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Design and optimization of self-nanoemulsifying drug delivery systems (SNEDDS) for enhanced dissolution of gemfibrozil.

International journal of pharmaceutics (2012-04-14)
Ana Maria Sierra Villar, Beatriz Clares Naveros, Ana Cristina Calpena Campmany, Monserrat Aróztegui Trenchs, Coloma Barbé Rocabert, Lyda Halbaut Bellowa
ABSTRACT

Self-nanoemulsifying drug delivery systems of gemfibrozil were developed under Quality by Design approach for improvement of dissolution and oral absorption. Preliminary screening was performed to select proper components combination. Box-Behnken experimental design was employed as statistical tool to optimize the formulation variables, X(1) (Cremophor(®) EL), X(2) (Capmul(®) MCM-C8), and X(3) (lemon essential oil). Systems were assessed for visual characteristics (emulsification efficacy), turbidity, droplet size, polydispersity index and drug release. Different pH media were also assayed for optimization. Following optimization, the values of formulation components (X(1), X(2), and X(3)) were 32.43%, 29.73% and 21.62%, respectively (16.22% of gemfibrozil). Transmission electron microscopy demonstrated spherical droplet morphology. SNEEDS release study was compared to commercial tablets. Optimized SNEDDS formulation of gemfibrozil showed a significant increase in dissolution rate compared to conventional tablets. Both formulations followed Weibull mathematical model release with a significant difference in t(d) parameter in favor of the SNEDDS. Equally amodelistic parameters were calculated being the dissolution efficiency significantly higher for SNEDDS, confirming that the developed SNEDDS formulation was superior to commercial formulation with respect to in vitro dissolution profile. This paper provides an overview of the SNEDDS of the gemfibrozil as a promising alternative to improve oral absorption.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Gemfibrozil
Supelco
Gemfibrozil, Pharmaceutical Secondary Standard; Certified Reference Material
Gemfibrozil, European Pharmacopoeia (EP) Reference Standard
Gemfibrozil for system suitability, European Pharmacopoeia (EP) Reference Standard

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