Implementing Spanlastics for Improving the Ocular Delivery of Clotrimazole: In vitro Characterization, Ex vivo Permeability, Microbiological Assessment and In vivo Safety Study

References

• Zubairu Y, Negi LM, Iqbal Z, Talegaonkar S. Design and development of novel bioadhesive niosomal formulation for the transcorneal delivery of anti-infective agent: in-vitro and ex-vivo investigations. Asian J Pharm Sci. 2015;10(4):322–330. doi:10.1016/j.ajps.2015.02.001
   Web of Science ®Google Scholar
• Thomas PA. Fungal infections of the cornea. Eye. 2003;17(8):852–862. doi:10.1038/sj.eye.6700557
   PubMed Web of Science ®Google Scholar
• Basha M, Abd El-Alim SH, Shamma RN, Awad GEA. Design and optimization of surfactant-based nanovesicles for ocular delivery of clotrimazole. J Liposome Res. 2013;23(3):203–210. doi:10.3109/08982104.2013.788025
   PubMed Web of Science ®Google Scholar
• Bolla PK, Meraz CA, Rodriguez VA, et al. Clotrimazole loaded ufosomes for topical delivery: formulation development and in-vitro studies. Molecules. 2019;24(17):3139. doi:10.3390/molecules24173139
   PubMed Web of Science ®Google Scholar
• Crowley PD, Gallagher HC. Clotrimazole as a pharmaceutical: past, present and future. J Appl Microbiol. 2014;117(3):611–617. doi:10.1111/jam.12554
   PubMed Web of Science ®Google Scholar
• Liu Y, Wang Y, Yang J, Zhang H, Gan L. Cationized hyaluronic acid coated spanlastics for cyclosporine A ocular delivery: prolonged ocular retention, enhanced corneal permeation and improved tear production. Int J Pharm. 2019;565(100):133–142. doi:10.1016/j.ijpharm.2019.05.018
   PubMedGoogle Scholar
• Kakkar S, Kaur IP. Spanlastics-a novel nanovesicular carrier system for ocular delivery. Int J Pharm. 2011;413(1–2):202–210. doi:10.1016/j.ijpharm.2011.04.027
   PubMed Web of Science ®Google Scholar
• ElMeshad AN, Mohsen AM. Enhanced corneal permeation and antimycotic activity of itraconazole against Candida albicans via a novel nanosystem vesicle. Drug Deliv. 2016;23(7):2115–2123. doi:10.3109/10717544.2014.942811
   PubMed Web of Science ®Google Scholar
• Shaker S, Gardouh A, Ghorab M. Factors affecting liposomes particle size prepared by ethanol injection method. Res Pharm Sci. 2017;12(5):346–352. doi:10.4103/1735-5362.213979
   PubMed Web of Science ®Google Scholar
• Abdelbary AA, Abd-Elsalam WH, Al-mahallawi AM. Fabrication of novel ultradeformable bilosomes for enhanced ocular delivery of terconazole: in vitro characterization, ex vivo permeation and in vivo safety assessment. Int J Pharm. 2016;513(1–2):688–696. doi:10.1016/j.ijpharm.2016.10.006
   PubMed Web of Science ®Google Scholar
• Mosallam S, Sheta NM, Elshafeey AH, Abdelbary AA. Fabrication of highly deformable bilosomes for enhancing the topical delivery of terconazole: in vitro characterization, microbiological evaluation, and In Vivo Skin Deposition Study. AAPS PharmSciTech. 2021;22(2):74. doi:10.1208/s12249-021-01924-z
   PubMed Web of Science ®Google Scholar
• Al-mahallawi AM, Fares AR, Abd-Elsalam WH. Enhanced permeation of methotrexate via loading into ultra-permeable niosomal vesicles: fabrication, statistical optimization, ex vivo studies, and in vivo skin deposition and tolerability. AAPS PharmSciTech. 2019;20(5):171. doi:10.1208/s12249-019-1380-5
   PubMedGoogle Scholar
• Elsherif NI, Al-Mahallawi AM, Abdelkhalek AA, Shamma RN. Investigation of the potential of nebivolol hydrochloride-loaded chitosomal systems for tissue regeneration: in vitro characterization and in vivo assessment. Pharmaceutics. 2021;13(5):700. doi:10.3390/pharmaceutics13050700
   PubMedGoogle Scholar
• Emad Eldeeb A, Salah S, Ghorab M. Proniosomal gel-derived niosomes: an approach to sustain and improve the ocular delivery of brimonidine tartrate; formulation, in-vitro characterization, and in-vivo pharmacodynamic study. Drug Deliv. 2019;26(1):509–521. doi:10.1080/10717544.2019.1609622
   PubMed Web of Science ®Google Scholar
• Ahmed MA, Al-mahallawi AM, El-Helaly SN, Abd-Elsalam WH. The effect of the saturation degree of phospholipid on the formation of a novel self-assembled nano-micellar complex carrier with enhanced intestinal permeability. Int J Pharm. 2019;569:118567. doi:10.1016/j.ijpharm.2019.118567
   PubMed Web of Science ®Google Scholar
• van den Bergh BAI, Wertz PW, Junginger HE, Bouwstra JA. Elasticity of vesicles assessed by electron spin resonance, electron microscopy and extrusion measurements. Int J Pharm. 2001;217(1–2):13–24. doi:10.1016/S0378-5173(01)00576-2
   PubMed Web of Science ®Google Scholar
• El Zaafarany GM, Awad GAS, Holayel SM, Mortada ND. Role of edge activators and surface charge in developing ultradeformable vesicles with enhanced skin delivery. Int J Pharm. 2010;397(1–2):164–172. doi:10.1016/j.ijpharm.2010.06.034
   PubMed Web of Science ®Google Scholar
• Zeb A, Qureshi OS, Kim HS, Cha JH, Kim HS, Kim JK. Improved skin permeation of methotrexate via nanosized ultradeformable liposomes. Int J Nanomedicine. 2016;11:3813–3824. doi:10.2147/IJN.S109565
   PubMed Web of Science ®Google Scholar
• Omar S, Ismail A, Hassanin K, Hamdy S. Formulation and evaluation of cubosomes as skin retentive system for topical delivery of clotrimazole. J Adv Pharm Res. 2019;3(2):68–82. doi:10.21608/aprh.2019.9839.1079
   Google Scholar
• Fetih G, Allam A. Sublingual fast dissolving niosomal films for enhanced bioavailability and prolonged effect of metoprolol tartrate. DDDT. 2016;10:2421–2433. doi:10.2147/DDDT.S113775
   PubMedGoogle Scholar
• Qi J, Dai Z, Lu Y, Wu W. Liposomes containing bile salts as novel ocular delivery systems for tacrolimus (FK506): in vitro characterization and improved corneal permeation. Int J Nanomedicine. 2013;8:1921. doi:10.2147/IJN.S44487
   PubMedGoogle Scholar
• Battaglia L, D’Addino I, Peira E, Trotta M, Gallarate M. Solid lipid nanoparticles prepared by coacervation method as vehicles for ocular cyclosporine. J Drug Deliv Sci Technol. 2012;22(2):125–130. doi:10.1016/S1773-2247(12)50016-X
   Web of Science ®Google Scholar
• Said M, Aboelwafa AA, Elshafeey AH, Elsayed I. Central composite optimization of ocular mucoadhesive cubosomes for enhanced bioavailability and controlled delivery of voriconazole. J Drug Deliv Sci Technol. 2021;61:102075. doi:10.1016/j.jddst.2020.102075
   Web of Science ®Google Scholar
• Esposito E, Sguizzato M, Bories C, Nastruzzi C, Cortesi R. Production and characterization of a clotrimazole liposphere gel for candidiasis treatment. Polymers. 2018;10(2):1–16. doi:10.3390/polym10020160
   Google Scholar
• Tunney MM, Ramage G, Field TR, Moriarty TF, Storey DG. Rapid colorimetric assay for antimicrobial susceptibility testing of Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2004;48(5):1879–1881. doi:10.1128/aac.48.5.1879-1881.2004
   PubMedGoogle Scholar
• Mosallam S, Ragaie MH, Moftah NH, Elshafeey AH, Abdelbary AA. Use of novasomes as a vesicular carrier for improving the topical delivery of terconazole: in vitro characterization, in vivo assessment and exploratory clinical experimentation. IJN. 2021;16:119–132. doi:10.2147/IJN.S287383
   Google Scholar
• Araújo J, Gonzalez-Mira E, Egea MA, Garcia ML, Souto EB. Optimization and physicochemical characterization of a triamcinolone acetonide-loaded NLC for ocular antiangiogenic applications. Int J Pharm. 2010;393(1–2):168–176. doi:10.1016/j.ijpharm.2010.03.034
   Google Scholar
• Schier L, Lima D, Dennison M, Araujo M, Pércio S. Adsorption modeling of Cr, Cd and Cu on activated carbon of different origins by using fractional factorial design Adsorption modeling of Cr, Cd and Cu on activated carbon of different origins by using fractional factorial design. Chem Eng J. 2011;166(3):881–889. doi:10.1016/j.cej.2010.11.062
   Google Scholar
• Chauhan B, Gupta R. Application of statistical experimental design for optimization of alkaline protease production from Bacillus sp. RGR-14. Process Biochem. 2004;39(12):2115–2122. doi:10.1016/j.procbio.2003.11.002
   Web of Science ®Google Scholar
• Kaushik R, Saran S, Isar J, Saxena RK. Statistical optimization of medium components and growth conditions by response surface methodology to enhance lipase production by Aspergillus carneus. J Mol Catal B Enzym. 2006;40(3–4):121–126. doi:10.1016/j.molcatb.2006.02.019
   Web of Science ®Google Scholar
• Bendas ER, Abdelbary AA. Instantaneous enteric nano-encapsulation of omeprazole: pharmaceutical and pharmacological evaluation. Int J Pharm. 2014;468(1–2):97–104. doi:10.1016/j.ijpharm.2014.04.030
   PubMedGoogle Scholar
• El Menshawe SF, Nafady MM, Aboud HM, Kharshoum RM, Elkelawy AMMH, Hamad DS. Transdermal delivery of fluvastatin sodium via tailored spanlastic nanovesicles: mitigated freund’s adjuvant-induced rheumatoid arthritis in rats through suppressing p38 MAPK signaling pathway. Drug Deliv. 2019;26(1):1140–1154. doi:10.1080/10717544.2019.1686087
   PubMed Web of Science ®Google Scholar
• Guinedi AS, Mortada ND, Mansour S, Hathout RM. Preparation and evaluation of reverse-phase evaporation and multilamellar niosomes as ophthalmic carriers of acetazolamide. Int J Pharm. 2005;306(1–2):71–82. doi:10.1016/j.ijpharm.2005.09.023
   PubMed Web of Science ®Google Scholar
• Moawad FA, Ali AA, Salem HF. Nanotransfersomes-loaded thermosensitive in situ gel as a rectal delivery system of tizanidine HCl: preparation, in vitro and in vivo performance. Drug Deliv. 2017;24(1):252–260. doi:10.1080/10717544.2016.1245369
   PubMed Web of Science ®Google Scholar
• Janoria KG, Gunda S, Boddu SHS, Mitra AK. Novel approaches to retinal drug delivery. Expert Opin Drug Deliv. 2007;4(4):371–388. doi:10.1517/17425247.4.4.371
   PubMed Web of Science ®Google Scholar
• Elsherif NI, Shamma RN, Abdelbary G. Terbinafine hydrochloride trans-ungual delivery via nanovesicular systems: in vitro characterization and ex vivo evaluation. AAPS PharmSciTech. 2017;18(2):551–562. doi:10.1208/s12249-016-0528-9
   PubMed Web of Science ®Google Scholar
• Sukmawati A, Utami W, Yuliani R, Da’i M, Nafarin A. Effect of tween 80 on nanoparticle preparation of modified chitosan for targeted delivery of combination doxorubicin and curcumin analogue. IOP Conf Ser Mater Sci Eng. 2018;311:012024. doi:10.1088/1757-899X/311/1/012024
   Google Scholar
• Wang C, Cui B, Guo L, et al. Fabrication and evaluation of lambda-cyhalothrin nanosuspension by one-step melt emulsification technique. Nanomaterials. 2019;9(2):145. doi:10.3390/nano9020145
   Web of Science ®Google Scholar
• Sugawara E, Nikaido H. Properties of AdeABC and AdeIJK efflux systems of Acinetobacter baumannii compared with those of the AcrAB-TolC system of Escherichia coli. intergovernmental panel on climate change, ed. Antimicrob Agents Chemother. 2014;58(12):7250–7257. doi:10.1128/AAC.03728-14
   PubMed Web of Science ®Google Scholar
• Soriano-Ruiz JL, Calpena-Capmany AC, Cañadas-Enrich C, et al. Biopharmaceutical profile of a clotrimazole nanoemulsion: evaluation on skin and mucosae as anticandidal agent. Int J Pharm. 2019;554:105–115. doi:10.1016/j.ijpharm.2018.11.002
   PubMedGoogle Scholar
• Abdelbary AA, AbouGhaly MHH. Design and optimization of topical methotrexate loaded niosomes for enhanced management of psoriasis: application of Box–Behnken design, in-vitro evaluation and in-vivo skin deposition study. Int J Pharm. 2015;485(1–2):235–243. doi:10.1016/j.ijpharm.2015.03.020
   PubMed Web of Science ®Google Scholar
• Varshosaz J, Pardakhty A, Hajhashemi VI, Najafabadi AR. Development and physical characterization of sorbitan monoester niosomes for insulin oral delivery. Drug Deliv. 2003;10(4):251–262. doi:10.1080/drd_10_4_251
   PubMed Web of Science ®Google Scholar
• Devaraj GN, Parakh SR, Devraj R, Apte SS, Rao BR, Rambhau D. Release studies on niosomes containing fatty alcohols as bilayer stabilizers instead of cholesterol. J Colloid Interface Sci. 2002;251(2):360–365. doi:10.1006/jcis.2002.8399
   PubMedGoogle Scholar
• Shazly G. Niosomes as an oral drug delivery system containing tenoxicam. Bull Pharm Sci Assiut. 2015;38(1):19–29. doi:10.21608/bfsa.2015.63170
   Google Scholar
• Ruckmani K, Jayakar B, Ghosal SK. Nonionic surfactant vesicles (niosomes) of cytarabine hydrochloride for effective treatment of leukemias: encapsulation, storage, and in vitro release. Drug Dev Ind Pharm. 2000;26(2):217–222. doi:10.1081/DDC-100100348
   PubMed Web of Science ®Google Scholar
• El-Nabarawi M, Ali A, Aboud H, Hassan A, Godah A. Transbuccal delivery of betahistine dihydrochloride from mucoadhesive tablets with a unidirectional drug flow: in vitro, ex vivo and in vivo evaluation. DDDT. 2016;10:4031–4045. doi:10.2147/DDDT.S120613
   PubMed Web of Science ®Google Scholar
• Roehm NW, Rodgers GH, Hatfield SM, Glasebrook AL. An improved colorimetric assay for cell proliferation and viability utilizing the tetrazolium salt XTT. J Immunol Methods. 1991;142(2):257–265. doi:10.1016/0022-1759(91)90114-u
   PubMed Web of Science ®Google Scholar
• Bondaryk M, Kurzątkowski W, Staniszewska M. Antifungal agents commonly used in the superficial and mucosal candidiasis treatment: mode of action and resistance development. Postepy Dermatol Alergol. 2013;30(5):293–301. doi:10.5114/pdia.2013.38358
   PubMedGoogle Scholar
• Jahn B, Martin E, Stueben A. Susceptibility testing of Candida albicans and Aspergillus species by a simple microtiter menadione-augmented tetrazolium bromide assay. J Clin Microbiol. 1995;33(3):661–667.
   PubMedGoogle Scholar