A Process for Active Pharmaceutical Ingredient Recovery from Tablets Using Green Engineering Technology,Organic Process Research & Development

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A Process for Active Pharmaceutical Ingredient Recovery from Tablets Using Green Engineering Technology
Organic Process Research & Development ( IF 3.1 ) Pub Date : 2017-07-20 00:00:00 , DOI: 10.1021/acs.oprd.7b00146
Daniel S. Hsieh ₁ , Mark Lindrud ₁ , Xujin Lu ₁ , Christopher Zordan ₁ , Liya Tang ₁ , Merrill Davies ₁

Affiliation

The objective of this study is to recover Active Pharmaceutical Ingredients (APIs) from tablets via green engineering technology to meet material requirements for downstream formulation development. A separation train, using water as the separation media, includes dissolution, centrifugal phase separation, diafiltration and reverse osmosis and has been developed based on the physical properties of the API and excipients. These properties include solubility, multiphase behaviors, particle densities, and size differences between API and excipients. The recovered API both meets purity specifications and contains no polymer. It is suitable for reuse in formulation process development. The recovery of the API from tablets is over 90%. A green engineering technology using water and separation methods is successfully developed and used to recover API from tablets.

中文翻译：

使用绿色工程技术从片剂中回收活性药物成分的工艺

这项研究的目的是通过绿色工程技术从片剂中回收活性药物成分（API），以满足下游制剂开发的材料要求。使用水作为分离介质的分离链包括溶解，离心相分离，渗滤和反渗透，并且已根据API和赋形剂的物理性质进行了开发。这些特性包括溶解度，多相行为，颗粒密度以及API和赋形剂之间的大小差异。回收的API均符合纯度规范，并且不含聚合物。它适合在配方过程开发中重复使用。平板电脑中API的回收率超过90％。

更新日期：2017-07-21

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