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泡腾片制造工艺:气流强制烘箱熔融制粒。

Process to manufacture effervescent tablets: air forced oven melt granulation.

作者信息

Yanze F M, Duru C, Jacob M

机构信息

Laboratoire de pharmacie galénique, pharmacotechnie et de Biopharmacie, Université Montpellier I, UFR de Sciences Pharmaceutiques, Montpellier, France.

出版信息

Pharmazie. 2000 Dec;55(12):919-24.

Abstract

In the present study we apply melt granulation in an air forced oven, called "are forced oven melt granulation" to the single-stage manufacture of effervescent granules consisting of anhydrous citric acid (43.2%) and sodium bicarbonate (56.8%) in order to make tablets. This study established that process parameters such as concentration of PEG 6000, residence time in the air forced oven, fineness of PEG 6000, fineness of the initial effervescent mix and efficiency of two lubricants markedly influenced several granule and tablet characteristics. The granules ready to be compressed into tablets were stable for 7 days at 60% RH/18 degrees C. It is a dry, simple, rapid, effective, economical, reproducible process particularly well suited to the manufacture of effervescent granules which are easily compressed into effervescent tablets. Of all the formulations tested, only formulations B2 and E2 melt granulated for 30 minutes gave tablets which had optimum compression characteristics without processing problems during compression.

摘要

在本研究中,我们将在一种称为“强制热风熔融制粒”的强制热风烘箱中进行的熔融制粒应用于由无水柠檬酸(43.2%)和碳酸氢钠(56.8%)组成的泡腾颗粒的单步制造,以制备片剂。本研究表明,诸如聚乙二醇6000的浓度、在强制热风烘箱中的停留时间、聚乙二醇6000的细度、初始泡腾混合物的细度以及两种润滑剂的效率等工艺参数显著影响了几种颗粒和片剂的特性。准备压片的颗粒在60%相对湿度/18摄氏度下可稳定保存7天。这是一个干燥、简单、快速、有效、经济且可重复的过程,特别适合制造易于压制成泡腾片的泡腾颗粒。在所有测试的配方中,只有熔融制粒30分钟的配方B2和E2制得的片剂具有最佳的压缩特性,且在压片过程中没有加工问题。

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