Formulation And Evaluation Of Dolutegravir Mouth Dissolving Thin Films

Abstract

Dolutegravir is an HIV-1 integrase inhibitor that blocks the strand transfer step of the integration of the viral genome into the host cell (INSTI). The aim of present study was to develop mouth dissolving films Dolutegravir by using various polymers with shorter disintegration time and greater drug release with a prospect of assisting various patients who have difficulty in swallowing conventional dosage forms & enhance bioavailability of drug and quick onset of action. MDFs also offer better convenience to patients with mental illness, as well as pediatrics, elderly, and developmentally disabled patients. MDFs were formulated using a solvent casting technique. The optimized MDF follows the evaluation parameters like Physical appearance, weight uniformity, drug content uniformity, Thickness, Folding endurance, Surface pH, In vitro disintegration time, Tensile Strength and Percent Elongation, Scanning electron microscope, Taste Evaluation Study by Spitting, In-vitro Dissolution study, Comparison of optimized formulation with marketed formulation, Drug release kinetic studies and Stability Studies. The % CDR of the optimized MDF in comparison, the market formulation was found to be 69.41±1.16% in 12 mins and optimized formulation yield 99.75±1.48% within 10 minutes.