CAPECITABINE PEDIATRIC TABLETS

摘要

A film coated pharmaceutical composition of capecitabine that comprises microcrystalline cellulose, a directly compressible polyhydric alcohol and a disintegrant selected from crospovidone and a mannitol/sorbitol combination. The crospovidone has a particle size in the range of 90% less than 15 microns to 90% less than 400 microns. The alcohol can be mannitol. The pharmaceutical composition disintegrates in water at 37 degrees Celsius in a USP Disintegration Apparatus in less than 2 minutes and has a hardness of 8-13 strong Cobb-Units.