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

Ottoboni, Sara and Coleman, Simon J. and Steven, Christopher and Siddique, Mariam and Fraissinet, Marine and Joannes, Marion and Laux, Audrey and Barton, Alastair and Firth, Paul and Price, Chris J. and Mulheran, Paul A. (2020) Understanding API static drying with hot gas flow : design and test of a drying rig prototype and drying modelling development. Organic Process Research and Development, 24 (11). pp. 2505-2520. ISSN 1083-6160

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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.

    ORCID iDs

    Ottoboni, Sara ORCID logoORCID: https://orcid.org/0000-0002-2792-3011, Coleman, Simon J., Steven, Christopher ORCID logoORCID: https://orcid.org/0000-0002-6784-7244, Siddique, Mariam, Fraissinet, Marine, Joannes, Marion, Laux, Audrey, Barton, Alastair, Firth, Paul, Price, Chris J. and Mulheran, Paul A. ORCID logoORCID: https://orcid.org/0000-0002-9469-8010;