Recommended and maximum allowable volumes for rectal and intravaginal administration of drugs of different animal species

Original article
УДК 615.076.9
DOI: 10.57034/2618723X-2023-01-04

A.V. Chernyshova*,
senior assistant of department of specific toxicology and pharmacodynamics,
https://orcid.org/0000-0003-4306-8059
E.A. Roshchina,
researcher of department of specific toxicology and pharmacodynamics,
https://orcid.org/0000-0002-9257-4241
L.I. Alekseeva,
junior researcher of toxicology group,
https://orcid.org/0000-0002-6510-9897
A.E. Katelnikova,
Candidate of Medical Sciences, head of department of specific toxicology and pharmacodynamics,
https://orcid.org/0000-0003-3203-9869
M.N. Makarova,
Doctor of Medical Sciences, director,
https://orcid.org/0000-0003-3176-6386

Research and manufacturing company “Home оf Pharmacy”,
188663, Russia, Leningrad oblast, Vsevolozhskiy district, Kuzmolovskiy t.s., Zavodskaya st. 3–245.

* Е-mail: [email protected]

Keywords: rectal administration intravaginal administration preclinical studies volume of administration
Acknowledgements

The study was performed without external funding.

For citation:

Chernyshova A.V., Roshchina E.A. , Alekseeva L.I., Katelnikova A.E., Makarova M.N. Recommended and maximum allowable volumes for rectal and intravaginal administration of drugs of different animal species. Laboratory Animals for Science. 2023; 1. https://doi.org/10.57034/2618723X-2023-01-04

Abstract

Rectal and intravaginal routes of administration are often used in clinical practice, in some cases they may be more preferable for certain groups of patients: in pediatric practice, the rectal route of administration is used, for antimicrobials for the treatment of diseases of the pelvic organs in women, the intravaginal route is used. Preclinical studies on animals are required for registration of medicines. Before the implementation of research work, the work of the bioethical commission is carried out, this in the course of its activities conducts a projects’ examination of these studies. The key stage of the discussion of the commission is the consideration of the project for compliance with the principles of “3Rs” (principles of humane experimental methodology). To date there are no uniform requirements, regional and international standards that would contain recommendations on the permissible volumes of administration by rectal and intravaginal routes to laboratory animals. The volumes calculated in this study will help to reduce the number of animals in the experiment, as well as minimize pain and distress. The aim of this study was to determine the recommended and maximum volumes for rectal and intravaginal routes of administration for animals of the following species: Syrian hamster, guinea pig, Wistar rat, ICR-CD1 mouse, gerbil, rabbit (Soviet chinchilla), ferret, cat (Russian blue), dog (beagle), pygmy pig, marmoset (Callithrix jacchus) and cynomolgus monkey (Macaca fascicularis). Commercially available suppositories for rectal and vaginal administration were used as test objects. Depending on the type of animal, suppositories were administered in the finished dosage form or in the form of a melt. The introduction was performed while fixing the animals, sedation was not used. The criteria for classifying the selected volumes as acceptable or maximum were indicators of clinical observation of animals, assessed in points. As a result of the work carried out, recommended (not causing concern or pain) and maximum allowable (causing some concern or short-term mild pain) volumes for rectal and vaginal administration were established.

Conflict of interest

M.N. Makarova is a member of the editorial board of Laboratory animals for science. The other authors declare no conflict of interest requiring disclosure in this article.

Authors contribution

A.V. Chernyshova — analysis of scientific and methodological literature, collection and analysis of data, statistical processing of data, writing, editing and finalizing the text of the manuscript, responsibility for all aspects of the work related to the reliability of the data.
Е.А. Roshchina — analysis of scientific and methodological literature, collection and analysis of data, work with literary sources, writing the text of the article.
L.I. Alekseeva — collection and analysis of data.
A.Е. Katelnikova — a nalysis of scientific and methodological literature, manuscript editing.
M.N. Makarova — research idea, manuscript editing, the final version of manuscript approval.

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Received: 2023-12-23
Reviewed: 2023-01-10
Accepted for publication: 2023-01-30

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