INTRODUCTION:

Drug Delivery Systems (DDS) refer to engineered technologies that enable the administration of therapeutic agents in a controlled, targeted, and efficient manner. These systems are designed to improve the pharmacokinetic and pharmacodynamic profiles of drugs, enhancing their efficacy while reducing adverse effects. Traditional drug delivery methods- oral tablets, injections, or topical formulations, often struggle with significant limitations, including poor solubility, enzymatic degradation, low bioavailability, rapid clearance, and non-specific distribution. These drawbacks compromise therapeutic outcomes and frequently necessitate higher doses, exacerbating toxicity and patient discomfort.^1,2

The advent of novel drug delivery systems was propelled by the pressing need to address these inadequacies. Innovations in materials science, particularly the development of nanocarriers, smart polymers, and lipid-based constructs, have enabled the creation of highly specialized delivery vehicles. These new systems are capable of responding to specific physiological triggers, such as pH, temperature, redox state, or enzyme presence- thus providing site-specific and controlled release of therapeutic agents. The convergence of pharmacology, bioengineering, and nanotechnology has birthed a dynamic interdisciplinary field that promises to reshape modern therapeutics.^2,3

The rise of nanomedicine underscores this paradigm shift. Nanoparticles, dendrimers, micelles, and exosomes offer finely tunable physicochemical properties that optimize drug loading, stability, and bio-distribution. Moreover, smart biomaterials now allow the integration of diagnostic and therapeutic functions into a single platform- laying the groundwork for theragnostic and personalized medicine.^4,5

This review aims to provide a comprehensive overview of the current landscape of novel drug delivery systems. It begins by examining the materials that serve as the backbone of these systems, followed by a detailed analysis of the mechanisms that enable precise delivery and controlled release. Subsequent sections explore the application of these technologies across major therapeutic areas, including oncology, central nervous system disorders, and infectious diseases. Finally, the review addresses existing challenges and outlines future directions, emphasizing the potential for interdisciplinary innovation to further revolutionize drug delivery.

Through this exploration, we aim to highlight both the transformative impact and the evolving complexities of next-generation drug delivery platforms in advancing global health outcomes.

1. Materials in Novel Drug Delivery:

The success of novel drug delivery systems (NDDS) is fundamentally rooted in the properties of the materials used as carriers. These materials not only determine the stability, loading capacity, and release kinetics of the drugs, but also govern their biocompatibility, targeting efficiency, and responsiveness to physiological stimuli. The continuous evolution of material science has led to the emergence of various carrier systems, each tailored to overcome specific pharmacological and therapeutic challenges. This section explores four primary classes of materials employed in NDDS: polymeric systems, lipid-based carriers, inorganic and hybrid materials, and biological carriers.^6,7

A. Polymeric Systems:

Polymeric materials are among the most versatile and extensively studied carriers in drug delivery. They can be categorized into synthetic and natural polymers.

· Synthetic polymers, such as poly (lactic-co-glycolic acid) (PLGA) and polyethylene glycol (PEG), offer high reproducibility and tunable degradation profiles. PLGA is FDA-approved and valued for its biodegradability and sustained release capabilities. PEG is frequently used to enhance solubility and extend circulation time through surface PEGylation, a modification that helps evade immune detection.⁸

· Natural polymers, including chitosan and alginate, are prized for their biocompatibility and low immunogenicity. Chitosan, a cationic polysaccharide, exhibits mucoadhesive properties and intrinsic antimicrobial activity. Alginate, derived from seaweed, can form hydrogels under mild conditions, making it ideal for sensitive drug molecules.⁹

Recent advances focus on creating stimuli-responsive polymers, materials that undergo conformational changes or degrade in response to specific triggers like pH, temperature, or redox potential. These properties allow for precise spatiotemporal control of drug release.¹⁰

B. Lipid-Based Carriers:

Lipid-based drug delivery systems have garnered significant attention due to their excellent biocompatibility and capacity for encapsulating both hydrophilic and lipophilic drugs.

· Liposomes, spherical vesicles composed of phospholipid bilayers, were among the first nanocarriers approved for clinical use. They can be functionalized with ligands or antibodies for targeted delivery and are used in several FDA-approved formulations.¹¹

· Solid lipid nanoparticles (SLNs) and nanostructured lipid carriers (NLCs) are newer alternatives designed to overcome the stability limitations of liposomes. SLNs consist of solid lipids, while NLCs incorporate both solid and liquid lipids, offering improved drug loading and controlled release.¹²

Lipid-based platforms have played a pivotal role in COVID-19 vaccine delivery, particularly in mRNA vaccines where lipid nanoparticles (LNPs) protect the genetic material and facilitate cellular uptake.^13,14

C. Inorganic and Hybrid Materials:

Inorganic nanoparticles provide unique advantages, including precise size control, surface modification, and intrinsic imaging capabilities.

· Gold nanoparticles (AuNPs) are widely studied for their plasmonic properties, enabling photothermal therapy where localized heating induces drug release and tumour ablation.

· Silica nanoparticles, especially mesoporous silica, offer high surface area for drug loading and customizable pore structures.

· Metal-organic frameworks (MOFs) are porous crystalline materials combining metal ions with organic linkers. They allow for high drug loading, pH-triggered release, and even co-delivery of multiple agents.

Hybrid systems that combine inorganic cores with polymeric or lipid coatings offer synergistic benefits, such as enhanced biocompatibility and multifunctionality, making them ideal candidates for theragnostic applications.^15,16

D. Biological Carriers:

Biological carriers are gaining momentum due to their innate compatibility with the human body and ability to evade immune detection.

· Exosomes, naturally secreted vesicles involved in intercellular communication, can carry proteins, lipids, and nucleic acids. Their endogenous origin allows them to cross biological barriers and delivers payloads efficiently.

· Viral vectors, though primarily used in gene therapy, are being explored for drug delivery due to their high transduction efficiency and cellular targeting capabilities. Efforts are ongoing to mitigate immunogenicity and improve safety.

· Red blood cell (RBC) membrane-coated nanoparticles represent a novel strategy that mimics the body's own cells to prolong circulation time and avoid immune clearance. These "camouflaged" particles can deliver therapeutic agents stealthily to disease sites.^17,18

2. Mechanisms and Targeting Strategies:

The efficacy of novel drug delivery systems (NDDS) hinges not only on the material composition of the carriers but also on their ability to release therapeutic agents in a spatially and temporally controlled manner. The design of these systems increasingly incorporates intelligent release mechanisms and precise targeting strategies to enhance bioavailability, minimize systemic toxicity, and improve therapeutic outcomes. This section explores the primary mechanisms of drug targeting and release, with a focus on passive targeting, active targeting, and stimuli-responsive systems.¹⁹

A. Passive Targeting:

Passive targeting exploits the physiological characteristics of diseased tissues, particularly tumours for preferential drug accumulation. The most widely studied example is the Enhanced Permeability and Retention (EPR) effect, which results from the leaky vasculature and poor lymphatic drainage in solid tumours. Nanocarriers ranging from 10–200nm can extravasate through these permeable vessels and remain entrapped within the tumour interstitial, leading to higher local drug concentrations compared to normal tissues.²⁰

However, despite extensive preclinical success, the EPR effect has shown limited translational success in clinical settings. Variability in tumour vascularization, interstitial fluid pressure, and patient-to-patient heterogeneity reduces the reliability of this mechanism. Moreover, certain tumours lack sufficient vasculature or present dense stromal barriers that impede nanoparticle penetration. As a result, passive targeting alone is often insufficient for consistent clinical efficacy.²¹

B. Active Targeting:

To overcome the limitations of passive targeting, active targeting strategies have been developed to enhance specificity. These approaches involve surface functionalization of drug carriers with ligands that bind to overexpressed receptors on target cells, thereby facilitating receptor-mediated endocytosis.²²

Common targeting ligands include:

· Folate: Targets folate receptors overexpressed in many cancers.

· Transferrin: Binds to transferrin receptors involved in iron uptake, commonly upregulated in tumours.

· Peptides: RGD peptides target integrins involved in angiogenesis and tumour progression.

· Antibodies: Monoclonal antibodies (e.g., trastuzumab for HER2) provide high specificity and affinity.

Active targeting enhances intracellular delivery and improves therapeutic efficacy while reducing off-target toxicity. However, it is not without challenges, such as potential immunogenicity of targeting moieties, loss of targeting efficiency due to ligand shedding, and the dynamic expression of receptors in the tumour microenvironment.^23–25

Figure 1. Mechanisms of Active vs. Passive Targeting²⁶

C. Stimuli-Responsive Systems:

Stimuli-responsive or "smart" drug delivery systems are designed to release their payload in response to specific internal or external triggers. This responsiveness adds another layer of control, enabling site-specific and condition-dependent drug release.

Internal stimuli include:

· pH: Exploits the acidic microenvironment of tumours or endosomes.

· Redox potential: Utilizes higher glutathione concentrations in cancer cells to trigger release.

· Enzymes: Targets disease-specific enzymes such as matrix metalloproteinases or proteases.^27,28

External stimuli include:

· Temperature: Heat-sensitive polymers like poly(N-isopropylacrylamide) can release drugs at elevated temperatures.

· Light: Photo-sensitive linkers enable controlled release upon exposure to specific wavelengths.

· Magnetic fields: Magnetically responsive nanoparticles can be directed and triggered using external magnetic fields.²⁹

These smart systems are often engineered using polymers that undergo structural or solubility changes upon encountering the target stimulus. For example, pH-sensitive hydrogels can swell or degrade in acidic conditions, releasing encapsulated drugs only within the tumour site. Such designs significantly reduce systemic exposure and improve therapeutic precision.³⁰

Figure 2. Stimuli-Responsive Release Mechanisms³¹

3. Therapeutic Frontiers and Applications:

The translation of novel drug delivery systems (NDDS) into clinical applications has significantly reshaped therapeutic strategies across diverse medical domains. With enhanced precision, biocompatibility, and efficacy, NDDS offer a promising paradigm for addressing complex diseases that were once considered refractory to conventional therapies. This section explores their practical utility in oncology, neurological disorders, infectious diseases, and chronic metabolic conditions.³²

A. Cancer:

Cancer remains one of the most intensely targeted areas for NDDS development. Traditional chemotherapeutic regimens often lead to systemic toxicity due to non-specific drug distribution. NDDS improve therapeutic indices through tumour-specific targeting, facilitated by both passive mechanisms like the EPR effect and active targeting with ligands specific to tumour markers.^33–35

Combination therapies, wherein NDDS co-deliver multiple agents such as chemotherapeutics and immunomodulators, are being explored to overcome resistance and enhance synergistic effects. Additionally, theragnostic platforms- nanocarriers incorporating both therapeutic and diagnostic functions, enable real-time monitoring of drug distribution and therapeutic response.³⁴

B. Neurological Disorders:

Treating central nervous system (CNS) disorders is notoriously difficult due to the blood–brain barrier (BBB), which restricts the entry of most therapeutics. NDDS have emerged as pivotal tools in circumventing this barrier.³⁶

Exosomes, owing to their endogenous origin and small size, naturally cross the BBB and have been engineered to deliver siRNA, proteins, or small molecules for conditions like Alzheimer’s and Parkinson’s disease. Similarly, polymeric and lipid nanoparticles functionalized with BBB-targeting ligands or exploiting transcytosis pathways show great promise for neurotherapeutics, improving both uptake and targeting precision.^37,38

C. Infectious Diseases:

NDDS enhance the efficacy and safety profiles of anti-infective agents, especially for chronic or drug-resistant infections. Liposomal amphotericin B exemplifies the clinical utility of lipid-based formulations, reducing nephrotoxicity while maintaining antifungal potency.^39,40

Nanocarriers are also being engineered as nano-antibiotics, encapsulating existing drugs to combat bacterial resistance by enhancing uptake and minimizing efflux. Notably, the COVID-19 pandemic catalysed the mainstream adoption of lipid nanoparticle (LNP) systems for mRNA vaccine delivery. These LNPs protect mRNA from degradation, facilitate endosomal escape, and enable efficient protein expression in host cells, marking a significant milestone in both vaccine technology and NDDS utility.⁴¹

D. Metabolic and Chronic Diseases:

NDDS are increasingly applied in chronic disease management, aiming to improve patient adherence and minimize systemic side effects.

In diabetes care, glucose-responsive insulin systems represent a leap toward autonomous glycaemic regulation. These systems release insulin in response to rising blood glucose levels via stimuli-sensitive materials like glucose oxidase or phenylboronic acid-functionalized hydrogels.^42,43

In cardiovascular diseases, long-acting formulations using polymeric or lipid-based systems ensure steady-state drug levels for antihypertensives or statins, reducing dosing frequency and improving compliance.⁴⁴

Table 2: NDDS Applications Across Therapeutic Domains

Therapeutic Area	NDDS Type	Key Applications
Cancer	Liposomes, PLGA NPs, AuNPs, Exosomes	Tumour targeting, combination therapy, theragnostic
Neurological Disorders	Exosomes, PEGylated NPs, Lipid NPs	BBB crossing, targeted delivery for Alzheimer’s, Parkinson’s
Infectious Diseases	Liposomes, Nano-antibiotics, LNPs	Antifungals, antibacterial resistance, mRNA vaccines
Chronic Diseases	Glucose-responsive systems, polymeric NPs	Insulin delivery, cardiovascular drugs, long-acting release

These examples underscore the therapeutic versatility and real-world impact of NDDS across clinical disciplines. From cancer nanomedicine to mRNA vaccine delivery, their applications continue to redefine the boundaries of medical treatment.

4. Limitations, Regulatory and Future Directions:

Despite their promising advantages, novel drug delivery systems (NDDS) face several critical challenges that hinder seamless clinical translation and widespread adoption. These limitations stem not only from material properties and biological interactions but also from manufacturing, regulatory, and policy barriers.⁴⁵

One of the most pressing concerns is toxicity and immunogenicity. While many NDDS are designed for biocompatibility, their long-term safety profiles remain underexplored, particularly for inorganic nanoparticles and hybrid systems. Accumulation in non-target organs, unforeseen immune responses, and the breakdown of carrier materials can result in adverse effects that are difficult to predict preclinically.⁴⁶

Scalability and reproducibility are additional hurdles. Sophisticated fabrication techniques that work efficiently at the laboratory scale often face difficulties in mass production. Variations in particle size, drug loading efficiency, and surface properties can compromise batch-to-batch consistency. This inconsistency also complicates storage and stability, as some nanocarriers require cold-chain logistics or are prone to aggregation and degradation over time.⁴⁷

From a regulatory standpoint, the field of nanomedicine faces a lack of harmonized standards and clear classification criteria. Agencies like the U.S. FDA and European Medicines Agency (EMA) have issued general guidance, but comprehensive frameworks specific to NDDS are still evolving. For instance, the FDA emphasizes a case-by-case review approach, considering product complexity, characterization, and potential toxicities, while the EMA stresses the need for detailed physicochemical and biological data to assess risk–benefit profiles.⁴⁸

Looking forward, emerging technologies promise to address many of these limitations. Artificial intelligence (AI) is increasingly applied to predict pharmacokinetic behaviours, optimize formulation parameters, and personalize treatment regimens.⁴⁹ 3D printing allows for the creation of complex, patient-specific drug delivery constructs with precise control over geometry and drug distribution. Furthermore, the rise of personalized DDS, integrating patient genomics and disease profiling, heralds a shift toward individualized medicine where therapies are tailored to the unique biological makeup of each patient.^50,51

While substantial challenges remain, the trajectory of NDDS is one of innovation and integration. Through advances in materials science, bioinformatics, and regulatory policy, the field is steadily evolving toward safer, more effective, and patient-specific solutions for drug delivery.

CONCLUSION:

The evolution of drug delivery systems from conventional methods to sophisticated, responsive platforms marks a pivotal advancement in modern medicine. Through the integration of smart materials, targeted mechanisms, and stimuli-responsive technologies, novel drug delivery systems (NDDS) have demonstrated immense potential to enhance therapeutic efficacy, minimize systemic toxicity, and transform patient care. Applications across oncology, neurology, infectious diseases, and chronic conditions affirm their clinical relevance and versatility.

While challenges persist in safety, scalability, and regulation, the field continues to progress through innovations in materials science, nanotechnology, and bioengineering. The incorporation of artificial intelligence and personalized medicine further strengthens the translational potential of these systems.

To fully realize the promise of NDDS, continued interdisciplinary collaboration and harmonized regulatory frameworks are essential. As research advances and clinical translation accelerates, NDDS are poised to redefine treatment paradigms and contribute significantly to the future of precision medicine.

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Received on 05.08.2025 Revised on 01.12.2025

Accepted on 02.02.2026 Published on 06.07.2026

Available online from July 20, 2026

Asian J. Pharm. Res. 2026; 16(3):262-268.

DOI: 10.52711/2231-5691.2026.00039

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.

Material Type	Examples	Key Properties	Advantages	Limitations
Synthetic Polymers	PLGA, PEG	Biodegradable, modifiable	Sustained release, scalable	Potential toxicity of degradation products
Natural Polymers	Chitosan, Alginate	Biocompatible, mucoadhesive	Low immunogenicity, mild processing	Batch variability, lower mechanical strength
Lipid-Based Systems	Liposomes, SLNs, NLCs	Amphiphilic, biocompatible	Versatile encapsulation, safe	Stability issues, storage sensitivity
Inorganic/Hybrid Materials	AuNPs, Silica NPs, MOFs	Precise control, imaging compatibility	Theragnostic potential, high drug loading	Long-term safety, clearance concerns
Biological Carriers	Exosomes, Viral Vectors, RBC-NPs	Biomimetic, immune-evasive	Targeting ability, barrier penetration	Complex production, regulatory hurdles