DESIGN AND STATISTICALLY OPTIMIZE BRIVARACETAM FAST DISSOLVING FILM BY EMPLOYING A 32 FACTORIAL DESIGN
DOI:
https://doi.org/10.22159/ijap.2026v18i4.58335Keywords:
Folding endurance, Fast dissolving film, Solvent casting, Brivaracetam, Oral dose, StabilityAbstract
Objective: This study aimed to design and statistically optimize Brivaracetam fast dissolving oral film (FDFs) using the solvent casting method by employing a 32-factorial design.
Methods: The FDFs were made by the solvent casting method, and they were optimized using a 32-factorial design. The physicochemical properties were evaluated using FTIR, DSC, and SEM. The independent variables in fast-dissolving films were the amount of pectin (A) and PEG400 (B). The dependent variables analyzed were disintegration time (DT) (Y1) and tensile strength (TS) (Y2). The resulting FDFs were characterized for several parameters like drug content, DT, TS, thickness, weight variation, folding endurance, percentage elongation, surface pH and percent drug dissolved in ten minutes (%DD10). The optimized formulation was evaluated for the accelerated stability studies according to ICH guidelines.
Results: FTIR and DSC studies confirm that there was no incompatibility between the drug and excipients. SEM confirms the amorphous nature of the film. The optimised FDF displayed a thickness of 131.27 ± 8.5 μm, a weight variation of 63.8 ± 4.1 mg, a DT of 27 ± 2, a drug content of 97.06 ± 2.4%, a TS of 1.871 N/mm2, and a %DD10 of 98.73 ± 2.5%. Accelerated stability studies over three months revealed no significant changes in drug content, mechanical strength, DT and %DD10, confirming the formulation’s stability and suitability for therapeutic use.
Conclusion: Brivaracetam FDFs were successfully developed and optimized using a 3² factorial design, exhibiting maximum drug release and minimal DT, demonstrating faster and more effective delivery. Brivaracetam FDFs have great potential as an efficient substitute for conventional oral dosage forms and may significantly boost patient compliance.
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