Formulation and Evaluation of Oral Thin Film of Simvastatin and Fenofibrate

Abstract

Cardiovascular disorders continue to represent a major global health burden, with elevated lipid levels recognized as one of the primary contributors to the development of atherosclerosis and related complications. Simvastatin and Fenofibrate are commonly utilized antihyperlipidemic agents for reducing cholesterol and triglyceride levels; however, their clinical performance is often restricted by poor water solubility, inadequate oral bioavailability, and the necessity for repeated administration. The present investigation focused on the development and evaluation of oral thin films (OTFs) incorporating Simvastatin and Fenofibrate through the solvent casting method using appropriate film-forming polymers and excipients. The prepared films were assessed for various physicochemical and mechanical parameters, including thickness uniformity, folding endurance, tensile strength, drug content, swelling behavior, disintegration time, and in-vitro drug release. The developed formulations exhibited smooth appearance, adequate flexibility, and rapid disintegration characteristics. Drug content uniformity was found within acceptable limits for both Simvastatin and Fenofibrate, indicating homogeneous distribution throughout the films. Dissolution studies demonstrated rapid and substantial release of both drugs within a short duration, suggesting improved dissolution behavior. Overall, the formulated oral thin films showed satisfactory mechanical properties, reproducible drug release, and formulation stability, indicating their suitability as an effective and patient-compliant alternative to conventional oral dosage forms for hyperlipidemia therapy.

Keywords: Simvastatin, Fenofibrate, Oral Thin Films, Hyperlipidemia, Solvent Casting, Fast-Dissolving Drug Delivery, Drug Release, Patient Compliance.