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Anionic Methacrylate Copolymer (AMC) is a fully polymerized copolymer used in the pharmaceutical industry as an enteric/delayed-release coating to permit the pH-dependent release of active ingredients in the gastrointestinal tract from oral dosage forms. This function is of potential use for food supplements. Oral administration of radiolabeled copolymer to rats resulted in the detection of chemically unchanged copolymer in the feces, with negligible absorption (

The present study describes the kinetics of tetrahydronaphthalene in male and female rats (five animals per dose per sex) at three dose levels (15, 50, and 150 mg/kg daily). Plasma concentration measurements were performed in the course of a subacute toxicity study of 28 days duration in an enriched study design. Two blood samples per animal were taken at different time points after application at day 1 and 16 (150 mg/kg daily) and at day 3 and 18 (15 and 50 mg/kg daily), respectively. Tetrahydronaphthalene was assayed by gas chromatography-mass spectrometry (GC-MS) after extraction. The data of plasma concentration time were analysed using non-linear mixed effects modelling as implemented in NONMEM. The structural model with the best fit employed one compartment kinetics with instantaneous drug input. Interindividual variability in both k and V was found to be very small [k, 0.201 h(-1), 0.013; V, 16.19 (kg), 1.77; population mean and SE]. No unequivocal evidence of dose dependence could be found. The kinetic parameter with the highest extent of variability was the extent of bioavailability which showed an coefficient of variation (CV) of 96%. Both gender and dose had no influence on the variability. The present approach is concluded to offer more insight into the relationship between dose, concentration and effect and into factors which explain variability in kinetics without additional testing or additional animals. Proposals for a refined sampling schedule are made.

Neutral Methacrylate Copolymer is a fully polymerised copolymer used in the pharmaceutical industry to permit pH-independent delayed release of active ingredients from oral dosage forms. This function has potential use with food supplements and this article describes available information on the safety of the substance. Oral administration of radiolabelled copolymer to rats resulted in the detection of chemically unchanged copolymer in the faeces, with negligible absorption. Safety studies revealed no adverse toxicity following repeated administration at doses of up to 2000 mg/kg bw/d in a sub-chronic study in rats or 250 mg/kg bw/d in a sub-chronic study in dogs. No reproductive toxicity occurred at up to 2000 mg/kg bw/d in rats or rabbits. The substance shows no evidence of genotoxicity, has low acute toxicity and no irritation or sensitisation potential. An ADI value of 20 mg/kg bw was concluded from two alternative approaches. Daily exposure from use in dietary supplements is estimated as up to 10.0 mg/kg bw in adults and 13.3 mg/kg bw in children. There would therefore appear to be no safety concerns under the intended conditions of use. The information provided is intended to support an evaluation that the substance may be "generally recognized as safe" (GRAS).

Basic Methacrylate Copolymer is a fully polymerised cationic copolymer with taste-masking and moisture protection properties. It is used as a pharmaceutical excipient and has potential use as a glazing/coating agent to solid food supplements. This article describes available information on the safety of the substance. Oral administration of radiolabelled copolymer to rats showed the major route of excretion to be via the faeces. Minor absorption may occur at