Research Progress on in vitro Physical-chemical Evaluation Methods for Intravaginal Rings
Objective:To study and analyze the research progress and application of in vitro physical-chemical evaluation methods for Intravaginal Rings(IVRs),discuss the existing problems,and to provide reference for the quality control and scientific supervision of such products in China.Methods:The current status of IVRs development and marketed products at home and abroad was investigated,and in vitro physical-chemical evaluation methods,such as drug release tests and mechanical property tests,were summarized and analyzed.Results:As a new type of drug-device combination product,there was currently a lack of standardized methods for in vitro physical-chemical evaluation of IVRs at home and abroad.Conclusion:IVRs have a broad application prospect in the prevention of AIDS and the treatment of gynaecological diseases.Due to the dual characteristics of drug and device,their quality control and evaluation methods cannot be carried out solely in accordance with the relevant requirements of drugs,and there is an urgent need to carry out research on the standardization of IVRs in vitro evaluation test methods.
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