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  1. AU="Emara, Yasmine"
  2. AU="Orbe, Paul"
  3. AU="Karel J van Erpecum"
  4. AU=Oltean Mihai
  5. AU="Relph, Katharine A"
  6. AU=Li Jifen AU=Li Jifen
  7. AU="Diamant, Eran"
  8. AU="Kyoung, Henry" AU="Kyoung, Henry"
  9. AU=al-Gazali L I
  10. AU="Maillet, Jean-Michel"
  11. AU="Enlong Liu"
  12. AU="Afria, Dikshant"
  13. AU="Duggal, M. S."
  14. AU="Narcisa G. Pricope"
  15. AU="Kunisada, Toshiyuki"
  16. AU="Barvkar, Vitthal"

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  1. Artikel: Workflow for building interoperable food and nutrition security (FNS) data platforms

    Emara, Yasmine / Seljak, Barbara Koroušić / Gibney, Eileen R. / Popovski, Gorjan / Pravst, Igor / Fantke, Peter

    Trends in food science & technology. 2022 Mar. 21,

    2022  

    Abstract: In response to growing needs for the integration of heterogeneous data on food and nutrition security (FNS), and the current fragmentation of interoperability resources, the ‘FNS-Cloud project’ aims to develop a cross-domain, interoperable ‘food-cloud’ ... ...

    Abstract In response to growing needs for the integration of heterogeneous data on food and nutrition security (FNS), and the current fragmentation of interoperability resources, the ‘FNS-Cloud project’ aims to develop a cross-domain, interoperable ‘food-cloud’ that integrates diverse FNS data. Currently, there is insufficient guidance on how to develop such an FNS data platform and integrate a variety of FNS data types that differ in both their syntax and semantics. In the present paper, we propose a generalizable workflow to guide data managers in building interoperable, cross-domain FNS data platforms, which centres around the definition of interoperability criteria (IC) that capture standardized data structures, terminologies and reporting formats for key variables across FNS data types. Information technology tools for automating different workflow steps are discussed. Finally, we include an illustrative case study, where we manually harmonize and link branded food datasets based on pre-defined IC to answer an example research question. Our work highlighted the unique harmonization requirements within the FNS field. We provide two examples of how generic and domain-specific IC addressing these requirements can be defined. Incoming FNS data must comply with defined IC in order to enable their (semi-)automated integration into a data platform. Our case study reinforced the importance of semantic annotation of FNS data, and the need for clear mapping rules to be included into a platform's internal semantic data model. The proposed workflow can be applied to any setting in which data managers strive towards harmonized and linked FNS data, and, thus, promotes an open-data and open-science environment.
    Schlagwörter automation ; case studies ; data collection ; food science ; information technology ; models ; nutrition
    Sprache Englisch
    Erscheinungsverlauf 2022-0321
    Erscheinungsort Elsevier Ltd
    Dokumenttyp Artikel
    Anmerkung Pre-press version
    ZDB-ID 1049246-x
    ISSN 1879-3053 ; 0924-2244
    ISSN (online) 1879-3053
    ISSN 0924-2244
    DOI 10.1016/j.tifs.2022.03.022
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  2. Artikel: Cradle-to-grave life cycle assessment of an ibuprofen analgesic

    Siegert, Marc-William / Saling, Peter / Mielke, Pascal / Czechmann, Carolin / Emara, Yasmine / Finkbeiner, Matthias

    Sustainable chemistry and pharmacy. 2020 Dec., v. 18

    2020  

    Abstract: The aim is to conduct a life cycle assessment of the analgesic Eudorlin® Extra to identify environmental hotspots along its life cycle, i.e. the manufacturing of the active pharmaceutical ingredient, the galenic formulation, packaging, distribution, use ... ...

    Abstract The aim is to conduct a life cycle assessment of the analgesic Eudorlin® Extra to identify environmental hotspots along its life cycle, i.e. the manufacturing of the active pharmaceutical ingredient, the galenic formulation, packaging, distribution, use and end-of-life. This publication is one of only few LCA studies that consider all life cycle stages of a pharmaceutical.The functional unit is the treatment of an adult in Germany with the purpose of pain relief for 4 days, the reference flow is one package Eudorlin® Extra (10 tablets with 400 mg ibuprofen per tablet). Primary data is provided by the manufacturing companies for the production stage. The impact assessment is conducted for impact categories that have been identified as germane for the sector. A contribution analysis is performed and relevant processes are evaluated by sensitivity analyses.The environmental profile is dominated by the production stage whereas the use and end-of-life are negligible. This seems to be plausible due to the high material usage during manufacturing, as opposed to the use stage where no additional inputs are required. However, methodological issues are identified which potentially affect the results such as the lack of characterization factors for the metabolites.The results are in alignment with existing studies which emphasize the environmental relevance of the production stage. Future research should focus on improving existing impact assessment methods, developing characterization factors for metabolites and publishing inventory data on substances that are frequently used in the pharmaceutical life cycle.
    Schlagwörter active pharmaceutical ingredients ; adults ; analgesia ; analgesics ; business enterprises ; cradle-to-grave ; green chemistry ; ibuprofen ; manufacturing ; metabolites ; packaging ; Germany
    Sprache Englisch
    Erscheinungsverlauf 2020-12
    Erscheinungsort Elsevier B.V.
    Dokumenttyp Artikel
    ISSN 2352-5541
    DOI 10.1016/j.scp.2020.100329
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  3. Artikel: Addressing the use and end-of-life phase of pharmaceutical products in life cycle assessment

    Siegert, Marc-William / Lehmann, Annekatrin / Emara, Yasmine / Finkbeiner, Matthias

    international journal of life cycle assessment. 2020 Aug., v. 25, no. 8

    2020  

    Abstract: PURPOSE: Pharmaceutical residues in the environment can pose significant risks to ecosystems and human beings due to adverse pharma-specific effects. Existing life cycle assessment (LCA) studies do not usually consider the use and end-of-life (EoL) phase ...

    Abstract PURPOSE: Pharmaceutical residues in the environment can pose significant risks to ecosystems and human beings due to adverse pharma-specific effects. Existing life cycle assessment (LCA) studies do not usually consider the use and end-of-life (EoL) phase of pharmaceuticals and thus exclude relevant potentially toxic emissions of an active pharmaceutical ingredient (API). Therefore, a simplified inventory model for the use and EoL phase of pharmaceuticals is provided by estimating API flows and emissions to the environment. METHODS: Both the qualitative description of the use and EoL phase of pharmaceuticals and the quantification of the flows within each life cycle phase are based on literature and expert knowledge. Existing approaches to determine the API emissions are adjusted to make them applicable in LCA. In addition, different uses and EoL scenarios (e.g. depending on the patients’ disposal behaviour) are specified, and assumptions are highlighted. Finally, the model is exemplarily applied to the oral intake of ibuprofen to test its applicability. RESULTS AND DISCUSSION: Eleven potential flows and emissions of an API are identified and quantified for different application forms (pulmonary, oral, cutaneous). The model is applied to ibuprofen where potential API emissions result from administered and unused products. Referred to the administered amount of ibuprofen (reference flow), the product is mainly metabolized (73.1%). The unmetabolized (parental) compound enters the sewage treatment plant where it is degraded (13.94%), or emitted to surface water (8.35%), air (0%) and sewage sludge (0.36%). The remainder cannot be clearly assigned to one of the flows (4.25%). The results of this example are hardly comparable to existing measured data because they are related to the functional unit. The effect of assumptions, limitations due to data availability and the geographic scope reveal the need for further research. CONCLUSIONS: To facilitate the consideration of the use and EoL phase of pharmaceuticals in future pharma-LCAs, a simplified inventory model specified for German conditions, is provided which allows to calculate inventory results with easily and publically accessible data. However, remaining challenges such as the lack of data to model the behaviour of metabolites in the sewage treatment plant, missing approaches to include specific pharmaceuticals (e.g. hormones, anticancer drugs), the consideration of other sewage treatment technologies such as ozonization, the integration of API emissions from sewage sludge (e.g. due to the use as fertilizer) or the scope expansion with regard to the geographic validity of the model shall be further examined.
    Schlagwörter active pharmaceutical ingredients ; air ; expert opinion ; fertilizers ; humans ; ibuprofen ; inventories ; life cycle assessment ; metabolites ; models ; ozonation ; sewage sludge ; sewage treatment ; surface water ; toxicity
    Sprache Englisch
    Erscheinungsverlauf 2020-08
    Umfang p. 1436-1454.
    Erscheinungsort Springer Berlin Heidelberg
    Dokumenttyp Artikel
    Anmerkung NAL-AP-2-clean
    ZDB-ID 2009386-X
    ISSN 1614-7502 ; 0948-3349
    ISSN (online) 1614-7502
    ISSN 0948-3349
    DOI 10.1007/s11367-019-01722-7
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  4. Artikel ; Online: Comparative selective pressure potential of antibiotics in the environment.

    Emara, Yasmine / Jolliet, Olivier / Finkbeiner, Matthias / Heß, Stefanie / Kosnik, Marissa / Siegert, Marc-William / Fantke, Peter

    Environmental pollution (Barking, Essex : 1987)

    2022  Band 318, Seite(n) 120873

    Abstract: To guide both environmental and public health policy, it is important to assess the degree of antibiotic resistance selection pressure under measured environmental concentrations (MECs), and to compare the efficacy of different mitigation strategies to ... ...

    Abstract To guide both environmental and public health policy, it is important to assess the degree of antibiotic resistance selection pressure under measured environmental concentrations (MECs), and to compare the efficacy of different mitigation strategies to minimize the spread of resistance. To this end, the resistance selection and enrichment potential due to antibiotic emissions into the environment must be analysed from a life cycle perspective, for a wide range of antibiotics, and considering variations in the underlying fitness costs between different resistance mutations and genes. The aim of this study is to consistently derive fitness cost-dependent minimum selective concentrations (MSCs) from readily available bacterial inhibition data and to build MSC-based species sensitivity distributions (SSDs). These are then used to determine antibiotic-specific resistance selection concentrations predicted to promote resistance in 5% of exposed bacterial species (RSC
    Sprache Englisch
    Erscheinungsdatum 2022-12-15
    Erscheinungsland England
    Dokumenttyp Journal Article
    ZDB-ID 280652-6
    ISSN 1873-6424 ; 0013-9327 ; 0269-7491
    ISSN (online) 1873-6424
    ISSN 0013-9327 ; 0269-7491
    DOI 10.1016/j.envpol.2022.120873
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  5. Artikel: Harmonized rules for future LCAs on pharmaceutical products and processes

    Siegert, Marc-William / Emara, Yasmine / Finkbeiner, Matthias / Lehmann, Annekatrin

    international journal of life cycle assessment. 2019 June, v. 24, no. 6

    2019  

    Abstract: PURPOSE: The manufacturing of pharmaceuticals and their occurrence in the environment generated growing concerns of stakeholders. Life Cycle Assessment (LCA) is a suitable tool to identify potential environmental impacts within the whole pharmaceutical ... ...

    Abstract PURPOSE: The manufacturing of pharmaceuticals and their occurrence in the environment generated growing concerns of stakeholders. Life Cycle Assessment (LCA) is a suitable tool to identify potential environmental impacts within the whole pharmaceutical value chain. However, existing pharma-LCAs revealed several methodological shortcomings and challenges. To support the development of future LCAs in the sector, draft Product Category Rules (PCR) for pharmaceuticals for human use and their manufacturing processes are proposed. METHODS: Existing LCA case studies were evaluated and compared based on the methodological requirements according to the ISO 14044 standard. In addition, PCRs from the pharmaceutical sector, generic LCA standards, and product-specific guidelines were reviewed. Subsequently, overlaps between and deviations from these sources were identified. It was determined whether methodological requirements can be adopted from existing standards and guidelines or whether additional rules or specifications for pharmaceutical products are needed. RESULTS AND DISCUSSION: The overall PCR structure was established in alignment with ISO 14044, ISO TS 14027, and the Guidance for PCR development (GPCRD). For the definition of product groups, the third level of the Anatomic Therapeutic Chemical (ATC) classification system was determined as appropriate level of detail (granularity). The methodological requirements, e.g., the definition of goal and scope, inventory analysis, as well as the impact assessment, were set considering the intended application and the product system. However, the majority of these proposed methodological requirements go beyond current practice in existing pharma-LCAs (e.g., definition of an effect-based functional unit). Moreover, the need for specific rules depending on the active pharmaceutical ingredient (API), the galenic formulation, and regional aspects was described and discussed. CONCLUSIONS: This work tackles current methodological challenges of LCA application in the pharmaceutical sector by providing harmonized rules to guide future studies on pharmaceutical products and processes. However, modelling the use- and end of life phase as well as considering pharma-specific impacts were revealed as remaining challenges.
    Schlagwörter active pharmaceutical ingredients ; case studies ; drugs ; environmental impact ; guidelines ; humans ; inventories ; manufacturing ; models ; product system ; stakeholders ; standards and grades ; supply chain ; therapeutics
    Sprache Englisch
    Erscheinungsverlauf 2019-06
    Umfang p. 1040-1057.
    Erscheinungsort Springer Berlin Heidelberg
    Dokumenttyp Artikel
    ZDB-ID 2009386-X
    ISSN 1614-7502 ; 0948-3349
    ISSN (online) 1614-7502
    ISSN 0948-3349
    DOI 10.1007/s11367-018-1549-2
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  6. Artikel ; Online: Modeling pharmaceutical emissions and their toxicity-related effects in life cycle assessment (LCA): A review.

    Emara, Yasmine / Lehmann, Annekatrin / Siegert, Marc-William / Finkbeiner, Matthias

    Integrated environmental assessment and management

    2018  Band 15, Heft 1, Seite(n) 6–18

    Abstract: Over the last few decades, worldwide detection of active pharmaceutical ingredients (APIs) in aquatic environments and the associated toxicological effects on wildlife and human health have become a matter of public and scientific debate. While life ... ...

    Abstract Over the last few decades, worldwide detection of active pharmaceutical ingredients (APIs) in aquatic environments and the associated toxicological effects on wildlife and human health have become a matter of public and scientific debate. While life cycle assessment (LCA) and life cycle impact assessment (LCIA) models are increasingly used to assess the potential eco- and human-toxicological effects of chemical emissions, few studies have looked into the issue of modeling pharmaceutical emissions specifically and their toxicity-related effects in an LCA context. This paper reviews the state of the art to inventory and characterize API emissions in LCA with the goal to identify relevant gaps and challenges. A search for 208 environmentally relevant APIs in 2 life cycle inventory (LCI) databases revealed a meager representation of this group of chemicals. Similarly, the LCIA model USEtox was found to include characterization factors (CFs) for less than 60 APIs. First approaches to model API emissions in LCA were identified on the basis of an examination of 40 LCA case studies in the pharmaceutical sector and in the field of wastewater treatment. Moreover, CFs for 79 additional APIs, expressing their ecotoxicity and/or human toxicity potential, were gathered from literature. An analysis of the variability of API-CFs in different LCIA models showed a variation of about 2-3 orders of magnitude. Based on the review results, 3 main gaps in the modeling and characterization of API emissions in an LCA context were identified: (1) incomplete modeling of API flows and API emissions along the life cycle of human pharmaceuticals, especially during their use and end-of-life phase, (2) limited API coverage in existing LCIA toxicity models, and (3) missing pharma-specific impact pathways (e.g., endocrine disruption and antibiotic resistance) in existing LCIA models. Recommendations to tackle these gaps are provided, and priority action steps are discussed. Integr Environ Assess Manag 2019;15:6-18. © 2018 SETAC.
    Mesh-Begriff(e) Ecotoxicology ; Environmental Monitoring/methods ; Models, Chemical ; Pharmaceutical Preparations/analysis ; Risk Assessment ; Water Pollutants, Chemical/analysis ; Water Pollutants, Chemical/toxicity
    Chemische Substanzen Pharmaceutical Preparations ; Water Pollutants, Chemical
    Sprache Englisch
    Erscheinungsdatum 2018-11-14
    Erscheinungsland United States
    Dokumenttyp Journal Article ; Review
    ZDB-ID 2234931-5
    ISSN 1551-3793 ; 1551-3777
    ISSN (online) 1551-3793
    ISSN 1551-3777
    DOI 10.1002/ieam.4100
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  7. Artikel ; Online: Integrating endocrine-related health effects into comparative human toxicity characterization.

    Emara, Yasmine / Fantke, Peter / Judson, Richard / Chang, Xiaoqing / Pradeep, Prachi / Lehmann, Annekatrin / Siegert, Marc-William / Finkbeiner, Matthias

    The Science of the total environment

    2020  Band 762, Seite(n) 143874

    Abstract: Endocrine-disrupting chemicals have the ability to interfere with and alter functions of the hormone system, leading to adverse effects on reproduction, growth and development. Despite growing concerns over their now ubiquitous presence in the ... ...

    Abstract Endocrine-disrupting chemicals have the ability to interfere with and alter functions of the hormone system, leading to adverse effects on reproduction, growth and development. Despite growing concerns over their now ubiquitous presence in the environment, endocrine-related human health effects remain largely outside of comparative human toxicity characterization frameworks as applied for example in life cycle impact assessments. In this paper, we propose a new methodological framework to consistently integrate endocrine-related health effects into comparative human toxicity characterization. We present two quantitative and operational approaches for extrapolating towards a common point of departure from both in vivo and dosimetry-adjusted in vitro endocrine-related effect data and deriving effect factors as well as corresponding characterization factors for endocrine-active/endocrine-disrupting chemicals. Following the proposed approaches, we calculated effect factors for 323 chemicals, reflecting their endocrine potency, and related characterization factors for 157 chemicals, expressing their relative endocrine-related human toxicity potential. Developed effect and characterization factors are ready for use in the context of chemical prioritization and substitution as well as life cycle impact assessment and other comparative assessment frameworks. Endocrine-related effect factors were found comparable to existing effect factors for cancer and non-cancer effects, indicating that (1) the chemicals' endocrine potency is not necessarily higher or lower than other effect potencies and (2) using dosimetry-adjusted effect data to derive effect factors does not consistently overestimate the effect of potential endocrine disruptors. Calculated characterization factors span over 8-11 orders of magnitude for different substances and emission compartments and are dominated by the range in endocrine potencies.
    Mesh-Begriff(e) Endocrine Disruptors/toxicity ; Endocrine System ; Humans ; Reproduction
    Chemische Substanzen Endocrine Disruptors
    Sprache Englisch
    Erscheinungsdatum 2020-12-03
    Erscheinungsland Netherlands
    Dokumenttyp Journal Article
    ZDB-ID 121506-1
    ISSN 1879-1026 ; 0048-9697
    ISSN (online) 1879-1026
    ISSN 0048-9697
    DOI 10.1016/j.scitotenv.2020.143874
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  8. Artikel: Predicting the environmental emissions arising from conventional and nanotechnology-related pharmaceutical drug products

    Jung, Fabian / Thurn, Manuela / Krollik, Katharina / Gao, Ge Fiona / Hering, Indra / Eilebrecht, Elke / Emara, Yasmine / Weiler, Marc / Günday-Türeli, Nazende / Türeli, Emre / Parnham, Michael J / Wacker, Matthias G

    Environmental research. 2021 Jan., v. 192

    2021  

    Abstract: Today, environmental pollution with pharmaceutical drugs and their metabolites poses a major threat to the aquatic ecosystems. Active substances such as fenofibrate, are processed to pharmaceutical drug formulations before they are degraded by the human ... ...

    Abstract Today, environmental pollution with pharmaceutical drugs and their metabolites poses a major threat to the aquatic ecosystems. Active substances such as fenofibrate, are processed to pharmaceutical drug formulations before they are degraded by the human body and released into the wastewater. Compared to the conventional product Lipidil® 200, the pharmaceutical product Lipidil 145 One® and Ecocaps take advantage of nanotechnology to improve uptake and bioavailability of the drug in humans. In the present approach, a combination of in vitro drug release studies and physiologically-based biopharmaceutics modeling was applied to calculate the emission of three formulations of fenofibrate (Lipidil® 200, Lipidil 145 One®, Ecocaps) into the environment. Special attention was paid to the metabolized and non-metabolized fractions and their individual toxicity, as well as to the emission of nanomaterials. The fish embryo toxicity test revealed a lower aquatic toxicity for the metabolite fenofibric acid and therefore an improved toxicity profile. When using the microparticle formulation Lipidil® 200, an amount of 126 mg of non-metabolized fenofibrate was emitted to the environment. Less than 0.05% of the particles were in the lower nanosize range. For the nanotechnology-related product Lipidil 145 One®, the total drug emission was reduced by 27.5% with a nanomaterial fraction of approximately 0.5%. In comparison, the formulation prototype Ecocaps reduced the emission of fenofibrate by 42.5% without any nanomaterials entering the environment. In a streamlined life cycle assessment, the lowered dose in combination with a lowered drug-to-metabolite ratio observed for Ecocaps led to a reduction of the full life cycle impacts of fenofibrate with a reduction of 18% reduction in the global warming potential, 61% in ecotoxicity, and 15% in human toxicity. The integrated environmental assessment framework highlights the outstanding potential of advanced modeling technologies to determine environmental impacts of pharmaceuticals during early drug development using preclinical in vitro data.
    Schlagwörter bioavailability ; drug development ; ecotoxicology ; embryotoxicity ; environmental assessment ; fenofibrate ; fish ; humans ; life cycle assessment ; metabolites ; microparticles ; pollution ; prototypes ; toxicity testing ; wastewater
    Sprache Englisch
    Erscheinungsverlauf 2021-01
    Erscheinungsort Elsevier Inc.
    Dokumenttyp Artikel
    Anmerkung NAL-AP-2-clean
    ZDB-ID 205699-9
    ISSN 1096-0953 ; 0013-9351
    ISSN (online) 1096-0953
    ISSN 0013-9351
    DOI 10.1016/j.envres.2020.110219
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  9. Artikel ; Online: Predicting the environmental emissions arising from conventional and nanotechnology-related pharmaceutical drug products.

    Jung, Fabian / Thurn, Manuela / Krollik, Katharina / Gao, Ge Fiona / Hering, Indra / Eilebrecht, Elke / Emara, Yasmine / Weiler, Marc / Günday-Türeli, Nazende / Türeli, Emre / Parnham, Michael J / Wacker, Matthias G

    Environmental research

    2020  Band 192, Seite(n) 110219

    Abstract: Today, environmental pollution with pharmaceutical drugs and their metabolites poses a major threat to the aquatic ecosystems. Active substances such as fenofibrate, are processed to pharmaceutical drug formulations before they are degraded by the human ... ...

    Abstract Today, environmental pollution with pharmaceutical drugs and their metabolites poses a major threat to the aquatic ecosystems. Active substances such as fenofibrate, are processed to pharmaceutical drug formulations before they are degraded by the human body and released into the wastewater. Compared to the conventional product Lipidil® 200, the pharmaceutical product Lipidil 145 One® and Ecocaps take advantage of nanotechnology to improve uptake and bioavailability of the drug in humans. In the present approach, a combination of in vitro drug release studies and physiologically-based biopharmaceutics modeling was applied to calculate the emission of three formulations of fenofibrate (Lipidil® 200, Lipidil 145 One®, Ecocaps) into the environment. Special attention was paid to the metabolized and non-metabolized fractions and their individual toxicity, as well as to the emission of nanomaterials. The fish embryo toxicity test revealed a lower aquatic toxicity for the metabolite fenofibric acid and therefore an improved toxicity profile. When using the microparticle formulation Lipidil® 200, an amount of 126 mg of non-metabolized fenofibrate was emitted to the environment. Less than 0.05% of the particles were in the lower nanosize range. For the nanotechnology-related product Lipidil 145 One®, the total drug emission was reduced by 27.5% with a nanomaterial fraction of approximately 0.5%. In comparison, the formulation prototype Ecocaps reduced the emission of fenofibrate by 42.5% without any nanomaterials entering the environment. In a streamlined life cycle assessment, the lowered dose in combination with a lowered drug-to-metabolite ratio observed for Ecocaps led to a reduction of the full life cycle impacts of fenofibrate with a reduction of 18% reduction in the global warming potential, 61% in ecotoxicity, and 15% in human toxicity. The integrated environmental assessment framework highlights the outstanding potential of advanced modeling technologies to determine environmental impacts of pharmaceuticals during early drug development using preclinical in vitro data.
    Mesh-Begriff(e) Animals ; Biological Availability ; Ecosystem ; Humans ; Nanotechnology ; Pharmaceutical Preparations ; Waste Water
    Chemische Substanzen Pharmaceutical Preparations ; Waste Water
    Sprache Englisch
    Erscheinungsdatum 2020-09-24
    Erscheinungsland Netherlands
    Dokumenttyp Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 205699-9
    ISSN 1096-0953 ; 0013-9351
    ISSN (online) 1096-0953
    ISSN 0013-9351
    DOI 10.1016/j.envres.2020.110219
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  10. Artikel ; Online: Predicting the environmental emissions arising from conventional and nanotechnology-related pharmaceutical drug products

    Jung, Fabian / Thurn, Manuela / Krollik, Katharina / Gao, Ge Fiona / Hering, Indra / Eilebrecht, Elke / Emara, Yasmine / Weiler, Marc / Günday-Türeli, Nazende / Türeli, Emre / Parnham, Michael J. / Wacker, Matthias G.

    2021  

    Abstract: Art. 110219, 12 S. ... Today, environmental pollution with pharmaceutical drugs and their metabolites poses a major threat to the aquatic ecosystems. Active substances such as fenofibrate, are processed to pharmaceutical drug formulations before they are ... ...

    Abstract Art. 110219, 12 S.

    Today, environmental pollution with pharmaceutical drugs and their metabolites poses a major threat to the aquatic ecosystems. Active substances such as fenofibrate, are processed to pharmaceutical drug formulations before they are degraded by the human body and released into the wastewater. Compared to the conventional product Lipidil® 200, the pharmaceutical product Lipidil 145 One® and Ecocaps take advantage of nanotechnology to improve uptake and bioavailability of the drug in humans. In the present approach, a combination of in vitro drug release studies and physiologically-based biopharmaceutics modeling was applied to calculate the emission of three formulations of fenofibrate (Lipidil® 200, Lipidil 145 One®, Ecocaps) into the environment. Special attention was paid to the metabolized and non-metabolized fractions and their individual toxicity, as well as to the emission of nanomaterials. The fish embryo toxicity test revealed a lower aquatic toxicity for the metabolite fenofibric acid and therefore an improved toxicity profile. When using the microparticle formulation Lipidil® 200, an amount of 126 mg of non-metabolized fenofibrate was emitted to the environment. Less than 0.05% of the particles were in the lower nanosize range. For the nanotechnology-related product Lipidil 145 One®, the total drug emission was reduced by 27.5% with a nanomaterial fraction of approximately 0.5%. In comparison, the formulation prototype Ecocaps reduced the emission of fenofibrate by 42.5% without any nanomaterials entering the environment. In a streamlined life cycle assessment, the lowered dose in combination with a lowered drug-to-metabolite ratio observed for Ecocaps led to a reduction of the full life cycle impacts of fenofibrate with a reduction of 18% reduction in the global warming potential, 61% in ecotoxicity, and 15% in human toxicity. The integrated environmental assessment framework highlights the outstanding potential of advanced modeling technologies to determine environmental impacts ...
    Schlagwörter environmental exposure ; modeling ; Fenofibrate ; Nanomaterial ; life cycle assessment ; pharmaceuticals ; 540 ; 360 ; 571 ; 572
    Thema/Rubrik (Code) 660
    Sprache Englisch
    Erscheinungsland de
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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