REVIEW ON DEVELOPMENT AND CHARACTERIZATION OF SELF MICRO EMULSIFYING DRUG DELIVERY SYSTEM OF LORATADINE

Loratadine is a second-generation antihistamine with poor aqueous solubility, which limits its dissolution rate and oral bioavailability. Self-Microemulsifying Drug Delivery Systems (SMEDDS) have emerged as an effective lipid-based formulation approach to overcome these limitations by enhancing drug solubility, dissolution, and gastrointestinal absorption. This review summarizes the formulation strategies, mechanism of self-emulsification, composition, preparation methods, characterization, and evaluation of SMEDDS for poorly water-soluble drugs, with a focus on loratadine. The roles of oils, surfactants, co-surfactants, and solid carriers in the development of stable and efficient SMEDDS formulations are discussed. The review also highlights formulation techniques such as phase titration and phase inversion, along with essential evaluation parameters including particle size, zeta potential, self-emulsification time, drug content, percentage transmittance, and in vitro drug release studies. Overall, SMEDDS represent a promising oral drug delivery platform capable of significantly improving the dissolution behavior, bioavailability, and therapeutic performance of loratadine and other Biopharmaceutics Classification System (BCS) Class II drugs. Future research should focus on optimizing formulation components, establishing robust in vitro–in vivo correlations, and exploring large-scale manufacturing to facilitate successful clinical translation.