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Patel Jinalbahen Bipinkumar* and Dr. Mukesh R. Patel


Most of the New Chemical Entities (NCE) that are being discovered are lipophilic in nature and have poor aqueous solubility (BCS class II and IV), which leads to poor oral bioavailability, high intra and inter subject variability and lack of dose proportionality. Among the approaches, SMEDDS is a novel and versatile approach for overcoming the formulation difficulties with poor aqueous solubility and low bioavailability. SMEDDS are the isotropic mixtures of oils, surfactants, co-surfactants and sometimes containing co-solvent, that have a unique ability of forming fine oil-in-water (o/w) emulsion upon gentle agitation. The digestive motility of the stomach and intestine provide the agitation necessary for self emulsification. A pseudo ternary phase diagram is used for identifying the micro-emulsification region. SMEDDS formulation can be filled into the soft or hard gelatin capsule. This review describes the formulation components, mechanism of self emulsification, formulation methodology, evaluation parameters and application of self micro emulsifying drug delivery system.

Keywords: SMEDDS (self micro emulsifying drug delivery system), Lipophilic, Oral bioavailability, Poor solubility, pseudo ternary phase diagram.

[Full Text Article]

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