Development of Orodispersible Film Containing Spray-Dried Rifampicin Nanosuspension

Tuberculosis (TB) is a major global health challenge, with high mortality rates. Conventional anti-TB dosage forms, such as tablets are often unsuitable for patients who struggle with swallowing, leading to poor compliance. Therefore, this study aimed to develop orodispersible film (ODF) containing rifampicin, a widely used anti-TB drug. Rifampicin’s low aqueous solubility poses challenges for its incorporation into ODF and affects its therapeutic effectiveness. To address these issues, rifampicin was first prepared as nanosuspension and subsequently dried before being formulated into ODF. Nanosuspension was stabilized using polyvinyl alcohol (PVA), poloxamer 188 (POX), and the combination at various concentrations. Nanosuspension was prepared using solvent-antisolvent precipitation followed by sonication and spray-drying. Spray-dried nanosuspension was characterized, and the optimal formula was used in ODF formulation through the solvent-casting method. Formulations PV2 (PVA 0.4%) and POX1 (POX 0.2%) showed the smallest particle sizes at 306±14.01 nm and 291±7.55 nm, respectively. After reconstitution, PV2 maintained particle size comparably to POX1. Spray-dried PV2 nanosuspension exhibited a 21.48-fold increase in saturated solubility compared to the pure rifampicin, and showed superior drug release, with 79% release versus 58% for the standard rifampicin suspension. ODF containing PV2 showed improved organoleptic properties and enhanced drug dissolution (82% vs 56%) compared to original rifampicin ODF. The formulation of rifampicin into nanosuspension stabilized by PVA and POX, followed by spray-drying, significantly improved solubility and drug release profile. This method also enhanced the organoleptic properties and dissolution of rifampicin in ODF, providing a promising strategy to boost rifampicin’s therapeutic efficacy in TB treatment, particularly for pediatric patients.