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Research Article

Novel instantly-dispersible nanocarrier powder system (IDNPs) for intranasal delivery of dapoxetine hydrochloride: in-vitro optimization, ex-vivo permeation studies, and in-vivo evaluation

ORCID Icon, , , &
Pages 1443-1450 | Received 08 Jan 2018, Accepted 24 Mar 2018, Published online: 18 Apr 2018

References

  • Mohee A, Eardley I. Medical therapy for premature ejaculation. Ther Adv Urol. 2011;3:211–222.
  • McCarty E, Dinsmore W. Dapoxetine: an evidence-based review of its effectiveness in treatment of premature ejaculation. Core Evid. 2012;7:1–14.
  • Modi NB, Dresser MJ, Simon M, et al. Single- and multiple-dose pharmacokinetics of dapoxetine hydrochloride, a novel agent for the treatment of premature ejaculation. J Clin Pharmacol. 2006;46:301–309.
  • McMahon CG. Dapoxetine: a new option in the medical management of premature ejaculation. Ther Adv Urol. 2012;4:233–251.
  • Andersson KE, Mulhall JP, Wyllie MG. Pharmacokinetic and pharmacodynamic features of dapoxetine, a novel drug for 'on-demand' treatment of premature ejaculation. BJU Int. 2006;97:311–315.
  • Srikant P, Mahesh S, Akash J, et al. Formulation development and evaluation of dapoxetine hydrochloride tablets approved for the treatment of premature ejaculation. Int J Pharm Sci Rev Res. 2014;26:328–332.
  • Turkyilmaz A, Gulay Y. Novel effervescent sachet formulations of dapoxetine and a PDE5 inhibitor. US patent 2015/0231092A1.
  • Fouad SA, Shamma RN, Basalious EB, et al. Novel instantly-soluble transmucosal matrix (ISTM) using dual mechanism solubilizer for sublingual and nasal delivery of dapoxetine hydrochloride: in-vitro/in-vivo evaluation. Int J Pharm. 2016;505:212–222.
  • Huh Y, Cho HJ, Yoon IS, et al. Preparation and evaluation of spray-dried hyaluronic acid microspheres for intranasal delivery of fexofenadine hydrochloride. Eur J Pharm Sci. 2010;40:9–15.
  • Piao HM, Balakrishnan P, Cho HJ, et al. Preparation and evaluation of fexofenadine microemulsions for intranasal delivery. Int J Pharm. 2010;395:309–316.
  • Hussain A, Foster T, Hirai S, et al. Nasal absorption of propranolol in humans. J Pharm Sci. 1980;69:1240.
  • Zaki NM, Awad GA, Mortada ND, et al. Enhanced bioavailability of metoclopramide HCl by intranasal administration of a mucoadhesive in situ gel with modulated rheological and mucociliary transport properties. Eur J Pharm Sci. 2007;32:296–307.
  • Costantino HR, Illum L, Brandt G, et al. Intranasal delivery: physicochemical and therapeutic aspects. Int J Pharm. 2007;337:1–24.
  • Luo Y, Chen D, Ren L, et al. Solid lipid nanoparticles for enhancing vinpocetine's oral bioavailability. J Control Release. 2006;114:53–59.
  • Soliman GM, Sharma R, Choi AO, et al. Tailoring the efficacy of nimodipine drug delivery using nanocarriers based on A2B miktoarm star polymers. Biomaterials. 2010;31:8382–8392.
  • Chandrasekhar R, Hassan Z, Alhusban F, et al. The role of formulation excipients in the development of lyophilised fast-disintegrating tablets. Eur J Pharm Biopharm. 2009;72:119–129.
  • Cevc G, Gebauer D, Stieber J, et al. Ultraflexible vesicles, transfersomes, have an extremely low pore penetration resistance and transport therapeutic amounts of insulin across the intact mammalian skin. Biochim Biophys Acta. 1998;1368:201–215.
  • Cevc G, Blume G. Hydrocortisone and dexamethasone in very deformable drug carriers have increased biological potency, prolonged effect, and reduced therapeutic dosage. Biochim Biophys Acta. 2004;1663:61–73.
  • Hiruta Y, Hattori Y, Kawano K, et al. Novel ultra-deformable vesicles entrapped with bleomycin and enhanced to penetrate rat skin. J Control Release. 2006;113:146–154.
  • Pisal SS, Paradkar AR, Mahadik KR, et al. Pluronic gels for nasal delivery of Vitamin B12. Part I: preformulation study. Int J Pharm. 2004;270:37–45.
  • Escobar-Chavez JJ, López-Cervantes M, Naïk A, et al. Applications of thermo-reversible pluronic F-127 gels in pharmaceutical formulations. J Pharm Pharm Sci. 2006;9:339–358.
  • Chen D, Xia D, Li X, et al. Comparative study of Pluronic((R)) F127-modified liposomes and chitosan-modified liposomes for mucus penetration and oral absorption of cyclosporine A in rats. Int J Pharm. 2013;449:1–9.
  • Dai Y, Zhou R, Liu L, et al. Liposomes containing bile salts as novel ocular delivery systems for tacrolimus (FK506): in vitro characterization and improved corneal permeation. Int J Nanomedicine. 2013;8:1921–1933.
  • Abdelbary AA, AbouGhaly MH. Design and optimization of topical methotrexate loaded niosomes for enhanced management of psoriasis: application of Box-Behnken design, in-vitro evaluation and in-vivo skin deposition study. Int J Pharm. 2015;485:235–243.
  • Basalious EB, Shawky N, Badr-Eldin SM. SNEDDS containing bioenhancers for improvement of dissolution and oral absorption of lacidipine. I: development and optimization. Int J Pharm. 2010;391:203–211.
  • Abdelbary G. Ocular ciprofloxacin hydrochloride mucoadhesive chitosan-coated liposomes. Pharm Dev Technol. 2011;16:44–56.
  • Salama HA, Mahmoud AA, Kamel AO, et al. Brain delivery of olanzapine by intranasal administration of transfersomal vesicles. J Liposome Res. 2012;22:336–345.
  • Scognamiglio I, De Stefano D, Campani V, et al. Nanocarriers for topical administration of resveratrol: a comparative study. Int J Pharm. 2013;440:179–187.
  • Guidance for Industry. Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. Food and Drug Administration (USA). Center for Drug Evaluation and Research (CDER); July 2005.
  • Salama HA, Mahmoud AA, Kamel AO, et al. Phospholipid based colloidal poloxamer-nanocubic vesicles for brain targeting via the nasal route. Colloids Surf B Biointerfaces. 2012;100:146–154.
  • Hao Y, Zhao F, Li N, et al. Studies on a high encapsulation of colchicine by a niosome system. Int J Pharm. 2002;244:73–80.
  • Abdelbary G, El-Gendy N. Niosome-encapsulated gentamicin for ophthalmic controlled delivery. AAPS PharmSciTech. 2008;9:740–747.
  • Rowe R, Sheskey PJ, Owen SC et al., editors. Handbook of pharmaceutical excipients. 6th ed. London; Chicago: APhA/Pharmaceutical Press; 2009.
  • Das S, Ng WK, Tan RB. Are nanostructured lipid carriers (NLCs) better than solid lipid nanoparticles (SLNs): development, characterizations and comparative evaluations of clotrimazole-loaded SLNs and NLCs? Eur J Pharm Sci. 2012;47:139–151.
  • Basha M, Abd El-Alim SH, Shamma RN, et al. Design and optimization of surfactant-based nanovesicles for ocular delivery of Clotrimazole. J Liposome Res. 2013;23:203–210.
  • Dora CP, Singh SK, Kumar S, et al. Development and characterization of nanoparticles of glibenclamide by solvent displacement method. Acta Pol Pharm. 2010;67:283–290.
  • van den Bergh BA, Wertz PW, Junginger HE, et al. Elasticity of vesicles assessed by electron spin resonance, electron microscopy and extrusion measurements. Int J Pharm. 2001;217:13–24.
  • Aburahma MH, Abdelbary GA. Novel diphenyl dimethyl bicarboxylate provesicular powders with enhanced hepatocurative activity: preparation, optimization, in vitro/in vivo evaluation. Int J Pharm. 2012;422:139–150.
  • Muller RH, Jacobs C, Kayser O. Nanosuspensions as particulate drug formulations in therapy. Rationale for development and what we can expect for the future. Adv Drug Deliv Rev. 2001;47:3–19.
  • Shamma RN, Elsayed I. Transfersomal lyophilized gel of buspirone HCl: formulation, evaluation and statistical optimization. J Liposome Res. 2013;23:244–254.
  • Varma MVS, Ashokraj Y, Dey CS, et al. P-glycoprotein inhibitors and their screening: a perspective from bioavailability enhancement. Pharmacol Res. 2003;48:347–359.
  • Wei Z, et al. Paclitaxel-loaded Pluronic P123/F127 mixed polymeric micelles: formulation, optimization and in vitro characterization. Int J Pharm. 2009;376:176–185.
  • Holm R, Jensen IH, Sonnergaard J. Optimization of self-microemulsifying drug delivery systems (SMEDDS) using a D-optimal design and the desirability function. Drug Dev Ind Pharm. 2006;32:1025–1032.
  • 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;485:329–340.
  • El Zaafarany GM, Awad GA, Holayel SM, et al. Role of edge activators and surface charge in developing ultradeformable vesicles with enhanced skin delivery. Int J Pharm. 2010;397:164–172.
  • Shokri J, Nokhodchi A, Dashbolaghi A, et al. The effect of surfactants on the skin penetration of diazepam. Int J Pharm. 2001;228:99–107.
  • Shoukri RA, Ahmed IS, Shamma RN. In vitro and in vivo evaluation of nimesulide lyophilized orally disintegrating tablets. Eur J Pharm Biopharm. 2009;73:162–171.

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