Abstract

FORMULATION AND IN VITRO EVALUATION OF ARIPIPRAZOLE NANOPARTICLES ORAL DISPERSIBLE FILMS

Ayesha Osman*, Abdul Mannan

Abstract

The present research was aimed at the formulation and in vitro evaluation of Aripiprazole nanoparticles incorporated into orodispersible films (ODFs) to enhance the solubility, dissolution rate, and bioavailability of the poorly water-soluble antipsychotic drug, Aripiprazole. Nanoparticles were prepared using the emulsion solvent evaporation method, employing PLGA and Chitosan as polymers and Polyvinyl alcohol (PVA) as a stabilizer. A series of formulations (F1–F8) were developed and optimized based on particle size, zeta potential, and surface morphology. The mean particle size of the optimized formulation (F7) was 261 nm, and the zeta potential was –22 mV, indicating good stability. Scanning Electron Microscopy (SEM) revealed that the nanoparticles were spherical, smooth, and free from aggregation. The optimized nanoparticles were incorporated into ODFs using HPMC and sodium alginate as film-forming polymers and PEG 400 as plasticizer. The prepared films were evaluated for thickness, folding endurance, drug content, moisture absorption and loss, tensile strength, disintegration time, and in vitro drug release. The results indicated uniformity and satisfactory mechanical properties across all formulations. The optimized film (F7) showed a disintegration time of 12 seconds and a drug release of 98.85% within 30 minutes, following zero-order kinetics (R² = 0.972). Stability studies conducted as per ICH guidelines (40 ± 2°C / 75 ± 5% RH) for three months confirmed the physical and chemical stability of the optimized formulation. In conclusion, the study successfully demonstrated that Aripiprazole nanoparticles loaded oro-dispersible films can serve as an effective, patient-friendly dosage form with enhanced solubility, faster onset of action, and improved bioavailability, providing a promising alternative to conventional oral tablets for psychiatric patients.

Keywords: Aripiprazole, PLGA, Chitosan, Emulsion solvent evaporation method, FTIR, In vitro drug release studies.