Development of oral paediatric furosemide liquid formulation using surfactant-rich micelles

Abstract Furosemide, a diuretic for managing edema in premature neonates and infants with congestive heart failure, is often formulated with alcohol and preservatives, posing risks like neurotoxicity and cardiovascular complications. This study aimed to develop a safe, alcohol-and preservative-free micellar liquid formulation of furosemide for pediatric use. Drug-loaded micelles were prepared using Kolliphor RH 40 (polyoxyl 40 hydrogenated castor oil) as a surfactant and hydroxypropyl-beta-cyclodextrin as a solubiliser and characterized for size, morphology, zeta potential, polydispersity, critical micelle concentration, stability, and microbiological quality. Of the twelve formulations, F11 and F12 were selected for their visual clarity and physical properties. The optimised batch (F11) formed nanosized micelles (19.16 ± 0.06 nm) with uniform distribution (PDI 0.292 ± 0.02) and steric stabilisation (zeta potential −0.43 ± 0.01 mV). Entrapment efficiency exceeded 98 %, and transmittance was >97 %, confirming high clarity. The formulation remained stable in SGF and SIF for 12 h with >99 % assay retention and complies with the stability protocol. The data obtained from stability studies indicate the physical, pharmaceutical, and microbial stability of the developed formulation. This alcohol- and preservative-free micellar formulation may offer a safe and effective treatment option for paediatric populations.