Development of the Optimal Composition of a Complex of Excipients for Producing Orally Dispersible Tablets by Direct Compression
摘要
The influence of the composition of excipients on the characteristics of orally dispersible tablets manufactured by direct compression was studied. The bulk properties of tableting mixtures and the strength and disintegration indices of the obtained tablets were selected as the main quality assessment criteria. The optimal composition of the complex of excipients was determined as dextrose monohydrate (59%), starch (20%), microcrystalline cellulose (20%), and aerosil (1%). The experimentally determined characteristics for placebo tablets obtained from this composition were tablet strength 79.4 ± 12.25 N and disintegration time 21.7 sec. This tableting mixture also had satisfactory slope angles and average Carr and Hausner indices. The flowability of 100 g of the mixture was 13.98 sec. The developed composition can be used as a ready-made complex in the industrial production of orally dispersible tablets.