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optimization of extended zero-order release gliclazide tablets using D-optimal mixture design
Xinghua Jin1, Yunhui Zhang, Li Xiao
1College of Pharmaceuticals and Biotechnology, Tianjin University, China.
Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan
|October 2, 2008
Summary
This study optimized gliclazide extended-release formulations using hydrophilic polymers like HPMC and sodium alginate. D-optimal mixture design successfully developed matrices with controlled drug release profiles.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Materials Science
Background:
- Gliclazide is a widely used antidiabetic medication.
- Developing extended-release formulations improves patient compliance and therapeutic efficacy.
- Hydrophilic matrix systems offer a promising approach for controlled drug release.
Purpose of the Study:
- To develop and optimize gliclazide extended-release (ER) formulations.
- To investigate the combined effect of HPMC K 15M and sodium alginate on drug release.
- To establish a controlled drug release profile for gliclazide ER tablets.
Main Methods:
- Utilized D-optimal mixture design to evaluate polymer concentrations (HPMC, sodium alginate) and lactose.
- Employed response surface methodology (RSM) for multiple response optimization.
- Defined target drug release percentages at 3, 6, 9, and 12 hours.
Main Results:
- The D-optimal design effectively guided the formulation and optimization process.
- RSM provided a high degree of prognostic ability for predicting drug release.
- Optimized formulations exhibited a zero-order drug release pattern, indicating sustained release.
Conclusions:
- D-optimal mixture design is a powerful tool for formulating gliclazide ER hydrophilic matrix systems.
- The combination of HPMC K 15M and sodium alginate effectively controlled gliclazide release.
- The developed ER formulations achieved desired drug release profiles, meeting target specifications.
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