[Tableting technology of a dry extract from Solidago virgaurea L. with the use of silicified microcrystalline cellulose (Prosolv) and other selected auxiliary substances].
Direct tableting is simpler and more cost-effective from the point of view of good manufacturing practice (GMP) than wet granulation or dry compacting. Moreover, the use of dry plant extracts in the process of direct tableting, omitting granulation, decreases the possibility of biological activity loss of active substances. Thus, pharmaceutical industry uses this particular process more and more frequently. Only few therapeutic substances form under compression tablets meeting current requirements. Very often addition of auxiliary substances appears to be indispensable. The aim of this study was to obtain uncoated tablets by the method of direct tableting with the use of selected auxiliary substances. Dry extract from Solidago virgaurea L. was the study material. Shrimp chitosan, silicified microcrystalline cellulose (Prosolv), polyvinylpyrrolidone, calcium carbonate and sodium stearyl fumarate were used as auxiliary substances. Eleven tablet batches were manufactured in a reciprocating instrumented tableting machine (Ewreka). The produced tablets were subjected to morphological tests comprising the tablet size, determination of batching accuracy (determination of mass uniformity of individual tablets), test of mechanical resistance (crushing strength), determination of disintegration time. The statistical hardness of the manufactured tablets was also estimated. Pharmaceutical availability tests were performed of the biologically active substances released from tablets to the acceptor fluid. The study was based on general and detailed regulations of Polish Pharmacopoeia VII (PP VII). The obtained results allow to conclude that the applied auxiliary substances appeared to be useful in adequate proportions in manufacturing tablets containing dry extract from Solidago virgaurea L. The properties of the obtained batches of tablets were in majority consistent with the current requirements. The applied method provides technological reproducibility and high durability of the drug. These tablets as compared to available herbal mixtures and aqueous extracts can be a more comfortable form of a drug.
Marczyiński
Zbigniew
Z
Zakad Farmacji Aptecznej, Katedra Farmacji Stosowanej, Uniwersytet Medyczny w Łodzi. zbigniew.marczynski@umed.lodz.pl
D001682:Biological Availability; D002119:Calcium Carbonate / Q000737:chemistry; D002482:Cellulose / Q000737:chemistry* / Q000493:pharmacokinetics; D048271:Chitosan / Q000737:chemistry; D004339:Drug Compounding / Q000379:methods; D005079:Excipients / Q000737:chemistry*; D005650:Fumarates / Q000737:chemistry; D008962:Models, Theoretical; D010936:Plant Extracts / Q000737:chemistry* / Q000493:pharmacokinetics; D036624:Solidago / Q000737:chemistry*; D013607:Tablets / Q000737:chemistry* / Q000493:pharmacokinetics; D013678:Technology, Pharmaceutical
D005079:Excipients; D005650:Fumarates; D010936:Plant Extracts; D013607:Tablets; C519579:sodium stearyl fumarate; D002482:Cellulose; D048271:Chitosan; D002119:Calcium Carbonate; C109691:microcrystalline cellulose