Brain Targeting of Duloxetine HCL via Intranasal Delivery of Loaded Cubosomal Gel: In vitro Characterization, ex vivo Permeation, and in vivo Biodistribution Studies

References

• Saminathan J, Sankar ASK, Anandakumar K, Vetrichelvan T. Simple UV spectrophotometric method for the determination of fluvastatin sodium in bulk and pharmaceutical formulations. E J Chem. 2009;6(4):1233–1239. doi:10.1155/2009/530206
   Google Scholar
• Bymaster FP, et al. Comparative affinity of duloxetine and venlafaxine for serotonin and norepinephrine transporters in vitro and in vivo, human serotonin receptor subtypes, and other neuronal receptors. Neuropsychopharmacology. 2001;25(6):871–880. doi:10.1016/S0893-133X(01)00298-611750180
   PubMed Web of Science ®Google Scholar
• Pandya P, Pandey NK, Singh SK, Kumar M. Formulation and characterization of ternary complex of poorly soluble duloxetine hydrochloride. J Appl Pharm Sci. 2015;5(6):088–096. doi:10.7324/JAPS.2015.50615
   Google Scholar
• Ganesh M, Ubaidulla U, Hemalatha P, Peng MM, Jang HT. Development of duloxetine hydrochloride loaded mesoporous silica nanoparticles: characterizations and in vitro evaluation. AAPS PharmSciTech. 2015;16(4):944–951. doi:10.1208/s12249-014-0273-x25604699
   PubMed Web of Science ®Google Scholar
• Patel K, Padhye S, Nagarsenker M. Duloxetine HCl lipid nanoparticles: preparation, characterization, and dosage form design. AAPS PharmSciTech. 2012;13(1):125–133. doi:10.1208/s12249-011-9727-622167415
   PubMed Web of Science ®Google Scholar
• Alam MI, Baboota S, Ahuja A, Ali M, Ali J, Sahni JK. Intranasal administration of nanostructured lipid carriers containing CNS acting drug: pharmacodynamic studies and estimation in blood and brain. J Psychiatr Res. 2012;46(9):1133–1138. doi:10.1016/j.jpsychires.2012.05.01422749490
   PubMed Web of Science ®Google Scholar
• Mathison S, Nagilla R, Kompella UB. Nasal route for direct delivery of solutes to the central nervous system: fact or fiction? J Drug Target. 1998;5(6):415–441. doi:10.3109/106118698089978709783675
   PubMed Web of Science ®Google Scholar
• Wang X, Chi N, Tang X. Preparation of estradiol chitosan nanoparticles for improving nasal absorption and brain targeting. Eur J Pharm Biopharm. 2008;70(3):735–740. doi:10.1016/j.ejpb.2008.07.00518684400
   PubMed Web of Science ®Google Scholar
• Sonvico F, Clementino A, Buttini F, et al. Surface-modified nanocarriers for nose-to-brain delivery: from bioadhesion to targeting. Pharmaceutics. 2018;10(1):34. doi:10.3390/pharmaceutics10010034
   PubMed Web of Science ®Google Scholar
• Nasr M, Ghorab MK, Abdelazem A. In vitro and in vivo evaluation of cubosomes containing 5-fluorouracil for liver targeting. Acta Pharm Sin B. 2015;5(1):79–88. doi:10.1016/j.apsb.2014.12.00126579429
   PubMed Web of Science ®Google Scholar
• Kulkarni CV, Vishwapathi VK, Quarshie A, et al. Self-assembled lipid cubic phase and cubosomes for the delivery of aspirin as a model drug. Langmuir. 2017;33(38):9907–9915. doi:10.1021/acs.langmuir.7b0248628826212
   PubMed Web of Science ®Google Scholar
• Gaballa S, El Garhy O, Abdelkader H. Cubosomes: composition, preparation, and drug delivery applications. J Adv Biomed Pharm Sci. 2019;3(1):1–9. doi:10.21608/jabps.2019.16887.1057
   Google Scholar
• Ahirrao M, Shrotriya S. In vitro and in vivo evaluation of cubosomal in situ nasal gel containing resveratrol for brain targeting. Drug Dev Ind Pharm. 2017;43(10):1686–1693. doi:10.1080/03639045.2017.133872128574732
   PubMed Web of Science ®Google Scholar
• Salama HA, Mahmoud AA, Kamel AO, Abdel Hady M, Awad GAS. Phospholipid based colloidal poloxamer–nanocubic vesicles for brain targeting via the nasal route. Colloids and Surfaces B: Biointerfaces. 2012;100:146–154. doi:10.1016/j.colsurfb.2012.05.01022766291
   PubMed Web of Science ®Google Scholar
• Jagdale S, Shewale N, Kuchekar BS. Optimization of thermoreversible in situ nasal gel of timolol maleate. Scientifica. 2016;6401267. doi:10.1155/2016/640126727293975
   PubMedGoogle Scholar
• Kumar R, Kumar S, Sinha VR. Evaluation and optimization of water-in-oil microemulsion using ternary phase diagram and central composite design. J Dispers Sci Technol. 2016;37(2):166–172. doi:10.1080/01932691.2015.1038351
   Web of Science ®Google Scholar
• Fares AR, Elmeshad AN, Kassem MAA. 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. 2018;25(1):132–142. doi:10.1080/10717544.2017.141951229275642
   PubMed Web of Science ®Google Scholar
• Alam MI, Baboota S, Ahuja A, Ali M, Ali J, Sahni JK. Intranasal infusion of nanostructured lipid carriers (NLC) containing CNS acting drug and estimation in brain and blood. Drug Deliv. 2013;20(6):247–251. doi:10.3109/10717544.2013.82294523869788
   PubMed Web of Science ®Google Scholar
• Khatoon M, Sohail MF, Shahnaz G, et al. Development and evaluation of optimized thiolated chitosan proniosomal gel containing duloxetine for intranasal delivery. AAPS PharmSciTech. 2019;20(7):288. doi:10.1208/s12249-019-1484-y31410741
   PubMed Web of Science ®Google Scholar
• Soga O, Van Nostrum CF, Fens M, et al. Thermosensitive and biodegradable polymeric micelles for paclitaxel delivery. J Control Release. 2005;103(2):341–353. doi:10.1016/j.jconrel.2004.12.00915763618
   PubMed Web of Science ®Google Scholar
• Zaki NM, Awad GA, Mortada ND, Abd ElHady SS. Enhanced bioavailability of metoclopramide HCl by intranasal administration of a mucoadhesive in situ gel with modulated rheological and mucociliary transport properties. Eur J Pharm Sci. 2007;32(4–5):296–307. doi:10.1016/j.ejps.2007.08.00617920822
   PubMed Web of Science ®Google Scholar
• Abdelrahman FE, Elsayed I, Gad MK, Badr A, Mohamed MI. Investigating the cubosomal ability for transnasal brain targeting: in vitro optimization, ex vivo permeation and in vivo biodistribution. Int J Pharm. 2015;490(1–2):281–291. doi:10.1016/j.ijpharm.2015.05.06426026251
   PubMed Web of Science ®Google Scholar
• Yang SC, Lu LF, Cai Y, Zhu JB, Liang BW, Yang CZ. Body distribution in mice of intravenously injected camptothecin solid lipid nanoparticles and targeting effect on brain. J Control Release. 1999;59(3):299–307. doi:10.1016/S0168-3659(99)00007-310332062
   PubMed Web of Science ®Google Scholar
• Rarokar NR, Saoji SD, Raut NA, Taksande JB, Khedekar PB, Dave VS. Nanostructured cubosomes in a thermoresponsive depot system: an alternative approach for the controlled delivery of docetaxel. AAPS PharmSciTech. 2016;17(2):436–445. doi:10.1208/s12249-015-0369-y26208439
   PubMed Web of Science ®Google Scholar
• Sherafudeen SP, Vasantha PV. Development and evaluation of in situ nasal gel formulations of loratadine. Res Pharm Sci. 2015;10(6):466–476.26779266
   PubMed Web of Science ®Google Scholar
• Elzahhar PA. Expanding the anticancer potential of 1,2,3-triazoles via simultaneously targeting Cyclooxygenase-2, 15-lipoxygenase and tumor-associated carbonic anhydrases. Eur J Med Chem. 2020;200:112439. doi:10.1016/j.ejmech.2020.11243932485532
   PubMed Web of Science ®Google Scholar
• Fathy U, Azzam MA, Mahdy F, El-Maghraby S, Allam RM. Synthesis and in vitro anticancer activity of some novel tetrahydroquinoline derivatives bearing pyrazol and hydrazide moiety. J Heterocycl Chem. 2020;57(5):2108–2120. doi:10.1002/jhet.3930
   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.2010.06.03420599487
   PubMed Web of Science ®Google Scholar
• Al-Mahallawi AM, Khowessah OM, Shoukri RA. 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. 2014;472(1–2):304–314. doi:10.1016/j.ijpharm.2014.06.04124971692
   PubMed Web of Science ®Google Scholar
• Osborne N, Avey MT, Anestidou L, Ritskes‐Hoitinga M, Griffin G. Improving animal research reporting standards. EMBO Reports. 2018;19(5):5. doi:10.15252/embr.20184606929237715
   PubMed Web of Science ®Google Scholar
• ICLAS Ethical Guideline for Researchers. http://iclas.org/guidelines-for-researchers.
   Google Scholar
• Reagan‐Shaw S, Nihal M, Ahmad N. Dose translation from animal to human studies revisited. FASEB J. 2008;22(3):659–661. doi:10.1096/fj.07-9574lsf17942826
   PubMed Web of Science ®Google Scholar
• El Sharawy AM, Shukr MH, Elshafeey AH. Formulation and optimization of duloxetine hydrochloride buccal films: in vitro and in vivo evaluation. Drug Deliv. 2017;24(1):1762–1769. doi:10.1080/10717544.2017.140221629172829
   PubMed Web of Science ®Google Scholar
• Vyas T, Shahiwala A, Marathe S, Misra A. Intranasal drug delivery for brain targeting. Curr Drug Deliv. 2005;2(2):165–175. doi:10.2174/156720105358604716305417
   PubMedGoogle Scholar
• Kozlovskaya L, Abou-Kaoud M, Stepensky D. Quantitative analysis of drug delivery to the brain via nasal route. J Control Release. 2014;189:133–140. doi:10.1016/j.jconrel.2014.06.05324997277
   PubMed Web of Science ®Google Scholar
• Younes NF, Abdel-Halim SA, Elassasy AI. Corneal targeted Sertaconazole nitrate loaded cubosomes: preparation, statistical optimization, in vitro characterization, ex vivo permeation and in vivo studies. Int J Pharm. 2018;553(1–2):386–397. doi:10.1016/j.ijpharm.2018.10.05730393167
   PubMed Web of Science ®Google Scholar
• El-enin HA, Al-shanbari AH. Nanostructured liquid crystalline formulation as a remarkable new drug delivery system of anti-epileptic drugs for treating children patients. Saudi Pharm J. 2018;26(6):790–800. doi:10.1016/j.jsps.2018.04.00430202219
   PubMed Web of Science ®Google Scholar
• Clayton KN, Salameh JW, Wereley ST, Kinzer-Ursem TL. Physical characterization of nanoparticle size and surface modification using particle scattering diffusometry. Biomicrofluidics. 2016;10(5):054107. doi:10.1063/1.496299227703593
   PubMed Web of Science ®Google Scholar
• Williams PM. Zeta Potential. Encyclopedia Membranes. 2016;2063–2064. doi:10.1007/978-3-662-44324-8_612
   Google Scholar
• Koo OMY. Pharmaceutical Excipients: Properties, Functionality, and Applications in Research and Industry; 2016. doi:10.1002/9781118992432
   Google Scholar
• Chong JYT, Mulet X, Waddington LJ, Boyd BJ, Drummond CJ. Steric stabilisation of self-assembled cubic lyotropic liquid crystalline nanoparticles: high throughput evaluation of triblock polyethylene oxide-polypropylene oxide-polyethylene oxide copolymers. Soft Matter. 2011;7(10):4768–4777. doi:10.1039/c1sm05181d
   Web of Science ®Google Scholar
• Miller SC, Donovan MD. Effect of poloxamer 407 gel on the miotic activity of pilocarpine nitrate in rabbits. Int J Pharm. 1982;12(2–3):147–152. doi:10.1016/0378-5173(82)90114-4
   Google Scholar
• Foxman EF, Storer JA, Fitzgerald ME, et al. Temperature-dependent innate defense against the common cold virus limits viral replication at warm temperature in mouse airway cells. Proc Natl Acad Sci U S A. 2015;112(3):827–832. doi:10.1073/pnas.141103011225561542
   PubMed Web of Science ®Google Scholar
• Shah JC. Cubic phase gels as drug delivery systems. Adv Drug Deliv Rev. 2001;47(2–3):229–250. doi:10.1016/S0169-409X(01)00108-911311994
   PubMed Web of Science ®Google Scholar
• Giuliano E, Paolino D, Fresta M, Cosco D. Mucosal applications of poloxamer 407-based hydrogels: an overview. Pharmaceutics. 2018;10(3):1–26. doi:10.3390/pharmaceutics10030159
   Web of Science ®Google Scholar
• Ban E, Park M, Jeong S, et al. Poloxamer-based thermoreversible gel for topical delivery of emodin: influence of P407 and P188 on solubility of emodin and its application in cellular activity screening. Molecules. 2017;22(2):246. doi:10.3390/molecules22020246
   PubMed Web of Science ®Google Scholar
• Yehia SA, Elshafeey AH, Elsayed I. Biodegradable donepezil lipospheres for depot injection: optimization and in-vivo evaluation. J Pharm Pharmacol. 2012;64(10):1425–1437. doi:10.1111/j.2042-7158.2012.01530.x22943173
   PubMed Web of Science ®Google Scholar
• Mei L, Zhang Y, Zheng Y, et al. A novel docetaxel-loaded poly (ε-caprolactone)/Pluronic F68 nanoparticle overcoming multidrug resistance for breast cancer treatment. Nanoscale Res Lett. 2009;4(12):1530–1539. doi:10.1007/s11671-009-9431-620652101
   PubMed Web of Science ®Google Scholar
• Bhatt M. An overview: formulation and product development of nasal spray. World J Pharm Res. 2017;404–413. doi:10.20959/wjpr20176-8557
   Google Scholar
• Patil J, Rajput R, Nemade R, Naik J. Preparation and characterization of artemether loaded solid lipid nanoparticles: a 3 2 factorial design approach. Mater Technol. 2020;35(11–12):719–726. doi:10.1080/10667857.2018.1475142
   Web of Science ®Google Scholar
• Yousry C, Fahmy RH, Essam T, El-laithy HM, Elkheshen SA. Nanoparticles as tool for enhanced ophthalmic delivery of vancomycin: a multidistrict-based microbiological study, solid lipid nanoparticles formulation and evaluation. Drug Dev Ind Pharm. 2016;42(11):1752–1762. doi:10.3109/03639045.2016.117133527093938
   PubMed Web of Science ®Google Scholar
• Patil S, Kadam C, Pokharkar V. QbD based approach for optimization of Tenofovir disoproxil fumarate loaded liquid crystal precursor with improved permeability. J Adv Res. 2017;8(6):607–616. doi:10.1016/j.jare.2017.07.00528794904
   PubMed Web of Science ®Google Scholar
• Ekambaram P, Abdul Hasan Sathali A. Abdul Hasan Sathali A. Formulation and evaluation of solid lipid nanoparticles of ramipril. J Young Pharm. 2011;3(3):216–220. doi:10.4103/0975-1483.8376521897661
   PubMedGoogle Scholar
• Karolewicz B, Gajda M, Górniak A, Owczarek A, Mucha MI. Pluronic F127 as a suitable carrier for preparing the imatinib base solid dispersions and its potential in development of a modified release dosage forms. J Therm Anal Calorim. 2017;130(1):383–390. doi:10.1007/s10973-017-6139-1
   Web of Science ®Google Scholar
• Patil S, Ujalambkar V, Rathore A, Rojatkar S, Pokharkar V. Galangin loaded galactosylated pluronic F68 polymeric micelles for liver targeting. Biomed Pharmacother. 2019;112:108691. doi:10.1016/j.biopha.2019.10869130798131
   PubMed Web of Science ®Google Scholar
• Singh A, Bali A. Formulation and characterization of transdermal patches for controlled delivery of duloxetine hydrochloride. J Anal Sci Technol. 2016;7(1):25. doi:10.1186/s40543-016-0105-6
   Web of Science ®Google Scholar
• Hashem F, Nasr M, Youssif YM. Formulation and characterization of cubosomes containing REB for improvement of oral absorption of the drug in human volunteers. J Adv Pharm Res. 2018;2(2):95–103. doi:10.21608/aprh.2018.5828
   Google Scholar
• Ali-Boucetta H, Al-Jamal KT, Müller KH, et al. Cellular uptake and cytotoxic impact of chemically functionalized and polymer-coated carbon nanotubes. Small. 2011;7(22):3230–3238. doi:10.1002/smll.20110100421919194
   PubMed Web of Science ®Google Scholar
• Desai HH, Bu P, Shah AV, Cheng X, Serajuddin ATM. Evaluation of cytotoxicity of self-emulsifying formulations containing long-chain lipids using Caco-2 cell model: superior safety profile compared to medium-chain lipids. J Pharm Sci. 2020;109(5):1752–1764. doi:10.1016/j.xphs.2020.01.03132035926
   PubMed Web of Science ®Google Scholar
• Shilo M, Sharon A, Baranes K, Motiei M, Lellouche J-PM, Popovtzer R. The effect of nanoparticle size on the probability to cross the blood-brain barrier: an in-vitro endothelial cell model. J Nanobiotechnology. 2015;13(1):19. doi:10.1186/s12951-015-0075-725880565
   PubMedGoogle Scholar
• Gao K, Jiang X. Influence of particle size on transport of methotrexate across blood brain barrier by polysorbate 80-coated polybutylcyanoacrylate nanoparticles. Int J Pharm. 2006;310(1–2):213–219. doi:10.1016/j.ijpharm.2005.11.04016426779
   PubMedGoogle Scholar
• Bourganis V, Kammona O, Alexopoulos A, Kiparissides C. Recent advances in carrier mediated nose-to-brain delivery of pharmaceutics. Eur J Pharm Biopharm. 2018;128:337–362. doi:10.1016/j.ejpb.2018.05.00929733950
   PubMed Web of Science ®Google Scholar
• Acosta E. Bioavailability of nanoparticles in nutrient and nutraceutical delivery. Curr Opin Colloid Interface Sci. 2009;14(1):3–15. doi:10.1016/j.cocis.2008.01.002
   Web of Science ®Google Scholar
• Pereira GR, Collett JH, Garcia SB, Thomazini JA, Bentley MVLB. Glycerol monooleate/solvents systems for progesterone transdermal delivery: in vitro permeation and microscopic studies. Revista Brasileira De Ciências Farmacêuticas. 2002;38(1):55–62. doi:10.1590/S1516-93322002000100005
   Google Scholar
• Bymaster FP, Beedle EE, Findlay J, et al. Duloxetine (Cymbalta™), a dual inhibitor of serotonin and norepinephrine reuptake. Bioorganic Med Chem Lett. 2003;13(24):4477–4480. doi:10.1016/j.bmcl.2003.08.079
   PubMed Web of Science ®Google Scholar
• Chow S-C. Bioavailability and bioequivalence in drug development. Wiley Interdiscip Rev Comput Stat. 2014;6(4):304–312. doi:10.1002/wics.131025215170
   PubMedGoogle Scholar
• Swamy NGN, Abbas Z. Mucoadhesive in situ gels as nasal drug delivery systems: an overview. Asian J Pharm Sci. 2012;7(3):168–180.
   Google Scholar
• Mahajan HS, Mahajan MS, Nerkar PP, Agrawal A. Nanoemulsion-based intranasal drug delivery system of saquinavir mesylate for brain targeting. Drug Deliv. 2014;21(2):148–154. doi:10.3109/10717544.2013.83801424128122
   PubMed Web of Science ®Google Scholar
• Natarajan J, Baskaran M, Humtsoe LC, Vadivelan R, Justin A. Enhanced brain targeting efficacy of Olanzapine through solid lipid nanoparticles. Artificial Cells, Nanomedicine, and Biotechnology. 2017;45(2):364–371. doi:10.3109/21691401.2016.1160402
   PubMed Web of Science ®Google Scholar