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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:
US15216903
公开号:
US20160324773A1
申请日:
2016.07.22
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 less than 250 μm, that remains uniformly distributed within a film matrix and contains at least one film forming polymer, and optional pharmaceutically-acceptable excipients, such as diluents, plasticizers, surfactants, sweeteners, and taste-masking agent(s), are prepared by a process including first providing the active agent in an amorphous particle form having a mean particle size diameter D50 equal or less than 250 μm. Next, the active agent is suspended in a liquid film-forming formulation without dissolving the active agent. Therefore, the solvent is removed to form a film.
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