SELECTION OF A FILLER FOR TABLETS MANUFACTURED WITH DIRECT COMPRESSION METHOD CONTAINING DRY GINGER EXTRACT

Abstract

The preliminary studies of physico-chemical and pharmaco-technological properties of the dry extract of ginger have determined the need for introduction of different groups of excipients for developing a solid dosage form for the treatment of type II diabetes mellitus. Aim. To choose the rational filler in the composition of tablets with ginger obtained by direct compression. Materials and methods. The study object was the dry extract of ginger (DEG) (producer “Megaprom”, Dnepr,Ukraine) and modern excipients for the production of tablets by direct compression: GalenIQ 721 (BENEO-Palatinit Gmb), Flowlac 100 (Meggle Co.), Tablettose 80 (Meggle Co.), Farmaxx (Merck), Microcelac 100 (Meggle Co.), Vivapur 112 and 102 (JRS Pharm), Prosolv HD 90, Prosolv SMCC 50 (JRS Pharm) manufactured in Germany. Pharmaco-technological and physico-chemical properties of the samples were studied according to conventional methods of the State Pharmacopoeia of Ukraine. Results and discussion. According to the results of the crystallographic analysis, the ability to the moisture absorption, resistance to crushing, disintegration time, fluidity indicators, angle of repose and bulk volume the effect of modern excipients on physicochemical and pharmaco-technological properties of the dry extract of ginger has been studied. Conclusions. According to the results of microscopic analysis, it has been found, that the rational fillers are GalenIQ 721, Prosolv HD 90, Prosolv SMCC 50, Vivapur 102 and Vivapur 112, as they provide a uniform system and the necessary resistance to destruction. The study of the kinetics of the moisture absorption has shown that addition of the fillers significantly reduces the increase in moisture compared to the dry extract. The mixture with GalenIQ 721 has the lowest parameters of moisture absorption at a relative air humidity of 45 %, 75 % and 100 %. In accordance with the results of the pharmaco-technological studies, it has been found that addition of GalenIQ 721 leads to improved flowability, disintegration, settling qualities; it indicates the feasibility of its inclusion into the composition of the solid dosage form.