ПРЕДПРОЕКТНОЕ ИЗУЧЕНИЕ СУБСТАНЦИИ ФОЗИНОПРИЛА НАТРИЯ - ЭТАП ФАРМАЦЕВТИЧЕСКОЙ РАЗРАБОТКИ АНТИГИПЕРТЕНЗИВНОГО ПРЕПАРАТА
Journal Title: INTERNATIONAL ACADEMY JOURNAL "Web of Scholar" - Year 2017, Vol 1, Issue 9
Abstract
A рreformulation studies of the physico-chemical characteristics of the active substance was carried out. Examined in accordance with Ph.Eur. the following quality indicators of the fosinopril sodium substance manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd., China: the size and shape of the crystals, solubility, bulk density before and after shrinkage, fluidity, compressibility, angle of repose, solubility, concomitant impurities, quantitative content, identification, water, heavy metals, microbiological purity. Methods used: microscopy, absorption spectrophotometry in the infrared region, liquid chromatography, gas chromatography, potentiometric titration, biological. Based on crystallographic studies, the size and shape of the powder crystals is established. The main fraction has a size of less than 35 μm. According to the results of the pharmaco-technological properties of the substance, it is shown that fosinopril sodium has poor volume characteristics, unsatisfactory fluidity. It is established that the drug substance is highly soluble in water, does not form agglomerates. Using IR spectrophotometry, the structure of the substance is established. Physico-chemical parameters and acceptance criteria fully comply with the requirements of the monograph "Fosinopril sodium" Ph.Eur. 8.0. The possibility of using the substance fosinopril sodium in the technology of the drug in the form of tablets is proved. The necessity of applying the wet granulation method in the technological process is substantiated.
Authors and Affiliations
Л. Н. Сиденко, Е. С. Назарова, Н. А. Казаринов
Keywords
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