Micronization of fenofibrate by rapid expansion of supercritical solution
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- 作者：Stevanus Hiendrawan ; Bambang Veriansyah ; Raymond R. Tj ; rawinata
- 关键词：Adj SS ; adjusted sum of squares ; Adj MS ; adjusted mean of squares ; ANOVA ; analysis of variance ; API ; active pharmaceutical ingredients ; ASES ; aerosol solvent extraction system ; B ; back pressure regulator ; CC ; precooler ; CH ; preheater ; DF ; degree of freedom ; DSC ; differential scanning calorimetry ; EMEA ; European Medicines Agency ; EV ; extraction vessel ; F ; frit filter ; F-value ; F-value in ANOVA ; FDA ; Food and Drug Administration ; FT-IR ; Fourier transform infrared ; GAS ; gas antisolvent ; HP ; high pr
- 刊名：Journal of Industrial and Engineering Chemistry
- 出版年：25 January, 2014
- 年：2014
- 卷：20
- 期：1
- 页码：54-60
- 全文大小：1616 K
文摘
Micronization of fenofibrate was investigated using rapid expansion of supercritical solution (RESS) process. Effects of pressure, temperature and nozzle on particle size were optimized using Taguchi's orthogonal array and analyzed using XRD, DSC, FT-IR, SEM, laser diffractometer and dissolution testing. Processed fenofibrate retained crystalline structure and has a similar chemical structure with unprocessed fenofibrate. The average particle size of fenofibrate was reduced from its original 68.779 卤 0.146 渭m to 3.044 卤 0.056 渭m under the optimum condition (T at 35 掳C, P at 200 bar and nozzle diameter at 200 渭m). The processed fenofibrate showed an enhanced dissolution rate by 8.13 times.