title: Formulation development of an albendazole self-emulsifying drug delivery system (SEDDS) with enhanced systemic exposure.
abstract: 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.
authors.affiliation: Drug Metabolism and Pharmacokinetics Jubilant Biosys Ltd, Industrial Suburb, Yeshwanthpur Bangalore-560022, India.
authors.forename: Ashok K
authors.initials: AK
authors.lastname: Meena
authors.forename: Kuldeep
authors.initials: K
authors.lastname: Sharma
authors.forename: Murugesh
authors.initials: M
authors.lastname: Kandaswamy
authors.forename: Sriram
authors.initials: S
authors.lastname: Rajagopal
authors.forename: Ramesh
authors.initials: R
authors.lastname: Mullangi
mesh_terms: D000284:Administration, Oral; D015766:Albendazole / Q000008:administration & dosage / Q000032:analysis* / Q000493:pharmacokinetics; D000818:Animals; D000871:Anthelmintics / Q000008:administration & dosage / Q000032:analysis* / Q000493:pharmacokinetics; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D016503:Drug Delivery Systems / Q000379:methods*; D045703:Emulsifying Agents / Q000008:administration & dosage / Q000032:analysis*; D008297:Male; D009821:Oils / Q000008:administration & dosage / Q000032:analysis*; D010316:Particle Size; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000032:analysis*; D011136:Polysorbates / Q000008:administration & dosage / Q000032:analysis*; D051381:Rats; D012995:Solubility; D013501:Surface-Active Agents / Q000008:administration & dosage / Q000032:analysis*
chemical_list: D000871:Anthelmintics; D045703:Emulsifying Agents; D009821:Oils; D011136:Polysorbates; D013501:Surface-Active Agents; D011092:Polyethylene Glycols; D015766:Albendazole