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Copyright @ Pol J Cosmetol
Pol J Cosmetol 2023, 26(2): 98-108pl  Pharmaceutical availability from a model tablet of phytochemicals contained in linden flower extractMarian M. Zgoda 1/, Zbigniew Marczyński 2/, Andrzej Stańczak 2/, Agnieszka Skowron 1/, Mirosława Świątek 3/, Joanna Gądek-Sobczyńska 3/, Jerzy Jambor 4/, Elżbieta Nowak 4/, Sławomira Nowak 5/ 1/ Wyższa Szkoła Kosmetyki i Nauk o Zdrowiu w Łodzi 2/ Zakład Farmacji Aptecznej, Katedra Farmacji Stosowanej Uniwersytetu Medycznego w Łodzi 3/ Katedra Chemii Bioorganicznej i Biokoordynacyjnej Uniwersytetu Medycznego w Łodzi 4/ Europlant Group Phytopharm Klęka S.A., Klęka 1, 63-040 Nowe Miasto n.Wartą 5/ Katedra Zakład Farmakognozji Uniwersytetu Medycznego w Łodzi Summary Introduction. The published results of research on the physicochemical properties of phytochemicals contained in the dry standardized extract of linden inflorescence (Tiliae flos ext.) were an inspiration to conduct comparative pre-formulation studies on the development of an innovative oral solid drug form with the expected pharmacotherapeutic effectiveness. Aim. The aim of the conducted research was to manufacture a model solid drug form with a fast disintegration time and high pharmaceutical availability using the direct tableting technique with the participation of modified microcrystalline cellulose of the following types: Vivapur 105, Vivapur 112, Vivapur 200, Prosolv SMCC50 and Prosolv Easy tab.SP. Material and methods. The methods applied in the industrial technology of the solid drug form (tablet) were used to produce a homogeneous granulometric tablet mass (granulate) formulated with the appropriate amount of dry linden inflorescence extract, a single excipient and a lubricant. Pharmacopoeial methods were used to determine the morphological and pharmacokinetic parameters of the manufactured model drug form. Results. An oral solid drug form (tablet) containing a statistical amount of a dry standard extract from linden inflorescence and granulometrically and chemically modified microcrystalline cellulose was designed and manufactured in industrial conditions using the direct tableting technique. Mathematical models allowed to estimate the correlation between pharmaceutical availability and exposure time in model acceptor fluids. Conclusions. The manufactured model of an oral solid drug form with the declared content of dry standard extract from linden inflorescence meets the pharmacopoeial requirements and the mathematical models used to assess the pharmaceutical availability in model (pharmacopoeial) acceptor fluids enabled the optimal selection of excipients for the direct tableting technique. Key words: Tiliae flos extract, pharmaceutical availability, mathematical models, Vivapur-type microcrystalline cellulose, Prosolv, fast disintegrating tablet |