NEW CO-PROCESSED EXCIPIENTS WITH MICROCRYSTALLINE CELLULOSE AND ISOMALT BY FLUID BED. AN OPTION FOR DIRECT COMPRESSION EXCIPIENTSAbstract
Objective: To elaborate and characterize new co-processed excipients for direct compression use. Methods: The new co-processed excipients were obtained with different proportions of microcrystalline cellulose (Avicel® PH101) and Isomalt (galenIQ® 800), using Starch® 1500 and Plasdone® K-25as binding agents in a fluid bed. Rheological characterization was performed; to determine their deformation pressure (Py), the Heckel model was applied. Tablets were elaborated with each polymer and each co-processed compound at different compaction pressures, and the behavior of the tensile strength curves was analyzed. Results: The range of particle size of the obtained co-processed compounds was 95.5 to 151µm. The flow velocity of the co-processed excipient elaborated with Avicel® PH101/galenIQ® 800 improved as compared to the velocity presented by the individual raw matters. Conclusions: The Avicel® PH101/galenIQ® 800 co-processed excipients elaborated at 60/40% and 70/30% proportions can be recommended to be used as direct compressible excipients because these proportions presented the best characteristics regarding flowability, less deformation pressure (Py) and a higher slope in the tensile strength graphs.
A. V. Vélez Godínez, E. Hernández Baltazar, E. Amador González and L.M. Melgoza Contreras *
Maestría en Ciencias Farmacéuticas and Departamento de Sistemas Biológicos, Universidad Autónoma Metropolitana-Xochimilco, Ciudad de México, México.
08 December 2020
24 March 2021
25 May 2021
01 November 2021