The Experts below are selected from a list of 287670 Experts worldwide ranked by ideXlab platform
Rajesh N Dave - One of the best experts on this subject based on the ideXlab platform.
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Critical Material attributes (CMAs) of strip films loaded with poorly water-soluble drug nanoparticles: III. Impact of drug nanoparticle loading.
International journal of pharmaceutics, 2017Co-Authors: Scott M Krull, Ecevit Bilgili, Jacqueline Moreno, Rajesh N DaveAbstract:Polymer strip films have emerged as a robust platform for poorly water-soluble drug delivery. However, the common conception is that films cannot exceed low drug loadings, mainly due to poor drug stability, slow release, and film brittleness. This study explores the ability to achieve high loadings of poorly water-soluble drug nanoparticles in strip films while retaining good mechanical properties and enhanced dissolution rate. Aqueous suspensions containing up to 30wt% griseofulvin nanoparticles were prepared via wet stirred media milling and incorporated into hydroxypropyl methylcellulose (HPMC) films. Griseofulvin loading in films was adjusted to be between 9 and 49wt% in HPMC-E15 films and 30 and 73wt% in HPMC-E4M films by varying the mixing ratio of HPMC solution-to-griseofulvin suspension. All films exhibited good content uniformity and nanoparticle redispersibility up to 50wt% griseofulvin, while E4M films above 50wt% griseofulvin had slightly worse content uniformity and poor nanoparticle redispersibility. Increasing drug loading in films generally required more time to achieve 100% release during dissolution, although polymer-drug clusters dispersed from E4M films above 50wt% griseofulvin, resulting in similar dissolution profiles. While all films exhibited good tensile strength, a significant decrease in percent elongation was observed above 40-50wt% GF, resulting in brittle films.
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Critical Material Attributes of Strip Films Loaded With Poorly Water-Soluble Drug Nanoparticles: II. Impact of Polymer Molecular Weight
Journal of pharmaceutical sciences, 2016Co-Authors: Scott M Krull, Ecevit Bilgili, Jennifer Ammirata, Sonia Bawa, Rajesh N DaveAbstract:Recent work established polymer strip films as a robust platform for delivery of poorly water-soluble drug particles. However, a simple means of manipulating rate of drug release from films with minimal impact on film mechanical properties has yet to be demonstrated. This study explores the impact of film-forming polymer molecular weight (MW) and concentration on properties of polymer films loaded with poorly water-soluble drug nanoparticles. Nanoparticles of griseofulvin, a model Biopharmaceutics Classification System class II drug, were prepared in aqueous suspension via wet stirred media milling. Aqueous solutions of 3 viscosity grades of hydroxypropyl methylcellulose (14, 21, and 88 kDa) at 3 viscosity levels (∼9500, ∼12,000, and ∼22,000 cP) were mixed with drug suspension, cast, and dried to produce films containing griseofulvin nanoparticles. Few differences in film tensile strength or elongation at break were observed between films within each viscosity level regardless of polymer MW despite requiring up to double the time to achieve 100% drug release. This suggests film-forming polymer MW can be used to manipulate drug release with little impact on film mechanical properties by matching polymer solution viscosity. In addition, changing polymer MW and concentration had no negative impact on drug content uniformity or nanoparticle redispersibility.
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Critical Material attributes cmas of strip films loaded with poorly water soluble drug nanoparticles i impact of plasticizer on film properties and dissolution
European Journal of Pharmaceutical Sciences, 2016Co-Authors: Scott M Krull, Hardik V Patel, Meng Li, Ecevit Bilgili, Rajesh N DaveAbstract:Abstract Recent studies have demonstrated polymer films to be a promising platform for delivery of poorly water-soluble drug particles. However, the impact of Critical Material attributes, for example plasticizer, on the properties of and drug release from such films has yet to be investigated. In response, this study focuses on the impact of plasticizer and plasticizer concentration on properties and dissolution rate of polymer films loaded with poorly water-soluble drug nanoparticles. Glycerin, triacetin, and polyethylene glycol were selected as film plasticizers. Griseofulvin was used as a model Biopharmaceutics Classification System class II drug and hydroxypropyl methylcellulose was used as a film-forming polymer. Griseofulvin nanoparticles were prepared via wet stirred media milling in aqueous suspension. A depression in film glass transition temperature was observed with increasing plasticizer concentration, along with a decrease in film tensile strength and an increase in film elongation, as is typical of plasticizers. However, the type and amount of plasticizer necessary to produce strong yet flexible films had no significant impact on the dissolution rate of the films, suggesting that film mechanical properties can be effectively manipulated with minimal impact on drug release. Griseofulvin nanoparticles were successfully recovered upon redispersion in water regardless of plasticizer or content, even after up to 6 months' storage at 40 °C and 75% relative humidity, which contributed to similar consistency in dissolution rate after 6 months' storage for all films. Good content uniformity (
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Critical Material attributes cmas of strip films loaded with poorly water soluble drug nanoparticles i impact of plasticizer on film properties and dissolution
European Journal of Pharmaceutical Sciences, 2016Co-Authors: Scott M Krull, Hardik V Patel, Ecevit Bilgili, Rajesh N DaveAbstract:Recent studies have demonstrated polymer films to be a promising platform for delivery of poorly water-soluble drug particles. However, the impact of Critical Material attributes, for example plasticizer, on the properties of and drug release from such films has yet to be investigated. In response, this study focuses on the impact of plasticizer and plasticizer concentration on properties and dissolution rate of polymer films loaded with poorly water-soluble drug nanoparticles. Glycerin, triacetin, and polyethylene glycol were selected as film plasticizers. Griseofulvin was used as a model Biopharmaceutics Classification System class II drug and hydroxypropyl methylcellulose was used as a film-forming polymer. Griseofulvin nanoparticles were prepared via wet stirred media milling in aqueous suspension. A depression in film glass transition temperature was observed with increasing plasticizer concentration, along with a decrease in film tensile strength and an increase in film elongation, as is typical of plasticizers. However, the type and amount of plasticizer necessary to produce strong yet flexible films had no significant impact on the dissolution rate of the films, suggesting that film mechanical properties can be effectively manipulated with minimal impact on drug release. Griseofulvin nanoparticles were successfully recovered upon redispersion in water regardless of plasticizer or content, even after up to 6months' storage at 40°C and 75% relative humidity, which contributed to similar consistency in dissolution rate after 6months' storage for all films. Good content uniformity (<4% R.S.D. for very small film sample size) was also maintained across all film formulations.
Scott M Krull - One of the best experts on this subject based on the ideXlab platform.
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Critical Material attributes (CMAs) of strip films loaded with poorly water-soluble drug nanoparticles: III. Impact of drug nanoparticle loading.
International journal of pharmaceutics, 2017Co-Authors: Scott M Krull, Ecevit Bilgili, Jacqueline Moreno, Rajesh N DaveAbstract:Polymer strip films have emerged as a robust platform for poorly water-soluble drug delivery. However, the common conception is that films cannot exceed low drug loadings, mainly due to poor drug stability, slow release, and film brittleness. This study explores the ability to achieve high loadings of poorly water-soluble drug nanoparticles in strip films while retaining good mechanical properties and enhanced dissolution rate. Aqueous suspensions containing up to 30wt% griseofulvin nanoparticles were prepared via wet stirred media milling and incorporated into hydroxypropyl methylcellulose (HPMC) films. Griseofulvin loading in films was adjusted to be between 9 and 49wt% in HPMC-E15 films and 30 and 73wt% in HPMC-E4M films by varying the mixing ratio of HPMC solution-to-griseofulvin suspension. All films exhibited good content uniformity and nanoparticle redispersibility up to 50wt% griseofulvin, while E4M films above 50wt% griseofulvin had slightly worse content uniformity and poor nanoparticle redispersibility. Increasing drug loading in films generally required more time to achieve 100% release during dissolution, although polymer-drug clusters dispersed from E4M films above 50wt% griseofulvin, resulting in similar dissolution profiles. While all films exhibited good tensile strength, a significant decrease in percent elongation was observed above 40-50wt% GF, resulting in brittle films.
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Critical Material Attributes of Strip Films Loaded With Poorly Water-Soluble Drug Nanoparticles: II. Impact of Polymer Molecular Weight
Journal of pharmaceutical sciences, 2016Co-Authors: Scott M Krull, Ecevit Bilgili, Jennifer Ammirata, Sonia Bawa, Rajesh N DaveAbstract:Recent work established polymer strip films as a robust platform for delivery of poorly water-soluble drug particles. However, a simple means of manipulating rate of drug release from films with minimal impact on film mechanical properties has yet to be demonstrated. This study explores the impact of film-forming polymer molecular weight (MW) and concentration on properties of polymer films loaded with poorly water-soluble drug nanoparticles. Nanoparticles of griseofulvin, a model Biopharmaceutics Classification System class II drug, were prepared in aqueous suspension via wet stirred media milling. Aqueous solutions of 3 viscosity grades of hydroxypropyl methylcellulose (14, 21, and 88 kDa) at 3 viscosity levels (∼9500, ∼12,000, and ∼22,000 cP) were mixed with drug suspension, cast, and dried to produce films containing griseofulvin nanoparticles. Few differences in film tensile strength or elongation at break were observed between films within each viscosity level regardless of polymer MW despite requiring up to double the time to achieve 100% drug release. This suggests film-forming polymer MW can be used to manipulate drug release with little impact on film mechanical properties by matching polymer solution viscosity. In addition, changing polymer MW and concentration had no negative impact on drug content uniformity or nanoparticle redispersibility.
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Critical Material attributes cmas of strip films loaded with poorly water soluble drug nanoparticles i impact of plasticizer on film properties and dissolution
European Journal of Pharmaceutical Sciences, 2016Co-Authors: Scott M Krull, Hardik V Patel, Meng Li, Ecevit Bilgili, Rajesh N DaveAbstract:Abstract Recent studies have demonstrated polymer films to be a promising platform for delivery of poorly water-soluble drug particles. However, the impact of Critical Material attributes, for example plasticizer, on the properties of and drug release from such films has yet to be investigated. In response, this study focuses on the impact of plasticizer and plasticizer concentration on properties and dissolution rate of polymer films loaded with poorly water-soluble drug nanoparticles. Glycerin, triacetin, and polyethylene glycol were selected as film plasticizers. Griseofulvin was used as a model Biopharmaceutics Classification System class II drug and hydroxypropyl methylcellulose was used as a film-forming polymer. Griseofulvin nanoparticles were prepared via wet stirred media milling in aqueous suspension. A depression in film glass transition temperature was observed with increasing plasticizer concentration, along with a decrease in film tensile strength and an increase in film elongation, as is typical of plasticizers. However, the type and amount of plasticizer necessary to produce strong yet flexible films had no significant impact on the dissolution rate of the films, suggesting that film mechanical properties can be effectively manipulated with minimal impact on drug release. Griseofulvin nanoparticles were successfully recovered upon redispersion in water regardless of plasticizer or content, even after up to 6 months' storage at 40 °C and 75% relative humidity, which contributed to similar consistency in dissolution rate after 6 months' storage for all films. Good content uniformity (
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Critical Material attributes cmas of strip films loaded with poorly water soluble drug nanoparticles i impact of plasticizer on film properties and dissolution
European Journal of Pharmaceutical Sciences, 2016Co-Authors: Scott M Krull, Hardik V Patel, Ecevit Bilgili, Rajesh N DaveAbstract:Recent studies have demonstrated polymer films to be a promising platform for delivery of poorly water-soluble drug particles. However, the impact of Critical Material attributes, for example plasticizer, on the properties of and drug release from such films has yet to be investigated. In response, this study focuses on the impact of plasticizer and plasticizer concentration on properties and dissolution rate of polymer films loaded with poorly water-soluble drug nanoparticles. Glycerin, triacetin, and polyethylene glycol were selected as film plasticizers. Griseofulvin was used as a model Biopharmaceutics Classification System class II drug and hydroxypropyl methylcellulose was used as a film-forming polymer. Griseofulvin nanoparticles were prepared via wet stirred media milling in aqueous suspension. A depression in film glass transition temperature was observed with increasing plasticizer concentration, along with a decrease in film tensile strength and an increase in film elongation, as is typical of plasticizers. However, the type and amount of plasticizer necessary to produce strong yet flexible films had no significant impact on the dissolution rate of the films, suggesting that film mechanical properties can be effectively manipulated with minimal impact on drug release. Griseofulvin nanoparticles were successfully recovered upon redispersion in water regardless of plasticizer or content, even after up to 6months' storage at 40°C and 75% relative humidity, which contributed to similar consistency in dissolution rate after 6months' storage for all films. Good content uniformity (<4% R.S.D. for very small film sample size) was also maintained across all film formulations.
Ecevit Bilgili - One of the best experts on this subject based on the ideXlab platform.
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Critical Material attributes (CMAs) of strip films loaded with poorly water-soluble drug nanoparticles: III. Impact of drug nanoparticle loading.
International journal of pharmaceutics, 2017Co-Authors: Scott M Krull, Ecevit Bilgili, Jacqueline Moreno, Rajesh N DaveAbstract:Polymer strip films have emerged as a robust platform for poorly water-soluble drug delivery. However, the common conception is that films cannot exceed low drug loadings, mainly due to poor drug stability, slow release, and film brittleness. This study explores the ability to achieve high loadings of poorly water-soluble drug nanoparticles in strip films while retaining good mechanical properties and enhanced dissolution rate. Aqueous suspensions containing up to 30wt% griseofulvin nanoparticles were prepared via wet stirred media milling and incorporated into hydroxypropyl methylcellulose (HPMC) films. Griseofulvin loading in films was adjusted to be between 9 and 49wt% in HPMC-E15 films and 30 and 73wt% in HPMC-E4M films by varying the mixing ratio of HPMC solution-to-griseofulvin suspension. All films exhibited good content uniformity and nanoparticle redispersibility up to 50wt% griseofulvin, while E4M films above 50wt% griseofulvin had slightly worse content uniformity and poor nanoparticle redispersibility. Increasing drug loading in films generally required more time to achieve 100% release during dissolution, although polymer-drug clusters dispersed from E4M films above 50wt% griseofulvin, resulting in similar dissolution profiles. While all films exhibited good tensile strength, a significant decrease in percent elongation was observed above 40-50wt% GF, resulting in brittle films.
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Critical Material Attributes of Strip Films Loaded With Poorly Water-Soluble Drug Nanoparticles: II. Impact of Polymer Molecular Weight
Journal of pharmaceutical sciences, 2016Co-Authors: Scott M Krull, Ecevit Bilgili, Jennifer Ammirata, Sonia Bawa, Rajesh N DaveAbstract:Recent work established polymer strip films as a robust platform for delivery of poorly water-soluble drug particles. However, a simple means of manipulating rate of drug release from films with minimal impact on film mechanical properties has yet to be demonstrated. This study explores the impact of film-forming polymer molecular weight (MW) and concentration on properties of polymer films loaded with poorly water-soluble drug nanoparticles. Nanoparticles of griseofulvin, a model Biopharmaceutics Classification System class II drug, were prepared in aqueous suspension via wet stirred media milling. Aqueous solutions of 3 viscosity grades of hydroxypropyl methylcellulose (14, 21, and 88 kDa) at 3 viscosity levels (∼9500, ∼12,000, and ∼22,000 cP) were mixed with drug suspension, cast, and dried to produce films containing griseofulvin nanoparticles. Few differences in film tensile strength or elongation at break were observed between films within each viscosity level regardless of polymer MW despite requiring up to double the time to achieve 100% drug release. This suggests film-forming polymer MW can be used to manipulate drug release with little impact on film mechanical properties by matching polymer solution viscosity. In addition, changing polymer MW and concentration had no negative impact on drug content uniformity or nanoparticle redispersibility.
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Critical Material attributes cmas of strip films loaded with poorly water soluble drug nanoparticles i impact of plasticizer on film properties and dissolution
European Journal of Pharmaceutical Sciences, 2016Co-Authors: Scott M Krull, Hardik V Patel, Meng Li, Ecevit Bilgili, Rajesh N DaveAbstract:Abstract Recent studies have demonstrated polymer films to be a promising platform for delivery of poorly water-soluble drug particles. However, the impact of Critical Material attributes, for example plasticizer, on the properties of and drug release from such films has yet to be investigated. In response, this study focuses on the impact of plasticizer and plasticizer concentration on properties and dissolution rate of polymer films loaded with poorly water-soluble drug nanoparticles. Glycerin, triacetin, and polyethylene glycol were selected as film plasticizers. Griseofulvin was used as a model Biopharmaceutics Classification System class II drug and hydroxypropyl methylcellulose was used as a film-forming polymer. Griseofulvin nanoparticles were prepared via wet stirred media milling in aqueous suspension. A depression in film glass transition temperature was observed with increasing plasticizer concentration, along with a decrease in film tensile strength and an increase in film elongation, as is typical of plasticizers. However, the type and amount of plasticizer necessary to produce strong yet flexible films had no significant impact on the dissolution rate of the films, suggesting that film mechanical properties can be effectively manipulated with minimal impact on drug release. Griseofulvin nanoparticles were successfully recovered upon redispersion in water regardless of plasticizer or content, even after up to 6 months' storage at 40 °C and 75% relative humidity, which contributed to similar consistency in dissolution rate after 6 months' storage for all films. Good content uniformity (
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Critical Material attributes cmas of strip films loaded with poorly water soluble drug nanoparticles i impact of plasticizer on film properties and dissolution
European Journal of Pharmaceutical Sciences, 2016Co-Authors: Scott M Krull, Hardik V Patel, Ecevit Bilgili, Rajesh N DaveAbstract:Recent studies have demonstrated polymer films to be a promising platform for delivery of poorly water-soluble drug particles. However, the impact of Critical Material attributes, for example plasticizer, on the properties of and drug release from such films has yet to be investigated. In response, this study focuses on the impact of plasticizer and plasticizer concentration on properties and dissolution rate of polymer films loaded with poorly water-soluble drug nanoparticles. Glycerin, triacetin, and polyethylene glycol were selected as film plasticizers. Griseofulvin was used as a model Biopharmaceutics Classification System class II drug and hydroxypropyl methylcellulose was used as a film-forming polymer. Griseofulvin nanoparticles were prepared via wet stirred media milling in aqueous suspension. A depression in film glass transition temperature was observed with increasing plasticizer concentration, along with a decrease in film tensile strength and an increase in film elongation, as is typical of plasticizers. However, the type and amount of plasticizer necessary to produce strong yet flexible films had no significant impact on the dissolution rate of the films, suggesting that film mechanical properties can be effectively manipulated with minimal impact on drug release. Griseofulvin nanoparticles were successfully recovered upon redispersion in water regardless of plasticizer or content, even after up to 6months' storage at 40°C and 75% relative humidity, which contributed to similar consistency in dissolution rate after 6months' storage for all films. Good content uniformity (<4% R.S.D. for very small film sample size) was also maintained across all film formulations.
Hardik V Patel - One of the best experts on this subject based on the ideXlab platform.
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Critical Material attributes cmas of strip films loaded with poorly water soluble drug nanoparticles i impact of plasticizer on film properties and dissolution
European Journal of Pharmaceutical Sciences, 2016Co-Authors: Scott M Krull, Hardik V Patel, Meng Li, Ecevit Bilgili, Rajesh N DaveAbstract:Abstract Recent studies have demonstrated polymer films to be a promising platform for delivery of poorly water-soluble drug particles. However, the impact of Critical Material attributes, for example plasticizer, on the properties of and drug release from such films has yet to be investigated. In response, this study focuses on the impact of plasticizer and plasticizer concentration on properties and dissolution rate of polymer films loaded with poorly water-soluble drug nanoparticles. Glycerin, triacetin, and polyethylene glycol were selected as film plasticizers. Griseofulvin was used as a model Biopharmaceutics Classification System class II drug and hydroxypropyl methylcellulose was used as a film-forming polymer. Griseofulvin nanoparticles were prepared via wet stirred media milling in aqueous suspension. A depression in film glass transition temperature was observed with increasing plasticizer concentration, along with a decrease in film tensile strength and an increase in film elongation, as is typical of plasticizers. However, the type and amount of plasticizer necessary to produce strong yet flexible films had no significant impact on the dissolution rate of the films, suggesting that film mechanical properties can be effectively manipulated with minimal impact on drug release. Griseofulvin nanoparticles were successfully recovered upon redispersion in water regardless of plasticizer or content, even after up to 6 months' storage at 40 °C and 75% relative humidity, which contributed to similar consistency in dissolution rate after 6 months' storage for all films. Good content uniformity (
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Critical Material attributes cmas of strip films loaded with poorly water soluble drug nanoparticles i impact of plasticizer on film properties and dissolution
European Journal of Pharmaceutical Sciences, 2016Co-Authors: Scott M Krull, Hardik V Patel, Ecevit Bilgili, Rajesh N DaveAbstract:Recent studies have demonstrated polymer films to be a promising platform for delivery of poorly water-soluble drug particles. However, the impact of Critical Material attributes, for example plasticizer, on the properties of and drug release from such films has yet to be investigated. In response, this study focuses on the impact of plasticizer and plasticizer concentration on properties and dissolution rate of polymer films loaded with poorly water-soluble drug nanoparticles. Glycerin, triacetin, and polyethylene glycol were selected as film plasticizers. Griseofulvin was used as a model Biopharmaceutics Classification System class II drug and hydroxypropyl methylcellulose was used as a film-forming polymer. Griseofulvin nanoparticles were prepared via wet stirred media milling in aqueous suspension. A depression in film glass transition temperature was observed with increasing plasticizer concentration, along with a decrease in film tensile strength and an increase in film elongation, as is typical of plasticizers. However, the type and amount of plasticizer necessary to produce strong yet flexible films had no significant impact on the dissolution rate of the films, suggesting that film mechanical properties can be effectively manipulated with minimal impact on drug release. Griseofulvin nanoparticles were successfully recovered upon redispersion in water regardless of plasticizer or content, even after up to 6months' storage at 40°C and 75% relative humidity, which contributed to similar consistency in dissolution rate after 6months' storage for all films. Good content uniformity (<4% R.S.D. for very small film sample size) was also maintained across all film formulations.
Kedar Badami - One of the best experts on this subject based on the ideXlab platform.
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A framework for firm-level Critical Material supply management and mitigation
Resources Policy, 2019Co-Authors: Gillian Griffin, Gabrielle Gaustad, Kedar BadamiAbstract:Abstract Organizations of all sizes are vulnerable to Critical Material supply disruptions. Although there is a significant body of literature that examines how large entities such as nations and governments can assess and mitigate Criticality, there is very little work that addresses firm-level Criticality in a way that is actionable for businesses. This work uses literature review and case study analysis to understand the impact of Critical Material supply risk at the firm level, and to determine salient internal indicators. A total of 42 Criticality studies were reviewed and the findings were used to develop a matrix to assess and monitor Criticality risk using internal firm-specific data. The matrix incorporates three categories of risk including product concept viability, production, and profitability. It also contains four key business functions including finance, procurement, marketing, and production. These aspects were chosen because they are relevant to all businesses that produce and sell manufactured goods, and because they represent dynamics that are within the control of an individual firm. Unlike the global and national level indicators emphasized in most current research, the indicators proposed in this research are derived from data that firms can compile with reasonable ease. Finally, this work considers the role of the organization in Criticality risk assessment and mitigation through an examination of the data needed to complete the aforementioned matrix and the likely sources of that information. The findings of this analysis elucidate the gap between internal and external and micro- and macro- Criticality assessment, as well as provide a framework for firm-level Criticality mitigation.
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Circular economy strategies for mitigating Critical Material supply issues
Resources Conservation and Recycling, 2017Co-Authors: Gabrielle G. Gaustad, Michele Bustamante, Mark Krystofik, Kedar BadamiAbstract:Raw Materials deemed Critical are defined as having potential issues in their supply, limited substitutes, and applications of importance, namely in clean energy, defense, healthcare, and electronics. Disruptions in supply of Critical Materials can have serious negative repercussions for firms, consumers, and economies. One potential set of mitigation strategies for firms dealing with Criticality issues is the implementation of circular economy principles in their supply chain, operations, and end-of-life management. This work conducts a literature review combined with case study analysis to examine how certain firms assess and monitor their vulnerability to Critical Material supply chain issues and provides specific business examples for integrating circularity strategies. Results indicate the potential for risk reduction that could be gained from implementation of these strategies; specifically recycling, for example, can provide an in-house source (for prompt or fabrication scrap) or at least domestic source (for post-consumer scrap) for Critical Materials; up to 24% for the case of indium usage in China. Just in time manufacturing techniques have the potential to both exacerbate supply issues (by encouraging low inventory or needed resources for manufacturing) and improve supply issues by introducing resiliency in the supply chain indicating that approach of firms in undertaking these strategies is important. Many cases reviewed show other quantifiable secondary benefits beyond risk reduction, such as economic savings, reduction in energy consumption, and improved corporate social responsibility via enhanced supply chain oversight.