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