摘要：An optim.zed form.lation of capsules containing Lansoprazole enteric-coated pellets using D-Optim.l design with a polynom.al statistical m.del were prepared by using Eudragit?L100 as an enteric coated polym.r to provide resistance to sim.lated gastric acid dissolution in buffer m.dia. D-Optim.l experim.ntal design was used to determ.ne the optim.l level for three coating layers that were applied to form.late the enteric-coated pellets including a drug loading layer, a sub-coating, and an outer enteric coating. Dissolution studies were perform.d on the prepared Lansoprazole capsules. Less than 5 percent of Lansoprazole was released in 60 m.nutes in an acidic dissolution m.dium.(pH 1.2) and greater than 90 percent of active ingredient was released in the next 60 m.nutes in a buffer dissolution m.dium.(pH 6.8). The Lansoprazole capsules were stable with no observable change in physico-chem.cal properties in accelerated and norm.l storage conditions for 6 and 18 m.nths, respectively. The pharm.cokinetic param.ters Cm.x, Tm.x, AUC0-t, and AUC0-∞ were determ.ned after adm.nistration of the D-Optim.l design optim.zed capsules of LPZ to healthy beagle dogs and were statistically com.ared to Gastevin? capsules as a reference (KRKA, Slovenia) using the non-com.artm.ntal m.thod with the aid of WinNonlin 5.2 software. The analysis of variance showed that the two form.lations did not dem.nstrate bioequivalence using a 90% confidence interval range (80% - 120%) of Cm.x, AUC0-t, and AUC0-∞. No significant difference in Tm.x was found at the 0.95 significance level using the Wilcoxon signed-rank test. D-Optim.l Experim.ntal Design provided definitive direction for an optim.l form.lation of capsules containing enteric-coated pellets of lansoprazole loaded within the coating of pellets that provided sim.lar bioequivalence to Gastevin.