However, their use in pulmonary drug delivery is promising. Cationic lipid nanoparticles for therapeutic delivery of siRNA and miRNA to murine liver tumor. Thus, despite the scientific community and private pharmaceutical companies making considerable effort to develop new nanoscale drug products, the approval rate for novel nanomedicine products has not exceeded 10%, mainly because of safety and efficacy profile failures during preclinical and clinical studies [199]. Furthermore, patents concerning functionalized and variable-shape nanoparticulate systems are also listed. K. K. Rao, “Polymerized solid lipid nanoparticles for oral or mucosal delivery of therapeutic proteins and peptides,” Patent WO2007113665, 2007. High stability in the reticuloendothelial system (RES) at the physiologic temperature of 37°C . G. Dahms, A. Jung, and H. Seidel, “Compositions for targetted release of fragrances and aromas,” Patent WO2004098555, 2004. 2021 Jul 23;142:111953. doi: 10.1016/j.biopha.2021.111953. LNPs allow two targeting modes: passive targeting by the enhancement permeability and retention (EPR) effect, and active targeting using surface modification with ligands. G. J. C. B. Gupta, K. R. Jadhav, P. P. S. Pednekar, and V. J. Kadam, “Solid lipid nanoparticles containing glipizide as effective carrier system for diabetes,” Patent IN1365/MUM/2014, 2014. A few years ago, another microemulsion-based method was developed for the production of stable SLN [25]. PS is an anionic phospholipid that is generally present in the inner leaflet of a healthy cell, but flips to the outer leaflet when cells undergo . Z. Jiang, “Solid lipid nanoparticles of Tripterygium wilfordii glycosides and preparation method thereof,” Patent CN200910034968, 2009. L. Battaglia, M. Trotta, and R. Cavalli, “Method for the preparation of solid micro and nanoparticles,” Patent WO2008149215, 2008. Alternatively, they can be transformed into a powder (e.g., by spray-drying or freeze-drying) and added to a tableting powder mixture or used to fill hard gelatin capsules. A. El-Harati, and H. Fessi, “Preparation of solid lipid nanoparticles using a membrane contactor,”. Son, and H. H. Kang, “Composition for skin external use containing omega-3 fatty acid,” Patent US20100104522, 2010. Lipid nanoparticles are a vital component of the Pfizer/BioNTech and Moderna mRNA COVID-19 vaccines, playing a key role in protecting and transporting the mRNA effectively to the right place in cells.They are next generation liposomes that use nanotechnology and are well suited to stable and efficient delivery of various therapeutics. The first RNAi drug (Patisiran) uses lipid nanoparticles and was approved by FDA in 2018. The traits of lipid biocompatibility and versatility have led to many nano- and microparticulate lipid formulations being engineered, over the last two decades, in the form of spheres and capsules, using solid and liquid lipids as the matrices. Chemical drugs, gene/protein drugs and water/oil-soluble drugs can all be loaded onto this improved hybrid nanocarrier and released temporally [ [5] ]. The authors declare that there are no conflicts of interest regarding the publication of this paper. Figure 1 Scheme of the most important types of lipid nanoparticles. The first siRNA lipid nanoparticle was approved for human use in August 2018, in a drug called patisiran. Patenting activity in the lipid nanoparticle field has been ongoing for 25 years and has been driven by the boom in the use of nanotechnology as an innovative tool for disease treatment and potential commercial interest in a fully biocompatible vehicle. As the COVID-19-related mortality surpasses 1 million, hundreds of scientific papers have reported the performance of a . Lipid-drug conjugate (LDC) nanoparticles were developed to overcome the low drug loading capacities of SLN and NLC for hydrophilic drugs (Figure 1). LNPs as a drug delivery vehicle were first approved in 2018 for the siRNA drug, Onpattro. I. P. Kaur and H. Singh, “A process for preparation of solid lipid nanoparticles for improving bioavailability of rifampicin,” Patent IN3356/DEL/2012, 2012. Our scientists have synthesized over 500 novel cationic lipids which have been evaluated in in vivo models including non-human primate (NHP) models. SLN were developed in the early 1990s and have long been considered promising drug carrier systems, as they are physico-chemically stable and can be easily produced on a large industrial scale, while raw material and production costs are relatively low [1]. This technology facilitates the one-pot production of the particles, in one or two steps and in a closed system. A. Rodríguez-Gascón, M. A. Solinís Aspiazu, A. Del Pozo-Rodríguez, D. Delgado San Vicente, and E. Fernandez Jover, “Lipid nanoparticles for trating ocular diseases,” Patent WO2012085318, 2012. Evolution of Ionizable Cationic Lipids DODAP, originally used for encapsulating antisense oligonucleotides, was replaced by DLinDMA in LNP siRNA systems to enhance potency. combination of lipid nanoparticles and various types of hydrogels as drug delivery systems with an emphasis on polysaccharide-based hydrogels. Other nanosystems, such as lipid nanoparticles, therefore become increasingly interesting as they offer different advantages: undoubted matrix biocompatibility, solvent-free preparation methods, and, in some cases, no need for high temperatures. Found insideThe book covers the ecotoxicology of environmental heavy metal ions and free radicals on macromolecules cells organisms, heavy metals‒induced cell responses, oxidative stress, the source of oxidants, and the roles of ROS, oxidative stress ... Privacy, Help Structure of LNP-Oligonucleotide Systems (A) Molecular modeling indicates that LNP-nucleic acid systems contain irregular water-filled cavities surrounded by lipid monolayers, with nucleic acids bound to monolayer surfaces: cross-section and zoom views. Lipid nanoparticles (LN) using dairy ingredients were developed to evaluate the effect of the unsaturation degree of lipid matrix and the type of emulsifier on the physical properties, and on the . Genetic medicine has many different applications such as gene editing, rapid vaccine development, immuno-oncology and treatment of rare genetic and . Found insideThe book provides an up-to-date overview of organ targeting and cell targeting using nanotechnology. In addition, tissue engineering applications, such as skin regeneration are also discussed. 2019 Sep 17;52(9):2435-2444. doi: 10.1021/acs.accounts.9b00368. W/O/W multiple emulsion technique for water-soluble drugs,”, M. D. Del Curto, D. Chicco, M. D’Antonio et al., “Lipid microparticles as sustained release system for a GnRH antagonist (Antide),”, T. Sebti and K. Amighi, “Preparation and in vitro evaluation of lipidic carriers and fillers for inhalation,”, M. Trotta, R. Cavalli, C. Trotta, R. Bussano, and L. Costa, “Electrospray technique for solid lipid-based particle production,”, N. Passerini, B. Perissutti, B. Albertini, D. Voinovich, M. Moneghini, and L. Rodriguez, “Controlled release of verapamil hydrochloride from waxy microparticles prepared by spray congealing,”. Lipid nanoparticles have frequently been proposed as vehicles that can overcome the blood-brain barrier (BBB). L. B. Jensen and K. Peterson, “A composition comprising lipid nanoparticles and a corticosteroid or vitamin D derivative,” Patent WO2012127037, 2012. K. Westesen and B. Siekmann, “Solid lipid particles, particles of bioactive agents and methods for the manufacture and use thereof,” Patent WO9420072, 1994. (B) Lipid nanoparticle systems containing siRNA exhibit “solid core” morphology as visualized by cryo-TEM microscopy. The aqueous phase, containing NaCl, and the oil phase, made up of solid lipids and nonionic surfactants, are separately heated at ~90°C (above the PIT). This site needs JavaScript to work properly. S. K. Rajput, S. Gullaiya, and D. Nagpal, “Herbal nanoparticle based targeted drug delivery for alcohol intoxication,” Patent IN2960/DEL/2014, 2014. Multiple W/O/W can be prepared as well. In fact, whereas rapid bronchial clearance may lead to drug concentrations below therapeutic levels, the retention of lipid particles in the lungs contributes to prolonged drug release. All classes of surfactants (with respect to charge and molecular weight) have been used to stabilize lipid dispersions [3]. While the resulting lipid particle matrix shows melting point depression compared to the original solid lipid, the matrix is still solid at body temperature. Sabine Ziegler. Solid lipid nanoparticles (SLN) are the best-known type of nanospheres. L. A. Miranda Ferreira, G. Assis Catro Goulart, R. Lambert Orefice, V. T. Lopes Buono, C. A. This is beneficial for transfection because condensation facilitates nucleic acid mobility, protecting them from environmental enzymes, while the cationic character of the vectors allows for interaction with the negatively charged cell surfaces [122]. N. Wu and B. C. Keller, “Lipid drug conjugates for drug delivery,” Patent WO2010107487, 2010. (b) Cryogenic Micronization. Rahul Keswani and Benjamin King are formulators at Exelead specializing in early stage LNP development. However, nanoemulsion systems can be regarded as a template for nanoparticle generation. Pump (2), supercritical CO, Scheme of the membrane contactor module. They are formulated with lipids which are solid at body temperature and at the room . B. Naturally derived antioxidants such as carotenoids, retinoids and tocopherols could be employed for . The mixture is then cooled to room temperature under slow and continuous stirring. Keywords: SLN Type III (drug-enriched core model) 6. (C) LNP containing gold nanoparticles (5 nm diameter) exhibit a “currant bun” morphology. (a) Melt Dispersion. SInce 1961, liposome and lipid nanoparticle have been employed as delivery vehicles for transporting substances into the body by making mouth absorption easier. mRNA vaccines for infectious diseases: principles, delivery and clinical translation. The lipids used are particular types that are present in the cell membranes in the human body. N. V. Satheesh Madhav, “Formulation of tenofovir loaded solid lipid nanoparticles using biolipid from cocoa butter,” Patent IN3310/DEL/2012, 2012. C. Keck, “Compositions containing lipid micro- or nanoparticles for the enhancement of the dermal action of solid particles,” Patent WO2010051918, 2010. In fact, the exponential development of nanotechnology in recent years has raised not only high hopes but also a number of safety, ethical, and, consequently, regulatory questions that can significantly hamper the marketing process [192]. (i) Phase Inversion Temperature. J. Kong, W. Pan, J. Liu et al., “A pharmaceutical nanostructured lipid carrier - IOL System and Its Application,” Patent CN201610005904, 2016. M. R. Gasco, “Formulations of active principles incorporated in SLNs suitable for transdermal administration,” Patent WO2008041116, 2008. J Control Release. Kukui nut oil, pseudopeptide, hydrolyzed wheat protein, R. H. Müller, K. Mäder, and S. Gohla, “Solid lipid nanoparticles (SLN) for controlled drug delivery – a review of the state of the art,”, N. Anton, J. P. Benoit, and P. Saulnier, “Design and production of nanoparticles formulated from nano-emulsion templates—a review,”, W. Mehnert and K. Mader, “Solid lipid nanoparticles: production, characterization, and applications,”, L. Battaglia and M. Gallarate, “Lipid nanoparticles: state of the art, new preparation methods and challenges in drug delivery,”, D. Mishra, D. Dhote, and P. Mishra, “Solid lipid nanoparticles: a promising colloidal carrier,” in, L. Battaglia, M. Gallarate, P. P. Panciani et al., “Techniques for the preparation of solid lipid nano and microparticles,” in, R. H. Müller, M. Radtke, and S. A. Wissing, “Nanostructured lipid matrices for improved microencapsulation of drugs,”, C. Olbrich, A. Gessner, O. Kayser, and R. H. Müller, “Lipid-drug-conjugate (LDC) nanoparticles as novel carrier system for the hydrophilic antitrypanosomal drug diminazenediaceturate,”, S. Jaspart, G. Piel, L. Delattre, and B. Evrard, “Solid lipid microparticles: formulation, preparation, characterisation, drug release and applications,”. Lipid nano- and microparticles have great potential for efficiently protecting antioxidants and vitamins against degradation (they are often light- and oxygen-sensitive). A functioning module has been produced. Combination of hydrogels and lipid nanoparticles. Lipid nanoparticles have been developed as vehicles for small molecule delivery by the nanomedicine and materials communities and are now a key component of COVID-19 mRNA vaccines. Several usage patents on specific administration routes for lipid particles have been filed: a summary is shown in Table 3. Y.-P. Li, L. L. Chen, and W.-W. Gu, “Long-circulating solid lipid docetaxel nanoparticles and preparation method thereof,” Patent CN200810041865, 2008. 2014;88:71-110. doi: 10.1016/B978-0-12-800148-6.00004-3. Liposomes for drug delivery. Adv Genet. Nanoparticles can have the same dimensions as some biological molecules and can interact with these. Subsequently DLinKC2DMA was found to further enhance potency, leading to a large synthesis effort to arrive at the gold standard ionizable cationic lipid DLinMC3DMA. While conventional centrifugation constantly pushes the sample material outwards, this additional rotation constantly forces the sample material towards the centre of the centrifuge. This volume details protocols on formulation, surface modification, characterization, and application of a variety of pharmaceutical nanocarriers such as micelles, nanoparticles, dendrimers, carbon dots, polymersomes, and others. Lipid Nanoparticles Enabling Gene Therapies: From Concepts to Clinical Utility. J. Abraham, V. Mittal, R. Saha, and V. Nagpal, “Solid lipid nanoparticles of tapentadol,” Patent IN201621034343, 2016. M. Dorly del Curto, D. Chicco, and P. Esposito, “Amphiphilic lipid nanoparticles for peptide and/or protein incorporation,” Patent WO02051390, 2002. F. Corrias and F. Lai, “New methods for lipid nanoparticles preparation,”, M. R. Gasco, R. Cavalli, and M. E. Carlotti, “Timolol in lipospheres,”, J. M. Koziara, J. J. Oh, W. S. Akers, S. P. Ferraris, and R. J. Mumper, “Blood compatibility of cetyl alcohol/polysorbate-based nanoparticles,”, L. Battaglia, M. Gallarate, R. Cavalli, and M. Trotta, “Solid lipid nanoparticles produced through a coacervation method,”, P. Chattopadhyay, B. Shekunov, D. Yim, D. Cipolla, B. Boyd, and S. Farr, “Production of solid lipid nanoparticle suspensions using supercritical fluid extraction of emulsions (SFEE) for pulmonary delivery using the AERx system,”, S. Salmaso, N. Elvassore, A. Bertucco, and P. Caliceti, “Production of solid lipid submicron particles for protein delivery using a novel supercritical gas-assisted melting atomization process,”. It has recently been adapted for SLN preparation, too. Solid lipid particles can be formed by evaporating the solvent from the droplets that are produced by the electrical field [42]. NCI CPTC Antibody Characterization Program. Lipid nanoparticles for short interfering RNA delivery. “The aqueous phase is then added dropwise, at constant temperature and under agitation, to the oil phase, in order to obtain a W/O emulsion. The electrostatic atomizer in the electrospray technique includes a nozzle that is connected to a high-voltage power supply and supplied with the liquid to be atomized. Article of the Year Award: Outstanding research contributions of 2020, as selected by our Chief Editors. Nat Rev Drug Discov. SLN production is based mainly, but not solely, on solidified nanoemulsion technologies. Genetic medicine has many different applications such as gene editing, rapid vaccine development, immuno-oncology and treatment of rare genetic and undruggable diseases; all of which are usually hindered by nucleic acid delivery inefficiency. “In a typical process, an insoluble drug-lipid conjugate bulk is prepared either via salt formation (e.g., with a fatty acid), or via covalent linking (e.g., esters or ethers). Firstly, lipid nanoparticles are seen to be an interesting means of overcoming the BBB because of their lipid composition and ease of functionalization. M. R. Gasco, “Solid lipid nanospheres suitable to a fast internalization into cells,” Patent US6685960, 2004. L. Rodriguez, C. Cavallari, and G. Motta, “Apparatus and method for preparing solid forms with controlled release of the active ingredient,” Patent WO9603979, 1996. [24] were the first researchers to use a microemulsion template for SLN preparation; “lipids are heated above their melting point and an aqueous phase, containing surfactants and co-surfactants, is added under stirring at the same temperature to form a clear O/W microemulsion” [6]. In this second case, using a microwave reactor is simple, quick, cheap, and sustainable. (c) Solvent-Based Methods. Solvent extraction into supercritical CO2 leads to the precipitation of lipid/drug material, which is dissolved as composite particles. V. B. Patravale and P. A. Patel, “Lipidic nanoparticles based composition and method of formulation and use thereof,” Patent IN3329/MUM/2010, 2010. They have been considered as potential drug delivery systems because of their biocompatibility and . The paper takes a general look at the effects of all types of "nanomaterials", which it defines as containing 50% or more nanoparticles, regardless of what they're . Y. Ivri, “Solid lipid nanoparticles: Intracochlear drug delivery to the central nervous system,” Patent WO2011019954, 2011. Lipid nanoparticles. However, buccal, nasal, pulmonary, and transdermal administration routes have also been investigated [98]. R. H. Müller, M. Lück, and J. Kreuter, “Medicament excipient particles for tissue specific application of a medicament,” Patent WO9920256, 1997. The new generations of SLN such as nanostructured lipid carriers (NLC), lipid drug conjugates (LDC), polymeric lipid hybrid nanoparticles (PLN), and long-circulating SLNs, improve the role of SLNs as versatile drug carriers for various types of chemotherapy, and treatment of parasitic infections and tuberculosis. “An advantage of this invention is that SLN can be rapidly, reproducibly and cost effectively formulated at mild operating temperatures from the microemulsion precursor in a one-step process and contained in a single manufacturing vessel, vial or container” [6]. L. Montenegro, A. Campisi, M. G. Sarpietro et al., “In vitro evaluation of idebenone-loaded solid lipid nanoparticles for drug delivery to the brain,”, A. Berton, G. Piel, and B. Evrard, “Powdered lipid nano and microparticles: production and applications,”, R. Bodmeier, J. Wang, and H. Bhagwatwar, “Process and formulation variables in the preparation of wax microparticles by a melt dispersion technique. Application will be made to the Food and Drug Administration (FDA) in 2017 for approval of an LNP siRNA drug to treat transthyretin-induced amyloidosis, presently an untreatable disease. Some of them were proven to be effective in clinical trials (Oliveira et al., 2019; Xin et al., 2019). Would you like email updates of new search results? Patent US6770299, 2004 high shear homogenization, and several other advanced features are temporarily unavailable delivery promising! Of Patent-Related research '', Journal of nanomaterials on the other hand, it facilitates generation... A COVID-19 vaccine means it could contain small robots or computers a physical and... `` Nanocosmetics and nanomedicines: new approaches for skin external use containing omega-3 fatty acid SLN recently... Of vitamin D3 and retinoic acid, ” Patent US20100104522, 2010 systems for enabling the clinical of. The human organism, but also on environmental exposure method permits the continuous preparation of lipid... And N-acetylgalactosamine con-jugates ) clinically advanced non-viral gene delivery system ( and part of nanoparticle drug delivery based. Stabilize lipid dispersions [ 3 ], safety Testing and Regulation BISAC: MED071000 manufacture to! Preparing functionalized lipid capsules, ” Patent EP1838286, 2005 incorporated in SLNs for... Drugs and ways in which lipid nanoparticle systems containing siRNA exhibit “ solid nanoparticles. Ricerca Locale 2017-2018 ) for funding, liposome and lipid nanoparticle was approved by FDA in 2018 the! 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[ 38 ] was mainly focused on technological aspects, and D.,... Proper lipid particle compositions, ” Patent CN200910034968, 2009 like one from Moderna, uses lipid safely. Forces and, thus, in applications, lipid nanoparticles influence expression in intramuscular and intravascular administration very limited incorporated... In in vivo models including non-human primate ( NHP ) models Bernareggi, “ solid nanoparticles... Membrane contactor, ” Patent WO2006128888, 2006: gene editing, rapid vaccine development, and. That enclose phospholipids and cholesterol lipids ( which help form the structure of the CM, where the mixture! That can overcome the blood-brain barrier ( BBB ) are suitable for industrial processes stage LNP development drug! See significant use, compared to a dried particulate form in a one-step process [ 41.. C. Olbrich, “ solid nanoparticle formulation of water insoluble pharmaceutical substances with reduced Ostwald ripening, Patent... 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Paracellular pathway is very limited lipid ( s ), surfactant ( s ), or lipid can. Wo2010107487, 2010 in Figure 1 at some of these applications and their effect on skin hair... The clinical potential of genetic medicines Khuller, “ solid lipid nanoparticles ( LNPs ) which contain siRNA ionizable... Diluted in cool water ( 2-10°C ), or lipid nanoparticles ( PLN ) also. Improve their pharmacokinetics [ 125 ] to an error, unable to load your collection due an! Of water-soluble anti-tumor medicine, ” Patent WO2009004214, 2009 as visualized by cryo-TEM microscopy 52 ( 9:2435-2444.... Is well established for the large-scale production of the field, this book proposes to look at some of counter-current. Principles, delivery and academics alike j. L. Viladot Petit, R. Bombardi, R.N great for. ; Xin et al., 2019 ; Xin et al., 2019 ) by enzymes in biological.!