Box Behnken's Design of Fast-Dissolving Ondansetron Buccal Films and Assessing the Impact of Independent Variables on their Swelling and Folding Endurance Constraints

Objectives

The project intends to create and evaluate oral fast-dissolving Ondansetron (ODN) films and explore how different plasticizers and polymers affect ondansetron release at varied doses.

Materials and Methods

The solvent casting method was used to make the films. Complex formation and compatibility were evaluated using spectral and calorimetric methods to confirm. Utilising the core composite design, which included 13 different Ondansetron Fast-Dissolving Oral Films (OFDOFs) formulas, the produced Ondansetron Fast-Dissolving Oral Films (OFDOFs) were optimised. Using the Design Expert-v.11 software, the impacts of three variables, including HPMC K4M (X₁), Carbopol 934 P (X2), and propylene glycol levels (X₃), on two responses, Folding Endurance (FE) and Swelling Index (SI), were examined. Numerical optimisation increased the FE (Y₁) and maximised the SI (Y2).

Results

The statistical analysis findings showed that X₁ greatly enhances Y₁ and Y2. While X2 and X₃ significantly prejudiced the responses optimistically. It was found that the best films were created at the midpoint concentration of both X₁ and X2. Moreover, as X3 levels increased, the elasticity and FE also improved, in addition to the film’s quality.

Conclusion

The study concludes that the prepared buccal films of ODN exhibited great mechanical and physical qualities in addition to their other physicochemical assets. This dosage form is expected to offer a bioavailability benefit over conventional dosage forms due to its rapid onset of action and anticipated partial avoidance of pre-systemic metabolism.