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MODIFIED DOSAGE FORMS OF TACROLIMUS
专利权人:
PANACEA BIOTEC LIMITED
发明人:
AMARJIT SINGH,SARABJIT SINGH,SHIVANAND PUTHLI,RAJESH JAIN
申请号:
BRPI0809563
公开号:
BRPI0809563A2
申请日:
2008.03.25
申请国别(地区):
BR
年份:
2014
代理人:
摘要:
The present invention provides a modified release dosage form of tacrolimus that releases two or more amount of tacrolimus upon oral administration, the first amount of tacrolimus releases from the immediate release dosage unit substantially immediately within 0-2 hours followed by a time interval ranging from about 1-10 hours during which substantially no amount of tacrolimus is released from the dosage form, after which a second amount of tacrolimus is released wherein said second amount is released from the delayed release dosage unit either immediately e.g. within 0-2 hours or over a period of time ranging from about 2-12 hours from its initial release from the delayed release dosage unit. The dosage form may further comprise additional amount of tacrolimus to provide additional pulse of tacrolimus. The dosage forms of tacrolimus exhibit improved bioavailability and reduced flux or fluctuation over existing composition of tacrolimus. A method of preparing the dosage forms is also described.
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