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Research Articles

Nanosized ethosomal dispersions for enhanced transdermal delivery of nebivolol using intradermal/transfollicular sustained reservoir: in vitro evaluation, confocal laser scanning microscopy, and in vivo pharmacokinetic studies

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Pages 40-51 | Received 31 Aug 2023, Accepted 09 Dec 2023, Published online: 19 Dec 2023

References

  • Abd-El-Azim H, Ramadan A, Nafee N, Khalafallah N. 2018. Entrapment efficiency of pyridoxine hydrochloride in unilamellar liposomes: experimental versus model-generated data. J Liposome Res. 28(2):112–116. doi: 10.1080/08982104.2016.1275679.
  • Abdulbaqi IM, Darwis Y, Khan NAK, Assi RA, Khan AA. 2016. Ethosomal nanocarriers: the impact of constituents and formulation techniques on ethosomal properties, in vivo studies, and clinical trials. Int J Nanomedicine. 11:2279–2304. doi: 10.2147/IJN.S105016.
  • Ahad A, Aqil M, Kohli K, Sultana Y, Mujeeb M. 2013. Enhanced transdermal delivery of an anti-hypertensive agent via nanoethosomes: statistical optimization, characterization and pharmacokinetic assessment. Int J Pharm. 443(1–2):26–38. doi: 10.1016/j.ijpharm.2013.01.011.
  • Ahmed S, Kassem MA, Sayed S. 2020. Bilosomes as promising nanovesicular carriers for improved transdermal delivery: construction, in vitro optimization, ex vivo permeation and in vivo evaluation. Int J Nanomedicine. 15:9783–9798. doi: 10.2147/IJN.S278688.
  • Ahmed TA, Khalid M, Aljaeid BM, Fahmy UA, Abd-Allah FI. 2016. Transdermal glimepiride delivery system based on optimized ethosomal nano-vesicles: preparation, characterization, in vitro, ex vivo and clinical evaluation. Int J Pharm. 500(1–2):245–254. doi: 10.1016/j.ijpharm.2016.01.017.
  • Albash R, Abdelbary AA, Refai H, El-Nabarawi MA. 2019. Use of transethosomes for enhancing the transdermal delivery of olmesartan medoxomil: in vitro, ex vivo, and in vivo evaluation. Int J Nanomedicine. 14:1953–1968. doi: 10.2147/IJN.S196771.
  • Alkhalidi HM, Naguib GH, Kurakula M, Hamed MT, Attar MH, Almatrook ZH, Aldryhim AY, Bahmdan RH, Khallaf RA, El Sisi AM, et al. 2018. In vitro and preclinical assessment of factorial design based nanoethosomal transdermal film formulation of mefenamic acid to overcome barriers to its use in relieving pain and inflammation. J Drug Delivery Sci Technol. 48:450–456. doi: 10.1016/j.jddst.2018.10.023.
  • Almazan EA, Castañeda PS, Torres RD, Escobar-Chavez JJ. 2020. Design and evaluation of losartan transdermal patch by using solid microneedles as a physical permeation enhancer. Iran J Pharm Res: IJPR. 19(1):138.
  • Amaral MH, Lobo JS, Ferreira D. 2001. Effect of hydroxypropyl methylcellulose and hydrogenated castor oil on naproxen release from sustained-release tablets. AAPS PharmSciTech. 2(2):E6–E21. doi: 10.1208/pt020206.
  • Asati S, Jain S, Choubey A. 2019. Bioadhesive or mucoadhesive drug delivery system: a potential alternative to conventional therapy. J Drug Deliv Ther. 9(4-A):858–867.
  • Asija R, Bhatt S, Asija S, Shah I, Yadav A. 2014. Solubility enhancement of nebivolol by solid dispersion technique. Asian J Pharm Technol. 4(3):134–140.
  • Barupal A, Gupta V, Ramteke S. 2010. Preparation and characterization of ethosomes for topical delivery of aceclofenac. Indian J Pharm Sci. 72(5):582–586. doi: 10.4103/0250-474X.78524.
  • Bertera FM, Del Mauro JS, Lovera V, Chiappetta D, Polizio AH, Taira CA, Höcht C. 2014. Enantioselective pharmacokinetics and cardiovascular effects of nebivolol in L-NAME hypertensive rats. Hypertens Res. 37(3):194–201. doi: 10.1038/hr.2013.140.
  • Bhatia C, Sachdeva M, Bajpai M. 2012. Formulation and evaluation of transdermal patch of pregabalin. Int J Pharm Sci Res. 3(2):569.
  • Bolmal UB, Mali SD, Masareddy RS. 2020. Formulation and evaluation of nebivolol hydrochloride sublingual tablets by using in situ microcrystals. World J Pharm Res. 9(7):1596–1613.
  • Censi R, Martena V, Hoti E, Malaj L, Di Martino P. 2012. Permeation and skin retention of quercetin from microemulsions containing Transcutol® P. Drug Dev Ind Pharm. 38(9):1128–1133. doi: 10.3109/03639045.2011.641564.
  • Choi H-G, Jung J-H, Ryu J-M, Yoon S-J, Oh Y-K, Kim C-K. 1998. Development of in situ-gelling and mucoadhesive acetaminophen liquid suppository. Int J Pharm. 165(1):33–44. doi: 10.1016/S0378-5173(97)00386-4.
  • Chourasia MK, Kang L, Chan SY. 2011. Nanosized ethosomes bearing ketoprofen for improved transdermal delivery. Results Pharma Sci. 1(1):60–67. doi: 10.1016/j.rinphs.2011.10.002.
  • Damgalı Ş, Özdemir S, Kaya G, Demirkoz AB, Üner M. 2022. Development of monolithic matrix type transdermal patches containing cinnarizine: physical characterization and permeation studies. Braz J Pharm Sci. 58. doi: 10.1590/s2175-97902022e19859.
  • Dubey V, Mishra D, Nahar M, Jain V, Jain NK. 2010. Enhanced transdermal delivery of an anti-HIV agent via ethanolic liposomes. Nanomedicine. 6(4):590–596. doi: 10.1016/j.nano.2010.01.002.
  • Elmowafy M, Shalaby K, Alruwaili NK, Elkomy MH, Zafar A, Soliman GM, Salama A, Barakat EH. 2022. EthoLeciplex: a new tool for effective cutaneous delivery of minoxidil. Drug Dev Ind Pharm. 48(9):457–469. doi: 10.1080/03639045.2022.2124261.
  • Elsherif NI, Al-Mahallawi AM, Abdelkhalek AA, Shamma RN. 2021. Investigation of the potential of nebivolol hydrochloride-loaded chitosomal systems for tissue regeneration: in vitro characterization and in vivo assessment. Pharmaceutics. 13(5):700. doi: 10.3390/pharmaceutics13050700.
  • El-Tokhy FSe, Abdel-Mottaleb MM, El-Ghany EA, Geneidi AS. 2021. Design of long acting invasomal nanovesicles for improved transdermal permeation and bioavailability of asenapine maleate for the chronic treatment of schizophrenia. Int J Pharm. 608:121080. doi: 10.1016/j.ijpharm.2021.121080.
  • Fouad SA, Basalious EB, El-Nabarawi MA, Tayel SA. 2013. Microemulsion and poloxamer microemulsion-based gel for sustained transdermal delivery of diclofenac epolamine using in-skin drug depot: in vitro/in vivo evaluation. Int J Pharm. 453(2):569–578. doi: 10.1016/j.ijpharm.2013.06.009.
  • Fouad SA, Shamma RN, Basalious EB, El-Nabarawi MM, Tayel SA. 2018. Novel instantly-dispersible nanocarrier powder system (IDNPs) for intranasal delivery of dapoxetine hydrochloride: in-vitro optimization, ex-vivo permeation studies, and in-vivo evaluation. Drug Dev Ind Pharm. 44(9):1443–1450. doi: 10.1080/03639045.2018.1459675.
  • Fouad SA, Teaima MH, Gebril MI, Abd Allah FI, El-Nabarawi MA, Elhabal SF. 2023. Formulation of novel niosomal repaglinide chewable tablets using coprocessed excipients: in vitro characterization, optimization and enhanced hypoglycemic activity in rats. Drug Deliv. 30(1):2181747. doi: 10.1080/10717544.2023.2181747.
  • Gannu R, Palem CR, Yamsani VV, Yamsani SK, Yamsani MR. 2010. Enhanced bioavailability of lacidipine via microemulsion based transdermal gels: formulation optimization, ex vivo and in vivo characterization. Int J Pharm. 388(1–2):231–241. doi: 10.1016/j.ijpharm.2009.12.050.
  • Gelfuso GM, Gratieri T, Souza JG, Thomazine JA, Lopez RF. 2011. The influence of positive or negative charges in the passive and iontophoretic skin penetration of porphyrins used in photodynamic therapy. Eur J Pharm Biopharm. 77(2):249–256. doi: 10.1016/j.ejpb.2010.11.018.
  • Godin B, Touitou E. 2004. Mechanism of bacitracin permeation enhancement through the skin and cellular membranes from an ethosomal carrier. J Control Release. 94(2–3):365–379. doi: 10.1016/j.jconrel.2003.10.014.
  • Godwin DA, Kim N-H, Felton LA. 2002. Influence of Transcutol® CG on the skin accumulation and transdermal permeation of ultraviolet absorbers. Eur J Pharm Biopharm. 53(1):23–27. doi: 10.1016/s0939-6411(01)00215-6.
  • Güngör S, Erdal MS, Özsoy Y. 2012. Plasticizers in transdermal drug delivery systems. Recent Adv Plast. 5:91–112.
  • Habib BA, Sayed S, Elsayed GM. 2018. Enhanced transdermal delivery of ondansetron using nanovesicular systems: fabrication, characterization, optimization and ex-vivo permeation study-Box-Cox transformation practical example. Eur J Pharm Sci. 115:352–361. doi: 10.1016/j.ejps.2018.01.044.
  • Honary S, Zahir F. 2013. Effect of zeta potential on the properties of nano-drug delivery systems – a review (Part 1). Trop J Pharm Res. 12(2):255–264. doi: 10.4314/tjpr.v12i2.19.
  • Ibrahim TM, Abdallah MH, El-Megrab NA, El-Nahas HM. 2019. Transdermal ethosomal gel nanocarriers; a promising strategy for enhancement of anti-hypertensive effect of carvedilol. J Liposome Res. 29(3):215–228. doi: 10.1080/08982104.2018.1529793.
  • Imran S, Snehalatha Nagaraja TS, Bharathi DR. 2019. Fabrication development and permeation studies of antihypertensive drug nebivolol hydrochloride transdermal patches. JBPR. 8(3):96–103. doi: 10.32553/jbpr.v8i3.617.
  • Jatav VS, Saggu JS, Sharma AK, Sharma A, Jat RK. 2013. Design, development and permeation studies of nebivolol hydrochloride from novel matrix type transdermal patches. Adv Biomed Res. 2(1):62. doi: 10.4103/2277-9175.115813.
  • John C. 2007. A review of the safety and efficacy of nebivolol in the mildly hypertensive patient. Vasc Health Risk Manag. 3(6):909–917.
  • Kaiser EA, Lotze U, Schäfer HH. 2014. Increasing complexity: which drug class to choose for treatment of hypertension in the elderly? Clin Interv Aging. 9:459–475. doi: 10.2147/CIA.S40154.
  • Kasongo W, Pardeike J, Müller RH, Walker RB. 2011. Selection and characterization of suitable lipid excipients for use in the manufacture of didanosine-loaded solid lipid nanoparticles and nanostructured lipid carriers. J Pharm Sci. 100(12):5185–5196. doi: 10.1002/jps.22711.
  • Kassem AA, Abd El-Alim SH, Asfour MH. 2017. Enhancement of 8-methoxypsoralen topical delivery via nanosized niosomal vesicles: formulation development, in vitro and in vivo evaluation of skin deposition. Int J Pharm. 517(1–2):256–268. doi: 10.1016/j.ijpharm.2016.12.018.
  • Khatoon K, Rizwanullah M, Amin S, Mir SR, Akhter S. 2019. Cilnidipine loaded transfersomes for transdermal application: formulation optimization, in-vitro and in-vivo study. J Drug Delivery Sci Technol. 54:101303. doi: 10.1016/j.jddst.2019.101303.
  • Lambers H, Piessens S, Bloem A, Pronk H, Finkel P. 2006. Natural skin surface pH is on average below 5, which is beneficial for its resident flora. Int J Cosmet Sci. 28(5):359–370. doi: 10.1111/j.1467-2494.2006.00344.x.
  • Lee W-R, Shen S-C, Lai H-H, Hu C-H, Fang J-Y. 2001. Transdermal drug delivery enhanced and controlled by erbium: YAG laser: a comparative study of lipophilic and hydrophilic drugs. J Control Release. 75(1–2):155–166. doi: 10.1016/s0168-3659(01)00391-1.
  • Li X-Q, Ye Z-M, Wang J-B, Fan C-R, Pan A-W, Li C, Zhang R-B. 2017. Mucoadhesive buccal films of tramadol for effective pain management. Rev Bras Anestesiol. 67(3):231–237. doi: 10.1016/j.bjan.2016.10.006.
  • Liu D, Xu H, Tian B, Yuan K, Pan H, Ma S, Yang X, Pan W. 2012. Fabrication of carvedilol nanosuspensions through the anti-solvent precipitation–ultrasonication method for the improvement of dissolution rate and oral bioavailability. AAPS Pharmscitech. 13(1):295–304. doi: 10.1208/s12249-011-9750-7.
  • Ma H, Guo D, Fan Y, Wang J, Cheng J, Zhang X. 2018. Paeonol-loaded ethosomes as transdermal delivery carriers: design, preparation and evaluation. Molecules. 23(7):1756. doi: 10.3390/molecules23071756.
  • Malaak FA, Zeid KA, Fouad SA, El-Nabarawi MA. 2019. Orodispersible tablets: novel strategies and future challenges in drug delivery. Res J Pharm Technol. 12(11):5575–5582. doi: 10.5958/0974-360X.2019.00966.1.
  • Malaiya MK, Jain A, Pooja H, Jain A, Jain D. 2018. Controlled delivery of rivastigmine using transdermal patch for effective management of Alzheimer’s disease. J Drug Deliv Sci Technol. 45:408–414. doi: 10.1016/j.jddst.2018.03.030.
  • Mehta SK, Jindal N, Kaur G. 2011. Quantitative investigation, stability and in vitro release studies of anti-TB drugs in Triton niosomes. Colloids Surf B Biointerfaces. 87(1):173–179. doi: 10.1016/j.colsurfb.2011.05.018.
  • Meyyanathan S, Rajan S, Muralidharan S, Birajdar AS, Suresh B. 2008. A validated RP-HPLC method for simultaneous estimation of nebivolol and hydrochlorothiazide in tablets. Indian J Pharm Sci. 70(5):687–689. doi: 10.4103/0250-474X.45420.
  • Mo L, Lu G, Ou X, Ouyang D. 2022. Formulation and development of novel control release transdermal patches of carvedilol to improve bioavailability for the treatment of heart failure. Saudi J Biol Sci. 29(1):266–272. doi: 10.1016/j.sjbs.2021.08.088.
  • Mohamed D, Skran W, Abo-Zeid Y. 2023. Application of several nano carriers to improve the solubility and the bioavailability of carvedilol. J Adv Pharm Res. 7(1):50–65. doi: 10.21608/aprh.2022.167884.1198.
  • Mounika K, Reddy BV, Reddy KN. 2014. Formulation and evaluation of carvedilol transdermal patches with hydrophilic polymers. World J Pharm Res. 3(10):815–826.
  • Nair AB, Shah J, Aljaeid BM, Al-Dhubiab BE, Jacob S. 2019. Gellan gum-based hydrogel for the transdermal delivery of nebivolol: optimization and evaluation. Polymers (Basel). 11(10):1699. doi: 10.3390/polym11101699.
  • Nandania J, Rajput S, Contractor P, Vasava P, Solanki B, Vohra M. 2013. Quantitative determination of nebivolol from human plasma using liquid chromatography–tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 923–924:110–119. doi: 10.1016/j.jchromb.2013.01.034.
  • Nnamani PO, Hansen S, Windbergs M, Lehr C-M. 2014. Development of artemether-loaded nanostructured lipid carrier (NLC) formulation for topical application. Int J Pharm. 477(1–2):208–217. doi: 10.1016/j.ijpharm.2014.10.004.
  • Olawi N, Krüger M, Grimm D, Infanger M, Wehland M. 2019. Nebivolol in the treatment of arterial hypertension. Basic Clin Pharmacol Toxicol. 125(3):189–201. doi: 10.1111/bcpt.13248.
  • Oza N, Trivedi R, Swati S. 2019. Systemic enhancement of nebivolol by using nanosuspension in-situ nasal spray. Inventi Rapid: NDDS. 2019:1–8.
  • Pathan IB, Jaware BP, Shelke S, Ambekar W. 2018. Curcumin loaded ethosomes for transdermal application: formulation, optimization, in-vitro and in-vivo study. J Drug Delivery Sci Technol. 44:49–57. doi: 10.1016/j.jddst.2017.11.005.
  • Peh KK, Wong CF. 1999. Polymeric films as vehicle for buccal delivery: swelling, mechanical, and bioadhesive properties. J Pharm Pharm Sci. 2(2):53–61.
  • Prasanthi D, Lakshmi P. 2012. Development of ethosomes with Taguchi robust design-based studies for transdermal delivery of alfuzosin hydrochloride. Int Curr Pharm J. 1(11):370–375. doi: 10.3329/icpj.v1i11.12063.
  • Prisant LM. 2008. Nebivolol: pharmacologic profile of an ultraselective, vasodilatory β1‐blocker. J Clin Pharmacol. 48(2):225–239. doi: 10.1177/0091270007310378.
  • Qadri GR, Ahad A, Aqil M, Imam SS, Ali A. 2017. Invasomes of isradipine for enhanced transdermal delivery against hypertension: formulation, characterization, and in vivo pharmacodynamic study. Artif Cells Nanomed Biotechnol. 45(1):139–145. doi: 10.3109/21691401.2016.1138486.
  • Rattanapak T, Young K, Rades T, Hook S. 2012. Comparative study of liposomes, transfersomes, ethosomes and cubosomes for transcutaneous immunisation: characterisation and in vitro skin penetration. J Pharm Pharmacol. 64(11):1560–1569. doi: 10.1111/j.2042-7158.2012.01535.x.
  • Ravi P, Vats R, Joseph S, Gadekar N. 2015. Development and validation of simple, rapid and sensitive LC-PDA ultraviolet method for quantification of Nebivolol in rat plasma and its application to pharmacokinetic studies. Acta Chromatogr. 27(2):281–294. doi: 10.1556/AChrom.27.2015.2.6.
  • Razavi H, Janfaza S. 2015. Ethosome: a nanocarrier for transdermal drug delivery. Arch Adv Biosci. 6(2):38–43.
  • Sakran W, Abdel-Rashid RS, Saleh F, Abdel-Monem R. 2022. Ethosomal gel for rectal transmucosal delivery of domperidone: design of experiment, in vitro, and in vivo evaluation. Drug Deliv. 29(1):1477–1491. doi: 10.1080/10717544.2022.2072542.
  • Salem HF, Kharshoum RM, Abou-Taleb HA, Farouk HO, Zaki RM. 2021. Fabrication and appraisal of simvastatin via tailored niosomal nanovesicles for transdermal delivery enhancement: in vitro and in vivo assessment. Pharmaceutics. 13(2):138. doi: 10.3390/pharmaceutics13020138.
  • Sarkar G, Saha NR, Roy I, Bhattacharyya A, Bose M, Mishra R, Rana D, Bhattacharjee D, Chattopadhyay D. 2014. Taro corms mucilage/HPMC based transdermal patch: an efficient device for delivery of diltiazem hydrochloride. Int J Biol Macromol. 66:158–165. doi: 10.1016/j.ijbiomac.2014.02.024.
  • Sarwa KK, Suresh PK, Rudrapal M, Verma VK. 2014. Penetration of tamoxifen citrate loaded ethosomes and liposomes across human skin: a comparative study with confocal laser scanning microscopy. Curr Drug Deliv. 11(3):332–337. doi: 10.2174/1567201811666140115113127.
  • Sayed, O. M., Abo El-Ela, F. I., Kharshoum, R. M., Salem, H. F. (2020). Treatment of basal cell carcinoma via binary ethosomes of vismodegib: in vitro and in vivo studies. AAPS PharmSciTech, 21, 1–11.
  • Selvan PS, Gowda KV, Mandal U, Solomon WS, Pal T. 2007. Simultaneous determination of fixed dose combination of nebivolol and valsartan in human plasma by liquid chromatographic–tandem mass spectrometry and its application to pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci. 858(1–2):143–150. doi: 10.1016/j.jchromb.2007.08.016.
  • Sethi B, Mazumder R. 2018. Comparative evaluation of selected polymers and plasticizer on transdermal drug delivery system. Int J App Pharm. 10(1):67–73. doi: 10.22159/ijap.2018v10i1.21960.
  • Shaker S, Gardouh AR, Ghorab MM. 2017. Factors affecting liposomes particle size prepared by ethanol injection method. Res Pharm Sci. 12(5):346–352. doi: 10.4103/1735-5362.213979.
  • Stasiak N, Kukula-Koch W, Glowniak K. 2014. Modern industrial and pharmacological applications of indigo dye and its derivatives – a review. Acta Pol Pharm. 71(71):215–221.
  • Teaima MH, Mohamed MAA, Abd El Rehem RT, Tayel SA, El-Nabarawi MA, Fouad SA. 2021. Enhanced transdermal delivery of bisoprolol hemifumarate via combined effect of iontophoresis and chemical enhancers: ex vivo permeation/in vivo pharmacokinetic studies. Pharmaceutics. 13(5):682. doi: 10.3390/pharmaceutics13050682.
  • Ubaidulla U, Reddy MV, Ruckmani K, Ahmad FJ, Khar RK. 2007. Transdermal therapeutic system of carvedilol: effect of hydrophilic and hydrophobic matrix on in vitro and in vivo characteristics. AAPS PharmSciTech. 8(1):E13–E20. doi: 10.1208/pt0801002.
  • Üstündağ-Okur N, Yurdasiper A, Gündoğdu E, Homan Gökçe E. 2016. Modification of solid lipid nanoparticles loaded with nebivolol hydrochloride for improvement of oral bioavailability in treatment of hypertension: polyethylene glycol versus chitosan oligosaccharide lactate. J Microencapsul. 33(1):30–42. doi: 10.3109/02652048.2015.1094532.
  • Wang Y, Thakur R, Fan Q, Michniak B. 2005. Transdermal iontophoresis: combination strategies to improve transdermal iontophoretic drug delivery. Eur J Pharm Biopharm. 60(2):179–191. doi: 10.1016/j.ejpb.2004.12.008.
  • Yong CS, Jung J-H, Rhee J-D, Kim C-K, Choi H-G. 2001. Physicochemical characterization and evaluation of buccal adhesive tablets containing omeprazole. Drug Dev Ind Pharm. 27(5):447–455. doi: 10.1081/ddc-100104320.

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