{"title":"Recent Advances in Lycopene Delivery Systems: Pharmaceutical, Nutraceutical, and Clinical Perspectives.","authors":"Shrutee Pawar, Shreya Garge, Shravi Shetty, Vasanti Suvarna","doi":"10.2174/0126673878388760251126123939","DOIUrl":"https://doi.org/10.2174/0126673878388760251126123939","url":null,"abstract":"<p><strong>Introduction: </strong>Lycopene, a naturally occurring carotenoid found in tomatoes and other red-pigmented fruits, demonstrates strong antioxidant activity and therapeutic potential in cancer, cardiovascular disease, and inflammatory disorders. However, its clinical use is limited by poor solubility, instability, and low systemic absorption.</p><p><strong>Methods: </strong>To overcome these limitations, various advanced drug delivery systems, including nanoemulsions, lipid-based carriers, hydrogels, and self-emulsifying systems, have been developed. Additionally, extraction techniques such as ultrasound-assisted and supercritical fluid extraction enhance lycopene recovery from natural matrices. Nanoformulations further optimize pharmacokinetics by improving solubility, stability, and targeted delivery.</p><p><strong>Results: </strong>These delivery strategies significantly enhance lycopene's absorption, bioavailability, and antioxidant activity while enabling sustained and targeted release. Preclinical and clinical findings support their efficacy in conditions such as prostate cancer, cardiovascular disease, and skin disorders.</p><p><strong>Discussion: </strong>The evidence highlights that optimized nanoformulations address lycopene's physicochemical limitations and broaden its translational potential. However, most data derived from preclinical studies, and limited clinical trials restricts definitive conclusions. Standardization in formulation, dosing, and evaluation remains as unexplored areas.</p><p><strong>Conclusion: </strong>Lycopene-based delivery systems show strong promise for therapeutic and nutraceutical applications. Future directions include harmonized protocols, long-term safety studies, and large-scale clinical validation to bridge the gap between bench and bedside.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147978456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kun Qiu, Hanling Shi, Ming Chen, Shusheng Lai, Kaibin Liew, Zhengtao Wang, Xiaohui Wei
{"title":"Synergistic PNS-NAC Bioadhesive Microspheres for Enhanced Intestinal Permeability and Oral Bioavailability.","authors":"Kun Qiu, Hanling Shi, Ming Chen, Shusheng Lai, Kaibin Liew, Zhengtao Wang, Xiaohui Wei","doi":"10.2174/0126673878437892260216073431","DOIUrl":"https://doi.org/10.2174/0126673878437892260216073431","url":null,"abstract":"<p><strong>Introduction: </strong>To overcome the poor oral bioavailability of Panax Notoginseng Saponins (PNS) caused by low permeability and acid instability, this study designed bioadhesive microspheres co-loaded with PNS and N-acetyl-L-cysteine (PNS-NAC-BMS). This system aims to protect PNS from gastric degradation and enhance its intestinal permeability and oral bioavailability.</p><p><strong>Methods: </strong>PNS-NAC-BMS were fabricated via solvent evaporation and characterized for morphology, particle size, drug loading, encapsulation efficiency, mucoadhesion, and in vitro release. Permeability was assessed using Purified Mucin Intestinal Mucus (PIM), Artificial Intestinal Mucus (AIM), and Rat Native Intestinal Mucus (RIM). Oral bioavailability was assessed through rat pharmacokinetic studies.</p><p><strong>Results: </strong>PNS-NAC-BMS exhibited spherical morphology with uniform particle sizes. They achieved high encapsulation efficiency (91.55%) and intestinal adhesion (94.83%), with sustained release. The system showed high apparent permeability coefficients across three models (PIM, AIM, RIM). Pharmacokinetic studies revealed prolonged release and a 2.6-fold increase in oral bioavailability versus PNS Active Pharmaceutical Ingredients (PNS APIs).</p><p><strong>Discussion: </strong>Recently, patents (US 20230338448, CN 118873498) describe PNS delivery using nanocomposites and liposomes. However, none exist for NAC-modified adhesive microspheres, underscoring the novelty of this study. The BMS system significantly improves the oral bioavailability through combined mucoadhesion and NAC-mediated penetration. NAC promotes drug transport across the mucus barrier by cleaving mucin disulfide bonds and increasing lipid solubility. However, promising long-term stability, scalable production, and mucosal safety of NAC require further study.</p><p><strong>Conclusion: </strong>PNS-NAC-BMS significantly enhanced intestinal adhesion and sustained drug release, thereby synergistically improving intestinal mucus permeability and oral bioavailability, demonstrating potential as an effective oral drug delivery system.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147978011","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Vishnu S, Charul Rathore, Manoj Dalabehera, Jaya Prakash Das
{"title":"Targeting Stubborn Acne Vulgaris with Natural-based Nanoformulations: Bridging Traditional Medicines with Nanosystems.","authors":"Vishnu S, Charul Rathore, Manoj Dalabehera, Jaya Prakash Das","doi":"10.2174/0126673878396312251201062041","DOIUrl":"https://doi.org/10.2174/0126673878396312251201062041","url":null,"abstract":"<p><p>Acne vulgaris, a multifactorial dermatological condition, often presents significant therapeutic challenges due to antibiotic resistance, inadequate drug penetration, and adverse effects associated with conventional treatments, highlighting the need for efficient alternatives, such as naturalbased molecules. Recent advancements in natural molecules, recognized for their antibacterial, antiinflammatory, and sebum-regulating potential, have transformed acne management. Moreover, the integration of nanotechnology has further enhanced drug stability, controlled release, and targeted delivery, making herbal-based nanoformulations promising alternatives. This review comprehensively summarizes various nanocarrier systems, including metallic nanoparticles, liposomes, niosomes, phytosomes, Solid Lipid Nanoparticles (SLNs), Nanostructured Lipid Carriers (NLCs), polymeric nanoparticles, and Mesoporous Silica Nanoparticles (MSNs), emphasizing their role in acne management. Additionally, an in-depth analysis of recent innovations in herbal combination strategies, responsive nanosystems, mechanistic insights, patents, and clinical trials is provided, bridging the gap between research advancements and clinical translation. While these novel approaches hold great promise, challenges such as regulatory approval, large-scale production, and long-term safety must be addressed to facilitate their widespread clinical adoption. This review underscores the transformative potential of herbal nanoformulations, paving the way for next-generation acne therapeutics.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147944213","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Smart Ingestible Injectable Devices: Novel Drug Devices for Oral Delivery of Biologics.","authors":"Kanimozhi Mani, Senduran Narayanasamy, Amalkrishnan Therayil, Jamuna Rani Ravinder","doi":"10.2174/0126673878443638260413050012","DOIUrl":"https://doi.org/10.2174/0126673878443638260413050012","url":null,"abstract":"<p><p>Biologics, or Biological therapeutics, are among the most intriguing therapeutic agents with the potential to transform the treatment of chronic diseases completely. However, the primary challenge with biologics is their need for parenteral administration, which leads to poor patient compliance and treatment failure. Delivering biologics via a non-invasive oral route could help achieve high patient compliance, but this is hindered by gastric barriers. Carrier-based systems, mucoadhesive systems, transdermal administration, implantable pumps, peptide modification techniques such as cyclization, PEGylation, glycosylation, etc., and co-formulation with permeation enhancers have been tried for the above-mentioned purpose, but with only minimal success. Therefore, in this short review, we gave an overview of the novel and emerging drug delivery technology - Ingestible Injectable or Ingestible Microneedle Robotic devices, which facilitate enhanced oral biologics uptake with higher compliance.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147848354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Versatile Drug Delivery Platforms: The Emerging Role of Hybrid Nanoparticles in Solid Tumor Therapy.","authors":"Neelesh Lodhi, Udita Agrawal, Sunny Rathee, Harshita Singhai, Umesh K Patil","doi":"10.2174/0126673878406553251206113703","DOIUrl":"https://doi.org/10.2174/0126673878406553251206113703","url":null,"abstract":"<p><p>Lipid-Polymer Hybrid Nanoparticles (LPHNPs) have emerged as a revolutionary drug delivery platform in oncology, addressing critical challenges such as poor drug bioavailability, nonspecific distribution, and systemic toxicity. These hybrid systems combine the complementary advantages of polymeric nanoparticles and liposomes, offering improved biocompatibility, high drugloading capacity, and precise tumor targeting. Their unique structural composition facilitates controlled drug release and enhanced stability, enabling sustained therapeutic effects. This review focuses on the characteristics, synthesis methods, and tumor-targeting mechanisms of LPHNPs, highlighting their pivotal role in advancing solid tumor drug delivery. Various preparation techniques, including traditional two-step, modified two-step, and single-step approaches, are discussed to elucidate their contributions to nanoparticle formulation and optimization. LPHNPs employ both passive and active targeting strategies, capitalizing on tumor microenvironment-specific factors, such as pH, enzymes, and temperature, for passive targeting, and leveraging specific ligands, such as folate, antibodies, and aptamers, for active targeting. These mechanisms enhance therapeutic precision and minimize off-target effects, significantly improving treatment outcomes. With advancements in emerging nanotechnologies, LPHNPs demonstrate immense potential as next-generation drug delivery systems, providing solutions to longstanding challenges in cancer therapy. They offer a promising path toward more effective, safe, and patient-specific treatments for solid tumors. This review provides a comprehensive overview of LPHNPs, highlighting their current applications and future prospects for transforming cancer therapeutics.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147725357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A Review on Nanocrystals in Transdermal Drug Delivery: A Paradigm Shift in Enhanced Skin Permeation, Bioavailability.","authors":"Prasurjya Saikia, Durgaprasad Kemisetti","doi":"10.2174/0126673878419498251227235540","DOIUrl":"https://doi.org/10.2174/0126673878419498251227235540","url":null,"abstract":"<p><strong>Introduction: </strong>In order to address significant issues in cutaneous and transdermal drug administration, the goal of this study is to offer thorough insights into the procedures, formulation strategies, preparation techniques, and therapeutic uses of nanocrystals (NCs).</p><p><strong>Methods: </strong>A comprehensive examination of the literature was carried out, gathering and examining information from clinical trials, peer-reviewed publications, and pharmaceutical patents. Data about the synthesis, characterisation, and therapeutic use of NCs in transdermal and cutaneous drug delivery were assessed.</p><p><strong>Results: </strong>Drug loading, saturation solubility, and passive diffusion across the stratum corneum were all shown to be much improved by nanocrystals. Their larger surface area and nanoscale size boosted retention at the absorption site, promoted deeper skin penetration, and improved pharmacokinetics. The creation of stable, bioavailable NC formulations was accomplished by both top-down (such as milling and high-pressure homogenisation) and bottom-up (such as precipitation) approaches. Their therapeutic efficacy in treating ailments, including psoriasis, acne, and fungal infections, was backed by clinical and commercial data.</p><p><strong>Discussion: </strong>Notwithstanding compelling preclinical data, regulatory obstacles, formulation stability issues, scale-up constraints, and a dearth of standardised testing methods continue to restrict the clinical translation of NC-based skin formulations. The development of NC-based treatments might be greatly advanced by addressing these problems.</p><p><strong>Conclusion: </strong>A potent next-generation method for transdermal and cutaneous medication delivery is nanocrystal technology. Although further study is needed to address translational limitations, NCs have tremendous promise in treating a variety of skin ailments due to their capacity to improve solubility, penetration, and bioavailability.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147679826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kuljeet Kaur, Honey Goel, Pooja A Chawla, Viney Chawla
{"title":"Trends and Perspectives in the Targeting of Brain Through Ethosomal Formulations.","authors":"Kuljeet Kaur, Honey Goel, Pooja A Chawla, Viney Chawla","doi":"10.2174/0126673878418338251203100909","DOIUrl":"https://doi.org/10.2174/0126673878418338251203100909","url":null,"abstract":"<p><p>Neurological diseases such as Alzheimer's disease, Schizophrenia, anxiety, Parkinson's disease, and migraine are serious conditions that continue to threaten mankind. The cases of brainrelated disorders are increasing worldwide and are closely related to physiological, genetic, and environmental factors. Direct drug delivery to the brain is crucial for the effective treatment and prevention of these conditions. However, due to the presence of a lipophilic barrier, i.e., the bloodbrain barrier, the entry of therapeutic agents into the brain is restricted, resulting in a lower concentration at the targeted site. As a solution to this problem, the direct nose-to-brain connection is attracting attention for its effective, precise, non-invasive delivery of drugs via the olfactory and trigeminal pathways. However, there are some limitations, like permeability across the nasal mucosa and mucociliary clearance. Therefore, to overcome these restrictions, the use of nanocarriers, particularly ethosomes, is being attempted. This review paper delves into recent research papers and reports on ethosomes developed for intranasal delivery towards the management of neurological conditions. Ethosomes demonstrated an exceptional capacity to facilitate drug accumulation at targeted sites, owing to their ability to bypass first-pass metabolism, their flexible nature, and the presence of penetration enhancers. The high ethanol content in the composition significantly increases the fluidity of the lipid bilayer, allowing for better interaction of this vesicular system with the blood-brain barrier. Furthermore, the functionalization of ethosomes can enhance the specific delivery of drugs, increase patient compliance, and minimize side effects. However, no intranasal ethosomes for direct brain delivery have progressed from preclinical testing to the bedside of patients. They are still in the experimental phase, particularly in animals or in vivo lab models. The possibilities of toxic effects, the use of high amounts of ethanol, and irregular nasal absorption are a few concerns that need to be addressed. The increasing demand for intranasal delivery suggests that ethosomes may play a pivotal role in the management and treatment of brain-related conditions, but this will only occur after a substantial number of clinical trials confirm their safety and efficacy for human consumption. This review explores such possibilities and highlights current trends and future perspectives in targeting the brain with ethosomal formulations.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147679846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Nanoparticles (NPs) as a Cutting-Edge Therapeutic Strategy and Their Current Status in Tuberculosis (TB): A Comprehensive Review.","authors":"Krati Shukla, Vasanth S, Rakhi Mishra, Subhashree Sahoo, Gunjan Saxena, Tapaskumar Mukeshkumar Shah, Atibur Rahaman, Himmat Singh Chawra, Rahul Pal","doi":"10.2174/0126673878403646251209194351","DOIUrl":"https://doi.org/10.2174/0126673878403646251209194351","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study is to explore the current status and therapeutic potential of nanoparticles (NPs) as a cutting-edge strategy for the treatment of tuberculosis (TB).</p><p><strong>Background: </strong>NPs have emerged as a promising drug delivery system (DDS) due to their ability to enhance the bioavailability (BA), stability, and targeted delivery of therapeutic agents. Current advancements in nanotechnology have resulted in the development of a range of NPs, including solid lipid nanoparticles, polymeric NPs, Hybrid NPs, and Metallic Nanoparticles, which hold promise for TB treatment.</p><p><strong>Methods: </strong>This review compiles and analyzes data from more than 100 studies on the use of NPs in TB from the past 10 years (January 1, 2015, to January 1, 2025). This review was conducted using scientific databases like PubMed, ScienceDirect, Google Scholar, NCBI, Google Patent, clinicaltrials.gov, etc. Result: The review found that NPs significantly improve drug delivery to TB-infected tissues, leading to enhanced therapeutic outcomes.</p><p><strong>Conclusion: </strong>Nanoparticles represent a cutting-edge therapeutic strategy with the potential to revolutionize the treatment of TB. The enhanced efficacy, specificity, and reduced toxicity of NPs-based DDs.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147679821","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Dakshinesh Parameswaran, Suriya Prakaash Kannan, Damodharan Narayanasamy
{"title":"QbD-Based Development of a pH-Responsive SLN-Loaded Hydrogel for Topical Management of Biofilm-Associated Diabetic Foot Ulcers.","authors":"Dakshinesh Parameswaran, Suriya Prakaash Kannan, Damodharan Narayanasamy","doi":"10.2174/0126673878439472251212211400","DOIUrl":"https://doi.org/10.2174/0126673878439472251212211400","url":null,"abstract":"<p><strong>Introduction: </strong>Diabetic foot ulcers (DFUs) are difficult to treat due to biofilm formation, poor drug penetration, and elevated wound pH. This study aimed to develop a pH-responsive solid lipid nanoparticle (SLN)-loaded hydrogel for targeted ciprofloxacin delivery using a Quality-byDesign (QbD) approach.</p><p><strong>Methods: </strong>SLNs were formulated via solvent emulsification-ultrasonication and optimized using a Box-Behnken design to study the effects of lipid concentration, surfactant concentration, and sonication time on particle size and entrapment efficiency. Optimized SLNs were coated with pHsensitive Eudragit L100 and incorporated into a Carbopol 974P hydrogel. The formulation was evaluated for particle size, zeta potential, entrapment efficiency, rheology, spreadability, occlusion, drug release, antimicrobial activity, and three-month stability.</p><p><strong>Results: </strong>Optimized SLNs showed a particle size of 141.24 ± 2.19 nm, polydispersity index (PDI) 0.236 ± 0.019, zeta potential -26.28 ± 1.31 mV, and an entrapment efficiency of 62.55 ± 1.07%. The hydrogel exhibited pseudoplastic flow, good spreadability, and enhanced occlusivity. Drug release was sustained and pH dependent, with greater release at pH 7.4 than at pH 5.5. The SLNloaded hydrogel showed stronger antibacterial activity than the free drug gel against E. coli, S. aureus, and P. aeruginosa. The formulation remained stable for three months at 4 °C with minimal variation in physicochemical properties.</p><p><strong>Discussion: </strong>The pH-responsive coating enabled targeted release in alkaline DFUs, and the SLN- hydrogel system improved drug retention, antibacterial activity, and formulation stability.</p><p><strong>Conclusion: </strong>A stable, pH-responsive SLN-loaded hydrogel was successfully developed, demonstrating strong potential for targeted topical treatment of biofilm-associated DFUs and future clinical application.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147679853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Integrating Bioavailability Enhancers with Beta-Sitosterol for Optimized Therapeutic Index: A Mechanistic Insight.","authors":"Monika Sharma, Jasmine Kaur, Renu Saharan, Suresh Kumar, Shushank Mahajan, Diksha Sharma, Sanchit Dhankhar","doi":"10.2174/0126673878424216251223051102","DOIUrl":"https://doi.org/10.2174/0126673878424216251223051102","url":null,"abstract":"<p><p>In recent decades, drug research has increasingly shifted toward herbal molecules instead of synthetic ones, due to their low toxicity and better compliance. Among these phytosterols, plantderived sterol compounds have garnered significant attention for their therapeutic and nutritional benefits. Specifically, β-Sitosterol (BSS) has been extensively studied because of its cholesterollowering, anti-inflammatory, and anticancer properties. However, its limited water solubility and modest absorption in the gastrointestinal tract, along with first-pass metabolism (FPM), greatly reduce its oral bioavailability, thus restricting its clinical usefulness. To address these challenges, advances in emerging drug delivery systems (NDDS)-such as nanoparticles, liposomes, micelles, and nanostructured lipid carriers-and formulation techniques like solid dispersions, hydrotropy, self-emulsifying drug delivery systems, and complexation methods, have proven effective in enhancing BSS solubility, stability, and systemic bioavailability. Innovative technologies like 3D printing-based dosage forms also offer promise for personalized and controlled drug release. The unique aspect of this review is its comprehensive approach, integrating traditional and novel strategies to improve BSS bioavailability and assessing their regulatory relevance through the Biopharmaceutics Classification System (BCS) framework. This paper not only summarizes the latest advances in NDDS for BSS but also highlights translational challenges, future prospects, and targeted delivery options, bridging the gap between laboratory research and clinical application.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2026-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147619173","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}