Viera-Herrera Camila, Santamaría-Aguirre Javier, Vizuete Karla, Debut Alexis, Whitehead Daniel C, Alexis Frank
School of Biological Sciences and Engineering, Yachay Tech University, Urcuquí 100650, Ecuador.
Faculty of Chemical Sciences, Universidad Central del Ecuador, Instituto de Investigación en Salud Pública y Zoonosis (CIZ), Quito 170130, Ecuador.
Nanomaterials (Basel). 2020 May 19;10(5):975. doi: 10.3390/nano10050975.
Excipients represent the complement of the active principle in any pharmaceutical form. Their function is to provide stability, protection, and to ensure absorption of the drug and acceptability in patients. Cellulose is a conventional excipient in many pharmaceutical solid dosage products. Most of the sources used to extract microcrystalline cellulose come from cotton or wood, which are expensive and in high demand from other industries. As plants are considered the main source of excipient production, we have taken advantage of the biodiversity of Ecuador to evaluate microcrystalline cellulose extracted from borojó (), a native plant, as an excipient for solid dosage formulations. The method of choice for tablet manufacturing was direct compression since it is a conventional fabrication method in the pharmaceutical industry. First, we performed scanning electron microscopy (SEM), Fourier-transform infrared (FTIR) spectroscopy, and X-ray diffraction (XRD) in order to compare the structure and characteristics of the extracted cellulose with two reference commercial cellulose materials. Second, we performed quality tests to evaluate the use of the isolate as an excipient including fluidity, hardness, friability, and disintegration. Compared with commercial and microcrystalline cellulose, the extracted cellulose from the native plant showed comparable characteristics and is consequently a potential excipient that could be used in the pharmaceutical industry. Last, we performed a dissolution test in which we concluded that all tablets have a short release time of active principle.
辅料是任何药物剂型中活性成分的补充部分。它们的作用是提供稳定性、保护作用,并确保药物的吸收以及患者的可接受性。纤维素是许多药物固体剂型产品中的传统辅料。用于提取微晶纤维素的大多数来源是棉花或木材,这些来源成本高昂且其他行业需求旺盛。由于植物被视为辅料生产的主要来源,我们利用厄瓜多尔的生物多样性来评估从本地植物博罗霍(borojó)中提取的微晶纤维素作为固体剂型配方的辅料。片剂制造的首选方法是直接压片,因为这是制药行业中的传统制造方法。首先,我们进行了扫描电子显微镜(SEM)、傅里叶变换红外(FTIR)光谱和X射线衍射(XRD)分析,以便将提取的纤维素的结构和特性与两种参考商业纤维素材料进行比较。其次,我们进行了质量测试,以评估该分离物作为辅料的用途,包括流动性、硬度、脆碎度和崩解性。与商业微晶纤维素相比,从本地植物中提取的纤维素表现出可比的特性,因此是一种可用于制药行业的潜在辅料。最后,我们进行了溶出度测试,得出的结论是所有片剂的活性成分释放时间都很短。