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制定开发和评估蒿甲醚20毫克/ Lumefantrine 120毫克固定剂量组合平板电脑

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背景:流行趋势在全球制药行业对非洲的访问各种壁垒基本医药产品。医药研究和开发管道运行干。在坦桑尼亚,由于数量不足制定专家和技术差,各种基本药物的可获得性仍不充分和不一致的;,这就解释了为什么超过90%推荐简单的疟疾的一线药物治疗(蒿甲醚Lumefantrrine)都是进口的。研究目的:蒿甲醚的目的是开发一个配方20毫克/ Lumefantrine 120毫克固定剂量组合平板电脑。材料与方法:这是一个实验研究设计Muhimbili大学健康和盟军进行科学的研究和发展实验室2019年12月至2020年7月。湿法造粒方法混合使用所需的活性药物成分(api)与适量赋形剂的潜力。粉末颗粒的压缩是在压片机EKOI 2(德国制造)。评价解散概要文件制定创新药物和药物产品的研究;相似之处和差异计算按国际药典。 Friability, Disintegration time, Assay and tablets contents uniformity of the formulated drug product are the critical parameters that were also evaluated as per United States Pharmacopoeia. Results: Tablets were successfully produced with the average weight of 240 mg, diameter 10 mm and thickness of 6 mm. The similarity and difference of 89% and 4.1% respectively were obtained. Friability, Disintegration time, Assay and tablets contents uniformity results were found to be 2 minutes and 29 seconds, Arte-98.1% Lum-99.2%, and Arte-98.0% Lume-101.3% respectively. Conclusion: The formulated and evaluated drug product of Artemether 20 mg and Lumefantrine 120 mg fixed dose combination tablet passed the quality requirements as per International Pharmacopoeias and Monographs. Scale up by our local pharmaceutical industry may be done by adopting this formula but should adhere to the official compendia.

Ibrahimu Kaswamila,玛丽j . Temu Eliangiringa Kaale,贝蒂Maganda,拉斐尔Shedafa,繁荣Tibelinda,西拉Shemdoe, Juma Ayubu

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