Abstract
Purpose: Ranibizumab is a monoclonal antibody fragment, targeting all isoforms of vascular endothelial growth factor A (VEGF-A), a protein involved in angiogenesis. It is used to treat age-related macular degeneration (AMD), retinal vein occlusion (RVO), and diabetic macular edema (DME), which are associated with blindness worldwide. However, proper treatment can decrease the loss of vision in about 90% of patients. Because of poor drug uptake in topical therapy and several adverse side effects of systemic irregularities and intravitreal injections, sustained-release drug delivery systems are more suitable for treatment. However, there are many challenges in the development of these systems due to the loss of protein activities. Methods: After drug complexation by the ion pairing method and preparation of a polymeric implant, containing the drug, the characteristics of the complexes were examined by Fourier-transform infrared spectroscopy and circular dichroism spectroscopy. The stability of antibody activity and biocompatibility of the released drug from the implant were assessed by bioassays and MTT assay, respectively. Finally, the release kinetics were investigated. Results: The bioassays showed the higher activity of the drug complex, compared to the free form, besides good biocompatibility in vitro. Also, the release data confirmed sustained and controlled release characteristics for the prepared implant. Conclusion: In this study, for the first time, we proposed a method for developing a sustained-release intraocular implant, consisting of ranibizumab by the heating method. This method allows for the industrial production of ranibizumab by extrusion and eliminates the complications related to reservoir systems.
Highlights
Considering the anatomical structure and physiological function of the eyes and eye tissues, design of ophthalmic drugs has always been a major challenge
Based on the results of previous studies, the pKa of sulfate c group in Dextran sulfate sodium (DS) was
The ranibizumab implant was successfully prepared by the melting method, with PHBV and Polyethylene glycol 600 (PEG600) as pore formers
Summary
Considering the anatomical structure and physiological function of the eyes and eye tissues, design of ophthalmic drugs has always been a major challenge. Eye drops and ointments are a conventional medications for the treatment of ophthalmic diseases. The use of these drugs minimizes drug delivery to the posterior region of the eye. They are commonly used to treat anterior ocular diseases. Treatment of neovascularization in the choroid and posterior areas is one of the major problems, many efforts are being currently made to deliver drugs to these posterior d regions.[1,2,3]
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