Uğurlu Timuçin, Halaçoğlu Mekin Doğa
a Department of Pharmaceutical Technology, Faculty of Pharmacy , Marmara University , Haydarpaşa , Istanbul , Turkey.
Pharm Dev Technol. 2016;21(4):415-27. doi: 10.3109/10837450.2015.1016617. Epub 2015 Feb 26.
The objective of this study was to investigate the lubrication properties of hexagonal boron nitride (HBN) on a (1:1) binary mixture of Avicel DG and Starch 1500 after using the dry granulation-slugging method and compare it with conventional lubricants, such as magnesium stearate (MGST), glyceryl behenate (COMP) and stearic acid (STAC). MGST is one of the most commonly used lubricants in the pharmaceutical industry. However, it has several adverse effects on tablet properties. In our current study, we employed various methods to eradicate the work hardening phenomenon in dry granulation, and used HBN as a new lubricant to overcome the adverse effects of other lubricants on tablet properties. HBN was found to be as effective as MGST and did not show any significant adverse effects on the crushing strength or work hardening. From the scanning electron microscope (SEM) images, it was concluded that HBN distributed better than MGST. As well as showing better distribution, HBN's effect on disintegration was the least pronounced. Semi-quantitative weight percent distribution of B and N elements in the tablets was obtained using EDS (energy dispersive spectroscopy). Based on atomic force microscope (AFM) surface roughness images, formulations prepared with 1% HBN showed better plastic character than those prepared with MGST.
本研究的目的是在采用干法制粒-压片法后,研究六方氮化硼(HBN)在微晶纤维素(Avicel DG)和淀粉1500的(1:1)二元混合物上的润滑性能,并将其与传统润滑剂进行比较,如硬脂酸镁(MGST)、山嵛酸甘油酯(COMP)和硬脂酸(STAC)。MGST是制药行业最常用的润滑剂之一。然而,它对片剂性能有多种不利影响。在我们目前的研究中,我们采用了各种方法来消除干法制粒中的加工硬化现象,并使用HBN作为新型润滑剂来克服其他润滑剂对片剂性能的不利影响。结果发现HBN与MGST一样有效,并且对压碎强度或加工硬化没有显示出任何显著的不利影响。从扫描电子显微镜(SEM)图像可以得出结论,HBN的分布比MGST更好。除了显示出更好的分布外,HBN对崩解的影响最不明显。使用能谱仪(EDS)获得了片剂中B和N元素的半定量重量百分比分布。基于原子力显微镜(AFM)表面粗糙度图像,用1%HBN制备的制剂比用MGST制备的制剂表现出更好的塑性特征。