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首页> 美国卫生研究院文献>AAPS PharmSciTech >A study on moisture isotherms of formulations: the Use of polynomial equations to predict the moisture isotherms of tablet products
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A study on moisture isotherms of formulations: the Use of polynomial equations to predict the moisture isotherms of tablet products

机译：制剂的水分等温线研究：使用多项式方程式预测片剂产品的水分等温线

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The objectives of this study were to investigate the effects of manufacturing parameters on the moisture sorption isotherms of some tablet formulations and to predict the moisture isotherms of the final formulations using polynomial equations. Three tablet formulations including a placebo and 2 drug products were prepared through wet granulation, drying, compression, and coating processes. Equilibrium moisture content of excipients and granules at 25°C with different relative humidities were determined using a dynamic moisture sorption microbalance, while such data for tablets were determined using desiccators. Moisture sorption isotherms were expressed in polynomial equations. Excipient isotherms were used to predict the moisture sorption isotherms of the 3 tablet products. Results showed that different physical properties of granules and tablets, such as particle size distribution, density, and porosity resulting from different granulation and compression conditions did not have significant effect on the moisture isotherms of the materials. Changing coating materials from a powder mixture to a film also did not change the moisture sorption characteristics significantly. The predicted moisture sorption isotherms of the formulations agreed well with the experimental results. These results show that moisture isotherms of solid pharmaceutical products manufactured with conventional processes may be predicted using the isotherms of excipients, and polynomial equations may be used as a tool for the prediction of moisture isotherms.
机译：这项研究的目的是研究制造参数对某些片剂的水分吸附等温线的影响，并使用多项式方程式预测最终制剂的水分等温线。通过湿法制粒，干燥，压制和包衣工艺制备了包括安慰剂和2种药物产品在内的三种片剂。使用动态水分吸附微量天平测定25°C不同相对湿度下的赋形剂和颗粒的平衡水分含量，而使用干燥剂测定片剂的此类数据。水分吸附等温线用多项式方程表示。赋形等温线用于预测3种片剂产品的水分吸收等温线。结果表明，由于不同的制粒和压缩条件而产生的颗粒和片剂的不同物理性质，例如粒度分布，密度和孔隙率，对材料的水分等温线没有显着影响。将涂料从粉末混合物更改为薄膜也不会明显改变吸湿特性。配方的预计吸湿等温线与实验结果吻合得很好。这些结果表明，可以使用赋形剂的等温线预测以常规方法制造的固体药物产品的等温线，并且多项式方程式可以用作预测等温线的工具。

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