The pharmacological safety of a combined pharmaceutical composition for the correction of placental dysfunction in pregnant women

Authors

DOI:

https://doi.org/10.24959/ubphj.20.290

Keywords:

pharmaceutical safety, pharmaceutical composition, nonfetotoxic active ingredient, placental dysfunction

Abstract

Topicality. Along with the pronounced pharmacological effectiveness, high requirements for the safety are applied to new medicines. To obtain the necessary information regarding the safety of a potential drug and predict the risk of further side effects, a preclinical study of possible toxic effects, primarily acute toxicity, is performed.

Aim. To study the acute toxicity of a new pharmaceutical composition for the correction of placental dysfunction in pregnant women.

Materials and methods. The study object was the pharmaceutical composition in the form of solid gelatinous capsules containing active pharmaceutical ingredients from basic therapeutic group of drugs used for fetoplacental dysfunction in pregnant women. The acute toxicity was determined according to the methodological guidelines “Preclinical studies of drugs” edited by A. Stefanov, in outbreed female rats weighing 200-250 g in compliance with the “European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes” (Strasburg, 1985).

Results and discussion. The study of the pharmaceutical safety has been performed by the acute toxicity criterion under the condition of short-term influence of a new pharmaceutical composition combining the required pharmaceutical ingredients in well-balanced doses affecting different chains of pathogenesis of placental dysfunction. Under the condition of the acute experiment a new combined composition (intraperitoneal introduction in the dose of 5000 mg/kg of the body weight) does not cause changes in the rat’s organism. It has been determined that this pharmaceutical composition belongs to practically nontoxic substances – Toxicity Class V according to the generally accepted classification system.

Conclusions. The data for the preclinical safety assessment of a new combined composition for the correction of placental dysfunction in pregnant women have been obtained.

Author Biographies

N. Seliukova, National University of Pharmacy of the Ministry of Health of Ukraine. State Institution “V. Danilevsky Institute for Endocrine Pathology Problems of the Academy of Medical Sciences of Ukraine”

Сandidate of Biology (Ph.D), teaching assistant of the Department of Veterinary Medicine and Pharmacy, National University of Pharmacy of the Ministry of Health of Ukraine. Senior researcher of the Department of Scientific Information and Patent and Licensing Work, State Institution “V. Danilevsky Institute for Endocrine Pathology Problems of the Academy of Medical Sciences of Ukraine”

S. Kustova, State Institution “V. Danilevsky Institute for Endocrine Pathology Problems of the Academy of Medical Sciences of Ukraine”

Саndidate of Pharmacy (Ph.D), senior researcher, head of the Pharmaceutical Technology Division of the Laboratory for Analytical and Physicochemical Research

M. Kudrya, State Institution “V. Danilevsky Institute for Endocrine Pathology Problems of the Academy of Medical Sciences of Ukraine”

Candidate of Biology (Ph.D), senior researcher, head of the Laboratory Toxicology and Hygienic Regulation of Medicines

N. Ustenko, State Institution “V. Danilevsky Institute for Endocrine Pathology Problems of the Academy of Medical Sciences of Ukraine”

researcher, of the Laboratory Toxicology and Hygienic Regulation of Medicines

M. Boiko, State Institution “V. Danilevsky Institute for Endocrine Pathology Problems of the Academy of Medical Sciences of Ukraine”

Candidate of Pharmacy (Ph.D), senior researcher of the harmaceutical Technology Division of the Laboratory for Analytical and Physicochemical Research

T. Matveeva, State Institution “V. Danilevsky Institute for Endocrine Pathology Problems of the Academy of Medical Sciences of Ukraine”

junior researcher of the Pharmaceutical Technology Division of the Laboratory for Analytical and Physicochemical Research

References

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Stasenko, T. (2016). Ukr. med. chasopys, 3 (113), 77–79. Available at: https://www.umj.com.ua/article/96925/zdorov-ya-ditej-zavdannya-vsiyei-medichnoi-spilnoti.

Kustova, S. P. et al. (2020). Pat. № 143079 (UA). MPK (2020.01) A61K 31/44, A61K 9/48, A61R 15/08. Biul., 13, 4.

Stefanov, O. V. (2001). Doklinichni doslidzhennia likarskykh zasobiv. Kyiv: Avitsenna, 528.

Yevropeiska konventsiia pro zakhyst khrebetnykh tvaryn, yaki vykorystovuiutsia dlia doslidnykh ta inshykh naukovykh tsilei: vid 18.03.1986 r. Available at: https://zakon.rada.gov.ua/laws/show/994_137.

Published

2020-12-07

Issue

Section

Pharmacology and biochemistry