Rapid expansion of supercritical solutions (RESS) technique was applied for the preparation of phenylbutazone fine particles. The operating temperature and pressure affected the yield of the drug fine particles, which was evaluated by dissolving the sprayed product of drug into ethanol. Effect of pre- and post-expansion conditions on the particle size distribution of phenylbutazone was investigated and the smallest sample (mean particle size: 1.59 microm) was obtained when the RESS method was operated at a pressure of 26 MPa combined with a temperature of 32 degrees C. Physicochemical properties of the fine particles were investigated by powder X-ray diffraction and differential scanning calorimetry. It was found that the phenylbutazone fine particles obtained were meta-stable beta form under the experimental conditions tested, suggesting polymorphic transformation during the RESS process.

译文

超临界溶液快速膨胀 (RESS) 技术用于制备保泰松细颗粒。操作温度和压力影响药物细颗粒的产率,这是通过将药物的喷雾产物溶解到乙醇中进行评估的。研究了膨胀前和膨胀后条件对保泰松粒度分布的影响,并在结合温度为32 ℃ 的压力下操作RESS法时获得了最小样品 (平均粒度: 1.59微米)。通过粉末x射线衍射和差示扫描量热法研究了细颗粒的理化性质。发现在测试的实验条件下,获得的保泰松细颗粒是亚稳定的 β 形式,表明在RESS过程中存在多态性转化。

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