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Abstract
The objective of the work was to develop, optimize and evaluate a self-microemulsifying drug delivery system of the poorly water soluble drug, lovastatin. Solubility of lovastatin was determined in various vehicles. Ternary phase diagrams were constructed to identify the efficient self-emulsification region using oils, surfactants, and co-surfactants in aqueous environment. Optimized formulations were assessed for drug content, spectroscopic clarity, emulsification time, contact angle, zeta potential, particle size and dissolution studies. Zeta potential was measured in absence and presence of oleylamine, a positive charge inducer. On the basis of similarity and dissimilarity of particle size distribution, formulations were characterized using principal component analysis and agglomerative hierarchy cluster analysis, the multivariate statistical analysis. Transmission electron microscopy of selected formulations (F5–F7) confirmed the spherical shape of globules with no signs of coalescence of globules and precipitation of drug, even after 24 h post dilution in distilled water. The relevance of differences in t50% and percentage dissolution efficiency was evaluated statistically by two-way ANOVA. Infrared spectroscopy, differential scanning calorimetric and x-ray diffraction studies indicated no incompatibility between drug, oil and surfactants. The results of this study indicate that the self-microemulsifying drug delivery system of lovastatin, owing to nanosize, has potential to enhance its absorption and without interaction or incompatibility between the ingredients.
Acknowledgements
The authors thank the Vice-Chancellor, Birla Institute of Technology, Mesra, for providing the facilities and encouragement, and Professor D. Sasmal and Dr S.M. Verma for helpful discussions. Dr Madhu Yashpal, Scientist, Department of Anatomy, Institute of Medical Sciences, Banaras Hindu University, is gratefully acknowledged for providing the facility of transmission electron microscopy. One of the authors (Sandeep K. Singh) gratefully acknowledges financial support in the form of a Senior Research Fellowship provided during the period of study by Birla Institute of Technology, Mesra, Ranchi, India.
Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the contents and writing of the papers.