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ASHA PATEL, Ripal Gaudana, Yi Hao, Nelson Sabates, Ashim Mitra; Development Of A Novel Nanoparticulate Based Formulation Of Antibody-polysaccharide HIP Complex. Invest. Ophthalmol. Vis. Sci. 2012;53(14):299.
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To optimize effect of different process variables on nanoparticulate based formulation of ranibizumab-dextran sulfate (HIP) complex.
HIP complex of Ranibizumab was prepared using dextran sulfate as a complexing agent. We have optimized complexation of Ranibizumab with dextran sulfate by varying pH of Ranibizumab solution and molar ratio of Ranibizumab to dextran sulfate. Fourier transform spectroscopy was also performed to establish ionic interaction. Indirect ELISA involving VEGF was explored to confirm VEGF binding ability of Ranibizumab after dissociation from HIP complex. Polymeric nanoparticles loaded with HIP complex were prepared by modified nanoprecipitation method. Moreover, effect of different grades of PLGA (PLGA 50:50, PLGA 65:35, PLGA 75:25) and different ratio of drug to polymer on entrapment efficiency was studied. Prepared nanoparticles were also characterized for particle size, zeta potential and surface morphology.
Binding efficiency of Ranibizumab was highly dependent on pH and molar ratio of Ranibizumab to dextran sulfate. The entrapment efficiency of nanoparticles was highly dependent on the nature of PLGA and drug to polymer ratio. As hydrophobicity of PLGA was increased, entrapment efficiency was enhanced and approximately 70%, 75% and 85% entrapment was obtained with PLGA(50:50), PLGA(65:35)and PLGA (75:25) respectively. When PLGA 65:35 was employed for nanoparticles preparation, entrapment efficiency of approximately 75% and 85% were obtained for drug to polymer ratio of 1:10 and 1:15 respectively. The size of the nanoparticles was around 150 nm in all the cases.
Development of a nanoparticulate formulation of macromolecule is a significant challenge. Different process variables have shown impact on the entrapment of HIP complex inside the nanoparticles. Nanoparticle preparation by nanoprecipitation method utilizing HIP complex has shown promising result with maximum entrapment of approximately 85%.
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