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KMID : 0369820100400050313
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Jorunal of Korean Pharmaceutical Sciences
2010 Volume.40 No. 5 p.313 ~ p.319
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Development and Optimization of a Novel Sustained-release Tablet Formulation for Bupropion Hydrochloride using Box-Behnken Design
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Cha Kwang-Ho
Lee Na-Young
Kim Min-Soo
Kim Jeong-Soo
Park Hee-Jun
Park Jun-sung
Cho Won-Kyung
Hwang Sung-Joo
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Abstract
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The objectives of this study were to evaluate the effect of formulation ingredients on the drug release and to optimize the novel sustained release matrix tablet formulations of bupropion hydrochloride. A three factor, three-level Box-Behnken design was used for the optimization procedure, with the amounts of PEO (X1), citric acid (X2) and Compritol 888 ATO (X3) as the independent variables. The selected dependent variables were the cumulative percentage values of bupropion hydrochloride that had dissolved after 1, 4 and 8 hr. Various dissolution profiles of the drug from sustained release matrix tablets were obtained. Optimization was performed for X1, X2 and X3 using the following target ranges; 30%≤Y1≤45%; 70≤Y2≤85%; 85%≤Y3≤100%. The optimized formulation for bupropion hydrochloride was achieved with 12.5% PEO (X1), 2.5% citric acid (X2) and 10% Compritol 888 ATO (X3). The sustained release matrix tablets with the optimized formulation provided a release profile that was close to predicted values. In addition, the dissolution profiles of the sustained release matrix tablet with the optimized formulation were similar to those of the commercial product Wellbutrin® SR tablets (f2=79.83).
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KEYWORD
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Bupropion, Sustained-release tablet, Box-Behnken design
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