ANALYSIS OF REFERENT AND GENERIC DRUGS OF AZELAIC ACID IN TERMS OF THE HYDRODYNAMIC RADIUS OF PARTICLES AND ZETA-POTENTIAL

DOI: https://doi.org/10.29296/25877313-2021-05-08
Issue: 
5
Year: 
2021

M.S. Nesterov Head of the Laboratory of Bioanalytical Research, Scientific Center of Biomedical Technologies of the Federal Medical and Biological Agency of Russia (Moscow region, Krasnogorsky district, village Bright mountains, Russia) E-mail: mdulya@gmail.com D.V. Khvostov Junior Research Scientist, the Laboratory of Molecular Biology and Bioinformatics, V.M. Gorbatov Federal Research Center for Food Systems, Russian Academy of Sciences (Moscow, Russia) E-mail: daniil_hvostov@mail.ru R.A. Ageldinov Research Scientist, Laboratory for Bioanalytical Research, Scientific Center of Biomedical Technologies of the Federal Medical and Biological Agency of Russia (Moscow region, Krasnogorsky district, village Bright mountains, Russia) E-mail: ageldinov@gmail.com D.D. Petrunin Ph.D. (Med.), Scientific Affairs Associate, Russia & CIS, LEO Pharma (Moscow, Russia) E-mail: prof.preobrazhenskii@gmail.com

For a long time azelaic acid (AZA) have been used for the topical treatment of acne, rosacea and melasma; cumulative clinical data acquired in high-quality randomized clinical trials of azelaic acid referent remedy demonstrates it’s efficacy and good safety profile. In recent time several AZA generic drugs have entered Russian market. In this experimental work, the size factor and zeta-potential (charge factor) of AZA particles in tested samples of the referent product Skinoren® and generics was studied. It was found out that AZA generics have higher parameters of hydrodynamic radius (size fac-tor) and smaller (in module) parameters of zeta-potential than the referent product; this can have a potentially negative impact on stability, shelf life and storage conditions of generics and, in some cases, potentially can affect cutaneous pharmacokinetics and resulting clinical efficacy of the latter.

Keywords: 
azelaic acid
referent drug
generic
particle size
zeta-potential

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