Acta Pharm. 62 (2012) 563-580

 

full paper

Original research paper

 

Formulation development of an albendazole self-emulsifying drug delivery system (SEDDS) with enhanced systemic exposure

Ashok K. Meena, Kuldeep SharmA, Murugesh KandaswamY, Sriram RajagopaL and Ramesh MullangI

mullangi_ramesh@jubilantinnovation.com

1 Preformulation Department

2 Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur, Bangalore-560 022, India

Accepted July 25, 2012

The aim of the study was to develop and evaluate a self-emulsifying drug delivery system (SEDDS) formulation to improve solubility and dissolution and to enhance systemic exposure of a BCS class II anthelmetic drug, albendazole (ABZ). In the present study, solubility of ABZ was determined in various oils, surfactants and co-surfactants to identify the microemulsion components. Pseudoternary phase diagrams were plotted to identify the microemulsification existence area. SEDDS formulation of ABZ was prepared using oil (Labrafac Lipopfile WL1349) and a surfactant/co-surfactant (Tween 80/PEG-400) mixture and was characterized by appropriate studies, viz., microemulsifying properties, droplet size measurement, in vitro dissolution, etc. Finally, PK of the ABZ SEDDS formulation was performed on rats in parallel with suspension formulation. It was concluded that the SEDDS formulation approach can be used to improve the dissolution and systemic exposure of poorly water-soluble drugs such as ABZ.

 

Keywords: albendazole, lipid based formulation, SEDDS, pharmacokinetics, rats