Formulation and In-Vitro Evaluation of Lemborexant Orodispersible Film

The current work focused on the formulation and in vitro evaluation of Lemborexant oral dispersible films (ODFs) loaded with nanoparticles to improve solubility, dissolution, and patient compliance in the treatment of insomnia. Lemborexant, a dual orexin receptor antagonist, has low water solubility, reducing its oral bioavailability. To overcome this limitation, nanoparticles were prepared using the solvent displacement method and incorporated into fast-dissolving polymeric films that contained hydroxypropyl methylcellulose (HPMC) and carboxymethyl cellulose (CMC) as film-forming agents, PEG as a plasticizer, and superdisintegrants for rapid disintegration. The produced films were tested for physicochemical and mechanical properties such as thickness, weight fluctuation, folding endurance, tensile strength, surface pH, drug content homogeneity, disintegration time, and in vitro drug release.The optimized formulation demonstrated uniform thickness and weight, as well as appropriate tensile strength. The films disintegrated quickly (15-30 seconds) and had considerably higher in vitro drug release than pure Lemborexant. FTIR tests verified the absence of drug-excipient interactions, while SEM revealed homogeneous nanoparticle dispersion. The findings suggested that Lemborexant-loaded nanoparticle oral dispersible films are a viable delivery platform for quick onset of action, increased bioavailability, and enhanced patient compliance, particularly in geriatric patients with swallowing issues. Additional in vivo investigations are needed to confirm the therapeutic efficacy and pharmacokinetic advantages of the proposed formulation. Keywords: Lemborexant, Oral Dispersible Film, Nanoparticles, Solvent Casting, In vitro drug release studies.