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Sudarshan Singh

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Beschreibung

Bio-based polymers are materials that are produced from renewable resources. Their biodegradable properties are the driver of worldwide interest among researchers and manufacturers in recent years due to the demand and need for alternatives to fossil fuel based polymers. The use of biodegradable polymers creates a sustainable industry. In contrast, the raw materials for synthetic polymers derived from petrochemicals will eventually deplete and most of them are non-biodegradable. Despite these advantages, bio-based polymers account for only a tiny fraction of the total global plastic market.
Non-biodegradability issues of synthetic pharmaceutical inactive ingredients strongly emphasized innovators towards the development of biopolymers. Recently natural biodegradable excipients gained significant attention due to their sustainability and engineered applications. Innovative technologies to transform these materials into value-added chemicals via novel graft-polymerization or co-processing techniques for the production of high-performance multifunctional and low-cost polymers with tunable structures are key parts of its sustainable development.
Biopolymers Towards Green and Sustainable Development elaborates on important issues that surround bio-based polymers. It gives the reader an overview of biopolymers, the impact of non-biodegradable polymers on the environment and health, emerging sources of biodegradable polymers, structural and morphological characterization techniques, thermomechanical properties, biodegradable plastics from biopolymers, pharmaceutical, biomedical, and textile applications, and pharmacokinetics and pharmacodynamics. Moreover, a brief bibliometric meta-analysis on bio-based pharmaceutical excipients provides an update about teams involved in the development of polymeric research that may be of interest to anyone who wants to work on sustainable biopolymer projects.
Key Features
- provides an updated summary on recently discovered natural polymeric materials
- gives a thorough breakdown of the vast range of biopolymer applications including fabrication of conventional and novel drug delivery, polymeric scaffolds, composites, microneedles, and green synthesis of metallic nanoparticles,
- summarizes pharmacology and pharmacokinetics of the inactive pharmaceutical ingredient and excipients
- presents a bibliometric meta-analysis indicating potential collaboration between country, organization, institution, and authors with a view on recent ongoing trends in tyhe biopolymer landscape.

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Table of Contents
BENTHAM SCIENCE PUBLISHERS LTD.
End User License Agreement (for non-institutional, personal use)
Usage Rules:
Disclaimer:
Limitation of Liability:
General:
FOREWORD
PREFACE
CONSENT FOR PUBLICATION
CONFLICT OF INTEREST
ACKNOWLEDGEMENTS
Key Feature
Overview on Bio-based Polymers
Abstract
Introduction
History of Biodegradable Polymers
Market Potential of Pharmaceutical Natural Excipients
Biopolymers Linkage with the Sustainable Agriculture Industry
Food and Drug Administrative Regulation
Conclusions and Future Perspective
References
Impact of Non-Biodegradable Polymers on the Environment and Human Health
Abstract
Introduction
Sustainability and Life-Cycle Assessments of Polymers on Eco-System
The Interactive Reaction Between Polymers and the Environment
Biodegradable Oxidizable Polymers
Biodegradable Hydrolyzable Polymers
Effect of Non-Biodegradable Polymers on Wild Life and Human Health
Conclusions and Future Prospects
References
Potential Sources of Biodegradable Polymers
Abstract
Introduction
Potential Polymers from Natural Resources
Silkworm Cocoon as a Potential Source of Biodegradable Polymers
Biopolymers from Peptide and Polypeptides
Lignin an Aromatic Biopolymers
Co-processed Bio-Based Polymers
Graft Co-Polymerizations
Biodegradable Polymers From Marine Origin
Conclusions And Future Prospects
References
Conformational, Morphological, and Physical Characterization of Bio-based Polymers
Abstract
Introduction
Chemistry Of Bio-Based Polymers
Chemistry Of Structurally Modified Bio-Based Polymers
Surface Morphology
Physio-Technical Characterization
Conclusions and Future Prospects
References
Thermo-Mechanical Properties of Bio-Based Polymers
Abstract
Introduction
Thermal Analysis
Mechanical Properties of Nanocomposites Fabricated Using Bio-Based Polymers
Conclusions and Future Aspects
REFERENCES
Pharmaceutical and Biomedical Applications of Bio-Based Excipients
Abstract
Introduction
Polymers in Conventional Drug Delivery System
Polymers in Modified And Novel Drug Delivery Systems
Polymeric Scaffolds for Tissue Engineering
Biodegradable Polymeric Composites
Biopolymers in Electrospinning Technology
Non-Invasive Micro-Needles Fabrication Using Biodegradable Bio-Based Polymer
Green Synthesis of Metallic Nanoparticles Using Bio-Based Excipient
Other Applications
Conclusions and Future Prospects
REFERENCES
Potential Application of Biopolymers as Biodegradable Plastic
Abstract
Introduction
Biopolymers as Biodegradable Plastics
Conclusions and Future Prospects
REFERENCES
Potential Application of Biopolymers in the Textile Industry
Abstract
Introduction
Biopolymers in the Textile Industry
Conclusions and Future Prospects
REFERENCES
Pharmacokinetics and Toxicology of Pharma- ceutical Excipients
Abstract
Introduction
Pharmacokinetic and Toxicology of Excipients
Basics of Pharmacokinetic and Pharmacodynamics
Pharmacokinetics Profiling of Active and Inactive Substances
Conclusions and Future Perspectives
REFERENCE
Bibliometric Analysis of Bio-Based Pharmaceutical Excipients
Abstract
Introduction
Study Design
Data Collection
Results and Discussion
Publication Trends During 2000 to 2020 and Distribution of Publication Based on the Theme
Co-Authorship of Authors
Occurrence of Authors Keywords and Co-Occurrence of all Keywords
Bibliographic Coupling of Countries
Co-Citation of Sources
Limitations of the Study
Conclusions
REFERENCES
Biopolymers Towards Green and Sustainable Development
Authored by
Sudarshan Singh
Department of Pharmaceutical Science
Faculty of Pharmacy, Chiang Mai University
Chiang Mai
Thailand
&
Warangkana Chunglok
School of Allied Health Sciences,
Walailak University,
Nakhon Si Thammarat,
Thailand

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FOREWORD

Associate Prof. Dr. Chuda Chittasupho
Faculty of Pharmacy
Chiang Mai University, Thailand

There has been growing concern about the negative impacts of environmental pollution from fossil fuels, waste from petroleum products, and non-biodegradable materials. A lot of research has been done into exploring another alternative to petroleum-based products which would be renewable as well as biodegradable and thus pose a lesser risk to the environment. Biopolymers are one such possible solution to the problem because they are typically biodegradable materials obtained from renewable sources. Moreover, biopolymers are produced by the cells of living organisms consisting of monomeric units that are covalently bonded to form large molecules. Some of the first modern biomaterials made from natural biopolymers include rubber, linoleum, celluloid, and cellophane. However, due to growing ecological concerns, the application of biopolymers enjoys renewed interest from the scientific community, the industrial sectors, and even other allied sectors.

Biopolymers towards green and sustainable development provide an up-to-date summary of polymeric materials characterized by biodegradability and sustainability. The book includes a thorough breakdown of the vast range of application areas, including pharmaceutical and medical, packaging, textile, biodegradable plastics, green synthesis of metallic nanoparticles, and many more, giving engineers critical materials information in an area that has traditionally been more limited than conventional inactive ingredients. This book aims to fulfill the current need of the researcher by providing an excellent bibliometric meta-analysis on bio-based polymers indicating potential collaboration between country, organization, institution, and authors. Moreover, a meta-analysis provided a view of recent ongoing trends in biopolymers.

I have, no doubt, that this book will be well-received by all those in the pharmaceutical and agro-industry, academia, and other research organizations who continually seek inactive functional biomaterials for improved drug formulation and development, especially scientists and students working with biopolymers.

Chuda Chittasupho Faculty of Pharmacy Chiang Mai University Thailand

PREFACE

Biopolymers are polymers synthesized by living organisms. They can be polynucleotides, peptides, or polysaccharides. These consist of long chains made of repeated, covalently bonded units, such as nucleotides, amino acids, or monosaccharides. Cellulose is the most common organic compound, and about 33% of the plant matter is cellulose. Biopolymers can be sustainable and carbon neutral and are always renewable because they are made from plant materials that grow indefinitely. These plant materials come from agricultural non-food crops. Therefore, the use of biodegradable polymers creates a sustainable industry. In contrast, the feedstock for synthetic polymers derived from petrochemicals will eventually deplete and most of them are non-biodegradable. Non-biodegradability issues of synthetic inactive pharmaceutical ingredients strongly emphasized innovators towards the development of biopolymers. Recently natural biodegradable excipients gained significant attention due to their sustainability and engineered applications. Innovative technologies to transform these materials into value-added chemicals via novel graft-polymerization or co-processing techniques for the production of high-performance multifunctional and low-cost polymers with tunable structures are key parts of its sustainable development. Besides, the development of state-of-the-art advanced characterization techniques for these engineered materials is an essential component in uncovering their specific structure and facilitates the application of these materials in the new research area. This expansion is driven by a remarkable progress in the process of refining biomass feedstock to produce bio-based building blocks. The book has been written to provide a broad platform for innovators and researchers in the area of biopolymers’ development with major biomedical and agro-industrial applications. Furthermore, to communicate the state-of-the-art work related to the transformation of natural materials into value-added pharmaceutical inactive ingredients, a brief on the modification and fabrication of new biopolymers, and their characterization including the application in the textile and plastic industry has been emphasized. Moreover, the book presents updated information and addresses various issues on emerging new sources of biopolymers with multifunctional efficacy, food, and drug administrative regulatory requirements, with their impact on the ecosystem and human health. Additionally, the book also provides updated information on a meta-analysis of bio-based pharmaceutical excipients.

There are numerous books about biopolymers covering the scientific research that is enabling the new generation of degradable plastics. The goal of this handbook is to bring together some of the core knowledge in the field to provide a practical and wide-ranging guide for engineers, product designers, and scientists involved in the commercial development of biopolymers and their use in the various biomedical, environmental, and agro applications. Additionally, information on the impact of non-biodegradable materials on human health and the environment has been taken into consideration. This book gives a brief account of inactive ingredients originating from plants and their characterization techniques with pharmacokinetics. The book also covers a summary of the bibliometric meta-analysis of bio-based polymers.

We acknowledge Walailak University for extending the library facility and providing access to Scopus. Moreover, Dr. Ozioma F Nwabor, Division of Infectious Diseases, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand is acknowledged for the valuable suggestions and critical comments.

CONSENT FOR PUBLICATION

Not applicable.

CONFLICT OF INTEREST

The author declares no conflict of interest, financial or otherwise.

ACKNOWLEDGEMENTS

Declared none.

Key Feature

• Provides an up-date summary on recently discovered natural polymeric materials

• Recently discovered new sources of biopolymers have been presented in this book.

• Presents a thorough breakdown of the vast range of application areas including fabrication of conventional and novel drug delivery, polymeric scaffolds, composites, microneedles, and green synthesis of metallic nanoparticles.

• Bibliometric meta-analysis indicating potential collaboration between country, organization, institution, and authors with a view on recent ongoing trends with biopolymers.

• A summary of pharmacology and pharmacokinetics on the inactive pharmaceutical ingredient presented

Sudarshan Singh Department of Pharmaceutical Science Faculty of Pharmacy, Chiang Mai University Chiang Mai ThailandWarangkana Chunglok School of Allied Health Sciences Walailak University Nakhon Si Thammarat Thailand

Overview on Bio-based Polymers

Singh Sudarshan,Chunglok Warangkana

Abstract

Synthetic polymers are an imperative manmade discovery that has long been under environmental scrutiny due to their several detriments such as slow or non-degradation, diminutive re-usage, and severe milieu effects. A rough estimate indicates that 8300 million metric tons of virgin plastic are produced using synthetic materials to date, of which only 9% have been recycled until 2015. The detrimental effects of a synthetic polymeric waste product on surroundings can be slowed down by replacing it with biopolymers. Biodegradable polymers are materials that degrade due to the action of either aerobic or anaerobic microorganisms and/or enzymes. Environmental protection agency and PlasticEurope indicated that biodegradable polymers have shown a promising impact on the environment with a decline in the waste and toxic gas produced by either burying or incinerating synthetic polymers and their products. Moreover, the replacement of plastic products with bio-polymeric material for general, pharmaceutical, and agricultural use has also shown a significant decline in waste plastic in landfills and oceans. Furthermore, the potential market share of biopolymers growing gradually and is projected to generate 10.6 billion US Dollars by 2026. However, the potential biodegradable polymers market capital share has yet not reached its peak, due to the non-availability of specific regulatory standards and approval process. Thus, a complete replacement of synthetic polymers with biodegradable polymeric materials can be a paradigm shift for nature and human beings. This chapter acmes on the history of biodegradable materials and their impact on nature with their regulatory requirements to gain market capital share.

Keywords: Biodegradable agro-materials, Biodegradable material, Biopolymer market, Biopolymers.

Introduction

Mankind was familiar with bio-based materials and their use since the beginning of civilizations. The synthetic polymer industry in its initial stage assured systematic preservation of the environment with progressive support to human beings. However, with the discovery of fossil fuels for the synthesis of petroleum-based polymers and their products, the development and innovation of natural polymers suffered major setbacks. Moreover, the innovation of single-use synthetic polymer-based plastic materials severely affected the ecosystem. In view of the potential disadvantages of synthetic polymers towards the environment, biodegradable polymer regained consideration among researchers,

pharmaceutical manufacturers, and other allied industrial sectors. Biopolymers are polymeric materials synthesized by living organisms that can be polynucleotides, and polypeptides, or polysaccharides. Biopolymer mainly consists of long chains made of repeating covalently bonded units, such as nucleotides, amino acids, or monosaccharides. Furthermore, biodegradable polymers have received significant attention in the last few decades due to their various potential application including the development of novel dosage forms, fabrication of agro-biotechnological products, etc. The biodegradability of such polymers or polymeric materials results in the formation of by-products such as CO2, N2, H2O, biomass, and inorganic salts upon breaking down either by aerobic or anaerobic microorganisms. However, this degradability does not include polylactides polymers that hydrolyze comparatively at a higher rate even at room temperature and neutral pH in the absence of hydrolytic enzyme. Moreover, biodegradation does not mean that all material can be processed into compost or humus. In addition, biodegradation significantly differs from the bio-erosion process. Bio-erosion is a process of conversion of initially water-insoluble material to a slow water-soluble material that may or may not involve any major chemical degradation. Polymers are versatile compounds and are classified based on several parameters such as the source of availability, type of polymerization, monomers in the repeating units of polymers, molecular forces, etc., as presented in Fig. (1). In this chapter, an overview is presented on the history of biopolymers and the impact of synthetic polymers on the ecosystem. Furthermore, a brief account of the regulation involved in the safety and efficacy of biopolymers and their market potential concerning the maintenance of the carbon cycle within the environment has been taken into consideration, with special attention to the use of the polymer-based product in the pharmaceutical and agroindustry.

History of Biodegradable Polymers

The term excipient is derived from the Latin word, excipiens, which means either to receive, to gather, or to take out. The definition of excipients has changed from time to time with its functions. The International Pharmaceutical Excipients Council (IPEC) defines an excipient as any substance other than the active drug or prodrug that is included in the manufacturing process or is contained in the finished pharmaceutical and relevant products [1]. Several incidences including phenytoin toxicity in 1968 and lack of strict regulations raised serious concerns and steered IPEC to mandate the manufacture for providing material safety data directly or indirectly consumed. The synthetic polymer market is growing exponentially and has become an integral part of day-to-day human life due to the enormous use of polymer-based products. These polymers are out product of petroleum oil industries or chemically synthesized via polymerization of several monomers. The market available petroleum-derived synthetic polymers are designed to resist the biological attack and stabilized with antioxidants and heat stabilizers that protect them from environmental degradation. Furthermore, synthetic polymers’ production was significantly accelerated by a global shift from reusable to single-use plastics and surpassed most manmade products. In consequence to that the share of plastics in municipal solid waste increased from less than 1% in 1960 to more than 10% by 2005 [2]. Although products made using synthetic polymers are a more economically feasible choice than biodegradable polymers, however, the scenario has changed as such synthetic polymers produce detrimental effects to the environment and health of several organisms on enduring use.

Fig. (1)) Classification of polymers [4].

Decreasing the use of non-biodegradable polymers and reducing the solid waste generated from them have become a high priority due to the rising cost of petroleum oils with increasing concern about the preservation of ecological systems. In addition, the use of synthetic polymers generates substantial environmental pollution and damage to wildlife. Additionally, incineration of the synthetic polymer-made product presents serious environmental issues due to toxic emissions including dioxins, furans, mercury, and polychlorinated biphenyls [3]. Moreover, toughen legal requirements of several countries for the management of waste caused a concern to focus on the expansion of biodegradable functional polymers. For such different issues, it is necessary to replace the synthetic polymer and its products partially or completely with biodegradable materials that can degrade with time. Furthermore, while selecting and using the renewable biomass or biodegradable material, a complete understanding of the carbon cycle is required. The carbon cycle is a complex process in which carbon is exchanged between the major reservoirs of carbon within the planet. The imbalance in the carbon cycle with a rapid release of CO2 that could not be completely compensated via the photosynthesis process leads to global warming (Fig. 2). Therefore, a biodegradable material is required that not only replaces the synthetic polymers but must help in re-balancing CO2 in the environment.

Fig. (2)) Suppressed carbon emission with deceiving green economy, surrounding circular economy, bio-economy, bio-based economy, and low carbon economy, with advantage offered by each economy [4] (For interpretation of the results to color in this Fig. legend, the reader referred to either web version of this chapter or color print).

The first replacement of a synthetic polymer and its product fabricated using petrochemicals has been identified as catgut sutures made of biodegradable materials, which dates back to at least 100 AD [5]. Although the first sutures were fabricated using the intestine of sheep, the modern sutures are manufactured using purified collagen extracted from the small intestine of cattle, sheep, or goats [6]. Moreover, the first manufactured bioplastic was prepared in 1862 by Alexander Parkes using Parkesine, latter in 1897 and 1930 a biodegradable plastic was fabricated using casein from milk and soybeans, respectively. Whereas the commercialization of biodegradable plastics and polymers in the market was first introduced in 1980 [7], however the exclusive biodegradable polymers received significant attention in 2012, when Geoffrey Coates of Cornell University, New York, United State of America received the Presidential Green Chemistry Challenging Award for developing green commercial biodegradable polymers. In recent years, there has been a marked increase in interest in the use of biodegradable materials including packaging, agriculture, medicine, and other areas. Several biodegradable polymers commonly known as starch or raw carbohydrates originating from fruits seeds and fiber extracted from natural resources have gained significant attention. The belief is that biodegradable polymer materials will reduce the dependency on synthetic polymer at a low cost, thereby producing a positive effect both environmentally and economically. Moreover, the current trends in biodegradable polymers indicate noteworthy developments in terms of unique design strategies and engineering that could offer advancements in polymers with excellent performance. However, until now, natural biodegradable polymers have not found extensive commercial applications in pharmaceutical and food-packaging industries to replace the conventional synthetic adjuvants which might be due to shortfalls in either technology transfer or production cost.

Biodegradable materials are those substances whose physio-chemical characteristics completely deteriorate and degrade when exposed to microorganisms, aerobic or anaerobic process, resulting in the generation of natural byproducts. However, the biodegradability of polymers depends on several factors including the surface area, molecular weight, glass transition temperature, melting point, and crystal structure. Biodegradable polymers naturally and synthetically made, consist of ester, amide, and ether functional groups. Moreover, the biodegradable polymer is often synthesized by ring-opening polymerization, condensation reactions, and metal catalysts. Furthermore, biodegradable polymers are classified according to their origin and synthesis method, composition, processing method, economic importance, application, etc. Fig. (3) shows the various applications of biopolymers with possible associated properties.

The biodegradable polymers gained tremendous interest of scientists and were developed using several novel technologies including tissue engineering, fabrication of responsive polymeric nanomaterials, edible food packaging, and additive manufacturing. This might be due to the great versatility of biodegradable polymers in terms of compatibility with other materials and additive processing approaches with customization of resulting devices. The researcher has investigated different classes of biodegradable polymers for additive manufacturing including proteins, polysaccharides, aliphatic polyesters, polyurethanes, etc. Additive manufacturing was defined by the American Society for Testing Materials (ASTM) in 2012 as the process of joining materials layer by layer that forms three-dimensional objects, controlled by computer-aided design and manufacturing software. Moreover, another breakthrough with biodegradable polymer is bioplastic innovation. Bioplastic has bought a significant revolution in the market with the potential to replace single-use synthetic petroleum product-derived plastic. In addition, valorization of the fruit husk from Garcinia mangostana, Nephelium lappaceum, Durio zibethinus [8], and Tamarindus indica [9] as biopolymers created another landmark in the fabrication of economic pharmaceutical products and biomedical devices.

Fig. (3)) Various applications of biopolymers with possible associated parameters and properties could affect the finished product.

Market Potential of Pharmaceutical Natural Excipients

The comprehensive pharmaceutical excipient market showed moderate to exponential growth and increased amalgamation with the expansion of biodegradable adjuvants in the emerging market for several categories of products during the last five years. In 2015, the excipients manufacturing industry became one of the largest businesses with a 43% market capital share of total market value followed by alcohol such as propylene glycol of 20% and sugar 3% [10]. Although excipients play an important role in the pharmaceutical formulations by accumulating functionality within the product, however excipients’ manufacturers need to respond to the varying pharmaceutical supply and demands considering their cost and other intermediates. Several new trends are emerging among pharmaceutical manufacturers including increased merging based on product-line enhancement or geographic expansion with selective investment in embryonic markets and targeted growth in selected product ranges. However, there are only a few manufacturers operating completely commercial scale-up production plants for the development of biodegradable polymers. This might be a possible reason that the market volume of biopolymers remains extremely low compared with petrochemical-originated synthetic polymers.

The global excipient market was valued at nearly $ 4.9 billion in 2011 according to the IMS Institute for Healthcare informatics and a market research firm Business Communications Company [10]. The valuation of excipients market by Business Communications Company reported considering several factors such as global pharmaceutical supply chain, application of quality by design by the manufacturer, overall drug safety concern, etc. Moreover, the international market of excipients was valued at 6.5% of the compound' annual growth rate (CAGR) in 2016. In addition, 11.1 billion pounds of excipients were consumed in 2011, increasing to 14 billion pounds by 2016 [10]. The demand for biodegradable polymers is driven by several factors including favorable regulation to reduce waste packaging and landfills, standard and certification procedure for packaging materials, composting infrastructures, and consumers’ awareness of the re-organization of benefits from biodegradable polymers.

The overall excipients market is expected to grow from $ 8.3 billion in 2021 to $ 10.6 billion by 2026, with a CAGR of 5.0% for the period of 2021-2026 [11]. Similarly, the worldwide market for contract pharmaceutical manufacturing, research, and packaging that significantly contribute to the expansion of the excipients is the market expected to develop from $ 168.0 billion in 2021 to $ 214.7 billion by 2026, at a CAGR of 5.0% during the forecast period of 2021-2026 [12]. Whereas, micro packaging market is estimated to grow from $ 540.4 million in 2021 to $ 704.2 million by 2026 at a CAGR of 5.4% from 2021 to 2026 [13]. Moreover, with the overall growth of polymeric hydrocolloids [14] and water-soluble polymers technologies [15], the market is valued to reach $ 7.0 billion and $ 49.6 billion by 2022 at a CAGR of 4.9 and 5.8%, respectively for the period of 2017-2022. In addition, the market volume of biodegradable polymers is expected to propagate from $ 1.0 kilotons in 2021 to $ 1.9 kilotons by 2026 with a CAGR of 14.0% during 2021-2026 [16]. The market capital for guar gum [17] and xanthan gum [18] was valued at $ 659.55 and 699.0 million in 2016 and is expected to rise by 194.95% and 139.05% in USD, respectively by 2022. Furthermore, the estimated value of alginate in Latin America was $ 18.22 billion in 2018, which is expected to rise to $ 21.81 billion by 2023. The global consumption and distribution of sustainable and biodegradable polymers by geographical regions in 2018 are presented in Fig. (4) [19].

Fig. (4)) Distribution of biodegradable polymer consumption worldwide as of 2018, by geographical region [28] (for interpretation of the results to color in this Fig. legend, the reader referred to either web version of this chapter or color print).

The recent market trends of biodegradable polymers show that a wide range of end-users are available even though potentially the market has yet not grown to its peak (Fig. 5). Continued progress in terms of product development and cost reduction is required before biopolymers can effectively compete with conventional petrochemical-based synthetic polymers for typical applications. The major replacement for non-biodegradable plastics is indicated by the development of starch-based biodegradable plastics for the manufacturing of various types of bags, rigid packaging including thermoformed trays, containers, and loose-fill packaging foams. Similarly, starch-based products are used in the fabrication of agriculture, horticulture, and other household products such as mulching film, covering film, plant pots, cartridges, etc. However, the cost of some biodegradable plastics is still higher than synthetic polymer plastics. Thus, necessary awareness and education on the detrimental impact of non-biodegradable materials use can significantly boost the market potential of biodegradable polymers with a hike in its market share.

Fig. (5)) Spectacles percentage share of global biodegradable polymer consumption by the end users [29] (for interpretation of the results to color in this Fig. legend, the reader referred to either web version of this chapter or color print).

Biopolymers Linkage with the Sustainable Agriculture Industry

Today the imagination of a world without synthetic polymers is very difficult, hitherto their large-scale fabrication and usage only date back to around 1950. Moreover, the growing world populations with several needs present various challenges, among them providing food and shelter to everyone, and the effect of non-biodegradable materials on the environment require an instant retort. Although, everyday science and technology create a new landmark and still the solutions to every problem are not found. Since 1950, a drastic upsurge has been observed in the usage of plastics and plastic-based products within the agriculture sector. The synthetic polymer-based materials for agriculture use were developed to provide durability and resistance to the fungal attack. By virtue of this anticipated market opportunity, several companies entered the arcade to manufacture a product using conventional resins similar to plastic with biodegradability. However, the manufacturing cost of the resins-based product was higher, compared to synthetic polymers. Later, another alternative to an expensive resin-based product was fabricated using polyethylene known as mulch. These mulches were manufactured using petroleum-based plastics, particularly polyethylene for agriculture use since it prevents crops and vegetables from weeds with control in soil temperature. Plastics mulching was first introduced to the agriculture sector in the 1950s and since then, it has successfully been used worldwide to increase productivity (Fig. 6). However, major landfills were produced by polyethylene mulches that typically degrade by burning and produce airborne pollutants such as dioxane [20]. In addition, long-term use of mulches leads to embrittlement and subsequently fragmentation within the soil. Whereas, the bacteria that could break down plastic wastes were discovered in 1975 by Japanese researchers during the treatment of wastewater from the nylon industry with strains of Flavobacterium such as Flavaobasgteria and Pseudomonas [21]. The list of recently reported bacterial and fungal cultures involved in the degradation of pharmaceutical waste is presented in Table 1.

Fig. (6)) Synthetic polymer based mulches and waste management strategies [4].
Table 1Bacterial and fungal culture involved in pharmaceutical waste treatment and antibiotics degradation.Bacterial CulturesWaste DegradationReferenceArthrobacter, Citrobacter youngae, Enterobacter hormaechei, Pseudomonas sp., and Rhodococcus equiDegradation of pharmaceutical mixture of NSAIDS[22]Castellaniella denitrificansDegradation of sulfonamides antibiotics[23]Flavobacterium johnsoniae, Pseudomonas aeruginosa, Pseudomonas pseudoalcaligenes, Paracoccus versutus, Moraxella osloensis, Sphingobacterium thalpophilum, and Tsukamurella inchonensisDegradation of organic pollutants and bio-sorbent of toxic heavy metals[24]Candida inconspicua, Fusarium solani, Fusarium udam, Galactomyces pseudocandidum, and Phaerochaete chrysosporiumDegradation of organic pollutants[24]Pseudallescheria boydii, Rhodotorula mucilaginosa, Trichosporon asahi, Trichosporon domesticumDegradation of organic pollutants[24]

The global consumption of plastics for agricultural purposes was reported to be 4% with a volume of 2,850,000 tons in 2003 [25]. Perhaps the worldwide usage of plastics by farmers reduced to 2% in 2010 and reached 6.96 million tons in 2017, the volume of waste generated is difficult to dispose of [26]. Non-biodegradable polymeric materials for agriculture use were listed by PasticEurope including greenhouses, tunnels, mulching, plastic reservoirs, irrigation systems, crates for crop collection [27], etc. Fig. (7) shows the cumulative plastic waste generation and disposal in million metric tons.

Fig. (7)) Accumulative plastic waste spawned and disposed of in million metric tons until date with an expected approximate volume until 2050. Solid chronological lines show past data from 1950 to 2015, whereas dashed lines show forecasts of bygone trends [30].

Food and Drug Administrative Regulation

Adherence to food and drug administrative regulation is a key factor towards the assurance of safety and efficacy of adjuvants added within pharmaceuticals for medical use. However, non-compliance to the regulation and notwithstanding care and precision during manufacturing might ruin the quality as well as the efficacy of therapeutics with severe health issues. The major official agencies responsible for the standardization of excipients include the United States Food and Drug Administration, the European Union, Swiss medic, etc., coordinated by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for human use. In addition to official regulatory agencies, several other associations also guide on supporting documents and provide details on the regulations with their application in specific situations. Some of the most influential organizations relevant to the pharmaceuticals are the International Society for Pharmaceutical Engineering, the United States Pharmacopeia, Parenteral Drug Association, Indian Pharmacopeia, and the World Health Organization. The United States Food and Drug Administration states that any inactive ingredient incorporated within the pharmaceutical should be “Generally Recognized as Safe” or regulated as adjuvants and used within the recommended limits. Biopolymers and their products are generally considered safe that completely degrade with complete elimination from the body by a natural metabolic process without producing any side effects. However, the United States Food and Drug Administration approved some biodegradable polymers such as poly(lactic-co-glycolic acid), poly(glycolic acid), poly(lactic acid) for a medical application that eliminate from the body in the form of carbon dioxide. Several other biodegradable polymers approved by the United States Food and Drug Administration for use in the formulation of pharmaceutical products are listed in Table 2.

Table 2List of major biopolymers approved by the united states food and drug administration for incorporating with therapeutics in pharmaceutical formulations [31].BiopolymerRoutes of AdministrationDosage FormMaximum Potency Per UnitMaximum Daily Exposure LimitAcaciaOralPowder and suspension648 – 1231 mg7386 mgAspartameOralTablet and suspension3.70 – 12 mg14.8 – 18 mgCarboxymethyl starchOralCapsule and tablet15 mg-Carboxymethyl celluloseOral and intramuscularTablet, injection, capsule, drops, powder, suspension, jelly, film, dental enteral, ophthalmic, etc.5 – 241 mg18 – 347 mgCarrageenanDental, nasal, oral, inhaler, and topicalPaste, powder, capsule, suspension, tablet, lotion, and film0.42 – 20.15 mg1 – 15 mgCellulose microcrystalline celluloseNasal and oralSpray, capsule, granule, powder, suspension, and tablet13.1 – 1975 mg60 – 800 mgCollagenTopical and oralGel, lotion, shampoo, liquid, and capsule75 – 270 mg-DextranOphthalmic and intravenousSolution, injection, and powder300 mg-Dextrose, dextrose monohydrateOral, intramuscular, intra-spinal, intravenous, and nasalLozenge, injection, powder, solution, spray, capsule, granule, pastille, syrup, and troche50 – 1600 mg200 – 30144 mgGalactose, galactose monohydrateOral and rectalPowder, solution, and tablet0.67 – 4.5 mg-GelatinBuccal, dental, intracavitary, intramuscular, intravenous, subcutaneous, nasal, oral, periodontal, and inhalerGum, paste, injection, powder, injection, solution, drops, capsule, elixir, and pastille14 – 65 mg288 – 4848 mgGuar gumBuccal, ophthalmic, oral, topical, and vagnialTablet, suspension, capsule, liquid, powder, lotion, and gum0.12 – 35.4 mg6 – 240 mgHypromelloseOral, nasal, ophthalmic, rectal, and topicalSuspension, tablet, troche, gel, cream, jelly, lotion, shampoo, solution, capsule, and granule1.7 – 221 mg10 – 1117 mgKaraya gumBuccalTablet68.1 mg-Lactose, lactose monohydrateBuccal, intramuscular, intravenous, and oralTablet, injection, powder, solution, capsule, and granule120 – 1682 mg150 – 4384 mgLanolinTopical, nasal, ophthalmic, and rectalSpray, ointment, cream, lotion, and emulsion1.5 – 3.0 (% w/w)-LecithinOral, rectal, topical, and vaginalInjection, capsule, powder, suspension, tablet, suppository, gel, and cream0.35 – 1 (% w/w)1 – 3900 mgLow-substituted Hydroxypropyl celluloseOralTablet and capsule25 – 94.29 mg13 – 480 mgMannitolIntravenous, ophthalmic, oral, and topicalInjection, capsule, granule, powder, lozenge, suspension, tablet, torche, wafer, cream, and emulsion37.11 – 750 mg14 – 6000 mgMethylcelluloseBuccal, intraarticular, intramuscular, nasal, ophthalmic, oral, sublingual, and topicalCream, tablet, injection, jelly, drops, solution, capsule, powder, suspension, syrup, aerosol, and sponge0.1% w/v-Microcrystalline celluloseOral, buccal, intravitrealTablet, capsule, granule, pellet, powder, torche1.66 – 789.6144 – 29520 mgPectinDental, nasal, and oralPaste, spray, capsule, powder, and tablet5.45 – 255 mg~ 1 mgPullulanOralTablet-10 mgSaccharinDental, oral, respiratory, sublingual, and topicalPaste, powder, drops, elixir, granule, solution, suspension, syrup, and tablet0.9 – 20 mg8 mgSodium alginateOral and topicalCapsule, lozenge, suspension, syrup, tablet, troche, and liquid80 – 320 mg700 – 955 mgSodium starch glycolateBuccal, oral, and sublingualTablet, capsule, and powder10 – 876 mg5 – 540 mgStarchBuccal and oralTablet, capsule, granule, powder, suspension, wafer, suppository, cream, and inserts0.17 – 430 mg-SucroseBuccal, intravenous, and oralLozenge, tablet, troche, injectable liposome, injectable emulsion, suspension, powder, capsule, pellets, drops, elixir, granule, lozenge, syrup, and tablet109 – 900 mg10 – 12000 mgTragacanthBuccal, oral, and topicalTablet, powder, suspension, wafer, and jelly5 – 60 mg12 – 70 mgXanthan gumOphthalmic, oral, rectal, and topicalSolution, capsule, film, granule, liquid, lozenge, paste, powder, suspension, tablet, troche, enema, suspension, aerosol foam, cream, gel, lotion, chewing gum, film, and spray0.01 – 275 mg1 – 600 mg

Conclusions and Future Perspective

Advancement in the human lifestyle and enormous utilization of non-biodegradable products has raised a serious concern about their surrounding and future impact. In addition, the consumption of polymers manufactured using synthetic materials engenders a severe impact on human beings as well as on the environment. To sustain life and maintain biological functions, nature requires selectively tailored molecular assemblies, and interfaces that provide specific chemical functions and structure, as well as a change in their environment. Although environmental sustainability is consistently gaining importance among individuals, however their utilization process towards green and sustainable development is moderate. In the meantime, it is not an easy way to completely avoid synthetic polymer and its product use due to its inherent quality, particularly in densely populated countries. Therefore, government and regulatory bodies should implement the legislation-governing increase in the production and use of biodegradable polymers for sustainable environment and economic development. Further, directive policies are required towards climate change and global warming due to the extensive use of non-degradable materials that produce toxic gas and initiate imbalance in the carbon cycle within the environment. Furthermore, recycling or degradation of existing non-biodegradable materials manufactured from synthetic polymers must be of prime importance.

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