Development and characterization of furosemide-loaded binary amorphous solid dispersion to enhance solubility and dissolution for pediatric oral administration

Binary co-amorphous systems, as solid dispersions of an active pharmaceutical ingredient with low molecular weight excipients, improve solubility, physical stability, and bioavailability relative to crystalline forms. This study aimed to enhance the solubility and dissolution of furosemide by developing a binary amorphous solid dispersion (BASD) and formulating it into granules for pediatric administration via a straw. Furosemide was blended with hydroxy methylcellulose E6, polyvinylpyrrolidone K30 (PVP), or Soluplus® in a 1:2 ratio using solvent evaporation, and the best formulation was produced via wet granulation. The furosemide-loaded BASD-PVP K30 (Formula F) demonstrated superior FTIR, DSC, and XRPD profiles. In vitro release testing showed that over 87.18% of furosemide was liberated within 120 minutes in a water solution containing 0.1% Tween 80. Moreover, the granules of Formula F9 exhibited excellent flow, disintegrated within 5–6 seconds, and released 79.86% of furosemide within four hours in a two-step dissolution study (0.1 N HCl and pH 6.8 phosphate buffer). Stability testing over three months revealed no perceptible changes in appearance or drug content. These findings support the effectiveness of BASD granules in enhancing furosemide dissolution and their potential for pediatric administration.