Studies on Correlation between Dissolution in Vitro and Absorption in Vivo of Levofloxacin Tablets
Abstract
OBJECTIVE To investigate the relationship between dissolution in vitro and absorption in vivo of levofloxacin tablets from two pharmaceutical coorperations(A and B).METHODS The dissolution of levofloxacin was determined in vitro according to Chinese pharmacopoeia (2005ed Part II) with different rotation speed. Levofloxacin concentration in plasma was determined by RP-HPLC after a single dose of oral levofloxacin tablets given to 18 healthy male volunteers. Their pharmacokinetic parameters were obtained by 3P97 program,and the absorption percentage was calculated according to Wangner-Nelson formula. RESULTS The two preparations were bioequivalent.The dissolution parameters of levofloxacin tablets with different rotation speed (50,75 and 100 r·min-1) all met the requirement of Chinese pharmacopoeia.The linear regressive equation was established between the absorption percentage in vivo fa and accumulate release percentage in vitro (50 r·min-1) ft of levofloxacin tablets as A:fa= 2.017 6ft+0.727 9,r=0.957(P0.05);B:fa=1.892 9ft+0.774 9,r=0.955(P0.05).CONCLUSION There was a significant relationship between absorption in vivo and in vitro.
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