Abstract
The study investigated the possibility of developing an in vitro – in vivo correlation for four commercial brands of aspirin tablets using USPXXI rotating basket apparatus and urinary excretion profiles from eight human volunteers. Various dissolution and pharmacokinetic parameters were obtained for all the brands. Significant rank order correlations were observed between all the in vitro dissolution parameters such as percent dissolved at 30 min, dissolution rate constants (k) and time for 50% dissolution (DT50%) and all the in vivobioavailability parameters such as cumulative amount excreted up to 8 h (E8), maximum excretion rate (dE/dt)max and time for maximum excretion rate (Tmax). However, no correlation could be established between the cumulative amount excreted up to 24 h (E24) and any of the in vitro dissolution parameters. Moreover, statistical analysis showed no significant inter-subject variation among the subjects that participated in the experiments. Key words: Aspirin tablets, dissolution rate constant, maximum excretion rate, cumulative amount excreted, in vitro-in vivo correlation (IV-IVC).
Highlights
The formulation and implementation of regulations concerning bioavailability of drugs made considerable attention to be given to correlation of in vitro dissolution rate with in vivo bioavailability (Emami, 2006)
Significant rank order correlations were observed between all the in vitro dissolution parameters such as percent dissolved at 30 min, dissolution rate constants (k) and time for 50% dissolution (DT50%) and all the in vivo bioavailability parameters such as cumulative amount excreted up to 8 h (E8), maximum excretion ratemax and time for maximum excretion rate (Tmax)
The purpose of this study is to investigate the possibility of developing an In vitro-in vivo correlation (IV-IVC) using four commercial brands of aspirin tablets marketed in Nigeria
Summary
The formulation and implementation of regulations concerning bioavailability of drugs made considerable attention to be given to correlation of in vitro dissolution rate with in vivo bioavailability (Emami, 2006). In vitro-in vivo correlation (IV-IVC) is a predictive mathematical treatment describing the relationship between an in vitro property of a dosage form (usually the rate or extent of drug release) and a relevant in vivo response (e.g. plasma drug concentrations or amount of drug absorbed). The study of drug in vitro availability and bioavailability are important part of the IV-IVC procedure for suitable drugs (Xiaohong et al, 2003). In order to develop safe and effective drugs and validate their formulation, it is important to identify the exact drug pharmacokinetic parameters and biopharmaceutical properties of the dosage forms
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