A Process for Active Pharmaceutical Ingredient Recovery from Tablets Using Green Engineering Technology

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 sepa...

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Bibliographic Details
Published in:Organic process research & development 2017-09, Vol.21 (9), p.1272-1285
Main Authors: Hsieh, Daniel S, Lindrud, Mark, Lu, Xujin, Zordan, Christopher, Tang, Liya, Davies, Merrill
Format: Article
Language:English
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Summary: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.
ISSN:1083-6160
1520-586X
DOI:10.1021/acs.oprd.7b00146