EP4653499A2 — Silicone material, silicone tube, implant, pharmaceutical composition, and test method for amount of drug released

USPTO Abstract

Disclosed are a silicone material, a silicone tube, an implant, a pharmaceutical composition, and a test method for the amount of a drug released. a raw material composition of the silicone material comprises the following components in parts by weight: 100 parts of R-vinyl silicone rubber; 20-80 parts of a reinforcing agent; 0.3-3.0 parts of hydrogen-containing silicone oil; and ≥ 0.000002 parts of a catalyst, preferably being 0.000002-0.00005 parts; the content of vinyl groups in the R-vinyl silicone rubber is 0.10-0.50 mol%; the content of Si-H groups in the hydrogen-containing silicone oil is 0.18-1.6 mol%; the molar ratio of the Si-H groups in the hydrogen-containing silicone oil to the vinyl groups in the R-vinyl silicone rubber is (0.5-4):1; and optionally, said material further comprises an inhibitor. A silicone tube prepared by the silicone material has an excellent mechanical property and good biocompatibility; and an implant made from the silicone tube, upon loading with an active drug, has a stable drug release curve.