Directly Compressible High Functionality Granular Microcrystalline Cellulose Based Excipient Manufacturing Process and Use Thereof

摘要

There is provided an improved excipient comprising substantially homogeneous particles of a microcrystalline cellulose-based excipient of compressible high-performance granules. The improved excipient comprises microcrystalline cellulose, a binder and a disintegrant and is formed by spraying a homogeneous slurry of the ingredients. The excipients provide improved flow / good flow characteristics, superior / high compressibility, and increased API usage and blendability over conventional excipients formed from the same and compared to the individual ingredients. The improved excipients have strong intragranular bonding bridges between the components, thus leading to distinctive structural forms, including meaningful open structures or hollowwork. The presence of the pores provides surface roughness that is an ideal environment for improved blending with the API.