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Development of extended zero-order release gliclazide tablets by central composite design
P Vijayalakshmi1, V Kusum Devi, C Narendra
1Department of Pharmaceutics, Al-Ameen College of Pharmacy, Bangalore, India. pvldss@yahoo.com
Drug Development and Industrial Pharmacy
|January 25, 2008
Summary
This study optimized extended-release gliclazide tablets using pH-dependent polymers. The developed formulation demonstrated desirable hardness and zero-order drug release kinetics, proving its feasibility for extended-release dosage forms.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
Background:
- Extended-release formulations aim to improve drug efficacy and patient compliance.
- Gliclazide is a widely used antidiabetic medication requiring controlled release for optimal therapeutic outcomes.
Purpose of the Study:
- To develop and optimize an extended-release tablet formulation for gliclazide.
- To investigate the impact of pH-dependent matrix polymers on drug release characteristics.
Main Methods:
- Central composite design and response surface methodology were employed for formulation optimization.
- Keltone-HVCR and Eudragit-EPO were used as independent variables to control drug release.
- Multiple response optimization and desirability function were utilized to achieve optimal formulation parameters.
Main Results:
- The interaction between Keltone-HVCR and Eudragit-EPO significantly influenced tablet hardness and drug release profiles.
- An optimized formulation with 8 mg Keltone-HVCR and 14.10 mg Eudragit-EPO exhibited suitable hardness and controlled release properties.
- The optimized formulation followed zero-order release kinetics, and dissolution profiles remained similar after stability studies.
Conclusions:
- The developed optimization technique is effective for creating extended-release gliclazide tablets.
- The optimized formulation shows promise for stable and effective drug delivery.
- pH-dependent polymers are suitable for designing controlled-release dosage forms.
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