Comparative study of the original technology of micronization of the purified flavonoid fraction of “Detralex®” and the technology of micronization of drugs D and N of the Ukrainian manufacturers

Abstract

Objective: The objective of the study was to compare the degree of micronization of the bioflavonoid fraction (90% diosmin and 10% hesperidin) of different manufacturers which used for the treatment of the chronic venous insufficiency. Methods: “Detralex®,” medicines N and D, 500 mg coated tablets each were used as studied objects. Microscopy of the tablets matrix of the investigational drugs was performed after spontaneous decomposition in a water solution at pH=6.8, using a modular light field microscope of the research class B-1000BF (Optika, Italy) with a digital camera Optikam HDMI Pro (Optika, Italy) with measuring of the size of the flavonoid fraction granules. Results : About 92.8% of the granules of the “Detralex®” tablets matrix were presented by the smallest size of the granules (1–5 μ), unlike D and N, in which 12.9% and 10% of the same size granules were observed. Giant granule size (up to 50 μm) was discovered in D and N tablets matrix and no such granules size were found in the “Detralex®” tablets matrix. Conclusion: Different degrees of micronization of the purified flavonoid fraction in the studied test samples indicate that the drugs D and N are not pharmaceutically equivalent to the original “Detralex®” drug and cannot be considered as copies without further research.