ESTIMATION OF IN VITRO AND IN VIVO PERFORMANCE OF METRONIDAZOLE ORAL DOSAGE FORMS

Objective: To estimate plasma concentrations-time profiles of metronidazole commercial tablets through in vitro dissolution data using the Inverse Release Function approach and a convolution method. Methods: Dissolution reference (500 mg) were obtained USP Apparatus 1 at 100 rpm, 4 16 ml/min, 0.1 N HCl, pH 4.5 acetate buffer 6.8 phosphate as media. Additionally, three generic drug products tested buffer. Drug was quantified 278 nm until 60 min. parameters such mean time, area under cumulative curve, efficiency calculated. Metronidazole levels predicted considering release published information. Percent prediction error (PE) for Cmax AUC0-inf each condition Results: When comparing with common (USP vs. 4) significant differences found (*P<0.05). Values PE within range (±15%) only Using these conditions when formulation, (*P<0.05) values out range. Conclusion: The information suggests to predict vivo performance tablets. impact all formulations confirmed performance.