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Authors Anab Fatima, Syed Baqir Naqvi, Iyad Naeem Mohammed, Shaheen Perveen, Iqbal Nasiri and Sheikh Abdul Khaliq
Description Various antibiotics whenever given orally along with antacid show significant pharmacokinetic interactions. During the present single dose, cross over, randomized study pharmacokinetic interaction between oral combination of amino penicillin i.e. 250 mg amoxicillin with an antacid(10 ml) containing aluminium, magnesium hydroxide and simethicone were evaluated. The study was conducted on ten healthy male volunteers. The study was performed on Pakistani population and data obtained was used to compare pharmacokinetic parameters of amoxicillin alone and with simultaneous administration of antacid in an open one compartmental model. Initially Physico-chemical test were performed for amoxicillin to check the quality of product. Plasma concentrations of amoxicillin were determined by validated high performance liquid chromatography techniques and pharmacokinetic parameters were estimated for both treatments. The analysis showed significant difference(P< 0.05,SPSS 16.0) when amoxicillin used along with antacid in various pharmacokinetic parameters. The values of mean Cmax of amoxicillin alone and with antacid found to be 8.88±0.09 and 7.84 ± 0.06 µg/ml at Tmax of 2 ±0.00 hrs and 3 ± 0.00 hrs with the values of AUC0-t(AUClast) and AUC 0-∞ were 33.33±0.70 and 37.89±0.70 alone and 36.25±0.43 and 41.64±1.15mg/ml.hr with antacid. Likewise significant difference in other pharmacokinetic parameters was observed between treatment groups (the values of Clearance(CL),Vd, absorption, distribution and elimination rate constants, MRT and AUMC).No serious adverse event observed during study period. The study demonstrated that oral absorption of amoxicillin may be affected by the presence of antacid therefore it must be recommended to avoid the combination of amoxicillin and antacid or to make a dose adjustment or close monitoring of patients.