Understanding API static drying with hot gas flow: design and test of a drying rig prototype and drying modelling development

Sara Ottoboni, Simon J. Coleman, Christopher Steven, Mariam Siddique, Marine Fraissinet, Marion Joannes, Audrey Laux, Alastair Barton, Paul Firth, Chris J. Price, Paul A. Mulheran

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Abstract

Developing a continuous isolation process to produce; 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 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 formation of interparticle bridges leading to lump formation. We demonstrate the feasibility of drying small batches on a timescale 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 modelling.
Original languageEnglish
Number of pages16
JournalOrganic Process Research and Development
Early online date16 Oct 2020
DOIs
Publication statusE-pub ahead of print - 16 Oct 2020

Keywords

  • pharmaceutical
  • drying
  • agglomeration
  • modeling
  • model validation

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    Ottoboni, S. (Creator), Coleman, S. (Contributor), Steven, C. R. (Contributor), Siddique, M. (Contributor), Price, C. J. (Contributor) & Mulheran, P. (Contributor), University of Strathclyde, 30 Sep 2020

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