The substantiation for the choice of excipients in the composition of “Viburnicor” tablets and the technology of their production
DOI:
https://doi.org/10.24959/nphj.24.129Keywords:
Key words: excipients; technology; tablets; Viburnum opulus fruit liquid extract (VOFLE); pharmacological and technological properties.Abstract
Aim. To substantiate the choice of excipients in order to manufacture tablets with cardioprotective and membrane-stabilizing effects based on the Viburnum opulus fruit liquid extract (VOFLE).
Materials and methods. The study subject is a liquid extract developed on the basis of Viburnum opulus L. and its excipients approved for medical use. Organoleptic, physicochemical and pharmacotechnological research methods were used in the study. Statistical processing of the data obtained was carried out according to generally accepted statistical methods using Excel (MS Office 2019) and Statistica 8.0 (StatSoftInc., USA). The data obtained were analyzed using the methods of variation statistics. The acceptable significance level was p < 0.05.
Results and discussion. According to the results of the tests conducted, the pharmacotechnological properties of 8 test samples of masses for tablets with VOFLE were studied, their indicators for disintegration, fluidity and pressability were determined; based on them, the rational composition of tablets under the conditional name “Viburnicor” was substantiated. Drafts of technological regulations were developed, considering the technological equipment of the production site of the workshop in the conditions of the Pharmaceutical Company “Zdorovye” LLC (Kharkiv). The results of the experimental studies were used to develop a flowchart of the technological process for manufacturing the cardioprotective and membrane-stabilizing tablets based on the plant substance VOFLE and a hardware scheme tested in industrial conditions at Pharmaceutical Company “Zdorovye” LLC (Kharkiv), as well as to establish controlled technological parameters for each stage of the technological process of manufacturing the medicine developed in the form of tablets.
Conclusions. As a result of the pharmacotechnological and physicochemical studies conducted to substantiate the choice of excipients for cardioprotective and membrane-stabilizing tablets based on the Viburnum opulus fruit liquid extract, the rational composition and optimal technology for manufacturing the herbal medicine developed in industrial conditions of domestic drug production have been proposed.
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