Development and characterization of Olmesartan Medoximil Self-Microemulsifying Fast Disintegrating Tablet

Olmesartan Medoxomil (OLM), is a BCS Class II hypertension drugs, with low solubility in water, leading to limited bioavailability. This study aimed to increase the dissolution rate of OLM using a Solid-Self Micro Emulsifying Drug Delivery System (S-SMEDDS). In the beginning, oils, surfactants, and co-surfactants were assessed for drugs solubility. Liquid SMEDDS was created by combining Capmul MCM (30-50%) as oil with Gelucire 44/14 and Transcutol HP (50-70%) as surfactants and co-surfactants. The method was tested for % transmittance, cloud point, reconstitution ability, stability, and drug content. Optimized SMEDDS, made up of Gelucire 44/14 (46.5%), Capmul MCM (40%), and Transcutol HP (23.5%), had good emulsification characteristics, including an adequate zeta potential, particle size, and polydispersity index (PDI). It was then adsorbed onto Neusilin U2 to obtain S-SMEDDS, which was further characterized by Differential Scanning Calorimetry (DSC) that confirmed no drug-excipient interactions, while Scanning Electron Microscopy (SEM) verified successful adsorption of liquid SMEDDS. The S-SMEDDS was formulated into a fast-dissolving tablet (FDT) using suitable excipients, exhibiting good flow properties and a disintegration time of 108 seconds. In vitro dissolution studies revealed 90% drug release in 60 minutes, significantly higher than the 35.4% release observed with pure drug. These results suggest that the S-SMEDDS-based fast-dissolving tablet of OLM could act as a novel drug delivery system for increasing solubility and bioavailability, offering a more effective oral treatment for hypertension. Keywords: Olmesartan Medoximil, S-SMEDDS, Croscarmellose Sodium, Fast Disintegrating Tablet