A pharmaceutical composition for use in treating an ocular disease or condition and a method for producing the composition
申请人:Allergan, Inc.
公开号:EP2425816A2
公开(公告)日:2012-03-07
The present invention provides a pharmaceutical composition for use in treating an ocular disease or condition, the composition comprising:
a chitosan composition comprising a treated chitosan, a modified chitosan, a modified and treated chitosan or a mixture thereof, each modified and/or treated chitosan exhibiting a different chemical, physical and/or performance property or characteristic relative to the corresponding unmodified/untreated chitosan, and
a therapeutic agent selected from a corticosteroid and a mixture of corticosteroids;
wherein:
each treated chitosan is obtained by dialyzing chitosan against water and a salt and/or anionic solution, and each modified chitosan is obtained by one or more of covalent attachment of one or more functional groups to chitosan, non-covalent association of one or more atomic or molecular agents with chitosan and coaddition of one or more atomic or molecular agents with chitosan,
the therapeutic agent is covalently bonded to at least one treated and/or modified chitosan directly or via a linker, and
the chitosan composition is adapted to release a therapeutically effective amount of the therapeutic agent over a period of time.
A process for manufacturing the pharmaceutical composition is also provided, the process comprising contacting the above chitosan composition with a therapeutically-effective amount of the above therapeutic agent under conditions such that the therapeutic agent is covalently bonded to at least one treated and/or modified chitosan.
本发明提供了一种用于治疗眼部疾病或病症的药物组合物,该组合物包括
壳聚糖组合物,包括经处理的壳聚糖、经改性的壳聚糖、经改性和处理的壳聚糖或其混合物,相对于相应的未改性/未处理的壳聚糖,每种经改性和/或处理的壳聚糖表现出不同的化学、物理和/或性能特性,以及
选自皮质类固醇和皮质类固醇混合物的治疗剂;
其中
每种处理过的壳聚糖是通过将壳聚糖与水和盐及/或阴离子溶液透析而获得的,每种改性壳聚糖是通过将一种或多种官能团共价连接到壳聚糖、一种或多种原子或分子剂与壳聚糖的非共价结合以及一种或多种原子或分子剂与壳聚糖的共添加而获得的、
治疗剂直接或通过连接体与至少一种经处理和/或修饰的壳聚糖共价键合,以及
壳聚糖组合物能够在一段时间内释放治疗有效量的治疗剂。
还提供了一种制造药物组合物的工艺,该工艺包括在使治疗剂与至少一种经处理和/或修饰的壳聚糖共价键合的条件下,将上述壳聚糖组合物与治疗有效量的上述治疗剂接触。