Nanomedicines: Nano based Drug Delivery Systems Challenges and Future of nanomedicines
Nawale Sejal Navnath, Nikam Unnati Sahebrao
Pravara Rural College of Pharmacy, Pravaranagar.
*Corresponding Author E-mail: nawalesejal227@gmail.com
ABSTRACT:
Over the past ten years, the research and delivery of drugs has emerged as a rapidly expanding, highly capital-intensive, and demanding industry. This procedure is costly and time-consuming, and it has to deal with issues with rapid excretion, degradability, toxicity, low efficacy, biocompatibility, and low bioavailability. Nanomaterial are superior to conventional drug because they have remarkable qualities such as a high invasion rate, regulated, targeted, and gradual drug release, as well as easy receptor accessibility. Despite all of its importance, one of the main issues with different nanoparticles utilized as medication delivery systems is their toxicity. This review discusses the issue surrounding conventional drugs, the importance of nanomedicines in medication administration, and their potential for toxicity and also their future aspect that helps to improve health.
KEYWORDS: Nanomaterials, Medication delivery methods, Toxicity, Enzymes, Drugs Nanomedicines.
1. INTRODUCTION:
A drug is a molecular substance that affects living cells, tissues, organs, or the entire body chemically and physiologically. They could also eradicate infections such Fungus, viruses, or bacteria. All medications are generally based on this idea. The term “active ingredient” refers to the chemical component of a medication that produces the physiological action1. Both active and inactive ingredients are present in small amounts in drugs, while inactive ingredients are utilized as excipients, fillers, binder, or lubricants that have no physiological effect on the body2. The majority of the time, medications work by attaching to particular enzymes or receptors and then blocking or otherwise modifying those activities.
A medicine must be able to endure in the body and not alter the characteristics of biomolecules other than the target molecules in order to be considered effective3. Originally derived mostly from plants, drugs are now artificially produced. They have assisted humanity in battling infectious diseases and epidemics and are utilized to treat practically every illness and abnormality4. Despite all of these important considerations, contemporary medication dosage forms still struggle with issues related to efficacy, bioavailability, toxicity, biocompatibility, side effects, and inactivity, which impedes the process of developing and delivering new drugs5. Highly developed engineered nanoparticles have been used to solve these issues in recent decades. We have covered the broad use of nanomaterials in drug delivery systems in this review, as well as the behaviour of nanoparticles in living organisms when combined with drug molecules and their potential applications in the future.
2. DELIVERY SYSTEM OF NANOFORMULATIONS:
Nano medicines can be delivered through intracellular transport, epileptic transport, and other routes. Intracellularization transporter-mediated endocytosis, and penetration via interactions through particle size and/or cell surface all aid in and regulate intercellular transport6,7. Furthermore, better intercellular transport results from smaller Nano medicine particle sizes, which influences the absorption, dispersion, and excretion of Nanomedicines as well as cell penetration. The size of the Nanomedicine molecule actually affects how well transporter-mediated endocytosis internalizes the cell. Similarly, opsonisation happens fast in large particle nanomedicine, and endothelial macrophages help remove it from the blood. The particle size of nanomedicines has been shown to affect the susceptibility of nanomedicinal cell surface transporters to them, which can also affect how well macrophages remove big particles from the circulation. Because of their hydrophilicity, non-charged polymers, surfactants, or polymer coatings that break down in vivo combine with cell surface receptors or ligands to enhance permeability or encourage internalization of nanomedicines. Additionally, nanomedicines enhance the intracellular delivery of active medicinal components by interacting with chelates or bioadhesive polymers. Through the opening of tight junctions and/or increased membrane permeability, different proteins, antibodies, and other in vivo polymers can move more freely within cells when active pharmacological substances are present. Chemotherapy would be more effective if anti-cancer chemicals with this kind of role were included. This would apply to treating brain cancers that are resistant to medications linked to close junctions, as well as routinely targeting cells and tumors. Using these technology, can minimized cytotoxicity and increase anticancer efficacy is achieved.
Reduction in the amount of nanomedicines inhaled into the lungs leads to an improvement since there is less degradation and absorption by lung mucosa or macrophages. This enhances the product processing time and product transfer to target. Through increased tumor permeation and retention duration, the enhanced permeability and retention (EPR) effect raises the effectiveness of anti-cancer treatments. By combining an antigen, enzyme, peptide, or polysaccharide that can be used to alter the delivery of nanomedicines to target tissues via receptor/ligand interactions or other physiologically sensitive cell regulation interactions, drug efficacy modification, or adverse reactions, the effect of the EPR also makes it possible to directly transmit nanomedicines to target tissue. Hydrophilic-coated nanomedicines have a longer half-life, which keeps them from opsonizing or building up in mucus. For example, in the lung tissue for prolonged periods of time due to particle size, by preventing disruption caused by macrophages or mucosal edema and evading removal by mucus ciliates, which could result in lung mucosa degradation or other macroscopic effects8. As a result, several formulations that employ delivery systems capable of controlling the pharmacokinetics and pharmacodynamics of nanomedicines have been developed.
3. NANOMATERIAL BASED DELIVERY SYSTEM:
Drug delivery via nanotechnology has the potential to revolutionize the treatment of a number of illnesses, including diabetes, cancer, neurodegenerative diseases, vascular diseases, etc.9. Most formulations based on nanotechnology that are sold are parenteral, however some are meant to be taken orally10. A large number of preclinical and clinical experiments are anticipated to result in the development of innovative nanotherapeutics meant for non-parenteral administration channels, including ophthalmic, cutaneous, vaginal, pulmonary, and nasal. Drug delivery systems (European Commission/ETP)11 are particularly concerned on the delivery option and the challenges that need to be overcome. Many nanoparticle-based formulations have been created over time to improve medication administration, some of which are covered here.
3.1 Polymeric nanoparticles:
The most popular chemical nanoparticles are made of synthetic polymers because natural polymers have variable purity and batch-to-batch quality, low repeatability, and regulated release actions for the trapped compounds. On the other hand, synthetic polymers that are readily available and have strong batch repeatability and purity make it easier to alter the drug release pattern from polymeric nanoparticles12. Synthetic polymer-based nanoparticle formulations have been extensively researched for drug delivery and distribution. Since it is difficult to maintain activity in an unfavourable environment, hydrophilic moieties will encapsulate onto synthetic polymer-based nanoparticles in double emulsion processes. Numerous synthetic polymers have been reported for drug delivery, including non-biodegradable polymers like polyacrylates and poly (methyl methacrylate) and biodegradable aliphatic polymers like polylactide (PLA), poly lactide-co-glycolide, copolymers (PLGA), and poly (ε-carpolactone)13. By effectively preventing unstable pharmaceuticals from deteriorating or degrading, polymer nanoparticles can prevent the negative consequences of hazardous medications. Alginate, chitosan, albumin, and gelatin are examples of natural product polymers that make up natural polymeric nanoparticles13.
3.2 Lipid nanoparticles:
Solid lipid nanoparticles (SLNs) are lipid nanoparticles that have been made using a solid matrix. These are made from oil in water nanoemulsions that have a solid lipid incorporated into them. Early in the 1990s saw the formation of the first SLN generations14. Cheap raw ingredients, the use of physiological lipids, avoiding organic solvents, simplicity of scaling up, good biocompatibility, improved bioavailability, protection of susceptible molds from environmental risks, and controlled drug release are some of the advantages of SLNs15. Ciprofloxacin (CIP)-loaded SLNs with significant antibacterial activity have recently been developed by ultrasonic melt emulsification16. These were made using a polydispersity index with good trapping effectiveness, which fell between 0.18 and 0.33, and a scale that varied from 165 to 320nm. The full burst reaction of many lipids was demonstrated by CIP release, indicating a controlled-release pattern that aids in the drug’s quick release. It was discovered that this CIPSTE mixture remained stable at room temperature for 120 days. SLNs have undergone significant in vitro and in vivo testing for several modes of delivery, including oral17, cutaneous18, pulmonary19, ophthalmic 20, and rectal21. Marketable SLN formulations include nano base and nano pearl22.
3.3 Dendrimers:
Dendrimers are unique nanopolymeric structures that are hyperbranched, globular, and three-dimensional. These are distinguished from other nano systems by appealing characteristics such water solubility, nanoscaled size, narrow polydispersity index, changeable molecular structure, internal cavity, and several peripheral functional groups.
Drug conjugation and targeting are facilitated by terminal functionality. Additionally, these peripheral functional groups give them specially designed attributes that increase their adaptability23. Polyamidoamine is the dendrimer that is explored the most for medication delivery. The amine group initiates its synthesis by interacting with methyl acrylate, which helps to generate two new dendrimer branches that are terminated by an ester. The methyl ester can then be amidated with ethylene diamine to generate the amine-terminated dendrimer “Full-generation.” PAMAM dendrimers feature functional terminal amine groups that can be changed to target medications, and they are non-immunogenic, biocompatible, and water-soluble24. In addition to increasing solubility, dendrimers have been extensively studied for biodelivery via transdermal, nasal, ocular, and pulmonary channels. Different cargo delivery is possible with many synthetic cationic polymers, including amidised acid-labile25. Problems relating to toxicity might be resolved by altering their structure24. According to a recent study, sonophoresis and arginine ended peptide dendrimers can greatly boost ketoprofen’s transdermal penetration.
3.4 Nanoemulsion:
Thermally stable and filtration-sterilisable, nanoemulsions present an intriguing colloidal drug delivery system26,27. Small-scale distributed nanodroplets are produced by the heterogeneous mixing of oil droplets in aqueous environments. The final nanoemulsions are examined to see whether they are clear or translucent, isotropic, and supported by the appropriate surfactant28. There are three kinds of nanoemulsions that can be made:
A. Nanoemulsion of water in oil
B. Nanoemulsion of oil in water
C. The nanoemulsion that is bi-continuous.
3.5 Nanogels:
It is possible to create nanogels as ordinary gels as they are made of flexible hydrophilic polymers29. The medication can be sporadically added to the nanogel once it has swelled. Consequently, the gel compresses, forming compact, solid nanoparticles with a lower solvent content. Because of their high moisture content, mechanical suitability, and biocompatibility, nanogels provide new uses for polymer-based drug carrier systems. These gels have an internal network for biomolecule trapping as well as increased polyvalent bioconjugation surface area. As a targeted route of drug delivery, the physical encapsulating of bioactive chemicals in polymeric interlocks together with their release pattern has been extensively studied30. A number of techniques are used to generate nanogels, such as heterogeneous controlled radical and free radical polymerizations, biopolymer modification, and micro-molding and photolithographic techniques31.
3.6 Nanosponges:
Nanosponges have drawn the interest of drug delivery scientists in pharmaceutical science as they have the capacity to load both hydrophilic and lipophilic moieties 32,33. These are thin, non-toxic, porous colloidal structures of scaffolds that have multiple cavities where drug molecules can be stuck. In the processing of these Nanocarriers, α-cyclodextrins are the most commonly used. It is possible to investigate different crosslinkers in their development, such as hexamethylene di-isocyanate, carbonyl di-imidazole, pyromellitic dianhydride, diphenyl carbonate, etc. In Water as well as in organic solvents, these structures are insoluble34, self-sterile35,36 and stable up to 300°C and pH range of 2–11. Using ultrasound-assisted synthesis techniques, Trotta and colleagues produced cyclodextrin nanosponges38 and examined them for anti-tumor drugs37.
4. Challenges related to Nanomedicines:
According to certain reports, fewer than 10% of basic knowledge was translated into clinical practice39,40.
Thus, it does not appear convenient for drugs to pass through the “valley of death.” This will increase the cost of healthcare overall by resulting in a laborious, drawn-out, and pointless process of evaluations41. Perhaps a variety of domains and procedural aspects contribute to this unpleasant state of affairs. The behavior of nanoparticles in vivo, which is anticipated to differ somewhat from that in vitro, is one of the main issues. The main issues that require in-depth investigation utilizing diverse animal (in vivo) models include diffusion, biocompatibility, tissue transfer, and cellular interactions. Conducting tests of this nature to offer sufficient evidence of efficacy and protection is neither easy nor inexpensive. The heterogeneity and diverse character of tumors in particular present another challenge for tumor-targeted nanoformulations. Tumor-targeted NPs may have difficulty penetrating and become less effective due to variations in gene expression profiles, molecular patterns, and drug resistance levels amongst various cancers42,43. Despite encouraging preclinical evidence from animals, this obstacle may result in a failed clinical study and the rejection of the investigated nanoformulations.Other parameters that require exact expert experimentation include relevant drug penetration into tumors, the effectiveness of drug release into target cells, and the quality of drug-loaded nanoparticles42.
This thorough investigation might not be feasible in all biomedical facilities due to time and financial constraints, which raises further concerns. An additional barrier to the acceptability of nanoformulations may come from their multifunctional composition and mode of activity. Numerous research nanoformulations feature distinct medicinal and diagnostic components and a hybrid structure. The long-term biocompatibility of such systems is still unclear, and additional studies are needed to verify their protection44,45. The regulatory authorities have differing constraints about this matter, and in order to ensure the long-term safety of these theranostic nanoformulations, extensive and expensive regulatory investigations will be required. Numerous traditional methods for synthesizing nanoformulations are still lacking and require further development and optimization. Another issue that may prevent sufficient stocks of nanoformulations from being developed for market approval is batch-to-batch volatility. It is anticipated that modernizing production processes and characterizing nanoformulations with extreme precision will be costly, time-consuming, and labor-intensive44,46.
5. Future of Nanomedicines and drug delivery system:
One of the most exciting fields of research right now is nanomedicine science. Over the past 20 years, a great deal of research in this field has already resulted in the filing of 1500 patents and the conclusion of several dozen clinical trials47. The greatest example of a disease whose diagnosis and treatment have benefited from non-medical technologies seems to be cancer. Applying nanomedicine and nano-drug delivery systems to accurately deliver medication to diseased cells, such as cancer/tumor cells, without interfering with normal cell physiology, is a promising trend that will undoubtedly continue to be the focus of research and development for many years to come. This is because different types of nanoparticles can be used for this purpose. While some nanoparticles are measured in sub-micrometers, the examples of nanoparticles demonstrated true measurement in nanometers. The next line of inquiry would be to investigate materials with more reliable homogeneity and drug loading and release capabilities. This review also covers a significant amount of advancement in the use of metal-based nanoparticles for diagnostic applications.
Future study in this area may lead to a larger use of nanomedicines. Examples of these metals are gold and silver, and their use in both diagnostic and therapy. Gold nanoparticles, which seem to be well absorbed in soft tumor tissues and make the tumor sensitive to radiation (such as in the near infrared area) based heat therapy for selective elimination, are one main source of interest in this direction. Even in the detection and treatment of cancer, the true influence of nanomedicine and nano-drug delivery systems on the healthcare system is still very small, despite the widespread understanding of their promising future. This is explained by the fact that there has only been two decades of substantial research in the field, making many important basic characteristics still unknown. The essential indicators of sick tissues containing crucial biological markers that allow absolute targeting without disrupting the normal cellular process is one main future field of research. Hence, future developments in nanomedicine applications will result from our growing awareness of the molecular markers of disease. Beyond what we have described in this study using the available nanoprobes and nanotheragnostics devices, more investigation is necessary to enable the broader use of nanomedicine. The idea of precisely releasing targeted medications at the affected locations, the technology to evaluate these occurrences, the impact of the drug at the cellular and tissue levels, and the theoretical mathematical models of prediction are still in their infancy.
Many studies in the field of nanomedicine are focused on formulation and biomaterials, which seem to be the first steps toward biomedicine applications. Research involving animals and diverse teams requiring significant time and financial resources will yield valuable data that may find use in pharmacological therapy and diagnostic tests. The trend toward more accurate diagnosis and medication delivery is becoming more widespread, and this bodes well for a more sophisticated and multi-centered approach to nanomedicine and nano-drug delivery technologies. A lot of excitement has been generated by the simple idea of developing nanorobots (and nanodevices) with full external control mechanisms for tissue diagnosis and repair. This is still a futuristic research goal that may be accomplished by humanity in the very near future; it has not yet become a reality.As with their benefits, however, the potential risk of nanomedicines both to humans and the environment at large require long term study too. Hence, proper impact analysis of the possible acute or chronic toxicity effects of new nanomaterials on humans and environment must be analyzed. As nanomedicines gain popularity, their afordability would be another area of research that needs more research input. Finally, the regulation of nanomedicines, as elaborated in the previous section will continue to evolve alongside the advances in nanomedicine applications.
CONCLUSION:
The present review discusses the recent advances in Nanomedicines, including technological progresses in the delivery of old and new drugs as well as novel diagnostic methodologies. A range of nano-dimensional materials, including nanorobots and nanosensors that are Applicable to diagnose, precisely deliver to targets, sense or activate materials in live system have been outlined. Initially, the use of nanotechnology was largely based on enhancing the solubility, absorption, bioavailability, and Controlled-release of drugs. Nowadays, as opposed to half a century ago, finding pharmacologically active chemicals in natural sources is not as popular; as a result, using nanotechnology to increase the potency of known natural bioactive compounds has become standard practice. The medicinal use of nanotechnology for resveratrol, quercetin, ellagic acid, berberine, and curcumin are good examples. The use of nanocarriers formulated with solid lipid nanoparticles, crystal nanoparticles, liposomes, micelles, superparamagnetic iron oxide nanoparticles, and dendrimers along with gold, silver, cadmium sulfide, and titanium dioxide polymeric nanoparticles has significantly increased the efficacy of these natural products. Because of their qualities of being biodegradable, biocompatible, easily available, renewable, and low toxicity, novel natural biomaterials have been in high demand.
Research on enhancing the stability of natural biopolymers, such as proteins and polysaccharides, in an industrial processing environment and biological matrix by means of crosslinking techniques is currently one of the most advanced areas of study. Surfactant-free emulsion polymerization, solvent evaporation, and emulsion polymerization have all been used extensively to create polymeric nanoparticles (nanospheres and nanocapsules). With cancer serving as a disease model, one of the main areas of focus in the development of nanomedicine in recent years has been the integration of therapy and diagnosis (theranostic).Some notable examples include the use of alginate and folic acid-based chitosan nanoparticles for photodynamic detection of colorectal cancer, the use of cathepsin B as a metastatic process, the conjugation of fluorogenic peptide probes to glycol chitosan nanoparticles, the use of iron oxide-coated hyaluronic acid as a biopolymeric material in cancer therapy, and dextran, among others.
The number of FDA-approved products based on nanotechnology and clinical trials has skyrocketed since the 1990s. These include nanocrystals, liposome formulations, micellar nanoparticles, protein nanoparticles, synthetic polymer particles, and many more, frequently used in conjunction with medications or biologics. Even though safety and toxicity evaluations and regulatory mechanisms for nanomedicines will continue to be researched and developed, nanomedicine has already fundamentally changed how we find and use medications in biological systems. The development of nanomedicine has made it possible for us to diagnose illnesses and even combine diagnosis and treatment.
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Received on 30.01.2024 Modified on 29.02.2024
Accepted on 20.03.2024 ©Asian Pharma Press All Right Reserved
Asian J. Pharm. Tech. 2024; 14(2):135-140.
DOI: 10.52711/2231-5713.2024.00024