摘要 |
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 µ), 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 37°C in a USP Disintegration Apparatus in less than 2 minutes, preferably 1 minute and have a hardness of 8-13 strong Cobb-Units. |
申请人 |
F. HOFFMANN-LA ROCHE AG;BACHYNSKY, MARIA OKSANA;INFELD, MARTIN HOWARD;RASHED, MOHAMMAD;SHAH, NAVNIT HARGOVINDAS |
发明人 |
BACHYNSKY, MARIA OKSANA;INFELD, MARTIN HOWARD;RASHED, MOHAMMAD;SHAH, NAVNIT HARGOVINDAS |