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

Authors : Archana NERELLA, Nagabhushanam MV

Pages : 1-14

Doi:10.52794/hujpharm.1072840

View : 52 | Download : 16

Publication Date : 2023-03-01

Article Type : Research Paper

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 insert ignore into journalissuearticles values(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 insert ignore into journalissuearticles values(p<0.05);. Finally optimization was performed using desirability functions approach to elucidate the best formulation.
Keywords : Orodispersible films, Bioavailability enhancement, Historical data designing, Quality by design, Response surface methodology

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