Surface-anchored microbial enzyme-responsive solid lipid nanoparticles enabling colonic budesonide release for ulcerative colitis treatment
Tóm tắt
Colon-targeted oral drug delivery systems (CDDSs) are desirable for the treatment of ulcerative colitis (UC), which is a disease with high relapse and remission rates associated with immune system inflammation and dysregulation localized within the lining of the large bowel. However, the success of current available approaches used for colon-targeted therapy is limited. Budesonide (BUD) is a corticosteroid drug, and its rectal and oral formulations are used to treat UC, but the inconvenience of rectal administration and the systemic toxicity of oral administration restrict its long-term use. In this study, we designed and prepared colon-targeted solid lipid nanoparticles (SLNs) encapsulating BUD to treat UC by oral administration. A negatively charged surfactant (NaCS-C12) was synthesized to anchor cellulase-responsive layers consisting of polyelectrolyte complexes (PECs) formed by negatively charged NaCS and cationic chitosan onto the SLNs. The release rate and colon-specific release behavior of BUD could be easily modified by regulating the number of coated layers. We found that the two-layer BUD-loaded SLNs (SLN-BUD-2L) with a nanoscale particle size and negative zeta potential showed the designed colon-specific drug release profile in response to localized high cellulase activity. In addition, SLN-BUD-2L exhibited excellent anti-inflammatory activity in a dextran sulfate sodium (DSS)-induced colitis mouse model, suggesting its potential anti-UC applications.
Tài liệu tham khảo
Seyedian SS, Nokhostin F, Malamir MD. A review of the diagnosis, prevention, and treatment methods of inflammatory bowel disease. J Med Life. 2019;12:10.
Greenwood-Van B, Meerveld G, Pharmacology, editors.Springer International Publishing, Cham, Vol. 239, 2017.
Cai Z, Wang S, Li J. Treatment of inflammatory bowel disease: a Comprehensive Review. Front Med. 2021;8:765474.
Sairenji T, Collins KL, Evans DV. An update on inflammatory bowel disease. Prim Care. 2017;44:673–92.
Raine T, Bonovas S, Burisch J, Kucharzik T, Adamina M, Annese V, et al. ECCO Guidelines on therapeutics in Ulcerative Colitis: Medical Treatment. J Crohn’s and Colitis. 2022;16:2–17.
Cunliffe RN, Scott BB. Review article：monitoring for drug side-effects in inflammatory bowel disease. Aliment Pharmacol Ther. 2002;16:647–62.
Ashton JJ, Green Z, Kolimarala V, Beattie RM. Inflammatory bowel disease: long-term therapeutic challenges. Expert Rev Gastroenterol Hepatol. 2019;13:1049–63.
Antonino RSCMQ, Nascimento TL, de Oliveira Junior ER, Souza LG, Batista AC, Lima EM. Thermoreversible mucoadhesive polymer-drug dispersion for sustained local delivery of budesonide to treat inflammatory disorders of the GI tract. J Controlled Release. 2019;303:12–23.
Date AA, Halpert G, Babu T, Ortiz J, Kanvinde P, Dimitrion P, et al. Mucus-penetrating budesonide nanosuspension enema for local treatment of inflammatory bowel disease. Biomaterials. 2018;185:97–105.
Hanauer SB, Robinson M, Pruitt R, Lazenby AJ, Persson T, Nilsson LG, et al. Budesonide enema for the treatment of active, distal ulcerative colitis and proctitis: a dose-ranging study. Gastroenterology. 1998;115:525–32.
Amidon S, Brown JE, Dave VS. Colon-targeted oral drug Delivery Systems: Design Trends and Approaches. AAPS PharmSciTech. 2015;16:731–41.
Eckburg PB, Bik EM, Bernstein CN, Purdom E, Dethlefsen L, Sargent M, et al. Diversity of the human intestinal Microbial Flora. Science. 2005;308:1635–8.
Froidurot A, Julliand V. Cellulolytic bacteria in the large intestine of mammals. Gut Microbes. 2022;14:2031694.
Macy JM, Farrand JR, Montgomery L. Cellulolytic and non-cellulolytic bacteria in rat gastrointestinal tracts. Appl Environ Microbiol. 1982;44:1428–34.
Wu Q-X, Guan Y-X, Yao S-J. Sodium cellulose sulfate: A promising biomaterial used for microcarriers’ designing. Front. Chem. Sci. Eng. 2019;13:46–58.
Zhang Q, Lin D, Yao S. Review on biomedical and bioengineering applications of cellulose sulfate. Carbohydr Polym. 2015;132:311–22.
Mendoza-Muñoz N, Urbán-Morlán Z, Leyva-Gómez G, Zambrano-Zaragoza M, de la ¨Piñón-Segundo L, Quintanar-Guerrero E. Solid lipid nanoparticles: an Approach to improve oral drug delivery. J Pharm Pharm Sci. 2021;24:509–32.
Salah E, Abouelfetouh MM, Pan YH, Chen DM, Xie SY. Solid lipid nanoparticles for enhanced oral absorption: A review. Colloids Surf. B. 2020;196:111305.
Schwarz C, Mehnert W, Lucks JS, Müller RH. Solid lipid nanoparticles (SLN) for controlled drug delivery. I. Production, characterization and sterilization. J Controlled Release. 1994;30:83–96.
Collnot E-M, Ali H, Lehr C-M. Nano- and microparticulate drug carriers for targeting of the inflamed intestinal mucosa. J Controlled Release. 2012;161:235–46.
Hua S, Marks E, Schneider JJ, Keely S. Advances in oral nano-delivery systems for colon targeted drug delivery in inflammatory bowel disease: selective targeting to diseased versus healthy tissue. Nanomedicine. 2015;11:1117–32.
Amasya G, Bakar-Ates F, Wintgens V, Amiel C. Layer by layer assembly of core-corona structured solid lipid nanoparticles with β-cyclodextrin polymers. Int J Pharm. 2021;592:119994.
Naeem M, Oshi MA, Kim J, Lee J, Cao J, Nurhasni H, et al. pH-triggered surface charge-reversal nanoparticles alleviate experimental murine colitis via selective accumulation in inflamed colon regions. Nanomedicine. 2018;14:823–34.
Li JF, Yang JS. Synthesis of folate mediated carboxymethyl cellulose fatty acid ester and application in drug controlled release. Carbohydr Polym. 2019;220:126–31.
Sakellari GI, Zafeiri I, Batchelor H, Spyropoulos F. Formulation design, production and characterisation of solid lipid nanoparticles (SLN) and nanostructured lipid carriers (NLC) for the encapsulation of a model hydrophobic active. Food Hydrocoll Health. 2021;1:100024.
Bantchev G, Lu ZH, Lvov Y. Layer-by-layer Nanoshell Assembly on Colloids through simplified Washless process. J Nanosci Nanotech. 2009;9:396–403.
Santos AC, Sequeira JAD, Pereira I, Cabral C, Collado Gonzallez M, Fontes-Ribeiro C, et al. Sonication-assisted layer-by-layer self-assembly nanoparticles for resveratrol delivery. Mater Sci Eng C. 2019;105:110022.
Zhu L-Y, Lin D-Q, Yao S-J. Biodegradation of polyelectrolyte complex films composed of chitosan and sodium cellulose sulfate as the controllable release carrier. Carbohydr Polym. 2010;82:323–8.
Woraphatphadung T, Sajomsang W, Rojanarata T, Ngawhirunpat T, Tonglairoum P, Opanasopit P. Development of Chitosan-Based pH-Sensitive polymeric Micelles containing curcumin for Colon-targeted drug delivery. AAPS PharmSciTech. 2018;19:991–1000.
Deshavath NN, Mukherjee G, Goud VV, Veeranki VD, Sastri CV. Pitfalls in the 3, 5-dinitrosalicylic acid (DNS) assay for the reducing sugars: interference of furfural and 5-hydroxymethylfurfural. Macromol. 2020;156:180–5.
Wirtz S, Popp V, Kindermann M, Gerlach K, Weigmann B, Fichtner-Feigl S, et al. Chemically induced mouse models of acute and chronic intestinal inflammation. Nat Protoc. 2017;12:1295–309.
Chung CH, Jung W, Keum H, Kim TW, Jon S. Nanoparticles derived from the natural antioxidant Rosmarinic Acid ameliorate Acute Inflammatory Bowel Disease. ACS Nano. 2020;14:6887–96.
Abdalla MI, Herfarth H. Budesonide for the treatment of ulcerative colitis. Expert Opin on Pharmacotherapy. 2016;17:1549–59.
Nasirizadeh S, Malaekeh-Nikouei B. Solid lipid nanoparticles and nanostructured lipid carriers in oral cancer drug delivery. J Drug Delivery Sci Technol. 2020;55:101458.
Basha SK, Dhandayuthabani R, Muzammil MS, Kumari VS. Solid lipid nanoparticles for oral drug delivery. Materials Today: Proceedings. 2021;36:313–24.
Yaghmur A, Mu H. Recent advances in drug delivery applications of cubosomes, hexosomes, and solid lipid nanoparticles. Acta Pharm Sin B. 2021;11:871–85.
Ali H, Weigmann B, Neurath MF, Collnot EM, Windbergs M, Lehr C-M. Budesonide loaded nanoparticles with pH-sensitive coating for improved mucosal targeting in mouse models of inflammatory bowel diseases. J Controlled Release. 2014;183:167–77.
Sangalli ME, Maroni A, Zema L, Busetti C, Giordano F, Gazzaniga A. In vitro and in vivo evaluation of an oral system for time and/or site-specific drug delivery. J Controlled Release. 2001;73:103–10.
Fallingborg J, Christensen LA, Jacobsen BA, Rasmussen SN. Very low intraluminal colonic pH in patients with active ulcerative colitis. Digest Dis Sci. 1993;38:1989–93.
Cui MX, Zhang M, Liu K. Colon-targeted drug delivery of polysaccharide-based nanocarriers for synergistic treatment of inflammatory bowel disease: a review. Carbohydr Polym. 2021;272:118530.
Tirosh B, Khatib N, Barenholz Y, Nissan A, Rubinstein A. Transferrin as a Luminal Target for negatively charged Liposomes in the Inflamed Colonic Mucosa. Mol Pharm. 2009;6:1083–91.
Naeem M, Choi M, Cao J, Lee Y, Lkram M, Yoon S et al. Colon-targeted delivery of budesonide using dual pH- and time-dependent polymeric nanoparticles for colitis therapy. DDDT. 2015;3789.
Friend DR. New oral delivery systems for treatment of inflammatory bowel disease. Adv Drug Deliv Rev. 2005;57:247–65.
Andreica B-I, Cheng XJ, Marin L. Quaternary ammonium salts of chitosan. A critical overview on the synthesis and properties generated by quaternization. Eur. Polym. J. 2020;139:110016.
Borges J, Mano JF. Molecular interactions driving the layer-by-Layer Assembly of Multilayers. Chem Rev. 2014;114:8883–942.
Finke JH, Schmolke H, Klages C-P, Müller-Goymann CC. Controlling solid lipid nanoparticle adhesion by polyelectrolyte multilayer surface modifications. Int J Pharm. 2013;449:59–71.
Lin C-H, Chen C-H, Lin Z-C, Fang J-Y. Recent advances in oral delivery of drugs and bioactive natural products using solid lipid nanoparticles as the carriers. J Food Drug Anal. 2017;25:219–34.
Kulkarni N, Jain P, Shindikar A, Suryawanshi P, Thorat N. Advances in the colon-targeted chitosan based multiunit drug delivery systems for the treatment of inflammatory bowel disease. Carbohydr Polym. 2022;288:119351.
Peterson CGB, Eklund E, Taha Y, Raab Y, Carlson M. A New Method for the quantification of Neutrophil and Eosinophil Cationic Proteins in feces: establishment of normal levels and clinical application in patients with inflammatory bowel disease. Am J Gastroenterol. 2002;97:8.
Schmitz H, Barmeyer C, Fromm M, Runkel N, Foss H-D, Bentzel CJ, et al. Altered tight junction structure contributes to the impaired epithelial barrier function in ulcerative colitis. Gastroenterology. 1999;116:301–9.
Lamprecht A. Selective nanoparticle adhesion can enhance colitis therapy. Nat Rev Gastroenterol Hepatol. 2010;7:311–2.