Crystallization process modifications to address polymorphic and particle size challenges in early stage development of an API salt

Autor:	M.S. Abhishek, Debasis Hazra, Gerry Steele, Sharmistha Pal
Rok vydání:	2020
Předmět:	Active ingredient chemistry.chemical_classification Aqueous solution Materials science 010405 organic chemistry Precipitation (chemistry) General Chemical Engineering Salt (chemistry) General Chemistry 010402 general chemistry 01 natural sciences 0104 chemical sciences law.invention Chemical engineering chemistry law Scientific method Particle size Crystallization Hydrate
Zdroj:	Chemical Engineering Research and Design. 164:400-411
ISSN:	0263-8762
Popis:	A case study highlighting the risk of generating undesired hydrate polymorph following seeded distillative crystallization of an active pharmaceutical ingredient (API) from aqueous alcoholic solution and a strategy to overcome the issue is presented. The API salt had two known crystalline forms, the desired anhydrate Form A, and hydrate Form B. Importance of water content at the time of seeding to minimize the risk of precipitation of From B is emphasized. A novel approach termed distillative pathway diagram (DPD) was developed to assess the risk of generation of Form B at larger scales. The application of this diagram to determine process parameters to address form issues during distillative crystallization is explained. Given the likely risk of Form B precipitation predicted by DPD, an alternate non-aqueous antisolvent crystallization process was developed that provided both form and particle size control.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::0085333484017e41c8685a9bf863a7de https://doi.org/10.1016/j.cherd.2020.09.021 Zobrazit plný text záznamu Full Text from ScienceDirect Plný text ve formátu HTML
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