abstract |
THERE IS PROVIDED A FILM COATED PHARMACEUTICAL COMPOSITION COMPRISING 5'-DEOXY-5-FLUORO-N- [(PENTYLOXY)-CARBONYL]-CYTIDINE (CAPECITABINE) AND AT LEAST ONE DISINTEGRANT SELECTED FROM THE GROUP COMPRISING OF CROSPOVIDONE (PARTICLE SIZE <15-400 ?), CROSCARMELLOSE SODIUM, SODIUM STARCH GLYCOLATE, LOW- SUBSTITUTED HYDROXYPROPYLCELLULOSE, PHARMABURST C OR ANY COMBINATION OF THESE, TOGETHER WITH OTHER PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS TO FORM A RAPIDLY DISINTEGRATING TABLET. THIS TABLET DISINTEGRATES IN WATER AT 37OC IN A USP DISINTEGRATION APPARATUS IN LESS THAN 2 MINUTES, PREFERABLY 1 MINUTE AND HAVE A HARDNESS OF 8-13 STRONG COBB-UNITS. |