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首页> 外文期刊>Journal of pharmaceutical sciences. >A novel method for deriving true density of pharmaceutical solids including hydrates and water-containing powders.
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A novel method for deriving true density of pharmaceutical solids including hydrates and water-containing powders.

机译：一种推导包括水合物和含水粉剂在内的药物固体真实密度的新方法。

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摘要

True density is commonly measured using helium pycnometry. However, most water-containing powders, for example, hydrates, amorphous drugs and excipients, and most tablet formulations, release water when exposed to a dry helium atmosphere. Because released water brings significant errors to the measured true density and drying alters the nature of water-containing solids, the helium pycnometry is not suitable for those substances. To overcome this problem, a novel method has been developed to accurately calculate powder true density from compaction data. No drying treatment of powder samples is required. Consequently, the true density thus obtained is relevant to tableting characterization studies because no alteration to the solid is induced by drying. This method involves nonlinear regression of compaction pressure-tablet density data based on a modified Heckel equation. When true density values of water-free powders derived by this novel method were plotted against values measured using pycnometry, aregression line with slope close to unity and intercept close to zero was obtained. Thus, the validity of this method was supported. Using this new method, it was further demonstrated that helium pycnometry always overestimates true densities of water containing powders, for example, hydrates, microcrystalline cellulose (MCC), and tablet formulations. The calculated true densities of powders were the same for different particle shapes and sizes of each material. This further suggests that true density values calculated using this novel method are characteristic of given materials and independent of particulate properties.
机译：真实密度通常使用氦比重瓶进行测量。但是，大多数含水粉末，例如水合物，无定形药物和赋形剂，以及大多数片剂，在暴露于干燥的氦气中都会释放出水。由于释放的水会给所测得的真实密度带来重大误差，并且干燥会改变含水固体的性质，因此氦比重瓶法不适用于这些物质。为了克服这个问题，已经开发了一种新颖的方法，可以根据压实数据准确计算出粉末的真实密度。无需对粉末样品进行干燥处理。因此，如此获得的真实密度与压片表征研究有关，因为干燥不会引起固体改变。该方法涉及基于修正的Heckel方程的压实压力片密度数据的非线性回归。将用这种新方法得出的无水粉末的真实密度值与比重瓶测得的值作图，得出斜率接近于单位且截距接近于零的回归线。因此，支持了该方法的有效性。使用这种新方法，进一步证明氦比重瓶法总是高估了含水粉末（例如水合物，微晶纤维素（MCC）和片剂）中水的真实密度。对于每种材料的不同颗粒形状和尺寸，计算得出的粉末真实密度相同。这进一步表明，使用这种新颖方法计算出的真实密度值是给定材料的特征，并且与颗粒性质无关。

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