Finite Dose In Vitro Permeation Testing: Significance of Occluding the Donor compartment, a Case study

IF 3.4 4区医学 Q2 PHARMACOLOGY & PHARMACY

AAPS PharmSciTech Pub Date : 2025-04-08 DOI:10.1208/s12249-025-03091-x

Prajwal N. Murthy, Mohammad Moinul Hossain, Santanu Kundu, Srinath Rangappa, Shivakumar H. N.

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Abstract

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.

Graphical Abstract

Abstract Image

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有限剂量体外渗透试验：封闭供体隔室的意义，一个个案研究

溶剂的蒸发引起配方的显著变化，直接影响其性能。外用产品的性能是由其内在质量属性和在临床相关剂量应用于皮肤时由于溶剂蒸发而发生的转化之间的相互作用决定的。为了准确评估体内性能，建议在进行体外渗透试验时，在皮肤上施用较小剂量并保持供体隔室开放，以使溶剂蒸发。这篇手稿强调了溶剂蒸发在区分两种不同组成产品的性能中的关键作用。一种凝胶配方含有酒精，而另一种不含酒精。虽然两者表现出相似的品质属性，但它们的干燥特征差异很大。封闭供体室（蒸发禁用（ED））进行的渗透研究未能揭示这些差异。然而，当供体隔间暴露在大气中使其蒸发（蒸发启用（EN））时，两种产品之间的性能差异变得明显。图形抽象

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来源期刊

AAPS PharmSciTech 医学-药学

CiteScore

6.80

自引率

3.00%

发文量

264

审稿时长

2.4 months

期刊介绍： AAPS PharmSciTech is a peer-reviewed, online-only journal committed to serving those pharmaceutical scientists and engineers interested in the research, development, and evaluation of pharmaceutical dosage forms and delivery systems, including drugs derived from biotechnology and the manufacturing science pertaining to the commercialization of such dosage forms. Because of its electronic nature, AAPS PharmSciTech aspires to utilize evolving electronic technology to enable faster and diverse mechanisms of information delivery to its readership. Submission of uninvited expert reviews and research articles are welcomed.