Formulation, development, and optimization of immediate release nateglinide tablets by factorial design
1Department of Pharmaceutics, Gayatri College of Pharmacy, Sambalpur, Orissa, India.
Drug Discoveries & Therapeutics
|April 12, 2012
Summary
Cross Carmellose Sodium (CCS) is the best superdisintegrant for immediate-release nateglinide tablets. Lower tablet hardness and higher CCS concentration improve drug disintegration and release.
Area of Science:
- Pharmaceutical Sciences
- Formulation Development
Background:
- Immediate-release tablets require effective disintegration and rapid drug release.
- Superdisintegrants play a crucial role in enhancing tablet dissolution profiles.
Purpose of the Study:
- To select the optimal superdisintegrant for immediate-release nateglinide tablets.
- To investigate the impact of superdisintegrant concentration and tablet hardness on drug release characteristics.
Main Methods:
- Screening of superdisintegrants: sodium starch glycolate, cross povidone, Starch-1500, and cross carmellose sodium (CCS).
- Utilized a 3(2) full factorial design to optimize formulation variables.
- Evaluated disintegration time and drug release at 30 minutes (DR(0.5h)).
Main Results:
- Cross Carmellose Sodium (CCS) was identified as the most effective superdisintegrant.
- Decreased tablet hardness and increased CCS concentration positively influenced disintegration time and drug release.
- Mathematical model validation confirmed formulation optimization.
Conclusions:
- CCS is a suitable superdisintegrant for developing immediate-release nateglinide tablets.
- Formulation variables significantly impact tablet performance, guiding optimized drug delivery.
- Stability studies confirmed the robustness of the optimized formulation.
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