Solutol HS15 based binary mixed micelles with penetration enhancers for augmented corneal delivery of sertaconazole nitrate: optimization, in vitro, ex vivo and in vivo characterization

References

• Abd-Elsalam WH, El-Zahaby SA, Al-Mahallawi AM. (2018). Formulation and in vivo assessment of terconazole-loaded polymeric mixed micelles enriched with Cremophor EL as dual functioning mediator for augmenting physical stability and skin delivery. Drug Deliv 25:484–92.
   PubMed Web of Science ®Google Scholar
• Abdelbary GA, Tadros MI. (2013). Brain targeting of olanzapine via intranasal delivery of core-shell difunctional block copolymer mixed nanomicellar carriers: in vitro characterization, ex vivo estimation of nasal toxicity and in vivo biodistribution studies. Int J Pharm 452:300–10.
   PubMed Web of Science ®Google Scholar
• Aggarwal AK, Jindal P. (2014). Modification of crystallization behaviour of sertaconazole by preparing its solid dispersions. J Pharm Allied Health Sci 4:1.
   Google Scholar
• Al-Badriyeh D, Neoh CF, Stewart K, Kong DC. (2010). Clinical utility of voriconazole eye drops in ophthalmic fungal keratitis. Clin Ophthalmol 4:391.
   PubMedGoogle Scholar
• Al-mahallawi AM, Khowessah OM, Shoukri RA. (2014). Nano-transfersomal ciprofloxacin loaded vesicles for non-invasive trans-tympanic ototopical delivery: in-vitro optimization, ex-vivo permeation studies, and in-vivo assessment. Int J Pharm 472:304–14.
   PubMed Web of Science ®Google Scholar
• Alani AW, Rao DA, Seidel R, et al. (2010). The effect of novel surfactants and solutol®HS 15 on paclitaxel aqueous solubility and permeability across a Caco-2 monolayer. J Pharm Sci 99:3473–85.
   PubMed Web of Science ®Google Scholar
• Albet C, Fernández J, Sacristán A, Ortiz J. (1992). Physico-chemical properties, analytical determinations and stability of sertaconazole nitrate. Arzneimittelforschung 42:695–8.
   PubMed Web of Science ®Google Scholar
• Aliabadi HM, Lavasanifar A. (2006). Polymeric micelles for drug delivery. Expert Opin Drug Deliv 3:139–62.
   PubMedGoogle Scholar
• Alvarez-Rivera F, Fernández-Villanueva D, Concheiro A, Alvarez-Lorenzo C. (2016). α-Lipoic acid in soluplus® polymeric nanomicelles for ocular treatment of diabetes-associated corneal diseases. J Pharm Sci 105:2855–63.
   PubMed Web of Science ®Google Scholar
• Ameeduzzafar, Imam SS, Bukhari SNA, et al. (2018). Preparation and evaluation of novel chitosan: gelrite ocular system containing besifloxacin for topical treatment of bacterial conjunctivitis: scintigraphy, ocular irritation and retention assessment. Artif Cells Nanomed Biotechno 46:959–67.
   Google Scholar
• Amrite AC, Kompella UB. (2005). Size-dependent disposition of nanoparticles and microparticles following subconjunctival administration. J Pharm Pharmacol 57:1555–63.
   PubMed Web of Science ®Google Scholar
• Ansari Z, Miller D, Galor A. (2013). Current thoughts in fungal keratitis: diagnosis and treatment. Curr Fungal Infect Rep 7:209–18.
   PubMedGoogle Scholar
• Ban J, Zhang Y, Huang X, et al. (2017). Corneal permeation properties of a charged lipid nanoparticle carrier containing dexamethasone. Int J Nanomedicine 12:1329.
   PubMed Web of Science ®Google Scholar
• Bhatta R, Chandasana H, Chhonker Y, et al. (2012). Mucoadhesive nanoparticles for prolonged ocular delivery of natamycin: in vitro and pharmacokinetics studies. Int J Pharm 432:105–12.
   PubMed Web of Science ®Google Scholar
• Caddeo C, Sales OD, Valenti D, et al. (2013). Inhibition of skin inflammation in mice by diclofenac in vesicular carriers: liposomes, ethosomes and PEVs. Int J Pharm 443:128–36.
   PubMed Web of Science ®Google Scholar
• Chen L, Sha X, Jiang X, et al. (2013). Pluronic P105/F127 mixed micelles for the delivery of docetaxel against Taxol-resistant non-small cell lung cancer: optimization and in vitro, in vivo evaluation. Int J Nanomedicine 8:73.
   PubMed Web of Science ®Google Scholar
• Chetoni P, Burgalassi S, Monti D, Saettone M. (2003). Ocular toxicity of some corneal penetration enhancers evaluated by electrophysiology measurements on isolated rabbit corneas. Toxicol In Vitro 17:497–504.
   PubMed Web of Science ®Google Scholar
• Croxtall JD, Plosker GL. (2009). Sertaconazole. Drugs 69:339–59.
   PubMed Web of Science ®Google Scholar
• Das S, Ng WK, Tan RB. (2012). Are nanostructured lipid carriers (NLCs) better than solid lipid nanoparticles (SLNs): development, characterizations and comparative evaluations of clotrimazole-loaded SLNs and NLCs? Eur J Pharm Sci 47:139–51.
   PubMed Web of Science ®Google Scholar
• Di Prima G, Saladino S, Bongiovì F, et al. 2017. Novel Inulin-Based Mucoadhesive Micelles Loaded With Corticosteroids as Potential Transcorneal Permeation Enhancers. Eur J Pharm Biopharm 117:385–399.
   PubMed Web of Science ®Google Scholar
• Duan Y, Cai X, Du H, Zhai G. (2015). Novel in situ gel systems based on P123/TPGS mixed micelles and gellan gum for ophthalmic delivery of curcumin. Colloids Surf B Biointerfaces 128:322–30.
   PubMed Web of Science ®Google Scholar
• Duan Y, Wang J, Yang X, et al. (2015). Curcumin-loaded mixed micelles: preparation, optimization, physicochemical properties and cytotoxicity in vitro. Drug Deliv 22:50–7.
   PubMed Web of Science ®Google Scholar
• El-Salamouni NS, Farid RM, El-Kamel AH, El-Gamal SS. (2018). Nanostructured lipid carriers for intraocular brimonidine localization; development, in-vitro and in-vivo evaluation. J Microencapsul 35:102–113.
   PubMed Web of Science ®Google Scholar
• ElKasabgy NA. (2014). Ocular supersaturated self-nanoemulsifying drug delivery systems (S-SNEDDS) to enhance econazole nitrate bioavailability. Int J Pharm 460:33–44.
   PubMed Web of Science ®Google Scholar
• Fares AR, ElMeshad AN, Kassem MA. (2018). Enhancement of dissolution and oral bioavailability of lacidipine via pluronic P123/F127 mixed polymeric micelles: formulation, optimization using central composite design and in vivo bioavailability study. Drug Deliv 25:132–42.
   PubMed Web of Science ®Google Scholar
• Fernández-Ferreiro A, Gonzalez-Barcia M, Gil-Martínez M, et al. others, (2016). Current use of antifungal eye drops and how to improve therapeutic aspects in keratomycosis. Fungal Genom Biol 6:2.
   Google Scholar
• Fouad SS, Habib BA, Elsayed GM. (2017). Tri-block co-polymer nanocarriers for enhancement of oral delivery of felodipine: preparation, in-vitro characterization and ex-vivo permeation. J Liposome Res 28:182–192.
   PubMed Web of Science ®Google Scholar
• Gan L, Gan Y, Zhu C, et al. (2009). Novel microemulsion in situ electrolyte-triggered gelling system for ophthalmic delivery of lipophilic cyclosporine A: in vitro and in vivo results. Int J Pharm 365:143–9.
   PubMed Web of Science ®Google Scholar
• Grimaudo MA, Pescina S, Padula C, et al. (2018). Poloxamer 407/TPGS mixed micelles as promising carriers for cyclosporine ocular delivery. Mol Pharm 15:571–84.
   PubMed Web of Science ®Google Scholar
• Habib BA, AbouGhaly MH. (2016). Combined mixture-process variable approach: a suitable statistical tool for nanovesicular systems optimization. Expert Opin Drug Deliv 13:777–88.
   PubMed Web of Science ®Google Scholar
• He D, Hao J, Gao S, et al. (2016). Etiological analysis of fungal keratitis and rapid identification of predominant fungal pathogens. Mycopathologia 181:75–82.
   PubMed Web of Science ®Google Scholar
• Hou J, Sun E, Sun C, et al. (2016). Improved oral bioavailability and anticacer efficacy on breast cancer of paclitaxel via Novel Soluplus® —Solutol® HS15 binary mixed micelles system. Int J Pharm 512:186–193.
   PubMed Web of Science ®Google Scholar
• Higa LH, Schilrreff P, Perez AP, et al. (2013). The intervention of nanotechnology against epithelial fungal diseases. J Biomater Tissue Eng 3:70–88.
   Web of Science ®Google Scholar
• Huang Y-B, Tsai Y-H, Yang W-C, et al. (2004). Once-daily propranolol extended-release tablet dosage form: formulation design and in vitro/in vivo investigation. Eur J Pharm Biopharm 58:607–14.
   PubMed Web of Science ®Google Scholar
• Imam SS, Bukhari SNA, Ahmed J, Ali A, et al. (2017). Formulation and optimization of Levofloxacin loaded Chitosan Nanoparticle for Ocular delivery: in-vitro characterization, ocular tolerance and antibacterial activity. Int J Biol Macromol 108:650–59.
   PubMed Web of Science ®Google Scholar
• Jaiswal M, Kumar M, Pathak K. (2015). Zero order delivery of itraconazole via polymeric micelles incorporated in situ ocular gel for the management of fungal keratitis. Colloids Surf B Biointerfaces 130:23–30.
   PubMed Web of Science ®Google Scholar
• Kaur IP, Rana C, Singh H. (2008). Development of effective ocular preparations of antifungal agents. J Ocul Pharmacol Ther 24:481–94.
   PubMed Web of Science ®Google Scholar
• Kaur IP, Smitha R. (2002). Penetration enhancers and ocular bioadhesives: two new avenues for ophthalmic drug delivery. Drug Dev Ind Pharm 28:353–69.
   PubMed Web of Science ®Google Scholar
• Kesavan K, Kant S, Singh PN, Pandit JK. (2013). Mucoadhesive chitosan-coated cationic microemulsion of dexamethasone for ocular delivery: in vitro and in vivo evaluation. Curr Eye Res 38:342–52.
   PubMed Web of Science ®Google Scholar
• Li J, Wu L, Wu W, et al. (2013). A potential carrier based on liquid crystal nanoparticles for ophthalmic delivery of pilocarpine nitrate. Int J Pharm 455:75–84.
   PubMed Web of Science ®Google Scholar
• Li X, Zhang Y, Fan Y, et al. (2011). Preparation and evaluation of novel mixed micelles as nanocarriers for intravenous delivery of propofol. Nanoscale Res Lett 6:275.
   PubMed Web of Science ®Google Scholar
• Liu L, Mao K, Wang W, et al. (2016). Kolliphor® HS 15 micelles for the delivery of coenzyme Q10: preparation, characterization, and stability. AAPS PharmSciTech 17:757–66.
   PubMed Web of Science ®Google Scholar
• Lu Y, Park K. (2013). Polymeric micelles and alternative nanonized delivery vehicles for poorly soluble drugs. Int J Pharm 453:198–214.
   PubMed Web of Science ®Google Scholar
• Mahaling B, Katti DS. (2016). Understanding the influence of surface properties of nanoparticles and penetration enhancers for improving bioavailability in eye tissues in vivo. Int J Pharm 501:1–9.
   PubMed Web of Science ®Google Scholar
• Malhotra M, Majumdar D. 2001. Permeation through cornea.Indian J Exp Biol39:11–24.
   Google Scholar
• Mandal A, Bisht R, Rupenthal ID, Mitra AK. 2017. Polymeric micelles for ocular drug delivery: From structural frameworks to recent preclinical studies. J Control Release 248:96–116.
   PubMed Web of Science ®Google Scholar
• Mehta P, Al-Kinani AA, Arshad MS, et al. (2017). Development and characterisation of electrospun timolol maleate-loaded polymeric contact lens coatings containing various permeation enhancers. Int J Pharm 532:408–20.
   PubMed Web of Science ®Google Scholar
• Moustafa MA, Elnaggar YS, El-Refaie WM, Abdallah OY. (2017). Hyalugel-integrated liposomes as a novel ocular nanosized delivery system of fluconazole with promising prolonged effect. Int J Pharm 534:14–24.
   PubMed Web of Science ®Google Scholar
• Nettey H, Darko Y, Bamiro OA, Addo RT. 2016. Ocular barriers. In: Addo RT, ed. Ocular drug delivery: advances, challenges and applications. Cham, Switzerland: Springer, 27–36.
   Google Scholar
• Nour SA, Abdelmalak NS, Naguib MJ, et al. (2016). Intranasal brain-targeted clonazepam polymeric micelles for immediate control of status epilepticus: in vitro optimization, ex vivo determination of cytotoxicity, in vivo biodistribution and pharmacodynamics studies. Drug Deliv 23:3681–95.
   PubMed Web of Science ®Google Scholar
• Panda M, Kamil M. 2017. Interaction of oxy-diester-linked cationic gemini surfactants with nonionic amphiphiles in aqueous medium. Colloid Polym Sci 295:2363–71.
   Web of Science ®Google Scholar
• Park SH, Park JO. 1998. Simultaneous optimization of multiple responses using a weighted desirability function. In: Abraham B, ed. Quality Improvement through Statistical Methods. Boston, MA: Birkhäuser, 299–311.
   Google Scholar
• Pepić I, Lovrić J, Hafner A, Filipović-Grčić J. (2014). Powder form and stability of Pluronic mixed micelle dispersions for drug delivery applications. Drug Dev Ind Pharm 40:944–51.
   PubMed Web of Science ®Google Scholar
• Prajna NV, Srinivasan M, Lalitha P, et al. others, (2013). Differences in clinical outcomes in keratitis due to fungus and bacteria. JAMA Ophthalmol 131:1088–9.
   PubMed Web of Science ®Google Scholar
• Qushawy M, Nasr A, Abd-Alhaseeb M, Swidan S. (2018). Design, optimization and characterization of a transfersomal gel using miconazole nitrate for the treatment of candida skin infections. Pharmaceutics 10:26.
   PubMed Web of Science ®Google Scholar
• Rajagopalan R, Hiemenz PC. 1997. Principles of colloid and surface chemistry. 3rd ed. New York: Marcel Dekker.
   Google Scholar
• Raval A, Bahadur P, Raval A. 2017. Effect of nonionic surfactants in release media on accelerated in-vitro release profile of sirolimus eluting stents with biodegradable polymeric coating. J Pharm Anal 8:45–54.
   PubMed Web of Science ®Google Scholar
• Ribeiro A, Sosnik A, Chiappetta DA, et al. (2012). Single and mixed poloxamine micelles as nanocarriers for solubilization and sustained release of ethoxzolamide for topical glaucoma therapy. J R Soc Interface 9:2059–69.
   PubMed Web of Science ®Google Scholar
• Romero A, Grau M, Villamayor F, et al. (1996). Ocular tolerance of sertaconazole gel. Mycoses 39:57–60.
   PubMed Web of Science ®Google Scholar
• Salama AH, Shamma RN. (2015). Tri/tetra-block co-polymeric nanocarriers as a potential ocular delivery system of lornoxicam: in-vitro characterization, and in-vivo estimation of corneal permeation. Int J Pharm 492:28–39.
   PubMed Web of Science ®Google Scholar
• Sezgin Z, Yüksel N, Baykara T. (2006). Preparation and characterization of polymeric micelles for solubilization of poorly soluble anticancer drugs. Eur J Pharm Biopharm 64:261–8.
   PubMed Web of Science ®Google Scholar
• Shubber S, Vllasaliu D, Rauch C, et al. (2015). Mechanism of mucosal permeability enhancement of CriticalSorb®(Solutol®HS15) investigated in vitro in cell cultures. Pharm Res 32:516–27.
   PubMed Web of Science ®Google Scholar
• Turco Liveri ML, Licciardi M, Sciascia L, et al. (2012). Peculiar mechanism of solubilization of a sparingly water soluble drug into polymeric micelles. Kinetic and equilibrium studies. J Phys Chem B 116:5037–46.
   PubMed Web of Science ®Google Scholar
• Vautier-Giongo C, Bakshi MS, Singh J, et al. (2005). Effects of interactions on the formation of mixed micelles of 1,2-diheptanoyl-sn-glycero-3-phosphocholine with sodium dodecyl sulfate and dodecyltrimethylammonium bromide. J Colloid Interface Sci 282:149–55.
   PubMed Web of Science ®Google Scholar
• Wei Z, Hao J, Yuan S, et al. (2009). Paclitaxel-loaded Pluronic P123/F127 mixed polymeric micelles: formulation, optimization and in vitro characterization. Int J Pharm 376:176–85.
   PubMed Web of Science ®Google Scholar
• Yan H, Song J, Zhang Z, Jia X. (2016). Optimization and anticancer activity in vitro and in vivo of baohuoside I incorporated into mixed micelles based on lecithin and Solutol HS 15. Drug Deliv 23:2911–18.
   PubMed Web of Science ®Google Scholar
• Yokoyama M. (2014). Polymeric micelles as drug carriers: their lights and shadows. J Drug Target 22:576–83.
   PubMed Web of Science ®Google Scholar
• Yoncheva K, Vandervoort J, Ludwig A. (2011). Development of mucoadhesive poly (lactide-co-glycolide) nanoparticles for ocular application. Pharm Dev Technol 16:29–35.
   PubMed Web of Science ®Google Scholar
• Zhou T, Zhu L, Xia H, et al. (2017). Micelle carriers based on macrogol 15 hydroxystearate for ocular delivery of terbinafine hydrochloride: In vitro characterization and in vivo permeation. Eur J Pharm Sci 109:288–96.
   PubMed Web of Science ®Google Scholar