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PRÉPARATION DE MICROPARTICULES POLYLACTIDE-POLYGLYCOLIDE AYANT UN PROFIL DE LIBÉRATION SIGMOÏDE
专利权人:
Pharmathen S.A.
发明人:
申请号:
EP14733524.4
公开号:
EP3010962B1
申请日:
2014.06.18
申请国别(地区):
EP
年份:
2017
代理人:
摘要:
The present invention relates to preparation of biodegradable microparticles formed from polylactide-polyglycolide copolymers (PLGA) polymer and how to achieve sigmoidal release of active pharmaceutical compound from the microparticles. In particular, the present invention relates to emulsification of an inner/oil phase to an outer/water phase followed by quenching and a single drying step for the preparation of microparticles having a preferred release profile of, preferably basic/nucleophilic compounds such as risperidone. Alternatively the present invention is also suitable for hydrophobic compounds that have poor water-solubility and a high drug loading of >;20%w/w is required. The release profile can be controlled by adjusting the degree of saturation of the outer/water phase with the organic solvent used in the inner/oil phase, the polymer concentration of the inner/oil phase and the temperature at the quenching step. In particular, an initial lag phase and a substantially sigmoidal release profile are achieved by using an outer aqueous phase over saturated with the solvent used in the inner phase at emulsification step, in combination with a low temperature during quenching.
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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