title: Polyethylene glycol-polyvinyl alcohol grafted copolymer: study of the bioavailability after oral administration to rats.
abstract: The absorption, urinary excretion, and the biliary excretion of a single oral dose of 10 or 1000 mg/kg bw of (14)C-polyethylene glycol-polyvinyl alcohol (PEG-PVA) grafted copolymer were studied in adult male and female rats. In a balance/excretion experiment, the total excretion of ingested radioactivity was determined over a period of 168 h and residual radioactivity was detected in selected tissues and the carcass. In a biliary excretion experiment, excretion of radioactivity via the bile duct was determined over a period of 48 h after administration of the substance to cannulated rats. Most, if not all, of the radioactivity (>100%) was excreted within 48 h via the feces regardless of sex or dose. Urinary excretion was very limited: 0.45-0.50% of dose at the low dose and 0.22-0.27% of dose at the high dose. At both dose levels, residual radioactivity in the carcass and all organs and tissues after 168 h was ≤ 0.02% of dose. Biliary excretion was 0.01-0.02% of dose. Based on these findings, the bioavailability of PEG-PVA grafted copolymer was determined to be <1% demonstrating that absorption was virtually negligible following a single oral administration to male and female rats.
authors: Product Safety Department, BASF SE, Ludwigshafen, Germany.
authors: Franziska F
authors: FF
authors: Heuschmid
authors: Paul
authors: P
authors: Schuster
authors: Birthe
authors: B
authors: Lauer
authors: Eric
authors: E
authors: Fabian
authors: Edgar
authors: E
authors: Leibold
authors: Bennard
authors: B
authors: van Ravenzwaay
mesh_terms: D000818:Animals; D001646:Bile / Q000378:metabolism; D001682:Biological Availability; D004305:Dose-Response Relationship, Drug; D005079:Excipients / Q000008:administration & dosage / Q000493:pharmacokinetics*; D005260:Female; D008297:Male; D011145:Polyvinyls / Q000008:administration & dosage / Q000493:pharmacokinetics*; D051381:Rats
chemical_list: D005079:Excipients; C519734:Kollicoat IR; D011145:Polyvinyls
keywords: Bioavailability; EFSA; EPA; European Food Safety Authority; Excipient; Film coating polymer; GLP; Good Laboratory Practice; JECFA; Kollicoat® IR; OECD; Oral; PEG; PEG–PVA; PVA; Polyethylene glycol–polyvinyl alcohol grafted copolymer; The Joint (FAO/WHO) Expert Committee on Food Additives; US Environmental Protection Agency; organisation for economic cooperation and development; polyethylene glycol; polyethylene glycol–polyvinyl alcohol; polyvinyl alcohol