Ilango Kumbakonam Balachandran, Gowthaman Senguttuvan, Seramaan Kumbakonam Ilango, Chidambaram Kumarappan, Bayan Mohammad F, Rahamathulla Mohamed, Balakumar Chandrasekaran
Department of Pharmaceutics, College of Pharmacy, Shree Venkateshwara College of Paramedical Sciences, Erode 638455, India.
Department of Pharmaceutics, Vellalar College of Pharmacy, Erode 638012, India.
Polymers (Basel). 2022 Jan 5;14(1):215. doi: 10.3390/polym14010215.
Natural eco-friendly materials are recently employed in products to replace synthetic materials due to their superior benefits in preserving the environment. The herb is widely distributed in continents like Asia and Africa and used traditionally to treat fever, leprosy, asthma, jaundice, and bronchitis. Mucilage of was accordingly extracted, isolated by a maceration technique, and precipitated. The mucilage was evaluated for its physicochemical, binding, and disintegrant properties in tablets using paracetamol as a model drug. The crucial physicochemical properties such as flow properties, solubility, swelling index, loss on drying, viscosity, pH, microbial load, cytotoxicity was evaluated and the compatibility was analyzed using sophisticated instrumental methods (TGA, DTA, DSC, and FTIR). The binding properties of the mucilage was used at three different concentrations and compared with starch and PVP as examples of standard binders. The disintegrant properties of mucilage were used at two different concentrations and compared with standard disintegrants MCCP, SSG, and CCS. The tablets were punched and evaluated for their hardness, friability, assay, disintegration time, in vitro dissolution profiles. In vitro cytotoxicity studies of the mucilage were performed in a human embryonic kidney (HEK) cell line. The outcome of the study indicated that the mucilage had good performance compared with starch and PVP. Further, the mucilage acts as a better disintegrant than MCCP, SSG and CCS for paracetamol tablets. Use of a concentration of 3% or less demonstrated the ability of the mucilage to act as a super disintegrating agent and showed faster disintegration and dissolution, which makes it as an attractive, promising disintegrant in formulating solid dosage forms to improve the therapeutic efficacy and patient compliance. Moreover, the in vitro cytotoxicity evaluation results demonstrated that the mucilage is non-cytotoxic to human cells and is safe.
由于天然环保材料在保护环境方面具有显著优势,近年来被广泛应用于产品中以替代合成材料。这种草药广泛分布于亚洲和非洲等各大洲,传统上用于治疗发烧、麻风病、哮喘、黄疸和支气管炎。因此,提取了该草药的黏液,采用浸渍技术进行分离并沉淀。以对乙酰氨基酚为模型药物,对该黏液在片剂中的物理化学性质、黏合性和崩解性能进行了评估。评估了关键的物理化学性质,如流动性、溶解度、膨胀指数、干燥失重、粘度、pH值、微生物负荷、细胞毒性,并使用先进的仪器方法(热重分析、差热分析、差示扫描量热法和傅里叶变换红外光谱法)分析了其相容性。以三种不同浓度使用该黏液的黏合性能,并与作为标准黏合剂示例的淀粉和聚乙烯吡咯烷酮进行比较。以两种不同浓度使用该黏液的崩解性能,并与标准崩解剂微晶纤维素磷酸钠、淀粉甘醇酸钠和交联羧甲基纤维素钠进行比较。将片剂冲压成型,并对其硬度、脆碎度、含量测定、崩解时间、体外溶出曲线进行评估。在人胚肾(HEK)细胞系中对该黏液进行了体外细胞毒性研究。研究结果表明,与淀粉和聚乙烯吡咯烷酮相比,该黏液具有良好的性能。此外,对于对乙酰氨基酚片剂,该黏液作为崩解剂比微晶纤维素磷酸钠、淀粉甘醇酸钠和交联羧甲基纤维素钠表现更好。使用3%或更低的浓度证明了该黏液作为超级崩解剂的能力,并显示出更快的崩解和溶解速度,这使其成为配制固体剂型以提高治疗效果和患者依从性的一种有吸引力、有前景的崩解剂。此外,体外细胞毒性评估结果表明,该黏液对人体细胞无细胞毒性且安全。