One-step solid-oil-water emulsion for sustained bioactive ranibizumab release

References

• Chappelow A, Kaiser P. Neovascular age-related macular degeneration. Drugs. 2008;68(8):1029–1036.
   PubMed Web of Science ®Google Scholar
• Pauleikhoff D. Neovascular age-related macular degeneration: natural history and treatment outcomes. Retina. 2005;25(8):1065–1084.
   PubMed Web of Science ®Google Scholar
• Congdon N, O’Colmain B, Klaver CCW, et al. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol. 2004;122(4):477–485.
   PubMed Web of Science ®Google Scholar
• Blumenkranz MS, Leung L-S, Martin DF. et al., Chapter 67 – Pharmacotherapy of age-related macular degeneration. Retina (Fifth Edition). 1213–1255. London: W.B. Saunders; 2013.
   Google Scholar
• CATT Research Group, Martin DF, Maguire MG, Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med 2011;364(20):1897–1908.
   PubMed Web of Science ®Google Scholar
• Martin DF, Maguire MG, Fine SL, et al. Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration. Ophthalmology. 2012;119(7):1388–1398
   PubMed Web of Science ®Google Scholar
• Bakri SJ, Snyder MR, Reid JM, et al. Pharmacokinetics of intravitreal ranibizumab (Lucentis). Ophthalmology. 2007;114(12):2179–2182.
   PubMed Web of Science ®Google Scholar
• Bakri SJ, Snyder MR, Reid JM, et al. Pharmacokinetics of intravitreal bevacizumab (Avastin). Ophthalmology. 2007;114(5):855–859.
   PubMed Web of Science ®Google Scholar
• Meyer CH, Holz FG. Preclinical aspects of anti-VEGF agents for the treatment of wet AMD: ranibizumab and bevacizumab. Eye (Lond). 2011;25(6):661–672.
   PubMed Web of Science ®Google Scholar
• Ferrara N, Damico L, Shams N, et al. Development of ranibizumab, an anti-vascular endothelial growth factor antigen binding fragment, as therapy for neovascular age-related macular degeneration. Retina. 2006;26(8):859–870.
   PubMed Web of Science ®Google Scholar
• Avery RL. What is the evidence for systemic effects of intravitreal anti-VEGF agents, and should we be concerned? Br J Ophthalmol. 2014;98(Suppl 1):i7–10.
   PubMedGoogle Scholar
• Ladas ID, Karagiannis DA, Rouvas AA, et al. Safety of repeat intravitreal injections of bevacizumab versus ranibizumab: our experience after 2,000 injections. Retina. 2009;29(3):313–318.
   PubMed Web of Science ®Google Scholar
• Abrishami M, Zarei-Ghanavati S, Soroush D, et al. Preparation, characterization, and in vivo evaluation of nanoliposomes-encapsulated bevacizumab (avastin) for intravitreal administration. Retina. 2009;29(5):699–703.
   PubMed Web of Science ®Google Scholar
• Hu CC, Chaw JR, Chen CF, et al. Controlled release bevacizumab in thermoresponsive hydrogel found to inhibit angiogenesis. Biomed Mater Eng. 2014;24(6):1941–1950.
   PubMed Web of Science ®Google Scholar
• Wang CH, Hwang YS, Chiang PR, et al. Extended release of bevacizumab by thermosensitive biodegradable and biocompatible hydrogel. Biomacromolecules. 2012;13(1):40–48.
   PubMed Web of Science ®Google Scholar
• Varshochian R, Jeddi-Tehrani M, Mahmoudi AR, et al. The protective effect of albumin on bevacizumab activity and stability in PLGA nanoparticles intended for retinal and choroidal neovascularization treatments. Eur J Pharm Sci. 2013;50(3–4):341–352.
   PubMed Web of Science ®Google Scholar
• Pandit J, Sultana Y, Aqil M. Chitosan-coated PLGA nanoparticles of bevacizumab as novel drug delivery to target retina: optimization, characterization, and in vitro toxicity evaluation. Artif Cells Nanomed Biotechnol. 2016;18:1–11.
   Google Scholar
• Pan CK, Durairaj C, Kompella UB, et al. Comparison of long-acting bevacizumab formulations in the treatment of choroidal neovascularization in a rat model. J Ocul Pharmacol Ther. 2011;27(3):219–224.
   PubMed Web of Science ®Google Scholar
• Li F, Hurley B, Liu Y, et al. Controlled release of bevacizumab through nanospheres for extended treatment of age-related macular degeneration. Open Ophthalmol J. 2012;6:54–58.
   PubMedGoogle Scholar
• Chang DP, Garripelli VK, Rea J, et al. Investigation of fragment antibody stability and its release mechanism from poly(lactide-co-glycolide)-triacetin depots for sustained-release applications. J Pharm Sci. 2015;104(10):3404–3417.
   PubMed Web of Science ®Google Scholar
• Yandrapu SK, Upadhyay AK, Petrash JM, et al. Nanoparticles in porous microparticles prepared by supercritical infusion and pressure quench technology for sustained delivery of bevacizumab. Mol Pharm. 2013;10(12):4676–4686.
   PubMed Web of Science ®Google Scholar
• Varshochian R, Riazi-Esfahani M, Jeddi-Tehrani M, et al. Albuminated PLGA nanoparticles containing bevacizumab intended for ocular neovascularization treatment. J Biomed Mater Res A. 2015;103(10):3148–3156.
   PubMed Web of Science ®Google Scholar
• Visscher GE, Robison RL, Maulding HV, et al. Biodegradation of and tissue reaction to 50:50 poly(DL-lactide-co-glycolide) microcapsules. J Biomed Mater Res. 1985;19(3):349–365.
   PubMed Web of Science ®Google Scholar
• Fournier E, Passirani C, Montero-Menei CN, et al. Biocompatibility of implantable synthetic polymeric drug carriers: focus on brain biocompatibility. Biomaterials. 2003;24(19):3311–3331.
   PubMed Web of Science ®Google Scholar
• Kompella UB, Amrite AC, Pacha Ravi R, et al. Nanomedicines for back of the eye drug delivery, gene delivery, and imaging. Prog Retin Eye Res. 2013;36:172–198.
   PubMed Web of Science ®Google Scholar
• Chang-Lin JE, Attar M, Acheampong AA, et al. Pharmacokinetics and pharmacodynamics of a sustained-release dexamethasone intravitreal implant. Invest Ophthalmol Vis Sci. 2011;52(1):80–86.
   PubMed Web of Science ®Google Scholar
• Elsaid N, Jackson TL, Elsaid Z, et al. PLGA microparticles entrapping chitosan-based nanoparticles for the ocular delivery of ranibizumab. Mol Pharm. 2016;13(9):2923–2940.
   PubMed Web of Science ®Google Scholar
• Osswald CR, Kang-Mieler JJ. Controlled and extended in vitro release of bioactive anti-vascular endothelial growth factors from a microsphere-hydrogel drug delivery system. Curr Eye Res. 2016;41(9):1216–1222.
   PubMed Web of Science ®Google Scholar
• Ye M, Kim S, Park K. Issues in long-term protein delivery using biodegradable microparticles. J Control Release. 2010;146(2):241–260.
   PubMed Web of Science ®Google Scholar
• van de Weert M, Hoechstetter J, Hennink WE, et al. The effect of a water/organic solvent interface on the structural stability of lysozyme. J Controlled Release. 2000;68(3):351–359.
   PubMed Web of Science ®Google Scholar
• Wu F, Jin T. Polymer-based sustained-release dosage forms for protein drugs, challenges, and recent advances. Aaps Pharmscitech. 2008;9(4):1218–1229.
   PubMed Web of Science ®Google Scholar
• Perez C, Castellanos IJ, Costantino HR, et al. Recent trends in stabilizing protein structure upon encapsulation and release from bioerodible polymers. J Pharm Pharmacol. 2002;54(3):301–313.
   PubMed Web of Science ®Google Scholar
• Giteau A, Venier-Julienne MC, Marchal S, et al. Reversible protein precipitation to ensure stability during encapsulation within PLGA microspheres. Eur J Pharm Biopharm. 2008;70(1):127–136.
   PubMed Web of Science ®Google Scholar
• van Apeldoorn AA, van Manen HJ, Bezemer JM, et al. Raman imaging of PLGA microsphere degradation inside macrophages. J Am Chem Soc. 2004;126(41):13226–13227.
   PubMed Web of Science ®Google Scholar
• Rygula A, Majzner K, Marzec KM, et al. Raman spectroscopy of proteins: a review. J Raman Spectroscopy. 2013;44(8):1061–1076.
   Web of Science ®Google Scholar
• Giteau A, Venier-Julienne MC, Aubert-Pouessel A, et al. How to achieve sustained and complete protein release from PLGA-based microparticles? Int J Pharm. 2008;350(1–2):14–26.
   PubMed Web of Science ®Google Scholar
• Yang YY, Chung TS, Ng NP. Morphology, drug distribution, and in vitro release profiles of biodegradable polymeric microspheres containing protein fabricated by double-emulsion solvent extraction/evaporation method. Biomaterials. 2001;22(3):231–241.
   PubMed Web of Science ®Google Scholar
• Bilati U, Allemann E, Doelker E. Strategic approaches for overcoming peptide and protein instability within biodegradable nano- and microparticles. Eur J Pharm Biopharm. 2005;59(3):375–388.
   PubMed Web of Science ®Google Scholar
• Sah H. Stabilization of proteins against methylene chloride/water interface-induced denaturation and aggregation. J Control Release. 1999;58(2):143–151.
   PubMed Web of Science ®Google Scholar
• Perez-Rodriguez C, Montano N, Gonzalez K, et al. Stabilization of alpha-chymotrypsin at the CH2Cl2/water interface and upon water-in-oil-in-water encapsulation in PLGA microspheres. J Control Release. 2003;89(1):71–85.
   PubMed Web of Science ®Google Scholar
• Maruoka S, Matsuura T, Kawasaki K, et al. Biocompatibility of polyvinylalcohol gel as a vitreous substitute. Curr Eye Res. 2006;31(7–8):599–606.
   PubMed Web of Science ®Google Scholar
• Siepmann J, Faisant N, Akiki J, et al. Effect of the size of biodegradable microparticles on drug release: experiment and theory. J Control Release. 2004;96(1):123–134.
   PubMed Web of Science ®Google Scholar
• Fredenberg S, Wahlgren M, Reslow M, et al. The mechanisms of drug release in poly(lactic-co-glycolic acid)-based drug delivery systems–a review. Int J Pharm. 2011;415(1–2):34–52.
   PubMed Web of Science ®Google Scholar
• Song X, Zhao Y, Hou S, et al. Dual agents loaded PLGA nanoparticles: systematic study of particle size and drug entrapment efficiency. Eur J Pharm Biopharm. 2008;69(2):445–453.
   PubMed Web of Science ®Google Scholar
• Panyam J, Dali MM, Sahoo SK, et al. Polymer degradation and in vitro release of a model protein from poly(D,L-lactide-co-glycolide) nano- and microparticles. J Control Release. 2003;92(1–2):173–187.
   PubMed Web of Science ®Google Scholar
• Wang J, Chua KM, Wang CH. Stabilization and encapsulation of human immunoglobulin G into biodegradable microspheres. J Colloid Interface Sci. 2004;271(1):92–101.
   PubMed Web of Science ®Google Scholar
• Lagarce F, Garcion E, Faisant N, et al. Development and characterization of interleukin-18-loaded biodegradable microspheres. Int J Pharm. 2006;314(2):179–188.
   PubMedGoogle Scholar
• Park TG. Degradation of poly(D,L-lactic acid) microspheres – Effect of molecular-weight. J Controlled Release. 1994;30(2):161–173.
   Web of Science ®Google Scholar
• Xu L, Lu T, Tuomi L, et al. Pharmacokinetics of ranibizumab in patients with neovascular age-related macular degeneration: a population approach. Invest Ophthalmol Vis Sci. 2013;54(3):1616–1624.
   PubMed Web of Science ®Google Scholar
• Krohne TU, Liu Z, Holz FG, et al. Intraocular pharmacokinetics of ranibizumab following a single intravitreal injection in humans. Am J Ophthalmol. 2012;154(4):682–686.
   PubMed Web of Science ®Google Scholar
• Langer R. Drug delivery and targeting. Nature. 1998;392(6679 Suppl):5–10.
   PubMed Web of Science ®Google Scholar
• Allen TM, Cullis PR. Drug delivery systems: entering the mainstream. Science. 2004;303(5665):1818–1822.
   PubMed Web of Science ®Google Scholar
• Park TG, Yong Lee H, Sung Nam Y. A new preparation method for protein loaded poly(D, L-lactic-co-glycolic acid) microspheres and protein release mechanism study. J Control Release. 1998;55(2–3):181–191.
   PubMed Web of Science ®Google Scholar
• Aubert-Pouessel A, Venier-Julienne MC, Clavreul A, et al. In vitro study of GDNF release from biodegradable PLGA microspheres. J Control Release. 2004;95(3):463–475.
   PubMed Web of Science ®Google Scholar
• Ferrara N, DavisSmyth T. The biology of vascular endothelial growth factor. Endocr Rev. 1997;18(1):4–25.
   PubMed Web of Science ®Google Scholar
• Olsson AK, Dimberg A, Kreuger J, et al. VEGF receptor signalling – In control of vascular function. Nat Rev Mol Cell Biol. 2006;7(5):359–371.
   PubMed Web of Science ®Google Scholar
• Senger D, Galli SJ, Dvorak AM, et al. Tumor cells secrete a vascular permeability factor that promotes accumulation of ascites fluid. Science. 1983;219(4587):983–985.
   PubMed Web of Science ®Google Scholar
• Lee RJ, Springer ML, Blanco-Bose WE, et al. VEGF gene delivery to myocardium: deleterious effects of unregulated expression. Circulation. 2000;102(8):898–901.
   PubMed Web of Science ®Google Scholar
• Epstein SE, Kornowski R, Fuchs S, et al. Angiogenesis therapy: amidst the hype, the neglected potential for serious side effects. Circulation. 2001;104(1):115–119.
   PubMed Web of Science ®Google Scholar
• Giordano RJ, Cardo-Vila M, Salameh A, et al. From combinatorial peptide selection to drug prototype (I): targeting the vascular endothelial growth factor receptor pathway. Proc Natl Acad Sci U S A. 2010;107(11):512–517.
   Web of Science ®Google Scholar
• Ferrara N, Damico L, Shams N, et al. Development of ranibizumab, an anti-vascular endothelial growth factor antigen binding fragment, as therapy for neovascular age-related macular degeneration. Retina. 2006;26(8):859–870.
   PubMed Web of Science ®Google Scholar
• Wang W, Liu GX, Li YH, et al. Inhibitory effect of tenomodulin versus ranibizumab on in vitro angiogenesis. Int J Ophthalmol. 2017;10(8):1212–1216.
   PubMed Web of Science ®Google Scholar