EX VIVO PERMEATION STUDY OF NANOSTRUCTURED DOSAGE FORM CONTAINING MANGO SEED KERNEL EXTRACT USING FRANZ CELL

Abstract

Background: mango seeds (Mangiferin indica L.) have the ability to inhibit P. acnes, S.aureus, and E. coli bacteria and inhibit inflammation, potentially for transdermal therapeutic dosage forms. The nano-emulsion dosage forms were prepared based on the SNEDDS system with nano-oil droplets containing mango seed extract. These dosage forms contributed to carrying the active ingredient deeply into the impact site, bringing the highest efficiency, but this needs to be proven. Thus, it is necessary to study the process to evaluate the permeability of these formulas to prove their availability improvement. Objectives: To assess the transdermal permeability and active substance release of nanostructured dosage forms by a validated procedure. Methods: an ex vivo experiment was designed by adding a sample to diffuse through Franz cells. In addition, to ensure the quality and effectiveness of preparations containing mango seeds, developing and validating a process for quantifying the total polyphenols in the preparation are extremely necessary. Total polyphenols were quantified by color complexing with Folin-Ciocalteu reagents, with maximum absorption at 765 nm. Results: the procedure had been validated according to the International Conference on Harmonization (ICH) on the criteria of specificity, system compatibility with RSD = 1.02%, linearity built on the concentration range of 10–50 µg/ml with R2 = 0.998, accuracy, precision with %recovery in the range of 97.73% to 102.56%. The results showed that more than 300 mg/g of polyphenol was released after 6 hours from the tested nanostructured dosage form, about 4.3 times as many as the total amount of polyphenols in the comparative cream. Conclusions: the quantification of polyphenols diffused through Franz cells helps evaluate the quality of the preparation. The procedure had been validated according to the International Conference on Harmonization (ICH) and could be applied to evaluate nanostructured dosage forms containing mango seed kernel.