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Understanding API Static Drying with Hot Gas Flow: Design and Test of a Drying Rig Prototype and Drying Modeling Development

By Ottoboni, S; Coleman, SJSteven, C; Siddique, M; Fraissinet, M; Joannes, M; Laux, A; Barton, A; Firth, P; Price, CJ; Mulheran, PA

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Abstract

Developing a continuous isolation process to produce a pure, dry, free-flowing active pharmaceutical ingredient (API) is the final barrier to the implementation of continuous end-to-end pharmaceutical manufacturing. Recent work has led to the development of continuous filtration and washing prototypes for pharmaceutical process development and small-scale manufacture. Here, we address the challenge of static drying of a solvent-wet crystalline API in a fixed bed to facilitate the design of a continuous filter dryer for pharmaceutical development, without excessive particle breakage or the formation of interparticle bridges leading to lump formation. We demonstrate the feasibility of drying small batches on a time scale suitable for continuous manufacturing, complemented by the development of a drying model that provides a design tool for process development. We also evaluate the impact of alternative washing and drying approaches on particle agglomeration. We conclude that our approach yields effective technology, with a performance that is amenable to predictive modeling.

Journal

Organic Process Research & Development. Volume 24, 2020, 2505-2520

DOI

10.1021/acs.oprd.0c00035

Type of publication

Peer-reviewed journal

Affiliations

  • University of Strathclyde
  • Alconbury Weston Ltd
  • UT Paul Sabatier; University of Strathclyde

Article Classification

Research Article

Classification Areas

  • API
  • Modeling

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