title: Dextran sulfate as a drug delivery platform for drug-coated balloons: Preparation, characterization, in vitro drug elution, and smooth muscle cell response.
abstract: Drug-coated balloons (DCBs) have now emerged as a promising approach to treat peripheral artery disease. However, a significant amount of drug from the balloon surface is lost during balloon tracking and results in delivering only a subtherapeutic dose of drug at the diseased site. Hence, in this study, the use of dextran sulfate (DS) polymer was investigated as a platform to control the drug release from balloons. An antiproliferative drug, paclitaxel (PAT), was incorporated into DS films (PAT-DS). The characterizations using SEM, FT-IR, and DSC showed that the films prepared were smooth and homogenous with PAT molecularly dispersed in the bulk of DS matrix in amorphous form. An investigation on the interaction of smooth muscle cells (SMCs) with control-DS and PAT-DS films showed that both films inhibited SMC growth, with a superior inhibitory effect observed for PAT-DS films. PAT-DS coatings were then produced on balloon catheters. The integrity of coatings was well-maintained when the balloons were either deflated or inflated. In this study, up to 2.2 µg/mm(2) of PAT was loaded on the balloons using the DS platform. Drug elution studies showed that only 10 to 20% of the total PAT loaded was released from the PAT-DS coated balloons during the typical time period of balloon tracking (1 min) and then ∼80% of the total PAT loaded was released during the typical time period of balloon inflation and treatment (from 1 min to 4 min). Thus, this study demonstrated the use of DS as a platform to control drug delivery from balloons. © 2015 The Authors Journal of Biomedical Materials Research Part B: Applied Biomaterials Published by Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 104B: 1416-1430, 2016.
authors.affiliation: Biomedical Engineering Program, The University of South Dakota, Sioux Falls, South Dakota, 57107.
authors.forename: Sujan
authors.initials: S
authors.lastname: Lamichhane
authors.affiliation: Biomedical Engineering Program, The University of South Dakota, Sioux Falls, South Dakota, 57107.
authors.forename: Jordan
authors.initials: J
authors.lastname: Anderson
authors.affiliation: Sanford Research, Sioux Falls, South Dakota, 57104.
authors.forename: Tyler
authors.initials: T
authors.lastname: Remund
authors.affiliation: Sanford Health, Sioux Falls, South Dakota, 57105.
authors.forename: Patrick
authors.initials: P
authors.lastname: Kelly
authors.affiliation: Biomedical Engineering Program, The University of South Dakota, Sioux Falls, South Dakota, 57107. Gopinath.Mani@usd.edu.
authors.forename: Gopinath
authors.initials: G
authors.lastname: Mani
mesh_terms: D000800:Angioplasty, Balloon / Q000295:instrumentation*; D002478:Cells, Cultured; D020099:Coated Materials, Biocompatible / Q000737:chemistry; D016264:Dextran Sulfate / Q000737:chemistry / Q000494:pharmacology; D016503:Drug Delivery Systems / Q000379:methods*; D006801:Humans; D008422:Materials Testing; D009131:Muscle, Smooth, Vascular / Q000166:cytology / Q000378:metabolism*; D032389:Myocytes, Smooth Muscle / Q000166:cytology / Q000378:metabolism*; D017239:Paclitaxel / Q000737:chemistry / Q000494:pharmacology; D058729:Peripheral Arterial Disease / Q000378:metabolism / Q000628:therapy
chemical_list: D020099:Coated Materials, Biocompatible; D016264:Dextran Sulfate; D017239:Paclitaxel
keywords: dextran sulfate; drug-coated balloons; peripheral artery disease; restenosis; smooth muscle cells