Lamotrigine Nanoparticle Laden Polymer Composite Oral Dissolving Films for Improving Therapeutic Potential of the Hydrophobic Antiepileptic Molecule.

Lamotrigine is used for neurological disorders and antiepileptic therapy at frequent dosing due to its poor solubility. The present work aims to study the influence of combining the Lamotrigine nanoparticles and polymer composite oral dissolving film to improve the solubility and dissolution kinetics of the drug. The Lamotrigine-Eudragit E100 nanoparticles were synthesized through solvent evaporation followed by precipitation process, which were laden in oral dissolving films through solvent casting technique. The optimized nanoparticles were assessed for particle size, colloidal stability, drug entrapment efficiency , in vitro release profile, physicochemical characteristics, and cytotoxicity. The optimized polymeric nanoparticles of Lamotrigine: Eudragit E100 (1:0.5) exhibited monodispersed particles with 103 nm average size, +7.96 mV zeta potential, and 82.96% ± 1.2% entrapment efficiency. The composite oral matrix films blended with polyvinyl alcohol and polyvinyl pyrrolidone (0.5:0.5 ratio) incorporated with the polymeric nanoparticles demonstrated >64% drug release within 2 h. The nanoparticles and its composite films exhibited 9- and 11-fold higher drug release than pure drug, respectively. The analytical characterization studies proved the formation of nanoparticles with mild drug-polymer interactions and optimum stability, which resulted in enhanced solubility and dissolution of drug. The nanoparticles displayed lesser cytotoxicity to the normal (Vero) cells at concentration of 10-50 μg/mL compared to pure drug. The optimized polymeric nanoparticle loaded oral films could be suitable for in vivo administration of Lamotrigine at low doses to improve bioavailability and therapeutic efficiency with reduced side effects .