The main stages of pharmaceutical development of emulgel “Probioskin”

Authors

DOI:

https://doi.org/10.15587/2519-4852.2021.249710

Keywords:

pharmaceutical development, probiotics, skin microbiome, dermatological diseases, emulgel, gelling agents

Abstract

The aim. To conduct research on the pharmaceutical development of a complex preparation with probiotic “Probioskin” in the form of an emulgel for the treatment of infectious and inflammatory dermatological diseases.

Methods. Uniformity was determined by visual inspection of the test samples using an XSP-128 ULAB biological microscope. The study of the rheological properties of the samples was carried out using a Rheolab QC rheovisosimeter (Anton Paar, Austria) using a system of coaxial cylinders C-CC27 / SS. Microbiological studies and biotesting on a biological model of ciliates were carried out in aseptic conditions of a laminar box (biological safety cabinet AC2-4E1 “Esco”, Indonesia) of the Department of Biotechnology of the National University of Pharmacy (completely). Pharmacological studies (determination of the parameters of acute toxicity and anti-inflammatory properties on the model of acute exudative inflammation of the foot in rats caused by zymosan and carrageenan) were carried out on the basis of the Central Research Laboratory of the NUPh.

Results. On the basis of the complex of the carried out studies, the composition of the complex preparation for skin use “Probioskin” was substantiated. The analysis of the microbiological purity of the developed agent during the proposed shelf life of 12 months showed that the drug meets the requirements of the State Pharmacopoeia Monograph for cutaneous application in terms of the level of microbial contamination by foreign microflora. The complex of pharmacological studies carried out indicates that the drug “Probioskin” can be attributed to group 6 of class and classified as a “relatively harmless” agent. The study of the anti-inflammatory effect of the drug indicates that the drug exhibits moderate anti-inflammatory properties. Under the condition of zymosan inflammation, which is associated with the activation of leukotrienes as inflammatory mediators, the average antiexudative activity of the drug is 33 %. The drug has a moderate antiexudative effect under the condition of carrageenan edema, which is evidence of its effect on exudation processes mediated by prostaglandins. The mean AEA of the study drug was 24 %.

Conclusions. For the development of a soft preparation for skin use for the treatment of infectious and inflammatory dermatological diseases, the following components have been selected: active – lactobacilli, dexpanthenol, lactic acid; auxiliary - propylene glycol, peach oil, polysorbate-80, aristophlex, tocopherol, the concentration of which was substantiated on the basis of a complex of organoleptic, physicochemical, pharmacological, microbiological and biological studies. It has been experimentally established that the “Probioskin” emulgel meets the requirements of the SPhU in terms of the level of microbial contamination by extraneous microflora. Pharmacological studies allow the drug to be classified as “relatively harmless” with anti-inflammatory properties at a level not lower than the reference drug

Author Biographies

Alina Soloviova, National University of Pharmacy

Postgraduate Student

Department of Biotechnology

Olha Kaliuzhnaia, National University of Pharmacy

PhD, Associate Professor

Department of Biotechnology

Oksana Strilets, National University of Pharmacy

Doctor of Pharmacy, Professor

Department of Biotechnology

Dmytro Lytkin, National University of Pharmacy

PhD, Vice-Director

Educational and Scientific Institute of Applied Pharmacy

Olga Goryacha, National University of Pharmacy

PhD, Assistant

Department of Pharmacognosy

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Published

2021-12-30

How to Cite

Soloviova, A., Kaliuzhnaia, O., Strilets, O., Lytkin, D., & Goryacha, O. (2021). The main stages of pharmaceutical development of emulgel “Probioskin”. ScienceRise: Pharmaceutical Science, (6 (34), 75–84. https://doi.org/10.15587/2519-4852.2021.249710

Issue

No. 6 (34) (2021)

Section

Pharmaceutical Science

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Copyright (c) 2021 Alina Soloviova, Olha Kaliuzhnaia, Oksana Strilets, Dmytro Lytkin, Olga Goryacha

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