Engineering mesoporous silica nanoparticles for drug delivery: where are we after two decades?

María Vallet-Regí *^ab, Ferdi Schüth ^c, Daniel Lozano ^ab, Montserrat Colilla ^ab and Miguel Manzano ^ab
aChemistry in Pharmaceutical Sciences, School of Pharmacy, Universidad Complutense de Madrid, Research Institute Hospital 12 de Octubre (i + 12), Pz/Ramón y Cajal s/n, Madrid 28040, Spain. E-mail: vallet@ucm.es
^bNetworking Research Centre on Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), Madrid 28029, Spain
^cDepartment of Heterogeneous Catalysis, Max-Planck-Institut für Kohlenforschung, Kaiser-Wilhelm-Platz 1, D-45470 Mülheim an der Ruhr, Germany

First published on 1st June 2022

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María Vallet-Regí

María Vallet-Regí, pioneer in the field of mesoporous silica materials with application in controlled drug release. She is the manager of the Intelligent Biomaterials Research Group (GIBI), CIBER-BBN, at Complutense University of Madrid, where currently she is developing different strategies to cure bone-related diseases such as cancer, osteoporosis or infections in implants. She was the first woman to receive the gold medal from the European Federation of Materials Science Societies (FEMS) and the George Winter Award from the European Biomaterials Society (ESB).

Ferdi Schüth

Ferdi Schüth studied Chemistry and Law in Münster, Germany, and completed his PhD in Chemistry in 1988. After one year as a postdoc at the University of Minnesota, he worked on a position equivalent to Assistant Professor at the University of Mainz. In 1995 he became a Full Professor at Frankfurt University, and in 1998 he became the director at the Max-Planck-Institut für Kohlenforschung in Mülheim/Ruhr. He was a vice president at the German Research Foundation (DFG) as well as at the Max Planck Society, and in 2022 he was appointed as a member of the Science Council of the German Government. His research fields include catalysis, zeolites, porous materials, and energy-related topics.

Daniel Lozano

Daniel Lozano was born in Madrid, Spain. He graduated in Biology at Universidad Autónoma de Madrid and obtained his PhD degree in 2010 in the field of osteogenic peptides for his work realized in Hospital Fundación Jiménez Díaz. In 2011 he moved to the Biomaterials and Bone Physiopathology Department of Hospital La Paz. In 2014 he moved to Chemistry in Pharmaceutical Sciences of the Faculty of Pharmacy at Universidad Complutense de Madrid. In 2019, he obtained a position as an assistant lecturer at the same Department. His research interests are focused on bioceramic materials for bone tissue engineering and other biomedical applications.

Montserrat Colilla

Montserrat Colilla studied Chemistry at Autonomous University of Madrid, Spain, and completed her PhD in Chemistry in 2004. She completed postdoctoral stays at the Spanish National Research Council (CSIC, Spain) and Pierre et Marie Curie University (CNRS, France). In 2005, she was incorporated into Complutense University of Madrid, Spain, where she currently holds a position as an Associate Professor at the Department of Pharmaceutical Sciences at School of Pharmacy since 2011. She is a member of the Intelligent Biomaterials Research Group (GIBI), where her research interests are focused on the field of nanomaterials with biomedical applications, including bacterial infection treatment, bone regeneration and antitumor therapy.

Miguel Manzano

Miguel Manzano was born in Madrid, Spain. He completed his studies in Organic Chemistry at Universidad Autónoma de Madrid in 2000 and received his PhD at the University of Surrey, United Kingdom (2004). Then, he moved back to Spain where he obtained a position as assistant lecturer at the Department of Pharmaceutical Sciences at the School of Pharmacy at Universidad Complutense de Madrid. In 2011 he went to the Massachusetts Institute of Technology, USA, to complete a postdoctoral research fellowship in the lab of Robert Langer at the Koch Institute, MIT. His research interests are focused on novel materials for biomedical applications.

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1. Introduction

1.1. Historical background of the synthesis of ordered mesoporous materials

Carriers for controlled drug delivery had traditionally been based on biopolymers or synthetic polymers,¹ but in the 1990s, silicas, especially in the form of nanoparticles, moved into the field of interest for scientists working on drug delivery;^2–5 early silica-based systems were porous glasses or disordered silica gels. However, at about the same time, ordered mesoporous silicas, based on mesostructuring using surfactants, were discovered independently by one of Kazuyuki Kuroda's groups⁶ and by scientists at Mobil Oil Corp.⁷ Since both fields were in their very infancy in the 1990s, it took about 10 years for these separate fields of research to come together. As far as we know, the first potential use of ordered mesoporous materials for drug delivery is mentioned, just as a “buzzword”, in the abstract of a little known paper from 1998 by one of the authors of this review, with no further explanation or discussion of this possible application in the main text of that publication.⁸ The first real description of such silicas as drug delivery matrices was given by Vallet-Regí et al.⁹ This seminal paper initiated the broad research field of biomedical applications of ordered mesoporous silicas, a field with very high current activity and more than a thousand publications appearing each year.

Ordered mesoporous silicas have a number of features, which make them highly suitable for drug delivery applications:¹⁰

An ordered porous network, which is very homogeneous in size and allows fine control of the drug load and release kinetics;

A high pore volume to host the required amount of pharmaceuticals;

A high surface area, which implies high potential for drug adsorption;

A silanol-containing surface that can be functionalized to allow better control over drug loading and release.

Fig. 1 gives an overview of the more important ordered mesoporous silicas, which are being used as drug release vectors.^11,12

Some of these features can also be realized with other materials, such as silica xerogels or aerogels or porous glasses, but all of these properties simultaneously exist only in ordered mesoporous materials. Moreover, to date, various facile methods for the synthesis of ordered mesoporous silica in the nanoparticulate form have been developed, which have several physiological advantages as carriers for bioactive agents. In the following, we will first discuss the early work on ordered mesoporous materials preceding the first publication on drug release and then cover the different pathways for the synthesis of such materials, with a focus on those most relevant for drug delivery. In the final part of the synthesis section, we will address approaches to create ordered mesoporous silica nanoparticles (MSNs), which is the form in which they are best applicable in the biomedicine field.

Surfactants, the key ingredients in the synthesis of ordered mesoporous materials, had been used in silica chemistry before for various purposes, and it is thus not completely surprising that materials resembling ordered mesoporous silicas disclosed in the early 1990s had been synthesized before. Probably the first synthesis of an ordered mesoporous material was described as early as 1971 in a patent,¹³ since an exact repetition of the patent procedure led to the formation of an ordered material having similar features to MCM-41.¹⁴ However, this initial patented procedure cannot be considered as the discovery of the material, since except for a low bulk density no specific properties are reported in the patent, and therefore the remarkable features of these surfactant-templated materials, such as their regular and ordered pore systems, were not observed. Moreover – and perhaps more importantly from a fundamental point of view – no ideas concerning supramolecular templating as a new synthetic concept were formulated.

The real discovery of the materials and the processes leading to these materials can be dated back to the end of the 1980s/beginning of the 1990s. The first description of a material having linear pores in the size range of 4 nm, which were hexagonally ordered, was published by Kuroda and coworkers.⁶ This paper, however, initially went largely unnoticed, attracting only six citations in the first four years until 1993 (according to the Web of Science, the current citation count is above 1500). This was both due to the journal in which it was published, which is not widely read, and due to the limited scope of the synthetic pathway: the intercalation of sheet silicates and subsequent transformation to ordered mesoporous solids did not seem to be a general route to a large variety of different materials.

This was different from the work published by the Mobil group in 1992;^7,15 it had previously been patented and also been presented as a recent research report poster at the 9th International Zeolite Conference in Montreal. This poster was probably the most intensively discussed and photographed poster at any conference the authors are aware of, and also some of the authors of this review took photos to immediately replicate the synthesis in their laboratories. In the written form, this work was published in high profile journals, and especially the very comprehensive J. Am. Chem. Soc. paper¹⁵ has a density of new information, which is rarely seen in publications. The extremely high long-term impact of these papers (together around 25000 citations to date) was probably not due to the description of a material with unusual textural properties; the decisive point appears to be the formulation of possible liquid crystal templating mechanisms, even if they were at that initial stage in a rather general and not very specific form. This introduced a novel concept for the creation of highly ordered, porous inorganic materials beyond the molecular scale, using supramolecular arrays as templates. An account of the history of discovery from the perspective of the Mobil-scientists was given in 2013.¹⁶

Following this seminal series of papers, important work expanding these discoveries was published. A more detailed formulation of the mechanism was put forward by the group of G. Stucky,¹⁷ who proposed that under most synthesis conditions the organic/inorganic mesostructure forms cooperatively via the interaction between multiply charged silicate oligomers and the positively charged surfactants. Subsequently, in a joint paper by Stucky's group and Schüth's group, the concept was generalized to other conditions, and, maybe more importantly, to other compositions.¹⁸ A major conceptual development with respect to the mechanism which helps to rationalize many of the synthetic pathways was also introduced by Stucky's group, first only briefly mentioned and not strongly elaborated on in 1995,¹⁹ but fully developed in a subsequent paper one year later.²⁰ It is based on the surfactant packing parameter introduced into surfactant science by Israelachvili,²¹ and allows the prediction of the development of certain phases based on simple geometric arguments.

Another major development line, which started in the middle of the 1990s, was the use of polymeric surfactants. Pinnavaia's group pioneered this approach with poly(ethyleneoxide) based surfactants,²² using dilute concentrations, while Attard et al.²³ used similar surfactants, but at such high concentrations that a liquid crystalline phase was present before the addition of an inorganic precursor. This so-called “true liquid crystal templating” (TLCT) introduced a new concept into the synthesis of ordered mesoporous materials. However, the element of predictability, which Attard et al. mentioned in their contribution, does not seem to be fully exploitable, since the addition of a precursor to the inorganic material in many cases seems to destroy the liquid crystalline phase, which subsequently reforms as an organic–inorganic composite. The pathway introduced by Pinnavaia and coworkers using more dilute surfactant systems was thus the more influential one.

The use of polymeric surfactants culminated in the discovery of SBA-15 in the Santa Barbara groups of Stucky and Chmelka.²⁴ The synthesis of SBA-15 is probably the most important single breakthrough after the original synthesis published in 1992. The properties of the material, such as the tunability of the pore sizes over a wider range than for MCM-41, thicker walls and correspondingly enhanced stability, and the connections between the mesopores through the micropores in the walls, make the material more promising than the original MCM-41 for most applications. This is the reason why over recent years SBA-15 and related materials seem to have been used perhaps even more than MCM-41, judging from the personal impression of the authors and also citation data.

Relying on pre-formed ordered mesoporous materials, Ryoo introduced a novel concept for the negative replication of such systems, first for the formation of a MCM-48 structure as a carbon replica material (CMK-1),²⁵ following a related, but not quite as successful, attempt at replicating the pore structure of a zeolite.²⁶ This approach has now substantially been broadened, and many different materials are accessible via this nanocasting process.

Surface modification of silica is a highly important feature for biomedical applications. In fact, it was back in 1990 when the Japanese Research Group headed by Kuroda reported for the first time the reaction of kanemite-derived mesoporous silica with a trimethylsilylating reagent to form a trimethylsilylated derivative.²⁷ Due to calcination of the silylated material at 700 °C, this functionalization was lost, though, in the final porous silica. Later on, a similar functionalization strategy was also applied by the Mobil team to perform the trimethylsilylation of the surface of MCM-41 pores,¹⁵ resulting in trimethylsilylated porous silica. This method established pathways for the silylation of mesoporous silica. For conventional silicas, also the synthesis of organosilicas from organically bridged silsesquioxanes was well established.²⁸ Based on this well-developed chemistry, also ordered mesoporous organosilicas, where each silicon atom in the structure is connected via an organic molecule to another silicon center, were created. Such materials are synthesized from organically bridged bis(trialkoxysilane) precursors. The process was independently discovered by three groups: Inagaki et al.,²⁹ Stein et al.³⁰ and Ozin et al.³¹ Inagaki subsequently also found that organosilicas bridged with phenylene groups had partly ordered wall structures,³² a feature which had been searched for essentially from the beginning of the research on ordered mesoporous materials, and only partly been achieved in the synthesis of block copolymer templated SBA-15 type materials, where the walls in some cases consist of nanocrystalline metal oxide domains.^33,34

1.2. Synthetic pathways for the production of ordered mesoporous materials

After the discussion of the major development lines in the early days of this research field, which had established the main classes of ordered mesoporous materials, especially silicas, we will take a closer look at the synthetic pathways available. The discussion will focus on silica, since this is the major matrix for biomedical applications. We will also highlight the options to modify and adapt properties towards specific application fields, such as for drug delivery or other biomedical applications. For the synthesis of specific ordered mesoporous silica, the collection of verified syntheses by Meynen, Cool and Vansant³⁵ is a great resource. This compilation does not specifically address the use of ordered mesoporous silicas for biomedical applications, but it is a perfect starting point for obtaining insight into the more often studied structures, their characterization and their synthesis. Moreover, many reviews that focus on the synthesis of ordered mesoporous materials exist; however, we would like to mention only a few focusing on different aspects.^36–39 Such a deep level of treatment as in these dedicated reviews cannot be given in an article focusing on drug delivery, but the following section serves as an introduction to the more important aspects in the synthesis of ordered mesoporous silica, and provides access to more detailed accounts in the literature.

1.3. Synthesis of mesoporous silica nanoparticles

The sections above mainly dealt with the adjustment of the mesostructures and the control of the surface chemistry of ordered mesoporous silica. However, for use in biomedical applications, the morphology of the individual particles is of high importance. While in the early days of research on ordered mesoporous silica the morphology was more or less accepted as obtained from a particular synthesis protocol, it is not sufficient anymore for a number of advanced applications. For drug delivery purposes the drug carrier particles need to be isolated and in the size range of around 10 nm to approximately a few hundred nanometers.^126,127

The excellent textural properties of mesoporous silica materials together with their ability to be used in drug delivery technology inspired the rapid translation from bulk to the nanoscale dimension. The reason that fueled this transition to the nanoscale could be found in the unique physicochemical properties that mesoporous nanoparticles could offer to drug delivery technologies. Among them, we like to highlight their great pharmacokinetic profile, the improved drug stability and solubility, and their outstanding control over the timing and location of the therapeutic release, which would contribute to reduce the potential toxicity of the therapeutic agent.

In the race of developing mesoporous silica nanoparticles for drug delivery technologies, the contribution of Victor Lin should be highlighted. Even though Prof. Lin passed away in 2010 at the age of 43,¹²⁸ his seminal contributions were essential for the development and applications of mesoporous silica nanoparticles, a term that he coined to illustrate nanoparticles made of mesoporous silica with a well-defined and controllable morphology.^129–132 He was also able to demonstrate the possibilities of MSNs through their application in a variety of different scientific areas, such as heterogeneous catalysis,¹³³ renewable energy,¹³⁴ biosensing¹³⁵ and nanomedicine,^136,137 among others.

However, strictly speaking, Stöber was the real pioneer in developing the synthesis of spherical monodisperse micron size silica particles.¹³⁷ Since then, many modifications have been made to the so-called Stöber method to yield many different types of monodispersed mesoporous nanosized silica particles. The reason for such popularity relies on the fact that manipulating the reaction parameters might result in materials with different morphologies (such as films, fibers, monoliths or particles) and sizes (macro, micro or nano-particles). In this sense, the first time that the Stöber method was modified towards the production of mesoporous silica particles was carried out by Grün et al., when they introduced a cationic surfactant to produce micrometer spheres of ordered mesoporous oxide MCM-41-like particles.¹³⁸ Then, nano-sized mesoporous silica particles were reported by the research teams of Cai,¹³⁹ Mann¹⁴⁰ and Ostafin.¹⁴¹ And then, Victor Lin was the one who popularized the term MSNs referring to mesoporous silica nanoparticles.¹³⁰ Since then, MSNs with a variety of morphologies, dimensions, pore sizes and pore structure have been explored by many different research groups. The conventional synthesis of MSNs is performed at low surfactant concentration to force the assembly of the ordered mesophases to depend on the interaction between the cationic surfactant and the growing anionic oligomers of the silica precursor, which in turn restraint the assembly of mesophases to small sizes. Once the reaction is complete, the organic surfactant is removed by either solvent extraction or calcination and the silica particles might be isolated. However, the synthesis conditions of MSNs can be modified in different aspects, such as the pH of the reaction mixture, the type of surfactants or copolymers employed as structure directing agents, or the concentrations and different types of silica precursors. There are outstanding reviews in the literature where the principles of the different synthetic methods employed for the formation of various MSNs are introduced and explained, together with their influence on the final properties.^{38,127,142–145}

There are several reasons, why for drug delivery applications NPs should be used – although MSNs have not been approved by the US Food and Drug Administration for medical applications, yet.¹²⁷ Such nanoparticles are isolated and can be made colloidally stable, which is crucial when a preparation for medical applications should be stored without settling of the solid fraction. The payload in porous silica NPs can be made high, if porosity is high, the surface can be functionalized almost at will by the methods discussed above, and with proper synthetic protocols, the size can be adjusted to pass certain barriers in the body.¹²⁶ As compared to bigger particles, NPs are more easily degraded and can thus leave the body faster. Biodegradability can be tuned over rather wide margins, so that release rates can be adjusted (although degradation of the carrier is not the only release mechanism).^125,127 The final degradation product of the silica moiety of the drug carrier is silicic acid, which is physiologically unproblematic and has thus been considered safe by the US FDA for 50 years.¹²⁶

Due to the high interest in MSNs and organosilicas, there is a vast number of review articles. These can certainly not all be listed here, since as of 2017 approximately 350 such review papers were identified.¹²⁶ However, several of these more recent reviews shall be highlighted here, since they are particularly useful and relevant in the field of drug delivery vectors. Some of these originate from the group of one of the authors of this review. In ref. 127, the field is broadly covered, while ref. 146, updated four years later¹⁴⁷ is focused on stimuli responsive drug delivery systems. Ref. 124 specifically covers organosilica nanoparticles for biomedical applications. Möller and Bein give an overview with an emphasis of different aspects of the synthesis and application of silica nanoparticles, amongst others for use in medicine.¹⁴⁸ Ref. 149 treats various types of silica NPs for biomedical applications, and MSNs are placed in this context. Sun et al. treat different methods and describe in detail influential factors to control the morphology of mesoporous silica, not only to produce NPs, but also other morphologies.¹⁵⁰ Croissant et al. provide broad coverage of biosafety and degradation of MSNs.^125,126 Two reviews from the group of Lindén address the medical applications with respect to materials properties and also discuss biodistribution and safety.^151,152 As stated above, this list falls very short of being complete, even with respect to review papers only. However, it allows access to the literature on this field from rather different angles, all with relevance to biomedical applications.

The most versatile method for the synthesis of ordered mesoporous silica combines two well-known approaches in silica chemistry, i.e. the so-called Stöber-method for the synthesis of monodisperse silica spheres with sizes in the low hundred nanometer size range, and templating of mesopores by different types of surfactants, as discussed extensively in the previous sections. The versatility of the synthesis of monodisperse, sub-μm sized silica spheres was described in a publication in 1968,¹⁵³ based on earlier observations of Kolbe.¹⁵⁴ The key element of the Stöber-synthesis is the addition of an alkoxysilane (mostly tetraethoxysilane is used) to an ammonia solution (mostly in ethanol/water with excess ethanol, but other solvent systems are also possible) under agitation at relatively high dilution. This results in the formation of solid monodisperse silica spheres with sizes typically in the range of 100–400 μm, but systems producing spheres somewhat outside of this range are also known. The key ingredient, which induces the formation of monodisperse spheres, is ammonia (ethanolamine and basic amino acids are alternatives), and thus the Stöber method typically proceeds under alkaline conditions. While the Stöber synthesis in the first decades after its description was only known to experts, it became highly popular for various applications around 2000, which recently led Ghimire and Jaroniec to speak about a renaissance of the method in a very useful recent review on this synthesis.¹⁵⁵ The synthesis is well established, and a hands-on guide for the synthesis of solid and porous Stöber-type spheres can be found in a methods and protocols paper, which focuses on hollow spheres, but contains much useful information also on the regular Stöber-process.¹⁵⁶ Giesche described in detail the precise adjustment of particle sizes by a seeded growth process, with control of sizes between about 20 nm and 3.5 μm; moreover, description of a continuous synthesis is included as well.¹⁵⁷

The Stöber-process is a rather robust synthesis, but the addition of surfactants to create mesoporous nanospheres is not straightforward, since conditions have to be adapted. The easiest method seems to be the combination of TEOS and octadecyltrimethoxysilane as silica sources. A reliable recipe for the synthesis of 350–400 μm sized porous spheres is given in ref. 156, and the particle size can be increased by increasing ammonia concentration and decreased by lowering ammonia concentration. Also, this type of synthesis can be carried out in a continuous fashion.¹⁵⁸ MCM-48 type monodisperse spheres were produced by an adaptation of the Stöber-synthesis with the addition of CTAB as the template, but the spheres are somewhat large for biomedical applications, about 800 nm judging from the micrograph.¹⁵⁹ This problem was solved later by Kim et al., who controlled particle size by using an additional surfactant, i.e. the block copolymer Pluronic F127.¹⁶⁰ While these silica NPs are typically obtained with spherical morphology, Wang et al. reported a synthesis of cubic or truncated cubic NPs, which have a structure similar to Pmn SBA-1.¹⁶¹ They are produced also in an ammonia system, but the TEOS is dissolved in hexane instead of in an alcohol.

A very versatile approach for the synthesis of silica NPs with different particles sizes, pore sizes, pore arrangement and functionalization was reported by Möller and Bein.¹⁴⁸ The key element in their synthesis is the use of triethanolamine as the base; in addition, small amounts of fluoride are added.

For materials, which are obtained under acidic conditions, there is no such general approach for the synthesis of monodisperse particles in the size range of around 100 nm, since the Stöber-method relies on the use of ammonia or amines as the mineralizer. The prototypical SBA-15 is normally obtained with broad particle size distribution at sizes exceeding 1 μm. Thus, synthesis conditions have to be explored, and for nanoparticle synthesis one needs to fine-tune the system by optimizing the synthesis conditions. Lee et al. published a comprehensive study, where various synthesis parameters were explored, resulting in different particle sizes and shapes, including sizes in the range of around 100 nm.¹⁶² For KIT-6, a synthesis was reported to yield 45 nm particles.¹⁶² However, the quality of the particles in this publication is difficult to judge, since only atomic force microscopy (AFM) data are shown. Generally, plate like particles could be interesting, since diffusion pathways are short, if the channels are perpendicular to the plate base. However, while plate like particles with thickness in the desired range are accessible, overall particle dimensions typically still exceed 1 μm.¹⁶³ Zhu et al. succeeded in synthesizing SBA-15 with dimensions of 400 × 400 nm and narrow particle size distribution by optimizing synthesis conditions, but here also no general procedure was developed for the synthesis of NPs.¹⁶⁴ Since SBA-15 has interesting properties, there is thus a need in drug delivery for the development of more controlled synthesis processes for the formation of SBA-15 and related materials in monodisperse and nanoparticle morphology.

There is one rather general method that allows the synthesis of surfactant templated ordered MSNs, irrespective of pH, which is evaporation induced self-assembly (EISA). This method had originally been developed for the preparation of coating, but was extended to aerosol-based syntheses to allow production of a wide variety of silica NPs.¹⁶⁵ Particles are in the right size range, but seem to have a rather broad particle size distribution. Due to the more complex setup and polydispersity of the products, NPs from aerosol-assisted EISA processes do not seem to have been often used for drug delivery applications, yet.

Due to the fact that a high level of control is required for the synthesis of ordered MSNs in any case, these processes are often suitable for the introduction of further functionality with high relevance into drug delivery. Fig. 7 schematically shows the different types of modification, which are useful for biomedical applications; they were recently very well reviewed in ref. 127 and 126. Introduction of organic groups, as discussed above, can modify the polarity of the materials and thus optimize the loading and release of drug molecules.

Organic groups can also be tailored to control biodegradation of the carrier. Magnetic NPs can be integrated to drive particles by magnetic fields or heated magnetically for drug release. Capping groups on the pore mouth allow stimuli-responsive release, for instance, by a pH change or optical switching, which changes the spatial arrangement of molecules. The methods for functionalization are almost limitless, and range far beyond drug release. Magnetically sensitive probes can be incorporated for MRI contrast, and fluorescent molecules, ions, or NPs in order to induce optical response upon stimulation. Moreover, the drug loaded NPs can also be directed to the regions in the organism, where the drug should be applied. Passive direction can make use of the shape of particles, because this may induce a preference for specific organs or cell types.¹⁶⁶ However, one can also attempt to more actively target the carrier system to the places, where the drug should be administered, and different approaches are discussed in ref. 127.

2. Mesoporous materials for drug delivery

Ideally, a drug delivery system should control the loading process and the rate and period of release of the corresponding drug as well as specifically directing it to a target tissue or cell.^{147,171–173} There are numerous research studies focused on the development and biomedical application of silica-based mesoporous matrices to host and release various antitumor, antimicrobial or other types of therapeutic agents.^171–175 The expansion and development of this type of studies were inspired by the pioneering research work of María Vallet-Regí's group on the MCM-41 material as a controlled delivery system with ibuprofen as the model drug.^9,10

The most outstanding properties that make mesoporous materials the best candidates for controlled drug delivery are mainly focused on: ordered pore structure (structural properties), narrow pore size distributions, large surface areas and volumes (textural properties) and high density of silanol groups that facilitate the covalent bonding of organic groups (chemical properties) (Fig. 8).^10,176

First of all, the biocompatibility of silica based materials has been widely demonstrated in different in vitro and in vivo models.^177,178 In terms of structural and textural properties, pore diameter, surface area and pore volume are crucial to obtain the best efficiency of these mesoporous siilica materials. The pore diameter must be adapted to the size of the drug molecules to be loaded and is consequently a limiting factor when choosing and loading the corresponding drug. In addition, the pore diameter acts as a regulator of release rate as it limits the diffusion of drugs along the pore into the release medium.¹⁷⁹ On the other hand, the surface area of these materials is also a key for a greater amount of drug to be loaded; the greater the surface area, the greater the interaction with the loaded molecules. In addition, in order to increase the amount of drug loaded into the materials, the pore volume and thus the filling of the materials can be increased, inducing an increase in drug–drug interactions within the mesoporous cavities.^101,180 With respect to the chemical properties, the amorphous silica surface has a high density of silanol groups. In this context, when the surface is hydroxylated to the maximum value, Zhuravlev determined the number of OH groups per unit surface area as a silanol number density, which has the numerical value of 4.9 OH per nm² (arithmetical mean);^101,180https://doi.org/10.1002/chem.200600226. While for pure silica mesoporous materials the interactions between the material and the drug are through weak interactions with the surface silanols, such as van der Waals forces or hydrogen bonds, it is possible to use the silanols for functionalization to improve the covalent anchoring of various organic groups. This fact allows working with a wide variety of hybrid organic–inorganic mesoporous materials.^98,179

As discussed above, the functionalization with organic groups of the surface of mesoporous silica materials makes them excellent candidates for drug delivery, since it allows to control the adsorption and release of drugs. There are basically two methods for functionalizing mesoporous silica matrices, the one-step synthesis or co-condensation method and the post-synthesis or grafting method (see above). The former method consists of a single step in the presence of a surfactant as a structure directing agent and involves different simultaneous hydrolysis and condensation reactions of the silica and organosilica precursors. Although this strategy allows the organic functions covering the entire silica surface, there is an upper functionalization limit to avoid the disorder of the mesoporous structure. The second method is usually performed to modify surfaces by grafting organic silanes ((RO)₃SiR′) under anhydrous conditions. This method allows a great versatility of selective functionalization of both the external surface of the silica and the internal and external surface of the mesopore, before or after surfactant extraction, respectively. As a consequence, this functionalization increases the wall thickness, and the organic molecules present in the mesopore decrease the textural properties of the material.⁹⁸ As is well known, the electronic interactions, host–guest interactions through electrostatic attractive forces, and hydrophilic–hydrophobic interactions present for the different functionalizations of mesoporous matrices allow a controlled and specific modulation of the charge and release kinetics of the correponding drugs.^10,180–182

3. Mesoporous silica nanoparticles for drug delivery

One of the most important aspects for any nanoparticles to be employed in drug delivery technologies, independently of the type of nanocarrier employed, is their capacity to transport their payload to precise locations in the body to increase efficacy and reduce potential side effects. In this regard, during the design of a nanocarrier, it is compulsory to consider its biological behaviour when it might be administered. Thus, it is necessary to take into account the biocompatibility, biodistribution, biodegradability and potential clearance of any engineered MSNs to be used as a drug delivery system.

3.1. Degradation, biodistribution and clearance

MSNs have gained the attention of many research groups to be used as drug delivery nanosystems. However, despite all the interest, they have not been approved yet to be used in medical applications by the regulatory agencies. In this sense, there are some prerequisites that need to be addressed before reaching clinical trials, such as the MSN degradation, biodistribution, clearance routes, and their final fate within the body.¹⁸³ This sequence of requirements is not exclusive for MSNs, because the performance of any potential nanocarriers, and the subsequent translation to the clinic, is dependent on the adsorption, distribution, metabolism, and elimination. The area of nanomedicine has included these processes into biokinetics that includes nanoparticle uptake, biodistribution and elimination.¹⁸⁴

Among all the possible routes of NP administration for drug delivery, the most common are intravenous, subcutaneous, intratumoral, intraosseous and intra-articular (Fig. 9). Therefore, the nanoparticle stability in blood, or any other physiological media, is one of the first requirements that should be addressed. In fact, there should be a balance between nanocarriers being robust enough to protect the payload during the journey and being biodegradable once they have accomplished their mission. This balance can only be reached through detailed understanding of the chemistry of the employed nanocarriers. Although MSNs are known to be mechanically, thermally and chemically stable, their potential degradation through lixiviation of the siloxane bonds from the silica network in aqueous media might present a strong influence on the release kinetics (Fig. 10).¹⁸⁵ Additionally, the orthosilicic acid by-products of the degradation products are not expected to be cytotoxic since they are biocompatible and excreted through the urine.¹²⁵ In fact, silicic acid has been recognized as safe by the US Food and Drug Administration (FDA) for over 50 years.¹²⁶

3.2. Targeting

As it has been mentioned above, the design and engineering of MSNs should include the ability to deliver the therapeutic cargo to precise locations. In this sense, the majority of the research on targeted NPs has been focused on the potential treatment of cancer, because these nanocarriers can selectively accumulate in tumour tissues to locally release their payload. When NPs are injected into the bloodstream, they preferentially accumulate in the tumour through what is called passive targeting. This is due to the particular architecture of the tumour's blood vessels, which have extensive fenestrations. In addition, these tumour tissues usually lack effective lymphatic drainage, so this is why this phenomenon of preferential accumulation is known as enhanced permeability and retention (EPR) effect,²²⁸ as it will be described below in the cancer section.

However, sometimes the efficiency of the EPR effect is not as high as expected for treating a disease such as cancer.^229,230 A potential alternative that can be employed together with the EPR effect is the active targeting, which is based on surface conjugation of molecular targeting ligands that might present high affinity towards specific membrane receptors overexpressed in the cell membranes. This approach enables the development of nanocarriers that are able to recognize biomolecules associated with specific disease conditions, such as cellular receptors overexpressed on the surface of cancer cells. Although targeted NPs have not yet reached the clinic, there are several approaches that are under investigation, and even some clinical trials are currently underway.²³¹ In this sense, there are several reasons that could explain some of the major disappointments of targeted nanocarriers, such as the immunological response due to the presence of the surface ligands, the increase of size due to the presence of voluminous ligands, or the binding site barriers, that occur when ligands bind with high affinity to target molecules so that further diffusion into the tissue is hampered. This is the reason why a balance between binding affinity and diffusion ability should be targeted in the design of nanocarriers.

Although targeted nanocarriers have not yet reached the market, they have been employed by many different researchers worldwide to increase the accumulation of MSNs in tumours using different targeting agents, as it will be reviewed below in the cancer treatment section. In fact, the different targeting approaches should be designed based on the tumour type to be treated.

3.3. Stimuli-response

One of the great advances of nanomedicine is the potential for triggered release of therapeutic agents in the tissue of interest. As described above, a suitable drug delivery system should meet a number of essential requirements to be used as a nanomedicine in the clinic, such as being able to encapsulate a high amount of therapeutic agents, being able to transport them to the specific tissue of the targeted disease avoiding any premature loss of the drug, and being able to release a large amount of the transported drug or biomolecule to achieve a high therapeutic concentration at the local level. It is thus desirable for any ideal nanomedicine to be able to release its payload on demand, i.e., in response to a provided stimulus, either an internal stimulus characteristic of the pathology to be treated or an external stimulus controlled from the outside by a physician. Both modalities have advantages and disadvantages, as will be described throughout this review. For instance, in the treatment of cancer, there are several stimuli in the tumour microenvironment than can be exploited as payload release triggers (Fig. 11), such as low pH, high concentrations of glutathione or elevated levels of certain enzymes. On the other hand, there are certain materials, such as inorganic nanocarriers, that can transform energy coming from external sources into heat that can be employed for therapy. The external energy source can be near-infrared light, ultrasounds or magnetic fields, that can be controlled from the outside and can be localised to a specific area reducing the potential side effects.

With respect to MSNs, their possible stimuli-sensitive behaviour is of particular interest, since their open porosity makes it relatively easy to introduce drugs into their pores. On the other hand, it is also very easy for these therapeutic agents to escape through the same way they entered. This would greatly reduce their efficiency and could increase certain side effects due to the massive distribution of certain drugs throughout the body. Therefore, it is necessary to devise different strategies to close the pore gates to prevent premature release of the cargo. Over the last few years, various strategies have been developed to close the pore gates depending on the pathology to be treated, as we will see in the following sections of this review. The present review will focus on smart nanocarriers based on MSNs capable of releasing high local concentration of the therapeutic cargo on-demand after the application of certain stimuli, such as endogenous stimuli (pH, redox, enzymes and small molecules) and/or exogenous stimuli (light, magnetic field, temperature and ultrasound).

4. Potential biomedical treatments using MSNs

4.1. Cancer

Cancer is a very complex disease that is characterised by an abnormal and uncontrolled cell division that leads to tumours that could spread to the surrounding tissues. In the last few decades, cancer has been ranked as one of the leading causes of death worldwide, with an estimated 20 million new cases and 10 million deaths worldwide only in 2021.²³²

Cancer is more than just one disease since there are many different types of cancer depending on the part of the body where it might start, and it could spread throughout the body in a process called metastasis. In an attempt to classify cancer, there are two main categories: hematologic or blood cancers, which are those of the blood cells, and solid tumour cancers, which are those of any of the other body organs or tissues. In the former cancer, nanotechnology is expected to play a key role in the promising area of immunotherapy and the development of CAR T cell therapy, while in the later cancers, nanocarriers are already being employed in the clinic as an alternative to conventional chemotherapy.²³¹ In any case, cancer is very heterogeneous and complex, and this is why developing effective cancer therapies is a very challenging process.

Conventional cancer treatments include surgery, radiotherapy and chemotherapy, which would depend on the type and stage of the cancer to be treated. Conventional chemotherapy is based on the systemic administration of drugs that target rapidly-growing and dividing cells. Their mechanism is commonly based on blocking key metabolites needed for replication, intercalating into DNA, competing with selected nucleotides or blocking microtubule development. However, these conventional anticancer drugs are commonly highly cytotoxic, poorly soluble in aqueous media, have low stability and bioavailability and, in most cases, they lack of specificity. All of these pitfalls often lead to severe side effects, which might include pain, cardio toxicity, diarrhoea, nausea, hair loss and potential depression of the patient immune system. Consequently, the dosage needs to be reduced, which might result in lower therapeutic effect and development of resistance to these drugs.

4.2. Bone diseases

Bone diseases and associated disorders have considerably grown in recent decades due to the increase in life expectancy.^597–599 The aging of the population is leading to an increase in bone fractures or defects and therefore the use of treatments to prevent or fix this situation. Most treatments focus on improving bone remodelling with surgery to implant a bone substitute or a bone graft, either natural or synthetic. However, these approaches have limitations such as biomechanics, immunogenicity, availability of a donor, etc. As is well known, the gold standard in this context is the use of autograft bone in the damaged area, but this treatment has some limitations, too.⁶⁰⁰ In this regard, tissue engineering has emerged as an alternative in various fields for decades, including the improvement of bone repair and the treatment of various associated diseases, such as osteoporosis, fractures or infections associated with implant surgery.^173,600,601

There are different biomaterials that have been used to improve bone regeneration as an alternative approach^602,603 to solve the limitations of the current treatments. These materials, mainly scaffolds, have been enriched with molecules, substances or mesenchymal stem cells that have improved their mechanical, osteogenic and angiogenic properties, in order to be similar to the bone to be replaced.⁶⁰⁰ In addition, the treatment of diseases such as osteoporosis or osteosarcoma, even if effective in reducing the risk of fracture or increasing the survival rate, respectively, also has certain limitations such as bioavailability, tissue specificity, long-term effect or development of resistance.^{597,598,600,604,605}

Recently, nanotechnologies have emerged as an ideal alternative, due to their unique properties previously mentioned.⁶⁰⁶ Different types of NPs, both inorganic and organic, are being used as vehicles for different osteogenic and angiogenic molecules to improve bone repair or treat osteoporosis. Within the inorganic NPs we can find silicon NPs (MSNs),⁶⁰⁷ hydroxyapatite NPs,⁶⁰⁸ gold NPs,⁶⁰⁹ magnetic NPs,⁶¹⁰ and platinum NPs,⁶⁰⁶ among others.⁶⁰⁶ These systems allow us to control the size and functionalization, and they can be used as vehicles of treatment or as contrast agents for diagnosis. Hydroxyapatite NPs have shown to be effective to induce bone tissue formation and serve as vehicles of osteogenic molecules. Gold NPs improved osteoblast differentiation and avoided osteoclast activity. Magnetic NPs are commonly used as vehicles for drug delivery and contrast agents for diagnosis. Platinum NPs have shown antioxidant and anti-osteoclastic properties.⁶⁰⁶ On the other hand, organic NPs have been used as drug delivery functionalized platforms of synthetic polymers. Among them, chitosan NPs (CS NPs),⁶¹¹ poly(lactic-co-glycolic acid) (PLGA NPs)⁶¹² and solid lipids NPs⁶¹³ are the most common organic NPs. CS NPs have shown to be effective for antioxidant treatment of age-related disorders and as an excellent nanosystem to load and release different proteins, a function shared with PLGA NPs. Solid lipids NPs increased availability in biological systems and the solubility.⁶⁰⁶

As we previously detailed, MSNs have shown to be biocompatible and biodegradable with excellent properties as drug delivery systems due their size, shape, surface chemistry and surface charge.^147,172 Furthermore, it is possible to functionalize the surface of MSNs with bone targeting molecules,⁶¹⁴ such as small bisphosphonates,⁶¹⁵ tetracyclines, peptides, and proteins, among others.^147,172 In this section, the osteogenic effects of MSNs as vehicles of different molecules or biological signals on bone metabolism^147,172,607 will be discussed (Table 3). In addition, the effects of MSNs on bone generation, fracture treatment and wound healing have been detailed, as well as in the treatment of several diseases as osteoporosis. Moreover, stimuli-responsive MSN systems and the synergistic effect of the combination of MSNs with other biomaterial platforms, such as hydrogels or scaffolds, have been explained.

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4.3. Infection diseases

Infections are increasingly emerging as a cause of morbidity and mortality worldwide, due to the rapid emergence and dissemination of drug-resistant pathogens that have acquired new resistance mechanisms, leading to antimicrobial resistance (AMR), which threaten our ability to treat common infections.^675–677 AMR occurs when bacteria, viruses, fungi and parasites change over time, when they are exposed to antimicrobial drugs, such as antibiotics, antivirals, antifungals, and anthelmintics, respectively. Consequently, the drugs become ineffective, and infections persist in the body, increasing the risk of spread to others, severe illness and death. In fact, due to the lack of effective antimicrobials for prophylaxis and treatment of infections, relevant medical procedures, such as cancer chemotherapy or diabetes management, as well as major surgery, such as organ transplantations, caesarean delivery, or prosthesis implantation and replacement, have become very risky.

According to the WHO, AMR is a major concern threatening human global health.⁶⁷⁸ Currently, drug-resistant diseases cause at least 700000 deaths each year, and this figure could grow to 10 million by 2050.⁶⁷⁹ In fact, it is foreseen that by this date, more people will die from AMR than cancer.⁶⁸⁰ Moreover, AMR increases the healthcare cost for the sanitary systems related to long-stay in hospitals and more intensive care required.⁶⁸¹

MSNs as multifunctional drug delivery nanodevices for the treatment of infectious diseases have entered into this challenging scenario, bringing up the opportunity to develop custom-made therapies through the release of appropriate antimicrobial cargo, in a controlled manner only at the target infection site. Thus, innovative MSN-based formulations have been proposed for the management of infectious diseases produced by parasites, fungi, virus and bacteria (Fig. 24).

A few studies can be found in the literature applying MSNs to treat parasitic diseases. Among them, MSNs containing SWAP (soluble worm antigenic preparation)⁶⁸² or loaded with praziquantel⁶⁸³ were evaluated to treat Schistosoma mansoni infection in mice; multifunctional MSNs containing benznidazole were tested against the parasite Trypanosoma cruzi, responsible for Chagas disease;⁶⁸⁴ and pH-responsive MSNs loaded with metronidazole for protozoal growth inhibition in vitro.⁶⁸⁵

Regarding fungal infections, the main research efforts have been focused on the design and development of MSN-based new formulations against Candida albicans. The challenge is to overcome the current drawbacks of multiple resistance mechanisms of this biofilm-forming pathogen to drugs such as fluconazole and amphotericin B.^686–688 Diverse approaches have been suggested. They include the development of MSNs modified with Rose Bengal as photodynamic therapy (PDT) and antimicrobial treatment.⁶⁸⁶ Antifungals exhibiting poor aqueous solubility, such as econazol⁶⁸⁹ or itraconazole,⁶⁹⁰ were loaded into MSNs to improve drug bioavailability and increase antifungal activity. pH-Responsive tebuconazole-loaded MSNs were fabricated to treat vaginal candidiasis.⁶⁹¹ Finally, loading of Ag NPs into MSNs by green synthesis, using Azadirachta indica leaf extract as the reducing agent, has been proposed as a promising alternative approach to the treatment of infections caused by C. albicans.⁶⁹²

To design and develop any viral infection treatment is essential to understand the mechanisms underlying the molecular interactions between virus and the host cells, which are key factors that govern its virulence and ability to spread. The big concern is the outstanding capability of a virus to change by genetic mutation to become drug resistant. The lack of broad-spectrum antiviral drugs, the quick and huge spreading capability of virus and the long-time required to elucidate its mechanism of action to design safe and efficient vaccines or antiviral drugs make viral infections an enormous threat to global health. Focusing on the design of novel antiviral drugs, the scientific community has dedicated impressive efforts to provide solutions to the millions of human deaths caused worldwide throughout human civilisation, such as the current pandemic situation caused by coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.^693,694 Since the aspects related to the design and development of vaccines will be tackled in another section, here we will just give an overview of the potential of MSNs as nanocarriers for antiviral drugs to treat viral infections. In a pioneering study, LaBauve et al. designed lipid-coated MSNs as nanocarriers of the ML336 antiviral for Venezuelan equine encephalitis virus (VEEV).⁶⁹⁵ The smart design of this nanosystem overcomes the great limitations of this drug for clinical translation, such as poor solubility and stability in biological media, showing promising results both in vitro and in vivo in VEEV infected mice. In another study, Le et al. designed glycosaminoglycans (GAG)-mimetic-functionalized MSNs to treat Herpes simplex virus (HSV), namely HSV-1 and HSV-2, infections.^696,697 In the first study,⁶⁹⁷ aryl sulfonate GAG mimetic-modified MSNs exhibited low toxicity, and most importantly inhibited HSV-1 and HSV-2 penetration into healthy cells whereas controls were inactive. In the second work, Lee et al.⁶⁹⁶ explored distinct functional groups related to the GAG structure attached to MSNs and studied their antiviral action against HSV-1 and HSV-2. Moreover, they evaluated GAG mimetic-functionalized MSNs as smart nanocarriers for acyclovir (ACV) delivery to simultaneously achieve inhibition of viral penetration and DNA replication. In vitro assays towards HSV-1 and HSV-2 opened an interesting alternative that can circumvent the current limitations of ACV and related compounds, such as antiviral drug resistance mostly in immunocompromised persons and poor bioavailability, which required the administration of high doses. However, as it will be discussed, MSNs are promising materials for developing vaccine delivery systems, and actually, hollow MSNs have been loaded with porcine circovirus type 2 (PCV2-ORF2) proteins to provoke specific antibodies and cell-mediated immune responses with no cytotoxic effects in vivo.⁶⁹⁸

Finally, we will focus on bacterial infections, which are caused by different pathogenic bacteria and have threatened the health and lives of people all over human history, leading to plague and tuberculosis that caused many human deaths over centuries. During the last century, the development of diverse antibiotics noticeably decreased mortality, but the extensive inappropriate and long-term use of antibiotics has produced the rapid global rise and expansion of pathogenic multi- and pan-resistant bacteria (also known as “superbugs”) that cause infections untreatable with common antibiotics.^681,699 In addition to the acquired AMR, bacteria have a natural defence mechanism called biofilms, which consist of bacterial communities that grow adhered to a surface and then are embedded in a protective self-produced extracellular matrix mainly composed of secreted polysaccharides.^700,701 The bacterial biofilms provide protection to the inner bacteria from hostile environments, including antimicrobial agents and immune system.^702,703 Considering that over 60–80% of chronic infections are associated with biofilms, the combination of AMR and bacterial biofilms becomes a severe clinical concern.⁷⁰⁴ Another big concern is the absence of new classes of antibiotics in the pipeline,⁷⁰⁵ which forces to treat the current bacterial infections with the antibiotics discovered until the early 1980s.⁷⁰⁶ To achieve antimicrobial effectivity of the existing antibiotics, high doses or several administrations of antibiotics are required, which does not only increase the toxicity and side effects but also elicit AMR. In this scenario, there is an urgent need of developing new therapeutic approaches based on drug delivery carriers with great membrane permeability and biofilm penetrability, to achieve high local antibiotic concentrations and prolonged circulation time. Nanotechnology has entered this arena, providing potent tools to engineer nanocarriers as efficient nanoformulations to fight bacterial infections. These NPs are foreseen as targeted nanomedicines for local treatments exhibiting high antimicrobial effect at low doses, and minimizing toxicity and side effects. Among different nanocarriers, MSNs exhibit unique properties for the assembly of multiple functions to treat bacterial infection. These elements include targeting elements for selective transport of antimicrobial agents to the site of infection, stimuli-responsive release capability without premature cargo leakage and the possibility of combination with other therapeutic approaches, such as photodynamic therapy (PDT), photothermal therapy (PTT), etc. as will be discussed in the following sections (Fig. 25).

4.4. Other therapies

5. Perspectives for clinical translation

Any treatment applied to the clinic, especially for the treatment of cancer, is based on the search for personalised medicine capable of adapting to the specific tumour to overcome the many limitations of traditional treatments which, although they succeed in mitigating or curing the disease, in many cases fail.  Most of the drugs developed to the treatment of cancer have been evaluated using stratified studies. These type of studies should be applied to the test of NPs, which are usually evaluated in non-stratified studies. This seems an important point to overcome if NPs are to see accelerated evolution in clinical trials, incorporating specific stratified patient populations leading to a more homogeneous treatment response.

In this sense, NPs are ideal candidates for personalized therapies as they can neutralize factors such as heterogeneous biological barriers and comorbidities. Different approaches with nanoparticles have been used for the diagnostic detection of different diseases.⁸³⁵ In addition, they have been used within the tumour microenvironment to promote the accumulation and penetration of the particles and thus increase the efficacy of drugs.^836,837

Different types of nanoparticles have been approved by the FDA for clinical applications, with more than 30 approved nanodevices and more than 100 in clinical trials.²⁴⁷ These include lipid nanoparticles such as Doxil for the treatment of ovarian cancer or for the cure of leukemia (Marqibo or Viseox, among others), polymer-based nanoparticles (Oncaspar and Copaxone, among others) or inorganic nanoparticles for the treatment of anemia (INFeD or DexFerrum) or kidney diseases (Venofer or Ferahem).²⁴¹ In addition, with the emergence of COVID and lipid nanoparticle-based mRNA vaccines, these NPs have been shown to be safe treatments and have demonstrated their great potential for the treatment of different diseases.

Concerning MSNs, their advantages for further clinical studies over organic or other inorganic NPs have already been extensively discussed in this review. In this regard, the food additive E551 is composed of 100 nm MSNs and colloidal silica has been used in the manufacture of tablets as a glidant, both of which are FDA approved.²⁴⁷ As a result, several formulations based on silica nanoparticles are now in phase I and II clinical trials. The safety, efficacy and viability of MSNs in humans are evident from 11 clinical trials and 2 clinical studies, including oral drug delivery and diagnostics.²⁴⁷ Despite preliminary data pointing to high safety and efficacy in their treatment in clinical trials, the translation of these nanoparticles to the clinic is very slow. One of the possible reasons is that most of the preclinical studies have been focused on small animal models such as rodents, whereas a few studies have been performed in large model animals such as pigs, sheep or monkeys, much more human-like animals.

In our opinion it seems that the key to making the final leap to the clinic lies in demonstrating the long-term safety of MSNs, testing different routes of administration, being able to scale up their production and thus making the synthesis reproducible on a commercial scale. In addition, optimization of the design of MSN-based nanosystems using FDA-approved elements whenever possible could be desired to allow easier translation to clinical trials.

6. Conclusions

Although silica is usually employed as an excipient in many drug formulations, silica-based nanocarriers have not been accepted yet by the regulatory agencies of different countries to be used in the clinic. However, there are other types of silica NPs that are currently undergoing clinical trials, such as C-dots (7 nm silica NPs for imaging in metastatic melanoma). Nevertheless, MSNs for drug delivery are still in the preclinical stage. They have been evaluated for oral administration in humans, finding that they are well tolerated and safe.⁸³⁸ They have also been evaluated as food additives with very promising results for a potential clinical trial.

For formulations relying on MSNs as carriers to be translated to clinical use, approval of MSNs by the regulatory bodies as a carrier material for different modes of administration is of highest importance. This does not necessarily include other components of complex composites, such as luminescent reporter species, capping agents, or others, which impart the functions highlighted throughout the text. However, if the basic ingredient, the MSN, is not approved, all other studies are lacking a sound foundation.

The world has observed the super-fast development of COVID-19 vaccines, which has been undoubtedly a spectacular success of science in this area. However, the quick advances in the formulation of the mRNA vaccines was possible thanks to vast previous research activities and experience in the basic science on nanovehicles, including lipid NPs. Similarly, these last 20 years of basic research on MSNs are expected to pave the way for future clinical applications using this type of nanocarriers, which are expected to come sooner or later. It is now the time to take steps in resolving regulatory issues with one or the other promising formulation for a disease with a high medical need and high potential advantages on MSN-based drug formulations. Herein, the discussion of the different approaches clearly demonstrates that even multifarious systems can be constructed with high precision, and it is expected that, should the need arise, they can be produced at scale and in amounts to treat high number of patients suffering from complex diseases.

The present review has tried to collate in a comprehensive and systematic manner the development history and current achievements on MSN based drug delivery systems, covering different synthetic routes, property engineering and disease treatment. The significance of this review relies on the fact that the story has been told by those who were among the pioneers in mesoporous materials and their applications in drug delivery technologies. This angle provides a particular view on the early obstacles encountered, the thought processes in choosing specific approaches, and a deeply experienced-based perspective on potential future developments. Fresh minds, who use this overview as a starting point will for sure pursue new avenues, and we look forward to see the new directions this field will take in the future.

Author contributions

All authors have contributed equally to this manuscript.

Conflicts of interest

There are no conflicts to declare.

Acknowledgements

The authors acknowledge financial support from The European Research Council through the ERC-2015-AdG-694160 (VERDI) project and the Spanish “Ministerio de Ciencia e Innovación” through the PID2019-106436RB-I00 (IBONE) project.

Notes and references

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