Development and Characterization of Self-Emulsifying Drug Delivery System (Sedds) for a Bcs Class Ii Drug

<p><strong>Abstract</strong></p> <p>Oral delivery presents unique challenges, as the bioavailability of many BCS Class II drugs is low and difficult to estimate because of their persistent weak solubility in water. In order to overcome this limitation, research and development of a self-emulsifying drug delivery system (SEDDS) were carried out. Since valsartan is a commonly used drug for hypertension, it was selected as a model medicine for the BCS Class II category. Even though its absorption is hindered in the acidic environment of the esophagus and stomach, its oral bioavailability is only around 25%. The reason for this is that it has a low rate of environmental absorption. The chemical composition of the mixture was determined to include isopropyl myristate in the oil phase, Capryol 90 and Tween 20 as surfactants, and Transcutol HP as a cosurfactant. The results of the solubility tests confirmed this. The component ratios were optimized using pseudo-ternary phase diagrams. Wet granulation, Avicel pH101, and hydroxypropyl methylcellulose (HPMC) were used to solidify the liquid SEDDS formulations. The intended outcomes necessitated this action. The formulations were tested for efficiency in emulsification, droplet size, and in vitro drug release. When tested in conditions meant to mimic the stomach (pH 1.2), the SEDDS and solid-SEDDS systems substantially increased valsartan's solubility. The commercial formulation had a much lower solubility before this. The release of the Avicel-based solid SEDDS was shown to be pH-insensitive and unaffected by the patient's dietary status or rapid eating, or fasting. These findings suggest that SEDDS is a strategy worth investigating further as a means to circumvent the solubility limitations of BCS Class II drugs and increase their oral bioavailability.</p> <p><strong>Keywords:</strong> Self-emulsifying drug delivery system (SEDDS), Solid SEDDS (S-SEDDS), Valsartan, BCS Class II drug, Solubility enhancement, Bioavailability improvement</p>