BIOEQUIVALENCE STUDIES OF AMOXICILLIN/CLAVULANATE TABLET FORMULATIONS

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MOSTAFAVI S.A.; MOGHAREH ABED A.R.; ZARGARZADEH M.R.; AZMIAN A.; KHAGHANI G.R.

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Journal: JOURNAL OF RESEARCH IN MEDICAL SCIENCES (JRMS) Year:2003 | Volume:7 | Issue:Supplement 2 Page(s): 162-166

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Title

BIOEQUIVALENCE STUDIES OF AMOXICILLIN/CLAVULANATE TABLET FORMULATIONS

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Keywords

AMOXICILLINQ3

CLAVULANIC ACIDQ4

BIOEQUIVALENCEQ4

Abstract

Introdution. AMOXICILLIN alone is used for a wide range of clinical indications. It is also available commercially as Augmentinø, an oral antibacterial combination containing ß-Lactamase inhibitor potassium clavulanate, the potassium salt of CLAVULANIC ACID. This combination is recently formulated and available commercially as Co-amoxyclav in Iran. The relative bioavailability of orally administered Co-amoxyclav and Augmentinø were compared following a single 625 mg dose (AMOXICILLIN 500 mg as AMOXICILLIN trihydrate, and CLAVULANIC ACID 125 mg as potassium clavulanates).Bioavailability parameters -including area under the serum concentration time curve (AUC) as a measure of the extent of drug absorption, and the highest concentration (Cmax )and the time to reach to a highest concentration (tmax)as a measure of the rate of absorption, were calculated from circulating drug levels and compared between the two products for each subject.Methods. twelve healthy adult male supjects were enrolled under fasted conditions using a two way cross over study. Samples of venous blood (10 ml) were obtained pre dose and at 0.33,0.66, 1, 1.5, 2, 3, 4, 5 and 7h post dose. Serum concentration of both AMOXICILLIN and clavulanate were measured by a reverse phase high performance liquid chromatography previously reported. Amoxycillin was determined by monitoring at 227 nm, and the limits of detection in human serum were 0.5 mg/ml. Calibration curves were linear through 0.05-10 mg/ml for both AMOXICILLIN and CLAVULANIC ACID (correlation coefficients> 0.99).For both active drugs, inter and intra day coefficients of variation were less than 10% at both low and high concentrations.Results and Discussion. AMOXICILLIN and CLAVULANIC ACID have mean half lives of 1.11 (0.2) and 0.8 (0.2) hours, respectively. Results from this study show that 90% confidence intervals were 1.05-1.12 and 1.14-1.16 for AUC0-t 1.06-1.15 and 1.02-1.16 for AUC0-¥ 0.97-1.03 and 0.99-1.19 for Cmax and 0.89-1.19 and 0.8D-1.07 for tmax for AMOXICILLIN and CLAVULANIC ACID respectively. These results clearly demonstrating BIOEQUIVALENCE of the two products.

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APA: Copy

MOSTAFAVI, S.A., MOGHAREH ABED, A.R., ZARGARZADEH, M.R., AZMIAN, A., & KHAGHANI, G.R.. (2003). BIOEQUIVALENCE STUDIES OF AMOXICILLIN/CLAVULANATE TABLET FORMULATIONS. JOURNAL OF RESEARCH IN MEDICAL SCIENCES (JRMS), 7(Supplement 2), 162-166. SID. https://sid.ir/paper/26686/en

Vancouver: Copy

MOSTAFAVI S.A., MOGHAREH ABED A.R., ZARGARZADEH M.R., AZMIAN A., KHAGHANI G.R.. BIOEQUIVALENCE STUDIES OF AMOXICILLIN/CLAVULANATE TABLET FORMULATIONS. JOURNAL OF RESEARCH IN MEDICAL SCIENCES (JRMS)[Internet]. 2003;7(Supplement 2):162-166. Available from: https://sid.ir/paper/26686/en

IEEE: Copy

S.A. MOSTAFAVI, A.R. MOGHAREH ABED, M.R. ZARGARZADEH, A. AZMIAN, and G.R. KHAGHANI, “BIOEQUIVALENCE STUDIES OF AMOXICILLIN/CLAVULANATE TABLET FORMULATIONS,” JOURNAL OF RESEARCH IN MEDICAL SCIENCES (JRMS), vol. 7, no. Supplement 2, pp. 162–166, 2003, [Online]. Available: https://sid.ir/paper/26686/en

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