Orodispersible Films of Meloxicam Inclusion Complexes for Bioavailability Enhancement: Optimization and Development through Quality by Design Approach

Abstract

Background: Owing to overcome the dissolution limited bioavailability of Meloxicam, the current research involves the development of Orodispersible films using Meloxicam by employing Quality by Design. Methods: In this work, the Meloxicam oral dispersible films were formulated by solvent casting method by altering three formulation factors viz. amount of film former, amount of the plasticizer, PEG 400 and type of film former (HPMC E3, HPMC E5, HPMC E15). Historical data designing under response surface methodology was selected as the experimental design. Disintegration time, dissolution of Meloxicam after 5 mins, folding endurance and tensile strength of the orodispersible films were taken as the responses. Results: All the formulations were found to have favorable tensile strength and folding endurance. The disintegration time values were found to be in a range of 9-15 sec, the values of amount of Meloxicam dissolved after 5 min were found to be in the range of 48-98%. The data obtained from the responses were statistically treated using ANOVA and the effect of the formulation factors were found to be significant. Conclusion: The optimization of these formulations indicated that a combined film former of 140mg of HPMC E15 and 50mg of HPMC E3 with 25mL plasticizer was found to be the optimized formulation. The films prepared at this combination showed disintegration time of 8 sec, drug release of 66.5% after 5 min which indicate that the formulated Meloxicam orodispersible films were successfully optimized and developed.