301. Tailoring and Optimization of Nifedipine Controlled Release Organogel via Quality by Design Approach.
- Author
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Dave, Pooja, Kariya, Sneha, and Dudhat, Kiran
- Abstract
Purpose: The primary aim of this study was to optimize, characterize, and test a controlled-release organogel of nifedipine for oral delivery. The formulation employed 12-hydroxy stearic acid as a gelator with soybean oil as a base. This research sought to investigate the potential of this organogel system to provide a controlled release alternative for nifedipine administration. Methods: Preformulation studies and drug-excipient compatibility tests were conducted for nifedipine and the selected excipients. A controlled release organogel was created using the heating method. A quadratic model was applied to design formulations (F1-F14) with varying concentrations of 12-hydroxy stearic acid and distinct cooling rates (gradual and quick cooling) at five levels, utilizing a one-factor response surface approach. The prepared formulations were evaluated using various assessment parameters. Design Expert 7.0 was employed to statistically derive the optimized batch. Differential scanning calorimetry and Fourier-transform infrared spectroscopy were used to compare the preformulation test results between nifedipine and the excipients. Results: The optimized controlled-release organogel exhibited a drug release profile of 86.02% at 10 h, which increased to 96.04% after 12 h. The data for the optimized formulation revealed a significant correlation between expected and actual responses, indicating the efficacy of the quadratic model and the response surface approach in predicting formulation behavior. Conclusions: The study concluded that an organogel formulation using 12-hydroxy stearic acid as an organogelator and soybean oil as a base could be beneficial for controlled-release formulations of nifedipine. The results suggest that this organogel system is a viable alternative for the controlled release of nifedipine, offering a promising method for its oral administration. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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