An optimized formulation of capsules containing Lansoprazole enteric-coated\npellets using D-Optimal design with a polynomial statistical model were prepared\nby using EudragitÃ?®L100 as an enteric coated polymer to provide resistance\nto simulated gastric acid dissolution in buffer media. D-Optimal experimental\ndesign was used to determine the optimal level for three coating layers\nthat were applied to formulate the enteric-coated pellets including a drug\nloading layer, a sub-coating, and an outer enteric coating. Dissolution studies\nwere performed on the prepared Lansoprazole capsules. Less than 5 percent of\nLansoprazole was released in 60 minutes in an acidic dissolution medium (pH\n1.2) and greater than 90 percent of active ingredient was released in the next\n60 minutes in a buffer dissolution medium (pH 6.8). The Lansoprazole capsules\nwere stable with no observable change in physico-chemical properties in\naccelerated and normal storage conditions for 6 and 18 months, respectively.\nThe pharmacokinetic parameters Cmax, Tmax, AUC0âË?â??t , and AUC0âË?â??âË?ž were determined\nafter administration of the D-Optimal design optimized capsules of\nLPZ to healthy beagle dogs and were statistically compared to GastevinÃ?® capsules\nas a reference (KRKA, Slovenia) using the non-compartmental method\nwith the aid of WinNonlin 5.2 software. The analysis of variance showed that\nthe two formulations did not demonstrate bioequivalence using a 90% confi-dence interval range (80% - 120%) of Cmax, AUC0âË?â??t, and AUC0âË?â??âË?ž. No significant\ndifference in Tmax was found at the 0.95 significance level using the Wilcoxon\nsigned-rank test. D-Optimal Experimental Design provided definitive\ndirection for an optimal formulation of capsules containing enteric-coated\npellets of lansoprazole loaded within the coating of pellets that provided similar\nbioequivalence to Gastevin.
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