Development of a rapidly made, easily personalized drug-eluting polymer film on the electrode array of a cochlear implant during surgery.

OBJECTIVE:To develop a drug-eluting polymer film which can be easily personalized and rapidly made on the electrode array of a cochlear implant during surgery. METHODS:A precursor solution was prepared with poly lactic-co-glycolic acid (PLGA) and trichloromethane. Using a dip-coating method, the silicone electrode array (HiFocus 1J, Advanced Bionics) was coated in polymer film produced from the precursor solution containing one of three drugs: dexamethasone sodium phosphate (DSP), cytosine arabinoside hydrochloride (Ara-C), or nicotinamide adenine dinucleotide (NAD), and the release of these drugs from the polymer film was studied. The drug-eluting film on the electrode array was analyzed by environmental scanning electron microscopy (ESEM). The water contact angle and the impedance of the electrode array were measured before and after coating. Drug release kinetics was evaluated in a quasi-stationary release model, using high performance liquid chromatography every 24 h for 15 days. RESULTS:Five electrode arrays were tested with each of the three drugs in the polymer film coating. Before and after coating, ESEM studies revealed that the drug-loaded PLGA coating yielded a smooth covering with an average thickness of 1.02 ± 0.05 μm. The mass of the coated electrode increased by 1.00 ± 0.03 mg. The water contact angle decreased after coating (102 ± 0.6° vs 77 ± 1.6°, p < 0.01) but there was no significant change in the average impedance of the electrodes after coating (0.9 ± 0.22 kΩ vs 1.0 ± 0.18 kΩ, p > 0.05). An in vitro drug kinetics study revealed a faster release in the first 24 h (63.4 ± 0.6%) and a sustained release over the following 15 days (78.3 ± 1.7% in 2 days, 95.6 ± 1.0% in 7 days and 99.1 ± 0.4% in 14 days). The release rate was not affected by the drug, dose or the thickness of the coating. CONCLUSION:The dip-coating method is feasible for rapid casting of a drug-eluting PLGA film on an electrode array during CI surgery. The coated electrode array maintained its original morphology and became more hydrophilic. The loaded drug is released in a sustained manner and is easily regulated, and so the method might represent a potential application for clinical use in cochlear implantation.