World Applied Sciences Journal 14 (11): 1703-1716, 2011 ISSN 1818-4952 IDOSI Publications, 2011

Eco Friendly Pharmaceutical Packaging Material

Anupama Singh, Pramod Kumar Sharma and Rishabha Malviya Department of Pharmaceutical Technology, Meerut Institute of Engineering and Technology, Bypass Road, Baghpat Crossing, NH-58, Meerut-250 005, U.P., India
Abstract: Eco friendly pharmaceutical packaging materials are the safe materials for environment which enclose pharmaceutical product in any of the dosage forms. They may be derived from natural resources, like starches, proteins etc. that inflict little or nearly no harm on the environment and the environment dependent species. This review highlight the eco friendly materials, their classification, uses, advantages and finally summarizes the scope and future need in respect of pharmaceutical packaging. Classification has been done under several categories based on their uses, chemical constituents and the type of raw material used for its manufacturing. This review, details all the above mentioned aspects and the responsibility of pharmaceutical sector for progressive development of such eco friendly packaging. Key words: Environment friendly % Pharmaceutical packaging % Biodegradable % Recyclable % Reusable INTRODUCTION Pharmaceutical packaging materials are the collection of different components which surround the pharmaceutical product since the time of production till its use. Thus pharmaceutical packaging, as a collective term, may be defined as the science, art and technology of enclosing or protecting products for distribution, storage, sale and usage including printed material, employed in the finishing of a pharmaceutical product [1, 2]. It serves as an economical means of providing identification, presentation, protection, information and convenience from the time of production until it is used or administered [3, 4]. The type of pharmaceutical packaging used depends upon its function and type of the material used. All packaging materials must finally be evaluated via testing of selected materials, sterilization, storage and stability studies. Packaging of pharmaceutical products plays a very significant role in the maintenance of their quality [1, 5]. Functions of Packaging [6] Barrier Protection: It is meant for protection against all adverse external influences that can alter the properties of the product, which may include moisture, light, oxygen and temperature variations. This type of protection can be provided by using blister packing (Pharma-grade Barrier films and Eco-friendly Halogenfree films). Biological Protection: It is meant for the protection against biological contaminants. Physical Protection: It is meant for the protection of pharmaceutical dosage forms against physical damage. Information Communication: In pharmaceutical context, packagings should carry the information on the correct usage of dosage forms, their contents, their provenance, side-effects and warnings. Identification: It is meant for identification of the product. Security: Pharmaceutical packaging possesses certain features to prevent it from counterfeiting. It also prevents small children from accessing the contents of formulations. Convenience: Packaging must be convenient enough to increase consumer access to products and improve distribution, handling, selling and using such products.

Corresponding Author: Anupama Singh, Department of Pharmaceutical Technology, Meerut Institute of Engineering and Technology, Bypass Road, Baghpat Crossing, NH-58, Meerut-250005, U.P. India. Tel: +91-9720200161.

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Marketing: It is often used as marketing tool to differentiate a product and/or to convey a certain message or brand image to highlight the pharmaceutical aspects for consumers. The kind of packaging and the materials used must be chosen in such a way that: C Packaging itself does not produce any adverse effect on the quality of the pharmaceutical product through chemical reactions, leaching of packaging materials, or absorption. Product does not produce any adverse effect on the quality of pharmaceutical packaging by changing its properties, or affecting its protective functions [7]. Packaging as well as the product itself should not have any adverse effect on the environment. Another important factor considered must be its low cost, ease of fabrication, availability and regulatory acceptance of the material as well as the final product used.

C C

The key philosophy of packaging is that it must be gentle to the environment and thus, most of the pharmaceutical companies are willing to accept this as their prime responsibility [8]. As a result pharmaceutical companies have also started the use of recycled resources for packaging and made their packaging easier to recycle [8]. Eco Friendly Pharmaceutical Packaging: The word eco friendly, also known as environmental friendly or nature friendly or green packaging materials are packaging that uses environment safe materials in its production thus to inflict minimal or no harm on the environment. Such environmental friendly pharmaceutical packaging materials often are marked with eco-labels. Various research and development projects are on the way to introduce the use of biodegradable and eco friendly packaging materials. The design of such biodegradable and eco friendly packaging materials are the present day need and thus must be used to replace an existing packaging material, or to complement one which are available in market [7, 8, 10-12]. Products for eco friendly packaging provides options which include paper/ cardboard (preferably recycled or from sustainable sources) and corn starch which are biodegradable in nature. Corn starch can be used to make a wide variety of different products including bags, trays and boxes and

provides a great alternative to plastic but with similar hard-wearing properties [13]. Once a product is in the market it is difficult to improve the environmental characteristics of packaging or a device hence, environmental considerations are taken into account at an early stage of development [14]. Packaging design is challenging enough to provide a solution for current ecological needs by providing efficient ways to package the formulation in pharmaceutical industry [7]. These designs also aim to reduce the amount of packaging material that is ultimately disposed off. Greener packaging designs fulfills the needs of most pharmaceutical manufacturers without sacrificing our environment. For this various types of eco friendly packaging materials have been developed. Packaging and devices are therefore designed and manufactured to allow recycling of a certain percentage by weight or have a minimum calorific value to allow optimization of energy recovery. Characteristics of eco friendly packaging include that it should be well-designed, streamlined, biodegradable and easily recyclable or reusable [8]. Pharma industry too is progressing towards the use of such reusable materials to meet the growing challenges of the present century. Two major concepts of eco-friendly pharmaceutical packaging material are that they are either recyclable or biodegradable. With the advent of new technology and increasing demand, biodegradable packaging has become cost-effective and many companies are boosting their sales due to their switch over to biodegradable packaging. Cosmetics and natural health products are also enhancing their brand image by adopting such type of packaging since, eco friendly pharmaceutical packaging is one of the hottest ethical global trends. It also adds brand value to a particular product [15]. The development of environment friendly pharmaceutical packaging material technology is still in the phase of growth [14]. CLASSIFICATION Environment friendly pharmaceutical packaging materials can be classified in several ways: C C C Based on their uses (given in Table 1) [16]. Based on the chemical constituent used. Polysaccharide.

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Table 1: Functional parameters of eco friendly pharmaceutical packaging material1 Parameters Barrier protection Biological protection Physical protection Information communication Identification Security Convenience Marketing Description Provides protection against moisture, light, oxygen and temperature variations Provides protection against biological contaminants Ensures protection against any physical damage Conveys information on the correct usage of dosage forms, their contents, their provenance, side-effects and warnings Easy identification of the product Protection from small children and against counterfeiting Increase consumer access to products and improve distribution, handling, selling and using such products Differentiate a product and/or to convey a certain message or brand image to highlight the pharmaceutical aspects for consumers

Starch: Starch, a polysaccharide, is a renewable, eco friendly and widely available raw material. It is obtained from various sources such as legumes, tubers, cereals. The primary source of starch is corn, potato, wheat and rice. It can be pressed into sheets for packing thin walled products such as trays, disposable dishes etc [17-24]. It is used as a loose fill for packaging, bags and sacks, flexible packaging, rigid packaging. Since starch packaging materials are brittle in nature when a high concentration of starch is used, various biodegradable plasticizers like glycerol and other low-molecular weight polyhydroxy compounds, polyethers and urea are added. Plasticizers inhibit the microbial growth by lowering the water activity [17]. In recent years, compostable materials involving starch based thermoplastic materials are dominating the market [17]. The blend of biodegradable starch based polymers like polylactide, polyhydroxybutyrate (PHB), polyhydroxyalkanoate (PHA) and a copolymer of PHB and valeric acid (V) with aliphatic polyesters or polyvinyl alcohol has increased some of their properties with significant use in various industrial applications. Four types of starch based polymers are available [24-27]: C C C C Starch synthetic aliphatic polyester blends. Thermoplastic starch products. Starch-Polyvinyl alcohol blends. Starch polybutylene succinate or polybutylene succinate adipate (PBSA) polyester blends.

cellulose, hydroxypropyl cellulose and cellulose acetate. Among these derivatives cellulose acetate is widely used in pharmaceutical packaging and other laboratory works [17, 22, 24, 28-30]. Xylan: It forms a group of substances called hemicellulose. It is a naturally occurring most common carbohydrate found in plant cell walls and some algae. It is also obtained as residue from agricultural industries. Like cardboard, xylan is biodegradable, compostable and hence eco friendly. Xylophane is thus used as an environment friendly packaging material [31-32]. Chitin/Chitosan: It occurs in the exoskeleton of invertebrates. It forms the second most abundant polysaccharide resource after cellulose. Chitin is widely used in packaging due to its antimicrobial property, thus maintains the preservative action and protects the product from unnecessary microbial growth. It has the unique property to absorb heavy metal ions and is mostly used as packaging material in edible coatings. Chitosan-cellulose and polycaprolactone forms the biodegradable laminate in modified atmosphere packaging of fresh product [17, 19]. Protein: A protein is formed of repeating units of amino acids. The chemical modification of side chain of these polymers through grafting help in tailoring the properties of packaging material. Cross linking of polymer and graft copolymerization of natural polymer with synthetic monomer is better alternative advancement towards biodegradable packaging films [17, 33]. Protein based raw materials are derived from replenishable, agricultural feed stocks often called agricultural materials or agro-packaging materials that are renewable and biodegradable and used in edible packaging. The concept of agro-packaging refers to the use of renewable products and control of the end

Cellulose: Cellophane is the most common cellulose-based biopolymer. Cellulose is a linear polymer of anhydroglucose that occurs most abundantly in nature. Cellulose derivatives widely used for packaging, are commercially produced; examples of which include methyl cellulose, ethyl cellulose, carboxymethyl cellulose, hydroxyethyl

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Table 2: Classification on basis of uses Type of packaging material Multi use packaging Material or chemical recycling packaging Packaging meant for burning i.e. energy recovery with energetic recycling Single-use packaging Edible packaging Examples Glass bottles for medicines, injection syringes Plastic bottles for medicated hand wash Glass, metal, paper and plastics for instance bottles from polyethylene terephthalate i.e. PET Paper, cardboard, plastics Paper and biodegradable plastics (PVC sheets) Starch, gelatin, pectins, wheat bran etc. Recycled Biodegradable Biodegradable Recycled Properties Refilled

products. Numerous plant and animal proteins are commonly used as raw material for agro-packaging materials. Thus proteins can be divided into proteins from plant origin (e.g. soy, gluten, pea, potato etc.) and proteins from animal origin (e.g. casein, whey, collagen, keratin etc.).The classification on the basis of origin has been illustrated in Table 2 [34-48]. Based on the Type of Raw Material Plastics: Plastic packaging constitutes 20% of the weight of all packaging. Plastic coating and packaging materials are often signaled out as the main environmental culprits hence technological advancements are now in the growth phase to find out more innovative ways to reduce the environmental impact of packaging thus making more biodegradable and hence eco friendly materials out of the existing one [49-53]. Previously plastics were produced from petrochemicals but they had contributed to environmental crisis due to their non recyclability, hence, as an alternative eco friendly bio plastics have now been obtained from plant sources like plant derived polysaccharides (corn, wheat, potatoes) and proteins which are recyclable, as already discussed [15, 54]. Polymers isolated from natural sources are processed to produce plastics. For example, lactic acid is extracted from corn to produce plastic, long chain polymers like poly lactic acids obtained by microbial transformation of starch extracted from plant sources. Hydrophilic synthetic polymer molecules are blended with these natural products to give environment friendly plastics [15]. Plastic forms the most versatile groups of materials used in packaging because they can be easily modified to satisfy a broad spectrum of packaging and other demands. Child-resistant plastic closures and leak-proof plastic containers for medicines and chemicals provide safety, convenience, ergonomics and ease of use. It is one of the most energy efficient, robust, eco friendly and economic pharmaceutical packaging material due to its light weight and relative strength [54].

Plastics can be molded to desired shape, protect against contamination and serves as the perfect materials for shipping and storing intricate medical instruments. The flexibility of plastics are particularly suitable in the field of pharmaceutical packaging for molded packaging with sealing systems for controlled dosage [55-58]. The two main types of biodegradable plastics are available in the market viz. hydrobiodegradable plastics (HBP) and oxo-biodegradable plastics (OBP). Hydro-biodegradable plastics (HBP) are made up of agricultural resources like corn, wheat, sugarcane. Some of the commonly used polymers include polyhydroxyalkanoates (PHA), polyhydroxybutyratevalerate (PHBV), polylactic acid (PLA), polycaprolactone (PCL), polyvinyl alcohol (PVA), polyethylene terephthalate (PET) etc. HBPs degrade and biodegrade somewhat more quickly to carbon dioxide (CO2), water (H2O) and biomass. Oxo-biodegradable plastics (OBP) consists of a mixture of small proportion of compounds of specific transition metals (iron, manganese, cobalt and nickel) and polyolefins such as polypropylene (PP), polyethylene (PE) and polystyrene (PS). OBP has an advantage over HBP that they do not emit methane in anaerobic conditions [59]. Plastic packaging material comes in various forms like PET, PVC, PS, polyamide, polyester, polyolefins and ethylene vinyl alcohol; which are used for various types of pharmaceutical products. It also involves preparation of flexible packaging [6]. The main use of such containers is for bags for parenteral solutions. Hence they must be safe enough to maintain the drug properties as well as not to impose any environmental adverse effect [60-61]. Among the above mentioned examples, polyolefins and polyesters are the most commonly used eco friendly plastic packaging materials. Polyolefins: It is a collective term for polypropylene and polyethylene, the two most commonly used plastics in pharmaceutical packaging. They both offers flexibility, lightness, strength, chemical resistance,

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stability, moisture, easy processability and are well opted for recycling and reuse. The two basic categories of polyethylene are high density polyethylene and low density polyethylene. The high density polyethylene plastic containers are the most recycled among these two plastic packaging materials [25, 62, 63]. Polyesters: Polyethylene naphthalate (PEN), polycarbonate and polyethylene terephthalate (PETE or PET) are the condensation polymers that are formed from ester monomers through reaction between carboxylic acid and alcohol. PETE is the most commonly used polyester in packaging as containers (bottles, jars and tubs), semi rigid sheets for thermoforming (trays and blisters) and thin oriented films (bags). PETE is recyclable to various other packaging applications. Polystyrene: Polystyrene is used in protective applications such as containers, disposable plastic syringes and for cushioning. It can be recycled or incinerated [62, 64]. Polystyrene in its pure form is non biodegradable, hence oxo-degradable polystyrene foam containers are formed which uses totally degradable plastic additives (TDPAC), mixed with the base resin that acts as a catalyst to promote degradation, without compromising performance [64]. Glass: Glass accounts for 20% of the weight of all packaging. Its raw materials are present in abundant quantity in nature hence it is considered greener. It can be reused and recycled easily to make new containers which further reduce its untoward environmental impact. Glass is the only packaging material rated 'GRAS' or 'generally regarded as safe' by the U.S. Food & Drug Administration [25, 64-66]. Glass is widely used as an eco friendly pharmaceutical packaging material. Various grades of glasses are classified official in pharmacopoeias based on their utility and chemical characteristics [67]. They are used as the first choice containers in cosmetics and certain pharmaceuticals including medicinal products for oral and local administration, for example, bottles for tablets, injections syringes for unit or multi-dose administration [6, 68]. Recycling of glass in the manufacture of new bottles and jars requires substantially less energy and is thus preferred from the resource conservation standpoint. Glass containers are more preferred for parenterals due to ease of sterilization and clear visibility. Although they can be processed in different forms according to the need, e.g. amber glass bottles are produced to prevent photo

degradation of light sensitive drugs. Also most of the parts of analytical instruments used in pharmaceuticals are made of glass to increase the visibility [64, 68]. Metals: Metal is the most versatile of all pharmaceutical packaging material. These have excellent barrier properties, physical protection, formability, durablility, decorative potential, consumer potential and recyclability [15, 68]. Metals are used as containers for pharmaceutical products for non parenteral administration such as tubes, cans, aerosol and gas cylinders and packs made from foils or blisters. Different types of metals used in pharmaceutical packaging materials include aluminum, tin plate, steel etc. Aluminum: It is mainly used for making seamless containers, as aluminum foils and laminates. It is recyclable into new products and hence forms the eco friendly pharmaceutical packaging material [25, 69, 70]. It has high intrinsic worth to reclaim the metal from packaging waste with less economic expense. Also the recycling process does not degrade the metal, so that new aluminum packs can be prepared from 100% recycled material [64]. Pure aluminum metal can be rolled into thin sheets, followed by annealing to prepare aluminum foils used for variety of pharmaceutical applications such as alu-alu blister packs, inner seals for pharmaceutical containers which provide tamper evident and a hermetic barrier. Binding of aluminum foil to plastic film or paper forms laminates of packaging which improve barrier properties. Another alternative to laminate packaging is metalized film, which are plastics containing a thin layer of aluminum metal. The individual components of laminates and metallized films are recyclable but separating them is difficult and hence this prevents their economic feasible recycling. The main advantage of these films is that they provide improved barrier protection to dosage forms against moisture, air, oils and odors. They also have high reflective surface that increases its acceptability to patients [64, 71]. Tinplate: Tinplate is produced from low carbon steel coated on both sides with thin layers of tin. It is widely used to form aerosol containers and package closures [25, 69]. It is easily recyclable many times to new packaging products without loss of quality and is cheaper than aluminum. It provides excellent barrier protection, amenability for printing, graphics, retorting, strength, formability, longer shelf life to the dosage form and above all eco friendliness [70, 71].

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Steel: Traditionally as much as 40% of steel scrap was recycled for the production of new steel. There are different types of steels such as Carbon Steels, Alloy Steels, Tool Steels, Stainless Steels. From an environmental standpoint, it can be readily and cheaply separated from mixed waste using magnets [64, 72]. Steel containers are used as both primary and secondary packaging for pharmaceutical products such as aerosols. It is also used in bottle caps and closures as a tamper proof packaging material. Steel recycling is more economical to aluminum [27, 71-73]. Paper and Paperboard: Paper and paperboard are made up of interlaced network of cellulose fibers, obtained from wood. In late 19th century there occurred increase in the use of paper and boards for packaging. Paper is always treated, coated, laminated or impregnated with materials such as waxes, resins or lacquers when used as primary packaging to improve functional and protective properties [6, 54, 74-75]. Different types of papers used in packaging are kraft paper, sulfite paper, grease proof paper, glassine and parchment paper. Having all the properties combined, paperboard is thicker than paper and in multiple layers with high weight per unit area. Paperboards can be classified as: Solid Board: It has multiple layers of bleached sulfate board. It is used to create liquid cartons (known as milk board) when laminated with polyethylene. White Board: It is made of several layers of bleached chemical pulp. It is used as primary packaging material when coated with wax or laminated with polyethylene for heat sealability. Moreover, white board paper is also used as the inner layer of a carton. Chipboard: It is lined with white board to improve appearance and strength and is made from recycled paper to make the outer layers of cartons. Fiberboard: It occurs in two forms: solid or corrugated. The solid board has an inner layer of white board and an outer layer of kraft. On laminating with aluminum or plastics barrier protection is improved to pack products in dry form. On the other hand, corrugated type is made of two layers of kraft paper with a central corrugating (or fluting) material. It has high resistance to impact abrasion which makes it suitable for packing products during shipping [25]. Paper forms to be the most recyclable naturally occurring material and hence suitably

opted for eco friendly pharmaceutical packaging [15]. They have a good environmental image because they are completely biodegradable and their raw materials are renewable. Paper and board are often coated and laminated with impermeable materials to improve their strength and rigidity when wet. Though this makes their recycling technically difficult and costly but not impossible to re-pulp these materials for use in similar applications [64, 76, 77]. Paperboard materials are widely used as secondary pharmaceutical packaging in the construction of corrugated boxes [6, 71, 78]. Rubber: Rubber is obtained from latex found in the sap of some plants. It is used in pharmaceutical packaging as closures [79, 80]. Eco friendly rubber contains a high percentage (up to 80 %) of recycled rubber and no such substances that harm the environment [80]. Mixed Material Packaging: It is a new type of packaging consisting of a mixture of several types of packaging material. Although each material used is recyclable yet combination of these materials makes recycling technically difficult but not impossible. Mixed material packaging are more resource and energy efficient than single material packaging. An example of this type of packaging is Tetra Pak which consists of 75% paper, 20% polyethylene and 5% aluminum foil. The mixed material packaging can be reprocessed into other new packs (all data depicted in Figure 1) [79-81]. Historically, packaging was used to transport the formulations from their place of manufacture till its use. Later the use of packaging became prominent in the preservation, identification and protection of formulations for longer shelf life. Since then various revolutionary changes have occurred according to latest WHO and cGMP guidelines catering to the ever expanding range of pharmaceutical products that are in the market. Previously, the packages were obtained from natural resources originated from plant material [64]. These materials were then processed to form packages that have improved properties according to the requirements of the dosage form. Although glass making began in 7000 B.C. but it was first industrialized in Egypt in 1500 B.C. Then glass containers of all shapes and sizes dominated the market from early 1900s till late 1960s for liquid formulations. The glass used in packaging today is the only type of glass accepted in US recycling programs. Other packaging materials

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gained popularity in 1970s such as plastics and metals. Metals e.g. iron and tin plated steel were also used as packaging materials in the early 19th century. Development of other metals like aluminum incorporated their use into pharmaceutical packaging to improve performance and functionality [54, 72, 83]. The first aluminum foil containers were designed in the early 1950s while the use of aluminum can appeared in 1959. Soon after paperboard, cartons and corrugated fiberboard boxes were introduced later in the 19th century. Their popularity gained pace throughout much of the 20th century. Advancements in packaging in the early 20th century introduced other packaging materials such as bakelite closures on bottles, transparent cellophane overwraps and panels on cartons. The advent of plastics between late 1970s and early 1980s significantly replaced paper and its related products in many pharmaceutical uses. Several plastics were discovered in the nineteenth century such as styrene in 1831, vinyl chloride in 1835 and celluloid in the late 1860s but, these materials did not become practical for packaging until twentieth century [84]. Currently, focus on newer packaging materials are in progress that incorporates recyclable and reusable resources. Research in the production of biodegradable packaging materials is the current aspect of developing eco friendly pharmaceutical packaging materials [49, 85]. To overcome the problem of biodegradation, more emphasis is now paid on flexible packaging. It is the source-reduced form of packaging that incorporates the least amount of material. Moreover, it reduces the weight of overall formulation as well as creates very little waste to be discarded. Cloth and paper are the oldest forms of flexible packaging. Decreasing the amount of material in pharmaceutical packaging is usually more important than the composition of the package to obtain the best eco friendly form of packaging. Other flexible pharmaceutical packagings introduced recently include collapsible, soft metal tubes made up of plastic [54]. Need for the Development of Eco Friendly Pharmaceutical Packaging Material: The primary function of any pharmaceutical packaging material is the protection of formulation against ambient environment to enhance its shelf life and conserve its contents. The focus must also be paid on the protection of the environment against the undesirable effect of pharmaceutical packaging materials. Environment protection is also a matter of great concern in many countries. The

development of pharmaceutical packaging involves considerations for environmental responsibility, sustainability and certain applicable environmental and recycling regulations. More attention has been paid to the disposal and recycling of packaging waste in many countries [79]. Traditionally used eco friendly pharmaceutical packaging covers a very small percentage of waste, but its disposal can cause environmental problem too. Provisions should be made to introduce newer eco friendly packaging materials with the aim of [79, 85]: Reduction of the Quantity of Packaging Material: Attempts should be made to reduce the bulk of pharmaceutical packaging material so that lesser waste will be generated which can be easily biodegradable, reusable, nontoxic and inert. Recycling of Pharmaceutical Packaging Material: The use of recyclable or biodegradable packaging material such as aluminum, paper and glass creates less or no waste and hence they are environmentally safe. Elimination and Incineration of Pharmaceutical Packaging: Incineration is recommended to eliminate contaminated packaging. The combustion heat thus generated can be used for various purposes. For example, those plastic materials that cannot be recycled are therefore incinerated. This process involves the waste treatment process done by combustion of organic substances contained in waste materials that coverts the waste into ash, flue gas and heat. This process also reduces the solid mass of the original waste by 80-85% and the volume by 95-96 %. Thus incineration does not completely replace land filling, but significantly reduces the necessary volume for disposal. Recently, more attention is paid on the development of eco friendly biodegradable pharmaceutical packaging materials from natural renewable resources such as, agro-based materials [86-88]. As these materials are renewable and biodegradable they contribute to development of pharmaceutical sustainable packaging and this reduces their environmental impact upon disposal. Such biodegradable packaging materials are suitable for single use disposable packaging applications. Qualities of Eco Friendly Pharmaceutical Packaging Material Reduce: It is the property of eco friendly packaging material to minimize the bulk of packaging. This reduces

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the unnecessary dumping of degradation products. Moreover, certain legislative standards also prevent the over packaging of some formulations. For example, it is good to use one large bottle of formulation instead of individual small bottles, multiple dosage containers rather than single use containers. Three most important aspects of reducing pharmaceutical packaging material include [72, 74, 79, 81, 82]: C C C Reduction of quantity of packaging waste Supporting eco friendly marketing campaigns Increasing shipping efficiency

Reuse: The property of eco friendly packaging material to be used over and over again is termed as reuse. This property involves the use of packaging material in its original form. For example a number of toiletries from the body shop and cleaning liquids are sold in reusable or returnable containers. Similarly, buying milk in reusable bottles avoids the creation of plastic waste [72, 79]. Renew: It is the property of eco friendly packaging material obtained from renewable natural resources that can be reprocessed into new packaging, e.g. thermoplastic. Repurpose: This is the property of eco friendly packaging material to be molded in another new form with another pharmaceutical purpose in mind [79]. Based upon these environmental issues and properties eco friendly pharmaceutical packaging materials are represented in table form as shown in Table 3 [25].

Recycle: It is the property of eco friendly packaging material to turn used packaging material into newer packaging. The examples include glass, metal, thermoplastic, paper and paperboards, which are recyclable eco friendly packaging material. Also materials reclaimed through glass and metal recycling are considerably safer for formulations against microorganisms [25, 79].
Table 3: Classification on basis of origin Plant Derived Proteins -----------------------------------------------------------------------------------------------Type Gluten Description Main storage protein in wheat and corn, plastic exhibits high gloss, resistant to water, does not dissolve in water but absorb water during immersion, have low price. Used in edible films, adhesives, molded biodegradable thermoplastic films for agricultural uses, windows in envelopes, surface coatings on paper, water-soluble bags with fertilizers, detergents, cosmetics. Soy protein Commercially available as soy concentrate, soy flour and soy isolate have different protein content. Used as adhesives or biodegradable plastics produced from soy isolate and concentrate by thermomolding process, as inks, paper coatings, oil for lubrication, soy films as coating materials for preservation. Whey By-product of cheese industry, rich in "-lactoglobulin which forms the basis for its use in packaging as edible coatings and films.

Animal Derived Proteins ----------------------------------------------------------------------------------------Type Casein Description Milk derived protein, easily processable. Used as a thermoset plastic, for bottle labeling due to excellent adhesive properties.

Keratin

Structural protein extracted from waste streams such as hair, nails and feathers, poor mechanical properties, cheapest protein. Used to produce fully biodegradable water insoluble plastic.

Collagen

Fibrous, flexible and structural protein with common repeating unit: proline, glycine and hydroproline, found in animal tissues particularly tendons, skin and bones. Used as packaging material in several pharmaceutical applications.

Zein

Comprises a group of alcohol soluble proteins (prolamines) found in corn endosperm. Zein based films used as biobased packaging material and in pharmaceutical coatings.

Gelatin

Obtained from skin and bones. Used as a packaging material for improving moisture sensitivity, as a raw material for photographic films, for microencapsulating aromas, vitamins and sweeteners, as gelatin films in pharmaceutical industry to fabricate tablets and capsules.

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Table 4: General Properties and environmental issues Types of packaging material -------------------------------Glass Properties of packaging material --------------------------------------------------------------------------Advantages # Inert # Withstand heat process # Impermeable to moisture and gases Metals Tin plate # Strong and formable # Impermeable to moisture and gases # Resistance to corrosion # Withstands heat process Aluminum # Impermeable to moisture and gases # Withstands heat process # Resistance to corrosion Tin free steel # Strong and formable # Impermeable to moisture and gases # Resistance to corrosion # Withstands heat process Paper # Light in weight # More resourceful and hence easily available Plastic Poly-olefins #Impermeable to moisture # Resistant to chemicals # Strong Poly-esters # Good barrier properties # Strong # Withstand for filling Poly-vinyl chloride Poly-vinylidene chloride # Moldable # Resistant to chemicals # Impermeable to moisture and gases # Heat sealable # Withstands filling # Recyclable # Recyclable # Recyclable # Permeable to moisture and gases # Easy to tear # Less ability of processing # Poor gas barrier # High energy source for incineration # Recyclable # Easily recyclable in semi rigid form but identification and separation more difficult for films # Easily recyclable in semi rigid form but identification and separation more difficult for films # Contains chlorine # Requires separation from other waste # Contains chlorine # Requires separation from other waste # Recyclable # Reusable # Bio-degradable # Reacts with formulations and hence coating required # Limited structural strength # Cannot be welded # Recyclable # Economic incentive to recycle # Light weight # Separation difficulties in laminated form #Reacts with formulations and hence coating required Disadvantages # Needs separate closure # Easily breakable Environmental Issues ------------------------------------------------------------Advantages # Recyclable # Reusable # Refillable #Recyclable # Magnetic thus can be separated # Heavier than aluminum Disadvantages #Heavy # Bulky to transport

Mechanism of Action of Their Eco Friendly Character: The main concept of eco friendly and user friendly packaging material is based upon its biodegradable efficacy. The total biodegradability of raw materials derived from replenishable agricultural feedstock such as starch, cellulose and proteins occurs to environment friendly benign products such as carbon dioxide, water and quality compost [19]. The simple mechanism of biodegradation of pharmaceutical packaging materials is the initial direct enzymatic scission of digestible macromolecules forming a chain.

Then the split portions are metabolized leading to the enzymatic dissimilation of the macromolecule from the chain ends. Oxidative cleavage of macromolecules constituting the basic skeleton of pharmaceutical packaging material often leads to better metabolization of the fragments which are smaller enough to be converted by microorganisms [9, 89, 90]. Ideally the eco friendly pharmaceutical packaging material will be decomposed in a bio waste collection and the later gets composted into environment friendly byproducts such as carbon dioxide and water.

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Another mechanism is photo degradation of pharmaceutical packaging material to smaller disposable materials which do not create any environmental hazard. Some biodegradable pharmaceutical packaging material experience rapid dissolution when exposed to particular chemical based aqueous solutions. This is then followed by full biodegradation of the aqueous solutions through microbial digestion. Such packaging materials that disintegrate upon exposure to aqueous solutions are utilized for the transport and disposal of pharmaceutical wastes. Scope of Eco Friendly Pharmaceutical Packaging Material: Government of China and Germany are encouraging the research activities towards the wide spread application of biodegradable materials to reduce the waste thus generated. A world leading chemical and plastic industry, BASF, is working on further development of starch and polyester based biodegradable plastic materials like Ecoflex [49-51]. Polyvinyl alcohol product known as Depart is another eco friendly pharmaceutical packaging material finding wider range of applications in hospital laundry bags and catheter bags. Developed countries like England already have a plastic department in London, which is now actively participating in the development of biocomposite pharmaceutical packaging [49]. They follow the European packaging directives for material recovery of packaging waste. Though European nations are the front runners in eco friendly pharmaceutical packaging material research and development activities but impressive development work is still in progress in other developing countries [50]. The ultimate goal of developments is to find an optimum pharmaceutical packaging material with full biodegradability. Biodegradable packaging is a latest step in sustainable packaging design. Moreover, some packaging also bears eco-friendly labeling which serve as an essential point of differentiation for formulations. It is required where biodegradable packaging becomes a tangible expression of a pharmaceutical products brand promise [49]. Nowadays standard organizations such as the ASTM and ISO have published methods for material tests on biodegradable plastic materials. The eco friendly pharmaceutical packaging industry has a positive future, along with the environmental benefits of using natural renewable resources. Currently pharmaceutical

industries are emphasizing more and more on environmental responsibility so it is an ideal time for further growth of eco friendly pharmaceutical packaging materials [9]. Although this is great news for the environment, it may be somewhat surprising to pharmaceutical marketers that the benefits from eco friendly packaging may not stop there. CONCLUSION There are a seemingly limitless number of areas where eco friendly pharmaceutical packaging materials may find use. Though environmental impact of packaging is increasingly coming under scrutiny, its positive contribution towards protecting pharmaceutical products and hence the environment is the area which can be explored. Before modifying any one among the new eco friendly packaging substances, they should find a standard ground for usage. Organizations such as ISO and WHO have already laid down norms for safe and effective packaging materials and technologies which are to be followed. Therefore, Pharma sector has to be specific enough while utilizing such eco friendly materials for packaging. As the history illustrates, these substances which can be safely and effectively employed, have been in use since ages in pharmaceutical industry. The applications of several aspects of such substances have already considered biodegradation and biocompatibility as illustrated in the review. Present day need focuses on the development of a new trend towards the generation of environmental friendly packaging material that adds value to the pharmaceutical product as well as creates a new outlook into the concept of eco friendly pharmaceutical packaging material. The target remains for pharmaceutical companies to focus on the development of a single such eco friendly packaging material that bears the combined characteristics of glass, metal, plastic, paper and rubber. REFERENCES 1. World Health Organization, 2002. Guidelines on packaging for pharmaceutical Product, Annex 9, 2002. (WHO Technical Report Series, No. 902) http://www.who.int/medicines/areas/quality_safety /quality_assurance/regulatory_standards/en/index. html.

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