Process analytical techniques for hot-melt extrusion and their application to amorphous solid dispersions
作者: Patrick HitzerTim BäuerleTobias DrieschnerEdwin OstertagKatharina PaulsenHolger van LishautGünter LorenzKarsten Rebner
作者单位: 1Reutlingen University
2AbbVie Deutschland GmbH & Co.KG
刊名: Analytical and Bioanalytical Chemistry, 2017, Vol.409 (18), pp.4321-4333
来源数据库: Springer Nature Journal
DOI: 10.1007/s00216-017-0292-z
关键词: Process analytical technologyHot-melt extrusionAmorphous solid dispersionsPharmaceutical manufacturingVibrational spectroscopyUV/VIS spectroscopy
原始语种摘要: Newly developed active pharmaceutical ingredients (APIs) are often poorly soluble in water. As a result the bioavailability of the API in the human body is reduced. One approach to overcome this restriction is the formulation of amorphous solid dispersions (ASDs), e.g., by hot-melt extrusion (HME). Thus, the poorly soluble crystalline form of the API is transferred into a more soluble amorphous form. To reach this aim in HME, the APIs are embedded in a polymer matrix. The resulting amorphous solid dispersions may contain small amounts of residual crystallinity and have the tendency to recrystallize. For the controlled release of the API in the final drug product the amount of crystallinity has to be known. This review assesses the available analytical methods that have been recently used...
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影响因子:3.659 (2012)

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关键词翻译
关键词翻译
  • amorphous 非晶质的
  • analytical 分析的
  • crystallinity 结晶度
  • solid 固体
  • recrystallize 再结晶
  • manufacturing 制造
  • resulting 引起的
  • crystalline 晶质的
  • spectroscopy 分光学
  • extrusion 喷出