Intranasal delivery of tapentadol hydrochloride–loaded chitosan nanoparticles: formulation, characterisation and its in vivo evaluation

References

• Agnihotri SA, Mallikarjuna NN, Aminabhavi TM. Recent advances on chitosan-based micro- and nanoparticles in drug delivery. J Control Release, 2004;100:5–28.
   PubMed Web of Science ®Google Scholar
• Aktas Y, Yemisci M, Andrieux K, Gürsoy RN, Alonso MJ, Fernandez-Megia E, Novoa-Carballal R, Quiñoá E, Riguera R, Sargon MF. Development and brain delivery of chitosan-PEG nanoparticles functionalized with the monoclonal antibody OX26. Bioconjug Chem, 2005;16:1503–11.
   PubMed Web of Science ®Google Scholar
• Al-Ghananeem AM, Saeed H, Florence R, Yokel RA, Malkawi AH. Intranasal drug delivery of didanosine-loaded chitosan nanoparticles for brain targeting; an attractive route against infections caused by AIDS viruses. J Drug Target, 2010;18:381–8.
   PubMed Web of Science ®Google Scholar
• Alam S, Khan ZI, Mustafa G, Kumar M, Islam F, Bhatnagar A, Ahmad FJ. Development and evaluation of thymoquinone-encapsulated chitosan nanoparticles for nose-to-brain targeting: A pharmacoscintigraphic study. Int J Nanomed, 2012;7:5705–18.
   PubMed Web of Science ®Google Scholar
• Ali J, Ali M, Baboota S, Kaur Sahni J, Ramassamy C, Dao L. Potential of nanoparticulate drug delivery systems by intranasal administration. Curr Pharm Des, 2010;16:1644–53.
   PubMed Web of Science ®Google Scholar
• Ali J, Ali N, Sultana Y, Baboota S, Faiyaz S. Development and validation of a stability-indicating HPTLC method for analysis of antitubercular drugs. Acta Chromatographica, 2007;18:168.
   Web of Science ®Google Scholar
• Bancroft JD, Gamble M. 2008. Theory and practice of histological techniques. Philadelphia, USA: Elsevier Health Sciences.
   Google Scholar
• Benediktsdóttir BE, Baldursson Ó, Másson M. Challenges in evaluation of chitosan and trimethylated chitosan (TMC) as mucosal permeation enhancers: From synthesis to in vitro application. J Control Release, 2014;173:18–31.
   PubMed Web of Science ®Google Scholar
• Borchard G, Lueßen HL, De Boer AG, Verhoef JC, Lehr CM, Junginger HE. The potential of mucoadhesive polymers in enhancing intestinal peptide drug absorption. III: Effects of chitosan-glutamate and carbomer on epithelial tight junctions in vitro. J Control Release, 1996;39:131–8.
   Web of Science ®Google Scholar
• Branch SK. Guidelines from the international conference on harmonisation (ICH). J Pharm Biomed Anal, 2005;38:798–805.
   PubMed Web of Science ®Google Scholar
• Costantino L, Boraschi D. Is there a clinical future for polymeric nanoparticles as brain-targeting drug delivery agents?. Drug Discov Today, 2012;17:367–78.
   PubMed Web of Science ®Google Scholar
• Courteix C, Bourget P, Caussade F, Bardin M, Coudore F, Fialip J, Eschalier A. Is the reduced efficacy of morphine in diabetic rats caused by alterations of opiate receptors or of morphine pharmacokinetics?. J Pharmacol Exp Ther, 1998;285:63–70.
   PubMed Web of Science ®Google Scholar
• Dyer A, Hinchcliffe M, Watts P, Castile J, Jabbal-Gill I, Nankervis R, Smith A, Illum L. Nasal delivery of insulin using novel chitosan based formulations: A comparative study in two animal models between simple chitosan formulations and chitosan nanoparticles. Pharm Res, 2002;19:998–1008.
   PubMed Web of Science ®Google Scholar
• Fathima N, Mamatha T, Qureshi HK, Anitha N, Rao JV. Drug-excipient interaction and its importance in dosage form development. IJPR, 2011;1:289–96.
   Google Scholar
• Fazil M, Md S, Haque S, Kumar M, Baboota S, Kaur Sahni J, Ali J. Development and evaluation of rivastigmine loaded chitosan nanoparticles for brain targeting. Eur J Pharm Sci, 2012;47:6–15.
   PubMed Web of Science ®Google Scholar
• Fernandez-Urrusuno R, Calvo P, Remuñán-López C, Vila-Jato JL, Alonso MJ. Enhancement of nasal absorption of insulin using chitosan nanoparticles. Pharm Res, 1999;16:1576–81.
   PubMed Web of Science ®Google Scholar
• Gandhi R, Khatri N, Baradia D, Vhora I, Misra A. Surface-modified epirubicin-HCl liposomes and its in vitro assessment in breast cancer cell-line: MCF-7. Drug Deliv, 2016;23:1152–62.
   PubMed Web of Science ®Google Scholar
• Gazori T, Khoshayand MR, Azizi E, Yazdizade P, Nomani A, Haririan I. Evaluation of alginate/chitosan nanoparticles as antisense delivery vector: Formulation, optimization and in vitro characterization. Carbohydr Polym, 2009;77:599–606.
   Web of Science ®Google Scholar
• Guideline IHT. 1999. Stability Testing Guidelines: Stability Testing of New Drug Substances and Products. ICH Q1A (R2)(CPMP/ICH/2736/99).
   Google Scholar
• Hao J, Fang X, Zhou Y, Wang J, Guo F, Li F, Peng X. Development and optimization of solid lipid nanoparticle formulation for ophthalmic delivery of chloramphenicol using a Box-Behnken design. Int J Nanomedicine, 2011;6:683–92.
   PubMed Web of Science ®Google Scholar
• Janes KA, Fresneau MP, Marazuela A, Fabra A, Alonso MaJ. Chitosan nanoparticles as delivery systems for doxorubicin. J Control Release, 2001;73:255–67.
   PubMed Web of Science ®Google Scholar
• Jang KI, Lee HG. Stability of chitosan nanoparticles for L-ascorbic acid during heat treatment in aqueous solution. J Agric Food Chem, 2008;56:1936–41.
   PubMed Web of Science ®Google Scholar
• Katas H, Alpar HO. Development and characterisation of chitosan nanoparticles for siRNA delivery. J Control Release, 2006;115:216–25.
   PubMed Web of Science ®Google Scholar
• Khan S, Patil K, Bobade N, Yeole P, Gaikwad R. Formulation of intranasal mucoadhesive temperature-mediated in situ gel containing ropinirole and evaluation of brain targeting efficiency in rats. J Drug Target, 2010;18:223–34.
   PubMed Web of Science ®Google Scholar
• Kumar M, Pandey RS, Patra KC, Jain SK, Soni ML, Dangi JS, Madan J. Evaluation of neuropeptide loaded trimethyl chitosan nanoparticles for nose to brain delivery. Int J Biol Macromol, 2013;61:189–95.
   PubMed Web of Science ®Google Scholar
• Landis MS, Boyden T, Pegg S. Nasal-to-CNS drug delivery: Where are we now and where are we heading? An industrial perspective. Ther Deliv, 2012;3:195–208.
   PubMedGoogle Scholar
• Lee KY, Ha WS, Park WH. Blood compatibility and biodegradability of partially N-acylated chitosan derivatives. Biomaterials, 1995;16:1211–6.
   PubMed Web of Science ®Google Scholar
• Md S, Ali M, Ali R, Bhatnagar A, Baboota S, Ali J. Donepezil nanosuspension intended for nose to brain targeting: in vitro and in vivo safety evaluation. Int J Biol Macromol, 2014;67:418–25.
   PubMed Web of Science ®Google Scholar
• Md S, Khan RA, Mustafa G, Chuttani K, Baboota S, Sahni JK, Ali J. Bromocriptine loaded chitosan nanoparticles intended for direct nose to brain delivery: Pharmacodynamic, pharmacokinetic and scintigraphy study in mice model. Eur J Pharm Sci, 2013;48:393–405.
   PubMed Web of Science ®Google Scholar
• Mistry A, Stolnik S, Illum L. Nanoparticles for direct nose-to-brain delivery of drugs. Int J Pharm, 2009;379:146–57.
   PubMed Web of Science ®Google Scholar
• Mitra S, Gaur U, Ghosh P, Maitra A. Tumour targeted delivery of encapsulated dextran–doxorubicin conjugate using chitosan nanoparticles as carrier. J Control Release, 2001;74:317–23.
   PubMed Web of Science ®Google Scholar
• Nadkarni SS, Abraham J, Khatri K. 2014. Pharmaceutical composition of tapentadol for parenteral administration. Google Patents.
   Google Scholar
• Nadkarni SS, Abraham J, Khatri K, Mittal V. 2013. Pharmaceutical invention of tapentadol. Google Patents.
   Google Scholar
• Papadimitriou S, Bikiaris D, Avgoustakis K, Karavas E, Georgarakis M. Chitosan nanoparticles loaded with dorzolamide and pramipexole. Carbohydr Polym, 2008;73:44–54.
   Web of Science ®Google Scholar
• Pardeshi CV, Belgamwar VS. Direct nose to brain drug delivery via integrated nerve pathways bypassing the blood–brain barrier: An excellent platform for brain targeting. Expert Opin Drug Deliv, 2013;10:957–72.
   PubMed Web of Science ®Google Scholar
• Patel D, Naik S, Chuttani K, Mathur R, Mishra AK, Misra A. Intranasal delivery of cyclobenzaprine hydrochloride-loaded thiolated chitosan nanoparticles for pain relief. J Drug Target, 2013;21:759–69.
   PubMed Web of Science ®Google Scholar
• Patel D, Naik S, Misra A. Improved transnasal transport and brain uptake of tizanidine HCl‐loaded thiolated chitosan nanoparticles for alleviation of pain. J Pharm Sci, 2012;101:690–706.
   PubMed Web of Science ®Google Scholar
• Pengpong T, Sangvanich P, Sirilertmukul K, Muangsin N. Design, synthesis and in vitro evaluation of mucoadhesive p-coumarate-thiolated-chitosan as a hydrophobic drug carriers. Euro J Pharm Biopharm, 2014;86:487–97.
   PubMed Web of Science ®Google Scholar
• Pires A, Fortuna A, Alves G, Falcão A. Intranasal drug delivery: How, why and what for? J Pharm Pharmaceut Sci, 2009;12:288–311.
   Google Scholar
• Sawant K, Pandey A, Patel S. Aripiprazole loaded poly (caprolactone) nanoparticles: Optimization and in vivo pharmacokinetics. Mater Sci Eng C, 2016;66:230–43.
   PubMed Web of Science ®Google Scholar
• Seju U, Kumar A, Sawant K. Development and evaluation of olanzapine-loaded PLGA nanoparticles for nose-to-brain delivery: in vitro and in vivo studies. Acta Biomaterialia, 2011;7:4169–76.
   PubMed Web of Science ®Google Scholar
• Singh DR, Nag K, Shetti AN, Krishnaveni N. Tapentadol hydrochloride: A novel analgesic. Saudi J Anaesth, 2013;7:322.
   PubMedGoogle Scholar
• Sonaje K, Chuang EY, Lin KJ, Yen TC, Su FY, Tseng MT, Sung HW. Opening of epithelial tight junctions and enhancement of paracellular permeation by chitosan: microscopic, ultrastructural, and computed-tomographic observations. Mol Pharm, 2012;9:1271–9.
   PubMed Web of Science ®Google Scholar
• Soppimath KS, Aminabhavi TM, Kulkarni AR, Rudzinski WE. Biodegradable polymeric nanoparticles as drug delivery devices. J Control Release, 2001;70:1–20.
   PubMed Web of Science ®Google Scholar
• Tamai I, Tsuji A. Drug delivery through the blood-brain barrier. Adv Drug Deliv Rev, 1996;19:401–24.
   Web of Science ®Google Scholar
• Turk DC, Wilson HD, Cahana A. Treatment of chronic non-cancer pain. Lancet, 2011;377:2226–35.
   PubMed Web of Science ®Google Scholar
• Tzschentke T, De Vry J, Terlinden R, Hennies HH, Lange C, Strassburger W, Haurand M, Kolb J, Schneider J, Buschmann H. Tapentadol hydrochloride. Drugs Future, 2006;31:1053–61.
   Web of Science ®Google Scholar
• Tzschentke TM, Christoph T, Kögel B, Schiene K, Hennies HH, Englberger W, Haurand M, Jahnel U, Cremers TI, Friderichs E. (–)-(1R, 2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol hydrochloride (tapentadol HCl): A novel μ-opioid receptor agonist/norepinephrine reuptake inhibitor with broad-spectrum analgesic properties. J Pharmacol Exp Ther, 2007;323:265–76.
   PubMed Web of Science ®Google Scholar
• Ugwoke MI, Verbeke N, Kinget R. The biopharmaceutical aspects of nasal mucoadhesive drug delivery. J Pharm Pharmacol, 2001;53:3–22.
   PubMed Web of Science ®Google Scholar
• Umukoro S, Ashorobi RB. Further studies on the antinociceptive action of aqueous seed extract of Aframomum melegueta. J Ethnopharmacol, 2007;109:501–4.
   PubMed Web of Science ®Google Scholar
• Wang X, Chi N, Tang X. Preparation of estradiol chitosan nanoparticles for improving nasal absorption and brain targeting. Eur J Pharm Biopharm, 2008;70:735–40.
   PubMed Web of Science ®Google Scholar
• Yang SC, Lu LF, Cai Y, Zhu JB, Liang BW, Yang CZ. Body distribution in mice of intravenously injected camptothecin solid lipid nanoparticles and targeting effect on brain. J Control Release, 1999;59:299–307.
   PubMed Web of Science ®Google Scholar
• Yin Y, Chen D, Qiao M, Lu Z, Hu H. Preparation and evaluation of lectin-conjugated PLGA nanoparticles for oral delivery of thymopentin. J Control Release, 2006;116:337–45.
   PubMed Web of Science ®Google Scholar