BI-LAMINATED ORAL DISINTEGRATING FILM FOR DUAL DELIVERY OF PITAVASTATIN CALCIUM AND LORNOXICAM: FABRICATION, CHARACTERIZATION AND PHARMACOKINETIC STUDY
Keywords:Bi-laminated; Oral disintegrating film; Pitavastatin calcium; Lornoxicam; Liquid Chromatography-Mass Spectrometry.
Objective: Pitavastatin calcium (PT) is an innovative drug of statins that enhances HDL-C and lowers LDL-C. However, myalgia has been reported in hyperlipidemic patients receiving statins. Therefore, co-administration of statins with NSAIDs such as Lornoxicam (LN) could be a solution to the former problem. Accordingly, this study aimed to formulate a bi-laminated oral disintegrating film (ODF) comprising PT in one layer and LN in the second one.
Methods: For the formulation and optimization of PT-ODFs, a 31.21 full factorial design was carried out, where the impact of polymer type and concentration on disintegration time (DT) and % PT released after 10 min (Q10) was studied. PT-ODFs were prepared via the solvent casting method and then evaluated. One PT-ODF was chosen to represent the optimum formula according to the criteria of scoring the fastest DT and the highest Q10. The optimized PT-ODF was merged with the second film layer containing LN, forming a bi-laminated ODF named S1 that underwent an in-vivo pharmacokinetic study compared to the commercially available tablets for PT (Lipidalon®) and LN (Lornoxicam®) using rats as an animal model. LC-MS/MS was used to analyze plasma drug concentrations.
Results: All PT-ODFs showed acceptable outcomes. F1 scored the fastest DT (18.6±1.5 s) and the highest Q10 (91.3±3.0 %). S1 successfully recorded a maximum plasma concentration (Cmax) of 2.04 and 2.24 folds increase for PT and LN, correspondingly, compared to commercially available tablets.
Conclusion: Merging PT and LN into bi-laminated ODF was promising for the fast delivery of both drugs with enhanced bioavailability.
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Copyright (c) 2021 MAHMOUD H. TEAIMA, KHALED M. ABDEL-HALEEM, MOHAD OSAMA, MOHAMED A. EL-NABARAWI, SAHAR M. FAYEZ
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