Perivascular patch using biodegradable polymers: Investigation of mechanical and drug elution characteristics

Intimal hyperplasia (IH) is the primary cause for the vascular graft stenosis. Perivascular devices offer a potential treatment option to reduce the impact of intimal hyperplasia by providing mechanical support and local administration of therapeutic agents to control cellular overgrowth. In the present study, a perivascular patch primarily made up of biodegradable polymer, Poly L-Lactide, has been designed with adequate mechanical strength and ability for sustained drug elution of anti-proliferative drug (Paclitaxel). The elastic modulus of the polymeric film has been optimized by blending the base polymer with different grades of biocompatible polyethylene glycols. Using design of experiments, the optimized parameters were obtained as PLLA with 2.5% PEG-6000 and have shown 3.14 MPa elastic modulus. The film prepared based on optimum conditions has been employed for prolonged drug delivery (about four months) under simulated physiological conditions. The addition of drug release rate enhancer (polyvinyl pyrrolidone K90F) has improved the drug elution rate and ∼83% drug was released over entire study period. The molecular weight of the base biodegradable polymer was estimated by gel permeation chromatography (GPC) which remained unchanged during the drug release study duration. Evidences of Paclitaxel drug crystallization were found to contribute to the sustained drug elution. The SEM examination of the surface morphology post-incubation revealed micropores on the surface, contributing to the overall drug release rate. The study concluded that perivascular biodegradable films could be tailored for their mechanical properties, and sustained drug elution could also be formulated with reasonable choices of biodegradable polymer and biocompatible additives.