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FILM DOSAGE FORMS CONTAINING AMORPHOUS ACTIVE AGENTS
专利权人:
发明人:
Nadine Paiement,Rodolphe Obeid,Billal Tir
申请号:
US14630699
公开号:
US20160243036A1
申请日:
2015.02.25
申请国别(地区):
US
年份:
2016
代理人:
摘要:
Oral thin film dosage form of a stable dispersion of non-solubilized amorphous or partially amorphous active agent(s), having a mean particle size diameter D50 equal or lower than 250 μm, that remains uniformly distributed within a film matrix and contains at least one film former polymer, and optional pharmaceutically-acceptable excipients, such as diluents, plasticizers, surfactants, sweeteners, and taste-masking agent(s). The oral thin film dosage exhibits increased solubility or rate of dissolution and enhanced bioavailability compared to a crystalline form of the active agent(s). The oral dosage form also exhibits long term stability confirmed by no changes in the dissolution profile over time.
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