Formulation Development And Evaluation Of Terbinafine Using Quality By Design Approach

Abstract

Terbinafine is an antifungal allylamine that is commonly used to treat infections caused by dermatophytes (Trichophyton, Epidermophyton, and Microspora), such as tinea infections. Terbinafine works by inhibiting the enzyme squalene epoxidase in fungal ergosterol biosynthesis, resulting in intracellular squalene accumulation and cell death. For seven sample batches, microcrystalline cellulose, sodium starch glycolate, hydroxyl propyl methylcellulose, magnesium stearate, and colloidal silicon dioxide were used in various quantities and compositions. The photostability study looked into the medicine excipient compatibility. In the photostability research, no significant alterations were found. The tablets were tested for disintegration, consistency of content, and friability. Drug release profile in vitro, Scale-up and large-scale manufacturing, as well as a validation process, may be created in the future for marketing approval.