Development and pharmaceutical performance of a novel co-processed excipient of alginic acid and microcrystalline cellulose

Abstract

In this study, a co-processed excipient (Cop AA-MCC) was prepared from alginic acid (AA) and microcrystalline cellulose (MCC101) using a laboratory scale high-shear granulator. The obtained granules were compared to the primary materials (AA, MCC101), to the dry mixture and to wet granulated MCC. The effect of the two components ratio, the amount of added water or binder during granulation and the particle size, on the properties of the prepared co-processed excipient, was investigated. Results showed that optimal granule and tablet properties were obtained using a ratio of 10% of alginic acid, 90% of MCC101 and 70% of water. Moreover, the co-processed product has shown good tabletability, enhanced powder flowability and a considerable faster disintegration time in comparison to the primary materials and to a commercial co-processed excipient (Prosolv® ODT). Finally, the designed product was found to offer effective functionalities, which supports its exploitation as a valuable industrial pharmaceutical excipient.