STUDY OF THE INFLUENCE OF EXCIPIENTS ON THE PHARMACO-TECHNOLOGICAL PROPERTIES OF THE COMPRESSION MIXTURE AND SOME QUALITY ATTRIBUTES OF TABLETS BASED ON MALVA SYLVESTRIS L. EXTRACT
DOI:
https://doi.org/10.11603/2312-0967.2023.2.13869Keywords:
pharmaceutical factors, Malva sylvestris L. extract, tablets, excipients, pharmaco-technological properties, compression mixture, quality attributesAbstract
The aim of the work. Study of the excipients influence on the pharmaco-technological properties of the compression mixture, and the quality attributes of the tablets based on the Malva sylvestris L. extract.
Materials and Methods. The main active substance is soft extracts of Malva sylvestris L. flowers; 16 excipients combined into 4 groups of pharmaceutical factors were used for the research. Excipients were kindly provided by Witec Industrial company.
The method of mathematical planning of the experiment have been used to study excipients influence on the pharmaco-technological properties of the compression mixture, and the quality attributes of the tablets based on the Malva sylvestris L. extract. The tablets were obtained by the method of direct compression. Investigation of the properties of the compression mixture and the quality attributes of the tablets were carried out in accordance with the requirements of the State Pharmacopoeia of Ukraine. The appearance and stability of the tablets on the moisture were studied too.
Results and Discussion. The article is devoted to the study of the influence of the excipients on the pharmaco-technological properties of the compression mixture, and quality attributes of the tablets based on the Malva sylvestris L. extract.
The influence of 16 excipients on the apparent volume, ability to settle, flow rate through an orifice, Hausner ratio and particle size distribution of the compression mixture, and tablets friability, resistance for crushing, disintegration, appearance and stability of tablets on moisture have been investigated.
Conclusions. The influence of excipients on the pharmaco-technological properties of the compression mixture and some quality attributes of the tablets based on the extract of Malva sylvestris L. have been studied. The ranging rows of the advantages for excipients influence on the 10 indicators in total were constructed. Based on the obtained results, it was concluded that such a composition of the excipients as GalenIQ™810, a mixture of F-melt® Type C with lactose, microcrystalline cellulose MCC 200 and Neusilin UFL-2® had the most positive effect on the pharmaco-technological properties of the compression mixture, and quality attributes of the tablets based on the Malva sylvestris L. extract.
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