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通过实验设计开发可生物降解微球的造粒工艺。

Development of prilling process for biodegradable microspheres through experimental designs.

作者信息

Fabien Violet, Minh-Quan Le, Michelle Sergent, Guillaume Bastiat, Van-Thanh Tran, Marie-Claire Venier-Julienne

机构信息

LUNAM Université, Micro et Nanomédecines Biomimétiques (MINT), F-49933 Angers, France; INSERM U1066, F-49933 Angers, France.

Aix Marseille Université, LISA, EA 4672, 13013 Marseille, France.

出版信息

Int J Pharm. 2016 Feb 10;498(1-2):96-109. doi: 10.1016/j.ijpharm.2015.11.051. Epub 2015 Dec 2.

Abstract

The prilling process proposes a microparticle formulation easily transferable to the pharmaceutical production, leading to monodispersed and highly controllable microspheres. PLGA microspheres were used for carrying an encapsulated protein and adhered stem cells on its surface, proposing a tool for regeneration therapy against injured tissue. This work focused on the development of the production of PLGA microspheres by the prilling process without toxic solvent. The required production quality needed a complete optimization of the process. Seventeen parameters were studied through experimental designs and led to an acceptable production. The key parameters and mechanisms of formation were highlighted.

摘要

喷雾造粒工艺提出了一种易于转移到药物生产中的微粒制剂,可得到单分散且高度可控的微球。聚乳酸-羟基乙酸共聚物(PLGA)微球用于携带包封的蛋白质,并在其表面黏附干细胞,为受损组织的再生治疗提供了一种工具。这项工作聚焦于通过无有毒溶剂的喷雾造粒工艺生产PLGA微球。所需的生产质量需要对该工艺进行全面优化。通过实验设计研究了17个参数,从而实现了可接受的生产。突出了关键参数和形成机制。

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