Response Surface Optimization of Ultra-Elastic Nanovesicles Loaded with Deflazacort Tailored for Transdermal Delivery: Accentuated Bioavailability and Anti-Inflammatory Efficacy

References

• Schleimer RP. An overview of glucocorticoid anti-inflammatory actions. Eur J Clin Pharmacol. 1993;45(1):S3–S7. doi:10.1007/BF01844196
   PubMedGoogle Scholar
• Joshi N, Rajeshwari K. Deflazacort. J Postgrad Med. 2009;55(4):296. doi:10.4103/0022-3859.58942
   PubMed Web of Science ®Google Scholar
• Corrêa G, Bellé LP, Bajerski L, et al. Development and validation of a reversed-phase HPLC method for the determination of deflazacort in pharmaceutical dosage forms. Chromatographia. 2007;65(9–10):591–594. doi:10.1365/s10337-007-0205-y
   Google Scholar
• Markham A, Bryson HM. Deflazacort. Drugs. 1995;50(2):317–333. doi:10.2165/00003495-199550020-00008
   PubMedGoogle Scholar
• Scremin A, Piazzon M, Silva MAS, et al. Spectrophotometric and HPLC determination of deflazacort in pharmaceutical dosage forms. Brazilian J Pharmaceutical Sci. 2010;46:281–287. doi:10.1590/S1984-82502010000200015
   Google Scholar
• Parente L. Deflazacort: therapeutic index, relative potency and equivalent doses versus other corticosteroids. BMC Pharmacol Toxicol. 2017;18(1):1. doi:10.1186/s40360-016-0111-8
   PubMedGoogle Scholar
• Sperandeo N, Kassuha D. Development and validation of a dissolution test for 6 mg deflazacort tablets. Sci Pharm. 2009;77(3):679–694. doi:10.3797/scipharm.090405
   Google Scholar
• Griggs RC, Miller JP, Greenberg CR, et al. Efficacy and safety of deflazacort vs prednisone and placebo for Duchenne muscular dystrophy. Neurology. 2016;87(20):2123–2131. doi:10.1212/WNL.0000000000003217
   PubMedGoogle Scholar
• Ferraris JR, Pasqualini T, Alonso G, et al. Effects of deflazacort vs. methylprednisone: a randomized study in kidney transplant patients. Pediatric Nephrology. 2007;22(5):734–741. doi:10.1007/s00467-006-0403-0
   PubMedGoogle Scholar
• Patil SK, et al. Strategies for solubility enhancement of poorly soluble drugs. Int J Pharm Sci Rev Res. 2011;8(2):74–80.
   Google Scholar
• Cevc G, et al. Ultra-High Efficiency of Drugs and Peptide Transfer Through the Intact Skin by Means of Novel Drug Carriers, Transfersomes. STS Publishing; 1993.
   Google Scholar
• Aziz DE, Abdelbary AA, Elassasy AI. Fabrication of novel elastosomes for boosting the transdermal delivery of diacerein: statistical optimization, ex-vivo permeation, in-vivo skin deposition and pharmacokinetic assessment compared to oral formulation. Drug Deliv. 2018;25(1):815–826.
   PubMed Web of Science ®Google Scholar
• Singh D, Pradhan M, Nag M, et al. Vesicular system: versatile carrier for transdermal delivery of bioactives. Artif Cells, Nanomed Biotechnol. 2015;43(4):282–290. doi:10.3109/21691401.2014.883401
   PubMed Web of Science ®Google Scholar
• Abdel-Hafez SM, Hathout RM, Sammour OA. Curcumin-loaded ultradeformable nanovesicles as a potential delivery system for breast cancer therapy. Colloids Surf B Biointerfaces. 2018;167:63–72. doi:10.1016/j.colsurfb.2018.03.051
   PubMed Web of Science ®Google Scholar
• Ahad A, Aqil M, Kohli K, et al. Enhanced transdermal delivery of an anti-hypertensive agent via nanoethosomes: statistical optimization, characterization and pharmacokinetic assessment. Int J Pharm. 2013;443(1):26–38. doi:10.1016/j.ijpharm.2013.01.011
   PubMedGoogle Scholar
• Schmid-Wendtner M-H, Korting HC. The pH of the skin surface and its impact on the barrier function. Skin Pharmacol Physiol. 2006;19(6):296–302. doi:10.1159/000094670
   PubMed Web of Science ®Google Scholar
• Abdelbary G, El-gendy N. Niosome-encapsulated gentamicin for ophthalmic controlled delivery. AAPS Pharmscitech. 2008;9(3):740–747. doi:10.1208/s12249-008-9105-1
   PubMed Web of Science ®Google Scholar
• Duangjit S, Opanasopit P, Rojanarata T, et al. Evaluation of meloxicam-loaded cationic transfersomes as transdermal drug delivery carriers. AAPS PharmSciTech. 2013;14(1):133–140. doi:10.1208/s12249-012-9904-2
   PubMed Web of Science ®Google Scholar
• Mahmoud MO, Aboud HM, Hassan AH, et al. Transdermal delivery of atorvastatin calcium from novel nanovesicular systems using polyethylene glycol fatty acid esters: ameliorated effect without liver toxicity in poloxamer 407-induced hyperlipidemic rats. J Control Release. 2017;254:10–22. doi:10.1016/j.jconrel.2017.03.039
   PubMed Web of Science ®Google Scholar
• Aboud HM, Ali AA, El-Menshawe SF, et al. Nanotransfersomes of carvedilol for intranasal delivery: formulation, characterization and in vivo evaluation. Drug Deliv. 2016;23(7):2471–2481. doi:10.3109/10717544.2015.1013587
   PubMed Web of Science ®Google Scholar
• El Menshawe SF, Nafady MM, Aboud HM, et al. Transdermal delivery of fluvastatin sodium via tailored spanlastic nanovesicles: mitigated Freund’s adjuvant-induced rheumatoid arthritis in rats through suppressing p38 MAPK signaling pathway. Drug Deliv. 2019;26(1):1140–1154. doi:10.1080/10717544.2019.1686087
   PubMed Web of Science ®Google Scholar
• Lei W, Yu C, Lin H, et al. Development of tacrolimus-loaded transfersomes for deeper skin penetration enhancement and therapeutic effect improvement in vivo. Asian j Pharmaceutical Sci. 2013;8(6):336–345. doi:10.1016/j.ajps.2013.09.005
   Google Scholar
• Aboud HM, Hassan AH, Ali AA, et al. Novel in situ gelling vaginal sponges of sildenafil citrate-based cubosomes for uterine targeting. Drug Deliv. 2018;25(1):1328–1339. doi:10.1080/10717544.2018.1477858
   PubMed Web of Science ®Google Scholar
• Muppidi K, Pumerantz AS, Wang J, et al. Development and stability studies of novel liposomal vancomycin formulations. ISRN Pharm. 2012;2012:2012. doi:10.5402/2012/636743
   Google Scholar
• Aboud HM, Mahmoud MO, Abdeltawab Mohammed M, et al. 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. J Drug Target. 2020;28(3):282–299. doi:10.1080/1061186X.2019.1650053
   PubMed Web of Science ®Google Scholar
• Abd-Allah FI, Dawaba HM, Ahmed A. Preparation, characterization, and stability studies of piroxicam-loaded microemulsions in topical formulations. Drug Discov Ther. 2010;4(4):267–275.
   PubMedGoogle Scholar
• Wasankar SR, Faizi SM, Deshmuk AD. Formulation and development of liposomal gel for topical drug delivery system. Int J Pharmaceutical Sci Res. 2012;3(11):4461.
   Google Scholar
• Escobar P, Vera AM, Neira LF, et al. Photodynamic therapy using ultradeformable liposomes loaded with chlorine aluminum phthalocyanine against L. (V.) braziliensis experimental models. Exp Parasitol. 2018;194:45–52. doi:10.1016/j.exppara.2018.09.016
   PubMed Web of Science ®Google Scholar
• Shakeel F, Baboota S, Ahuja A, et al. Skin permeation mechanism and bioavailability enhancement of celecoxib from transdermally applied nanoemulsion. J Nanobiotechnology. 2008;6(1):8. doi:10.1186/1477-3155-6-8
   PubMedGoogle Scholar
• El Zaafarany GM, Awad GAS, Holayel SM, et al. 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.2010.06.034
   PubMed Web of Science ®Google Scholar
• Moawad FA, Ali AA, Salem HF. Nanotransfersomes-loaded thermosensitive in situ gel as a rectal delivery system of tizanidine HCl: preparation, in vitro and in vivo performance. Drug Deliv. 2017;24(1):252–260. doi:10.1080/10717544.2016.1245369
   Google Scholar
• Salem HF, Kharshoum RM, Sayed OM, et al. Formulation design and optimization of novel soft glycerosomes for enhanced topical delivery of celecoxib and cupferron by Box-Behnken statistical design. Drug Dev Ind Pharm. 2018;44(11):1871–1884. doi:10.1080/03639045.2018.1504963
   PubMed Web of Science ®Google Scholar
• Mei Z, Wu Q, Hu S, et al. Triptolide loaded solid lipid nanoparticle hydrogel for topical application. Drug Dev Ind Pharm. 2005;31(2):161–168. doi:10.1081/DDC-200047791
   PubMed Web of Science ®Google Scholar
• Özgüney IS, Karasulu HY, Kantarci G, et al. Transdermal delivery of diclofenac sodium through rat skin from various formulations. AAPS Pharmscitech. 2006;7(4):E39–E45. doi:10.1208/pt070488
   PubMed Web of Science ®Google Scholar
• Morris CJ. Carrageenan-induced paw edema in the rat and mouse. Inflammation Protocols. 2003;115–121.
   Google Scholar
• Elkomy MH, Elmenshawe SF, Eid HM, et al. Topical ketoprofen nanogel: artificial neural network optimization, clustered bootstrap validation, and in vivo activity evaluation based on longitudinal dose response modeling. Drug Deliv. 2016;23(9):3294–3306. doi:10.1080/10717544.2016.1176086
   PubMed Web of Science ®Google Scholar
• Escudero A, Marín P, Cárceles CM, et al. Pharmacokinetics of deflazacort in rabbits after intravenous and oral administration and its interaction with erythromycin. J Vet Pharmacol Ther. 2018;41(1):e10–e15. doi:10.1111/jvp.12442
   PubMedGoogle Scholar
• Özkan Y, Savaşer A, Taş Ç, et al. Drug dissolution studies and determination of deflazacort in pharmaceutical formulations and human serum samples by RP‐HPLC. J Liq Chromatogr Relat Technol. 2003;26(13):2141–2156. doi:10.1081/JLC-120022399
   Web of Science ®Google Scholar
• Holm R, Jensen I, Sonnergaard J. Optimization of self-microemulsifying drug delivery systems (SMEDDS) using a D-optimal design and the desirability function. Drug Dev Ind Pharm. 2006;32(9):1025–1032. doi:10.1080/03639040600559024
   PubMed Web of Science ®Google Scholar
• Berger MP, Wong W-K. Applied Optimal Designs. John Wiley & Sons; 2005.
   Google Scholar
• Abdel-Hafez SM, Hathout RM, Sammour OA. Towards better modeling of chitosan nanoparticles production: screening different factors and comparing two experimental designs. Int J Biol Macromol. 2014;64:334–340. doi:10.1016/j.ijbiomac.2013.11.041
   PubMed Web of Science ®Google Scholar
• Franceschini G, Macchietto S. Model-based design of experiments for parameter precision: state of the art. Chem Eng Sci. 2008;63(19):4846–4872. doi:10.1016/j.ces.2007.11.034
   Web of Science ®Google Scholar
• Hussain A, Singh S, Sharma D, et al. Elastic liposomes as novel carriers: recent advances in drug delivery. Int J Nanomedicine. 2017;12:5087. doi:10.2147/IJN.S138267
   PubMed Web of Science ®Google Scholar
• Aggarwal N, Goindi S. Preparation and evaluation of antifungal efficacy of griseofulvin loaded deformable membrane vesicles in optimized guinea pig model of Microsporum canis—Dermatophytosis. Int J Pharm. 2012;437(1):277–287. doi:10.1016/j.ijpharm.2012.08.015
   PubMedGoogle Scholar
• Chaudhary H, Kohli K, Kumar V. Nano-transfersomes as a novel carrier for transdermal delivery. Int J Pharm. 2013;454(1):367–380. doi:10.1016/j.ijpharm.2013.07.031
   PubMed Web of Science ®Google Scholar
• Singh S, et al. The role of surfactants in the formulation of elastic liposomal gels containing a synthetic opioid analgesic. Int J Nanomedicine. 2016;11:1475.
   PubMed Web of Science ®Google Scholar
• Aggarwal D, Garg A, Kaur IP. Development of a topical niosomal preparation of acetazolamide: preparation and evaluation. J Pharmacy Pharmacol. 2004;56(12):1509–1517. doi:10.1211/0022357044896
   PubMed Web of Science ®Google Scholar
• Abdelkader H, et al. Preparation of niosomes as an ocular delivery system for naltrexone hydrochloride: physicochemical characterization. Die Pharmazie Int J Pharmaceutical Sci. 2010;65(11):811–817.
   Google Scholar
• Ali MH, Moghaddam B, Kirby DJ, et al. The role of lipid geometry in designing liposomes for the solubilisation of poorly water soluble drugs. Int J Pharm. 2013;453(1):225–232. doi:10.1016/j.ijpharm.2012.06.056
   PubMed Web of Science ®Google Scholar
• Bunker A, Magarkar A, Viitala T. Rational design of liposomal drug delivery systems, a review: combined experimental and computational studies of lipid membranes, liposomes and their PEGylation. Biochimica Et Biophysica Acta (BBA)-Biomembranes. 2016;1858(10):2334–2352. doi:10.1016/j.bbamem.2016.02.025
   PubMed Web of Science ®Google Scholar
• Bnyan R, Khan I, Ehtezazi T, et al. Surfactant effects on lipid-based vesicles properties. J Pharm Sci. 2018;107(5):1237–1246. doi:10.1016/j.xphs.2018.01.005
   PubMed Web of Science ®Google Scholar
• Abd-Elal RM, Shamma RN, Rashed HM, et al. Trans-nasal zolmitriptan novasomes: in-vitro preparation, optimization and in-vivo evaluation of brain targeting efficiency. Drug Deliv. 2016;23(9):3374–3386. doi:10.1080/10717544.2016.1183721
   PubMed Web of Science ®Google Scholar
• Elnaggar YS, et al. Lecithin-based nanostructured gels for skin delivery: an update on state of art and recent applications. J Controlled Release. 2014;180:10–24. doi:10.1016/j.jconrel.2014.02.004
   PubMed Web of Science ®Google Scholar
• Mishra D, et al. Elastic liposomes mediated transdermal delivery of an anti-hypertensive agent: propranolol hydrochloride. J Pharm Sci. 2007;96(1):145–155. doi:10.1002/jps.20737
   PubMed Web of Science ®Google Scholar
• El-Refaie WM, Elnaggar YSR, El-Massik MA, et al. Novel curcumin-loaded gel-core hyaluosomes with promising burn-wound healing potential: development, in-vitro appraisal and in-vivo studies. Int J Pharm. 2015;486(1–2):88–98. doi:10.1016/j.ijpharm.2015.03.052
   PubMedGoogle Scholar
• Malakar J, Sen SO, Nayak AK, et al. Formulation, optimization and evaluation of transferosomal gel for transdermal insulin delivery. Saudi Pharmaceutical j. 2012;20(4):355–363. doi:10.1016/j.jsps.2012.02.001
   PubMed Web of Science ®Google Scholar
• El-Laithy HM, Shoukry O, Mahran LG. Novel sugar esters proniosomes for transdermal delivery of vinpocetine: preclinical and clinical studies. European j Pharmaceutics Biopharmaceutics. 2011;77(1):43–55. doi:10.1016/j.ejpb.2010.10.011
   PubMed Web of Science ®Google Scholar
• Zheng W-S, et al. Preparation and quality assessment of itraconazole transfersomes. Int J Pharm. 2012;436(1–2):291–298. doi:10.1016/j.ijpharm.2012.07.003
   PubMed Web of Science ®Google Scholar
• Jain S, et al. Transfersomes—a novel vesicular carrier for enhanced transdermal delivery: development, characterization, and performance evaluation. Drug Dev Ind Pharm. 2003;29(9):1013–1026. doi:10.1081/DDC-120025458
   PubMed Web of Science ®Google Scholar
• Al-mahallawi AM, Abdelbary AA, Aburahma MH. Investigating the potential of employing bilosomes as a novel vesicular carrier for transdermal delivery of tenoxicam. Int J Pharm. 2015;485(1):329–340. doi:10.1016/j.ijpharm.2015.03.033
   PubMedGoogle Scholar
• Ruckmani K, Sankar V. Formulation and optimization of zidovudine niosomes. AAPS Pharmscitech. 2010;11(3):1119–1127. doi:10.1208/s12249-010-9480-2
   PubMed Web of Science ®Google Scholar
• Mekkawy A, Fathy M, El-Shanawany S. Formulation and in vitro evaluation of fluconazole topical gels. British Journal of Pharmaceutical Research. 2013;3:293–313. doi:10.9734/BJPR/2013/2775
   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.2014.06.041
   PubMed Web of Science ®Google Scholar
• Cipolla D, et al. Modifying the release properties of liposomes toward personalized medicine. J Pharm Sci. 2014;103(6):1851–1862. doi:10.1002/jps.23969
   PubMed Web of Science ®Google Scholar
• Elsayed MM, Abdallah OY, Naggar VF, et al. Deformable liposomes and ethosomes: mechanism of enhanced skin delivery. Int J Pharm. 2006;322(1–2):60–66. doi:10.1016/j.ijpharm.2006.05.027
   PubMed Web of Science ®Google Scholar
• Zylberberg C, Matosevic S. Pharmaceutical liposomal drug delivery: a review of new delivery systems and a look at the regulatory landscape. Drug Deliv. 2016;23(9):3319–3329. doi:10.1080/10717544.2016.1177136
   PubMed Web of Science ®Google Scholar
• Mokhtar M, Sammour OA, Hammad MA, et al. Effect of some formulation parameters on flurbiprofen encapsulation and release rates of niosomes prepared from proniosomes. Int J Pharm. 2008;361(1):104–111. doi:10.1016/j.ijpharm.2008.05.031
   PubMedGoogle Scholar
• Panwar P, et al. Preparation, characterization, and in vitro release study of albendazole-encapsulated nanosize liposomes.. Int J Nanomedicine. 2010;5(101):8. doi:10.2147/ijn.s8030
   Google Scholar
• Ghanbarzadeh S, Arami S. Enhanced transdermal delivery of diclofenac sodium via conventional liposomes, ethosomes, and transfersomes. Biomed Res Int. 2013;2013:1–7. doi:10.1155/2013/616810
   Web of Science ®Google Scholar
• Shaji J, Lal M. Preparation, Optimization and evaluation of transferosomal formulation for enhanced transdermal delivery of a COX-2 Inhibitor. Int J Pharmacy Pharmaceutical Sci. 2014;6(1):467–477.
   Google Scholar
• Naguib SS, Hathout RM, Mansour S. Optimizing novel penetration enhancing hybridized vesicles for augmenting the in-vivo effect of an anti-glaucoma drug. Drug Deliv. 2017;24(1):99–108. doi:10.1080/10717544.2016.1233588
   PubMed Web of Science ®Google Scholar
• Khalil RM, Abdelbary A, Kocova El-Arini S, et al. Evaluation of bilosomes as nanocarriers for transdermal delivery of tizanidine hydrochloride: in vitro and ex vivo optimization. J Liposome Res. 2019;29(2):171–182. doi:10.1080/08982104.2018.1524482
   PubMed Web of Science ®Google Scholar
• El-Alim SHA, Kassem AA, Basha M, et al. Comparative study of liposomes, ethosomes and transfersomes as carriers for enhancing the transdermal delivery of diflunisal: in vitro and in vivo evaluation. Int J Pharm. 2019;563:293–303. doi:10.1016/j.ijpharm.2019.04.001
   PubMedGoogle Scholar
• Varma VNSK, Maheshwari PV, Navya M, et al. Calcipotriol delivery into the skin as emulgel for effective permeation. Saudi Pharmaceutical J. 2014;22(6):591–599. doi:10.1016/j.jsps.2014.02.007
   PubMedGoogle Scholar
• Ammar HO, Salama HA, Ghorab M, et al. Nanoemulsion as a potential ophthalmic delivery system for dorzolamide hydrochloride. AAPS Pharmscitech. 2009;10(3):808. doi:10.1208/s12249-009-9268-4
   PubMed Web of Science ®Google Scholar
• Sharma VK, Sarwa KK, Mazumder B. Fluidity enhancement: a critical factor for performance of liposomal transdermal drug delivery system. J Liposome Res. 2014;24(2):83–89. doi:10.3109/08982104.2013.847956
   PubMed Web of Science ®Google Scholar
• Wakaskar RR. General overview of lipid–polymer hybrid nanoparticles, dendrimers, micelles, liposomes, spongosomes and cubosomes. J Drug Target. 2018;26(4):311–318. doi:10.1080/1061186X.2017.1367006
   PubMed Web of Science ®Google Scholar
• Cosco D, et al. Ultradeformable liposomes as multidrug carrier of resveratrol and 5-fluorouracil for their topical delivery. Int J Pharm. 2015;489(1–2):1–10. doi:10.1016/j.ijpharm.2015.04.056
   PubMedGoogle Scholar
• El Menshawe SF, et al. A novel nanogel loaded with chitosan decorated bilosomes for transdermal delivery of terbutaline sulfate: artificial neural network optimization, in vitro characterization and in vivo evaluation. Drug Deliv Transl Res. 2020;10(2):471–485.
   PubMed Web of Science ®Google Scholar
• Mali N, Darandale S, Vavia P. Niosomes as a vesicular carrier for topical administration of minoxidil: formulation and in vitro assessment. Drug Deliv Transl Res. 2013;3(6):587–592. doi:10.1007/s13346-012-0083-1
   PubMed Web of Science ®Google Scholar
• Balakrishnan P, Shanmugam S, Lee WS, et al. Formulation and in vitro assessment of minoxidil niosomes for enhanced skin delivery. Int J Pharm. 2009;377(1):1–8. doi:10.1016/j.ijpharm.2009.04.020
   PubMedGoogle Scholar