High-dose modified-release formulation of a poorly soluble drug via twin-screw melt coating and granulation

[Display omitted] Favipiravir, a high dose antiviral drug effective for oral treatment for COVID-19, with poor water solubility is formulated using a simple, low-cost melt coating and granulation methodology. High-dose (82.5 % w/w API) tablets (600 mg and 800 mg) with desired release profiles are developed while minimizing excipient burden. First, twin-screw melt coating and granulation (MCG) of Favipiravir, using Poloxamer P188 as a binder as well as a surfactant, was utilized to create Favipiravir granules with high solubility and tabletability. These granules were then blended with a small amount of extra-granular ingredients (high molecular weight Hydroxypropylmethyl Cellulose and Magnesium Stearate) and compacted into tablets with desired controlled-release tablets. Results demonstrate that the application of MCG to coat and granulate a poorly soluble drug, using a low melting point surfactant as a binder and wetting agent, can be an effective approach to manufacture high-dose modified release formulations for low solubility drugs that are common in the treatment of infectious diseases, cancer, autoimmune diseases, and many other conditions.