Formulation and In Vivo Efficacy Study of Cetuximab Decorated Targeted Bioadhesive Nanomedicine for Non-Small-Cell Lung Cancer Therapy

References

• Dogan N , DoganI. Global patterns of incidence and mortality in lung cancer. EJMO3(1), 28–32 (2019).
   Google Scholar
• Ferlay J , ColombetM, SoerjomataramIet al. Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods. Int. J. Cancer144(8), 1941–1953 (2019).
   PubMed Web of Science ®Google Scholar
• Global Burden of Disease Cancer Collaboration , FitzmauriceC, AbateDet al.Global, regional, and national cancer incidence, mortality, years of life lost, years lived with disability, and disability-adjusted life-years for 29 cancer groups, 1990 to 2017: a systematic analysis for the global burden of disease study. JAMA Oncol.5(12), 1749–1768 (2019).
   PubMed Web of Science ®Google Scholar
• Curioni-Fontecedro A , PerentesJY, GelpkeHet al. Preoperative chemotherapy and radiotherapy concomitant to cetuximab in resectable stage IIIB NSCLC: a multicentre phase 2 trial (SAKK 16/08). Br. J. Cancer120(10), 968–974 (2019).
   PubMed Web of Science ®Google Scholar
• Hui R , NishioM, ReckMet al. Randomized, double-blind, Phase III trial of first-line pembrolizumab+ platinum doublet chemotherapy (chemo)±lenvatinib in patients (pts) with metastatic nonsquamous non–small-cell lung cancer (NSCLC): LEAP-006. J. Clin. Oncol.37(15), TPS9118–TPS9118 (2019).
   Web of Science ®Google Scholar
• Qin A , LuskE, Daignault-NewtonS, SchneiderBJ. Chemotherapy and radiation versus chemotherapy alone for elderly patients with N3 stage IIIB NSCLC. Clin. Lung Cancer20(4), e495–e503 (2019).
   PubMed Web of Science ®Google Scholar
• Agrawal P , SinghRP, KumariLet al. TPGS-chitosan cross-linked targeted nanoparticles for effective brain cancer therapy. Mater. Sci. Eng. C Mater. Biol. Appl.74, 167–176 (2017).
   PubMed Web of Science ®Google Scholar
• Sonali , ViswnadhMK, SinghRP, AgrawalPet al. Nanotheranostics: emerging strategies for early diagnosis and therapy of brain cancer. Nanotheranostics2(1), 70 (2018).
   PubMedGoogle Scholar
• Muthu MS , SinghS. Targeted nanomedicines: effective treatment modalities for cancer, AIDS and brain disorders. Nanomedicine (Lond.)4(1), 105–118 (2009).
   PubMed Web of Science ®Google Scholar
• Torchilin V . Tumor delivery of macromolecular drugs based on the EPR effect. Adv Drug Deliv. Rev.63(3), 131–135 (2011).
   PubMed Web of Science ®Google Scholar
• Mehata AK , BhartiS, SinghPet al. Trastuzumab decorated TPGS-g-chitosan nanoparticles for targeted breast cancer therapy. Colloids Surf. B Biointerfaces173, 366–377 (2019).
   PubMed Web of Science ®Google Scholar
• Thandapani G , PrasadS, SudhaP, SukumaranA. Size optimization and in vitro biocompatibility studies of chitosan nanoparticles. Int. J. Biol. Macromol.104, 1794–1806 (2017).
   PubMed Web of Science ®Google Scholar
• Zhang X , YangX, JiJ, LiuA, ZhaiG. Tumor targeting strategies for chitosan-based nanoparticles. Colloids Surf. B Biointerfaces.148, 460–473 (2016).
   PubMed Web of Science ®Google Scholar
• Zhang Z , TanS, FengSS. Vitamin E TPGS as a molecular biomaterial for drug delivery. Biomaterials33(19), 4889–4906 (2012).
   PubMed Web of Science ®Google Scholar
• Choudhury H , GorainB, PandeyMet al. Recent advances in TPGS-based nanoparticles of docetaxel for improved chemotherapy. Int. J. Pharm.529(1–2), 506–522 (2017).
   PubMed Web of Science ®Google Scholar
• Muthu MS , KuttyRV, LuoZ, XieJ, FengSS. Theranostic vitamin E TPGS micelles of transferrin conjugation for targeted co-delivery of docetaxel and ultra bright gold nanoclusters. Biomaterials39, 234–248 (2015).
   PubMed Web of Science ®Google Scholar
• Collnot E-M , BaldesC, SchaeferUF, EdgarKJ, WempeMF, LehrCM. Vitamin E TPGS P-glycoprotein inhibition mechanism: influence on conformational flexibility, intracellular ATP levels, and role of time and site of access. Mol. Pharm.7(3), 642–651 (2010).
   PubMed Web of Science ®Google Scholar
• Dintaman JM , SilvermanJA. Inhibition of P-glycoprotein by D-α-tocopheryl polyethylene glycol 1000 succinate (TPGS). Pharm. Res.16(10), 1550–1556 (1999).
   PubMed Web of Science ®Google Scholar
• Wempe MF , WrightC, LittleJLet al. Inhibiting efflux with novel non-ionic surfactants: rational design based on vitamin E TPGS. Int. J. Pharm.370(1–2), 93–102 (2009).
   PubMedGoogle Scholar
• Das M , WakeleeH. Targeting VEGF in lung cancer. Expert Opin. Ther. Targets16(4), 395–406 (2012).
   PubMed Web of Science ®Google Scholar
• Dempke WC , SutoT, ReckM. Targeted therapies for non-small-cell lung cancer. Lung Cancer67(3), 257–274 (2010).
   PubMed Web of Science ®Google Scholar
• Hall RD , LeTM, HaggstromDE, GentzlerRD. Angiogenesis inhibition as a therapeutic strategy in non-small-cell lung cancer (NSCLC). Transl. Lung Cancer Res.4(5), 515 (2015).
   PubMed Web of Science ®Google Scholar
• Yewale C , BaradiaD, VhoraI, PatilS, MisraA. Epidermal growth factor receptor targeting in cancer: a review of trends and strategies. Biomaterials34(34), 8690–8707 (2013).
   PubMed Web of Science ®Google Scholar
• Moradi-Kalbolandi S , HosseinzadeA, SalehiMet al. Monoclonal antibody-based therapeutics, targeting the epidermal growth factor receptor family: from herceptin to Pan HER. J. Pharm. Pharmacol.70(7), 841–854 (2018).
   PubMed Web of Science ®Google Scholar
• Hasegawa H , YasudaH, HamamotoJet al. Efficacy of afatinib or osimertinib plus cetuximab combination therapy for non-small-cell lung cancer with EGFR exon 20 insertion mutations. Lung Cancer127, 146–152 (2019).
   PubMed Web of Science ®Google Scholar
• Yamaguchi A , AchmadA, HanaokaHet al. Immuno-PET imaging for non-invasive assessment of cetuximab accumulation in non-small-cell lung cancer. BMC Cancer19(1), 1–8 (2019).
   PubMed Web of Science ®Google Scholar
• Zhang Q , LiuQ, DuMet al. Cetuximab and doxorubicin loaded dextran-coated Fe3O4 magnetic nanoparticles as novel targeted nanocarriers for non-small-cell lung cancer. J. Magn. Magn. Mater.481, 122–128 (2019).
   Web of Science ®Google Scholar
• Herbst RS , KhuriFR. Mode of action of docetaxel - a basis for combination with novel anticancer agents. Cancer Treat. Rev.29(5), 407–415 (2003).
   PubMed Web of Science ®Google Scholar
• Rapalli VK , KhosaA, SinghviG, GirdharV, JainR, DubeySK. Application of QbD principles in nanocarrier-based drug delivery systems. In: Pharmaceutical Quality by Design (1st Edition).BegS, HasnainNS ( Eds). Academic Press, London, UK, 255–296 (2019).
   Google Scholar
• Pharmaceutical Quality by Design: A Practical Approach. SchlindweinWS, GibsonM. ( Eds). Wiley, NJ, USA (2018).
   Google Scholar
• Hasnain MS , AhmedSA, AnsariMT, NayakAK. ‘Quality by design’ approach for development of multiparticulate drug delivery systems. In: Pharmaceutical Quality by Design (1st Edition).BegS, HasnainNS ( Eds). Academic Press, London, UK, 351–365 (2019).
   Google Scholar
• Patil H , FengX, YeX, MajumdarS, RepkaMA. Continuous production of fenofibrate solid lipid nanoparticles by hot-melt extrusion technology: a systematic study based on a quality by design approach. AAPS J17(1), 194–205 (2015).
   PubMed Web of Science ®Google Scholar
• Waghule T , RapalliVK, SinghviGet al. Voriconazole loaded nanostructured lipid carriers based topical delivery system: qbD based designing, characterization, in-vitro and ex-vivo evaluation. J. Drug Deliv. Sci. Technol.52, 303–315 (2019).
   Web of Science ®Google Scholar
• ICH Expert Working Group . ICH Harmonized tripartite guideline. Pharmaceutical development Q8 (R2). Presented at: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2009).
   Google Scholar
• Committee for Human Medicinal Products . ICH guideline Q9 on quality risk management. Presented at: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2005).
   Google Scholar
• Chaves LL , CostaLima SA, VieiraACet al. pH-sensitive nanoparticles for improved oral delivery of dapsone: risk assessment, design, optimization and characterization. Nanomedicine (Lond.)12(16), 1975–1990 (2017).
   PubMed Web of Science ®Google Scholar
• Dhat S , PundS, KokareC, SharmaP, ShrivastavaB. Risk management and statistical multivariate analysis approach for design and optimization of satranidazole nanoparticles. Eur. J. Pharm. Sci.96, 273–283 (2017).
   PubMed Web of Science ®Google Scholar
• De Mattos CB , ArgentaDF, DeLima Melchiades Get al. Nanoemulsions containing a synthetic chalcone as an alternative for treating cutaneous leshmaniasis: optimization using a full factorial design. Int. J. Nanomed.10, 5529 (2015).
   PubMed Web of Science ®Google Scholar
• Sreekumar S , GoycooleaFM, MoerschbacherBM, Rivera-RodriguezGR. Parameters influencing the size of chitosan-TPP nano-and microparticles. Sci. Rep.8(1), 4695 (2018).
   PubMedGoogle Scholar
• Gohel M , AminAF. Formulation optimization of controlled release diclofenac sodium microspheres using factorial design. J. Control. Rel.51(2–3), 115–122 (1998).
   PubMed Web of Science ®Google Scholar
• Shah M , PathakK. Development and statistical optimization of solid lipid nanoparticles of simvastatin by using 2(3) full-factorial design. AAPS PharmSciTech11(2), 489–496 (2010).
   PubMed Web of Science ®Google Scholar
• Agrawal S , AhmadH, DwivediMet al. PEGylated chitosan nanoparticles potentiate repurposing of ormeloxifene in breast cancer therapy. Nanomedicine (Lond.)11(16), 2147–2169 (2016).
   PubMed Web of Science ®Google Scholar
• Fischer MJ . Amine coupling through EDC/NHS: a practical approach. Methods Mol. Biol.627, 55–73 (2010).
   PubMedGoogle Scholar
• Jazayeri MH , AmaniH, PourfatollahAA, Pazoki-ToroudiH, SedighimoghaddamB. Various methods of gold nanoparticles (GNPs) conjugation to antibodies. Sens. Biosens. Res.9, 17–22 (2016).
   Google Scholar
• Banala RR , NagatiVB, KarnatiPR. Green synthesis and characterization of Carica papaya leaf extract coated silver nanoparticles through X-ray diffraction, electron microscopy and evaluation of bactericidal properties. Saudi J. Biol. Sci.2(5), 637–644 (2015).
   Google Scholar
• Behbahani ES , GhaediM, AbbaspourM, RostamizadehK. Optimization and characterization of ultrasound assisted preparation of curcumin-loaded solid lipid nanoparticles: application of central composite design, thermal analysis and x-ray diffraction techniques. Ultrason. Sonochem.38, 271–280 (2017).
   PubMed Web of Science ®Google Scholar
• Dobrovolskaia MA , PatriAK, PotterTM, RodriguezJC, HallJB, McNeilSE. Dendrimer-induced leukocyte procoagulant activity depends on particle size and surface charge. Nanomedicine (Lond.)7(2), 245–256 (2012).
   PubMed Web of Science ®Google Scholar
• Lee H , FongeH, HoangB, ReillyRM, AllenC. The effects of particle size and molecular targeting on the intratumoral and subcellular distribution of polymeric nanoparticles. Mol. Pharm.7(4), 1195–1208 (2010).
   PubMed Web of Science ®Google Scholar
• Harde H , AgrawalAK, JainS. Development of stabilized glucomannosylated chitosan nanoparticles using tandem crosslinking method for oral vaccine delivery. Nanomedicine (Lond.)9(16), 2511–2529 (2014).
   PubMed Web of Science ®Google Scholar
• Monsalve Y , TosiG, RuoziBet al. PEG-g-chitosan nanoparticles functionalized with the monoclonal antibody OX26 for brain drug targeting. Nanomedicine (Lond.)10(11), 1735–1750 (2015).
   PubMed Web of Science ®Google Scholar
• Kutty RV , FengSS. Cetuximab conjugated vitamin E TPGS micelles for targeted delivery of docetaxel for treatment of triple negative breast cancers. Biomaterials34(38), 10160–10171 (2013).
   PubMed Web of Science ®Google Scholar
• Viswanadh MK , MuthuMS.Targeted bioadhesive nanomedicine: an effective approach for synergistic drug delivery to cancers. Nanomedicine (Lond.)13(12), 1401–1403 (2018).
   PubMed Web of Science ®Google Scholar
• Cheng Y , JiY. Mitochondria-targeting nanomedicine self-assembled from GSH-responsive paclitaxel-ss-berberine conjugate for synergetic cancer treatment with enhanced cytotoxicity. J. Control. Rel.318, 38–49 (2019).
   PubMed Web of Science ®Google Scholar
• Gao W , XiangB, MengTT, LiuF, QiXR. Chemotherapeutic drug delivery to cancer cells using a combination of folate targeting and tumor microenvironment-sensitive polypeptides. Biomaterials34(16), 4137–4149 (2013).
   PubMed Web of Science ®Google Scholar
• Govindaraju S , RoshiniA, LeeMH, YunK. Kaempferol conjugated gold nanoclusters enabled efficient for anticancer therapeutics to A549 lung cancer cells. Int. J. Nanomed.14, 5147 (2019).
   PubMed Web of Science ®Google Scholar
• Matesanz MC , VilaM, FeitoMJet al. The effects of graphene oxide nanosheets localized on F-actin filaments on cell-cycle alterations. Biomaterials34(5), 1562–1569 (2013).
   PubMed Web of Science ®Google Scholar
• Bagre AP , JainK, JainNK. Alginate coated chitosan core shell nanoparticles for oral delivery of enoxaparin: in vitro and in vivo assessment. Int. J. Pharm.456(1), 31–40 (2013).
   PubMed Web of Science ®Google Scholar
• Burande AS , ViswanadhMK, JhaAet al. EGFR targeted paclitaxel and piperine co-loaded liposomes for the treatment of triple negative breast cancer. AAPS Pharmscitech21(5), 151 (2020).
   PubMed Web of Science ®Google Scholar
• Sun L , ChenY, ZhouYet al. Preparation of 5-fluorouracil-loaded chitosan nanoparticles and study of the sustained release in vitro and in vivo. Asian J. Pharm. Sci.12(5), 418–423 (2017).
   PubMed Web of Science ®Google Scholar
• Chakraborty SP , MahapatraSK, SahuSK, PramanikP, RoyS. Antioxidative effect of folate-modified chitosan nanoparticles. Asian Pac. J. Trop. Biomed.1(1), 29–38 (2011).
   PubMedGoogle Scholar
• Perumal V , ManickamT, BangKS, VelmuruganP, OhBT. Antidiabetic potential of bioactive molecules coated chitosan nanoparticles in experimental rats. Int. J. Biol. Macromol.92, 63–69 (2016).
   PubMed Web of Science ®Google Scholar
• Goel MK , KhannaP, KishoreJ. Understanding survival analysis: Kaplan–Meier estimate. Int. J. Ayurveda Res.1(4), 274 (2010).
   PubMedGoogle Scholar
• He L , LongLR, AntaniS, ThomaGR, BiomedicinePI. Histology image analysis for carcinoma detection and grading. Comput. Methods Programs Biomed.107(3), 538–556 (2012).
   PubMed Web of Science ®Google Scholar
• Jensen EC . Quantitative analysis of histological staining and fluorescence using ImageJ. Anat. Rec. (Hoboken)296(3), 378–381 (2013).
   PubMedGoogle Scholar
• Walter J , PryceD. The histology of lung cancer. Thorax10(2), 107 (1955).
   PubMedGoogle Scholar
• Helal FH , EsraaAA, AhmedGHet al. Modulation of rifampicin-induced hepatotoxicity using poly(lactic-co-glycolic acid) nanoparticles: a study on rat and cell culture models. Nanomedicine (Lond.)15(14), 1375–1390 (2020).
   PubMed Web of Science ®Google Scholar
• Vandana M , SahooSK. Optimization of physicochemical parameters influencing the fabrication of protein-loaded chitosan nanoparticles. Nanomedicine (Lond.)4(7), 773–785 (2009).
   PubMed Web of Science ®Google Scholar
• Monsalve Y , TosiG, RuoziBet al. PEG-g-chitosan nanoparticles functionalized with the monoclonal antibody OX26 for brain drug targeting. Nanomedicine (Lond.)10(11), 1735–1750 (2015).
   PubMed Web of Science ®Google Scholar
• Poudel I , AhiwaleR, PawarAet al. Development of novel biotinylated chitosan-decorated docetaxel-loaded nanocochleates for breast cancer targeting. Artif. Cells Nanomed. Biotechnol.46(2), 229–240 (2018).
   PubMedGoogle Scholar
• Pan J , LiuY, FengSS. Multifunctional nanoparticles of biodegradable copolymer blend for cancer diagnosis and treatment. Nanomedicine (Lond.)5(3), 347–360 (2010).
   PubMed Web of Science ®Google Scholar
• Agrawal S , AhmadH, DwivediMet al. PEGylated chitosan nanoparticles potentiate repurposing of ormeloxifene in breast cancer therapy. Nanomedicine (Lond.)11(16), 2147–2169 (2016).
   PubMed Web of Science ®Google Scholar
• Garanti T , AlhnanMA, WanKW. RGD-decorated solid lipid nanoparticles enhance tumor targeting, penetration and anticancer effect of asiatic acid. Nanomedicine (Lond.)15(16), 1567–1583 (2020).
   PubMed Web of Science ®Google Scholar
• Mirzaie ZH , IraniS, MirfakhraieRet al. Docetaxel–chitosan nanoparticles for breast cancer treatment: cell viability and gene expression study. Chem. Biol. Drug Des.88(6), 850–858 (2016).
   PubMed Web of Science ®Google Scholar
• Patel K , DoddapaneniR, ChowdhuryNet al. Tumor stromal disrupting agent enhances the anticancer efficacy of docetaxel loaded PEGylated liposomes in lung cancer. Nanomedicine (Lond.)11(11), 1377–1392 (2016).
   PubMed Web of Science ®Google Scholar
• Yeo CD , KimYA, LeeHYet al. Roflumilast treatment inhibits lung carcinogenesis in benzo(a)pyrene-induced murine lung cancer model. Eur. J. Pharmacol.812, 189–195 (2017).
   PubMed Web of Science ®Google Scholar