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Titolo:
Dose-proportionality of oral thioctic acid - coincidence of assessments via pooled plasma and individual data
Autore:
Breithaupt-Grogler, K; Niebch, G; Schneider, E; Erb, K; Hermann, R; Blume, HH; Schug, BS; Belz, GG;
Indirizzi:
Ctr Cardiovasc Pharmacol, D-55116 Mainz, Germany Ctr Cardiovasc PharmacolMainz Germany D-55116 l, D-55116 Mainz, Germany Corp Res ASTA Med AG, Dept Clin Pharmacol, Frankfurt, Germany Corp Res ASTA Med AG Frankfurt Germany in Pharmacol, Frankfurt, Germany Corp Res ASTA Med AG, Dept Biochem, Frankfurt, Germany Corp Res ASTA Med AG Frankfurt Germany Dept Biochem, Frankfurt, Germany SocraTec R&D, Frankfurt, Germany SocraTec R&D Frankfurt GermanySocraTec R&D, Frankfurt, Germany
Titolo Testata:
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
fascicolo: 1, volume: 8, anno: 1999,
pagine: 57 - 65
SICI:
0928-0987(199904)8:1<57:DOOTA->2.0.ZU;2-A
Fonte:
ISI
Lingua:
ENG
Soggetto:
ALPHA-LIPOIC ACID; BIOAVAILABILITY; BIOEQUIVALENCE; ANTIOXIDANT; FORMULATIONS; ENANTIOMERS; NEUROPATHY;
Keywords:
thioctic acid enantiomers; enantio-selective pharmacokinetics; pooled plasma samples; dose-linearity; dose-proportionality;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
17
Recensione:
Indirizzi per estratti:
Indirizzo: Belz, GG Ctr Cardiovasc Pharmacol, Mathildenstr 8, D-55116 Mainz, Germany Ctr Cardiovasc Pharmacol Mathildenstr 8 Mainz Germany D-55116 ny
Citazione:
K. Breithaupt-Grogler et al., "Dose-proportionality of oral thioctic acid - coincidence of assessments via pooled plasma and individual data", EUR J PH SC, 8(1), 1999, pp. 57-65

Abstract

Thioctic acid (TA), a racemate of R-(+)- and S-(-)-enantiomers of alpha-lipoic acid, acts as a powerful lipophilic, free-radical scavenger and is used in the treatment of diabetic neuropathy. This trial investigated the dose-linearity of enantiomer pharmacokinetics following the oral administrationof single doses of 50 to 600 mg TA (formulation provided by ASTA (Medica))in healthy volunteers. TA enantiomer concentrations in individual and pooled plasma samples were determined using enantioselective, high-performance liquid chromatography. TA was rapidly absorbed (t(max), 0.5 to 1 h). Maximum plasma concentrations (C-max) of the R-(+)-enantiomer were about 40-50% higher than those of the S-(-)-enantiomer (50 mg: 135.45 ng/ml R-(+)-TA, 67.83 ng/ml S-(-)-TA; 600 mg: 1812.32 ng/ml R-(+)-TA, 978.20 ng/ml S-(-)-TA; geometric means). The decline observed in the plasma concentration was steep(t(1/2), 0.5 h). The dose-linearity and proportionality of pharmacokineticparameters could be demonstrated on an intra-individual basis and for the group geometric means. An analysis of pooled plasma samples proved to be a suitable means for deriving reliable first-sight results prior to individual assessments. (C) 1999 Published by Elsevier Science B.V. All rights reserved.

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Documento generato il 24/09/20 alle ore 01:35:45