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Sanjib Das, Stuart Williams, Janet Tully, Ayush Verma, Jeremy Hansen, Melissa Hernandez, Tyler Pegoraro, Tomas Navratil, Benjamin Maynor, Benjamin Yerxa; Sustained Release Biodegradable Steroid Formulations for Intravitreal Delivery . Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4165.
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© ARVO (1962-2015); The Authors (2016-present)
Intraocular implants for the delivery of steroids are used for treatment of Retinal Vein Occlusion (RVO), uveitis and Diabetic Macular Edema (DME). Current therapies are limited by their ability to design specific shape and size ocular implants or microsuspensions with efficacious loadings of steroid. It is desirable to design implants that are biodegradable, tolerable and release therapeutic levels of steroid six months or longer. We have demonstrated the ability to precisely fabricate intraocular implants and microparticle suspensions for the tunable release of steroids.
Specific size and shape biodegradable dexamethasone-polymer steroids implants and particles were fabricated with controlled loadings of dexamethasone using the proprietary PRINT® technology. Implant and microparticle size, shape and morphology were determined by Scanning Electron Microscopy (SEM). Dexamethasone content was measured by RP-HPLC The mobile phase consisted of a gradient of 0.1% TFA in purified water and 0.1% TFA in acetonitrile over 5 minutes at 1.0 mL/min. UV absorbance of the steroid was measured at 245 nm. Dexamethasone release was characterized in vitro in Triton X-100 in 1X PBS at 370C and measured by HPLC.
Predefined size and shape biodegradable dexamethasone implants and microparticles were fabricated using the PRINT technology with a high degree of mass uniformity and dexamethasone content. In vitro release was controlled by tuning of the implant formulations. Syringeable high concentration particle suspension formulations were developed allowing for the delivery of mg quantities of steroids in small gauge needle sizes.
The PRINT technology uniquely allows for the fabrication of intraocular implants with uniform size, shape and dose. These formulations demonstrate tunable, sustained release of steroid. High concentration particulate suspensions allow for the delivery of mg quantities of drug in small needle gauges with potential for sustained release applications.
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