Quality by Design Approach for Optimization and Development of Orodispersible Films of Lornoxicam Inclusion Complexes

Abstract

Lornoxicam is a non-steroidal anti-inflammatory drug, indicated in the treatment of osteoarthritis and rheumatoid arthritis. Lornoxicam is a poor water-soluble drug and hence possesses dissolution limited bioavailability. The aim of the current research work was to develop and characterize orodispersible films of Lornoxicam to enhance its bioavailability by employing Quality-by-Design (QbD) approach. Solvent casting method was used to formulate the Lornoxicam mouth dissolving films. Three formulation factors viz. amount of polymer, amount of PEG 400 and type of polymer were varied at different levels. The responses selected were disintegration time and percent drug dissolved after 5mins. Under the response surface methodology, historical data design was employed to perform the statistical analysis using Design Expert software. The developed films were found to have good elasticity, folding endurance and favorable tensile strength. The disintegration time was found to be 9 to 17 seconds and drug dissolved after 5 minutes was 49 to 95%. The statistical analysis of the results by ANOVA elucidated that there was a significant effect of all the formulation factors on the selected responses (p