Kimaro Emmanuel, Tibalinda Prosper, Shedafa Raphael, Temu Mary, Kaale Eliangiringa
Department of Pharmaceutics, Catholic University of Health and Allied Sciences (CUHAS), Mwanza, Tanzania.
Department of Pharmaceutics, Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzania.
Heliyon. 2019 Dec 19;5(12):e02911. doi: 10.1016/j.heliyon.2019.e02911. eCollection 2019 Dec.
Albendazole is an orally administered broad-spectrum anthelmintic. Currently it is mostly used in the treatment of soil transmitted helminthes, hydatidosis and neurocysticercosis caused Aim of the study. To develop and optimize a formulation of chewable albendazole tablet with improved dissolution rate.
This study was specifically focused on formulation development which passes compatibility studies and optimization of the developed formulation. The formulations were evaluated on assay, dissolution, friability, hardness, weight variation, disintegration and similarity in comparison with the reference product on the market. Analysis was required to be undertaken by High performance thin layer chromatography (HPTLC) analytical methods. Design of Expert version 7 software was used for selection or making scientific decisions in selecting the best composition of the best formulation.
Five formulations out of ten (F-6, F-7, F-8, F-9 and F10) had all parameters in acceptable range. On optimization, one formulation with independent variables, Sodium Laury Sulphate (SLS) 1.911%, polyvinyl pyrrolidone (PVP-K30) 3.128%, and Sodium Cross carmellose (CCM) 4.95% was selected out of ten predictions made with Design expert version 7.0. It was found that assay of the best formulation is 99.23% which was within the in-house assay specification 95-105%. Dissolution single point in 30 min was found to be 91.5% disintegration between 2-5 min and friability 0.45%.The optimized formulation was tested and found to be within the acceptable limits. The formulation was comparable to the reference product on the market with similarity factor (f2) 62 and difference factor (f1) of 6 at pH1.2.
A new generic albendazole tablet with improved dissolution rate was formulated, developed and optimized by using a wet granulation method.
阿苯达唑是一种口服的广谱驱虫药。目前它主要用于治疗土源性蠕虫感染、包虫病和神经囊尾蚴病。研究目的：开发并优化一种溶出速率提高的阿苯达唑咀嚼片制剂。
本研究专门聚焦于制剂开发，包括进行相容性研究以及对所开发制剂进行优化。对制剂进行含量测定、溶出度、脆碎度、硬度、重量差异、崩解度等方面的评估，并与市场上的参比产品进行相似性比较。需要采用高效薄层色谱（HPTLC）分析方法进行分析。使用专家设计版本7软件来选择或做出科学决策，以挑选出最佳制剂的最佳组成。
十种制剂中有五种（F-6、F-7、F-8、F-9和F10）所有参数均在可接受范围内。经过优化，在使用专家设计版本7.0进行的十次预测中，选出了一种自变量为月桂醇硫酸酯钠（SLS）1.911%、聚乙烯吡咯烷酮（PVP-K30）3.128%和交联羧甲基纤维素钠（CCM）4.95%的制剂。发现最佳制剂的含量测定结果为99.23%，在内部含量测定规格95 - 105%范围内。30分钟时的溶出单点测定结果为91.5%，崩解时间在2 - 5分钟之间，脆碎度为0.45%。经测试，优化后的制剂在可接受限度内。该制剂与市场上的参比产品具有可比性，在pH1.2条件下相似因子（f2）为62，差异因子（f1）为6。
通过湿法制粒法制备、开发并优化了一种溶出速率提高的新型阿苯达唑仿制药片。
