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Modification of the solid-state property of active pharmaceutical ingredients using supercritical antisolvent process
[2017/04/21]
Modification of the solid-state property of active pharmaceutical ingredients using supercritical antisolvent process

In the pharmaceutical industry, controlling and modifying the solid-state properties of active pharmaceutical ingredients (APIs) are critical in improving drug bioavailability, designing drug development strategies, and developing formulation processes. In this study, supercritical antisolvent process (SAS) was employed to recrystallize two APIs, primidone and sulfasalazine, with control over its mean particle size, crystal habit, and polymorphic form. Supercritical CO2 was used as an antisolvent in this SAS study. The effects of the operating parameters of SAS, namely, the solvent system, operating temperature and pressure, solution concentration, CO2 and solution flow rate, and nozzle diameter were investigated and discussed. The solid-state properties of original and SAS-processed API were analyzed and compared by SEM, PXRD, DSC, TGA, FTIR and particle size analyzer. According to our experimental results, operating slightly above the mixture critical point of CO2/solvent binary mixture, and operating at a higher CO2 mole fraction in crystallizer are beneficial for SAS recrystallization. At appropriate operating conditions, API micro-crystals with regular crystal habit were obtained. Furthermore, two novel crystal forms of promidone, and spherical micro-crystals of sulfasalazine were produced in this SAS study. These results demonstrate that through SAS the solid-state properties of APIs can be controlled and modified efficiently.

 

Time: 3:10 PM, 21th Apr 2017

93456, 4F, Dept. Chem. Eng.


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