Formulation Optimization Utilizing D-Optimal Experimental Design of Oral Capsules Containing Enteric-Coated Pellets of Lansoprazole and In Vivo Bioequivalence

An optimized formulation of capsules containing Lansoprazole enteric-coated pellets using D-Optimal design with a polynomial statistical model were prepared by using Eudragit®L100 as an enteric coated polymer to provide resistance to simulated gastric acid dissolution in buffer media. D-Optimal experimental design was used to determine the optimal level for three coating layers that were applied to formulate the enteric-coated pellets including a drug loading layer, a sub-coating, and an outer enteric coating. Dissolution studies were performed on the prepared Lansoprazole capsules. Less than 5 percent of Lansoprazole was released in 60 minutes in an acidic dissolution medium (pH 1.2) and greater than 90 percent of active ingredient was released in the next 60 minutes in a buffer dissolution medium (pH 6.8). The Lansoprazole capsules were stable with no observable change in physico-chemical properties in accelerated and normal storage conditions for 6 and 18 months, respectively. The pharmacokinetic parameters Cmax, Tmax, AUC0−t, and AUC0−∞ were determined after administration of the D-Optimal design optimized capsules of LPZ to healthy beagle dogs and were statistically compared to Gastevin® capsules as a reference (KRKA, Slovenia) using the non-compartmental method with the aid of WinNonlin 5.2 software. The analysis of variance showed that the two formulations did not demonstrate bioequivalence using a 90% confiHow to cite this paper: Luong, A.Q., Vu, T.N., Nguyen, D.H., Alshahrani, S.M., Christensen, J.M. and Nguyen, C.N. (2017) Formulation Optimization Utilizing D-Optimal Experimental Design of Oral Capsules Containing Enteric-Coated Pellets of Lansoprazole and In Vivo Bioequivalence. Pharmacology & Pharmacy, 8, 153-171. https://doi.org/10.4236/pp.2017.85011 Received: April 8, 2017 Accepted: May 19, 2017 Published: May 22, 2017 Copyright © 2017 by authors and Scientific Research Publishing Inc. This work is licensed under the Creative Commons Attribution International License (CC BY 4.0). http://creativecommons.org/licenses/by/4.0/ Open Access DOI: 10.4236/pp.2017.85011 May 22, 2017