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T. Ruez, M. E. Mathews, M. Kaufman, A. Riga, R. P. Singh; Non-invasive Delivery of Ranibizumab and Triamcinolone Acetonide to Retinal Tissues Using Macroesis. Invest. Ophthalmol. Vis. Sci. 2009;50(13):5957.
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To determine the efficacy of Macroesis for drug delivery to the posterior segment.
Macroesis is a non-invasive method of drug delivery that uses alternating current (AC) to deliver drugs to target tissues. It offers several advantages over implant devices and intravitreal injections, such as increased patient safety, the ability to deliver both small and large compounds, programmable dose control, and lower cost of care. Two in-vitro models of drug delivery were used for validity studies. Ranibizumab (48kd) and Triamcinolone Acetonide (435kd) were used for all studies. In the first model, full thickness rabbit tissue (conjunctiva to retina) was mounted on the surface of an inter-digitated electrode. The test compound (Triamcinolone) was placed on the surface of the tissue and the AC electrical field was activated. One millivolt of electricity was applied at various frequencies. In the second model, an inter-digitated electrode was placed on a full thickness rabbit tissue section (conjunctiva to retina). The test compounds were placed on the surface of the tissue and the AC electrical field was activated. 3 cc of medium was placed underneath the tissue to simulate vitreous. Various frequencies, voltages, and time periods were tested. The solution below the tissue was sampled for analysis.
In the first in-vitro model, a change in electric conductivity within the tissue was noted at 12 minutes reflecting transport of drug into the tissue. In the second model, studies using Triamcinolone yielded concentrations ranging from 0.280-0.970 mg/ml depending on the voltage, frequency, and time applied. In as little as 6.7 minutes, clinically efficacious doses could be reached in the preclinical system. Studies using Ranibizumab, yielded concentrations of 0.070-0.171 mg/ml depending on the voltage, frequency, and time applied. In as little at 6.7 minutes, 92.8% throughput could be achieved.
Macroesis can successfully deliver Ranibizumab and Triamcinolone Acetonide in a non-invasive manner using the Buckeye Ocular delivery system. Prototype device designs and in-vitro studies will be discussed.
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