Bi-Laminated Oral Disintegrating Film for Dual Delivery of Pitavastatin Calcium and Lornoxicam: Fabrication, Characterization and Pharmacokinetic Study

Abstract

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.

Transethosomes as Breakthrough Tool for Controlled Transdermal Delivery of Dexketoprofen Trometamol: Design, Fabrication, Statistical Optimization, in Vitro, and Ex Vivo Characterization

“…Potassium bromide (KBR) pellet technique was adopted to perform FT-IR analysis of pure DKT and the optimal formula where a mixture of sample and KBr was pulverized at 10 kg/cm in a hydraulic press, yielding a translucent pellet which inserted in the sample container and scanned in FT-IR from 4000 cm -1 to 500 cm -1 [23][24][25].…”