Advanced drug delivery reviews最新文献

Advanced intelligent drug-device combination systems: regulatory landscapes, technological foundations, and clinical translation. 先进的智能药物装置组合系统：监管景观，技术基础和临床翻译。

IF 17.6 1区医学

Advanced drug delivery reviews Pub Date : 2026-05-07 DOI: 10.1016/j.addr.2026.115886

Zhengci Wang, Han Zhou, Ruixi Liao, Xue Chen, Qingjie Zhang, Ji Liu, Wenli Zhang, Yan Shen

{"title":"Advanced intelligent drug-device combination systems: regulatory landscapes, technological foundations, and clinical translation.","authors":"Zhengci Wang, Han Zhou, Ruixi Liao, Xue Chen, Qingjie Zhang, Ji Liu, Wenli Zhang, Yan Shen","doi":"10.1016/j.addr.2026.115886","DOIUrl":"https://doi.org/10.1016/j.addr.2026.115886","url":null,"abstract":"<p><p>Drug-device combinations (DDCs) have evolved from simple drug-coated implants into sophisticated intelligent platforms capable of real-time sensing, adaptive drug delivery, and closed-loop therapeutic control. This transformation is driven by converging advances in nanotechnology, biomaterials, controlled release mechanisms, wireless communication, artificial intelligence, and additive manufacturing. This review first systematically compares the divergent regulatory frameworks governing DDCs in the United States, European Union, and China. It then examines key enabling technologies and their integration into implantable, wearable, oral, and next-generation DDC platforms, emphasizing how functional convergence enables transition from passive delivery to feedback-controlled, patient-adaptive systems. Clinical applications are evaluated across therapeutic areas including ophthalmology, orthopedics, cardiovascular diseases, diabetes, oncology, and neurology, with attention to mechanistic distinctions and translational status. Finally, the review analyzes persistent technical, regulatory, and translational barriers. By connecting regulatory considerations, technological foundations, and clinical applications, this review offers a coherent roadmap for the next generation of intelligent DDCs.</p>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":" ","pages":"115886"},"PeriodicalIF":17.6,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147863256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Near-infrared fluorescence imaging-guided targeted drug delivery in gastric tumors: From molecular design to clinical translation. 近红外荧光成像引导胃肿瘤靶向给药：从分子设计到临床转化。

IF 17.6 1区医学

Advanced drug delivery reviews Pub Date : 2026-05-07 DOI: 10.1016/j.addr.2026.115891

Yuanyuan Ji, Nassuf Mourdi, Kai Bao, Yuanhao Su, Yongke Wu, Zhishen Ge, Hak Soo Choi, Zhidong Wang

{"title":"Near-infrared fluorescence imaging-guided targeted drug delivery in gastric tumors: From molecular design to clinical translation.","authors":"Yuanyuan Ji, Nassuf Mourdi, Kai Bao, Yuanhao Su, Yongke Wu, Zhishen Ge, Hak Soo Choi, Zhidong Wang","doi":"10.1016/j.addr.2026.115891","DOIUrl":"https://doi.org/10.1016/j.addr.2026.115891","url":null,"abstract":"<p><p>Intraoperative image guidance has become a central component of modern surgical oncology, with near-infrared (NIR) fluorescence imaging emerging as a powerful platform for real-time visualization and precision intervention. Owing to its favorable optical characteristics, including reduced tissue autofluorescence, improved penetration depth, and excellent safety profile, NIR fluorescence imaging has rapidly evolved from experimental validation to clinical integration in gastrointestinal surgery. This review summarizes recent advances in both nonspecific and molecularly targeted NIR fluorescence imaging strategies for gastric tumors, with a particular emphasis on their integration with targeted drug delivery and theranostic applications. Preclinical studies demonstrate that NIR fluorophores conjugated to drugs, antibodies, or tumor-specific ligands enable high-contrast visualization of primary and metastatic lesions while supporting image-guided resection and localized phototherapy in gastric cancer (GC), gastrointestinal stromal tumors (GISTs), and neuroendocrine tumors. Large-animal models further validate the translational feasibility of NIR imaging for intraoperative assessment of vascular perfusion, anastomotic integrity, and sentinel lymph node (SLN) mapping. Clinically, NIR fluorescence imaging, most commonly using indocyanine green, enhances SLN detection, identifies metastatic lymphatic pathways beyond conventional dissection fields, and enables objective evaluation of tissue perfusion, thereby reducing postoperative complications. Collectively, NIR fluorescence imaging represents a versatile platform that bridges molecular imaging, drug delivery, and surgical intervention. Its integration into gastric tumor management has the potential to improve surgical precision, optimize therapeutic delivery, and accelerate the development of personalized and minimally invasive treatment strategies.</p>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":" ","pages":"115891"},"PeriodicalIF":17.6,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147863223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Redox responsive nanosystems for medicine: from reactive species mapping to precision treatment. 用于医学的氧化还原反应纳米系统：从反应性物种定位到精确治疗。

IF 17.6 1区医学

Advanced drug delivery reviews Pub Date : 2026-05-07 DOI: 10.1016/j.addr.2026.115892

Rui Sang, Biyao Yang, Kainat Zahra, Fei Deng, Zi Gu, Ewa M Goldys, Wei Deng

{"title":"Redox responsive nanosystems for medicine: from reactive species mapping to precision treatment.","authors":"Rui Sang, Biyao Yang, Kainat Zahra, Fei Deng, Zi Gu, Ewa M Goldys, Wei Deng","doi":"10.1016/j.addr.2026.115892","DOIUrl":"https://doi.org/10.1016/j.addr.2026.115892","url":null,"abstract":"<p><p>Redox dysregulation is a hallmark of numerous pathological conditions, including cancer, chronic inflammatory diseases, fibrosis, neurodegenerative disorders and cardiovascular diseases, where aberrant production of reactive oxygen, nitrogen, sulfur and carbonyl species disrupts cellular signalling, metabolism, immune responses and tissue homeostasis. Despite its central role in disease progression, clinical assessment and therapeutic modulation of redox imbalance remain largely indirect, non-specific, failing to adequately capture the spatially heterogeneous and highly dynamic nature of redox dysregulation. Redox-responsive nanosystems offers the potential to bridge this gap by incorporating redox-sensitive materials that can spatiotemporally sense and respond to disease-associated oxidative or reductive microenvironments. Through predictable chemical or structural transformations triggered by endogenous redox cues, these nanoplatforms enable site-specific imaging, on-demand drug release, catalytic therapy and signal amplification. These capabilities position redox-responsive nanomedicine as a powerful approach for enhancing therapeutic precision while minimising off-target toxicity. This review provides a comprehensive and mechanism-informed overview of redox-responsive nanosystems for advanced drug delivery and precision medicine. We systematically connect disease-associated redox mechanisms with nanoplatform design strategies and functional outcomes across diagnostic, therapeutic and combined theranostic applications. In addition, we critically discuss key translational challenges, including biosafety, pharmacokinetics, large-scale manufacturing and regulatory considerations. Finally, we outline future directions toward clinically translatable, redox-guided nanomedicine.</p>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":" ","pages":"115892"},"PeriodicalIF":17.6,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147863294","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A glimpse into the future of model-informed drug discovery and development. 一窥模型信息药物发现和开发的未来。

IF 17.6 1区医学

Advanced drug delivery reviews Pub Date : 2026-05-07 DOI: 10.1016/j.addr.2026.115890

Yu-Wei Lin, S Y Amy Cheung, Hak-Kim Chan, Lena E Friberg

引用次数: 0

Microfluidics meets organoids: Kidney and bladder-on-Chip models for preclinical drug delivery assessment. 微流体与类器官：用于临床前给药评估的肾脏和膀胱芯片模型。

IF 17.6 1区医学

Advanced drug delivery reviews Pub Date : 2026-05-05 DOI: 10.1016/j.addr.2026.115887

C Ma, D Koh, T Nishimura, Y Takata, Y Kameda, R Negoro, N Ishiguro, M Shibuta, I Namatame, K Tetsuka, T Araoka, M Takasato, J Jang, J Yoon, R Yokokawa

{"title":"Microfluidics meets organoids: Kidney and bladder-on-Chip models for preclinical drug delivery assessment.","authors":"C Ma, D Koh, T Nishimura, Y Takata, Y Kameda, R Negoro, N Ishiguro, M Shibuta, I Namatame, K Tetsuka, T Araoka, M Takasato, J Jang, J Yoon, R Yokokawa","doi":"10.1016/j.addr.2026.115887","DOIUrl":"https://doi.org/10.1016/j.addr.2026.115887","url":null,"abstract":"<p><p>High clinical attrition rates in drug development are frequently driven by unforeseen drug-induced nephrotoxicity, a challenge exacerbated by the profound interspecies differences and limited predictivity of conventional animal models. This translational gap is further compounded by the difficulty of recapitulating the complex, multilineage architecture of the human kidney and the stratified urothelial barrier of the bladder using traditional static cultures. Human induced pluripotent stem cell (hiPSC)-derived organoids integrated into microphysiological systems (MPS) offer a transformative opportunity to overcome these hurdles by merging human-specific biological complexity with precisely controlled engineering niches. In this review, we evaluate the evolution of kidney and bladder models from foundational platforms utilizing immortalized or primary cells to hiPSC-derived organoid-integrated chips, focusing on their quantitative capability to predict renal drug disposition and intravesical delivery. We detail the strategic integration of these human-relevant parameters into industrial physiologically based pharmacokinetic (PBPK) modeling and regulatory workflows. Furthermore, we highlight emerging synergies with multi-omics, computational \"Digital Twins,\" and multidisciplinary engineering advances, including vascularization, real-time biosensing, and 3D bioprinting technologies with AI-guided automation for scalable, reproducible production. These platforms promise to transform preclinical assessment by delivering mechanistically precise, human-relevant data for de-risking therapeutics.</p>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":" ","pages":"115887"},"PeriodicalIF":17.6,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147832191","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Corrigendum to “Role of integrated cancer nanomedicine in overcoming drug resistance” [Adv. Drug Deliv. Rev. 65 (2013) 1784–1802] “综合癌症纳米医学在克服耐药性中的作用”的勘误表[Adv. drug delivery .]Rev. 65 (2013) 1784-1802]

IF 16.1 1区医学

Advanced drug delivery reviews Pub Date : 2026-04-04 DOI: 10.1016/j.addr.2026.115860

Arun K. Iyer, Amit Singh, Srinivas Ganta, Mansoor M. Amiji

引用次数: 0

A strategic guide of techniques for biomedical and tissue engineering applications to measure mechanical properties of soft matter, eye and skin 生物医学和组织工程应用技术的战略指南，以测量软物质，眼睛和皮肤的机械特性

IF 17.6 1区医学

Advanced drug delivery reviews Pub Date : 2026-04-01 Epub Date: 2026-01-31 DOI: 10.1016/j.addr.2026.115792

Claudia Muñoz Villaescusa , Diana van der Ven , Miguel A. Quetzeri-Santiago , David Fernandez Rivas

{"title":"A strategic guide of techniques for biomedical and tissue engineering applications to measure mechanical properties of soft matter, eye and skin","authors":"Claudia Muñoz Villaescusa , Diana van der Ven , Miguel A. Quetzeri-Santiago , David Fernandez Rivas","doi":"10.1016/j.addr.2026.115792","DOIUrl":"10.1016/j.addr.2026.115792","url":null,"abstract":"<div><div>A comprehensive understanding of tissue mechanics at the microscale is critical for advancing personalised therapies, controlled drug release, and tissue engineering. Characterising the mechanical properties of complex, soft biological materials—particularly multilayered and anisotropic organs such as the skin and eye—remains a significant challenge due to their variable water content and scale-dependent behaviour. Traditional continuum models and linear material responses often fail to capture the dynamic and nonlinear nature of these tissues under physiologically relevant conditions.</div><div>This review provides a strategic overview of state-of-the-art techniques for probing the mechanical properties of soft biological tissues, with a focus on skin and ocular systems. Our focus on the skin and eye reflects their favourable barrier properties for topical drug delivery. We examine visualisation methods including optical imaging, interferometry, digital image correlation, optical coherence microscopy, and acoustic imaging. In parallel, we assess actuation mechanisms such as indentation, cavitation rheology, and flow elastography, highlighting their suitability for <em>in vivo</em> applications. Each technique is benchmarked against key operational parameters—spatial resolution, acquisition rate, invasiveness, and strain rate—relevant to drug delivery and therapeutic engineering.</div><div>By mapping the landscape of mechanical characterisation tools, this work offers a valuable resource for researchers in biomedical engineering and beyond, including fields such as physics and chemistry, where accurate dynamic analysis of soft complex materials is essential.</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"231 ","pages":"Article 115792"},"PeriodicalIF":17.6,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146095684","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Rational modification of PROTACs for tumor-selective protein degradation 合理修饰PROTACs用于肿瘤选择性蛋白降解

IF 17.6 1区医学

Advanced drug delivery reviews Pub Date : 2026-03-01 Epub Date: 2026-01-09 DOI: 10.1016/j.addr.2026.115775

Zhongliang Fu , Meichen Pan , Chunrong Yang , Hongwei Hou , Jinghong Li

{"title":"Rational modification of PROTACs for tumor-selective protein degradation","authors":"Zhongliang Fu , Meichen Pan , Chunrong Yang , Hongwei Hou , Jinghong Li","doi":"10.1016/j.addr.2026.115775","DOIUrl":"10.1016/j.addr.2026.115775","url":null,"abstract":"<div><div>Proteolysis-targeting chimeras (PROTACs) are heterobifunctional molecules that hijack the ubiquitin-proteasome system to catalytically degrade pathogenic proteins. With the ability to target “undruggable” proteins and exert sustained pharmacological effects, PROTACs hold considerable promise for cancer therapy. However, achieving tumor-selective protein degradation remains a central challenge. This review outlines the application of PROTACs in cancer treatment and systematically summarizes emerging strategies to enhance tumor specificity. These approaches leverage hallmark features of tumors, distinctive surface biomarkers and a unique tumor microenvironment (TME), and are broadly categorized into two classes: active targeting, which employs tumor-selective ligands to enrich PROTACs in malignant cells; and conditionally activated strategies, where TME cues either selectively trigger PROTAC prodrugs or induce structural transformations in nanocarriers to enhance drug accumulation at the tumor site. By elucidating these mechanisms, we aim to bridge medicinal chemistry and intelligent nanomedicine, underpinning the tumor-selective protein degradation strategies and offering perspectives on future research directions to improve the biodistribution, safety, and therapeutic efficacy of next-generation PROTACs.</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"230 ","pages":"Article 115775"},"PeriodicalIF":17.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145949886","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Biologics-device combinations: Enabling prolonged therapies in the posterior segment ocular disease 生物制剂-器械组合：延长后段眼病的治疗时间

IF 17.6 1区医学

Advanced drug delivery reviews Pub Date : 2026-03-01 Epub Date: 2026-01-09 DOI: 10.1016/j.addr.2026.115773

Shuqian Zhu , Jianjun Zhang , Xuling Jiang , Cheng Peng , Huiqin Liu , Feng Qian

{"title":"Biologics-device combinations: Enabling prolonged therapies in the posterior segment ocular disease","authors":"Shuqian Zhu , Jianjun Zhang , Xuling Jiang , Cheng Peng , Huiqin Liu , Feng Qian","doi":"10.1016/j.addr.2026.115773","DOIUrl":"10.1016/j.addr.2026.115773","url":null,"abstract":"<div><div>Posterior segment ocular diseases (e.g., age-related macular degeneration and diabetic retinopathy, etc.) often necessitate frequent intravitreal (IVT) injections of biologics, due to the rapid drug clearance and formidable ocular barriers. While molecular engineering strategies and high-concentration protein formulations could extend the administration intervals to a certain extent, they are confronted with critical challenges, protein aggregation, high viscosity, and limited duration. This has spurred the development of innovative biologics-device combination products, which represent a paradigm shift towards prolonged therapy. This comprehensive review examines the latest advancements of these combination platforms, including refillable implants (e.g., SUSVIMO®), encapsulated cell technology (e.g., ENCELTO™), and recombinant adeno-associated virus (rAAV) vectors (e.g., LUXTURNA®). The progress in biologics - device combination technologies has significantly reduced the frequency of ocular injections. However, substantial hurdles, such as instability caused by material-biologics interactions, potential risks during the sterilization and manufacturing processes, safety risks, and the evolving regulatory landscape, still need to be addressed. Achieving a balance between the stability of biologics and advanced device design, enhancing long-term safety, and developing responsive smart systems with real-time monitoring and feedback capabilities remain crucial for the advancement of next-generation ophthalmic therapies.</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"230 ","pages":"Article 115773"},"PeriodicalIF":17.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145920277","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Bioconjugates for improved delivery of oligonucleotide therapeutics to the central nervous system 用于改善向中枢神经系统递送寡核苷酸疗法的生物偶联物

IF 17.6 1区医学

Advanced drug delivery reviews Pub Date : 2026-03-01 Epub Date: 2026-01-15 DOI: 10.1016/j.addr.2026.115778

Hye Jin Lee , Yunxuan Xie , Colin F. Greineder , Peter M. Tessier

{"title":"Bioconjugates for improved delivery of oligonucleotide therapeutics to the central nervous system","authors":"Hye Jin Lee , Yunxuan Xie , Colin F. Greineder , Peter M. Tessier","doi":"10.1016/j.addr.2026.115778","DOIUrl":"10.1016/j.addr.2026.115778","url":null,"abstract":"<div><div>Oligonucleotide therapeutics, including antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs), have gained increasing attention as a novel modality for gene-targeted interventions for central nervous system (CNS) disorders, particularly in the context of rare and inherited neurological conditions. By correcting pathogenic abnormalities in gene splicing or expression, oligonucleotide therapeutics offer a combination of extreme specificity and disease-modifying or even curative effects. However, achieving robust delivery to the CNS after systemic administration remains a significant challenge due to the presence of the blood-brain barrier and the intrinsic physicochemical limitations of oligonucleotide therapeutics, such as their large molecular size, high charge, and susceptibility to enzymatic degradation. Peptide-, antibody-, and lipid-based conjugates have emerged as versatile strategies for CNS oligonucleotide delivery, offering distinct advantages in molecular recognition, tunability, biocompatibility, and structural uniformity. Here, we review emerging design principles for engineering peptide, antibody, and lipid conjugates to enhance binding affinity, target selectivity, pharmacokinetics, and pharmacodynamics of oligonucleotide therapeutics for CNS applications. We also discuss how engineered delivery platforms have the potential to improve therapeutic efficacy across a spectrum of neurological disorders, from rare hereditary syndromes to highly prevalent neurodegenerative diseases.</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"230 ","pages":"Article 115778"},"PeriodicalIF":17.6,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145993315","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0