Experimental justification of the choice of suppository base for extemporaneous pessaries for childbirth preparation

Keywords: Extemporaneous pessaries; suppository base; melting temperature; complete deformation time, disintegration time, microbiological purity

Abstract

The purpose of the work was to conduct physicochemical and pharmaco-technological studies on the choice of a rational suppository base during creation of extemporaneous pessaries (vaginal suppositories) with hyaluronic acid and CO2-extracts of aloe, calendula and green tea, designed to prepare the birth canal and reduce the risk of soft tissue ruptures during childbirth.

Materials and methods. The object of the study was pessary samples prepared by casting method using as active pharmaceutical ingredients: hyaluronic acid, CO2-extracts of aloe, calendula and green tea. Samples of pessaries were prepared by using as suppository bases: Witepsol H-15, cocoa butter, solid confectionery fat and cocoa butter in an alloy with emulsion wax in a ratio of 95:5. During the studies, homogeneity, average weight, pH, melting point, time of complete deformation, disintegration time and microbiological purity of pessaries were determined according to SPhU methods. Biopharmaceutical studies were performed using the conventional “agar plate” method.

Results. Based on physicochemical and pharmaco-technological studies, cocoa butter: emulsion wax (95:5) was chosen as a rational suppository base. The main indicators of the quality of samples of pessaries (vaginal suppositories) were studied: organoleptic characteristics (color, surface, odor, consistency), average weight, melting point, time of complete deformation, disintegration time, pH, which meet the requirements of the SPhU. As a result of determining the microbiological purity, it was established that the total number of viable microorganisms (TAMC) does not exceed 102 CFU/ml, the total number of yeasts and molds (TYMC) does not exceed 101. The test results obtained comply with the requirements of the State Pharmacopoeia of Ukraine for pessaries in terms of the indicator “Microbiological purity". Biopharmaceutical studies have shown that the greatest release of active substances occurs from pessaries prepared on cocoa butter: emulsion wax (95:5) compared to samples prepared on the basis of Witepsol H-15.

Conclusions. Physicochemical and pharmaco-technological studies have been carried out on the choice of a suppository base during creation of extemporaneous pessaries (vaginal suppositories) with hyaluronic acid and CO2-extracts of aloe, calendula and green tea. Cocoa butter: emulsion wax (95:5) selected as a rational base. Physicochemical and pharmaco-technological indicators of pessaries were studied: homogeneity, melting point, time of complete deformation, disintegration time, pH, average weight, corresponding to the requirements of SPhU 2.0 article “Suppositories and pessaries prepared in a pharmacy”.

Author Biographies

G. M. Melnyk, National University of Pharmacy

PhD (Pharmacy), postdoctoral student of the Technology of Drugs Department, National University of Pharmacy, Kharkiv, Ukraine. e-mail: tl@nuph.edu.ua

T. G. Yarnykh, National University of Pharmacy

DSc (Pharmacy), Professor, head of the Technology of Drugs Department, National University of Pharmacy, Kharkiv, Ukraine

I. V. Herasymova, National University of Pharmacy

PhD (Pharmacy), Ass. Prof. of the Technology of Drugs Department, National University of Pharmacy, Kharkiv, Ukraine. e-mail: iryna_herasymova@ukr.net

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Published
2021-07-01
How to Cite
Melnyk, G. M., Yarnykh, T. G., & Herasymova, I. V. (2021). Experimental justification of the choice of suppository base for extemporaneous pessaries for childbirth preparation. Ukrainian Journal of Military Medicine, 2(2), 70-81. https://doi.org/10.46847/ujmm.2021.2(2)-070