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The Scientific World Journal
Volume 2013, Article ID 856967, 6 pages
Research Article

Isotretinoin Oil-Based Capsule Formulation Optimization

1Department of Business Administration, I-Shou University, No. 1, Section 1, Syuecheng Road, Dashu Township, Kaohsiung County 840, Taiwan
2School of Pharmacy, Kaohsiung Medical University, 100 Shih-Chuan 1st Road, Kaohsiung City 80708, Taiwan
3Graduate Institute of Clinical Pharmacy, Kaohsiung Medical University, 100 Shih-Chuan 1st Road, Kaohsiung City 80708, Taiwan

Received 7 June 2013; Accepted 28 July 2013

Academic Editors: A. Concheiro, H. Maibach, and A. Nokhodchi

Copyright © 2013 Pi-Ju Tsai et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


The purpose of this study was to develop and optimize an isotretinoin oil-based capsule with specific dissolution pattern. A three-factor-constrained mixture design was used to prepare the systemic model formulations. The independent factors were the components of oil-based capsule including beeswax (), hydrogenated coconut oil (), and soybean oil (). The drug release percentages at 10, 30, 60, and 90 min were selected as responses. The effect of formulation factors including that on responses was inspected by using response surface methodology (RSM). Multiple-response optimization was performed to search for the appropriate formulation with specific release pattern. It was found that the interaction effect of these formulation factors (, , and ) showed more potential influence than that of the main factors (, , and ). An optimal predicted formulation with , , , and release values of 12.3%, 36.7%, 73.6%, and 92.7% at , , and of 5.75, 15.37, and 78.88, respectively, was developed. The new formulation was prepared and performed by the dissolution test. The similarity factor was 54.8, indicating that the dissolution pattern of the new optimized formulation showed equivalence to the predicted profile.