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Selected excipients and surfactants in oral solid dosage form with extract of Phaseoli pericarpium (Phaseolus vulgaris L.)

Author:
Marczyński, Zbigniew, Kowalczykiewicz, Katarzyna, Bodek, Kazimiera Henryka
Source:
Herba Polonica 2016 v.61 no.4 pp. 78-92
ISSN:
0018-0599
Subject:
Phaseolus vulgaris, active ingredients, annuals, beans, calcium, cholesterol, color, drug formulations, edema, excretion, gastric juice, kidney diseases, manufacturing, mechanical damage, pericarp, pods, raw materials, surfactants, Poland
Abstract:
Introduction: The common bean (Phaseolus vulgaris L.) is an annual plant grown in many countries all over the world including its different varieties in Poland. Herbal raw material are elongated pods – pericarp. Phaseoli pericarpium decreases the glucose blood level. Phaseoli pericarpium extracts manifest duretic properties, can be used in the treatment of edema, kidney diseases with decreased urinary excretion, nephrolithiasis.Objectives: To investigate the usefullness of selected excipients as carriers of dry extract from Phaseolus vulgaris pericarp.Methods: The method of direct tableting was used. In the further stage, the obtained tablets were subjected to appropriate tests. The first stage of the study evaluates Prosolv SMCC 50, PROSOLV EASYtab, EMDEX, Carmellose calcium and PRUV. These were used to manufacture 4 batches of tablets. In the second stage, an oral solid dosage was manufactured on the basis of the formulation composition of batch 1 tablets (Phaseoli pericarpium extract, Prosolv SMCC 50, PRUV). Then, different surfactants (cholesterol oxyethylate nTE = 30, cholesterol oxyethylate nTE = 40, Rofam nTE = 50), were successively added to this formulation, to obtain 3 batches of tablets. All 7 batches were manufactured in the Erweka tableting machine. Then, they were subjected to morphological tests and physicochemical evaluation. The release of active substances to 3 selected acceptor fluids (water, artificial gastric juice, artificial intestinal juice) was measured in accordance with the requirements of the general and specific monographs in European Pharmacopoeia 7.Results: The manufactured tablets had a smooth uniform surface with no stains, spalls or mechanical damage and yellow color originating from the extract. The obtained tablets, with surfactants in their composition, demonstrated pharmaceutical availability slightly higher than batch 1 tablets without surfactants.Conclusions: Excipients applied in appropriate proportions appear to be useful in the manufacturing of uncoated tablets containing extract of Phaseoli pericarpium.
Agid:
5200796