Study of Acute Toxicity and Irritant Effect of Nasal Spray Naltrexone Hydrochloride

Introduction. Acute toxicity of naltrexone hydrochloride nasal spray during intragastric administration to mice and local irritant effect on rabbits was studied. At all stages of the experiment, observations were made on the General condition of the animals. The state of homeostasis was evaluated us...

Full description

Saved in:
Bibliographic Details
Main Authors: Yu. M. Domnina, V. V. Suslov, S. A. Kedik, D. A. Akhmedova, A. P. Malkova
Format: Article
Language:Russian
Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2021-05-01
Series:Разработка и регистрация лекарственных средств
Subjects:
Online Access:https://www.pharmjournal.ru/jour/article/view/856
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1839586719699042304
author Yu. M. Domnina
V. V. Suslov
S. A. Kedik
D. A. Akhmedova
A. P. Malkova
author_facet Yu. M. Domnina
V. V. Suslov
S. A. Kedik
D. A. Akhmedova
A. P. Malkova
author_sort Yu. M. Domnina
collection DOAJ
description Introduction. Acute toxicity of naltrexone hydrochloride nasal spray during intragastric administration to mice and local irritant effect on rabbits was studied. At all stages of the experiment, observations were made on the General condition of the animals. The state of homeostasis was evaluated using functional, hematological and morphometric methods. According to the results of research, there was no local irritant effect on the eyes of rabbits, as well as no toxic effect of high doses of the drug on animals. Introduction. Naltrexone hydrochloride in doses of 1.5– 5 mg/day has shown its effectiveness in the treatment of a number of diseases. Due to the lack of such a "low-dose" naltrexone registered on the pharmaceutical market, we have developed the composition of the nasal spray naltrexone hydrochloride. One of the stages of our research is to study the safety of the drug being developed. The first step in this direction was to study its acute toxicity and local irritant effect.Aim. Study of acute toxicity and local irritant effect of naltrexone hydrochloride nasal spray.Materials and methods. The object of the study was a nasal spray of naltrexone hydrochloride. Acute toxicity studies were performed on outbred adult mice (females). Study of local irritant effect on Soviet chinchilla rabbits (males).Results and discussion. The study of acute toxicity showed that the drug, at a dose significantly higher than the estimated maximum daily therapeutic dose for humans, did not have a significant toxic effect on the body of laboratory animals. The presence of a local irritant effect in the studied drug was not established in the framework of the experiment.Conclusion. As part of the experiment, the drug under study did not have a local irritant or toxic effect on the animal body. The results obtained allow us to continue the development and study of the nasal spray naltrexone hydrochloride.
format Article
id doaj-art-31c29ca9b9884b92b68422182cca8b38
institution Matheson Library
issn 2305-2066
2658-5049
language Russian
publishDate 2021-05-01
publisher LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
record_format Article
series Разработка и регистрация лекарственных средств
spelling doaj-art-31c29ca9b9884b92b68422182cca8b382025-08-03T19:23:56ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492021-05-0110210110510.33380/2305-2066-2021-10-2-101-105800Study of Acute Toxicity and Irritant Effect of Nasal Spray Naltrexone HydrochlorideYu. M. Domnina0V. V. Suslov1S. A. Kedik2D. A. Akhmedova3A. P. Malkova4Federal State Budget Educational Institution of Higher Education "MIREA – Russian Technological University"; JSC Institute of Pharmaceutical TechnologiesFederal State Budget Educational Institution of Higher Education "MIREA – Russian Technological University"; JSC Institute of Pharmaceutical TechnologiesFederal State Budget Educational Institution of Higher Education "MIREA – Russian Technological University"; JSC Institute of Pharmaceutical TechnologiesFederal State Budget Educational Institution of Higher Education "MIREA – Russian Technological University"; JSC Institute of Pharmaceutical TechnologiesANO "Institute for Biomedical Research and Technology" ("IMBIIT")Introduction. Acute toxicity of naltrexone hydrochloride nasal spray during intragastric administration to mice and local irritant effect on rabbits was studied. At all stages of the experiment, observations were made on the General condition of the animals. The state of homeostasis was evaluated using functional, hematological and morphometric methods. According to the results of research, there was no local irritant effect on the eyes of rabbits, as well as no toxic effect of high doses of the drug on animals. Introduction. Naltrexone hydrochloride in doses of 1.5– 5 mg/day has shown its effectiveness in the treatment of a number of diseases. Due to the lack of such a "low-dose" naltrexone registered on the pharmaceutical market, we have developed the composition of the nasal spray naltrexone hydrochloride. One of the stages of our research is to study the safety of the drug being developed. The first step in this direction was to study its acute toxicity and local irritant effect.Aim. Study of acute toxicity and local irritant effect of naltrexone hydrochloride nasal spray.Materials and methods. The object of the study was a nasal spray of naltrexone hydrochloride. Acute toxicity studies were performed on outbred adult mice (females). Study of local irritant effect on Soviet chinchilla rabbits (males).Results and discussion. The study of acute toxicity showed that the drug, at a dose significantly higher than the estimated maximum daily therapeutic dose for humans, did not have a significant toxic effect on the body of laboratory animals. The presence of a local irritant effect in the studied drug was not established in the framework of the experiment.Conclusion. As part of the experiment, the drug under study did not have a local irritant or toxic effect on the animal body. The results obtained allow us to continue the development and study of the nasal spray naltrexone hydrochloride.https://www.pharmjournal.ru/jour/article/view/856naltrexone hydrochloridenasal sprayacute toxicitylaboratory animals
spellingShingle Yu. M. Domnina
V. V. Suslov
S. A. Kedik
D. A. Akhmedova
A. P. Malkova
Study of Acute Toxicity and Irritant Effect of Nasal Spray Naltrexone Hydrochloride
Разработка и регистрация лекарственных средств
naltrexone hydrochloride
nasal spray
acute toxicity
laboratory animals
title Study of Acute Toxicity and Irritant Effect of Nasal Spray Naltrexone Hydrochloride
title_full Study of Acute Toxicity and Irritant Effect of Nasal Spray Naltrexone Hydrochloride
title_fullStr Study of Acute Toxicity and Irritant Effect of Nasal Spray Naltrexone Hydrochloride
title_full_unstemmed Study of Acute Toxicity and Irritant Effect of Nasal Spray Naltrexone Hydrochloride
title_short Study of Acute Toxicity and Irritant Effect of Nasal Spray Naltrexone Hydrochloride
title_sort study of acute toxicity and irritant effect of nasal spray naltrexone hydrochloride
topic naltrexone hydrochloride
nasal spray
acute toxicity
laboratory animals
url https://www.pharmjournal.ru/jour/article/view/856
work_keys_str_mv AT yumdomnina studyofacutetoxicityandirritanteffectofnasalspraynaltrexonehydrochloride
AT vvsuslov studyofacutetoxicityandirritanteffectofnasalspraynaltrexonehydrochloride
AT sakedik studyofacutetoxicityandirritanteffectofnasalspraynaltrexonehydrochloride
AT daakhmedova studyofacutetoxicityandirritanteffectofnasalspraynaltrexonehydrochloride
AT apmalkova studyofacutetoxicityandirritanteffectofnasalspraynaltrexonehydrochloride