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.