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<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
References
- 1. Jassim ZE, Mohammed MF, Sadeq ZA: Formulation and evaluation of fast dissolving film of lornoxicam. Asian Journal of Pharmaceutical and Clinical Research 2018, 11(9):217-23.
- 2. Kalyanappa S, Krishna MR, Goli D: Design and in vitro evaluation of a novel sustained release double layered tablets of lornoxicam by using semi synthetic polymers. Indian Journal of Pharmaceutical Education and Research 2015, 49:281-91.
- 3. Musazzi UM, Selmin F, Franze S, Gennari CG, Rocco P, Minghetti P, Cilurzo F: Poly (methyl methacrylate) salt as film forming material to design orodispersible films. European Journal of Pharmaceutical Sciences 2018, 115:37-42.
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<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 methodoloy
References
- 1. Jassim ZE, Mohammed MF, Sadeq ZA: Formulation and evaluation of fast dissolving film of lornoxicam. Asian Journal of Pharmaceutical and Clinical Research 2018, 11(9):217-23.
- 2. Kalyanappa S, Krishna MR, Goli D: Design and in vitro evaluation of a novel sustained release double layered tablets of lornoxicam by using semi synthetic polymers. Indian Journal of Pharmaceutical Education and Research 2015, 49:281-91.
- 3. Musazzi UM, Selmin F, Franze S, Gennari CG, Rocco P, Minghetti P, Cilurzo F: Poly (methyl methacrylate) salt as film forming material to design orodispersible films. European Journal of Pharmaceutical Sciences 2018, 115:37-42.
Details
| Primary Language | English |
|---|---|
| Subjects | Pharmacology and Pharmaceutical Sciences |
| Journal Section | Research Articles |
| Authors | |
| Publication Date | March 1, 2023 |
| Acceptance Date | August 3, 2022 |
| Published in Issue | Year 2023 Volume: 43 Issue: 1 |