Intranasal brain-targeted clonazepam polymeric micelles for immediate control of status epilepticus: in vitro optimization, ex vivo determination of cytotoxicity, in vivo biodistribution and pharmacodynamics studies

References

• Abd-Elal RM, Shamma RN, Rashed HM, et al. (2016). Trans-nasal Zolmitriptan Novasomes: in-vitro preparation, optimization and in-vivo evaluation of brain targeting efficiency. Drug delivery. doi:10.1080/10717544.2016.1183721
   PubMedGoogle Scholar
• Abdelbary AA, Al-Mahallawi AM, Abdelrahim ME, et al. (2015). Preparation, optimization, and in vitro simulated inhalation delivery of carvedilol nanoparticles loaded on a coarse carrier intended for pulmonary administration. Int J Nanomedicine 10:6339–53
   PubMed Web of Science ®Google Scholar
• Abdelbary GA, Tadros MI. (2013). Brain targeting of olanzapine via intranasal delivery of core-shell difunctional block copolymer mixed nanomicellar carriers: in vitro characterization, ex vivo estimation of nasal toxicity and in vivo biodistribution studies. Int J Pharm 452:300–10
   PubMed Web of Science ®Google Scholar
• Aboelwafa AA, Makhlouf AIA. (2012). In vivo evaluation and application of central composite design in the optimization of amisulpride self-emulsifying drug delivery system. Am J Drug Discov Deliv 2:1–16
   Google Scholar
• Aghajani M, Shahverdi AR, Amani A. (2012). The use of artificial neural networks for optimizing polydispersity index (PDI) in nanoprecipitation process of acetaminophen in microfluidic devices. AAPS PharmSciTech 13:1293–301
   PubMed Web of Science ®Google Scholar
• Al-Saraj A. (2010). Use of saturated sodium chloride solution as a tissue fixative. Iraqi J Vet Sci 24:53–8
   Google Scholar
• Amin L. (2013). P-glycoprotein inhibition for optimal drug delivery. Drug Target Insights 7:27–34
   PubMedGoogle Scholar
• Annadurai G, Ling LY, Lee JF. (2008). Statistical optimization of medium components and growth conditions by response surface methodology to enhance phenol degradation by Pseudomonas putida. J Hazard Mater 151:171–8
   PubMed Web of Science ®Google Scholar
• Anon. (2015). American speech-language-hearing association. 2015 ICD-10-CM Diagnosis Codes,1-38. Available at: http://www.asha.org/uploadedFiles/ICD-10-Codes-SLP.pdf
   Google Scholar
• BASF. (2004). Pluronic® L121. Technical bulletin, 6, pp. 8–11. Available at: http://worldaccount.basf.com/wa/NAFTA/Catalog/ChemicalsNAFTA/doc4/BASF/PRD/30085763/.pdf?asset_type=pi/pdf&language=EN&urn=urn:documentum:eCommerce_sol_EU:09007bb28001f6f3.pdf
   Google Scholar
• Batrakova EV, Li S, Alakhov VY, et al. (2003). Optimal structure requirements for Pluronic block copolymers in modifying P-glycoprotein drug efflux transporter activity in bovine brain microvessel endothelial cells. J Pharmacol Exp Therap 304:845–54
   PubMed Web of Science ®Google Scholar
• Brophy GM, Bell R, Claassen J, et al. (2012). Guidelines for the evaluation and management of status epilepticus. Neurocrit Care 17:3–23
   PubMed Web of Science ®Google Scholar
• Chen H, Chen CC, Acosta C, et al. (2014). A new brain drug delivery strategy: focused ultrasound-enhanced intranasal drug delivery. PLoS One 9:e108880
   PubMed Web of Science ®Google Scholar
• Chen JW, Wasterlain CG. (2006). Status epilepticus: pathophysiology and management in adults. Lancet Neurol 5:246–56
   PubMed Web of Science ®Google Scholar
• Chiappetta DA, Sosnik A. (2007). Poly(ethylene oxide)-poly(propylene oxide) block copolymer micelles as drug delivery agents: improved hydrosolubility, stability and bioavailability of drugs. Eur J Pharm Biopharm 66:303–17
   PubMed Web of Science ®Google Scholar
• Cho HJ, Park JW, Yoon IS, et al. (2014). Surface-modified solid lipid nanoparticles for oral delivery of docetaxel: enhanced intestinal absorption and lymphatic uptake. Int J Nanomedicine 9:495–504
   PubMed Web of Science ®Google Scholar
• Coté CJ, Lerman J, Anderson B. (2013). A practice of anesthesia for infants and children: expert consult: online and print. Elsevier Health Sciences. 495
   Google Scholar
• de Lima LS, Araujo MDM, Quináia SP, et al. (2011). Adsorption modeling of Cr, Cd and Cu on activated carbon of different origins by using fractional factorial design. Chem Eng J 166:881–9
   Web of Science ®Google Scholar
• Du G, Gao Y, Nie S, et al. (2006). The permeation of nalmefene hydrochloride across different regions of ovine nasal mucosa. Chem Pharm Bull 54:1722–4
   PubMed Web of Science ®Google Scholar
• Dua JS, Rana AC, Bhandari AK. (2012). Liposomes: methods of preparation and applications. Int J Pharm Stud Res III:14–20
   Google Scholar
• Dutra LMU, Ribeiro MENP, Cavalcante IM, et al. (2015). Binary mixture micellar systems of F127 and P123 for griseofulvin solubilization. Polímeros 25:433–9
   Web of Science ®Google Scholar
• El-Dahmy RM, Elsayed I, Elshafeey AH, et al. (2014). Optimization of long circulating mixed polymeric micelles containing vinpocetine using simple lattice mixture design, in vitro and in vivo characterization. Int J Pharm 477:39–46
   PubMed Web of Science ®Google Scholar
• Essa BM, Sakr TM, Khedr MA, et al. (2015). 99mTc-amitrole as a novel selective imaging probe for solid tumor: in silico and preclinical pharmacological study. Eur J Pharm Sci 79:102–9
   PubMed Web of Science ®Google Scholar
• Florence K, Manisha L, Kumar BA, et al. (2011). Intranasal clobazam delivery in the treatment of status epilepticus. J Pharm Sci 100:692–703
   PubMed Web of Science ®Google Scholar
• Francis MF, Cristea M, Winnik FM. (2004). Polymeric micelles for oral drug delivery: why and how. Pure Appl Chem 76:1321–35
   Web of Science ®Google Scholar
• Gaber NN, Darwis Y, Peh KK, et al. (2006). Characterization of polymeric micelles for pulmonary delivery of beclomethasone dipropionate. J Nanosci Nanotechnol 6:3095–101
   PubMed Web of Science ®Google Scholar
• Geskovski N, Kuzmanovska S, Simonoska Crcarevska M, et al. (2013). Comparative biodistribution studies of technetium-99 m radiolabeled amphiphilic nanoparticles using three different reducing agents during the labeling procedure. J Labelled Comp Radiopharm 56:689–95
   PubMed Web of Science ®Google Scholar
• Han X, Liu J, Liu M, et al. (2009). 9-NC-loaded folate-conjugated polymer micelles as tumor targeted drug delivery system: preparation and evaluation in vitro. Int J Pharm 372:125–31
   PubMed Web of Science ®Google Scholar
• Haque S, Md S, Sahni JK, et al. (2014). Development and evaluation of brain targeted intranasal alginate nanoparticles for treatment of depression. J Psychiatr Res 48:1–12
   PubMed Web of Science ®Google Scholar
• Heurtault B, Saulnier P, Pech B, et al. (2003). Physico-chemical stability of colloidal lipid particles. Biomaterials 24:4283–300
   PubMed Web of Science ®Google Scholar
• Higuchi T. (1963). Mechanism of sustained-action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J Pharm Sci 52:1145–9
   PubMed Web of Science ®Google Scholar
• Honary S, Zahir F. (2013). Effect of zeta potential on the properties of nano-drug delivery systems – a review (Part 2). Trop J Pharm Res 12:265–73
   Web of Science ®Google Scholar
• Hornig S, Bunjes H, Heinze T. (2009). Preparation and characterization of nanoparticles based on dextran-drug conjugates. J Colloids Interface Sci 338:56–62
   PubMed Web of Science ®Google Scholar
• Illum L. (2003). Nasal drug delivery-possibilities, problems and solutions. J Control Release 87:187–98
   PubMed Web of Science ®Google Scholar
• Jagtap P, Jadhav K, Dand N. (2015). Formulation and ex vivo evaluation of solid lipid nanoparticles (SLNS) based hydrogel for intranasal drug delivery. Int J Med Health Biomed Bioeng Pharm Eng 9:43–53
   Google Scholar
• Jain R, Nabar S, Dandekar P, et al. (2010). Micellar nanocarriers: potential nose-to-brain delivery of zolmitriptan as novel migraine therapy. Pharm Res 27:655–64
   PubMed Web of Science ®Google Scholar
• Jelenkovic AV, Jovanovic MD, Stanimirovic DD, et al. (2008). Beneficial effects of ceftriaxone against pentylenetetrazole-evoked convulsions. Exp Biol Med 233:1389–94
   Web of Science ®Google Scholar
• Juggernauth KA, Gros AE, Meznarich NA, et al. (2011). In situ photogelation kinetics of laponite nanoparticle-based photorheological dispersions. Soft Matter 7:10108–15
   Web of Science ®Google Scholar
• Kanazawa T, Taki H, Tanaka K, et al. (2011). Cell-penetrating peptide-modified block copolymer micelles promote direct brain delivery via intranasal administration. Pharm Res 28:2130–9
   PubMed Web of Science ®Google Scholar
• Khan S, Patil K, Yeole P, et al. (2009). Brain targeting studies on buspirone hydrochloride after intranasal administration of mucoadhesive formulation in rats. J Pharm Pharmacol 61:669–75
   PubMed Web of Science ®Google Scholar
• Kim S, Shi Y, Kim JY, et al. (2010). Overcoming the barriers in micellar drug delivery: loading efficiency, in vivo stability, and micelle-cell interaction. Exp Opin Drug Deliv 7:49–62
   PubMed Web of Science ®Google Scholar
• Kolsure PK, Rajkapoor B. (2012). Development of zolmitriptan gel for nasal administration. Asian J Pharm Clin Res 5:1–7
   Google Scholar
• Kumar A, Sharma P, Chaturvedi A, et al. (2009). Formulation development of sertraline hydrochloride microemulsion for intranasal delivery. Int J ChemTech Res 1:941–7
   Google Scholar
• Kunieda H, Uddin MH, Horii M, et al. (2001). Effect of hydrophilic- and hydrophobic-chain lengths on the phase behavior of A–B-type silicone surfactants in water. J Phys Chem B 105:5419–26
   Web of Science ®Google Scholar
• Lee ES, Oh YT, Youn YS, et al. (2011). Binary mixing of micelles using Pluronics for a nano-sized drug delivery system. Colloids Surf B Biointerfaces 82:190–5
   PubMed Web of Science ®Google Scholar
• Leyva-Gómez G, González-Trujano ME, López-Ruiz E, et al. (2014). Nanoparticle formulation improves the anticonvulsant effect of clonazepam on the pentylenetetrazole-induced seizures: behavior and electroencephalogram. Pharm Nanotechnol 103:2509–19
   Google Scholar
• Lockey AS. (2002). Emergency department drug therapy for status epilepticus in adults. Emerg Med J 19:96–100
   PubMed Web of Science ®Google Scholar
• Macri E. (2010). Management of status epilepticus. Available at: http://www.ohsu.edu/health/_resources/uploads/uploads/SE%20symposium-macri.pdf
   Google Scholar
• Manno EM. (2003). New management strategies in the treatment of status epilepticus. Mayo Clinic Proc 78:508–18
   PubMed Web of Science ®Google Scholar
• Marx D, Williams G, Birkhoff M. (2015). Intranasal drug administration – an attractive delivery route for some drugs. Drug Discov Dev 299–320. Available at: https://pharma.aptar.com/sites/default/files/publications/intranasal_drug_administration_inthec.pdf
   PubMed Web of Science ®Google Scholar
• Moore IW, Flanner HH. (1996). Mathematical comparison of curves with an emphasis on in-vitro dissolution profiles. Pharm Technol 20:64–74
   Google Scholar
• Motaleb MA, El-Kolaly MT, Rashed HM, et al. (2012). Radioiodinated paroxetine, a novel potential radiopharmaceutical for lung perfusion scan. J Radioanal Nucl Chem 292:629–35
   Web of Science ®Google Scholar
• Nardi AE, Machado S, Ferreira Almada L, et al. (2013). Clonazepam for the treatment of panic disorder. Curr Drug Targets 14:353–64
   PubMed Web of Science ®Google Scholar
• Nour SA, Abdelmalak NS, Naguib MJ. (2015). Bumadizone calcium dihydrate microspheres compressed tablets for colon targeting: formulation, optimization and in vivo evaluation in rabbits. Drug Deliv 22:286–97
   PubMed Web of Science ®Google Scholar
• Oh KT, Bronich TK, Kabanov AV. (2004). Micellar formulations for drug delivery based on mixtures of hydrophobic and hydrophilic Pluronic® block copolymers. J Control Release 94:411–22
   PubMed Web of Science ®Google Scholar
• Patel R, Purohit N. (2009). Physico-chemical characterization and in vitro dissolution assessment of clonazepam-cyclodextrins inclusion compounds. AAPS PharmSciTech 10:1301–12
   PubMed Web of Science ®Google Scholar
• Patel VB, Dave JB, Patel FM. (2012). Spectrophotometric method for identification and estimation of clonazepam in tablet dosage form. Int J Pharm Res Biosci 1:62–70
   Google Scholar
• Pires A, Fortuna A, Alves G, et al. (2009). Intranasal drug delivery: how, why and what for? J Pharm Pharm Sci 12:288–311
   PubMed Web of Science ®Google Scholar
• Rashed HM, Ibrahim IT, Motaleb MA, et al. (2014). Preparation of radioiodinated ritodrine as a potential agent for lung imaging. J Radioanal Nucl Chem 300:1227–33
   Web of Science ®Google Scholar
• Rey E, Tréluyer JM, Pons G. (1999). Pharmacokinetic optimization of benzodiazepine therapy for acute seizures. Focus on delivery routes. Clin Pharmacokinet 36:409–24
   PubMed Web of Science ®Google Scholar
• Roche. (2009). Klonopin tablets (clonazepam): prescription information. pp. 1–19. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017533s045,020813s005lbl.pdf
   Google Scholar
• Roni MA, Islam MS, Kibria G, et al. (2011). Effects of poloxamer and HPMC on the dissolution of clonazepam-polyethylene glycol solid dispersions and tablets. Indian J Pharm Educ Res 45:139–44
   Web of Science ®Google Scholar
• Ryu J, Jeong YI, Kim IS, et al. (2000). Clonazepam release from core-shell type nanoparticles of poly(epsilon-caprolactone)/poly(ethylene glycol)/poly(epsilon-caprolactone) triblock copolymers. Int J Pharm 200:231–42
   PubMed Web of Science ®Google Scholar
• Sakr TM, Moustapha ME, Motaleb MA. (2013). 99mTc-nebivolol as a novel heart imaging radiopharmaceutical for myocardial infarction assessment. J Radioanal Nucl Chem 295:1511–16
   Web of Science ®Google Scholar
• Salama HA, Mahmoud AA, Kamel AO, et al. (2012). Brain delivery of olanzapine by intranasal administration of transfersomal vesicles. J Liposome Res 22:336–45
   PubMed Web of Science ®Google Scholar
• Samia O, Hanan R, Kamal ET. (2012). Carbamazepine mucoadhesive nanoemulgel (MNEG) as brain targeting delivery system via the olfactory mucosa. Drug Deliv 19:58–67
   PubMed Web of Science ®Google Scholar
• Sang LC, Coppens MO. (2011). Effects of surface curvature and surface chemistry on the structure and activity of proteins adsorbed in nanopores. Supplement Mater 13:1–8
   Google Scholar
• Serralheiro A, Alves G, Fortuna A, et al. (2014). Intranasal administration of carbamazepine to mice: a direct delivery pathway for brain targeting. Eur J Pharm Sci 60:32–9
   PubMed Web of Science ®Google Scholar
• Shaji J, Aditi P. (n.d.). Intranasal clonazepam mucoadhesive microspheres: factorial designing and primary evaluation. Available at: http://priory.com/pharmacy/clonazepam.htm
   Google Scholar
• Sharma D, Maheshwari D, Philip G, et al. (2014). Formulation and optimization of polymeric nanoparticles for intranasal delivery of Lorazepam using Box-Behnken design: in vitro and in vivo evaluation. BioMed Res Int 2014:1–14
   Google Scholar
• Srivalli KMR, Lakshmi PK. (2012). Overview of P-glycoprotein inhibitors: a rational outlook. Brazil J Pharm Sci 48:353–67
   Web of Science ®Google Scholar
• Svensson B, Olsson U, Alexandridis P. (2000). Self-assembly of block copolymers in selective solvents: influence of relative block size on phase behavior. Langmuir 16:6839–46
   Web of Science ®Google Scholar
• Tang J, Bian Z, Hu J, et al. (2012). The effect of a P123 template in mesopores of mesocellular foam on the controlled-release of venlafaxine. Int J Pharm 424:89–97
   PubMed Web of Science ®Google Scholar
• Taylor MJ, Tanna S, Sahota T. (2010). In vivo study of a polymeric glucose-sensitive insulin delivery system using a rat model. J Pharm Sci 99:4215–27
   PubMed Web of Science ®Google Scholar
• Torchilin V, Amiji MM. (2010). Polymeric micelles as versatile carriers for drugs and nucleic acids delivery. In: Handbook of materials for nanomedicine. Danvers (MA): Pan Stanford Publishing, 190–210
   Google Scholar
• Vandekerckhove A, Glorieux S, Van den Broeck W, et al. (2009). In vitro culture of equine respiratory mucosa explants. Vet J 181:280–7
   PubMed Web of Science ®Google Scholar
• Vyas TK, Babbar AK, Sharma RK, et al. (2006). Intranasal mucoadhesive microemulsions of clonazepam: preliminary studies on brain targeting. J Pharm Sci 95:1–11
   Web of Science ®Google Scholar
• Wei Z, Hao J, Yuan S, et al. (2009). Paclitaxel-loaded pluronic P123/F127 mixed polymeric micelles: formulation, optimization and in vitro characterization. Int J Pharm 376:176–85
   PubMed Web of Science ®Google Scholar
• Wiens T, Redelmeier T, Av-Gay Y. (2004). Development of a liposome formulation of ethambutol. Antimicrob Agents Chemother 48:1887–8
   PubMed Web of Science ®Google Scholar
• Xu W, Cui Y, Ling P, et al. (2012). Preparation and evaluation of folate-modified cationic pluronic micelles for poorly soluble anticancer drug. Drug Deliv 19:208–19
   PubMed Web of Science ®Google Scholar
• Yang ZZ, Zhang YQ, Wang ZZ, et al. (2013). Enhanced brain distribution and pharmacodynamics of rivastigmine by liposomes following intranasal administration. Int J Pharm 452:344–54
   PubMed Web of Science ®Google Scholar
• Zhang QZ, Zha LS, Zhang Y, et al. (2006). The brain targeting efficiency following nasally applied MPEG-PLA nanoparticles in rats. J Drug Target 14:281–90
   PubMed Web of Science ®Google Scholar
• Zhao Y, Yue P, Tao T. (2007). Drug brain distribution following intranasal administration of Huperzine A in situ gel in rats. Acta Pharmacol Sin 28:273–8
   PubMed Web of Science ®Google Scholar