ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
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1.
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-
3.
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Bruschi F, Gradoni L, 2018. The Leishmaniases: Old Neglected Tropical Diseases, 1st edition. Springer.
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Pourmohammadi B, Motazedian M, Handjani F, Hatam G, Habibi S, Sarkari B, 2011. Glucantime efficacy in the treatment of zoonotic cutaneous leishmaniasis. Southeast Asian J Trop Med Public Health 42: 502–508.
-
7.
Varshosaz J, Arbabi B, Pestehchian N, Saberi S, Delavari M, 2018. Chitosan-titanium dioxide-Glucantime nanoassemblies effects on promastigote and amastigote of Leishmania major. Int J Biol Macromol 107: 212–221.
-
8.
Roberts WL, McMurray WJ, Rainey PM, 1998. Characterization of the antimonial antileishmanial agent meglumine antimonate (Glucantime). Antimicrob Agents Chemother 42: 1076–1082.
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9.
Mohammadzadeh M, Behnaz F, Golshan Z, 2013. Efficacy of Glucantime for treatment of cutaneous leishmaniasis in central Iran. J Infect Public Health 6: 120–124.
-
10.
Alishahi M, Khorram M, Asgari Q, Davani F, Goudarzi F, Emami A, Arastehfar A, Zomorodian K, 2020. Glucantime-loaded electrospun core-shell nanofibers composed of poly (ethylene oxide)/gelatin-poly (vinyl alcohol)/chitosan as dressing for cutaneous leishmaniasis. Int J Biol Macromol 163: 288–297.
-
11.
Navaei A, Rasoolian M, Momeni A, Emami S, Rafienia M, 2013. Double-walled microspheres loaded with meglumine antimoniate: preparation, characterization and in vitro release study. Drug Dev Ind Pharm 40: 701–710.
-
12.
Oliveira MJA, Silva EO, Braz LMA, Maia R, Amato VS, Lugão AB, Parra DF, 2014. Influence of chitosan/clay in drug delivery of Glucantime from PVP membranes. Radiat Phys Chem 94: 194–198.
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13.
Marwah H, Garg T, Goyal AK, Rath G, 2016. Permeation enhancer strategies in transdermal drug delivery. Drug Deliv 23: 564–578.
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Ganesan P, Narayanasamy D, 2017. Lipid nanoparticles: different preparation techniques, characterization, hurdles, and strategies for the production of solid lipid nanoparticles and nanostructured lipid carriers for oral drug delivery. Sustain Chem Pharm 6: 37–56.
-
15.
Lee SG, Jeong JH, Lee KM, Jeong KH, Yang H, Kim M, Jung H, Lee S, Choi YW, 2014. Nanostructured lipid carrier-loaded hyaluronic acid microneedles for controlled dermal delivery of a lipophilic molecule. Int J Nanomedicine 9: 289–299.
-
16.
Wu H, Ramachandran C, Weiner ND, Roessler BJ, 2001. Topical transport of hydrophilic compounds using water-in-oil nanoemulsions. Int J Pharm 220: 63–75.
-
17.
Czajkowska-Kośnik A, Szekalska M, Winnicka K, 2019. Nanostructured lipid carriers: a potential use for skin drug delivery systems. Pharmacol Rep 71: 156–166.
-
18.
Ghorbanzadeh M, Golmohammadzadeh S, Karimi M, Farhadian N, 2022. Evaluation of vitamin D3 serum level of microemulsion based hydrogel containing Calcipotriol drug. Mater Today Commun 33: 104409.
-
19.
Doktorovova S, Souto EB, 2009. Nanostructured lipid carrier-based hydrogel formulations for drug delivery: a comprehensive review. Expert Opin Drug Deliv 6: 165–176.
-
20.
Kalat SM, Khamesipour A, Bavarsad N, Fallah M, Khashayarmanesh Z, Feizi E, Neghabi K, Abbasi A, Jaafari MR, 2014. Use of topical liposomes containing meglumine antimoniate (Glucantime) for the treatment of L. major lesion in BALB/c mice. Exp Parasitol 143: 5–10.
-
21.
Momeni A, Rasoolian M, Momeni A, Navaei A, Emami S, Shaker Z, Mohebali M, Khoshdel A, 2013. Development of liposomes loaded with anti-leishmanial drugs for the treatment of cutaneous leishmaniasis. J Liposome Res 23: 134–144.
-
22.
Ekambaram P, Sathali AAH, Priyanka K, 2012. Solid lipid nanoparticles: a review. Sci Rev Chem Comm 2: 80–102.
-
23.
Mehnert W, Mäder K, 2012. Solid lipid nanoparticles: production, characterization and applications. Adv Drug Deliv Rev 64: 83–101.
-
24.
Zheng M, Falkeborg M, Zheng Y, Yang T, Xu X, 2013. Formulation and characterization of nanostructured lipid carriers containing a mixed lipids core. Colloids Surf A Physicochem Eng Asp 430: 76–84.
-
25.
Ebrahimi S, Farhadian N, Karimi M, Ebrahimi M, 2020. Enhanced bactericidal effect of ceftriaxone drug encapsulated in nanostructured lipid carrier against gram-negative Escherichia coli bacteria: drug formulation, optimization, and cell culture study. Antimicrob Resist Infect Control 9: 1–12.
-
26.
Hayati F, Ghamsari SM, Dehghan MM, Oryan A, 2018. Effects of carbomer 940 hydrogel on burn wounds: an in vitro and in vivo study. J Dermatolog Treat 29: 593–599.
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27.
Motawea A, El Abd AE-GH, Borg T, Motawea M, Tarshoby M, 2019. The impact of topical phenytoin loaded nanostructured lipid carriers in diabetic foot ulceration. Foot 40: 14–21.
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28.
Ghorbanzadeh M, Farhadian N, Golmohammadzadeh S, Karimi M, Ebrahimi M, 2019. Formulation, clinical and histopathological assessment of microemulsion based hydrogel for UV protection of skin. Colloids Surf B Biointerfaces 179: 393–404.
-
29.
Khan AA, Mudassir J, Akhtar S, Murugaiyah V, Darwis Y, 2019. Freeze-dried lopinavir-loaded nanostructured lipid carriers for enhanced cellular uptake and bioavailability: statistical optimization, in vitro and in vivo evaluations. Pharmaceutics 11: 97.
-
30.
Ortiz AC, Yañez O, Salas-Huenuleo E, Morales JO, 2021. Development of a nanostructured lipid carrier (NLC) by a low-energy method, comparison of release kinetics and molecular dynamics simulation. Pharmaceutics 13: 531.
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Gaba B, Fazil M, Khan S, Ali A, Baboota S, Ali J, 2015. Nanostructured lipid carrier system for topical delivery of terbinafine hydrochloride. Bull Fac Pharm Cairo Univ 53: 147–159.
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Flores FC et al., 2015. Hydrogels containing nanocapsules and nanoemulsions of tea tree oil provide antiedematogenic effect and improved skin wound healing. J Nanosci Nanotechnol 15: 800–809.
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Bolla PK, Clark BA, Juluri A, Cheruvu HS, Renukuntla J, 2020. Evaluation of formulation parameters on permeation of ibuprofen from topical formulations using Strat-M® membrane. Pharmaceutics 12: 151.
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El-Sherbiny IM, Yacoub MH, 2013. Hydrogel scaffolds for tissue engineering: progress and challenges. Glob Cardiol Sci Pract 2013: 38–128.
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Deuschle VCKN, Deuschle RAN, Bortoluzzi MR, Athayde ML, 2015. Physical chemistry evaluation of stability, spreadability, in vitro antioxidant, and photo-protective capacities of topical formulations containing Calendula officinalis L. leaf extract. Braz J Pharm Sci 51: 63–75.
-
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Dehghani F, Farhadian N, Golmohammadzadeh S, Biriaee A, Ebrahimi M, Karimi M, 2017. Preparation, characterization and in-vivo evaluation of microemulsions containing tamoxifen citrate anti-cancer drug. Eur J Pharm Sci 96: 479–489.
-
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Golmohammadzadeh S, Farhadian N, Biriaee A, Dehghani F, Khameneh B, 2017. Preparation, characterization and in vitro evaluation of microemulsion of raloxifene hydrochloride. Drug Dev Ind Pharm 43: 1619–1625.
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A Novel Topical Formulation of the Leishmaniasis Drug Glucantime as a Nanostructured Lipid Carrier-Based Hydrogel
Faranak Dehghani
Faranak Dehghani
Chemical Engineering Department, Faculty of Engineering, Ferdowsi University of Mashhad, Mashhad, Iran;
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Nafiseh Farhadian
Nafiseh Farhadian
Chemical Engineering Department, Faculty of Engineering, Ferdowsi University of Mashhad, Mashhad, Iran;
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Vahid Mashayekhi Goyonlo
Vahid Mashayekhi Goyonlo
Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran;
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Omid Ahmadi
Omid Ahmadi
Department of Parasitology and Mycology, Torbat Jam Faculty of Medical Sciences, Torbat Jam, Iran
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ABSTRACT.
Leishmaniasis is a parasitic disease caused by Leishmania parasites. Meglumine antimoniate, or Glucantime, is the primary drug used to treat this disease. Glucantime with a standard painful injection administration route has high aqueous solubility, burst release, a significant tendency to cross into aqueous medium, rapid clearance from the body, and insufficient residence time at the injury site. Topical delivery of Glucantime can be a favorable option in the treatment of localized cutaneous leishmaniasis. In this study, a suitable transdermal formulation in the form of nanostructured lipid carrier (NLC)-based hydrogel containing Glucantime was prepared. In vitro drug release studies confirmed controllable drug release behavior for hydrogel formulation. An in vivo permeation study on healthy BALB/C female mice confirmed appropriate penetration of hydrogel into the skin and sufficient residence time in the skin. In vivo performance of the new topical formulation on the BALB/C female mice showed a significant improvement in reduction of leishmaniasis wound size, lowering parasites number in lesions, liver, and spleen compared with commercial ampule. Hematological analysis showed a significant reduction of the drug’s side effects, including variance of enzymes and blood factors. NLC-based hydrogel formulation is proposed as a new topical administration to replace the commercial ampule.
Author Notes
Financial support: This research was supported by
Authors’ addresses: Faranak Dehghani and Nafiseh Farhadian, Chemical Engineering Department, Faculty of Engineering, Ferdowsi University of Mashhad, Mashhad, Iran, E-mails: faranak.dehghani351@yahoo.com and n.farhadian@um.ac.ir. Vahid Mashayekhi Goyonlo, Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Sciences, Mashhad, Iran, E-mail: mashayekhiv@mums.ac.ir. Omid Ahmadi, Department of Parasitology and Mycology, Torbat Jam Faculty of Medical Sciences, Torbat Jam, Iran, E-mail: ahmadio961@mums.ac.ir.
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
1.
Torres-Guerrero E, Quintanilla-Cedillo MR, Ruiz-Esmenjaud J, Arenas R, 2017. Leishmaniasis: a review. F1000Research 6: 750.
-
2.
Santos DO et al., 2008. Leishmaniasis treatment – a challenge that remains: a review. Parasitol Res 103: 1–10.
-
3.
Tamiru HF, Mashalla YJ, Mohammed R, Tshweneagae GT, 2019. Cutaneous leishmaniasis a neglected tropical disease: community knowledge, attitude and practices in an endemic area, northwest Ethiopia. BMC Infect Dis 19: 1–10.
-
4.
Bruschi F, Gradoni L, 2018. The Leishmaniases: Old Neglected Tropical Diseases, 1st edition. Springer.
-
5.
Jamshaid H, ud Din F, Khan GM, 2021. Nanotechnology based solutions for anti-leishmanial impediments: a detailed insight. J Nanobiotechnol 19: 1–51.
-
6.
Pourmohammadi B, Motazedian M, Handjani F, Hatam G, Habibi S, Sarkari B, 2011. Glucantime efficacy in the treatment of zoonotic cutaneous leishmaniasis. Southeast Asian J Trop Med Public Health 42: 502–508.
-
7.
Varshosaz J, Arbabi B, Pestehchian N, Saberi S, Delavari M, 2018. Chitosan-titanium dioxide-Glucantime nanoassemblies effects on promastigote and amastigote of Leishmania major. Int J Biol Macromol 107: 212–221.
-
8.
Roberts WL, McMurray WJ, Rainey PM, 1998. Characterization of the antimonial antileishmanial agent meglumine antimonate (Glucantime). Antimicrob Agents Chemother 42: 1076–1082.
-
9.
Mohammadzadeh M, Behnaz F, Golshan Z, 2013. Efficacy of Glucantime for treatment of cutaneous leishmaniasis in central Iran. J Infect Public Health 6: 120–124.
-
10.
Alishahi M, Khorram M, Asgari Q, Davani F, Goudarzi F, Emami A, Arastehfar A, Zomorodian K, 2020. Glucantime-loaded electrospun core-shell nanofibers composed of poly (ethylene oxide)/gelatin-poly (vinyl alcohol)/chitosan as dressing for cutaneous leishmaniasis. Int J Biol Macromol 163: 288–297.
-
11.
Navaei A, Rasoolian M, Momeni A, Emami S, Rafienia M, 2013. Double-walled microspheres loaded with meglumine antimoniate: preparation, characterization and in vitro release study. Drug Dev Ind Pharm 40: 701–710.
-
12.
Oliveira MJA, Silva EO, Braz LMA, Maia R, Amato VS, Lugão AB, Parra DF, 2014. Influence of chitosan/clay in drug delivery of Glucantime from PVP membranes. Radiat Phys Chem 94: 194–198.
-
13.
Marwah H, Garg T, Goyal AK, Rath G, 2016. Permeation enhancer strategies in transdermal drug delivery. Drug Deliv 23: 564–578.
-
14.
Ganesan P, Narayanasamy D, 2017. Lipid nanoparticles: different preparation techniques, characterization, hurdles, and strategies for the production of solid lipid nanoparticles and nanostructured lipid carriers for oral drug delivery. Sustain Chem Pharm 6: 37–56.
-
15.
Lee SG, Jeong JH, Lee KM, Jeong KH, Yang H, Kim M, Jung H, Lee S, Choi YW, 2014. Nanostructured lipid carrier-loaded hyaluronic acid microneedles for controlled dermal delivery of a lipophilic molecule. Int J Nanomedicine 9: 289–299.
-
16.
Wu H, Ramachandran C, Weiner ND, Roessler BJ, 2001. Topical transport of hydrophilic compounds using water-in-oil nanoemulsions. Int J Pharm 220: 63–75.
-
17.
Czajkowska-Kośnik A, Szekalska M, Winnicka K, 2019. Nanostructured lipid carriers: a potential use for skin drug delivery systems. Pharmacol Rep 71: 156–166.
-
18.
Ghorbanzadeh M, Golmohammadzadeh S, Karimi M, Farhadian N, 2022. Evaluation of vitamin D3 serum level of microemulsion based hydrogel containing Calcipotriol drug. Mater Today Commun 33: 104409.
-
19.
Doktorovova S, Souto EB, 2009. Nanostructured lipid carrier-based hydrogel formulations for drug delivery: a comprehensive review. Expert Opin Drug Deliv 6: 165–176.
-
20.
Kalat SM, Khamesipour A, Bavarsad N, Fallah M, Khashayarmanesh Z, Feizi E, Neghabi K, Abbasi A, Jaafari MR, 2014. Use of topical liposomes containing meglumine antimoniate (Glucantime) for the treatment of L. major lesion in BALB/c mice. Exp Parasitol 143: 5–10.
-
21.
Momeni A, Rasoolian M, Momeni A, Navaei A, Emami S, Shaker Z, Mohebali M, Khoshdel A, 2013. Development of liposomes loaded with anti-leishmanial drugs for the treatment of cutaneous leishmaniasis. J Liposome Res 23: 134–144.
-
22.
Ekambaram P, Sathali AAH, Priyanka K, 2012. Solid lipid nanoparticles: a review. Sci Rev Chem Comm 2: 80–102.
-
23.
Mehnert W, Mäder K, 2012. Solid lipid nanoparticles: production, characterization and applications. Adv Drug Deliv Rev 64: 83–101.
-
24.
Zheng M, Falkeborg M, Zheng Y, Yang T, Xu X, 2013. Formulation and characterization of nanostructured lipid carriers containing a mixed lipids core. Colloids Surf A Physicochem Eng Asp 430: 76–84.
-
25.
Ebrahimi S, Farhadian N, Karimi M, Ebrahimi M, 2020. Enhanced bactericidal effect of ceftriaxone drug encapsulated in nanostructured lipid carrier against gram-negative Escherichia coli bacteria: drug formulation, optimization, and cell culture study. Antimicrob Resist Infect Control 9: 1–12.
-
26.
Hayati F, Ghamsari SM, Dehghan MM, Oryan A, 2018. Effects of carbomer 940 hydrogel on burn wounds: an in vitro and in vivo study. J Dermatolog Treat 29: 593–599.
-
27.
Motawea A, El Abd AE-GH, Borg T, Motawea M, Tarshoby M, 2019. The impact of topical phenytoin loaded nanostructured lipid carriers in diabetic foot ulceration. Foot 40: 14–21.
-
28.
Ghorbanzadeh M, Farhadian N, Golmohammadzadeh S, Karimi M, Ebrahimi M, 2019. Formulation, clinical and histopathological assessment of microemulsion based hydrogel for UV protection of skin. Colloids Surf B Biointerfaces 179: 393–404.
-
29.
Khan AA, Mudassir J, Akhtar S, Murugaiyah V, Darwis Y, 2019. Freeze-dried lopinavir-loaded nanostructured lipid carriers for enhanced cellular uptake and bioavailability: statistical optimization, in vitro and in vivo evaluations. Pharmaceutics 11: 97.
-
30.
Ortiz AC, Yañez O, Salas-Huenuleo E, Morales JO, 2021. Development of a nanostructured lipid carrier (NLC) by a low-energy method, comparison of release kinetics and molecular dynamics simulation. Pharmaceutics 13: 531.
-
31.
Gaba B, Fazil M, Khan S, Ali A, Baboota S, Ali J, 2015. Nanostructured lipid carrier system for topical delivery of terbinafine hydrochloride. Bull Fac Pharm Cairo Univ 53: 147–159.
-
32.
Flores FC et al., 2015. Hydrogels containing nanocapsules and nanoemulsions of tea tree oil provide antiedematogenic effect and improved skin wound healing. J Nanosci Nanotechnol 15: 800–809.
-
33.
Bolla PK, Clark BA, Juluri A, Cheruvu HS, Renukuntla J, 2020. Evaluation of formulation parameters on permeation of ibuprofen from topical formulations using Strat-M® membrane. Pharmaceutics 12: 151.
-
34.
El-Sherbiny IM, Yacoub MH, 2013. Hydrogel scaffolds for tissue engineering: progress and challenges. Glob Cardiol Sci Pract 2013: 38–128.
-
35.
Sabale V, Kunjwani H, Sabale P, 2011. Formulation and in vitro evaluation of the topical antiageing preparation of the fruit of Benincasa hispida. J Ayurveda Integr Med 2: 124–128.
-
36.
Deuschle VCKN, Deuschle RAN, Bortoluzzi MR, Athayde ML, 2015. Physical chemistry evaluation of stability, spreadability, in vitro antioxidant, and photo-protective capacities of topical formulations containing Calendula officinalis L. leaf extract. Braz J Pharm Sci 51: 63–75.
-
37.
Dehghani F, Farhadian N, Golmohammadzadeh S, Biriaee A, Ebrahimi M, Karimi M, 2017. Preparation, characterization and in-vivo evaluation of microemulsions containing tamoxifen citrate anti-cancer drug. Eur J Pharm Sci 96: 479–489.
-
38.
Golmohammadzadeh S, Farhadian N, Biriaee A, Dehghani F, Khameneh B, 2017. Preparation, characterization and in vitro evaluation of microemulsion of raloxifene hydrochloride. Drug Dev Ind Pharm 43: 1619–1625.
-
39.
Araújo J, Garcia ML, Mallandrich M, Souto EB, Calpena AC, 2012. Release profile and transscleral permeation of triamcinolone acetonide loaded nanostructured lipid carriers (TA-NLC): in vitro and ex vivo studies. Nanomedicine 8: 1034–1041.
-
40.
Binesh N, Farhadian N, Mohammadzadeh A, 2021. Enhanced antibacterial activity of uniform and stable chitosan nanoparticles containing metronidazole against anaerobic bacterium of Bacteroides fragilis. Colloids Surf B Biointerfaces 202: 111691.
-
41.
Ezatpour B, Saedi Dezaki E, Mahmoudvand H, Azadpour M, Ezzatkhah F, 2015. In vitro and in vivo antileishmanial effects of Pistacia khinjuk against Leishmania tropica and Leishmania major. Evid Based Complement Altern Med 2015: 149707.
-
42.
Riaz A, Ahmed N, Khan MI, Haq I-u, ur Rehman A, Khan GM, 2019. Formulation of topical NLCs to target macrophages for cutaneous leishmaniasis. J Drug Deliv Sci Technol 54: 101232.
-
43.
Mahmoudvand H, Tavakoli R, Sharififar F, Minaie K, Ezatpour B, Jahanbakhsh S, Sharifi I, 2015. Leishmanicidal and cytotoxic activities of Nigella sativa and its active principle, thymoquinone. Pharm Biol 53: 1052–1057.
-
44.
Shah PP, Desai PR, Channer D, Singh M, 2012. Enhanced skin permeation using polyarginine modified nanostructured lipid carriers. J Control Release 161: 735–745.
-
45.
Veninga T, Wieringa R, Morse H, 1989. Pigmented spleens in C57BL mice. Lab Anim 23: 16–20.
-
46.
Parasuraman S, Raveendran R, Kesavan R, 2010. Blood sample collection in small laboratory animals. J Pharmacol Pharmacother 1: 87.
-
47.
Averill H, Roche J, King C, 1929. Synthetic glycerides. I. Preparation and melting points of glycerides of known constitution. J Am Chem Soc 51: 866–872.
-
48.
Li J, Liu D, Tan G, Zhao Z, Yang X, Pan W, 2016. A comparative study on the efficiency of chitosan-N-acetylcysteine, chitosan oligosaccharides or carboxymethyl chitosan surface modified nanostructured lipid carrier for ophthalmic delivery of curcumin. Carbohydr Polym 146: 435–444.
-
49.
Bhatia V, Barber R, 1955. The effect of pH variations of ointment bases on the local anesthetic activity of incorporated ethyl aminobenzoate. I. Hydrophilic ointment USP. J Am Pharm Assoc 44: 342–343.
-
50.
Sezer AD, Cevher E, Hatıpoğlu F, Oğurtan Z, Baş AL, Akbuğa J, 2008. Preparation of fucoidan-chitosan hydrogel and its application as burn healing accelerator on rabbits. Biol Pharm Bull 31: 2326–2333.
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