Method to evaluate the dustiness of pharmaceutical powders
Method to evaluate the dustiness of pharmaceutical powders
复制标题
DOI：
10.1093/annhyg/mel004
复制
发表时间：
2006-07-01
影响因子：
--
通讯作者：
Polton, Thomas
中科院分区：
文献类型：
--
作者：
Boundy, Maryanne;Leith, David;Polton, Thomas
制药公司开发选择性强效药物的趋势促使该行业考虑到每种有害成分在空气中传播的可能性。粉尘问题并不是制药行业所独有的，而是与任何混合、转移和处理粉末材料的行业有关。对工人健康、工厂爆炸的可能性和防止产品损失的担忧也推动了人们对工业的兴趣。与其他行业不同，制药行业在产品开发过程中受到可用于测试的粉末材料的毫克数量的限制。这些需求导致了台式粉尘测试仪的开发，它只需要10毫克的粉末，并完全包含产生的气溶胶。粉末被分散在一个5.7升的玻璃室中，该玻璃室包含一个可呼吸质量取样器和一个封闭面取样器，以量化在给定能量输入下产生的可呼吸性和总粉尘。该测试仪区分了五种不同粉末的粉尘水平差异。粉末越细粉尘含量越高，呼吸性粉尘占总粉尘的比例始终小于总粉尘的比例。已经建立了四个测试器，并使用制药级乳糖进行了评估。使用所有四个测试器确定的粉尘测量具有可比性。制药行业在测试中使用乳糖等替代品来代表活性化合物，以估计新生产操作中可能出现的粉尘浓度。活性化合物的含尘量与其替代物之间的差异，对替代试验能否代表工作场所的真实暴露提出了挑战。该测试仪可以确定活性化合物及其替代物的粉尘浓度，所得比率可以帮助解释来自替代测试的粉尘浓度。此外，粉尘信息可能允许药物研究人员选择在工作场所呈现低空气传播浓度的粉末配方。
The trend among pharmaceutical companies to develop selective drugs of high potency has pushed the industry to consider the potential of each hazardous ingredient to become airborne. Dustiness issues are not unique to the pharmaceutical industry, but are relevant to any industry where powdered materials are mixed, transferred and handled. Interest in dustiness is also driven by concerns for worker health, the potential for plant explosions and the prevention of product loss. Unlike other industries, the pharmaceutical industry is limited by the milligram quantity of powdered material available for testing during product development. These needs have led to the development of a bench-top dustiness tester that requires only 10 mg of powder and fully contains the generated aerosol. The powder is dispersed within a 5.7 liter glass chamber that contains a respirable mass sampler and a closed-face sampler to quantify the respirable and total dust that are generated with a given energy input. The tester distinguished differences in dustiness levels of five different powders. Finer powders were dustier, and the respirable dust percentage was always less than that for total dust. Four testers have been built and evaluated using pharmaceutical grade lactose. Dustiness measurements determined using all four testers were comparable. The pharmaceutical industry uses surrogates such as lactose to represent active compounds in tests that estimate the dust concentration likely to occur in a new manufacturing operation. Differences between the dustiness of the active compound and its surrogate challenge the relevance of the surrogate tests to represent true exposures in the workplace. The tester can determine the dustiness of both the active compound and its surrogate, and the resultant ratio can help to interpret dust concentrations from surrogate tests. Further, dustiness information may allow the pharmaceutical researcher to select powder formulations that present low airborne concentrations in the workplace.