Yanze F M, Duru C, Jacob M
Laboratoire de pharmacie galénique, pharmacotechnie et de Biopharmacie, Université Montpellier I, UFR de Sciences Pharmaceutiques, France.
Drug Dev Ind Pharm. 2000 Nov;26(11):1167-76. doi: 10.1081/ddc-100100988.
The purpose of the present study was to apply melt granulation in a fluidized bed dryer (fluidized bed dryer melt granulation) to manufacture one-step effervescent granules composed of anhydrous citric acid and sodium bicarbonate to make tablets. This study permitted us to establish that such process parameters as concentrations of polyethylene glycol (PEG) 6000, residence times in the fluidized bed dryer, fineness of PEG6000, fineness of initial mixture effervescent systems, and efficiency of two lubricants markedly affect some granule and tablet characteristics. It is a dry process that is simple, rapid, effective, economical, reproducible, and particularly adapted to produce effervescent granules that are easily compressed into effervescent tablets.
本研究的目的是应用流化床干燥器中的熔融制粒法(流化床干燥器熔融制粒)来制造由无水柠檬酸和碳酸氢钠组成的一步泡腾颗粒,以制备片剂。本研究使我们能够确定,诸如聚乙二醇(PEG)6000的浓度、在流化床干燥器中的停留时间、PEG6000的细度、初始混合物泡腾体系的细度以及两种润滑剂的效率等工艺参数,会显著影响一些颗粒和片剂的特性。这是一种干法工艺,简单、快速、有效、经济、可重复,特别适合生产易于压制成泡腾片的泡腾颗粒。