BI-LAMINATED ORAL DISINTEGRATING FILM FOR DUAL DELIVERY OF PITAVASTATIN CALCIUM AND LORNOXICAM: FABRICATION, CHARACTERIZATION AND PHARMACOKINETIC STUDY

MAHMOUD H. TEAIMA; KHALED M. ABDEL-HALEEM; MOHAD OSAMA; MOHAMED A. EL-NABARAWI; SAHAR M. FAYEZ

doi:10.22159/ijap.2022v14i2.43534

Authors

MAHMOUD H. TEAIMA Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt https://orcid.org/0000-0002-7565-301X
KHALED M. ABDEL-HALEEM Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, October 6 University, Giza, Egypt https://orcid.org/0000-0001-7272-2676
MOHAD OSAMA Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, October 6 University, Giza, Egypt
MOHAMED A. EL-NABARAWI Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt
SAHAR M. FAYEZ Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, October 6 University, Giza, Egypt https://orcid.org/0000-0002-0001-6147

DOI:

https://doi.org/10.22159/ijap.2022v14i2.43534

Keywords:

Bi-laminated, Oral disintegrating film, Pitavastatin calcium, Lornoxicam, Bi-laminated; Oral disintegrating film; Pitavastatin calcium; Lornoxicam; Liquid Chromatography-Mass Spectrometry.

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 (C_max) 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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