Lute Sushma V, Dhenge Ranjit M, Salman Agba D
Department of Chemical and Biological Engineering, University of Sheffield, Mappin Street, Sheffield S1 3JD, UK.
Pharmaceutics. 2018 Jun 2;10(2):68. doi: 10.3390/pharmaceutics10020068.
Lactose and mannitol are some of the most commonly used powders in the pharmaceutical industry. The limited research published so far highlights the effects of process and formulation parameters on the properties of the granules and the tablets produced using these two types of powders separately. However, the comparison of the performance of these two types of powders during twin screw wet granulation has received no attention. The present research is focused on understanding the granulation mechanism of different grades of two pharmaceutical powders with varying properties (i.e., primary particle size, structure, and compressibility). Three grades each of lactose and mannitol were granulated at varying liquid to solid ratios (L/S) and screw speed. It was noticed that primary powder morphology plays an important role in determining the granule size and structure, and tablet tensile strength. It was indicated that the processed powders such as spray-dried and granulated lactose and mannitol can be used in formulation for wet granulation where flowability of active pharmaceutical ingredient (API) is poor.
乳糖和甘露醇是制药行业中最常用的一些粉末。迄今为止发表的有限研究突出了工艺和配方参数对分别使用这两种类型粉末生产的颗粒和片剂性质的影响。然而,这两种类型的粉末在双螺杆湿法制粒过程中的性能比较尚未受到关注。本研究的重点是了解具有不同性质(即初级粒径、结构和可压缩性)的两种药用粉末不同等级的制粒机制。乳糖和甘露醇各三个等级在不同的液固比(L/S)和螺杆转速下进行制粒。结果发现,初级粉末形态在决定颗粒大小和结构以及片剂抗张强度方面起着重要作用。结果表明,经过加工的粉末,如喷雾干燥和制粒的乳糖和甘露醇,可用于活性药物成分(API)流动性较差的湿法制粒配方中。