1. INTRODUCTION:

1.1 Drug Delivery:

Drug delivery is the process of administering a pharmacological material to humans or animals in order to achieve a therapeutic effect. Inhalation, topical (skin), transmucosal (nasal, buccal, sublingual, vaginal, ophthalmic, and rectal), and oral (through the mouth) are the most widely used non-invasive administration methods.Since many medications, such as peptide and protein, antibodies, vaccines, and gene-based drugs, may be susceptible to enzymatic degradation or ineffectively absorbed into the systemic circulation due to issues with molecular size and charge, they may not be administered through these routes for therapeutic purposes. Injections must be used to give medications that contain proteins and peptides.¹

1.2 Novel Drug Delivery System:

A new approach to safely delivering pharmaceutical compounds into the body where they are needed to create the desired pharmacological effects is known as a novel drug delivery system (NDDS). It entails innovative approaches, new technologies, formulations, and creative innovation.² When a medicinal ingredient is delivered throughout the body as needed to safely provide the desired therapeutic effects, it is referred to as a "novel drug delivery system" (NDDS).³ The innovative gadget uses a cutting-edge approach to medicine delivery. Recent advances in our understanding of the pharmacokinetic and pharmacodynamic behaviour of medications have made it possible to design the optimal medication administration system in a more rational manner.

The novel drug delivery systems (NDDS) carriers keep the drug concentration within the therapeutic range for long periods of time.⁴ Drug carriers include soluble polymers, microparticles made of natural and synthetic polymers that are either insoluble or biodegradable, microcapsules, cells, cell ghosts, lipoproteins, liposomes, and micelles. The effectiveness of a drug can be significantly impacted by how it is administered. For certain medications, the greatest therapeutic benefit can be obtained at a range of concentrations; dosages outside of this range may be hazardous or have no effect at all. However, a growing need for a multidisciplinary approach to delivering drugs to particular targets within tissues has been highlighted by the poor progress made in improving the efficacy of treating critical disorders. New concepts were consequently developed to regulate the pharmacokinetics, pharmacodynamics, immunogenicity, biorecognition, and non-specific toxicity of medications. These innovative methods, referred to as "drug delivery systems" (DDS), are founded on interdisciplinary approaches that integrate bioconjugate chemistry, pharmaceutics, polymer science, and molecular biology. In order to reduce drug loss and degradation, avoid adverse effects, improve medication bioavailability, and raise the proportion of the drug accumulated in the necessary zone, numerous drug delivery and targeting systems are now being developed. Previously only a dream or, probably, a potential, managed.⁵

2. Objective of NDDS:

· The primary goals in developing nanoparticles as delivery devices are:-

· To monitor particle size

· To monitor surface quality

· To the delivery of active pharmaceuticals to provide site-specific action rapidly.

· To establish a medication dosing schedule

· To minimize adverse interactions

3. Characteristics of Novel Drug Delivery System:

· Boost the bioavailability

· Deliver the medication in a controlled manner.

· Under a variety of physiological conditions, stability and delivery are maintained.

· Safe, dependable, and simple to administer. economical.

4. METHOD AND MATERIALS:

4.1 Classification of Novel Drug Delivery System (NDDS):

Flow Chart 1: Classification of Novel Drug Delivery System.^2,3,5,7,17

4.2 Targeted Drug Delivery System:

medications. ^2,
5 Advanced technologies known as targeted drug delivery systems (TDDS) are made to more precisely administer medications to particular parts of the body, reducing side effects and enhancing therapeutic results. By ensuring that the active pharmaceutical ingredient (API) is released at the appropriate time, in the appropriate dosage, and at the appropriate location, these systems seek to increase the bioavailability and effectiveness of.

4.3 Sustained Release:

Out of all the drug administration routes, the oral route is the most effective. This is a result of benefits like low production costs, simplicity of use, and other alternatives that have been investigated for systemic drug delivery via a range of pharmaceutical products with diverse dose forms. The main objective of many medications is to reach a steady state blood level that is both therapeutically effective and long-lasting without being harmful. To do this, the appropriate dosage form design is a crucial component.⁶ By continually releasing medication over a lengthy period following the administration of a single dose, sustained-release dosage forms were created to create a prolonged therapeutic impact.⁷ The main objective of developing sustained-release formulations was to change and improve the medicine's efficacy by extending its duration of action, decreasing the frequency of dosages, lowering the necessary dosage, and guaranteeing steady drug delivery.⁸ Continuous-release drug delivery systems have witnessed a significant increase in interest during the past two to three decades. It has turned out to be unaffordable to develop new drug entities. The expiration of existing globalisation patents, the creation of novel polymeric components that can extend drug release, and the enhancement of therapeutic efficacy and safety brought about by these delivery systems are further significant causes.⁹ A sustained-release formulation maintains a constant blood level of the drug, which enhances pharmacological efficacy and patient compliance. The kind and amount of various natural and synthetic polymers used in the formulation of a sustained release dosage form largely dictates the release rate. Continuous-release dose forms are constructed using a common matrix of hydrophilic polymers.¹⁰ By offering site-specific targeting, regulated, and prolonged release, the sustained release matrix type drug delivery system (SDDS), a novel drug delivery system (NDDS), significantly increases the therapeutic efficacy of medications.¹¹ To minimise adverse effects, the drug is administered at a constant dosage for a specified period of time. The basic concept of a sustained-release drug delivery system is to maximise its use, reduce its side effects, and effectively cure the disease by optimising its pharmacokinetic, pharmacodynamic, and biopharmaceutical features in comparison to traditional dose forms.

Graph 1: Plasma drug concentration profile for conventional release, a sustained release and zero-order controlled release formulation ^12,13

Advantage:

· decreased frequency of dose.

· increased adherence from patients.

· decreased toxicity as a result of overdosing.

· Dosing at night can be avoided.

· consistent release of medicinal ingredients throughout time.

· Minimise negative side effects.

· consistent pharmacological reaction.

Disadvantages:

· delay in the action's start.

· Dumping doses.

· increased formulation costs.

· decreased possibility of changing the dosage.

4.4 Controlled Release:

In order to minimise adverse effects and maintain a consistent drug concentration for a defined period of time, a controlled or sustained release dosage form delivers a pharmaceutical at a predetermined rate. With a single dose, this kind of dosing is used to extend the therapeutic effect.¹⁴ Even if the dose size is larger than one normal dose, the overall daily dose is decreased. As a result, much research has been conducted to reduce the frequency of administration. The outcome is the development of a medication delivery system with sustained or regulated release.¹⁵ When a polymer and medication or active ingredient are combined, controlled delivery of the medication is made possible, allowing the drug to be released at the right time, place, and rate. The primary objective of controlled drug administration is to alter the pharmacokinetic and pharmacodynamic properties of the pharmacological substance. This can be achieved by employing a special drug delivery technique or by altering the molecular structure and physiological properties¹⁶.

Graph 2: Comparison of conventional and controlled release profiles ^12,13

Advantage:

· Use the bare minimum of drugs.

· shorter length of time for treatment.

· enhanced safety or efficacy ratio.

· More quickly confirm cure or control.

· Reduce drug buildup with long-term dosage. .

· CRDDS Increase bioavailability by improving absorption and utilisation.

· consistent medication effect.

Disadvantage:

· Reduce systemic accessibility.

· In vitro-in vivo correlation is poor.

· elevated poisoning risk.

· challenging in the event of toxicity.

· The system needs to be physically taken out of the implant locations.

· reduces the amount of room for dose modification.

4.5 Drug Carriers:

Diagram 1: ^2,3,5,17

4.5.1. Nanoparticles:

From a scientific perspective, we know that creating engineering nanomaterials has a significant benefit in improving disease diagnosis and treatment.¹⁸ By specifically altering nanomaterials and delivering desired molecules to certain organelles, nanotechnology can help with medicine distribution. Over the past 20 years, the nanotechnology program has developed globally since the US National Science and Technology Council (NSTC) formed the National Nanotechnology Initiative (NNI) in 2000 and offered precise goals and key difficulties in this field.¹⁹ Nanoparticles (NPs), which differ in their source and processing, are a major component of all designs. Forever, a number of variables, including temperature, pH, the chemical structures of the tiny medicinal molecules and their transporters, formulation, NP composition, and others²⁰ impact the NPs' stability and solubility, improving their efficacy and safety in the process. NPs have grown in popularity and shown encouraging results in pre-clinical and clinical settings with these objectives in mind.²¹ It is particularly important to have a complete understanding of NPs' development as soon as possible, given the broad spectrum of applications for nanoparticle-based precision treatments, such as immunotherapy, cancer treatment, and most recently, viral infections.²² We will review and report on many of the most often utilised NPs in terms of preparation and precision medicine application to help optimise approaches from design to clinical use.²³

Method For Synthesis Nanoparticles:

The synthesis of nanoparticles can be done in three primary ways, which are as follows: 1) Physical approach: Electrochemical, ultrasonication, laser ablation, irradiation, evaporation, and condensation nanoparticles are sub-methods of the physical method. 2) Chemical Method: Etching, Mechanical Milling, Laser Ablation, Sputtering, and Thermal Decomposition are examples of chemical procedures and their sub-methods. 3) Biology Method: Green synthesis is a component of the biological method and is separated into two categories. 1) Plants: The leaves, roots, flowers, fruits, and other plant parts are utilised to create synthesis nanoparticles. 2) Microorganisms: A variety of microorganisms, including fungi, bacteria, algae, and yeast, are utilised to synthesise nanoparticles.^{25, 26}

Green Synthesis (Plants):

Flow Chart 2: In the Flow Chart Biosynthesis of Nanoparticle via the green route using plant Extract^27,28

Mechanism Of Actions Nanoparticle: By interacting with biological systems at the cellular and molecular levels, nanoparticles mostly use one of several modes of action to achieve their effects. Through mechanisms such as endocytosis and receptor-mediated uptake, they can permeate cell membranes and enable the targeted delivery of therapeutic substances or medications. Once within the cell, nanoparticles can localise to particular organelles, release their payload, or produce reactive oxygen species, all of which can increase the effectiveness of treatment. Their surface characteristics also enable interactions with proteins, resulting in the formation of a protein corona that affects biological behaviour. In the end, these systems make it possible to use drugs, imaging, and targeted therapy, which could lead to better treatment outcomes for a variety of illnesses.^{25, 26, 29}

Nanoparticles Based Different Types of Drug Delivery Systems:

Flow Chart 3: Nanoparticle-Based Different Types of Drug Delivery Systems ^{22, 24,
30, 31}

4.5.2. Phytosome:

Plants are referred to as "phyto" and cell-like structures as "some." It is a proprietary technique developed and introduced by a top herbal medicine and nutraceutical firm.³² Phytosomes are a novel, cutting-edge dose formulation technique that improves the absorption of herbal goods and medications, leading to superior outcomes compared to traditional herbal extracts.³³ This phytosome technology represents a substantial advancement in terms of improved bioavailability, increased clinical benefit, guaranteed tissue delivery, and preservation of nutrient safety. By reacting with the phospholipids also known as the phytosomes, some water-soluble phytomolecules (mostly flavonoids and other polyphenols) can be converted into lipid-friendly complexes.³⁴

Although phosphatidylcholine, phosphatidylserine, phosphatidylethanolamine, and phosphatidylinositol are among the phospholipids used, phosphatidylcholine is most commonly used because of its potential therapeutic benefit in cases of alcoholic steatosis, drug-induced liver damage, hepatitis, and liver disorders. Phospholipids are also utilised as carriers of nutrients that are both fat- and water-miscible and as natural aids in digestion.³⁵ The stratum corneum layer of the skin and the lipophilic pathway of enterohepatic cell membranes are both easily penetrated by phytosomes. Phytosomes are standardised plant extracts, mostly derived from flavonoids. Among the groups from which flavonoids are chosen are luteolin, luteolin glucoside, apigenin-7-glucoside, kaemferol, quercetin, quercetin-3, rhamnoglucoside, quercetin-3-rhamnoside, hyperoxide, vitexin, diosmin, 3-rhamnoside, (+) catechin, (-) epicatechin, ginkgonetine, isoginkgonetine, and bilobate.³⁶

Phytosomes Technology:

Flavonoids and terpenoids, found in plant extracts, are very favourable for direct binding to phosphatidylcholine. Phytosomes are created when a stoichiometric amount of phospholipid (phosphatidylcholine) reacts with a standardised extract or polyphenolic components (such simple flavonoids) in a nonpolar solvent.³⁷ Phosphatidylcholine is a bifunctional molecule due to the phosphatidyl and hydrophilic properties of the choline moiety and the phosphatidyl. The lipid-soluble phosphatidyl part, which is made up of the body and tail, envelops the choline-bound material, whereas the choline head of phosphatidylcholine attaches to these compounds specifically. As a result, the phytoconstituents create a phospholipid-compatible molecular complex called the phyto-phospholipid complex. Certain spectroscopic techniques can demonstrate that molecules have a chemical link with the phospholipids' polar choline head. The unit phytosome is frequently a flavonoid molecule linked to one or more phosphatidylcholine molecules, per exact chemical analyses. The result is the creation of a microscopic cell or microsphere. The phytosome method produces a small cell that protects the plant extract or its active ingredient from being broken down by stomach fluids and gut microorganisms since phosphatidylcholine has a gastroprotective.³⁸

Diagram 3: Structure Of Phytosomes^32,37

Formulations of Phytosomes:

Flow Chart 4 Formulations of Phytosomes: ^{33,35,36,37,39}

Mechanism Of Actions Phytosomes:

The poor absorption of nutrients including flavonoids can be attributed to two basic factors. First of all, these multiple-ring molecules are too big to diffuse from the colon into the blood or be efficiently absorbed by the intestinal lining, in contrast to numerous vitamins and minerals.⁴⁰ Second, flavonoid molecules typically have a limited miscibility with oils and other lipids. This severely reduces their ability to pass through the lipid-rich outer membranes of the enterocytes, the cells that line the small intestine. Phytosome technology provides a solution to this problem.⁴¹ Phytosomes are created when a standardised extract or polyphenolic components (such simple flavonoids) react with a stoichiometric amount of phospholipid (phosphatidylcholine) in a non-polar solvent.⁴² Phosphatidylcholine is a bifunctional molecule because its phosphatidyl and choline moieties are hydrophilic and lipophilic, respectively. The lipid-soluble phosphatidyl portion of the molecule, which includes the body and tail, envelops the choline-bound material, whereas the choline head of phosphatidylcholine attaches to these molecules specifically.⁴³ As a result, the phytophospholipid complex is a lipid-compatible molecular complex made up of phospholipids and phytoconsfacilitatediertain spectroscopic methods can demonstrate that molecules are chemically bound to the phospholipids' polar choline head.⁴⁴ Precise chemical research indicates that the unit phytosome is typically composed of a flavonoid molecule linked to at least one phosphatidylcholine molecule. This results in the formation of a microscopic microsphere or cell.⁴⁵

4.5.3. Liposomes:

Liposomes are spherical, concentric vesicles that were created by combining the Greek words "Lipos," which means fat, and "Soma," which means body. Bangham found that the phosphatidylcholine molecule was producing a closed bilayer shape with an aqueous segment confined by a lipid bilayer when he inadvertently distributed it in water in 1961. As a result, liposomes were first described.⁴⁶ Because liposomes may be readily altered to meet a variety of delivery needs, their adaptable physicochemical and biophysical characteristics make them a desirable delivery option. Liposomes are concentric, bi-layered vesicles that range in diameter from 0.01 to 5.0 μm. Membrane proteins, fatty acids, glycolipids, long chains of fatty acids, non-toxic surfactants, and sphingolipids can all make up their composition.⁴⁷ Liposomes are tiny colloidal particles composed of water areas encircled by one or more concentric spheres of lipid bilayer. Because liposomes can carry both hydrophilic and lipophilic compounds, they have attracted a lot of interest as a drug carrier for drug delivery systems (DDSs).⁴⁸ The word "liposome" can also refer to synthetic, microscopic vesicles made of one or more phospholipid concentric layers and a fluid compartment. Additional content, including peptides, proteins, hormones, enzymes, antibiotics, antifungals, and anticancer medicines, is contained in the sphere-like encapsulated liquid interior. Liposomes are tiny, spherical, manufactured vesicles with varying sizes, hydrophobic and hydrophilic properties that can produce cholesterol and naturally non-toxic phospholipids. They serve as delivery systems for nutrition and prescription medications. They exhibit the following characteristics: 1) Hydrophilic head; 2) Lipophilic tail.⁴⁹

Structural Components of Liposomes: Liposomes are lipid bilayers with a width ranging from 50 to 1000 nm that are used as targeted delivery vehicles for biological compounds. The two main components of a liposome are cholesterol and phospholipids.

Phospholipids: It is an essential component of the construction of the liposome. It is amphiphilic by nature and has outstanding biocompatibility. There are two types of phospholipids found in it: sphingolipids and phosphoglycerides. Phospholipids are most commonly found as PC molecules. Phospholipids transport drugs that are soluble in fat or water to their intended location. Examples of phospholipids include: ⁵⁰ Lecithin, or phosphatidyl choline, Cephalin, or phosphatidyl ethanolamine - PE, PS, or phosphatidyl serine, Inositol phosphatidyl (PI), Glycerol phosphatidyl (PG)

Cholesterol: Cholesterol is another essential component in liposome structure. This is a commonly used sterol. The presence of steroids modifies the function of stiffness and rigidity. It cannot build a bilayer structure by itself 11. Up to a molar ratio of 1:1 or 2:1 between phosphatidylcholine and cholesterol, it is incorporated into phospholipids at extremely high concentrations. When cholesterol is present, the lipid bilayer becomes more stable and forms a robust, well-organised structure. Cholesterol improves cellular membranes' resilience and mobility while reducing their capacity to transfer water-soluble molecules. Cholesterol prevented liposome destabilisation and interaction.⁵¹

Mechanism of Actions Liposomes: Originally described as a biological membrane model in 1965, liposomes were quickly employed to deliver medications to cells. Liposomes are classified as either pH-sensitive liposomes or cationic liposomes because they can trap DNA in one of two ways. Positively charged liposomes known as cationic liposomes form a stable bond with negatively charged DNA strands.⁵³ Cationic liposomes are composed of a positively charged lipid and a co-lipid. Co-lipids that are frequently used include dioleoyl phosphatidylcholine (DOPC) and dioleoyl phosphatidylethanolamine (DOPE). Co-lipids, sometimes referred to as helper lipids, are typically required for the liposome complex to stabilise. Many formulations of positively charged lipids are already available on the market, and many more are in the process of being created. One of the cationic lipids that is most frequently cited is lipofectin. In 1987, Phil Felgner first demonstrated the possibility of gene transfer to cultured cells using lipofection, a commercially available cationic lipid.⁵⁴ Lipofection is a mixture of N- [1-(2, 3-dioleyloyx) propyl]. N-N-N-trimethylammonia chloride (DOTMA) and DOPE. Complexes with 100% loading efficiency are created spontaneously by the combination of DNA and lipofection. In other words, all of the DNA is complexed with lipofection if there is enough of it available. The DOTMA's positively charged groups are thought to interact with the DNA molecule's negative charge. The lipid:DNA ratio and total lipid concentrations used to create these complexes are essential for efficient gene transfer and vary based on the application. RNA, plasmid DNA, and linear DNA have all been introduced into a variety of cultivated cells using lipofectin. Shortly after its debut, it was shown that lipofection may be used to transmit genes in vivo. Following intravenous administration of lipofection-DNA complexes, the lung and liver showed a significant tendency for both transgenic expression and absorption of these complexes.⁵⁵ Although the results of injecting these complexes into various organs have been mixed, lipofection-mediated gene transfer into the liver or lung is often more effective. Negatively-charged liposomes, which are pH-sensitive, trap DNA instead of forming complexes with it. Because the lipid and the DNA have identical charges, repulsion rather than complex formation takes place. Nevertheless, some DNA can become trapped in the liposomes' watery interior. The phrase "pH-sensitive" refers to the fact that low pH can sometimes destabilise these liposomes. When it comes to gene delivery, cationic liposomes have outperformed pH-sensitive liposomes thus far, both in vivo and in vitro. Compared to their cationic counterparts, pH-sensitive liposomes have the potential to be far more effective at delivering DNA in vivo and should be less toxic and susceptible to serum protein interference.⁵⁶

4.5.4. Niosomes:

A nonionic surfactant, cholesterol admixture, and a charges-inducer are combined to form niosomes, which are lamellar microscopic structures that are then hydrated in watery environments.⁵⁷ They have been tested in a number of pharmaceutical applications and contain an infrastructure of hydrophobic and hydrophilic moieties that can hold drug molecules with a variety of solubilities. The ability to slow down drug release from the body and reduce systemic toxicity by encapsulating therapy agents are notable benefits in clinical application.⁵⁸

4.5.5. Transdermal Drug Delivery Systems (TDDS):

Transdermal drug delivery systems (TDDS), sometimes known as "patches," are dosage forms designed to administer a therapeutically effective dosage of medication through a patient's skin. The entire morphological, biophysical, and physicochemical characteristics of the human skin must be considered when administering therapeutic medications for systemic effects through the skin. By increasing patient compliance and preventing first-pass metabolism, transdermal administration offers a competitive advantage over injectables and oral techniques, respectively. Transdermal distribution not only makes it possible to continuously provide drugs with short biological half-lives, but it also stops pulsed entry into the systemic circulation, which commonly leads to undesirable side effects. Thanks to technical improvements, the pharmaceutical sector has made all of its resources fashionable. In place of the traditional dosage form that we previously employed, we now employ a novel medication delivery system. One of the most inventive ways to distribute new medications is through transdermal patches. One advantage of transdermal drug delivery systems is that they are a painless way to provide medications.⁵⁹ Nowadays, 74% of drugs are taken orally, and they aren't as helpful as most people believe. To enhance these attributes, transdermal drug delivery devices were created. With the creation of contemporary pharmaceutical dosage forms, transdermal drug delivery systems (TDDS) emerged as a key element of novel drug delivery systems. Because of their special advantages, transdermal dosage forms are becoming more and more popular even if they are more costly than traditional formulations. Increased bioavailability, regulated absorption, more stable plasma levels, painless and fewer side effects, simplicity of use, and the option to halt drug administration by simply removing the patch from the skin are some potential advantages of transdermal pharmaceutical delivery.⁶⁰ TDDS is a component of the novel drug delivery system. Since the beginning of time, people have applied a variety of materials to their skin as cosmetics and therapeutics. The skin was first used as a long-term drug delivery system in the tenth century. One of the most reliable and effective ways to deliver medication is through the skin. Transdermal delivery has become one of the most innovative and effective ways to administer medications.⁶¹ Transdermal drug delivery systems are polymeric patches containing dissolved or dispersed medications that gradually distribute therapeutic agents through the skin. Despite the fact that transdermal delivery has greatly enhanced medical practice, its potential as an alternative to oral and hypodermic injections has not yet been fully realised. The theory behind TDDS is that it can continually deliver medications over a long period of time while preserving the drug's plasma concentration. It is possible to configure TDDS to maintain plasma drug levels and input medications at the proper rate for therapeutic efficacy. The efficacy of a transdermal system ultimately depends on the drug's ability to sufficiently penetrate the skin to have the desired therapeutic effect.⁶²

The fact that transdermal medicine administration is typically painless is one advantage. The skin is a common option for drug delivery due to its huge surface area, systemic access through underlying lymphatic and circulatory networks, simplicity of access, and noninvasive drug delivery. Ciba-Geigy first used transdermal distribution, or the transmission of drugs through the skin for a systemic impact, in 1981 when they created Transderm to treat nausea and vomiting associated with motion sickness. A stable blood level profile, controlled drug release into the patient, a reduction in systemic side effects, and sometimes even greater efficacy than other dosing forms are all made possible by transdermal medicine delivery. A transdermal drug delivery system's main objective is to distribute medication via the skin at a predetermined rate with the least amount of variation possible within and among individuals.⁶³ TDDS has had a significant impact on the delivery of several therapeutic drugs, especially in the fields of hormone therapy, pain management, and the treatment of heart and central nervous system problems. Because TDDS does not require transit via the gastrointestinal tract, drugs can be given without being affected by intestinal flora, pH, or enzymes. Loss from first-pass metabolism is also eliminated. Moreover, TDDS can be used to control the release of medications by limiting their consumption, which increases the method's high persistence. Most significantly, TDDS, a noninvasive administration approach that imposes minimal discomfort or pressure on the patient, makes it possible to safely and conveniently administer medications to elderly or young patients.⁶⁴

5. CONCLUSION:

Innovative Drug Delivery System (NDDS): When paired with cutting-edge technique, new dose forms—also referred to as NDDS—are a far better choice than conventional dosage forms. Patient benefits, improved therapy, improved comfort and quality of life, effective use of expensive drugs and excipients, and lower production costs are all advantages of the Novel Drug Delivery System. The basic types of novel drug delivery systems include targeted drug delivery, controlled drug delivery, and other related strategies. Innovative methods are used in pharmaceutical research to target and deliver drugs. Drug delivery, vaccine delivery, gene therapy, and the creation of new commercially available products including transdermal drug delivery systems, phytosomes, liposomes, niosomes, and nanoparticles are a few examples. Nanoparticle-based trading systems regulate and target drug delivery systems. Nanoparticles are one of the cutting-edge medication delivery technologies; they can be used in paints, textiles, and cosmetics in addition to controlling and directing drug administration. It seems that the biopharmaceutical sector sees nanoparticulate drug delivery systems as a viable and promising strategy, given the current level of interest and the track record of success.

6. RESULT:

Novel drug delivery systems, or NDDS, are a significant development in the pharmaceutical business that aim to improve the efficacy, safety, and patient compliance of the treatments. These systems use a number of state-of-the-art methods, such as liposomes, dendrimers, nanoparticles, and micelles, to more precisely deliver drugs to particular body locations. One of the key benefits of NDDS is that increasing a drug's bioavailability guarantees that a greater concentration of the drug reaches the intended site of action. When adverse effects are eliminated and the required dosage is reduced through targeted delivery, treatments become more compassionate and effective for patients. For instance, in cancer treatment, NDDS can deliver chemotherapy medications straight to malignant cells while preserving healthy tissues and reducing toxicity. The creation of NDDS has been sped up by recent advancements in nanotechnology, which have also made it feasible to create intelligent drug delivery systems that respond to specific stimuli like pH, temperature, or enzyme levels. These systems allow for the controlled release of drugs, which has long-term therapeutic advantages. With more personalised and efficient treatment options for a range of diseases, NDDS has the potential to drastically change the way we deliver medication.

7. REFERENCE:

1. Nuno Martinho, Christiane Damge, Catarina Pin. Recent Advances in Drug Delivery Systems. Journal of Biomaterials and Nanobiotechnology. 2011; 2: 510-526

2. Snehal Ashok Gavhane Aditi Tukaram Gade. The Novel Drug Delivery System. International Journal of Creative Research Thoughts (IJCRT). 2021; 9(9): 373-385

3. Bhagwat N. Poul, Vikas Ashokrao Kokare, Anil Kumar, Suhas Narayan Sakarkar, Neha Laxane, Anamika Singh, Amit Sureshrao Sontakke, Yash Dhubkaria and Gourab Saha. Novel Drug Delivery System: an approach of drug delivery. World Journal of Pharmaceutical and Life Sciences. 2024; 10(20: 122-128

4. Mohd. Gayoor Khan. Topic - The Novel Drug Delivery System. World Journal of Pharmacy and Pharmaceutical Sciences. 2017; 6(7): 477-487

5. Kanchan R. Pagar, Sarika V. Khandbahale. A Review on Novel Drug Delivery System: A Recent Trend. Asian Journal of Pharmacy and Technology. 2019; 9(2): 135-140

6. Sandhya Mishra. Sustained Release Oral Drug Delivery System: A Concise Review. International Journal of Pharmaceutical Sciences Review and Research. 2018; 54(1): 5-15

7. Sarika S. Lokhande, Phalke N. N. and Badadare S. S. A Review On Sustained Release Technologies. World Journal of Pharmaceutical and Medical Research. 2019; 5(11): 60-65

8. A. Rohit Kumar and Arjun Sai Sreekar Aeila. Sustained Release Matrix Type Drug Delivery System: An Overview. World Journal of Pharmacy and Pharmaceutical Sciences. 2019; 8(12): 470-480

9. Sahilhusen I Jethara, Mukesh R Patel, and Alpesh D Patel. Sustained Release Drug Delivery Systems: A Patent Overview. Aperito Journal of Drug Designing and Pharmacology. 2014; 1(1): 1-14

10. Pawan Jalwal, Balvinder Singh and Surender Singh. A comprehensive review on sustained release drug delivery systems. The Pharma Innovation Journal. 2017; 7(1): 349-352

11. Obaid Afzal, Abdulmalik S. A. Altamimi, Muhammad Shahid Nadeem, Sami I. Alzarea, Waleed Hassan Almalki, Aqsa Tariq, Bismillah Mubeen, Bibi Nazia Murtaza, Saima Iftikhar, Naeem Riaz and Imran Kazmi. Review Nanoparticles in Drug Delivery: From History to Therapeutic Applications. Nanomaterials. 2022; 12: 1-27

12. Udhir Karna, Shashank Chaturvedi, Vipin Agrawal, Mohammad Alim. Formulation Approaches for Sustained Released Dosage Form: A Review. Asian Journal of Pharmaceutical and Clinical Research. 2015; 8(5): 46-53

13. Priyanka Prajapat, Dilip Agrawal, Gaurav Bhaduka. A Brief Overview of Sustained Released Drug Delivery System. Journal of Applied Pharmaceutical Research. 2022; 10(3): 5-11

14. Debjit Bhowmik, Harish Gopinath, B. Pragati Kumar, S. Duraivel, K. P. Sampath Kumar. Controlled Release Drug Delivery Systems. The Pharma Innovation. 2012; 1(10): 24-32

15. Bindu Kumari, Ayush Garg, Jayesh Dwivedi and Ranu Sharma. A Review on Controlled and Sustained Released Drug Delivery System. 2022; 11(11): 213-234

16. Sukanya Patil Jaya Agnihotri. Sustained and Controlled Drug Delivery System: A Review. International Journal of Pharmacy and Pharmaceutical Research. 2022; 23(4): 258-282

17. Sameeksha Jain, Meena Kirar, Mahima Bindeliya, Lucky Sen, Madhur Soni, Md Shan, Arpana Purohit, Prateek Kumar Jain. Novel Drug Delivery Systems: An Overview. Asian Journal of Dental and Health Sciences. 2022; 2(1): 33-39

18. Ashara Kalpesh C., Paun Jalpa S., Soniwala M.M., Chavada J.R., Badjatiya J.K. Nanoparticulate Drug Delivery System: A Novel Approach. International Journal of Drug Regulatory Affairs. 2013; 1(2): 39-48

19. Adaeze Linda Onugwu, Chinekeu Sheridan Nwagwu, Obinna Sabastine Onugwu, Adaeze Vhidiebere Echezona, Chinazom Precious Agbo, Stella Amarachi Ihim, Prosper Emeh, Obioma N namani, Anthony Amaechi Attama, Vitaliy V. Khutoryanskiy. Review article Nanotechnology-based drug delivery systems for the treatment of anterior segment eye diseases. Journal of Controlled Release. 2023; 354: 465-488

20. O. Cenk Aktas, Kathrin Puchert, Ekrem Efekan Vurucu, Bilge Ersöz, Salih Veziroglu and Sinan Sen. A review on nanocomposite coatings in dentistry. J Mater Sci Functional Nanocomposite Materials. 2024; 10: 1007,

21. Lakshmi Kumari, Yash Choudhari, Preeti Patel, Ghanshyam Das Gupta, Dilpreet Singh, Jessica M. Rosenholm, Kuldeep Kumar Bansal, and Balak Das Kurmi. Review Advancement in Solubilization Approaches: A Step towards Bioavailability Enhancement of Poorly Soluble Drugs. Life. 2023; 13(1099): 1-33

22. Ahmed A. H. Abdellatif and Abdullah Fahad Alsowinea, Approved and marketed nanoparticles for disease targeting and applications in COVID-19. De Gruyter. 2021; 10(1515): 1941-1967

23. Jianhua Yang, Chengyou Jia, Jianshe Yang. Designing Nanoparticle-based Drug Delivery Systems for Precision Medicine. International Journal of Medical Sciences. 2021; 18(13): 2943-2949

24. Fangyu Yang, Jianjiang Xue, Guixue Wang and Qizhi Diao. Nanoparticle-based drug delivery systems for the treatment of cardiovascular diseases. FPHAR. 2022; 2022: 999404

25. Faryad Khan, Mohammad Shariq, Mohd Asif, Mansoor Ahmad Siddiqui, Pieter Malan and Faheem Ahmad. Review Green Nanotechnology: Plant-Mediated Nanoparticle Synthesis and Application. Nanomaterials, 2022; 12: 673

26. Jagpreet Singh, Tanushree Dutta, Ki‑Hyun Kim, Mohit Rawat, Pallabi Samddar, and Pawan Kumar. Green synthesis of metals and their oxide nanoparticles: applications for environmental remediation. J Nanobiotechnol. 2018; 16(84): 1-24

27. Jayanta Kumar Patra and Kwang-Hyun Baek. Review Article Green Nanobiotechnology: Factors Affecting Synthesis and Characterization Techniques. Hindawi Publishing Corporation Journal of Nanomaterials. 2011; 417305: 1-12

28. Shobha G, Vinutha Moses and Ananda S. Biological Synthesis of Copper Nanoparticles and its impact - a Review. International Journal of Pharmaceutical Science Invention. (2014), 3, 8, 28-38

29. Pramila Khandel, Sushil Kumar Shahi. Microbes mediated synthesis of metal nanoparticles: current status and prospects. International Journal of Nanomaterials and Biostructures. 2016; 6(1): 1-24

30. Anirbid Sircar, Kamakshi Rayavarapu, Namrata Bist, Kriti Yadav, Surbhi Singh. Applications of nanoparticles in enhanced oil recovery. Petroleum Research. 2021. https://doi.org/10.1016/j.ptlrs.2021.08.004

31. Tarun Sahu, Yashwant Kumar Ratre, Sushma Chauhan, L.V.K.S. Bhaskar, Maya P. Nair, Henu Kumar Verma. Review article Nanotechnology based drug delivery system: Current strategies and emerging therapeutic potential for medical science. Journal of Drug Delivery Science and Technology. 2021; 63: 102487

32. R. P. Singh, S. Parpani, R. Narke, R. Chavan. Phytosomes: Recent Advances Research for Novel Drug Delivery System. Asian Journal of Pharmaceutical Research and Development. 2014; 2(30: 15-29

33. Chetan K. Nimbalkar, Ketan Hatware. Phytosomes- Novel Drug Delivery System. Indian Journal of Drugs. 2017; 5(10: 16-36

34. Jagruti Patela, Rakesh Patelb, Kapil Khambholjab, Nirav Patela. An overview of phytosomes as an advanced herbal drug delivery system, An overview of phytosomes. Asian Journal of Pharmaceutical Sciences. 2009; 4(6): 363-371

35. Ankur Choubey. Phytosomes: A Novel Approach for Herbal Drug Delivery. International Journal of Pharmaceutical Sciences and Research. 2011; 2(4); 807-815

36. Mahadev B. Khanzode Archana D. Kajale, Madhuri A. Channawar and Shilpa R. Gawande. Review on phytosomes: A novel drug delivery system. GSC Biological and Pharmaceutical Sciences. (2020), 13, 1, 203-211

37. Nilesh Jain, Brahma P Gupta, Navneet Thakur, Ruchi Jain, Jitendra Banweer, Deepak Kumar Jain, Surendra Jain. Phytosome: A Novel Drug Delivery System for Herbal Medicine. International Journal of Pharmaceutical Sciences and Drug Research. 2010; 2(4): 224-228

38. Amrita I. Jadhav, Amol A. Wadhave, Vilas A. Arsul, H. S. Sawarkar. Phytosomes: A Novel Approach in Herbal Drugs Delivery Systems. International Journal of Pharmaceutical and Drug Analysis. 2014; 2(5); 478-486

39. Devender Sharma, Ankita A. Bhujbale. Phytosomes is a Novel Drug Delivery System based herbal formulation: A Review. PharmaTutor. 2018; 6(3): 23-26

40. Kinjal Bera, and Madhavi Patel. Phyto Vesicular Drug Delivery System: A Review. Journal of Natural Remedies. 2022; 24(4); 503-515

41. Kattamanchi Gnananath, Kalakonda Sri Nataraj, Battu Ganga Rao. Phospholipid Complex Technique for Superior Bioavailability of Phytoconstituents. Advanced Pharmaceutical Bulletin. 2017; 7(1): 35-39

42. Vipin K Agrawal, Amresh Gupta, Shashank Chaturvedi. Improvement in Bioavailability of Class-lll Drug: Phytolipid Delivery System. International Journal of Pharmacy and Pharmaceutical Sciences. 2011; 4(1): 37-40

43. Anupama Singha, Vikas Anand Saharanb, Manjeet Singha, Anil Bhandaria. Phytosome: Drug Delivery System for Polyphenolic Phytoconstituents. Iranian Journal of Pharmaceutical Sciences. 2011; 7(4); 209-217

44. Shayeri Chatterjee Ganguly, Aliviya Das, SK Sangram, Disha Bhattacharya, Sayani Paul. Emergence of Phytosomes in the Field of Novel Drug Delivery System. Futuristic Trends in Pharmacy and Nursing. 2024; 3(18): 109-124

45. Afshin Babazadeh, Seid Mahdi Jafari, Bingyang Shi. Encapsulation of food ingredients by nanophytosomes, Lipid-Based Nanostructures for Food Encapsulation Purposes. 2019: 405-443 https://doi.org/10.1016/B978-0-12-815673-5.00010-6

46. Mohammad Shoaib Shaikh Hamid, Pooja R. Hatwar, Ravindrakumar L. Bakal and Nitin B. Kohale. A comprehensive review on Liposomes: As a novel drug delivery system. GSC Biological and Pharmaceutical Sciences. 2024; 27(1): 199–210

47. Faisal Farooque, Mohd Wasi, Mohd Muaz Mughees. Liposomes as Drug Delivery System: An Updated Review. Journal of Drug Delivery and Therapeutics. 2021; 11(5): 149-158

48. Nasim Karami, Eskandar Moghimipour, Anayatollah Salimi. Liposomes as a Novel Drug Delivery System: Fundamental and Pharmaceutical Application Definition and History. Asian Journal of Pharmaceutics. 2018; 12(1): 31-41

49. Ganesh Shankar Sawant, Kiran Vilas Sutar, Akhil S. Kanekar, Liposome: A Novel Drug Delivery System. International Journal of Research and Review. 2021; 8(4): 252-268

50. Harshita Mishra, Vaishali Chauhan, Kapil Kumar, Deepak Teotia. A comprehensive review on Liposomes: a novel drug delivery system. Journal of Drug Delivery and Therapeutics. 2018; 8(6): 400-404

51. Patel, N., and Panda, S. Liposome drug delivery system: a critic review. Journal Of Pharmaceutical Sciences and Bioscientific Research. 2012; 2(4): 169-175.

52. Nagasamy Venkatesh Dhandapani, Anup Thapa, Goti Sandip, Ayush Shrestha, Niroj Shrestha, Rajan Sharma Bhattarai. Liposomes as novel drug delivery system: A comprehensive review. International Journal of Research in Pharmaceutical Sciences. 2013; 4(2); 187-193

53. Douweh Leyla Gbian and Abdelwahab Omri. Review Lipid-Based Drug Delivery Systems for Diseases Managements, biomedicines. 2022; 10(2137); 1-16

54. Kosheli Thapa Magar, George Frimpong Boafo, Xiaotong Li, Zhongjian Chen. Review Liposome-based delivery of biological drugs. Chinese Chemical Letters. 2021; 16(16): 1-10

55. George Frimpong Boafo, Kosheli Thapa Magar, Marlene Davis Ekpo, Wang Qian, Songwen Tan, and Chuanpin Chen. Review the Role of Cryoprotective Agents in Liposome Stabilization and Preservation. Int. J. Mol. Sci. 2022; 23: 12487

56. Bharathi Karunakaran, Raghav Gupta, Pranav Patel, Sagar Salave, Amit Sharma, Dhruv Desai, Derajram Benival and Nagavendra Kommineni. Review Emerging Trends in Lipid-Based Vaccine Delivery: A Special Focus on Developmental Strategies. Fabrication Methods, and Applications. Vaccines. 2023; 11(661): 1-31

57. Jianhua Yang, Chengyou Jia, Jianshe Yang. Designing Nanoparticle-based Drug Delivery Systems for Precision Medicine. International Journal of Medical Sciences. 2021; 18(13),: 2943-2949

58. Vijay Mishra, Pallavi Nayak, Manvendra Singh, Pavani Sriram, Ashish Suttee. Niosomes: Potential Nanocarriers for Drug Delivery. IJPQA. 2020; 11(3); 389-394

59. Mali, A. D. An updated review on transdermal drug delivery systems. Skin. 2015; 8(9): 244-254.

60. Ghulaxe, C., and Verma, R. A review on transdermal drug delivery system. The Pharma Innovation. 2015; 4(1, Part A): 37.

61. Rawat, A., Bhatt, G. K., and Kothiyal, P. Review on transdermal drug delivery system. Indo Am J Pharm Sci. 2016; 3: 423-428.

62. John, L. Review on transdermal drug delivery system. Int J Pharm Res Health Sci. 2014; 2(4): 261-272.

63. Patel, A. V., and Shah, B. N. Transdermal Drug Delivery Systems: A Review. Pharma Science Monitor. 2018; 9(1).

64. Jeong, W. Y., Kwon, M., Choi, H. E., and Kim, K. S. Recent advances in transdermal drug delivery systems: A review. Biomaterials Research. 2021; 25(1): 24.