Development and optimization of a novel oral controlled delivery system for tamsulosin hydrochloride using response surface methodology

Min Soo Kim, Jeong Soo Kim, Yeon Hee You, Hee Jun Park, Sibeum Lee, Jeong Sook Park, Jong Soo Woo, Sung Joo Hwang

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70 Citations (Scopus)


The purpose of this study was to develop and optimize oral controlled-release formulations for tamsulosin hydrochloride using a combination of two cellulose ester derivatives, hydroxypropyl methylcellulose (HPMC) and hydroxypropyl methylcellulose phthalate (HPMCP), with Surelease® as a coating material. A three-factor, three-level Box-Behnken design was used to prepare systematic model formulations, which were composed of three formulation variables, the content of HPMC (X1) and HPMCP (X2) and the coating level (X3), as independent variables. The response surface methodology (RSM) and multiple response optimization utilizing the polynomial equation were used to search for the optimal coating formulation with a specific release rate at different time intervals. The drug release percentages at 2, 3 and 5 h were the target responses and were restricted to 15-30% (Y1), 50-65% (Y2) and 80-95% (Y3), respectively. The optimal coating formulation was achieved with 10% HPMC and 20% HPMCP at a coating level of 25%, and the observed responses coincided well with the predicted values from the RSM optimization technique. The drug release from pellets coated with the optimized formulation showed a controlled-release pattern (zero-order), in comparison with a commercial product (Harunal® capsule). In conclusion, a novel, oral, controlled-release delivery system for tamsulosin hydrochloride was successfully developed by incorporating HPMC and HPMCP as coating additives into Surelease® aqueous ethylcellulose dispersion.

Original languageEnglish
Pages (from-to)97-104
Number of pages8
JournalInternational Journal of Pharmaceutics
Issue number1-2
Publication statusPublished - 2007 Aug 16

Bibliographical note

Funding Information:
This work was supported by the Korea Science and Engineering Foundation (KOSEF) through the National Research Lab. Program funded by the Ministry of Science and Technology (No. M10300000301-06J0000-30110).

All Science Journal Classification (ASJC) codes

  • Pharmaceutical Science


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