Population pharmacokinetics of orally administrated bromopride: Focus on the absorption process
Bromopride is a prokinetic and antiemetic drug used to treat nausea and vomiting. Although its prescription is common in Brazil, there is a lack of studies about bromopride pharmacokinetics. Therefore, the aims of this study were to investigate the population pharmacokinetics of bromopride and to ev...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Lachi-Silva, Larissa [verfasserIn] |
|---|
| Format: |
E-Artikel |
|---|---|
| Sprache: |
Englisch |
| Erschienen: |
2020transfer abstract |
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| Übergeordnetes Werk: |
Enthalten in: The face of wrongdoing? An expectancy violations perspective on CEO facial characteristics and media coverage of misconducting firms - Heyden, Mariano L.M. ELSEVIER, 2022, official journal of the European Federation for Pharmaceutical Sciences, New York, NY [u.a.] |
|---|---|
| Übergeordnetes Werk: |
volume:142 ; year:2020 ; day:15 ; month:01 ; pages:0 |
| Links: |
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| DOI / URN: |
10.1016/j.ejps.2019.105081 |
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ELV048828017 |
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| 520 | |a Bromopride is a prokinetic and antiemetic drug used to treat nausea and vomiting. Although its prescription is common in Brazil, there is a lack of studies about bromopride pharmacokinetics. Therefore, the aims of this study were to investigate the population pharmacokinetics of bromopride and to evaluate the influence of covariates on its absorption. This study is a retrospective analysis of data collected from bioequivalence studies. The data was modeled using MONOLIX 2018R2. Assuming one-compartment and linear elimination, the absorption phase was evaluated with different structural models. The model of sequential first- and zero-order with combined error and exponential inter-individual variability in all parameters best described the atypical absorption profile of bromopride. Population estimates were first-order absorption rate (ka) of 0.08 h − 1, fraction of dose absorbed by first-order (Fr) of 32.60%, duration of the zero-order absorption (Tk0) of 0.88 h with latency time (Tlag) of 0.47 h, volume of distribution of 230 l and clearance of 46.80 l h − 1. Bodyweight affects Tk0, dosage form was found to correlate with Tk0 and Tlag, while gender affects Tlag. However, simulations evaluating the clinical importance of these covariates on steady-state indicated minimal changes on bromopride exposure. The mixed absorption model was reasonable to describe the absorption process of bromopride because it had the flexibility to fit multiple-peaks profile and shows good agreement with physicochemical properties of drug. | ||
| 520 | |a Bromopride is a prokinetic and antiemetic drug used to treat nausea and vomiting. Although its prescription is common in Brazil, there is a lack of studies about bromopride pharmacokinetics. Therefore, the aims of this study were to investigate the population pharmacokinetics of bromopride and to evaluate the influence of covariates on its absorption. This study is a retrospective analysis of data collected from bioequivalence studies. The data was modeled using MONOLIX 2018R2. Assuming one-compartment and linear elimination, the absorption phase was evaluated with different structural models. The model of sequential first- and zero-order with combined error and exponential inter-individual variability in all parameters best described the atypical absorption profile of bromopride. Population estimates were first-order absorption rate (ka) of 0.08 h − 1, fraction of dose absorbed by first-order (Fr) of 32.60%, duration of the zero-order absorption (Tk0) of 0.88 h with latency time (Tlag) of 0.47 h, volume of distribution of 230 l and clearance of 46.80 l h − 1. Bodyweight affects Tk0, dosage form was found to correlate with Tk0 and Tlag, while gender affects Tlag. However, simulations evaluating the clinical importance of these covariates on steady-state indicated minimal changes on bromopride exposure. The mixed absorption model was reasonable to describe the absorption process of bromopride because it had the flexibility to fit multiple-peaks profile and shows good agreement with physicochemical properties of drug. | ||
| 700 | 1 | |a Barth, Aline B. |4 oth | |
| 700 | 1 | |a Santos, Gustavo Mendes Lima |4 oth | |
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| 700 | 1 | |a Bruschi, Marcos Luciano |4 oth | |
| 700 | 1 | |a Kimura, Elza |4 oth | |
| 700 | 1 | |a de Araújo, Bibiana Verlindo |4 oth | |
| 700 | 1 | |a Diniz, Andréa |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |n Elsevier |a Heyden, Mariano L.M. ELSEVIER |t The face of wrongdoing? An expectancy violations perspective on CEO facial characteristics and media coverage of misconducting firms |d 2022 |d official journal of the European Federation for Pharmaceutical Sciences |g New York, NY [u.a.] |w (DE-627)ELV009954198 |
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10.1016/j.ejps.2019.105081 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000000948.pica (DE-627)ELV048828017 (ELSEVIER)S0928-0987(19)30354-9 DE-627 ger DE-627 rakwb eng 300 330 360 VZ 85.05 bkl 85.06 bkl 89.52 bkl Lachi-Silva, Larissa verfasserin aut Population pharmacokinetics of orally administrated bromopride: Focus on the absorption process 2020transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Bromopride is a prokinetic and antiemetic drug used to treat nausea and vomiting. Although its prescription is common in Brazil, there is a lack of studies about bromopride pharmacokinetics. Therefore, the aims of this study were to investigate the population pharmacokinetics of bromopride and to evaluate the influence of covariates on its absorption. This study is a retrospective analysis of data collected from bioequivalence studies. The data was modeled using MONOLIX 2018R2. Assuming one-compartment and linear elimination, the absorption phase was evaluated with different structural models. The model of sequential first- and zero-order with combined error and exponential inter-individual variability in all parameters best described the atypical absorption profile of bromopride. Population estimates were first-order absorption rate (ka) of 0.08 h − 1, fraction of dose absorbed by first-order (Fr) of 32.60%, duration of the zero-order absorption (Tk0) of 0.88 h with latency time (Tlag) of 0.47 h, volume of distribution of 230 l and clearance of 46.80 l h − 1. Bodyweight affects Tk0, dosage form was found to correlate with Tk0 and Tlag, while gender affects Tlag. However, simulations evaluating the clinical importance of these covariates on steady-state indicated minimal changes on bromopride exposure. The mixed absorption model was reasonable to describe the absorption process of bromopride because it had the flexibility to fit multiple-peaks profile and shows good agreement with physicochemical properties of drug. Bromopride is a prokinetic and antiemetic drug used to treat nausea and vomiting. Although its prescription is common in Brazil, there is a lack of studies about bromopride pharmacokinetics. Therefore, the aims of this study were to investigate the population pharmacokinetics of bromopride and to evaluate the influence of covariates on its absorption. This study is a retrospective analysis of data collected from bioequivalence studies. The data was modeled using MONOLIX 2018R2. Assuming one-compartment and linear elimination, the absorption phase was evaluated with different structural models. The model of sequential first- and zero-order with combined error and exponential inter-individual variability in all parameters best described the atypical absorption profile of bromopride. Population estimates were first-order absorption rate (ka) of 0.08 h − 1, fraction of dose absorbed by first-order (Fr) of 32.60%, duration of the zero-order absorption (Tk0) of 0.88 h with latency time (Tlag) of 0.47 h, volume of distribution of 230 l and clearance of 46.80 l h − 1. Bodyweight affects Tk0, dosage form was found to correlate with Tk0 and Tlag, while gender affects Tlag. However, simulations evaluating the clinical importance of these covariates on steady-state indicated minimal changes on bromopride exposure. The mixed absorption model was reasonable to describe the absorption process of bromopride because it had the flexibility to fit multiple-peaks profile and shows good agreement with physicochemical properties of drug. Barth, Aline B. oth Santos, Gustavo Mendes Lima oth Ahamadi, Malidi oth Bruschi, Marcos Luciano oth Kimura, Elza oth de Araújo, Bibiana Verlindo oth Diniz, Andréa oth Enthalten in Elsevier Heyden, Mariano L.M. ELSEVIER The face of wrongdoing? An expectancy violations perspective on CEO facial characteristics and media coverage of misconducting firms 2022 official journal of the European Federation for Pharmaceutical Sciences New York, NY [u.a.] (DE-627)ELV009954198 volume:142 year:2020 day:15 month:01 pages:0 https://doi.org/10.1016/j.ejps.2019.105081 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 85.05 Betriebssoziologie Betriebspsychologie VZ 85.06 Unternehmensführung VZ 89.52 Politische Psychologie Politische Soziologie VZ AR 142 2020 15 0115 0 |
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10.1016/j.ejps.2019.105081 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000000948.pica (DE-627)ELV048828017 (ELSEVIER)S0928-0987(19)30354-9 DE-627 ger DE-627 rakwb eng 300 330 360 VZ 85.05 bkl 85.06 bkl 89.52 bkl Lachi-Silva, Larissa verfasserin aut Population pharmacokinetics of orally administrated bromopride: Focus on the absorption process 2020transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Bromopride is a prokinetic and antiemetic drug used to treat nausea and vomiting. Although its prescription is common in Brazil, there is a lack of studies about bromopride pharmacokinetics. Therefore, the aims of this study were to investigate the population pharmacokinetics of bromopride and to evaluate the influence of covariates on its absorption. This study is a retrospective analysis of data collected from bioequivalence studies. The data was modeled using MONOLIX 2018R2. Assuming one-compartment and linear elimination, the absorption phase was evaluated with different structural models. The model of sequential first- and zero-order with combined error and exponential inter-individual variability in all parameters best described the atypical absorption profile of bromopride. Population estimates were first-order absorption rate (ka) of 0.08 h − 1, fraction of dose absorbed by first-order (Fr) of 32.60%, duration of the zero-order absorption (Tk0) of 0.88 h with latency time (Tlag) of 0.47 h, volume of distribution of 230 l and clearance of 46.80 l h − 1. Bodyweight affects Tk0, dosage form was found to correlate with Tk0 and Tlag, while gender affects Tlag. However, simulations evaluating the clinical importance of these covariates on steady-state indicated minimal changes on bromopride exposure. The mixed absorption model was reasonable to describe the absorption process of bromopride because it had the flexibility to fit multiple-peaks profile and shows good agreement with physicochemical properties of drug. Bromopride is a prokinetic and antiemetic drug used to treat nausea and vomiting. Although its prescription is common in Brazil, there is a lack of studies about bromopride pharmacokinetics. Therefore, the aims of this study were to investigate the population pharmacokinetics of bromopride and to evaluate the influence of covariates on its absorption. This study is a retrospective analysis of data collected from bioequivalence studies. The data was modeled using MONOLIX 2018R2. Assuming one-compartment and linear elimination, the absorption phase was evaluated with different structural models. The model of sequential first- and zero-order with combined error and exponential inter-individual variability in all parameters best described the atypical absorption profile of bromopride. Population estimates were first-order absorption rate (ka) of 0.08 h − 1, fraction of dose absorbed by first-order (Fr) of 32.60%, duration of the zero-order absorption (Tk0) of 0.88 h with latency time (Tlag) of 0.47 h, volume of distribution of 230 l and clearance of 46.80 l h − 1. Bodyweight affects Tk0, dosage form was found to correlate with Tk0 and Tlag, while gender affects Tlag. However, simulations evaluating the clinical importance of these covariates on steady-state indicated minimal changes on bromopride exposure. The mixed absorption model was reasonable to describe the absorption process of bromopride because it had the flexibility to fit multiple-peaks profile and shows good agreement with physicochemical properties of drug. Barth, Aline B. oth Santos, Gustavo Mendes Lima oth Ahamadi, Malidi oth Bruschi, Marcos Luciano oth Kimura, Elza oth de Araújo, Bibiana Verlindo oth Diniz, Andréa oth Enthalten in Elsevier Heyden, Mariano L.M. ELSEVIER The face of wrongdoing? An expectancy violations perspective on CEO facial characteristics and media coverage of misconducting firms 2022 official journal of the European Federation for Pharmaceutical Sciences New York, NY [u.a.] (DE-627)ELV009954198 volume:142 year:2020 day:15 month:01 pages:0 https://doi.org/10.1016/j.ejps.2019.105081 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 85.05 Betriebssoziologie Betriebspsychologie VZ 85.06 Unternehmensführung VZ 89.52 Politische Psychologie Politische Soziologie VZ AR 142 2020 15 0115 0 |
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10.1016/j.ejps.2019.105081 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000000948.pica (DE-627)ELV048828017 (ELSEVIER)S0928-0987(19)30354-9 DE-627 ger DE-627 rakwb eng 300 330 360 VZ 85.05 bkl 85.06 bkl 89.52 bkl Lachi-Silva, Larissa verfasserin aut Population pharmacokinetics of orally administrated bromopride: Focus on the absorption process 2020transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Bromopride is a prokinetic and antiemetic drug used to treat nausea and vomiting. Although its prescription is common in Brazil, there is a lack of studies about bromopride pharmacokinetics. Therefore, the aims of this study were to investigate the population pharmacokinetics of bromopride and to evaluate the influence of covariates on its absorption. This study is a retrospective analysis of data collected from bioequivalence studies. The data was modeled using MONOLIX 2018R2. Assuming one-compartment and linear elimination, the absorption phase was evaluated with different structural models. The model of sequential first- and zero-order with combined error and exponential inter-individual variability in all parameters best described the atypical absorption profile of bromopride. Population estimates were first-order absorption rate (ka) of 0.08 h − 1, fraction of dose absorbed by first-order (Fr) of 32.60%, duration of the zero-order absorption (Tk0) of 0.88 h with latency time (Tlag) of 0.47 h, volume of distribution of 230 l and clearance of 46.80 l h − 1. Bodyweight affects Tk0, dosage form was found to correlate with Tk0 and Tlag, while gender affects Tlag. However, simulations evaluating the clinical importance of these covariates on steady-state indicated minimal changes on bromopride exposure. The mixed absorption model was reasonable to describe the absorption process of bromopride because it had the flexibility to fit multiple-peaks profile and shows good agreement with physicochemical properties of drug. Bromopride is a prokinetic and antiemetic drug used to treat nausea and vomiting. Although its prescription is common in Brazil, there is a lack of studies about bromopride pharmacokinetics. Therefore, the aims of this study were to investigate the population pharmacokinetics of bromopride and to evaluate the influence of covariates on its absorption. This study is a retrospective analysis of data collected from bioequivalence studies. The data was modeled using MONOLIX 2018R2. Assuming one-compartment and linear elimination, the absorption phase was evaluated with different structural models. The model of sequential first- and zero-order with combined error and exponential inter-individual variability in all parameters best described the atypical absorption profile of bromopride. Population estimates were first-order absorption rate (ka) of 0.08 h − 1, fraction of dose absorbed by first-order (Fr) of 32.60%, duration of the zero-order absorption (Tk0) of 0.88 h with latency time (Tlag) of 0.47 h, volume of distribution of 230 l and clearance of 46.80 l h − 1. Bodyweight affects Tk0, dosage form was found to correlate with Tk0 and Tlag, while gender affects Tlag. However, simulations evaluating the clinical importance of these covariates on steady-state indicated minimal changes on bromopride exposure. The mixed absorption model was reasonable to describe the absorption process of bromopride because it had the flexibility to fit multiple-peaks profile and shows good agreement with physicochemical properties of drug. Barth, Aline B. oth Santos, Gustavo Mendes Lima oth Ahamadi, Malidi oth Bruschi, Marcos Luciano oth Kimura, Elza oth de Araújo, Bibiana Verlindo oth Diniz, Andréa oth Enthalten in Elsevier Heyden, Mariano L.M. ELSEVIER The face of wrongdoing? An expectancy violations perspective on CEO facial characteristics and media coverage of misconducting firms 2022 official journal of the European Federation for Pharmaceutical Sciences New York, NY [u.a.] (DE-627)ELV009954198 volume:142 year:2020 day:15 month:01 pages:0 https://doi.org/10.1016/j.ejps.2019.105081 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 85.05 Betriebssoziologie Betriebspsychologie VZ 85.06 Unternehmensführung VZ 89.52 Politische Psychologie Politische Soziologie VZ AR 142 2020 15 0115 0 |
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10.1016/j.ejps.2019.105081 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000000948.pica (DE-627)ELV048828017 (ELSEVIER)S0928-0987(19)30354-9 DE-627 ger DE-627 rakwb eng 300 330 360 VZ 85.05 bkl 85.06 bkl 89.52 bkl Lachi-Silva, Larissa verfasserin aut Population pharmacokinetics of orally administrated bromopride: Focus on the absorption process 2020transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Bromopride is a prokinetic and antiemetic drug used to treat nausea and vomiting. Although its prescription is common in Brazil, there is a lack of studies about bromopride pharmacokinetics. Therefore, the aims of this study were to investigate the population pharmacokinetics of bromopride and to evaluate the influence of covariates on its absorption. This study is a retrospective analysis of data collected from bioequivalence studies. The data was modeled using MONOLIX 2018R2. Assuming one-compartment and linear elimination, the absorption phase was evaluated with different structural models. The model of sequential first- and zero-order with combined error and exponential inter-individual variability in all parameters best described the atypical absorption profile of bromopride. Population estimates were first-order absorption rate (ka) of 0.08 h − 1, fraction of dose absorbed by first-order (Fr) of 32.60%, duration of the zero-order absorption (Tk0) of 0.88 h with latency time (Tlag) of 0.47 h, volume of distribution of 230 l and clearance of 46.80 l h − 1. Bodyweight affects Tk0, dosage form was found to correlate with Tk0 and Tlag, while gender affects Tlag. However, simulations evaluating the clinical importance of these covariates on steady-state indicated minimal changes on bromopride exposure. The mixed absorption model was reasonable to describe the absorption process of bromopride because it had the flexibility to fit multiple-peaks profile and shows good agreement with physicochemical properties of drug. Bromopride is a prokinetic and antiemetic drug used to treat nausea and vomiting. Although its prescription is common in Brazil, there is a lack of studies about bromopride pharmacokinetics. Therefore, the aims of this study were to investigate the population pharmacokinetics of bromopride and to evaluate the influence of covariates on its absorption. This study is a retrospective analysis of data collected from bioequivalence studies. The data was modeled using MONOLIX 2018R2. Assuming one-compartment and linear elimination, the absorption phase was evaluated with different structural models. The model of sequential first- and zero-order with combined error and exponential inter-individual variability in all parameters best described the atypical absorption profile of bromopride. Population estimates were first-order absorption rate (ka) of 0.08 h − 1, fraction of dose absorbed by first-order (Fr) of 32.60%, duration of the zero-order absorption (Tk0) of 0.88 h with latency time (Tlag) of 0.47 h, volume of distribution of 230 l and clearance of 46.80 l h − 1. Bodyweight affects Tk0, dosage form was found to correlate with Tk0 and Tlag, while gender affects Tlag. However, simulations evaluating the clinical importance of these covariates on steady-state indicated minimal changes on bromopride exposure. The mixed absorption model was reasonable to describe the absorption process of bromopride because it had the flexibility to fit multiple-peaks profile and shows good agreement with physicochemical properties of drug. Barth, Aline B. oth Santos, Gustavo Mendes Lima oth Ahamadi, Malidi oth Bruschi, Marcos Luciano oth Kimura, Elza oth de Araújo, Bibiana Verlindo oth Diniz, Andréa oth Enthalten in Elsevier Heyden, Mariano L.M. ELSEVIER The face of wrongdoing? An expectancy violations perspective on CEO facial characteristics and media coverage of misconducting firms 2022 official journal of the European Federation for Pharmaceutical Sciences New York, NY [u.a.] (DE-627)ELV009954198 volume:142 year:2020 day:15 month:01 pages:0 https://doi.org/10.1016/j.ejps.2019.105081 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 85.05 Betriebssoziologie Betriebspsychologie VZ 85.06 Unternehmensführung VZ 89.52 Politische Psychologie Politische Soziologie VZ AR 142 2020 15 0115 0 |
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10.1016/j.ejps.2019.105081 doi /cbs_pica/cbs_olc/import_discovery/elsevier/einzuspielen/GBV00000000000948.pica (DE-627)ELV048828017 (ELSEVIER)S0928-0987(19)30354-9 DE-627 ger DE-627 rakwb eng 300 330 360 VZ 85.05 bkl 85.06 bkl 89.52 bkl Lachi-Silva, Larissa verfasserin aut Population pharmacokinetics of orally administrated bromopride: Focus on the absorption process 2020transfer abstract nicht spezifiziert zzz rdacontent nicht spezifiziert z rdamedia nicht spezifiziert zu rdacarrier Bromopride is a prokinetic and antiemetic drug used to treat nausea and vomiting. Although its prescription is common in Brazil, there is a lack of studies about bromopride pharmacokinetics. Therefore, the aims of this study were to investigate the population pharmacokinetics of bromopride and to evaluate the influence of covariates on its absorption. This study is a retrospective analysis of data collected from bioequivalence studies. The data was modeled using MONOLIX 2018R2. Assuming one-compartment and linear elimination, the absorption phase was evaluated with different structural models. The model of sequential first- and zero-order with combined error and exponential inter-individual variability in all parameters best described the atypical absorption profile of bromopride. Population estimates were first-order absorption rate (ka) of 0.08 h − 1, fraction of dose absorbed by first-order (Fr) of 32.60%, duration of the zero-order absorption (Tk0) of 0.88 h with latency time (Tlag) of 0.47 h, volume of distribution of 230 l and clearance of 46.80 l h − 1. Bodyweight affects Tk0, dosage form was found to correlate with Tk0 and Tlag, while gender affects Tlag. However, simulations evaluating the clinical importance of these covariates on steady-state indicated minimal changes on bromopride exposure. The mixed absorption model was reasonable to describe the absorption process of bromopride because it had the flexibility to fit multiple-peaks profile and shows good agreement with physicochemical properties of drug. Bromopride is a prokinetic and antiemetic drug used to treat nausea and vomiting. Although its prescription is common in Brazil, there is a lack of studies about bromopride pharmacokinetics. Therefore, the aims of this study were to investigate the population pharmacokinetics of bromopride and to evaluate the influence of covariates on its absorption. This study is a retrospective analysis of data collected from bioequivalence studies. The data was modeled using MONOLIX 2018R2. Assuming one-compartment and linear elimination, the absorption phase was evaluated with different structural models. The model of sequential first- and zero-order with combined error and exponential inter-individual variability in all parameters best described the atypical absorption profile of bromopride. Population estimates were first-order absorption rate (ka) of 0.08 h − 1, fraction of dose absorbed by first-order (Fr) of 32.60%, duration of the zero-order absorption (Tk0) of 0.88 h with latency time (Tlag) of 0.47 h, volume of distribution of 230 l and clearance of 46.80 l h − 1. Bodyweight affects Tk0, dosage form was found to correlate with Tk0 and Tlag, while gender affects Tlag. However, simulations evaluating the clinical importance of these covariates on steady-state indicated minimal changes on bromopride exposure. The mixed absorption model was reasonable to describe the absorption process of bromopride because it had the flexibility to fit multiple-peaks profile and shows good agreement with physicochemical properties of drug. Barth, Aline B. oth Santos, Gustavo Mendes Lima oth Ahamadi, Malidi oth Bruschi, Marcos Luciano oth Kimura, Elza oth de Araújo, Bibiana Verlindo oth Diniz, Andréa oth Enthalten in Elsevier Heyden, Mariano L.M. ELSEVIER The face of wrongdoing? An expectancy violations perspective on CEO facial characteristics and media coverage of misconducting firms 2022 official journal of the European Federation for Pharmaceutical Sciences New York, NY [u.a.] (DE-627)ELV009954198 volume:142 year:2020 day:15 month:01 pages:0 https://doi.org/10.1016/j.ejps.2019.105081 Volltext GBV_USEFLAG_U GBV_ELV SYSFLAG_U 85.05 Betriebssoziologie Betriebspsychologie VZ 85.06 Unternehmensführung VZ 89.52 Politische Psychologie Politische Soziologie VZ AR 142 2020 15 0115 0 |
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Population pharmacokinetics of orally administrated bromopride: Focus on the absorption process |
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Bromopride is a prokinetic and antiemetic drug used to treat nausea and vomiting. Although its prescription is common in Brazil, there is a lack of studies about bromopride pharmacokinetics. Therefore, the aims of this study were to investigate the population pharmacokinetics of bromopride and to evaluate the influence of covariates on its absorption. This study is a retrospective analysis of data collected from bioequivalence studies. The data was modeled using MONOLIX 2018R2. Assuming one-compartment and linear elimination, the absorption phase was evaluated with different structural models. The model of sequential first- and zero-order with combined error and exponential inter-individual variability in all parameters best described the atypical absorption profile of bromopride. Population estimates were first-order absorption rate (ka) of 0.08 h − 1, fraction of dose absorbed by first-order (Fr) of 32.60%, duration of the zero-order absorption (Tk0) of 0.88 h with latency time (Tlag) of 0.47 h, volume of distribution of 230 l and clearance of 46.80 l h − 1. Bodyweight affects Tk0, dosage form was found to correlate with Tk0 and Tlag, while gender affects Tlag. However, simulations evaluating the clinical importance of these covariates on steady-state indicated minimal changes on bromopride exposure. The mixed absorption model was reasonable to describe the absorption process of bromopride because it had the flexibility to fit multiple-peaks profile and shows good agreement with physicochemical properties of drug. |
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Bromopride is a prokinetic and antiemetic drug used to treat nausea and vomiting. Although its prescription is common in Brazil, there is a lack of studies about bromopride pharmacokinetics. Therefore, the aims of this study were to investigate the population pharmacokinetics of bromopride and to evaluate the influence of covariates on its absorption. This study is a retrospective analysis of data collected from bioequivalence studies. The data was modeled using MONOLIX 2018R2. Assuming one-compartment and linear elimination, the absorption phase was evaluated with different structural models. The model of sequential first- and zero-order with combined error and exponential inter-individual variability in all parameters best described the atypical absorption profile of bromopride. Population estimates were first-order absorption rate (ka) of 0.08 h − 1, fraction of dose absorbed by first-order (Fr) of 32.60%, duration of the zero-order absorption (Tk0) of 0.88 h with latency time (Tlag) of 0.47 h, volume of distribution of 230 l and clearance of 46.80 l h − 1. Bodyweight affects Tk0, dosage form was found to correlate with Tk0 and Tlag, while gender affects Tlag. However, simulations evaluating the clinical importance of these covariates on steady-state indicated minimal changes on bromopride exposure. The mixed absorption model was reasonable to describe the absorption process of bromopride because it had the flexibility to fit multiple-peaks profile and shows good agreement with physicochemical properties of drug. |
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Bromopride is a prokinetic and antiemetic drug used to treat nausea and vomiting. Although its prescription is common in Brazil, there is a lack of studies about bromopride pharmacokinetics. Therefore, the aims of this study were to investigate the population pharmacokinetics of bromopride and to evaluate the influence of covariates on its absorption. This study is a retrospective analysis of data collected from bioequivalence studies. The data was modeled using MONOLIX 2018R2. Assuming one-compartment and linear elimination, the absorption phase was evaluated with different structural models. The model of sequential first- and zero-order with combined error and exponential inter-individual variability in all parameters best described the atypical absorption profile of bromopride. Population estimates were first-order absorption rate (ka) of 0.08 h − 1, fraction of dose absorbed by first-order (Fr) of 32.60%, duration of the zero-order absorption (Tk0) of 0.88 h with latency time (Tlag) of 0.47 h, volume of distribution of 230 l and clearance of 46.80 l h − 1. Bodyweight affects Tk0, dosage form was found to correlate with Tk0 and Tlag, while gender affects Tlag. However, simulations evaluating the clinical importance of these covariates on steady-state indicated minimal changes on bromopride exposure. The mixed absorption model was reasonable to describe the absorption process of bromopride because it had the flexibility to fit multiple-peaks profile and shows good agreement with physicochemical properties of drug. |
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