Clinical comparative study of optimized metronidazole loaded lipid nanocarrier vaginal emulgel for management of bacterial vaginosis and its recurrence

References

• Akhtari H, Fazly Bazzaz BS, Golmohammadzadeh S, et al. (2020). Rifampin and cis-2-decenoic acid co-entrapment in solid lipid nanoparticles as an efficient nano-system with potent anti-biofilm activities. J Pharma Innov 10:1–9.
   PubMed Web of Science ®Google Scholar
• Albash R, Elmahboub Y, Baraka K, et al. (2020). Ultra-deformable liposomes containing terpenes (terpesomes) loaded fenticonazole nitrate for treatment of vaginal candidiasis: Box-Behnken design optimization, comparative ex vivo and in vivo studies. Drug Deliv 27:1514–23.
   PubMed Web of Science ®Google Scholar
• Albash R, Yousry C, Al-Mahallawi AM, Alaa-Eldin AA. (2021). Utilization of PEGylated cerosomes for effective topical delivery of fenticonazole nitrate: in-vitro characterization, statistical optimization, and in-vivo assessment. Drug Deliv 28:1–9.
   PubMed Web of Science ®Google Scholar
• Bachhav Y, Patravale V. (2010). Formulation of meloxicam gel for topical application: in vitro and in vivo evaluation. Acta Pharm 60:153–63.
   PubMed Web of Science ®Google Scholar
• Badawi N, El-Say K, Attia D, et al. (2020). Development of pomegranate extract-loaded solid lipid nanoparticles: quality by design approach to screen the variables affecting the quality attributes and characterization. ACS Omega 5:21712–21.
   PubMed Web of Science ®Google Scholar
• Badawi NM, Teaima MH, El-Say KM, et al. (2018). Pomegranate extract-loaded solid lipid nanoparticles: design, optimization, and in vitro cytotoxicity study. Int J Nanomedicine 13:1313–26.
   PubMed Web of Science ®Google Scholar
• Bazzaz BSF, Khameneh B, Zarei H, Golmohammadzadeh S. (2016). Antibacterial efficacy of rifampin loaded solid lipid nanoparticles against Staphylococcus epidermidis biofilm. Microb Pathog 93:137–44.
   PubMed Web of Science ®Google Scholar
• Bhowmik BB, Nayak BS, Chatterjee A. (2009). Formulation development and characterization of metronidazole microencapsulated bioadhesive vaginal gel. Int J Pharm Pharm Sci 1:240–57.
   Google Scholar
• Brandt M, Abels C, May T, et al. (2008). Intravaginally applied metronidazole is as effective as orally applied in the treatment of bacterial vaginosis, but exhibits significantly less side effects. Euro J Obstet Gynecol Reprod Biol 141:158–62.
   PubMed Web of Science ®Google Scholar
• Cassano R, Trombino S. (2019). Solid lipid nanoparticles based on L-cysteine for progesterone intravaginal delivery. Int J Polym Sci 2019:1–10.
   Web of Science ®Google Scholar
• Chavoustie SE, Jacobs M, Reisman HA, et al. (2015). Metronidazole vaginal gel 1.3% in the treatment of bacterial vaginosis: a dose-ranging study. J Low Genit Tract Dis 19:129–34.
   PubMed Web of Science ®Google Scholar
• El-Hammadi M, Arias J. (2015). Nano-sized platforms for vaginal drug delivery. Curr Pharm Des 21:1633–44.
   PubMed Web of Science ®Google Scholar
• Emami J, Mohiti H, Hamishehkar H, Varshosaz J. (2015). Formulation and optimization of solid lipid nanoparticle formulation for pulmonary delivery of budesonide using Taguchi and Box-Behnken design. Res Pharm Sci 10:17–33.
   PubMed Web of Science ®Google Scholar
• Esber A, Vicetti Miguel RD, Cherpes TL, et al. (2015). Risk of bacterial vaginosis among women with herpes simplex virus type 2 infection: a systematic review and meta-analysis. J Infect Dis 212:8–17.
   PubMed Web of Science ®Google Scholar
• Freitas C, Müller RH. (1998). Effect of light and temperature on zeta potential and physical stability in solid lipid nanoparticle (SLN™) dispersions. Int J Pharm 168:221–9.
   Web of Science ®Google Scholar
• Gönüllü Ü, Üner M, Yener G, et al. (2015). Formulation and characterization of solid lipid nanoparticles, nanostructured lipid carriers and nanoemulsion of lornoxicam for transdermal delivery. Acta Pharmaceutica 65:1–13.
   PubMed Web of Science ®Google Scholar
• Harivardhan Reddy L, Murthy RS. (2005). Etoposide-loaded nanoparticles made from glyceride lipids: formulation, characterization, in vitro drug release, and stability evaluation. AAPs PharmSciTech 6:E158–66.
   PubMed Web of Science ®Google Scholar
• Hosny KM. (2016). Alendronate sodium as enteric coated solid lipid nanoparticles; preparation, optimization, and in vivo evaluation to enhance its oral bioavailability. PLoS One 11:e0154926.
   PubMed Web of Science ®Google Scholar
• Islan GA, Tornello PC, Abraham GA, et al. (2016). Smart lipid nanoparticles containing levofloxacin and DNase for lung delivery. Design and characterization. Colloids Surf B Biointerfaces 143:168–76.
   PubMed Web of Science ®Google Scholar
• Kalita B, Saikia K, Kalita B. (2017). Formulation and evaluation of metronidazole microspheres-loaded bioadhesive vaginal gel. Asian J Pharm Clin Res 10:418–24.
   Google Scholar
• Kenyon C, Colebunders R, Crucitti T. (2013). The global epidemiology of bacterial vaginosis: a systematic review. Am J Obstet Gynecol 209:505–23.
   PubMed Web of Science ®Google Scholar
• Kesharwani R, Sachan A, Singh S, Patel D. (2016). Formulation and evaluation of solid lipid nanoparticle (SLN) based topical gel of etoricoxib. J App Pharm Sci 6:124–31.
   Google Scholar
• Madan JR, Khude PA, Dua K. (2014). Development and evaluation of solid lipid nanoparticles of mometasone furoate for topical delivery. Int J Pharm Investig 4:60–4.
   PubMedGoogle Scholar
• Mainardes RM, Evangelista RC. (2005). PLGA nanoparticles containing praziquantel: effect of formulation variables on size distribution. Int J Pharm 290:137–44.
   PubMed Web of Science ®Google Scholar
• Malaekeh-Nikouei B, Bazzaz BSF, Mirhadi E, et al. (2020). The role of nanotechnology in combating biofilm-based antibiotic resistance. J Drug Delivery Sci Technol 60:101880.
   Web of Science ®Google Scholar
• Maru S, Gathu L, Mathenge A, et al. (2012). In vitro drug release studies of metronidazole topical formulations through cellulose membrane. East and Central African J Pharma Sci 15:57–62.
   Google Scholar
• Masoudi M, Miraj S, Rafieian-Kopaei M. (2016). Comparison of the effects of Myrtus communis L, Berberis vulgaris and metronidazole vaginal gel alone for the treatment of bacterial vaginosis. J Clin Diagn Res 10:QC04.
   PubMed Web of Science ®Google Scholar
• Mehnert W, Mäder K. (2001). Solid lipid nanoparticles: production, characterization and applications. Adv Drug Delivery Rev 47:165–96.
   PubMed Web of Science ®Google Scholar
• Mekkawy A, Fathy M, El-Shanawany S. (2013). Formulation and in vitro evaluation of fluconazole topical gels. Br J Pharma Res 3:293–313.
   Google Scholar
• Montenegro L, Sinico C, Castangia I, et al. (2012). Idebenone-loaded solid lipid nanoparticles for drug delivery to the skin: in vitro evaluation. Int J Pharm 434:169–74.
   PubMed Web of Science ®Google Scholar
• Mosallaei N, Jaafari MR, Hanafi-Bojd MY, et al. (2013). Docetaxel-loaded solid lipid nanoparticles: preparation, characterization, in vitro, and in vivo evaluations. J Pharm Sci 102:1994–2004.
   PubMed Web of Science ®Google Scholar
• Mudhney D, Morris P, Lohiya G, Avari J. (2015). Formulation and evaluation of mucoadhesive vaginal gel containing novel combination of metronidazole and miconazole nitrate for the treatment of vaginitis. World J Pharm Sci 3:910–8.
   Google Scholar
• Nabi-Meibodi M, Vatanara A, Najafabadi AR, et al. (2013). The effective encapsulation of a hydrophobic lipid-insoluble drug in solid lipid nanoparticles using a modified double emulsion solvent evaporation method. Colloids Surf B Biointerfaces 112:408–14.
   PubMed Web of Science ®Google Scholar
• Nohemann L, Almeida MPd, Ferrari PC. (2017). Floating ability and drug release evaluation of gastroretentive microparticles system containing metronidazole obtained by spray drying. Braz J Pharm Sci 53:1–13.
   Web of Science ®Google Scholar
• Pandey M, Choudhury H, Abdul-Aziz A, et al. (2020). Promising drug delivery approaches to treat microbial infections in the vagina: a recent update. Polymers 13:26.
   PubMed Web of Science ®Google Scholar
• Rençber S, Karavana SY, Şenyiğit ZA, et al. (2017). Mucoadhesive in situ gel formulation for vaginal delivery of clotrimazole: formulation, preparation, and in vitro/in vivo evaluation. Pharm Dev Technol 22:551–61.
   PubMed Web of Science ®Google Scholar
• Schwebke JR, Desmond RA. (2011). Tinidazole vs metronidazole for the treatment of bacterial vaginosis. Am J Obstet Gynecol 204:211.e1–e6.
   PubMed Web of Science ®Google Scholar
• Shah R, Eldridge D, Palombo E, Harding I. (2014). Optimisation and stability assessment of solid lipid nanoparticles using particle size and zeta potential. J Phys Sci 25:59. 28
   Google Scholar
• Shah R, Malherbe F, Eldridge D, et al. (2014). Physicochemical characterization of solid lipid nanoparticles (SLNs) prepared by a novel microemulsion technique. J Colloid Interface Sci 428:286–94. [pubmedMismatch] 33
   PubMed Web of Science ®Google Scholar
• Sharma M, Gupta N, Gupta S. (2016). Implications of designing clarithromycin loaded solid lipid nanoparticles on their pharmacokinetics, antibacterial activity and safety. RSC Adv 6:76621–31.
   Web of Science ®Google Scholar
• Singh B, Vuddanda PR, Vijayakumar M, et al. (2014). Cefuroxime axetil loaded solid lipid nanoparticles for enhanced activity against S. aureus biofilm. Colloids Surf B Biointerfaces 121:92–8.
   PubMed Web of Science ®Google Scholar
• Soper DE. (2020). Bacterial vaginosis and surgical site infections. Am J Obstet Gynecol 222:219–23.
   PubMed Web of Science ®Google Scholar
• Taylor EN, Kummer KM, Dyondi D, et al. (2014). Multi-scale strategy to eradicate Pseudomonas aeruginosa on surfaces using solid lipid nanoparticles loaded with free fatty acids. Nanoscale 6:825–32.
   PubMed Web of Science ®Google Scholar
• Tomás M, de Oliveira AP, Simões S, et al. (2020). Bacterial vaginosis: standard treatments and alternative strategies. Int J Pharm 587:119659.
   PubMedGoogle Scholar
• Tran TH, Choi JY, Ramasamy T, et al. (2014). Hyaluronic acid-coated solid lipid nanoparticles for targeted delivery of vorinostat to CD44 overexpressing cancer cells. Carbohydr Polym 114:407–15.
   PubMed Web of Science ®Google Scholar
• Venkateswarlu V, Manjunath K. (2004). Preparation, characterization and in vitro release kinetics of clozapine solid lipid nanoparticles. J Controlled Release 95:627–38.
   PubMed Web of Science ®Google Scholar
• Verwijs MC, Agaba SK, Darby AC, van de Wijgert JH. (2020). Impact of oral metronidazole treatment on the vaginal microbiota and correlates of treatment failure. Am J Obstet Gynecol 222:157.e1–e13.
   PubMed Web of Science ®Google Scholar
• Wang S, Chen T, Chen R, et al. (2012). Emodin loaded solid lipid nanoparticles: preparation, characterization and antitumor activity studies. Int J Pharm 430:238–46.
   PubMed Web of Science ®Google Scholar
• Yang H, Li J, Patel SK, et al. (2019). Design of poly (lactic-co-glycolic acid)(PLGA) nanoparticles for vaginal co-delivery of griffithsin and dapivirine and their synergistic effect for HIV prophylaxis. Pharmaceutics 11:184.
   PubMed Web of Science ®Google Scholar
• Yao ML, Patel JC. (2001). Rheological characterization of body lotions. Appl Rheol 11:83–8.
   Google Scholar
• Zare A, Moshfeghy Z, Zarshenas MM, et al. (2019). Quercus brantii Lindl. vaginal cream versus placebo on bacterial vaginosis: a randomized clinical trial. J Herbal Med 16:100247.
   Web of Science ®Google Scholar