Capecitabine pediatric tablets

Details Capecitabine pediatric tablets Capecitabine pediatric tablets

A - Human Necessities

61

K

A61K 9/00 (2006.01) A61K 9/28 (2006.01)

Patent

CA 2664922

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.

L'invention concerne une composition pharmaceutique pelliculée comprenant de la 5'-désoxy-5-fluoro-N-[(pentyloxy)carbonyl]cytidine (capécitabine) et au moins un délitant sélectionné dans le groupe constitué de la crospovidone (taille des particules <15-400 µm), de la croscarmellose sodique, du glycolate d'amidon sodique, de l'hydroxypropylcellulose faiblement substituée, du Pharmaburst C ou de n'importe quelle association de ceux-ci, ainsi que d'autres excipients acceptables du point de vue pharmaceutique pour former un comprimé se délitant rapidement. Ce comprimé se délite dans de l'eau à 37°C dans un appareil de délitement selon la pharmacopée USP en moins de 2 minutes, de préférence en moins de 1 minute, et a une dureté de 8-13 unités de Strong-Cobb.

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