Journal
ORGANIC PROCESS RESEARCH & DEVELOPMENT
Volume 19, Issue 12, Pages 1987-1996Publisher
AMER CHEMICAL SOC
DOI: 10.1021/acs.oprd.5b00234
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Funding
- Agency for Science, Technology and Research (A*STAR)
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The alpha-form of the first-line antituberculosis drug pyrazinamide (PZA), which is the thermodynamically stable polymorph at ambient conditions, exhibits a fine needle shape that easily forms a mesh-like structure, making it undesirable for downstream processing. This study implements the Quality by Design (QbD) approach to develop a robust design space for isolating the metastable delta-form of PZA. A solvent mixture of methanol and 1,4-dioxane is selected for the process. Five process parameters are considered in the development of the design space: cooling rate, seeding temperature, seed loading, solvent composition, and seed preparation technique. The robustness of the established design space is verified by model uncertainty evaluation and demonstrated through experiments.
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