Triphala formulation is one of the most common traditional medicines used for several health conditions. The study investigated the pharmacokinetics of gallic acid following an oral dose administration in rats. The pharmacokinetics of gallic acid was investigated in rats following a daily oral dose of 1,000 and 5,000 mg/kg body weight (28 days). Plasma concentrations of gallic acid were measured using liquid chromatography-mass spectrometry (LC-MS/MS). Non-compartmental pharmacokinetic analysis approach was applied for data analysis. The pharmacokinetics was linear without dose-dependent characteristics. Gallic acid was rapidly absorbed, reaching maximum concentration within 1 h and was also rapidly cleared from rat systemic circulation within 12 h of administration. The pharmacokinetics of gallic acid was linear with about 5-fold increase in Cmax and systemic exposure AUC0- when the dose was increased from 1,000 to 5,000 mg/kg body weight. The pharmacokinetics of gallic acid following both regimens was similar. Terminal phase elimination half-life (t1/2z), apparent volume of distribution (Vz/F) and total clearance (CL/F) ranged from 0.7-1.7 h, 327-1,159 L and 195-607 L/h/kg. The pharmacokinetics of gallic acid obtained from the present study in rats provides preliminary information for designing proper pharmacokinetic studies in humans for further dose optimization of appropriate dosage regimens of Triphala formulation for treatment of various diseases or health conditions.
Key words: Triphala formulation, pharmacokinetics, gallic acid.
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