Oral Thin Film: A New Approach for Drug Delivery

Abstract

Hyperlipidemia remains a major global health concern and a leading risk factor for cardiovascular diseases. Conventional oral dosage forms of lipid-lowering agents like Simvastatin and Fenofibrate often face limitations such as poor aqueous solubility, extensive first-pass metabolism, variable bioavailability, and poor patient adherence. Oral thin film (OTF)technology has emerged as a promising fast-dissolving drug delivery system designed to overcome these limitations, offering improved drug dissolution, enhanced bioavailability, and ease of administration without the need for water. The present review focuses on the formulation and evaluation of oral thin films incorporating Simvastatin and Fenofibrate for synergistic management of hyperlipidemia. It highlights the pharmacological rationale for combining these agents, discusses formulation strategies including polymer selection, plasticizers, solubilization techniques, and manufacturing methods, and summarizes evaluation parameters such as mechanical properties, disintegration time, drug content, in-vitro dissolution, and stability studies. The review emphasizes the potential of oral thin films as a novel patient-friendly dosage form capable of improving therapeutic outcomes, bioavailability, and patient compliance in the treatment of hyperlipidemia. Further research and clinical studies are recommended to optimize formulation variables and validate clinical efficacy.

Keywords: Simvastatin; Fenofibrate; Oral thin films; Hyperlipidemia; Bioavailability enhancement; Fast-dissolving dosage forms; Patient compliance; Drug delivery system; Synergistic therapy; Cardiovascular disease.