ABSTRACT:
Objective: The study aimed to formulate and evaluate Oro-dispersible film of solubility enhanced Aripiprazole for the management of psychosis. Methods: Aripiprazole–methyl-β-cyclodextrin inclusion complexes (1:0.5 to 1:1.5) were freeze-dried and characterized by KBr-pellet FTIR spectroscopy. Films (F1–F9) were prepared via solvent casting using Pullulan (300–500 mg) and PEG 400 (125–325 mg) based on a 32 factorial design. Evaluated parameters included film thickness, weight variation, surface pH, folding endurance, disintegration time, drug content uniformity, and in-vitro release in pH 6.8 phosphate buffer. Results: FTIR confirmed drug–excipient compatibility with no degradation of major drug peaks (N–H at 3261 cm⁻¹, C=O at 1673 cm⁻¹). Across formulations F1 to F9, thickness was 0.07–0.12 mm, weight 0.047–0.101 mg, surface pH 6.2–6.9, folding endurance 40–58, disintegration time 34–42 s, drug content 87.11–96.91%, and in-vitro release 89.58–100.26%. Formulation F5 (400 mg pullulan, 225 mg PEG 400) was optimized, displaying 0.10 mm thickness, 0.071 mg weight, 6.8 surface pH, 50 folding endurance, 38 s disintegration time, 96.91% drug content, and 93.53% drug release. Low percentage errors (< 5%) validated the response surface model. Conclusion: Optimized film F5 provides rapid oral disintegration, high flexibility, near-neutral pH compatibility, and fast drug release, serving as an effective, patient-compliant platform for psychosis treatment.