QUALITY CONTROL OF DISTILLED WATER USED FOR RECONSTITUTION OF POWDERS FOR ORAL SUSPENSION IN PHARMACIES ON THE TERRITORY OF BOSNIA AND HERZEGOVINA

Ž. Gagić, Irena Kasagić Vujanović, Nina Okuka, D. Knezevic
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Abstract

In this paper, presented are the results of quality control of distilled water used for the reconstitution of powders for oral suspension usually intended for pediatric population. By reviewing the legislation, there is no clearly defined shelf life and storage instruction for this type of water. The conducted analyses confirmed that some pharmacies on the territory of Bosnia and Herzegovina use technical distilled water (water for accumulators, iron and antifreeze dilution), but also distilled water that does not meet quality requirements prescribed by European Pharmacopoeia. The tested water samples did not have adequately labeled packaging (production time and shelf life). The results showed that out of a total of 10 samples, 2 had conductivity greater than permissible, 3 had an exceeded limit for heavy metals, and 2 of the samples showed the presence of oxidisable substances. Out of all tested samples, only one sample met microbiological criteria for purified water. Based on the results of these analyses, it can be assumed that in many pharmacies around the country, inadequate distilled water is used which could endanger the stability of the pharmaceutical preparation and the safety of the patient. Bearing in mind that antibiotic oral suspensions are prescribed from the age of the infant, and that a large number of children consume these products for a long period due to frequent infections, the question arises as to whether prepared drugs accomplish their purpose and whether pharmacists are sufficiently aware of the importance of the quality of this type of water?
波斯尼亚和黑塞哥维那境内药房用于重组口服悬浮液粉末的蒸馏水的质量控制
在这篇论文中,提出了用于口腔悬浮液粉末重组的蒸馏水的质量控制的结果,通常用于儿科人群。通过审查立法,这类水没有明确的保质期和储存说明。所进行的分析证实,波斯尼亚和黑塞哥维那境内的一些药房使用技术蒸馏水(用于蓄积器、铁和防冻剂稀释的水),但也使用不符合欧洲药典规定的质量要求的蒸馏水。测试水样没有适当的包装标签(生产时间和保质期)。结果显示,在10个样本中,2个样本的电导率超过允许值,3个样本的重金属含量超过允许值,2个样本显示存在可氧化物质。在所有测试样本中,只有一个样本符合纯净水的微生物标准。根据这些分析的结果,可以假设,在全国各地的许多药房,蒸馏水使用不足,这可能危及药物制剂的稳定性和患者的安全。考虑到抗生素口服混悬液从婴儿开始就被开处方,而且由于经常感染,大量儿童长期服用这些产品,那么问题来了,制备的药物是否达到了它们的目的,药剂师是否充分意识到这类水的质量的重要性?
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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