Rosuvastatin calcium-based novel nanocubic vesicles capped with silver nanoparticles-loaded hydrogel for wound healing management: optimization employing Box–Behnken design: in vitro and in vivo assessment

References

• Abdel Messih, H.A., et al., 2017. Nanoethosomes for transdermal delivery of tropisetron HCl: multi-factorial predictive modeling, characterization, and ex vivo skin permeation. Drug development and industrial pharmacy, 43 (6), 958–971.
   PubMed Web of Science ®Google Scholar
• Aboud, H.M., et al., 2016. Nanotransfersomes of carvedilol for intranasal delivery: formulation, characterization and in vivo evaluation. Drug delivery, 23 (7), 2471–2481.
   PubMed Web of Science ®Google Scholar
• Aboud, H.M., et al., 2018. Novel in situ gelling vaginal sponges of sildenafil citrate-based cubosomes for uterine targeting. Drug delivery, 25 (1), 1328–1339.
   PubMed Web of Science ®Google Scholar
• Aboud, H.M., et al., 2020. Preparation and appraisal of self-assembled valsartan-loaded amalgamated Pluronic F127/Tween 80 polymeric micelles: boosted cardioprotection via regulation of Mhrt/Nrf2 and Trx1 pathways in cisplatin-induced cardiotoxicity. Journal of drug targeting, 28 (3), 282–299.
   PubMed Web of Science ®Google Scholar
• Ahmed, Y.M., et al., 2019. Effects of ticagrelor, empagliflozin and tamoxifen against experimentally-induced vascular reactivity defects in rats in vivo and in vitro. Pharmacological reports, 71 (6), 1034–1043.
   PubMed Web of Science ®Google Scholar
• Akman, E., et al., 2011. Effect of femtosecond Ti: Sapphire laser wavelengths on plasmonic behaviour and size evolution of silver nanoparticles. Photonics and nanostructures-fundamentals and applications, 9 (3), 276–286.
   Web of Science ®Google Scholar
• Alkhalidi, H.M., 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. Journal of drug delivery science and technology, 48, 450–456.
   Web of Science ®Google Scholar
• Aly, U.F., et al., 2019. Formulation and evaluation of simvastatin polymeric nanoparticles loaded in hydrogel for optimum wound healing purpose. Drug design, development and therapy, 13, 1567–1580.
   PubMed Web of Science ®Google Scholar
• Amin, S. G., Shah, D. A., and Dave, R. H., 2017. Formulation and Evaluation of Liposomes of Fenofibrate Prepared by Thin Film Hydration Technique. Long Island University, The Brooklyn Center.
   Google Scholar
• Archana, A., et al., 2015. Curcumin loaded nano cubosomal hydrogel: preparation, in vitro characterization and antibacterial activity. Chemical science transaction, 4, 75–80.
   Google Scholar
• Balakumar, K., et al., 2013. Self nanoemulsifying drug delivery system (SNEDDS) of rosuvastatin calcium: design, formulation, bioavailability and pharmacokinetic evaluation. Colloids and surfaces. B biointerfaces, 112, 337–343.
   PubMed Web of Science ®Google Scholar
• Bancroft, J. D., and Gamble, M., 2008. Theory and practice of histological techniques. London: Churchill Livingstone.
   Google Scholar
• Barriga, H.M., Holme, M.N., and Stevens, M.M., 2019. Cubosomes: the next generation of smart lipid nanoparticles? Angewandte Chemie (International ed. in English)), 58 (10), 2958–2978.
   PubMed Web of Science ®Google Scholar
• Brauchli, Y.B., Jick, S.S., and Meier, C.R., 2011. Statin use and risk of first-time psoriasis diagnosis. Journal of the American academy of dermatology, 65 (1), 77–83.
   PubMed Web of Science ®Google Scholar
• Bueno, L., Ferre, J.-P., and Ruckebusch, Y., 1978. Effects of anesthesia and surgical procedures on intestinal myoelectric activity in rats. American journal of digestive diseases, 23 (8), 690–695.
   PubMedGoogle Scholar
• Cho, H.-J., et al., 2014. Surface-modified solid lipid nanoparticles for oral delivery of docetaxel: enhanced intestinal absorption and lymphatic uptake. International journal of nanomedicine, 9, 495–504.
   PubMed Web of Science ®Google Scholar
• Cramer, M.P., and Saks, S.R., 1994. Translating safety, efficacy and compliance into economic value for controlled release dosage forms. Pharmacoeconomics, 5 (6), 482–504.
   PubMed Web of Science ®Google Scholar
• Dayan, N., and Touitou, E., 2000. Carriers for skin delivery of trihexyphenidyl HCl: ethosomes vs. liposomes. Biomaterials, 21 (18), 1879–1885.
   PubMed Web of Science ®Google Scholar
• de Oliveira, S., et al., 2016. Neutrophil migration in infection and wound repair: going forward in reverse. Nature reviews immunology, 16 (6), 378–391.
   PubMed Web of Science ®Google Scholar
• Dehnavi, A.S., Raisi, A., and Aroujalian, A., 2013. Control size and stability of colloidal silver nanoparticles with antibacterial activity prepared by a green synthesis method. Synthesis and reactivity in inorganic, metal-organic, and nano-metal chemistry, 43 (5), 543–551.
   Web of Science ®Google Scholar
• Doktorovova, S., and Souto, E.B., 2009. Nanostructured lipid carrier-based hydrogel formulations for drug delivery: a comprehensive review. Expert opinion on drug delivery, 6 (2), 165–176.
   PubMed Web of Science ®Google Scholar
• Eming, S.A., et al., 2014. Wound repair and regeneration: mechanisms, signaling and translation. Science translational medicine, 6 (265), 265sr5.
   Web of Science ®Google Scholar
• Erukova, V.Y., et al., 2000. Effect of ethylene oxide and propylene oxide block copolymers on the permeability of bilayer lipid membranes to small solutes including doxorubicin. Biochimica et biophysica acta (Bba) - biomembranes, 1468 (1-2), 73–86.
   PubMed Web of Science ®Google Scholar
• Farsaei, S., Khalili, H., and Farboud, E.S., 2012. Potential role of statins on wound healing: review of the literature. International wound journal, 9 (3), 238–247.
   PubMed Web of Science ®Google Scholar
• Hao, J., et al., 2011. Development and optimization of solid lipid nanoparticle formulation for ophthalmic delivery of chloramphenicol using a Box–Behnken design. International journal of nanomedicine, 6, 683.
   PubMed Web of Science ®Google Scholar
• Hwang, M.-R., et al., 2010. Gentamicin-loaded wound dressing with polyvinyl alcohol/dextran hydrogel: gel characterization and in vivo healing evaluation. Aaps pharmscitech, 11 (3), 1092–1103.
   PubMed Web of Science ®Google Scholar
• Imam, S.S., et al., 2015. Formulation by design-based proniosome for accentuated transdermal delivery of risperidone: in vitro characterization and in vivo pharmacokinetic study. Drug delivery, 22 (8), 1059–1070.
   PubMed Web of Science ®Google Scholar
• Imam, S.S., et al., 2017. Formulation by design based risperidone nano soft lipid vesicle as a new strategy for enhanced transdermal drug delivery: in-vitro characterization, and in-vivo appraisal. Materials science & engineering. C, 75, 1198–1205.
   Google Scholar
• Ingle, A. P., et al., 2017. Nanoformulations for wound infections. Nanotechnology applied to pharmaceutical technology. Cham: Springer, 223–246.
   Google Scholar
• AIM-HIGH Investigators. 2011. Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy. New England journal of medicine, 365 (24), 2255–2267.
   PubMed Web of Science ®Google Scholar
• Jain, J., et al., 2009. Silver nanoparticles in therapeutics: development of an antimicrobial gel formulation for topical use. Molecular pharmaceutics, 6 (5), 1388–1401.
   PubMed Web of Science ®Google Scholar
• Jhawat, V.C., et al., 2013. Transdermal drug delivery systems: approaches and advancements in drug absorption through skin. International journal of pharmaceutical sciences review and research, 20 (1), 47–56.
   Google Scholar
• Ju-Nam, Y., and Lead, J.R., 2008. Manufactured nanoparticles: an overview of their chemistry, interactions and potential environmental implications. Science of the total environment, 400 (1-3), 396–414.
   PubMed Web of Science ®Google Scholar
• Katakam, M., Bell, L.N., and Banga, A.K., 1995. Effect of surfactants on the physical stability of recombinant human growth hormone. Journal of pharmaceutical sciences, 84 (6), 713–716.
   PubMed Web of Science ®Google Scholar
• Khallaf, R.A., Aboud, H.M., and Sayed, O.M., 2020. Surface modified niosomes of olanzapine for brain targeting via nasal route; preparation, optimization, and in vivo evaluation. Journal of liposome research, 30 (2), 163–111.
   PubMed Web of Science ®Google Scholar
• Khallaf, R.A., Salem, H.F., and Abdelbary, A., 2016. 5-Fluorouracil shell-enriched solid lipid nanoparticles (SLN) for effective skin carcinoma treatment. Drug delivery, 23 (9), 3452–3460.
   PubMed Web of Science ®Google Scholar
• Kumar, P.T., Mishra, J., and Podder, A., 2016. Design, fabrication and evaluation of rosuvastatin pharmacosome-a novel sustained release drug delivery system. European journal of pharmaceutical and medicine research, 3, 332–350.
   Google Scholar
• Lee, B., and Firestone, M.A., 2008. Electron density mapping of triblock copolymers associated with model biomembranes: Insights into conformational states and effect on bilayer structure. Biomacromolecules, 9 (6), 1541–1550.
   PubMed Web of Science ®Google Scholar
• Lobna, A., et al., 2018. Role of atorvastatin in treatment of chronic spontaneous urticaria patients: a controlled clinical trial. Egyptian journal of immunology, 25 (2), 133–139.
   PubMedGoogle Scholar
• Lynch, M.L., et al., 2003. Enhanced loading of water-soluble actives into bicontinuous cubic phase liquid crystals using cationic surfactants. Journal of colloid and interface science, 260 (2), 404–413.
   PubMed Web of Science ®Google Scholar
• Maged, A., et al., 2020. Spray-Dried Rosuvastatin Nanoparticles for Promoting Hair Growth. AAPS Pharmscitech, 21 (6), 1–12.
   Web of Science ®Google Scholar
• Manca, M.L., et al., 2013. Glycerosomes: a new tool for effective dermal and transdermal drug delivery. International journal of pharmaceutics, 455 (1-2), 66–74.
   PubMed Web of Science ®Google Scholar
• Marcato, P.D., et al., 2015. In vivo evaluation of complex biogenic silver nanoparticle and enoxaparin in wound healing. Journal of nanomaterials, 2015, 1–10.
   Web of Science ®Google Scholar
• Newa, M., et al., 2007. Preparation, characterization and in vivo evaluation of ibuprofen binary solid dispersions with poloxamer 188. International journal of pharmaceutics, 343 (1-2), 228–237.
   PubMed Web of Science ®Google Scholar
• Omar, S., et al., 2019. Formulation and Evaluation of Cubosomes as Skin Retentive System for Topical Delivery of Clotrimazole. Journal of advanced pharmacy research, 3 (2), 68–82.
   Google Scholar
• Pani, N.R., et al., 2012. Application of DSC, IST, and FTIR study in the compatibility testing of nateglinide with different pharmaceutical excipients. Journal of thermal analysis and calorimetry, 108 (1), 219–226.
   Web of Science ®Google Scholar
• Patel, M., et al., 2008. Solubility enhancement of lovastatin by modified locust bean gum using solid dispersion techniques. Aaps pharmscitech, 9 (4), 1262–1269.
   PubMed Web of Science ®Google Scholar
• Rangaraj, A., Harding, K., and Leaper, D., 2011. Role of collagen in wound management. Wounds, 7 (2), 54–63.
   Google Scholar
• Rattanapak, T., et al., 2012. Comparative study of liposomes, transfersomes, ethosomes and cubosomes for transcutaneous immunisation: characterisation and in vitro skin penetration. The Journal of pharmacy and pharmacology, 64 (11), 1560–1569.
   PubMed Web of Science ®Google Scholar
• Redd, M.J., et al., 2004. Wound healing and inflammation: embryos reveal the way to perfect repair. Philosophical transactions of the royal society of London B biological sciences, 359 (1445), 777–784.
   PubMed Web of Science ®Google Scholar
• Rizk, M.N., and Ameen, A.I., 2013. Comorbidities associated with Egyptian diabetic foot disease subtypes. Egyptian journal of internal medicine, 25 (3), 154.
   Google Scholar
• Salah, S., Mahmoud, A.A., and Kamel, A.O., 2017. Etodolac transdermal cubosomes for the treatment of rheumatoid arthritis: ex vivo permeation and in vivo pharmacokinetic studies. Drug delivery, 24 (1), 846–856.
   PubMed Web of Science ®Google Scholar
• Salama, H.A., et al., 2012. Phospholipid based colloidal poloxamer-nanocubic vesicles for brain targeting via the nasal route. Colloids and surfaces B biointerfaces, 100, 146–154.
   PubMed Web of Science ®Google Scholar
• Salem, H.F., et al., 2018. Preparation and optimization of tablets containing a self-nano-emulsifying drug delivery system loaded with rosuvastatin. Journal of liposome research, 28 (2), 149–160.
   PubMed Web of Science ®Google Scholar
• Salem, H.F., et al., 2019. Nanosized transferosome-based intranasal in situ gel for brain targeting of resveratrol: formulation, optimization, in vitro evaluation, and in vivo pharmacokinetic study. Aaps pharmscitech, 20 (5), 181.
   PubMed Web of Science ®Google Scholar
• Salem, H.F., et al., 2019. Treatment of breast cancer with engineered novel pH-sensitive triaryl-(Z)-olefin niosomes containing hydrogel: an in vitro and in vivo study. Journal of liposome research, 30(2):126–135.
   PubMed Web of Science ®Google Scholar
• Salem, H.F., et al., 2020a. Novel enhanced therapeutic efficacy of dapoxetine HCl by nano-vesicle transdermal gel for treatment of carrageenan-induced rat paw edema. AAPS PharmSciTech, 21 (3), 1–13.
   Web of Science ®Google Scholar
• Salem, H.F., et al., 2020b. A novel transdermal nanoethosomal gel of lercanidipine HCl for treatment of hypertension: optimization using Box-Benkhen design, in vitro and in vivo characterization. Drug delivery and translational research, 10 (1), 227–240.
   PubMed Web of Science ®Google Scholar
• Salem, H.F., et al., 2020c. Mitigation of rheumatic arthritis in a rat model via transdermal delivery of dapoxetine HCl amalgamated as a nanoplatform: in vitro and in vivo assessment. International journal of nanomedicine, 15, 1517–1535.
   PubMed Web of Science ®Google Scholar
• Salem, H., Kam, E., and Sharaf, M., 2011. Formulation and evaluation of silver nanoparticles as antibacterial and antifungal agents with a minimal cytotoxic effect. International journal of drug delivery, 3 (2), 293.
   Google Scholar
• Samberg, M.E., Oldenburg, S.J., and Monteiro-Riviere, N.A., 2010. Evaluation of silver nanoparticle toxicity in skin in vivo and keratinocytes in vitro. Environmental health perspectives, 118 (3), 407–413.
   PubMed Web of Science ®Google Scholar
• Serra, M.B., et al., 2017. From inflammation to current and alternative therapies involved in wound healing. International journal of inflammation, 2017, 1–17.
   Web of Science ®Google Scholar
• Sezgin-Bayindir, Z., Antep, M.N., and Yuksel, N., 2015. Development and characterization of mixed niosomes for oral delivery using candesartan cilexetil as a model poorly water-soluble drug. AAPS pharmscitech, 16 (1), 108–117.
   PubMed Web of Science ®Google Scholar
• Shankaran, V., Brooks, M., and Mostow, E., 2013. Advanced therapies for chronic wounds: NPWT, engineered skin, growth factors, extracellular matrices. Dermatologic therapy, 26 (3), 215–221.
   PubMed Web of Science ®Google Scholar
• Shelke, S., et al., 2016. Poloxamer 407-based intranasal thermoreversible gel of zolmitriptan-loaded nanoethosomes: formulation, optimization, evaluation and permeation studies. Journal of liposome research, 26 (4), 313–323.
   PubMed Web of Science ®Google Scholar
• Tanaka, S-i., et al., 2013. Statins exert the pleiotropic effects through small GTP-binding protein dissociation stimulator upregulation with a resultant Rac1 degradation. Arteriosclerosis, thrombosis, and vascular biology, 33 (7), 1591–1600.
   PubMed Web of Science ®Google Scholar
• Thangamani, S., et al., 2015. Exploring simvastatin, an antihyperlipidemic drug, as a potential topical antibacterial agent. Scientific reports, 5, 16407
   PubMed Web of Science ®Google Scholar
• Thurmond, R.L., et al., 1994. Structure and packing of phosphatidylcholines in lamellar and hexagonal liquid-crystalline mixtures with a nonionic detergent: a wide-line deuterium and phosphorus-31 NMR study. Journal of physical chemistry, 98 (3), 972–983.
   Web of Science ®Google Scholar
• Trotta, M., et al., 2004. Deformable liposomes for dermal administration of methotrexate. International journal of pharmaceutics, 270 (1-2), 119–125.
   PubMed Web of Science ®Google Scholar
• Ubaid, M., et al., 2016. Formulation and in vitro evaluation of carbopol 934-based modified clotrimazole gel for topical application. Anais da Academia Brasileira de Ciencias, 88 (4), 2303–2317.
   PubMed Web of Science ®Google Scholar
• Wang, J., Mongayt, D., and Torchilin, V.P., 2005. Polymeric micelles for delivery of poorly soluble drugs: preparation and anticancer activity in vitro of paclitaxel incorporated into mixed micelles based on poly(ethylene glycol)-lipid conjugate and positively charged lipids . Journal of drug targeting, 13 (1), 73–80.
   PubMed Web of Science ®Google Scholar
• Wei, L., et al., 2015. Silver nanoparticles: synthesis, properties, and therapeutic applications. Drug discovery today, 20 (5), 595–601.
   PubMed Web of Science ®Google Scholar
• Widayanti, A., Elfiyani, R., and Lestari, D., 2017. Effect of Lecithin’s concentration of entrapment vitamin E acetate liposomes using thin layers hydration method. Advanced science letters, 23 (12), 12510–12513.
   Google Scholar
• Wu, H., et al., 2016. The topical application of rosuvastatin in preventing knee intra-articular adhesion in rats. Medical science monitor, 22, 1403–1409.
   PubMed Web of Science ®Google Scholar
• Wu, Z., et al., 2019. A multiscale study on the effect of sodium cholate on the deformation ability of elastic liposomes. AAPS pharmscitech, 20 (8), 311.
   PubMed Web of Science ®Google Scholar
• Yang, D., Armitage, B., and Marder, S.R., 2004. Cubic liquid-crystalline nanoparticles. Angewandte Chemie, 43 (34), 4402–4409.
   Google Scholar
• Yeo, L.K., Chaw, C.S., and Elkordy, A.A., 2019. The effects of hydration parameters and co-surfactants on methylene blue-loaded niosomes prepared by the thin film hydration method. Pharmaceuticals, 12 (2), 46.
   Web of Science ®Google Scholar
• Zielińska, A., et al., 2009. Preparation of silver nanoparticles with controlled particle size. Procedia chemistry, 1 (2), 1560–1566.
   Google Scholar