Understanding API Static Drying with Hot Gas Flow: Design and Test of a Drying Rig Prototype and Drying Modeling Development
| Autor: | Alastair Barton, Mariam Siddique, Chris John Price, Sara Ottoboni, Marine Fraissinet, Simon Coleman, Paul A. Mulheran, Audrey Laux, Christopher Steven, Paul Firth, Marion Joannes |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
model validation
Computer science 010402 general chemistry 01 natural sciences Article law.invention Breakage law pharmaceutical drying Physical and Theoretical Chemistry Process engineering Filtration TP155 Active ingredient agglomeration 010405 organic chemistry business.industry Economies of agglomeration Scale (chemistry) Organic Chemistry Design tool modeling 0104 chemical sciences Scientific method Pharmaceutical manufacturing business |
| Zdroj: | Organic Process Research & Development |
| ISSN: | 1083-6160 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|