Optimization of Lovastatin Self-Nanoemulsifying Solid Dosage Form

ACKNOWLEDGEMENTS: I am very thankful to Dr Sanjay S. Patel for his great support for this research work. We are also thankful to Manager of Abitech Corporation, USA, Corel Chemical Ltd., Ahmedabad, and Torrent Pharmaceuticals Ltd., Ahmedabad for providing us necessary ingredients. We are thankful to Shri B. M. Shah College of Pharmaceutical Education and Research, Modasa for providing technical support in form of instruments and guidance.Aim: The aim of present study was to develop and optimized self-nanoemulsifying solid dosage form (SNESDF) of Lovastatin for enhancing its solubility. Lovastatin (whose water solubility is 0.4 x 10-3 mg/mL) is considered to be a reasonable drug because of its high log P value (4.3) and good solubility in oils. Materials and Methods: The formulations were optimized by Box-Behnken statistical design in which the independent variables like Ratio of surfactant: co-surfactant (X1), oil: surfactant co surfactant (X2), and % Aerosil (X3). The formulations were characterized for its dependent variables such as Droplet size (Y1), transmittance (Y3), percentage of drug released within 5 minutes (Y3), and within 15 minutes (Y4). Results and Conclusion: Droplet size and zeta potential of the optimized batch was found to be 21.89 nm and -6.4 mV, respectively. 44.32 % and 90.78 % of the drug was found to be released within 5 min and 15 min, respectively. Hence, by formulating into SNESDF, the solubility of Lovastatin was found to be significantly improved.Objetivo: El objetivo del presente estudio fue desarrollar y optimizar la auto-nanoemulsión forma de dosificación sólida (SNESDF) de la Lovastatina para aumentar su solubilidad. Lovastatina (cuya solubilidad en agua es 0,4 x 10-3 mg / ml) se considera que es un fármaco razonable debido a su alto valor de log P (4,3) y una buena solubilidad en aceites. Materiales y Métodos: Las formulaciones fueron optimizadas por el diseño estadístico Box-Behnken en el cual las variables independientes como relación de tensioactivo: tensioactivo co-(X1), aceite: tensioactivo co tensioactivo (X2), y% Aerosil (X3). Las formulaciones se caracterizan por sus variables dependientes, tales como tamaño de la gota (Y1), la transmitancia (Y3), el porcentaje de fármaco liberado en 5 minutos (Y3), y dentro de 15 minutos (Y4). Resultados y Conclusiones: tamaño de la gota y el potencial zeta del lote optimizado resultó ser 21,89 nm y -6,4 mV, respectivamente. 44,32% y 90,78% del fármaco se encontró que se libera dentro de 5 min y 15 min, respectivamente. Por lo tanto, mediante la formulación en SNESDF de lovastatina , se encontró que la solubilidad mejoraba significativamente