Biological Evaluation of Medical Devices in the Form of Suppositories for Rectal and Vaginal Use

Background. Programs of preclinical safety studies the health care products depend on regulatory status investigated products. The classification such products, in particular suppositories for rectal and vaginal use, is a critical step developing tactics their biological evaluation. Adaptation evaluation methods medical devices based combination biologically active substances, as well results urgent task biomedicine. Objective. To substantiate to carry out form octenidine dihydrochloride ("Prodexyn") Saw palmetto, Levisticum officinale Calendula officinalis extracts ("Pravenor"). Methods. Biological was conducted according requirements ISO 10993 standards using vitro vivo test systems (cytotoxicity cell culture MTT test, sensitizing irritating effect guinea pigs). Results. cytotoxicity (СС50) device "Prodexyn" extract Vero 8.35 μg/ml calculated 416.65 dexpanthenol. "Pravenor" found be non-toxic culture. According MMT assay CC50 1.67 μg/ml, 83.33 – indicators different ingredients were following: 50 mg/ml dwarf palm berries (Saw palmetto), 16.67 lovage roots (Levisticum officinale), calendula flowers (Calendula officinalis). No or skin effects observed pigs. Conclusions. performed systems. It demonstrated an acceptable level 5 times more sensitive than method determination cytotoxicity.