Prednisolone-loaded nanocapsules as ocular drug delivery system: development, in vitro drug release and eye toxicity

References

• Alany RG, Rades T, Nicoll J, Tucker IG, Davies NM. W/O microemulsions for ocular delivery: Evaluation of ocular irritation and precorneal retention. J Control Release, 2006;111:145–52
   PubMed Web of Science ®Google Scholar
• Alvarez-Lorenzo C, Hiratani H, Concheiro A. Contact lens for drug delivery: Achieving sustained release with novel systems. Am J Drug Deliv, 2006;4:131–51
   Google Scholar
• Ansel HC, Allen Jr LV, Popovich NG. 2011. Special solutions and suspensions. In: Ansel HC, Allen Jr LV, Popovich NG, eds. Ansel’s pharmaceutical dosage forms and drug delivery systems. Baltimore, MA: Lippincott Williams & Wilkins, pp. 531–5
   Google Scholar
• Arici MK, Arici DS, Topalkara A, Güler CA. Adverse effects of topical antiglaucoma drugs on the ocular surface. J Clin Exp Ophthalmol, 2000;28:113–17
   Google Scholar
• Barile FA. Validating and troubleshooting ocular in vitro toxicology tests. J Pharmacol Toxicol Methods, 2010;61:136–45
   PubMed Web of Science ®Google Scholar
• Bonferoni MC, Chetoni P, Giunchedi P, Rossi S, Ferrari F, Burgalassi S, Caramella C. Carrageenan-gelatin mucoadhesive systems for ion-exchange based ophthalmic delivery: in vitro and preliminary in vivo studies. Eur J Pharm Biopharm, 2004;57:465–72
   PubMed Web of Science ®Google Scholar
• Cariello AJ, Souza GF, Lowen MS, Oliveira MG, Höfling-Lima AL. Assessment of ocular surface toxicity after topical instillation of nitric oxide donors. Arq Bras Oftalmol, 2013;76:38--4
   Google Scholar
• Chrai SS, Patton TF, Mehta A, Robinson JR. Lachrimal and instilled fluid dynamics in rabbit eyes. J Pharm Sci, 1973;62:1112–21
   PubMed Web of Science ®Google Scholar
• Contri RV, Kaiser M, Poletto FS, Pohlmann AR, Guterres SS. Chitosan hydrogel containing capsaicinoids-loaded nanocapsules: An innovative formulation for topical delivery. Soft Mater, 2010;8:370–85
   Web of Science ®Google Scholar
• Cunha Júnior AS, Fialho SL, Carneiro LB, Oréfice F. Microemulsões como veículos de drogas para administração ocular tópica. Arq Bras Oftalmol, 2003;66:385–91
   Google Scholar
• Dillen K, Vandervoort J, Van den Mooter G, Ludwig A. Evaluation of ciprofloxacin-loaded Eudragit® RS100 or RL100/PLGA nanoparticles. Int J Pharm, 2006;314:72–82
   PubMed Web of Science ®Google Scholar
• Domingues GS, Guterres SS, Beck RCR, Pohlmann AR. Micropartículas nanorrevestidas contendo um fármaco modelo hidrofóbico: Preparação em etapa única e caracterização biofarmacêutica. Quim Nova, 2008;31:1966–72
   Web of Science ®Google Scholar
• EVONIK Industries AG, INFO 7. 7/E: Specification and test methods for EUDRAGIT® RL 100 and EUDRAGIT® RL PO, EUDRAGIT® RS 100 and EUDRAGIT® RS PO. Available at: http://eudragit.evonik.com/product/eudragit/Documents/evonik-specification-eudragit-rl-100-rl-po-rs-100-rs-po.pdf. Accessed 10 July 2013.
   Google Scholar
• Fessi H, Puisieux F, Devissaguet JP. 1998. Procédé de préparation dês systèmes coloïdaux d’une substance sous forme de nanocapsules. Eur Patent 0274961 A1
   Google Scholar
• Fialho SL, Rego MGB, Cardillo JA, Siqueira RC, Jorge R, Cunha Júnior AS. Biodegradable implants for intraocular drug delivery. Arq Bras Oftalmol, 2003;66:891–6
   Google Scholar
• Finamor LP, Finamor Jr F, Muccioli C. Corticosteroid therapy and uveitis. Arq Bras Oftalmol, 2002;65:118–36
   Google Scholar
• Fiscella RG. 2008. Ophthalmic drug formulations. In: Bartlett JD, Jaanus SD, eds. Clinical ocular pharmacology. St Louis, MO: Elsevier Health Sciences, pp. 17–38
   Google Scholar
• Flores FC, Ribeiro RF, Ourique AF, Rolim CMB., da Silva CB, Pohlmann AR, Beck RCR, Guterres SS. Nanostructured systems containing an essential oil: Protection against volatilization. Quim Nova, 2011;34:968–72
   Web of Science ®Google Scholar
• Fontana MC, Coradini K, Guterres SS, Pohlmann AR, Beck RCR. Nanoencapsulation as a way to control the release and to increase the photostability of clobetasol propionate: Influence of the nanosctructured system. J Biomed Nanotech, 2009;5:1–10
   PubMed Web of Science ®Google Scholar
• Guideline on validation of analytical procedures: Methodology in International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. 2005. United States of America
   Google Scholar
• Guo X, Yang XF, Yang Y, Hans R, Cai JH, Xue JY, Tan XH, Xie XP, Xiong XK, Huang JM. Prediction of ocular irritancy of 26 chemicals and 26 cosmetic products with isolated rabbit eye (IRE) test. Biomed Environ Sci, 2012;25:359
   Google Scholar
• Gupta H, Agil M, Khar RK, Ali A, Bhatnagar A, Mittal G. Sparfloxacin-loaded PLGA nanoparticles for sustained ocular drug delivery. Nanomedicine, 2010;6:324–33
   PubMed Web of Science ®Google Scholar
• Guterres SS, Fessi H, Barratt G, Devissaguet JP, Puisieux F. Poly(d,l-lactide) nanocapsules containing diclofenac: Formulation and stability study. Int J Pharm, 1995;13:57–63
   Web of Science ®Google Scholar
• Guterres SS, Weiss V, Freitas LL, Pohlmann AR. Influence of benzyl benzoate as oil core on the physicochemical properties of spray-dried powders from polymeric nanocapsules containing indomethacin. Drug Deliv, 2000;7:195–9
   PubMed Web of Science ®Google Scholar
• Hussein OA, Salama HA, Ghorab M, Mahmoud AA. Nanoemulsion as a potential ophthalmic delivery system for dorzolamide hydrochloride. AAPS PharmSciTech, 2009;10:808–19
   PubMed Web of Science ®Google Scholar
• Ibrahim MM, Abd-Elgawad AH, Soliman OA, Jablonski MM. Nanoparticle-based topical ophthalmic formulations for sustained celecoxib release. J Pharm Sci, 2013;102:1036–53
   PubMed Web of Science ®Google Scholar
• Jarvinen K, Jarvinen T, Urtti A. Ocular absorption following topical delivery. Adv Drug Deliv Rev, 1995;16:3–19
   Web of Science ®Google Scholar
• Katzer T, Chaves PS, Bernardi A, Pohlmann AR, Guterres SS, Beck RCR. Castor oil and mineral oil nanoemulsion: Development and compatibility with a soft contact lens. Pharm Dev Technol, 2013 ;19:232–7
   PubMed Web of Science ®Google Scholar
• Kishore AS, Surekha PA, Sekhar PVR, Srinivas A, Murthy PB. Hen egg chorioallantoic membrane bioassay: An in vitro alternative to draize eye irritation test for pesticide screening. Int J Toxicol, 2008;27:449–53
   PubMedGoogle Scholar
• Kshirsagar SJ, Bhalekar MR, Patel JN, Mohapatra SK, Shewale NS. Preparation and characterization of nanocapsules for colon-targeted drug delivery system. Pharm Dev Technol, 2012;17:607–13
   PubMed Web of Science ®Google Scholar
• Le Bourlais C, Acar L, Zia H, Sado PA, Needham T, Leverge R. Ophthalmic drug delivery systems-recent advances. Prog Retin Eye Res, 1998;17:33–58
   PubMed Web of Science ®Google Scholar
• Le TT, Saveyn P, Hoa HD, Van der Meeren P. Determination of heat-induced effects on the particle size distribution of casein micelles by dynamic light scattering and nanoparticle tracking analysis. Int Dairy J, 2008;18:1090–6
   Web of Science ®Google Scholar
• Lemarchand C, Couvreur P, Vauthier C, Costantini D, Gref R. Study of emulsion stabilization by graft copolymers using the optical analyzer Turbiscan. Int J Pharm, 2003;254:77–82
   PubMed Web of Science ®Google Scholar
• Luepke NP. Hen's eggs chorioallantoic membrane test for irritation potential. Food Chem Toxicol, 1995;23:287–91
   Google Scholar
• Mediero A, Crooke A, Pintor J. Diadenosine polyphosphates, Ap4A and Ap3A, increase epithelial cell proliferation during corneal wound healing. J Emmetropia, 2010;1:81–7
   Google Scholar
• Mello Filho PAA, Maia M, Rodrigues EB, Farah ME. Ocular pharmacology in the treatment of vitreous, retina and choroid diseases. Arq Bras Oftalmol, 2010;73:294–9
   PubMed Web of Science ®Google Scholar
• Müller CR, Schaffazick SR, Pohlmann AR, Freitas LL, da Silveira NP, Dalla Costa T, Guterres SS. Spray-dried diclofenac poly(ε-caprolactone) nanocapsules and nanospheres: Preparation and physicochemical characterization. Pharmazie, 2001;56:864–7
   PubMed Web of Science ®Google Scholar
• Nagarwal RC, Kant S, Singh PN, Maiti P, Pandit JK. Polymeric nanoparticulate system: A potential approach for ocular drug delivery. J Control Release, 2009;136:2–13
   PubMed Web of Science ®Google Scholar
• Nagarwal RC, Singh PN, Kant S, Maiti P, Pandit JK. Chitosan nanoparticles of 5-fluorouracil for ophthalmic delivery: Characterization, in-vitro and in-vivo study. Chem Pharm Bull, 2011;59:272–8
   PubMed Web of Science ®Google Scholar
• Pignatello R, Amico D, Chiechio S, Spadaro C, Puglisi G, Giunchedi P. Preparation and analgesic activity of Eudragit® RS100 microparticles containing diflunisal. Drug Deliv, 2001;8:35–45
   PubMed Web of Science ®Google Scholar
• Pignatello R, Bucolo C, Ferrara P, Maltese A, Puleo A, Puglisi G. Eudragit® RS100 nanosuspensions for the ophthalmic controlled delivery of ibuprofen. Eur J Pharm Sci, 2002a;16:53–61
   PubMed Web of Science ®Google Scholar
• Pignatello R, Bucolo C, Puglisi G. Ocular tolerability of Eudragit® RS100 and RL®100 nanosuspensions as carriers for ophthalmic controlled drug delivery. J Pharm Sci, 2002b;91:2636–41
   PubMed Web of Science ®Google Scholar
• Pignatello R, Ricupero N, Bucolo C, Maugeri F, Maltese Puglisi AG. Preparation and characterization of Eudragit retard nanosuspensions for the ocular delivery of cloricromene. AAPS PharmSciTech, 2006;7:E1–7
   PubMed Web of Science ®Google Scholar
• Pohlmann AR, Mezzalira G, Venturini CG, Cruz L, Bernardi A, Jäger E, Battastini AMO, Silveira NP, Guterres SS. Determining the simultaneous presence of drug nanocrystals in drug-loaded polymeric nanocapsule aqueous suspensions: A relation between light scattering and drug content. Int J Pharm, 2008;359:288–93
   PubMed Web of Science ®Google Scholar
• Poletto F, Beck RCR, Guterres SS, Pohlmann AR. 2011. Polymeric nanocapsules: Concepts and applications. In: Beck RCR, Guterres SS, Pohlmann AR, eds. Nanocosmetics and nanomedicines: New approaches for skin care. Heidelberg: Springer Verlag, pp. 49–58
   Google Scholar
• Reddy IK, Ganesan MG. 1999. Ocular therapeutics and drug delivery: An overview. In: Reddy IK, ed. Ocular therapeutics and drug delivery. Lancaster: Technomic Publishing Co, pp. 3–29
   Google Scholar
• Réus M, Carmignan F, Lemos-Senna E, Campos A. Nanopartículas Poliméricas na Administração Tópica Ocular de Fármacos. Lat Am J Pharm, 2009;28:125–32
   Web of Science ®Google Scholar
• Salminen L. Review: Systemic absorption of topically applied ocular drugs in humans. J Ocul Pharmacol, 1990;6:243–9
   PubMedGoogle Scholar
• Schaffazick SR, Guterres SS, Freitas LL, Pohlmann AR. Caracterização e estabilidade físico-química de sistemas poliméricos nanoparticulados para administração de fármacos. Quim Nova, 2003;26:726–37
   Web of Science ®Google Scholar
• Schaffazick SR, Pohlmann AR, Mezzalira G, Guterres SS. Development of nanocapsule suspensions and nanocapsule spray-dried powders containing melatonin. J Braz Chem Soc, 2006;17:562–9
   Web of Science ®Google Scholar
• Shakeel F, Ramadan W, Ahmed MA. Investigation of true nanoemulsion for transdermal potential of indomethacin: Characterization, rheological characteristics, and ex vivo skin permeation studies. J Drug Target, 2009;17:435–41
   PubMed Web of Science ®Google Scholar
• Spielmann H, Kalweit S, Liebsch M, Wirnsberger T, Gerner I, Bertram-Neis E, Krauser K, Kreiling R, Miltenburger HG, Pape W, Steiling W. Validation study of alternatives to the draize eye irritation test in Germany: Cytotoxicity testing and HET-CAM test with 136 industrial chemicals. Toxicol In Vitro, 1993;7:505–10
   PubMed Web of Science ®Google Scholar
• Strober W. Trypan blue exclusion test of cell viability. Curr Prot Immunol, 2001; appendix 3:appendix 3b
   Google Scholar
• Tomlinson A, Khanal S. Assessment of tear film dynamics: Quantification approach. Ocul Surf, 2005;3:81–95
   PubMed Web of Science ®Google Scholar
• Urtti A, Salminen L. Minimizing systemic absorption of topically administered ophthalmic drugs. Surv Ophthalmol, 1993;37:435–57
   PubMed Web of Science ®Google Scholar
• Vandamme TF. Microemulsions as ocular drug delivery systems: recent developments and future challenges. Progr Retin Eye Res, 2002;21:15–34
   PubMed Web of Science ®Google Scholar
• Vandervoort J, Ludwig A. Preparation and evaluation of drug-loaded gelatin nanoparticles for topical ophthalmic use. Eur J Pharm Biopharm, 2004;57:251–61
   PubMed Web of Science ®Google Scholar
• Zarbin MA, Montemagno C, Leary JF, Ritch R. Nanomedicine in ophthalmology: The new frontier. Am J Ophthalmol, 2010;150:144–62
   PubMed Web of Science ®Google Scholar