Development and Evaluation of Modified Release Multi Particulate Formulation of Anti Epileptic Drug

Abstract

This research work includes a study on the multi-particulate pellet formulation of anti-epileptic drug. Hot-Melt coating is a solvent less coating technology which utilizes some low melting materials as a functional coating agent to modulate the drug release profile. Core pellets of actives are manufactured with Extrusion spheronization process and then core pellets are then coated using hot melt coating technology. Different factors like the type of material used in coating, level of hot melt coating, level of hydrophilic pore former needs to be optimized to achieve targeted release profile. Processing parameters like operation temperatures, spray rate and Atomization air pressure also needs optimized settings to be process reproducible and consistent. Study includes an evaluation and optimization for Formulation and Processing variables using QbD and DOE for 2 different anti-epileptic drugs (i) Oxcarbazepine and (ii) Levetiracetam.