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

• Published in: Asian journal of pharmaceutical and clinical research 2018-10, Vol.11 (10), p.504
• Main Authors: Zupanets, Igor, Shebeko, Sergey, Zimin, Stanislav
• Format: Article
• Language: English
• ISSN: 0974-2441; 0974-2441
• DOI: 10.22159/ajpcr.2018.v11i10.28140

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.