SODIUM ALGINATE COATED NIOSOME: A NOVEL ORAL DELIVERY SYSTEM OF SIMVASTATIN FOR THE TREATMENT OF HYPERLIPIDEMIA

Hyperlipidemia is a metabolic disorder characterized by abnormally elevated levels of lipids, including cholesterol and triglycerides, in the blood. It is considered as one of the major risk factors for the development of cardiovascular diseases, atherosclerosis, and stroke. Statins are the first-line drugs used for the management of hyperlipidemia. Simvastatin, a BCS Class II drug, is a potent HMG-CoA reductase inhibitor used to lower cholesterol levels. Despite its therapeutic efficacy, simvastatin possesses poor aqueous solubility and low oral bioavailability due to extensive first-pass metabolism, which limits its clinical application. To overcome these limitations, novel drug delivery systems have been explored to enhance the solubility and bioavailability of poorly soluble drugs. Among various approaches, vesicular drug delivery systems such as niosomes have gained significant attention due to their ability to encapsulate both hydrophilic and lipophilic drugs. Furthermore, surface modification of niosomes with mucoadhesive polymers can improve gastrointestinal residence time and provide controlled release. The aim of the present research work was to develop and characterize sodium alginate coated niosomes of simvastatin as an oral delivery system for the treatment of hyperlipidemia. Niosomes were prepared by thin film hydration technique using non-ionic surfactant Span 60 and tween 80 and cholesterol. The prepared niosomes were coated with sodium alginate. The developed formulations were evaluated for various parameters including particle size, polydispersity index, zeta potential, entrapment efficiency, surface morphology, drug-excipient compatibility studies by FTIR, and in-vitro drug release studies. The objective was to achieve sustained release of simvastatin and thereby improve its oral bioavailability for effective management of hyperlipidemia.