Pharmacokinetics, toxicokinetics, distribution, metabolism and excretion of linezolid in mouse, rat and dog
1. Linezolid (ZYVOX™), the first of a new class of antibiotics, the oxazolidinones, is approved for treatment of Gram-positive bacterial infections. 2. The aim was to determine the absorption, distribution, metabolism and excretion (ADME) of linezolid in mouse, rat and dog in support of preclinical...
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Published in | Xenobiotica Vol. 32; no. 10; pp. 907 - 924 |
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Main Authors | , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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London
Informa UK Ltd
01.10.2002
Taylor & Francis |
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Abstract | 1. Linezolid (ZYVOX™), the first of a new class of antibiotics, the oxazolidinones, is approved for treatment of Gram-positive bacterial infections. 2. The aim was to determine the absorption, distribution, metabolism and excretion (ADME) of linezolid in mouse, rat and dog in support of preclinical safety studies and clinical development. 3. Conventional replicate study designs were employed in animal experiments, and biofluids were assayed by HPLC or HPLC-MS. 4. Linezolid was rapidly absorbed after p.o. dosing with an p.o. bioavailability of > 95% in rat and dog, and > 70% in mouse. Twenty-eight-day i.v./p.o. toxicokinetic studies in rat (20-200mg kg−1 day−1) and dog (10-80mg kg−1 day−1) revealed neither a meaningful increase in clearance nor accumulation upon multiple dosing. 5. Linezolid had limited protein binding (<35%) and was very well distributed to most extravascular sites, with a volume of distribution at steady-state (Vss) approximately equal to total body water. 6. Linezolid circulated mainly as parent drug and was excreted mainly as parent drug and two inactive carboxylic acids, PNU-142586 and PNU-142300. Minor secondary metabolites were also characterized. In all species, the clearance rate was determined by metabolism. 7. Radioactivity recovery was essentially complete within 24-48h. Renal excretion of parent drug and metabolites was a major elimination route. Parent drug underwent renal tubular reabsorption, significantly slowing parent drug excretion and allowing a slow metabolic process to become rate-limiting in overall clearance. 8. It is concluded that ADME data were relatively consistent across species and supported the rat and dog as the principal non-clinical safety species. |
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AbstractList | 1. Linezolid (ZYVOX), the first of a new class of antibiotics, the oxazolidinones, is approved for treatment of Gram-positive bacterial infections. 2. The aim was to determine the absorption, distribution, metabolism and excretion (ADME) of linezolid in mouse, rat and dog in support of preclinical safety studies and clinical development. 3. Conventional replicate study designs were employed in animal experiments, and biofluids were assayed by HPLC or HPLC-MS. 4. Linezolid was rapidly absorbed after p.o. dosing with an p.o. bioavailability of > 95% in rat and dog, and > 70% in mouse. Twenty-eight-day i.v./p.o. toxicokinetic studies in rat (20-200mg kg(-1) day(-1)) and dog (10-80 mg kg(-1) day(-1)) revealed neither a meaningful increase in clearance nor accumulation upon multiple dosing. 5. Linezolid had limited protein binding (<35%) and was very well distributed to most extravascular sites, with a volume of distribution at steady-state (V(ss)) approximately equal to total body water. 6. Linezolid circulated mainly as parent drug and was excreted mainly as parent drug and two inactive carboxylic acids, PNU-142586 and PNU-142300. Minor secondary metabolites were also characterized. In all species, the clearance rate was determined by metabolism. 7. Radioactivity recovery was essentially complete within 24-48 h. Renal excretion of parent drug and metabolites was a major elimination route. Parent drug underwent renal tubular reabsorption, significantly slowing parent drug excretion and allowing a slow metabolic process to become rate-limiting in overall clearance. 8. It is concluded that ADME data were relatively consistent across species and supported the rat and dog as the principal non-clinical safety species. 1. Linezolid (ZYVOX™), the first of a new class of antibiotics, the oxazolidinones, is approved for treatment of Gram-positive bacterial infections. 2. The aim was to determine the absorption, distribution, metabolism and excretion (ADME) of linezolid in mouse, rat and dog in support of preclinical safety studies and clinical development. 3. Conventional replicate study designs were employed in animal experiments, and biofluids were assayed by HPLC or HPLC-MS. 4. Linezolid was rapidly absorbed after p.o. dosing with an p.o. bioavailability of > 95% in rat and dog, and > 70% in mouse. Twenty-eight-day i.v./p.o. toxicokinetic studies in rat (20-200mg kg −1 day −1 ) and dog (10-80mg kg −1 day −1 ) revealed neither a meaningful increase in clearance nor accumulation upon multiple dosing. 5. Linezolid had limited protein binding (<35%) and was very well distributed to most extravascular sites, with a volume of distribution at steady-state (V ss ) approximately equal to total body water. 6. Linezolid circulated mainly as parent drug and was excreted mainly as parent drug and two inactive carboxylic acids, PNU-142586 and PNU-142300. Minor secondary metabolites were also characterized. In all species, the clearance rate was determined by metabolism. 7. Radioactivity recovery was essentially complete within 24-48h. Renal excretion of parent drug and metabolites was a major elimination route. Parent drug underwent renal tubular reabsorption, significantly slowing parent drug excretion and allowing a slow metabolic process to become rate-limiting in overall clearance. 8. It is concluded that ADME data were relatively consistent across species and supported the rat and dog as the principal non-clinical safety species. 1. Linezolid (ZYVOX™), the first of a new class of antibiotics, the oxazolidinones, is approved for treatment of Gram-positive bacterial infections. 2. The aim was to determine the absorption, distribution, metabolism and excretion (ADME) of linezolid in mouse, rat and dog in support of preclinical safety studies and clinical development. 3. Conventional replicate study designs were employed in animal experiments, and biofluids were assayed by HPLC or HPLC-MS. 4. Linezolid was rapidly absorbed after p.o. dosing with an p.o. bioavailability of > 95% in rat and dog, and > 70% in mouse. Twenty-eight-day i.v./p.o. toxicokinetic studies in rat (20-200mg kg−1 day−1) and dog (10-80mg kg−1 day−1) revealed neither a meaningful increase in clearance nor accumulation upon multiple dosing. 5. Linezolid had limited protein binding (<35%) and was very well distributed to most extravascular sites, with a volume of distribution at steady-state (Vss) approximately equal to total body water. 6. Linezolid circulated mainly as parent drug and was excreted mainly as parent drug and two inactive carboxylic acids, PNU-142586 and PNU-142300. Minor secondary metabolites were also characterized. In all species, the clearance rate was determined by metabolism. 7. Radioactivity recovery was essentially complete within 24-48h. Renal excretion of parent drug and metabolites was a major elimination route. Parent drug underwent renal tubular reabsorption, significantly slowing parent drug excretion and allowing a slow metabolic process to become rate-limiting in overall clearance. 8. It is concluded that ADME data were relatively consistent across species and supported the rat and dog as the principal non-clinical safety species. |
Author | Ozawa, N. Adams, L. A. Peng, G. W. Schuette, M. R. Slatter, J. G. Koike, S. Bush, E. C. Feenstra, K. L. Sams, J. P. Yamazaki, S. Chiba, K. Daley-Yates, P. T. |
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Cites_doi | 10.1016/S0021-9258(18)73708-3 10.1128/AAC.41.10.2127 10.1016/S0731-7085(98)00310-0 10.1016/S0731-7085(99)00104-1 10.2174/1389200003338929 10.1007/BF01065191 10.1128/AAC.41.10.2132 10.1016/0009-8981(56)90020-1 |
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Keywords | Linezolid Fissipedia Carnivora Intravenous administration Rat Rodentia Oral administration Metabolism Vertebrata Antibiotic Mammalia Mouse Animal Pharmacokinetics Dog |
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References | BOXENBAUM H (CIT0001) 1980; 8 LIN A. H. (CIT0009) 1997; 41 SHINABARGER D. L. (CIT0015) 1997; 41 SLATTER J. G. (CIT0017) 2001; 29 JAUCIT R. (CIT0007) 1990; 360 VICKERS S. (CIT0024) 2000; 1 NICHOLLS A. W. (CIT0010) 1999; 20 WYNALDA M. A. (CIT0026) 2000; 28 PENG G. W. (CIT0013) 1999; 20 HEYROVSKY A (CIT0006) 1956; 1 TOCCO D. J. (CIT0023) 1980; 8 BRATTON C. (CIT0002) 1939; 128 CIT0014 TANNI E (CIT0022) 1994; 44 |
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Snippet | 1. Linezolid (ZYVOX™), the first of a new class of antibiotics, the oxazolidinones, is approved for treatment of Gram-positive bacterial infections. 2. The aim... 1. Linezolid (ZYVOX), the first of a new class of antibiotics, the oxazolidinones, is approved for treatment of Gram-positive bacterial infections. 2. The aim... |
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SubjectTerms | Acetamides - metabolism Acetamides - pharmacokinetics Animals Anti-Infective Agents - metabolism Anti-Infective Agents - pharmacokinetics Antibacterial agents Antibiotics. Antiinfectious agents. Antiparasitic agents Biological and medical sciences Chromatography, High Pressure Liquid Dogs Dose-Response Relationship, Drug Female Humans Kinetics Linezolid Male Mass Spectrometry Medical sciences Mice Models, Chemical Oxazolidinones - metabolism Oxazolidinones - pharmacokinetics Pharmacology. Drug treatments Rats Rats, Sprague-Dawley Time Factors Tissue Distribution |
Title | Pharmacokinetics, toxicokinetics, distribution, metabolism and excretion of linezolid in mouse, rat and dog |
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