manufacture of PVC film in the prior art involves the use of various additives such as mordents and accelerators and non-food grade plasticizers, which renders the PVC unsuitable for the pharmaceutical applications. For pharmaceutical use only food/pharmaceutical grade can be used. Also these prior art films cannot be thermoformed easily and hence cannot be applicable for blister packaging applications.

Plasticizers are substances added to plastic compounds to improve their flexibility, extensibility and process ability. It is characteristic of plasticizer substances that they lower the melting temperature, elastic modulus and second order transaction temperature of polymers but do not alter the chemical nature of the micro molecules. By varying the concentration of plasticizers one can vary the desirable application properties of polymers. Plasticizers can be classified as re primary plasticizers and secondary plasticizers. Primary plasticizers are required to gel a polymer rapidly in the normal processing temperature range. Example: Monomeric Di and Tri esters, Di octyl Phthalate etc. Secondary plasticizers have lower gelatin capacity and limited compatibility with the polymers. Example: Petroleum derivatives consist of aliphatic, Aromatic or chlorinated Hydrocarbon.

Many polymers require high processing temperature and they may decompose at this temperature but on addition of certain stabilizers have very good heat resistance to prevent discoloration or decomposition of the polymeric material. Plasticizers also increases the flexibility of polymeric films material and impart good low temperature performance considerably, give good weathering resistance and improved chemical resistances thereby increasing the life of the PVC end products. However, there is possibility of leaching out i.e. Migration, which is a non-compliance with food content regulations, and Evaporation of plasticizers during processing. This obviated from the use of plasticizer containing PVC in the pharmaceutical and food industry.

Additives on the other hand are widely used in thermoplastic and thermosetting polymers to adjust the handling, processing the properties.

These materials are added to polymeric material to enhance or obtain specific desire properties and also some time to reduce the cost without compromising on properties.

Additives improve or modify the mechanical properties, increase the resistance to degradation during processing or application, improve the appearance of the product and improve the process ability and productivity. Examples include: Mineral particles, Fibers, Pigments, 1,4 Benzenedicarboxylic acid, Calcium carbonate, Aluminium silicate, Fatty acids, Carbon black, Ethylene methyl acrylate co polymer, Adipate, Antimony Oxide, 4,4-Isopropylidenediphenol alkyli, Methylitin 2-mercaptoethyloleate sulfide, Phosphorus acid and Pentaerythritol and the like.

Use of additives and plasticizers result in polymeric film having certain heavy metals like lead, cadmium, and mercury and hexavalent chromium being present. The level of Heavy metal in polymeric material is determined by means of Atomic Absorption Spectrophotometer. The level of the heavy metal in polymeric film should not be exceeding 100 PPM by weight. It is known that within the plastic layer particles tends to migrate. The migration of particles in plastic material, which contain additives or other processing aids, which can contaminate the ingredient and even harm the consumer of the product. Universally certain migration limits (10 mg/dm.sup.2 or 60 ppm.) have been specified for the usage of plastic material for food & drug packaging. Regular PVC also contains some traces Vinyl Chloride Monomer (VCM), which is not polymerized and cannot be separated after the polymerization. For food/pharmaceutical grade PVC the VCM content level in the material should be below the 1 PPM. The level of VCM content in material is determined by means of Gas Chromatography using the headspace method.

Use of metallized PVC films is relatively unknown in the pharmaceutical or food industry.

The existing ultra barrier films of polymer or Aluminium based structures are not cost effective & hence are not always economically viable. The objective of this invention is to create an economically viable moisture barrier film for the protective packaging of moisture sensitive substances.

Processes for improving the barrier against unwanted diffusion of substances which are known from other fields of the art, e.g., the chemical modification of plastic surfaces of petrol tanks by sulphonation or fluorination, have not acquired any significance in the packaging of pharmaceutical compositions as extensive toxicity and stability tests are required. The prior art also discloses laminate films coated with SiO. sub. x but because of the rigid layer of SiO. sub. x these foils are unable to deform, which means that it is impossible to form wells in order to produce a blister.

In order to achieve a broad barrier effect against gases, water vapour and organic solvents in the case of rigid plastics containers, it is known to provide the plastics container with a coating of special organic and inorganic materials. In this context reference is made to the article "Multilayer Barrier Coating System Produced by Plasma-impulse Chemical Vapour Deposition (PICVD)₇" M. Walther, M. Heming, M. Spallek, Surface and Coatings Technology 80 (1996), pp. 200-202, which discloses rigid plastics containers having a layer of SiO.sub.xC.sub.yH.sub.z or TiO.sub.xC.sub.yH.sub.z as barrier layer. The coating is done by the PICVD process (plasma impulse chemical vapour deposition) which is known for example from DE 40 08 405 Cl and U.S. Pat. No. 5,154,943.

OBJECT OF THE INVENTION

The object of the invention is to provide a metallized thermoformed plastic container system. Another object of the invention is to provide a metallized thermoformed plastic blister pack system for pharmaceutical and healthcare products.

Yet another object of the invention is to provide a metallized thermoformed PVC blister pack system for pharmaceutical and healthcare products.

Further object of the invention is to provide a metallized thermoformed plastic container system for pharmaceutical and healthcare products, which gives better barrier properties against water vapour and gases.

Yet another object of the invention is to provide a metallized thermoformed plastic container system for pharmaceutical and healthcare products, which has better transparency to facilitate visual inspection of the packed product within.

Yet another objective is to create a metallized surface film container by laminating the metallized thin film on a normal polymer film and forming a blister container.

In accordance with a preferred embodiment of this invention there is provided a thermoformed metallized container for pharmaceutical packaging, which has preferably a high to medium barrier film for the protection of pharmaceutical solid dosage forms.

Another object of this invention is to provide a metallized blister- packaging container with translucent appearance, through which a packed product is visible. Another object is to provide a metallized thermoformed container so that an online NFD (non filled detection) system can be used on the complete packed system also. Conventional Aluminium packaging is opaque and therefore is unsuitable for an NFD system in the packed condition.

Yet another object of this invention is to provide a metallized thermoformed container, which provides an anti-counterfeit solution since the metallizing is not easily imitated by counterfeiters.

Yet another object of this invention is to provide a metallized thermoformed container having better aesthetics and metallic luster and therefore creates a brand identity.

Still another object of this invention is to provide a metallized thermoformed container, which can be formed on both rotary, vacuum forming and flat, pressure forming thermoforming machines with high productivity.

Yet another object of this invention is to provide a metallized thermoformed container, being in the nature of a multilayered film, which can be produced by either, keeping the metallized layer as a sandwich layer or as the surface layer.

Yet another object of this invention is to provide a metallized thermoformed container having high barrier properties and an aesthetically better container at lower cost than conventional high barrier films by laminating normally available thin metallized films on regular thick films. SUMMARY OF THE INVENTION According to this invention, therefore there is provided a metallized thermoformed plastic container system comprising a multi-layer thermoformable, translucent pharmaceutical and food packaging film comprising a substrate of 100 to 1000 microns thickness of food grade polyvinyl chloride, and a metallized layer of a thickness of 0.02 to 0.2 microns provided at least on one side of the said substrate and at least one to 250 microns thick of a food and pharmaceutical grade polymeric layer provided at least on one side of the substrate.

Typically a multi-layer thermoformable, translucent pharmaceutical and food packaging film, in which the polymeric layer is provided on the polyvinyl chloride substrate non metallized side.

Typically a multi-layer thermoformable, translucent pharmaceutical and food packaging film, in which the polymeric layer is provided on the polyvinyl chloride substrate metallized side.

Typically a multi-layer thermoformable translucent pharmaceutical and food packaging film, in which the metallized layer is formed on the substrate.

Typically a multi-layer thermoformable, translucent pharmaceutical and food packaging film, in which the metallized layer is applied on the substrate.

Typically a multi-layer thermoformable, translucent pharmaceutical and food packaging film as, in which the metallized layer is formed on the substrate by vacuum deposition. Typically a multi-layer thermoformable, translucent pharmaceutical and food packaging film, in which the metallized layer consists of Aluminium.

Typically a multi-layer thermoformable, translucent pharmaceutical and food packaging film, in which the polymeric layer is formed on the metallized layer.

Typically a multi-layer thermoformable, translucent pharmaceutical and food packaging film, in which the polymeric layer is formed on the polyvinyl chloride substrate on the non metallized side.

Typically a multi-layer thermoformable, translucent pharmaceutical and food packaging film, in which the polymeric layer is applied on the metallized layer.

Typically a multi-layer thermoformable, translucent pharmaceutical and food packaging film, which gives better barrier properties against water vapour and gases.

Typically a multi-layer thermoformable, translucent pharmaceutical and food packaging film, which has better transparency to facilitate visual inspection of the packed product within.

Preferably a multi-layer thermoformed container having a translucent pharmaceutical and food packaging film, in which the polymer layer is a layer of polyvinylidine chloride of thickness from 0.01 micron to 100 microns.

Preferably a multi-layer thermoformed container having ^• a translucent pharmaceutical and food packaging film, in which the metallized layer is a composite film with a thickness of 10 to 100 microns, comprising a polymeric layer and a metallized layer of thickness 0.02 to 0.2 micron, which composite film is laminated on the substrate.

Preferably a multi-layer thermoformed container having a translucent pharmaceutical and food packaging film, in which the metallized layer is a composite film with a thickness of 10 to 100 microns, comprising a polyvinyl chloride layer and a metallized layer with a thickness of 0.02 to 0.2 micron, which composite film is laminated on the substrate.

Preferably a multi-layer thermoformed container having a translucent pharmaceutical and food packaging film, in which the metallized layer is composite film with a thickness of 10 to 100 microns, of comprising a cast polypropylene layer and a metallized layer with a thickness of 0.02 to 0.2 micron, which composite film is laminated on the substrate.

Preferably a multi-layer thermoformed container having a translucent pharmaceutical and food packaging film, in which the polymer layer is a layer of LDPE and HDPE with a thickness of 0.5 micron to 50 microns.

Preferably a multi-layer thermoformed container having a, translucent pharmaceutical and food packaging film, in which the polymer layer is a layer of cyclic-olefin copolymer with a thickness of 0.01 to 250 microns.

Typically a multi-layer thermoformed container having a translucent pharmaceutical and food packaging film, in which at least one polymeric layer provided is laminated over the metallized layer using a tie layer of polyvinylidine chloride. Typically a multi-layer thermoformed container having a translucent pharmaceutical and food packaging film, in which the film is provided with a coating of silicone on at least one side of the film.

Typically a multi-layer thermoformed container having a translucent pharmaceutical and food packaging film, which further includes at least one colored lacquer layer with a thickness of 0.02 to 50 micron.

Typically a multi-layer thermoformable translucent film, in which the polymer layer is cast metallized polyvinyl chloride.

Typically a multi-layer thermoformed container having a translucent pharmaceutical and food packaging film, having water vapour transmission rate in the range of between 0.05 to 5.0 g/m²/d.

Typically a multi-layer thermoformed container having a translucent pharmaceutical and food packaging film, which has better transparency in the range of between 0 to 61 %.

This invention provides a thermoformed container having a polymer/metallic combination, its position in the multi layered structure & the individual layer thickness that provide synergy to achieve optimum & coherent functional qualities in the final composite container & metallizing effect on the thicker film by lamination of commonly available metallized thin films on regular 150-400 micron PVC films & various shades of metallized film by applying colored lacquer on the top of the metallized film. Each polymeric substance is known for its diverse physical characteristic properties & hence while forming a multi-layered structure, synergy of these properties is very important to impart cohesiveness to the final film. The properties like thermal stability, elongation characteristics, flexibility, yield; sealability, tensile, strength, impact resistance, gloss, transparency & the barrier properties are characteristics of individual polymer films. This property, in turn, influences the functional qualities packaging aesthetics, cost, protection level, sealing integrity etc. Hence selection of the composite layer position, its thickness all are very important to get functional properties for the composite film.

Use of PVC metallized films is relatively unknown in the pharmaceutical or food industry.

The existing ultra barrier films of polymer or Aluminium based structures are not cost effective & hence are not always economically viable. The objective of this invention is to create an economically viable moisture barrier container for the protective packaging of moisture sensitive substances.

This invention teaches the usage of metallized food grade PVC blister pack for pharmaceutical packaging.

Particularly, this invention relates to a high to medium barrier multi layer thermoformed container structure as viable alternatives for high cost polymeric / Aluminium structures.

Still particularly, this invention relates to a thermoformed container having for use in the packaging of highly to medium moisture sensitive substances.

This invention envisages a thermoformed container, which can become a viable alternative to the existing Aluminium & polymeric structures. The invention has for its object the creation of multi- layered container by thermoforming having at least two layers some of them being of different polymeric substances leading to a film with ultra high moisture barrier with excellent gas barrier property.

Typically, the metallized thermoformed container envisaged is of thickness above 100 microns.

A multi layered thermoformed container essentially comprising at least 3 layers is developed which has the capacity to provide high to medium barrier against moisture.

The multi-layered container developed comprises of an inner layer (Layer coming in contact with the range substance which is packed) made up of Poly Vinyl Chloride (PVC) having a thickness range between 100 to 400 microns. This PVC film is coated with a fine metallic deposition, typically of Aluminium in the range of 0.02 to 0.2 microns. The metal deposition in such thin layers results in a metallized film with enhanced moisture barrier properties with a loss of transparency of the film resulting in a metallized translucent film.

The product envisaged in accordance with this invention is a multi layer thermoformed container based on metallized PVC having thickness above 100 micron and thin metallized films of PVC, CPP, PET or BOPP having thickness less than 100 micron is laminated in to PVC film of higher thickness. The metallized layer may have thickness varying from 0.02 to 0.2 microns.

Other layers on the film, typically one of them being a tie layer could be one or combination of Polyvinylidine chloride (PVdC) (from 0.01 micron to 100 microns); Olefins (LDPE, HDPE) (0.5 micron to 50 microns); Cyclic olefin copolymer (COC) (0.01 to 250 microns).

The packaging film is formed in two ways. In one method the substrate PVC surface is in contact with the packed material & also will be in contact with the enclosing (liding film/foil) with metallized film secured to subsequent polymeric layers by either lamination, coating or co-extrusion process preferably by using an adhesive tie layer of PVdC having thickness range between 0.01 micron to 100 micron. In the second type the metallized surface is exposed to the atmosphere with subsequent polymer coating done on the non- metallized side, which comes in contact with the material and the liding foil for blister packing application.

These composite films may typically be given a silicone coating for enhancing the barrier property.

The thickness of the PVDC determines the barrier properties. Mildly barrier to very barrier films are produced by coating 0 microns to 100 microns respectively. The flexibility and drawability of the film is improved by lamination of the film with LDPE. The basic strength of the film is, improved by using higher thickness PVC film for metallization. The opacity and barrier property of the film is improved by increasing the thickness of the metallic layer.

DETAILED DESCRIPTION OF THE INVENTION

This invention relates to metallized packaging container.

Still further this invention relates to metallized packaging container for use in the packaging of food and pharmaceutical products. Still particularly, this invention relates to a multi layer container having high to medium moisture barrier property.

Metallizing of polymeric films are per se known. Typically in the prior art films such as PET, [polyethylene terepthalate] PP [poly propylene], LDPE Low density polyethylene metallized films have been used for photosensitive and oxygen scavenging/oxygen barrier films for use at very low thickness (less than 100 microns).

Metallization on thin films are generally done by vapourizing Aluminium in a vacuum chamber under very high vacuum. The Aluminium vapour will be then condensed on to the film surface, which forms a thin Aluminium layer (about 0.4 microns).

Metallization imparts additional water vapour, gas and UV barrier properties to the film. These thin metallized films have generally not been used flexible packaging of food and cosmetic items.

The invention provides a container having a polymer/metallic combination, its position in the multi layered structure & the individual layer thickness that provide synergy to achieve optimum & coherent functional qualities in the final composite film & Metallizing effect on the thicker film by lamination of commonly available metallized thin films on regular 150-400 micron PVC films & various shades of metallized film by applying colored lacquer on the top of the metallized film. Each polymeric substance is known for its diverse physical characteristic properties & hence while forming a multi-layered structure, synergy of these properties is very important to impart cohesiveness to the final film. The properties like thermal stability, elongation characteristics, flexibility, yield, sealability, tensile, strength, impact resistance, gloss, transparency & the barrier properties are characteristics of W 2

individual polymer films. This property, in turn, influences the functional qualities packaging aesthetics, cost, protection level, sealing integrity etc. Hence selection of the composite layer position, its thickness all are very important to get functional properties for the composite film.

The existing ultra barrier films of polymer or Aluminium based structures are not cost effective & hence are not always economically viable. The objective of this invention is to create an economically viable moisture barrier film for the protective packaging of moisture sensitive substances. This invention teaches the usage of metallized food grade PVC container for pharmaceutical packaging particularly blister packaging applications.

Particularly, this invention relates to a high to medium barrier multi layer container structure as viable alternatives for high cost polymeric / Aluminium structures.

Still particularly, this invention relates to a container having for use in the packaging of highly to medium moisture sensitive substances.

This invention envisages a thermoformed container, which can become a viable alternative to the existing Aluminium & polymeric structures.

Typically, the metallized film envisaged is of thickness above 100 microns.

In accordance with a preferred embodiment of this invention there is provided a thermoformed metallized film container for pharmaceutical packaging, which is preferably a high to medium barrier film for the protection of pharmaceutical solid dosage forms.

With this objective, a multi layered film container essentially comprising at least 3 layers is developed which has the capacity to provide high to medium barrier against moisture.

The product envisaged in accordance with this invention is a multi layer film container based on metallized PVC having thickness above 100 micron and thin metallized films of PVC,CPP,PET or BOPP having thickness less than 100 micron is laminated in to PVC film of higher thickness. The metallized layer may have thickness varying from 0.02 to 2 microns.

Other layers on the film container, typically one of them being a tie layer could be one or combination of Polyvinylidine chloride (PVdC) (from 0.01 micron to 100 microns); Olefins (LDPE₇ HDPE) (0.5 micron to 50 microns); Cyclic olefin copolymer (COC) (0.01 to 250 microns).

The packaging container is formed in two ways. In one method the substrate PVC surface is in contact with the packed material & also will be in contact with the enclosing (liding film/foil) with metallized film secured to subsequent polymeric layers by either lamination, coating or co-extrusion process preferably by using an adhesive tie layer of PVdC having thickness range between 0.01 micron to 100 micron. In the second type the metallized surface is exposed to the atmosphere with subsequent polymer coating done on the non- metallized side, which comes in contact with the material and the liding foil for blister packing application.

These composite films may typically be given a silicone coating for enhancing the barrier property. The metallization of the PVC film is done by vacuum deposition or sputtering process or electrolysis process. Thickness of metallization deposition is measured by electrical resistivity (ohms) of the metallized surface. Additional layers of polymeric material such as olefins are applied by lamination process. The PVdC layer is formed by dispersion coating method. Lamination and coating could be done in either on the metallized side or non-metallized side of PVC.

The thickness of the PVDC determines the barrier properties. Mildly barrier to very barrier films are produced by coating 0 microns to 100 microns respectively. The flexibility and drawability of the film is improved by lamination of the film with LDPE. The basic strength of the film is, improved by using higher thickness PVC film for metallization. The opacity and barrier property of the film is improved by increasing the thickness of the metallic layer. Opacity of the film is measuerd before and after blister formation of metallized film. Results of opacity measured were Opacity before blister formation = 98.5 % Opacity after blister formation (0 size capsule cavity) = 39.1 % Opacity of the film (Tablet type cavity) = 45.92 %

EXAMPLES

Examples of typical blister pack in accordance with this invention are provided in following accompanying examples.

EXAMPLE 1

A 250 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.05 micron. A 10 micron PVDC layer was applied on the PVC film by dispersion method on non metallized side. Opacity of the film was 92.20 % measured before blister formation. WVTR of the film was 0.78 measured before blister formation. The said film was deformed on a tablet blister packing machine, wherein metallized side was facing outside the pack and not touching the packed product.

Opacity of the film was 33.64 % measured after blister formation. WVTR of the film was 6.70 % measured after blister formation. An analgesic formulation of Paracetamol in tablet dosage form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

Each blister pack was scanned by visual inspection and by automated laser scanner for empty blisters and broken tablet in blisters. An accuracy of 100 % was achieved over a quantity of about 5000 blister packs, by both methods of inspection, which clearly indicated suitability of metallized PVC for blister pack.

EXAMPLE 2

A 150 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 20 micron PVDC layer was applied on the PVC film by dispersion method on non metallized side.

Opacity of the film was 98.50 % measured before blister formation.

WVTR of the film was 0.32 % measured before blister formation.

The said film was deformed on a tablet blister packing machine, wherein metallized side was facing outside the pack and not touching the packed product.

Opacity of the film was 39.10 % measured after blister formation.

WVTR of the film was 1.90 % measured after blister formation.

An analgesic formulation of Paracetamol in tablet dosage form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

EXAMPLE 3

A 150 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 15 micron PVDC layer was applied on the PVC film by dispersion method on non metallized side and metallized side.

Opacity of the film was 98.70 % measured before blister formation.

WVTR of the film was 0.27 % measured before blister formation.

Opacity of the film was 39.20 % measured after blister formation.

WVTR of the film was 1.72 % measured after blister formation.

EXAMPLE 4

A 200 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 10 micron PVDC layer was applied on the PVC film by dispersion method on non metallized side. A 10 micron colorless lacquer was applied on PVC film on metallized side.

Opacity of the film was 98.20 % measured before blister formation.

WVTR of the film was 0.88 % measured before blister formation. The said film was deformed on a tablet blister packing machine, wherein metallized side was facing outside the pack and not touching the packed product.

Opacity of the film was 38.80 % measured after blister formation. WVTR of the film was 7.0 % measured after blister formation. One set of medium sensitive antibiotic formulation in capsule form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

Each blister pack was scanned by visual inspection and by automated laser scanner for empty blisters and broken capsule in blisters. An accuracy of 100 % was achieved over a quantity of about 5000 blister packs, by both methods of inspection, which clearly indicated suitability of metallized PVC for blister pack.

EXAMPLE 5

A 200 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A lO micron PVDC layer was applied on the PVC film by dispersion method on non metallized side. A lO micron red colored lacquer was applied on PVC film on metallized side.

Opacity of the film was 99.20 % measured before blister formation.

WVTR of the film was 0.88 % measured before blister formation.

Opacity of the film was 40.50 % measured after blister formation.

WVTR of the film was 7.0 % measured after blister formation.

One set of medium sensitive antibiotic formulation in capsule form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

EXAMPLE 6

A 250 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.05 micron. A 10 micron LDPE layer was applied on the PVC film by lamination method on non metallized side.

Opacity of the film was 92.0 % measured before blister formation.

WVTR of the film was 1.50 % measured before blister formation.

Opacity of the film was 33.0 % measured after blister formation.

WVTR of the film was 10.80 % measured after blister formation.

A set of Ethambutol hydrochloride formulation in tablet form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

EXAMPLE 7

A 150 micron PVC film was Aluminium metallized by vacuum deposition method with thickness of 0.08 micron. A 20 micron LDPE layer was applied on the PVC film by lamination method on non metallized side.

Opacity of the film was 98.60 % measured before blister formation.

WVTR of the film was 2.70 % measured before blister formation.

The said film was deformed on a tablet blister packing machine, wherein metallized side was facing outside the pack and not touching the packed product. Opacity of the film was 39.40 % measured after blister formation. WVTR of the film was 12.60 % measured after blister formation. One set of lozenges tablets dosage form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil. Each blister pack was scanned by visual inspection and by automated laser scanner for empty blisters and broken tablet in blisters. An accuracy of 100 % was achieved over a quantity of about 5000 blister packs, by both methods of inspection, which clearly indicated suitability of metallized PVC for blister pack.

EXAMPLE 8

A 150 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 15 micron LDPE layer was applied on the PVC film by lamination method on non metallized side and metallized side.

Opacity of the film was 98.70 % measured before blister formation.

WVTR of the film was 2.60 % measured before blister formation.

Opacity of the film was 39.50 % measured after blister formation.

WVTR of the film was 12.0 % measured after blister formation.

Each blister pack was scanned by visual inspection and by automated laser scanner for empty blisters and broken tablet in blisters. An accuracy of 100 % was achieved over a quantity of about 5000 blister packs, by both methods of inspection, which clearly indicated suitability of metallized PVC for blister pack. EXAMPLE 9

A 200 micron PVC film was Aluminium metallized by vacuum deposition method with thickness of 0.08 micron. A 10 micron LDPE layer was applied on the PVC film by lamination method on non metallized side. A 10-micron colourless lacquer was applied on PVC film on metallized side.

Opacity of the film was 98.25 % measured before blister formation.

WVTR of the film was 1.50 % measured before blister formation.

Opacity of the film was 38.90 % measured after blister formation.

WVTR of the film was 7.0 % measured after blister formation.

EXAMPLE 10

A 200 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 10 micron LDPE layer was applied on the PVC film by lamination method on non metallized side. A 10 micron red colored lacquer was applied on PVC film on metallized side.

Opacity of the film was 99.10 % measured before blister formation.

WVTR of the film was 1.50 % measured before blister formation. OThe said film was deformed on a tablet blister packing machine, wherein metallized side was facing outside the pack and not touching the packed product.

Opacity of the film was 39.90 % measured after blister formation. WVTR of the film was 7.10 % measured after blister formation. One set of medium sensitive antibiotic formulation in capsule form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

EXAMPLE l I

A 250 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.05 micron. A 10 micron HDPE layer was applied on the PVC film by lamination method on non metallized side.

Opacity of the film was 94.70 % measured before blister formation.

WVTR of the film was 0.85 % measured before blister formation.

Opacity of the film was 35.60 % measured after blister formation.

WVTR of the film was 5.50 % measured after blister formation.

One set of lozenges tablets dosage form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

Each blister pack was scanned by visual inspection and by automated laser scanner for empty blisters and broken tablet in blisters. An accuracy of 100 % was achieved over a quantity of about 5000 blister packs, by both methods of inspection, which clearly indicated suitability of metallized PVC for blister pack. EXAMPLE 12

A 150 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 20 micron HDPE layer was applied on the PVC film by lamination method on non metallized side.

Opacity of the film was 98.90 % measured before blister formation.

WVTR of the film was 2.40 % measured before blister formation.

Opacity of the film was 40.10 % measured after blister formation.

WVTR of the film was 11,50 % measured after blister formation.

EXAMPLE 13

A 150 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 15 micron HDPE layer was applied on the PVC film by lamination method on non metallized side and metallized side. _v

Opacity of the film was 99.20 % measured before blister formation.

WVTR of the film was 2.35 % measured before blister formation.

Opacity of the film was 40.20 % measured after blister formation. WVTR of the film was 11.20 % measured after blister formation. A set of Ethambutol hydrochloride formulation in tablet dosage form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

EXAMPLE 14

A 200 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 10 micron HDPE layer was applied on the PVC film by lamination method on non metallized side. A 10 micron colorless lacquer was applied on PVC film on metallized side.

Opacity of the film was 99.10 % measured before blister formation.

WVTR of the film was 0.85 % measured before blister formation.

Opacity of the film was 40.50 % measured after blister formation.

WVTR of the film was 3.30 % measured after blister formation.

Each blister pack was scanned by visual inspection and by automated laser scanner for empty blisters and broken capsule in blisters. An accuracy of 100 % was achieved over a quantity of about 5000 blister packs, by both methods of inspection, which clearly indicated suitability of metallized PVC for blister pack. - ^ K_fefli_V ] _$

EXAMPLE 15

A 200 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 10 micron HDPE layer was applied on the PVC film by lamination method on non metallized side. A 10 micron red colored lacquer was applied on PVC film on metallized side.

Opacity of the film was 99.40 % measured before blister formation.

WVTR of the film was 0.81 % measured before blister formation.

Opacity of the film was 41.20 % measured after blister formation.

WVTR of the film was 3.30 % measured after blister formation.

EXAMPLE 16

A 250 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.05 micron. A 10 micron cyclic-olefin copolymer layer was applied on the PVC film by lamination method on non metallized side.

Opacity of the film was 92.20 % measured before blister formation.

WVTR of the film was 0.76 % measured before blister formation.

The said film was deformed on a tablet blister packing machine, wherein metallized side was facing outside the pack and not touching the packed product. Opacity of the film was 33.60 % measured after blister formation. WVTR of the film was 6.0 % measured after blister formation. One set of lozenges tablets dosage form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil. Each blister pack was scanned by visual inspection and by automated laser scanner for empty blisters and broken tablet in blisters. An accuracy of 100 % was achieved over a quantity of about 5000 blister packs, by both methods of inspection, which clearly indicated suitability of metallized PVC for blister pack.

EXAMPLE 17

A 150 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 20 micron cyclic-olefin copolymer layer was applied on the PVC film by lamination method on non metallized side.

Opacity of the film was 99.0 % measured before blister formation.

WVTR of the film was 1.40 % measured before blister formation.

Opacity of the film was 39.80 % measured after blister formation.

WVTR of the film was 6.60 % measured after blister formation.

Each blister pack was scanned by visual inspection and by automated laser scanner for empty blisters and broken tablet in blisters. An accuracy of 100 % was achieved over a quantity of about 5000 blister packs, by both methods of inspection, which clearly indicated suitability of metallized PVC for blister pack. EXAMPLE 18

A 150 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 15 micron cyclic-olefin copolymer layer was applied on the PVC film by lamination method on non metallized side and metallized side. Opacity of the film was 99.10 % measured before blister formation. WVTR of the film was 1.35 % measured before blister formation. The said film was deformed on a tablet blister packing machine, wherein metallized side was facing outside the pack and not touching the packed product.

Opacity of the film was 40.0 % measured after blister formation. WVTR of the film was 6.40 % measured after blister formation. One set of lozenges tablets dosage form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil. Each blister pack was scanned by visual inspection and by automated laser scanner for empty blisters and broken tablet in blisters. An accuracy of 100 % was achieved over a quantity of about 5000 blister packs, by both methods of inspection, which clearly indicated suitability of metallized PVC for blister pack.

EXAMPLE 19

A 200 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 10 micron cyclic-olefin copolymer layer was applied on the PVC film by lamination method on non metallized side. A 10 micron colorless lacquer was applied on PVC film on metallized side.

Opacity of the film was 98.90 % measured before blister formation.

WVTR of the film was 0.92 % measured before blister formation.

Opacity of the film was 39.10 % measured after blister formation.

WVTR of the film was 3.60 % measured after blister formation. A set of Ethambutol hydrochloride formulation in tablet form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

EXAMPLE 20

A 200 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 10 micron cyclic-olefin copolymer layer was applied on the PVC film by lamination method on non metallized side. A 10 micron red colored lacquer was applied on PVC film on metallized side.

Opacity of the film was 99.20 % measured before blister formation.

WVTR of the film was 0.92 % measured before blister formation.

Opacity of the film was 40.30 % measured after blister formation.

WVTR of the film was 3.60 % measured after blister formation.

Each blister pack was scanned by visual inspection and by automated laser scanner for empty blisters and broken tablet in blisters. An accuracy of 100 % was achieved over a quantity of about 5000 blister packs, by both methods of inspection, which clearly indicated suitability of metallized PVC for blister pack. EXAMPLE 21

A 150 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.05 micron. A 10 micron PVDC layer was applied on the PVC film by dispersion method on non metallized side.

Opacity of the film was 92.40 % measured before blister formation.

WVTR of the film was 0.78 % measured before blister formation.

Opacity of the film was 33.0 % measured after blister formation.

WVTR of the film was 6.70 % measured after blister formation.

A set of highly sensitive multi vitamin capsules form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

EXAMPLE 22

A 250 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 20 micron PVDC layer was applied on the PVC film by dispersion method on non metallized side.

Opacity of the film was 98.50 % measured before blister formation.

WVTR of the film was 0.55 % measured before blister formation. The said film was deformed on a tablet blister packing machine, wherein metallized side was facing outside the pack and not touching the packed product.

Opacity of the film was 39.14 % measured after blister formation. WVTR of the film was 2.10 % measured after blister formation. A set of highly sensitive multi vitamin capsules form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

EXAMPLE 23

A 250 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 15 micron PVDC layer was applied on the PVC film by dispersion method on non metallized side and metallized side.

Opacity of the film was 98.50 % measured before blister formation.

WVTR of the film was 0.28 % measured before blister formation.

Opacity of the film was 39.14 % measured after blister formation.

WVTR of the film was 1.70 % measured after blister formation.

A set of highly sensitive multi vitamin capsules dosage form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

Each blister pack was scanned by visual inspection and by automated laser scanner for empty blisters and broken capsule in blisters. An accuracy of 100 % was achieved over a quantity of W about 5000 blister packs, by both methods of inspection, which clearly indicated suitability of metallized PVC for blister pack.

EXAMPLE 24

A 100 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 10 micron PVDC layer was applied on the PVC film by dispersion method on non metallized side. A 10 micron colorless lacquer was applied on PVC film on metallized side.

Opacity of the film was 99.20 % measured before blister formation.

WVTR of the film was 1.0 % measured before blister formation.

Opacity of the film was 40.40 % measured after blister formation.

WVTR of the film was 4.0 % measured after blister formation.

One set of medium sensitive of herbal formulation in capsule form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

EXAMPLE 25

A 100 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 10 micron PVDC layer was applied on the PVC film by dispersion method on non metallized side. A 10 micron red colored lacquer was applied on PVC film on metallized side.

Opacity of the film was 99.20 % measured before blister formation. WVTR of the film was 1.0 % measured before blister formation. The said film was deformed on a tablet blister packing machine, wherein metallized side was facing outside the pack and not touching the packed product.

Opacity of the film was 40.20 % measured after blister formation. WVTR of the film was 4.0 % measured after blister formation. One set of medium sensitive of herbal formulation in capsule form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

EXAMPLE 26

A 150 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.05 micron. A 10 micron LDPE layer was applied on the PVC film by lamination method on non metallized side.

Opacity of the film was 98.40 % measured before blister formation.

WVTR of the film was 2.0 % measured before blister formation.

Opacity of the film was 38.60 % measured after blister formation.

WVTR of the film was 7.80 % measured after blister formation.

EXAMPLE 27

A 250 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 20 micron LDPE layer was applied on the PVC film by lamination method on non metallized side.

Opacity of the film was 98.50 % measured before blister formation.

WVTR of the film was 1.70 % measured before blister formation.

Opacity of the film was 39.14 % measured after blister formation.

WVTR of the film was 9.95 % measured after blister formation.

EXAMPLE 28

A 250 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 15 micron LDPE layer was applied on the PVC film by lamination method on non metallized side and metallized side.

Opacity of the film was 98.0 % measured before blister formation.

WVTR of the film was 0.90 % measured before blister formation. The said film was deformed on a tablet blister packing machine, wherein metallized side was facing outside the pack and not touching the packed product.

Opacity of the film was 38.0 % measured after blister formation. WVTR of the film was 5.70 % measured after blister formation. A set of highly sensitive multi vitamin capsules form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

EXAMPLE 29

A 100 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 10 micron LDPE layer was applied on the PVC film by lamination method on non metallized side. A 10 micron colorless lacquer was applied on PVC film on metallized side.

Opacity of the film was 99.0 % measured before blister formation. WVTR of the film was 2.40 % measured before blister formation. The said film was deformed on a tablet blister packing machine, wherein metallized side was facing outside the pack and not touching the packed product.

Opacity of the film was 39.80 % measured after blister formation. WVTR of the film was 8.60 % measured after blister formation. One set of medium sensitive herbal formulation in capsule form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil. Each blister pack was scanned by visual inspection and by automated laser scanner for empty blisters and broken capsule in blisters. An accuracy of 100 % was achieved over a quantity of about 5000 blister packs, by both methods of inspection, which clearly indicated suitability of metallized PVC for blister pack.

EXAMPLE 30

A 100 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 10 micron LDPE layer was applied on the PVC film by lamination method on non metallized side. A 10 micron red colored lacquer was applied on PVC film on metallized side.

Opacity of the film was 99.10 % measured before blister formation.

WVTR of the film was 2.40 % measured before blister formation.

Opacity of the film was 39.90 % measured after blister formation.

WVTR of the film was 8.60 % measured after blister formation.

One set of medium sensitive herbal formulation in capsule form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

EXAMPLE 31

A 150 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.05 micron. A 10 micron HDPE W 2 layer was applied on the PVC film by lamination method on non metallized side.

Opacity of the film was 92.90 % measured before blister formation. WVTR of the film was 1.10 % measured before blister formation. The said film was deformed on a tablet blister packing machine, wherein metallized side was facing outside the pack and not touching the packed product.

Opacity of the film was 32.80 % measured after blister formation. WVTR of the film was 7.80 % measured after blister formation. One set of lozenges tablets dosage form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil. Each blister pack was scanned by visual inspection and by automated laser scanner for empty blisters and broken tablet in blisters. An accuracy of 100 % was achieved over a quantity of about 5000 blister packs, by both methods of inspection, which clearly indicated suitability of metallized PVC for blister pack.

EXAMPLE 32

A 250 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 20 micron HDPE layer was applied on the PVC film by lamination method on non metallized side.

Opacity of the film was 99.0 % measured before blister formation.

WVTR of the film was 0.70 % measured before blister formation.

Opacity of the film was 40.0 % measured after blister formation. WVTR of the film was 5.12 % measured after blister formation. A set of Ethambutol hydrochloride formulation in tablet form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

EXAMPLE 33

A 250 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 15 micron HDPE layer was applied on the PVC film by lamination method on non metallized side and metallized side.

Opacity of the film was 98.50 % measured before blister formation.

WVTR of the film was 0.72 % measured before blister formation.

Opacity of the film was 38.70 % measured after blister formation.

WVTR of the film was 5.20 % measured after blister formation.

A set of Ethambutol hydrochloride formulation in tablet dosage form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil.

Each blister pack was scanned by visual inspection and by automated laser scanner for empty blisters and broken tablet in blisters. An accuracy of 100 % was achieved over a quantity of about 5000 blister packs, by both methods of inspection, which clearly indicated suitability of metallized PVC for blister pack. W

EXAMPLE 34

A 100 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 10 micron HDPE layer was applied on the PVC film by lamination method on non metallized side. A 10 micron colorless lacquer was applied on PVC film on metallized side.

Opacity of the film was 99.20 % measured before blister formation.

WVTR of the film was 2.30 % measured before blister formation.

Opacity of the film was 40.0 % measured after blister formation.

WVTR of the film was 8.10 % measured after blister formation.

EXAMPLE 35

A 100 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 10 micron HDPE layer was applied on the PVC film by lamination method on non metallized side. A 10 micron red colored lacquer was applied on PVC film on metallized side.

Opacity of the film was 99.20 % measured before blister formation.

WVTR of the film was 2.30 measured before blister formation. The said film was deformed on a tablet blister packing machine, wherein metallized side was facing outside the pack and not touching the packed product.

Opacity of the film was 40.0 % measured after blister formation.

WVTR of the film was 8.20 measured after blister formation.

EXAMPLE 36

A 150 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.05 micron. A 10 micron cyclic-olefin copolymer layer was applied on the PVC film by lamination method on non metallized side.

Opacity of the film was 92.80 % measured before blister formation.

WVTR of the film was 0.90 % measured before blister formation.

Opacity of the film was 32.90 % measured after blister formation.

WVTR of the film was 7.80 % measured after blister formation.

EXAMPLE 37

A 250 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 20 micron cyclic-olefin copolymer layer was applied on the PVC film by lamination method on non metallized side.

Opacity of the film was 98.0 % measured before blister formation.

WVTR of the film was 0.69 % measured before blister formation.

Opacity of the film was 39.0 % measured after blister formation.

WVTR of the film was 5.50 % measured after blister formation.

EXAMPLE 38

A 250 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 15 micron cyclic-olefin copolymer layer was applied on the PVC film by lamination method on non metallized side and metallized side. Opacity of the film was 98.20 % measured before blister formation. WVTR of the film was 0.70 % measured before blister formation. The said film was deformed on a tablet blister packing machine, wherein metallized side was facing outside the pack and not touching the packed product.

Opacity of the film was 38.80 % measured after blister formation. WVTR of the film was 5.40 % measured after blister formation. One set of lozenges tablets dosage form was packed in each blister with 25 micron VMCH coated Aluminium as the liding foil. Each blister pack was scanned by visual inspection and by automated laser scanner for empty blisters and broken tablet in blisters. An accuracy of 100 % was achieved over a quantity of about 5000 blister packs, by both methods of inspection, which clearly indicated suitability of metallized PVC for blister pack.

EXAMPLE 39

A 100 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 10 micron cyclic-olefin copolymer layer was applied on the PVC film by lamination method on non metallized side. A 10 micron colorless lacquer was applied on PVC film on metallized side.

Opacity of the film was 98.90 % measured before blister formation.

WVTR of the film was 2.20 % measured before blister formation.

Opacity of the film was 38.90 % measured after blister formation.

WVTR of the film was 6.80 % measured after blister formation.

EXAMPLE 40

A 100 micron PVC film was Aluminium metallized by vaccum deposition method with thickness of 0.08 micron. A 10 micron cyclic-olefin copolymer layer was applied on the PVC film by lamination method on non metallized side. A 10 micron red colored lacquer was applied on PVC film on metallized side.

Opacity of the film was 98.90 % measured before blister formation.

WVTR of the film was 2.0 % measured before blister formation.

Opacity of the film was 38.90 % measured after blister formation.

WVTR of the film was 5.90 % measured after blister formation.

All the films in the aforesaid examples were tested for water vapour transmission rate (WVTR). The WVTR is given in TABLE 1. Water vapour transmission rate is measured as follows:

Water vapour transmission rate is the measure of the permeability of water vapour through the film/package under specified conditions of temperature & humidity and is denoted in gm/(m.sup.2. 24 hr.) at 38 degree C & 90% RH. Moisture barrier property and pack integrity of packaging can best be determined with accurate WVTR measurement. Optimum packaging selection, protection level of composite designs, package configuration, closure efficiency of seal/cap design & shelf life prediction of the packed product at various climatic conditions all can be accurately carried out with precise measurement of WVTR. The testing is done using MOCON Permetan WVTR measuring instrument. The moisture that permeates through the film is carried by the carrier gas and analysed by the IR modulated detector giving accurate and fast results of WVTR. TABLE 1

Claims

Claims:

1. A multi-layer thermoformed container having a lid and a base, the base comprising pharmaceutical and food packaging film substrate of thickness 100 to 1000 microns of food grade polyvinyl chloride, and a metallized layer of a thickness of 0.02 to 0.2 microns provided at least on one side of the said substrate, said film having an opacity of 95 % to 100 % in its flat undeformed configuration and an opacity of 35 % to 45 % in its deformed configuration in which at least one blister is thermoformed therein.

2. A multi-layer thermoformed container having a translucent pharmaceutical and food packaging film as claimed in claim 1, in which the metallized layer is formed on the substrate.

3. A multi-layer thermoformed container having a translucent pharmaceutical and food packaging film as claimed in claim 1, in which the metallized layer is applied on the substrate.

4. A multi-layer thermoformed container having a translucent pharmaceutical and food packaging film as claimed in claim 1, in which the metallized layer is formed on the substrate by at least one of the processes of metallization consisting of vacuum deposition, indirect metallization, electroless plating, electrolytic plating and lacquer painting.

5. A multi-layer thermoformed container having a translucent pharmaceutical and food packaging film as claimed in claim 1, in which the metallized layer consists of at least one of the metals from a group of metals consisting of Aluminium, Copper, Silver, Gold, Brass and Bronze.

6. A multi-layer thermoformed container having a translucent pharmaceutical and food packaging film of claim 1, in which an additional being predominantly organic layer of thickness 0.02 to 50 microns is provided on the polyvinyl chloride substrate non metallized side.

7. A multi-layer thermoformed container having a translucent pharmaceutical and food packaging film as claimed in claim 1, in which an additional being predominantly organic layer of thickness 0.02 to 50 microns is provided on the polyvinyl chloride substrate metallized side.

8. A multi-layer thermoformed container having a translucent pharmaceutical and food packaging film as claimed in claim 6, in which the organic layer is formed on the polyvinyl chloride substrate on the non metallized side.

9. A multi-layer thermoformed container having a translucent pharmaceutical and food packaging film as claimed in claim 7, in which the organic layer is formed on the metallized layer.

10. A multi-layer thermoformed container having a translucent pharmaceutical and food packaging film as claimed in claim 6, in which the organic layer is applied on the polyvinyl chloride substrate on the non metallized side.

11. A multi-layer thermoformed container having a translucent pharmaceutical and food packaging film as claimed in claim I₁ in which the organic layer is applied on the polyvinyl chloride substrate on the metallized side.

12. A multi-layer thermoformed container having a translucent pharmaceutical and food packaging film as claimed in claim 6 and 7, in which the organic polymer layer is a layer of at least one compound selected from a group of compounds consisting of polyvinylidine chloride, LDPE, HDPE, cyclic-olefin copolymer, colored or colorless lacquer and silicone.

13. A multi-layer thermoformed container having a translucent pharmaceutical and food packaging film as claimed in claim 6 and 7, in which at least one organic layer provided is laminated over the metallized layer using a tie layer of polyvinylidine chloride.

14. A multi-layer thermoformed container having a translucent film as claimed in claim 1, in which the polymer layer is cast metallized polyvinyl chloride.