Application and efficacy of a customized intravaginal ring device of hot-melt extrusion progesterone
OBJECTIVE To employed hot melt extrusion(HME)technology to prepare intravaginal rings(IVRs)and cus-tomize an HME device specifically for IVR production based upon the characteristics and processing properties of IVRs.METHODS The customized HME device consists of extrusion,granulation,coating and cooling-curing systems.Extrusion and coating heads are utilized for extruding drug cores and coating IVRs with controlled-release membranes.This device is suitable for preparing various matrix and reservoir types of IVRs.Levonorgestrel reservoir-type IVRs were prepared with ethylene-vinyl acetate copolymer(EVA)as a carrier material and drug preparation effects analyzed.The effects of different matrix materials,drug loading levels and membrane thicknesses on IVR preparation were examined through a single-factor experimental approach.In vitro drug release of obtained IVRs was determined with a paddle method for evaluating the application effectiveness of this device.RESULTS The customized HME IVR device exhibited excellent processing performance.Levonorgestrel IVRs were successfully prepared with various EVA matrix materials(EVA9,EVA16,EVA18,EVA28,EVA33&EVA40),drug loading levels(10％/20％/30％/40％,wt％)and membrane thicknesses(0.02/0.06/0.08/0.15 mm).The resulting IVRs displayed uniform appearance and achieved the expected controlled-release effects with stable drug release profiles.CONCLUSION The customized HME IVR device enables effective drug preparation.It provides an efficient and straightforward method for intra-vaginal ring formulation with broad applications.
hot-melt extrusionintravaginal ringsolid dispersionslow and controlled release
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