Murthy Prajwal N, Hossain Mohammad Moinul, Kundu Santanu, Rangappa Srinath, H N Shivakumar
Institute for Drug Delivery and Biomedical Research, Bangalore, Karnataka, India.
Dave C Swalm School of Chemical Engineering, Mississippi State University, Starkville, Mississippi, USA.
AAPS PharmSciTech. 2025 Apr 8;26(4):103. doi: 10.1208/s12249-025-03091-x.
The evaporation of the solvent induces significant changes in formulation, directly impacting its performance. The performance of topical products is determined by the interplay between their inherent quality attributes and the transformations that occur due to solvent evaporation when applied to the skin in clinically relevant doses. To accurately assess, in vivo performance, it is advisable to apply smaller doses to the skin and keep the donor compartment open to enable evaporation of solvents while carrying out in vitro permeation tests. This manuscript highlights the critical role of solvent evaporation in differentiating the performance of two compositionally distinct products. One gel formulation contained alcohol, while the other did not. Although both exhibited similar quality attributes, their drying profiles varied significantly. Permeation studies conducted with closed donor compartments (Evaporation-disabled (ED)) failed to reveal these differences. However, when the donor compartments were exposed to the atmosphere to allow evaporation (Evaporation-enabled (EN)), the performance differences between the two products became evident.
溶剂的蒸发会引起制剂的显著变化，直接影响其性能。局部用产品的性能取决于其固有质量属性与在临床相关剂量下应用于皮肤时因溶剂蒸发而发生的转变之间的相互作用。为了准确评估体内性能，建议在进行体外渗透试验时，在皮肤上涂抹较小剂量，并保持供体隔室开放以实现溶剂蒸发。本手稿强调了溶剂蒸发在区分两种成分不同的产品性能方面的关键作用。一种凝胶制剂含有酒精，而另一种则不含。尽管两者表现出相似的质量属性，但其干燥曲线却有显著差异。在封闭供体隔室（无蒸发（ED））条件下进行的渗透研究未能揭示这些差异。然而，当供体隔室暴露在大气中以允许蒸发（有蒸发（EN））时，两种产品之间的性能差异就变得明显了。
