Multivariate statistical approach to optimizing sustained-release tablet formulations containing diltiazem hydrochloride as a model highly water-soluble drug

International Journal of Pharmaceutics
Shingo Kikuchi, Kozo Takayama

Abstract

A multivariate statistical technique was applied to designing a tablet for the sustained release over 24h of diltiazem hydrochloride, a model highly water-soluble drug. Tablets of a hydrophilic matrix composed of dextran derivatives and hypromellose were prepared. The formulations were optimized using a nonlinear-response surface method incorporating thin-plate spline interpolation (RSM-S). A bootstrap (BS) resampling method was used to estimate the confidence intervals of the optimal formulations. The response surfaces estimated by RSM-S visualized the effects of the formulation factors, and the optimal release profile for diltiazem was predicted quantitatively as a function of the quantities of the formulation factors, using RSM-S. The simultaneous optimal solutions and their confidence intervals were estimated using RSM-S and BS resampling. The results clearly indicate nonlinear relationships between the formulation factors and the response variables. The observed responses of the optimal preparation coincided well with the predicted responses. The optimal hydrophilic matrix tablet allowed almost zero-order release of diltiazem hydrochloride for 24h. In conclusion, an oral sustained-release tablet formulation, active over a ...Continue Reading

Citations

Oct 6, 2012·Biological & Pharmaceutical Bulletin·Sureewan DuangjitKozo Takayama
Feb 2, 2012·Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan·Kazumi IshitsukaKozo Takayama
Feb 22, 2012·Drug Development and Industrial Pharmacy·Changshan SunWeisan Pan
Jul 31, 2013·Journal of Pharmaceutical Sciences·Yoshihiro HayashiKozo Takayama
Mar 10, 2012·International Journal of Pharmaceutics·Jelena PetrovićZorica Đurić
Jan 11, 2013·Chemical & Pharmaceutical Bulletin·Tadashi NoriokaKozo Takayama
May 11, 2018·Chemical & Pharmaceutical Bulletin·Hiroaki TodoKenji Sugibayashi

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