کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5520070 1544560 2016 44 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Building the design, translation and development principles of polymeric nanomedicines using the case of clinically advanced poly(lactide(glycolide))-poly(ethylene glycol) nanotechnology as a model: An industrial viewpoint
ترجمه فارسی عنوان
اصول طراحی، ترجمه و توسعه نانومواد های پلیمری با استفاده از نانو تکنولوژی پلی (لکتید (گلیکولید)) - پلی (اتیلن گلیکول) بالینی پیشرفته به عنوان یک مدل: دیدگاه صنعتی
موضوعات مرتبط
علوم زیستی و بیوفناوری بیوشیمی، ژنتیک و زیست شناسی مولکولی بیوتکنولوژی یا زیست‌فناوری
چکیده انگلیسی

The design of the first polymeric nanoparticles could be traced back to the 1970s, and has thereafter received considerable attention, as evidenced by the significant increase of the number of articles and patents in this area. This review article is an attempt to take advantage of the existing literature on the clinically tested and commercialized biodegradable PLA(G)A-PEG nanotechnology as a model to propose quality building and outline translation and development principles for polymeric nano-medicines. We built such an approach from various building blocks including material design, nano-assembly - i.e. physicochemistry of drug/nano-object association in the pharmaceutical process, and release in relevant biological environment - characterization and identification of the quality attributes related to the biopharmaceutical properties.More specifically, as envisaged in a translational approach, the reported data on PLA(G)A-PEG nanotechnology have been structured into packages to evidence the links between the structure, physicochemical properties, and the in vitro and in vivo performances of the nanoparticles. The integration of these bodies of knowledge to build the CMC (Chemistry Manufacturing and Controls) quality management strategy and finally support the translation to proof of concept in human, and anticipation of the industrialization takes into account the specific requirements and biopharmaceutical features attached to the administration route. From this approach, some gaps are identified for the industrial development of such nanotechnology-based products, and the expected improvements are discussed. The viewpoint provided in this article is expected to shed light on design, translation and pharmaceutical development to realize their full potential for future clinical applications.

This article provides an industrial viewpoint on quality by design based polymeric nanomedicines design, translation and pharmaceutical development to realized their full potential for future clinical applications, from the case of clinically advanced poly(lactide(glycolide))-poly(ethylene glycol) nanotechnology. We built such approach from various building blocks including material design, nano-assembly i.e., physicochemistry of drug/nano-object association in the pharmaceutical process, and release in relevant biological environment i.e., characterization and identification of the quality attributes related to the biopharmaceutical properties.85

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Advanced Drug Delivery Reviews - Volume 107, 15 December 2016, Pages 289-332
نویسندگان
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