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QUICKLY SOLUBLE FILM PREPARATIONS
专利权人:
发明人:
申请号:
EP03723367.3
公开号:
EP1504765B1
申请日:
2003.05.14
申请国别(地区):
EP
年份:
2015
代理人:
摘要:
A rapidly soluble film-shaped preparation containing a drug and an edible polymer, wherein the breaking strength of a film thereof is from 200 to 3, 000 g/φ7 mm, the tensile strength of the film is from 200 to 3, 000 g/15 mm, the water disintegration time Y [sec] is within 300 seconds (Y≤300), and when the reciprocal [mg/mm2] of the specific surface area [mm2/mg] of the film is taken as X (X≥0), the relationship of water disintegration time Y [sec]≥7500X2 is satisfied, and the rapidly soluble film-shaped preparation comprising one drug-containing layer, or having a support layer on one side or both sides of the drug-containing layer, wherein the edible polymer is hydroxypropyl cellulose and/or hydroxypropylmethyl cellulose, the compounding ratio of the drug is from 0.01 to 40% by weight based on the whole preparation, and that of the edible polymer is from 40 to 99.99% by weight based on the whole preparation.
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