Review & Monography

The research progress of patch on in vitro release test, in vitro experimental methodology and in vivo-in vitro

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  • 1. Dalian University of Technology, Department of Pharmacy, Dalian 116024, China;
    2. National Institutes for Food and Drug Control, Chemical Drug Control Agency, Beijing 102629, China;
    3. Dalian Kexiang Technology Development Co., Ltd., Dalian 116024, China

Revised date: 2023-11-22

  Online published: 2024-06-21

Abstract

Patch refers to a thin sheet flexible preparation made of raw drug and suitable material for sticking on the skin, which can produce systemic or local effects. In vitro release test (IVRT) and in vitro permeation test (IVPT) are important contents of preclinical pharmaceutical research for formulation process optimization, quality control and safety and effectiveness evaluation of patch. The experimental equipment and methods used are different, the obtained experimental samples and data are different from each other, and the accuracy and precision of the experimental data are also different. Therefore, the selection of experimental equipment and the establishment of experimental methods in the in vitro experiment of IVRT & IVPT is a problem worthy of attention. In this paper, the research status of patch was summarized, the requirements of pharmacopoeia of different countries for IVRT experiments were briefly introduced, and the differences of different methods were reviewed. For IVPT experiments that have not yet been prescribed by relevant standards, the common types of experimental equipment and experimental conditions were introduced in detail, the applicability of different equipment and the influence of main experimental conditions (temperature, stirring speed, composition of acceptor solution, selected skin, etc.) on the experimental results were summarized, and the research progress of in vivo and in vitro correlation was introduced. At the same time, the validity of the experimental data was discussed, hoping to provide a useful reference for the development and research of the in vitro experimental methodology of the patch.

Cite this article

SI Wen-xuan, MA Xun, WANG Hong-xia, CHEN Hua, WANG Qing . The research progress of patch on in vitro release test, in vitro experimental methodology and in vivo-in vitro[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44(1) : 11 -22 . DOI: 10.16155/j.0254-1793.2024.01.02

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