Lipid-Nanopotentiated Combinatorial Delivery of Tamoxifen and Sulforaphane: Ex Vivo, In Vivo and Toxicity Studies

References

• Chang BY, Kim SA, Malla B, Kim SY. The effect of selective estrogen receptor modulators (serms) on the tamoxifen resistant breast cancer cells. Toxicol. Res. 27(2), 85–93 (2011).
   PubMedGoogle Scholar
• Jain AK, Thanki K, Jain S. Co-encapsulation of tamoxifen and quercetin in polymeric nanoparticles: implications on oral bioavailability, antitumor efficacy, and drug-induced toxicity. Mol. Pharm. 10(9), 3459–3474 (2013).
   PubMed Web of Science ®Google Scholar
• Mangla B, Alam O, Rub RA et al. Development and validation of a high throughput bioanalytical UPLC-MS/MS method for simultaneous determination of tamoxifen and sulphoraphane in rat plasma: application to an oral pharmacokinetic study. J. Chromatogr. B 1152, 122260 (2020).
   PubMed Web of Science ®Google Scholar
• Dunn SE, Hardman RA, Kari FW, Barrett JC. Insulin-like growth factor 1 (IGF-1) alters drug sensitivity of HBL100 human breast cancer cells by inhibition of apoptosis induced by diverse anticancer drugs. Cancer Res. 57(13), 2687–2693 (1997).
   PubMed Web of Science ®Google Scholar
• Shete H, Patravale V. Long chain lipid based tamoxifen NLC. Part I: preformulation studies, formulation development and physicochemical characterization. Int. J. Pharm. 454(1), 573–583 (2013).
   PubMed Web of Science ®Google Scholar
• SreeHarsha N, Hiremath JG, Chilukuri S et al. An approach to enhance dissolution rate of tamoxifen citrate. Biomed. Res. Int. 2019, 1–11 (2019).
   Web of Science ®Google Scholar
• Shin S-C, Choi J-S. Effects of epigallocatechin gallate on the oral bioavailability and pharmacokinetics of tamoxifen and its main metabolite, 4-hydroxytamoxifen, in rats. Anticancer Drugs 20(7), 584–588 (2009).
   PubMed Web of Science ®Google Scholar
• Yu Q, Huo J, Zhang Y et al. Tamoxifen-induced hepatotoxicity via lipid accumulation and inflammation in zebrafish. Chemosphere 239, 124705 (2020).
   PubMed Web of Science ®Google Scholar
• Khosrow-Khavar F, Filion KB, Al-Qurashi S et al. Cardiotoxicity of aromatase inhibitors and tamoxifen in postmenopausal women with breast cancer: a systematic review and meta-analysis of randomized controlled trials. Ann. Oncol. 28(3), 487–496 (2017).
   PubMed Web of Science ®Google Scholar
• Tabassum H, Parvez S, Rehman H et al. Nephrotoxicity and its prevention by taurine in tamoxifen induced oxidative stress in mice. Hum. Exp. Toxicol. 26(6), 509–518 (2007).
   PubMed Web of Science ®Google Scholar
• Shafi S, Khan S, Hoda F et al. Decoding novel mechanisms and emerging therapeutic strategies in breast cancer resistance. Curr. Drug Metab. 21(13), 119–210 (2020).
   Google Scholar
• Singh A, Neupane YR, Mangla B, Shafi S, Kohli K. PEGylated nanoliposomes potentiated oral combination therapy for effective cancer treatment. Curr. Drug Deliv. 17 (2020).
   Web of Science ®Google Scholar
• Verma D, Thakur PS, Padhi S, Khuroo T, Talegaonkar S, Iqbal Z. Design expert assisted nanoformulation design for co-delivery of topotecan and thymoquinone: optimization, in vitro characterization and stability assessment. J. Mol. Liq. 242, 382–394 (2017).
   Web of Science ®Google Scholar
• Kaithwas V, Dora CP, Kushwah V, Jain S. Nanostructured lipid carriers of olmesartan medoxomil with enhanced oral bioavailability. Colloids Surf. B Biointerfaces 154, 10–20 (2017).
   PubMed Web of Science ®Google Scholar
• Khuroo T, Verma D, Khuroo A, Ali A, Iqbal Z. Simultaneous delivery of paclitaxel and erlotinib from dual drug loaded PLGA nanoparticles: formulation development, thorough optimization and in vitro release. J. Mol. Liq. 257, 52–68 (2018).
   Web of Science ®Google Scholar
• Hauer- M, Bose C, Awasthi S et al. Sulforaphane potentiates anticancer effects of doxorubicin and attenuates its cardiotoxicity in a breast cancer model. PLoS ONE 13(3), e0193918 (2018).
   PubMed Web of Science ®Google Scholar
• Jose A, Ninave KM, Karnam S, Venuganti VVK. Temperature-sensitive liposomes for co-delivery of tamoxifen and imatinib for synergistic breast cancer treatment. J. Liposome Res. 29(2), 153–162 (2019).
   PubMed Web of Science ®Google Scholar
• Li Y, Zhang T, Korkaya H et al. Sulforaphane, a dietary component of broccoli/broccoli sprouts, inhibits breast cancer stem cells. Clin. Cancer Res. 16(9), 2580–2590 (2010).
   PubMed Web of Science ®Google Scholar
• Su X, Jiang X, Meng L, Dong X, Shen Y, Xin Y. Anticancer activity of sulforaphane: the epigenetic mechanisms and the Nrf2 signaling pathway. Oxid. Med. Cell. Longev. 2018, 5438179 (2018).
   PubMed Web of Science ®Google Scholar
• Cao S, Wang L, Zhang Z, Chen F, Wu Q, Li L. Sulforaphane-induced metabolomic responses with epigenetic changes in estrogen receptor positive breast cancer cells. FEBS Open Bio. 8(12), 2022–2034 (2018).
   PubMed Web of Science ®Google Scholar
• Farag MA, Motaal AA. Sulforaphane composition, cytotoxic and antioxidant activity of crucifer vegetables. J. Adv. Res. 1(1), 65–70 (2010).
   Google Scholar
• Jabbarzadeh Kaboli P, Afzalipour Khoshkbejari M, Mohammadi M et al. Targets and mechanisms of sulforaphane derivatives obtained from cruciferous plants with special focus on breast cancer – contradictory effects and future perspectives. Biomed. Pharmacother. 121, 109635 (2020).
   PubMed Web of Science ®Google Scholar
• Pawlik A, Słomińska-Wojewódzka M, Herman-Antosiewicz A. Sensitization of estrogen receptor-positive breast cancer cell lines to 4-hydroxytamoxifen by isothiocyanates present in cruciferous plants. Eur. J. Nutr. 55(3), 1165–1180 (2016).
   PubMed Web of Science ®Google Scholar
• Singh P, Sharma R, McElhanon K et al. Sulforaphane protects the heart from doxorubicin-induced toxicity. Free Radic. Biol. Med. 86, 90 (2015).
   PubMed Web of Science ®Google Scholar
• Atilano-Roque A, Wen X, Aleksunes LM, Joy MS. Nrf2 activators as potential modulators of injury in human kidney cells. Toxicol. Rep. 3, 153–159 (2016).
   PubMedGoogle Scholar
• Dos Santos NAG, Rodrigues MAC, Martins NM, Dos Santos AC. Cisplatin-induced nephrotoxicity and targets of nephroprotection: an update. Arch. Toxicol. 86(8), 1233–1250 (2012).
   PubMed Web of Science ®Google Scholar
• Kikuchi M, Ushida Y, Shiozawa H et al. Sulforaphane-rich broccoli sprout extract improves hepatic abnormalities in male subjects. World J. Gastroenterol. 21(43), 12457–12467 (2015).
   PubMed Web of Science ®Google Scholar
• Mangla B, Neupane YR, Singh A, Kohli K. Tamoxifen and Sulphoraphane for the breast cancer management: a synergistic nanomedicine approach. Med. Hypotheses 132, 109379 (2019).
   PubMed Web of Science ®Google Scholar
• Paul B, Li Y, Tollefsbol TO. The effects of combinatorial genistein and sulforaphane in breast tumor inhibition: role in epigenetic regulation. Int. J. Mol. Sci. 19(6), 1754 (2018).
   PubMed Web of Science ®Google Scholar
• Hussain A, Mohsin J, Prabhu SA et al. Sulforaphane inhibits growth of human breast cancer cells and augments the therapeutic index of the chemotherapeutic drug, gemcitabine. Asian Pacific J. Cancer Prev. 14(10), 5855–5860 (2013).
   PubMedGoogle Scholar
• Kumar P, Sharma G, Kumar R et al. Stearic acid based, systematically designed oral lipid nanoparticles for enhanced brain delivery of dimethyl fumarate. Nanomedicine 12(23), 2607–2621 (2017).
   PubMed Web of Science ®Google Scholar
• Campos J, Varas-Godoy M, Haidar ZS. Physicochemical characterization of chitosan-hyaluronan-coated solid lipid nanoparticles for the targeted delivery of paclitaxel: a proof-of-concept study in breast cancer cells. Nanomedicine 12(5), 473–490 (2017).
   PubMed Web of Science ®Google Scholar
• Singh A, Shafi S, Upadhyay T, Najmi AK, Kohli K, Pottoo FH. Insights into nanotherapeutic strategies as an impending approach for liver cancer treatment. Curr. Top. Med. Chem. 20 (2020).
   Web of Science ®Google Scholar
• García-Pinel B, Porras-Alcalá C, Ortega-Rodríguez A et al. Lipid-based nanoparticles: application and recent advances in cancer treatment. Nanomaterials 9(4), 638 (2019).
   Web of Science ®Google Scholar
• Neupane YR, Srivastava M, Gyenwalee S, Ahmad N, Soni K, Kohli K. Solid lipid nanoparticles for oral delivery of decitabine: formulation optimization, characterization, stability and ex-vivo gut permeation studies. Sci. Adv. Mater. 7(3), 433–445 (2015).
   Web of Science ®Google Scholar
• Morales JO, Valdés K, Morales J, Oyarzun-Ampuero F. Lipid nanoparticles for the topical delivery of retinoids and derivatives. Nanomedicine (Lond.) 10(2), 253–269 (2015).
   PubMed Web of Science ®Google Scholar
• Singh A, Neupane YR, Mangla B, Kohli K. Nanostructured lipid carriers for oral bioavailability enhancement of exemestane: formulation design, in vitro, ex vivo and in vivo studies. J. Pharm. Sci. 108(10), 3382–3395 (2019).
   PubMed Web of Science ®Google Scholar
• Karamanidou T, Bourganis V, Kammona O, Kiparissides C. Lipid-based nanocarriers for the oral administration of biopharmaceutics. Nanomedicine (Lond.) 11(22), 3009–3032 (2016).
   PubMed Web of Science ®Google Scholar
• Kushwaha AK, Vuddanda PR, Karunanidhi P, Singh SK, Singh S. Development and evaluation of solid lipid nanoparticles of raloxifene hydrochloride for enhanced bioavailability. Biomed Res. Int. 2013, 1–9 (2013).
   Web of Science ®Google Scholar
• Kasongo WA, Pardeike J, Müller RH, Walker RB. Selection and characterization of suitable lipid excipients for use in the manufacture of didanosine-loaded solid lipid nanoparticles and nanostructured lipid carriers. J. Pharm. Sci. 100(12), 5185–5196 (2011).
   PubMed Web of Science ®Google Scholar
• Kawish SM, Ahmed S, Gull A et al. Development of nabumetone loaded lipid nano-scaffold for the effective oral delivery; optimization, characterization, drug release and pharmacodynamic study. J. Mol. Liq. 231, 514–522 (2017).
   Web of Science ®Google Scholar
• Soni NK, Sonali L, Singh A, Mangla B, Neupane YR, Kohli K. Nanostructured lipid carriers potentiated oral delivery of raloxifene for breast cancer treatment. Nanotechnology. 31(47), 475101 (2020).
   PubMed Web of Science ®Google Scholar
• Zolgharnein J, Shahmoradi A, Ghasemi JB. Comparative study of Box-Behnken, central composite, and Doehlert matrix for multivariate optimization of Pb (II) adsorption onto Robinia tree leaves. J. Chemom. 27(1–2), 12–20 (2013).
   Web of Science ®Google Scholar
• Neupane YR, Sabir MD, Ahmad N, Ali M, Kohli K. Lipid drug conjugate nanoparticle as a novel lipid nanocarrier for the oral delivery of decitabine: ex vivo gut permeation studies. Nanotechnology 24(41), 415102 (2013).
   PubMed Web of Science ®Google Scholar
• Singh A, Neupane YR, Shafi S, Mangla B, Kohli K. PEGylated liposomes as an emerging therapeutic platform for oral nanomedicine in cancer therapy: in vitro and in vivo assessment. J. Mol. Liq. 303, 112649 (2020).
   Web of Science ®Google Scholar
• Ahmad N, Amin S, Neupane YR, Kohli K. Anal fissure nanocarrier of lercanidipine for enhanced transdermal delivery: formulation optimization, ex vivo and in vivo assessment. Expert Opin. Drug Deliv. 11(4), 467–478 (2014).
   PubMed Web of Science ®Google Scholar
• Rui TQ, Zhang L, Qiao HZ et al. Preparation and physicochemical and pharmacokinetic characterization of ginkgo lactone nanosuspensions for antiplatelet aggregation. J. Pharm. Sci. 105(1), 242–249 (2016).
   PubMed Web of Science ®Google Scholar
• Neupane YR, Srivastava M, Ahmad N, Kumar N, Bhatnagar A, Kohli K. Lipid based nanocarrier system for the potential oral delivery of decitabine: formulation design, characterization, ex vivo, and in vivo assessment. Int. J. Pharm. 477(1–2), 601–612 (2014).
   PubMed Web of Science ®Google Scholar
• Singh A, Neupane YR, Panda BP, Kohli K. Lipid Based nanoformulation of lycopene improves oral delivery: formulation optimization, ex vivo assessment and its efficacy against breast cancer. J. Microencapsul. 34(4), 416–429 (2017).
   PubMed Web of Science ®Google Scholar
• Masiiwa WL, Gadaga LL. Intestinal permeability of artesunate-loaded solid lipid nanoparticles using the everted gut method. J. Drug Deliv. 2018, 1–9 (2018).
   Google Scholar
• Altmeyer C, Karam TK, Khalil NM, Mainardes RM. Tamoxifen-loaded poly(L-lactide) nanoparticles: development, characterization and in vitro evaluation of cytotoxicity. Mater. Sci. Eng. C 60, 135–142 (2016).
   PubMed Web of Science ®Google Scholar
• Khalil El-Bary AA, Kassem MA, Ghorab MM, Basha M. Influence of formulation parameters on the physicochemical properties of meloxicam-loaded solid lipid nanoparticles. Egypt. Pharm. J. 12(1), 63 (2013).
   Google Scholar
• Jia L-J, Zhang D-R, Li Z-Y et al. Preparation and characterization of silybin-loaded nanostructured lipid carriers. Drug Deliv. 17(1), 11–18 (2010).
   PubMed Web of Science ®Google Scholar
• Sütő B, Berkó S, Kozma G et al. Development of ibuprofen-loaded nanostructured lipid carrier-based gels: characterization and investigation of in vitro and in vivo penetration through the skin. Int. J. Nanomedicine 11, 1201–1212 (2016).
   PubMed Web of Science ®Google Scholar
• Teng Z, Yu M, Ding Y et al. Preparation and characterization of nimodipine-loaded nanostructured lipid systems for enhanced solubility and bioavailability. Int. J. Nanomedicine 14, 119–133 (2019).
   PubMed Web of Science ®Google Scholar
• ScienceDirect. Glycerol palmitostearate - an overview. https://www.sciencedirect.com/topics/nursing-and-health-professions/glycerol-palmitostearate
   Google Scholar
• Lawrence MJ, Rees GD. Microemulsion-based media as novel drug delivery systems. Adv. Drug Deliv. Rev. 45(1), 89–121 (2000).
   PubMed Web of Science ®Google Scholar
• Constantinides PP. Lipid Microemulsions for improving drug dissolution and oral absorption: physical and biopharmaceutical aspects. Pharm. Res. 12(11), 1561–1572 (1995).
   PubMed Web of Science ®Google Scholar
• Osborne DW, Musakhanian J. Skin penetration and permeation properties of Transcutol®—neat or diluted mixtures. AAPS PharmSciTech. 19(8), 3512–3533 (2018).
   PubMed Web of Science ®Google Scholar
• Tan SW, Billa N, Roberts CR, Burley JC. Surfactant effects on the physical characteristics of Amphotericin B-containing nanostructured lipid carriers. Colloids Surf. A Physicochem. Eng. Asp. 372(1–3), 73–79 (2010).
   Web of Science ®Google Scholar
• Kim MH, Kim KT, Sohn SY et al. Formulation and evaluation of nanostructured lipid carriers (NLCs) of 20(s)-protopanaxadiol (PPD) by box-behnken design. Int. J. Nanomedicine 14, 8509–8520 (2019).
   PubMed Web of Science ®Google Scholar
• Wachsmann P, Lamprecht A. Ethylcellulose nanoparticles with bimodal size distribution as precursors for the production of very small nanoparticles. Drug Dev. Ind. Pharm. 41(7), 1165–1171 (2015).
   PubMed Web of Science ®Google Scholar
• Gomes MJ, Martins S, Ferreira D, Segundo MA, Reis S. Lipid nanoparticles for topical and transdermal application for alopecia treatment: development, physicochemical characterization, and in vitro release and penetration studies. Int. J. Nanomedicine 9, 1231–1242 (2014).
   PubMed Web of Science ®Google Scholar
• Khosa A, Reddi S, Saha RN. Nanostructured lipid carriers for site-specific drug delivery. Biomed. Pharmacother. 103, 598–613 (2018).
   PubMed Web of Science ®Google Scholar
• Huang ZR, Hua SC, Yang YL, Fang JY. Development and evaluation of lipid nanoparticles for camptothecin delivery: a comparison of solid lipid nanoparticles, nanostructured lipid carriers, and lipid emulsion. Acta Pharmacol. Sin. 29(9), 1094–1102 (2008).
   PubMed Web of Science ®Google Scholar
• Emami F, Vatanara A, Park EJ, Na DH. Drying technologies for the stability and bioavailability of biopharmaceuticals. Pharmaceutics 10(3), 131 (2018).
   PubMed Web of Science ®Google Scholar
• Franze S, Selmin F, Samaritani E, Minghetti P, Cilurzo F. Lyophilization of liposomal formulations: still necessary, still challenging. Pharmaceutics 10(3), 139 (2018).
   PubMed Web of Science ®Google Scholar
• Kumar KN, Mallik S, Sarkar K. Role of freeze-drying in the presence of mannitol on the echogenicity of echogenic liposomes. J. Acoust. Soc. Am. 142(6), 3670–3676 (2017).
   PubMed Web of Science ®Google Scholar
• Jiang H, Geng D, Liu H, Li Z, Cao J. Co-delivery of etoposide and curcumin by lipid nanoparticulate drug delivery system for the treatment of gastric tumors. Drug Deliv. 23(9), 3665–3673 (2016).
   PubMed Web of Science ®Google Scholar
• Li X, Jia X, Niu H. Nanostructured lipid carriers co-delivering lapachone and doxorubicin for overcoming multidrug resistance in breast cancer therapy. Int. J. Nanomedicine 13, 4107–4119 (2018).
   PubMed Web of Science ®Google Scholar
• Verma S, Singh SK, Verma PRP. Fabrication of lipidic nanocarriers of loratadine for facilitated intestinal permeation using multivariate design approach. Drug Dev. Ind. Pharm. 42(2), 288–306 (2016).
   PubMed Web of Science ®Google Scholar
• Ahmad N, Afzali R, Neupane YR, Amin S, Kohli K. Optimization of gel based system of lercanidipine by statistical design for transdermal delivery: histopathological examination. Biopharmaceutics Sciences. 2(1), 15–25 (2014).
   Google Scholar
• Ros E. Intestinal absorption of triglyceride and cholesterol. Dietary and pharmacological inhibition to reduce cardiovascular risk. Atherosclerosis 151(2), 357–379 (2000).
   PubMed Web of Science ®Google Scholar
• Chen CC, Tsai TH, Huang ZR, Fang JY. Effects of lipophilic emulsifiers on the oral administration of lovastatin from nanostructured lipid carriers: physicochemical characterization and pharmacokinetics. Eur. J. Pharm. Biopharm. 74(3), 474–482 (2010).
   PubMed Web of Science ®Google Scholar
• Tiwari R, Pathak K. Nanostructured lipid carrier versus solid lipid nanoparticles of simvastatin: comparative analysis of characteristics, pharmacokinetics and tissue uptake. Int. J. Pharm. 415(1–2), 232–243 (2011).
   PubMedGoogle Scholar