Advanced drug delivery reviews最新文献

{"title":"MIDD in Japan– Implementations, challenges and opportunities","authors":"Mayumi Hasegawa ,&nbsp;Shinichi Kijima","doi":"10.1016/j.addr.2025.115553","DOIUrl":"10.1016/j.addr.2025.115553","url":null,"abstract":"<div><div>In Japan, there has been a growing adoption of Model Informed Drug Development (MIDD) approaches as the rationale for optimal dose decision and modeling outputs have supported better characterizing the risk–benefit profile of a drug by accelerating development period and regulatory-approval pathways. Three primary guidelines on pharmacometric analysis tools issued in Japan between 2019 and 2020 function as a shared communication medium between pharmaceutical companies and the regulatory agency in Japan and have contributed to increasing number of MIDD applications embedded into new drug application documents. This review article describes how the Pharmaceuticals and Medical Devices Agency have been promoting the adoption of modeling and simulation and how MIDD applications have been implemented in Japan by introducing multiple case studies. The intent is to share the knowledge and to promote the harmonization of regulations globally for accelerating the appropriate utilization of MIDD tools and implementation of various new technologies. (149 words)</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"220 ","pages":"Article 115553"},"PeriodicalIF":15.2,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143526123","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}

{"title":"Beyond the EPR effect: Intravital microscopy analysis of nanoparticle drug delivery to tumors","authors":"Iaroslav B. Belyaev ,&nbsp;Olga Yu. Griaznova ,&nbsp;Alexey V. Yaremenko ,&nbsp;Sergey M. Deyev ,&nbsp;Ivan V. Zelepukin","doi":"10.1016/j.addr.2025.115550","DOIUrl":"10.1016/j.addr.2025.115550","url":null,"abstract":"<div><div>Delivery of nanoparticles (NPs) to solid tumors has long relied on enhanced permeability and retention (EPR) effect, involving permeation of NPs through a leaky vasculature with prolonged retention by reduced lymphatic drainage in tumor. Recent research studies and clinical data challenge EPR concept, revealing alternative pathways and approaches of NP delivery. The area was significantly impacted by the implementation of intravital optical microscopy, unraveling delivery mechanisms at cellular level <em>in vivo</em>. This review presents analysis of the reasons for EPR heterogeneity in tumors and describes non-EPR based concepts for drug delivery, which can supplement the current paradigm. One of the approaches is targeting tumor endothelium by NPs with subsequent intravascular drug release and gradient-driven drug transport to tumor interstitium. Others exploit various immune cells for tumor infiltration and breaking endothelial barriers. Finally, we discuss the involvement of active transcytosis through endothelial cells in NP delivery. This review aims to inspire further understanding of the process of NP extravasation in tumors and provide insights for developing next-generation nanomedicines with improved delivery.</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"219 ","pages":"Article 115550"},"PeriodicalIF":15.2,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143495754","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acoustic tweezers for targeted drug delivery","authors":"Léa Guerassimoff ,&nbsp;Stefaan C. De Smedt ,&nbsp;Félix Sauvage ,&nbsp;Michael Baudoin","doi":"10.1016/j.addr.2025.115551","DOIUrl":"10.1016/j.addr.2025.115551","url":null,"abstract":"<div><div>Acoustic tweezers are a highly promising technology for targeted drug delivery thanks to their unique capabilities: (i) they can effectively operate in both <em>in vitro</em> and <em>in vivo</em> environments, (ii) they can manipulate a wide range of particle sizes and materials, and (iii) they can exert forces several orders of magnitude larger than competing techniques while remaining safe for biological tissues. In particular, tweezers capable of selectively capturing and manipulating objects in 3D with a single beam, known as ‘single beam tweezers’, open new perspectives for delivering drug carriers to precise locations. In this review, we first introduce the fundamental physical principles underlying the manipulation of particles using acoustic tweezers and highlight the latest advancements in the field. We then discuss essential considerations for the design of drug delivery carriers suitable for use with acoustic tweezers. Finally, we summarise recent promising studies that explore the use of acoustic tweezers for <em>in vitro</em>, <em>ex vivo</em>, and <em>in vivo</em> drug delivery.</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"220 ","pages":"Article 115551"},"PeriodicalIF":15.2,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143470991","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}

{"title":"PhotoChem Interplays: Lighting the Way for Drug Delivery and Diagnosis","authors":"Asmita Banstola,&nbsp;Zuan-Tao Lin,&nbsp;Yongli Li,&nbsp;Mei X. Wu","doi":"10.1016/j.addr.2025.115549","DOIUrl":"10.1016/j.addr.2025.115549","url":null,"abstract":"<div><div>Light, a non-invasive tool integrated with cutting-edge nanotechnologies, has driven transformative advancements in imaging-based diagnosis and drug delivery for cancer and bacterial treatments. This review discusses recent progress in these areas, beginning with emerging imaging technologies. Unlike traditional photosensors activated by visible light, alternative energy sources such as near-infrared (NIR) light, X-rays, and ultrasound have been extensively investigated to activate various photosensors, achieving high sensitivity, wavelength versatility, and spatial resolution for deep-tissue imaging. Moreover, to address challenges like tissue autofluorescence in real-time fluorescence imaging, afterglow luminescent nanoparticles are being developed by integrating these alternative energy sources for real-time imaging and sensing in deep tissue for precise cancer diagnosis and treatment beyond superficial tissues. In addition to deep tissue imaging, light-responsive nanomedicines are revolutionizing anticancer and antimicrobial phototherapy by enabling spatially and temporally controlled drug release. These smart nanoparticles are engineered to release therapeutic cargo at target sites in response to microenvironmental cues specific to tumors or infections. In anticancer phototherapy, these nanoparticles facilitate controlled drug release via photoisomerization, photothermal, and photodynamic processes. To enhance circulation time and specific targeting, biomimetic nanoparticles, which mimic natural anti-tumor responses by our body, have attracted increasing attention. In antimicrobial phototherapy, research has been focused on the chemical modification of the photosensitizer to enable targeted drug delivery. An intriguing strategy has recently emerged involving the development of “pro-photosensitizers” that are specifically activated within bacterial cells upon light irradiation, offering a high margin of safety. These advancements leverage photochemical reactions and nanotechnology to enhance precision therapy and diagnosis in addressing critical health challenges.</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"219 ","pages":"Article 115549"},"PeriodicalIF":15.2,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143452232","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}

{"title":"Application of photosensitive microalgae in targeted tumor therapy","authors":"Ruoxi Wang ,&nbsp;Zhouyue Wang ,&nbsp;Min Zhang ,&nbsp;Danni Zhong ,&nbsp;Min Zhou","doi":"10.1016/j.addr.2025.115519","DOIUrl":"10.1016/j.addr.2025.115519","url":null,"abstract":"<div><div>Microalgae present a novel and multifaceted approach to cancer therapy by modulating the tumor-associated microbiome (TAM) and the tumor microenvironment (TME). Through their ability to restore gut microbiota balance, reduce inflammation, and enhance immune responses, microalgae contribute to improved cancer treatment outcomes. As photosynthetic microorganisms, microalgae exhibit inherent anti-tumor, antioxidant, and immune-regulating properties, making them valuable in photodynamic therapy and tumor imaging due to their capacity to generate reactive oxygen species. Additionally, microalgae serve as effective drug delivery vehicles, leveraging their biocompatibility and unique structural properties to target the TME more precisely. Microalgae-based microrobots further expand their therapeutic potential by autonomously navigating complex biological environments, offering a promising future for precision-targeted cancer treatments. We position microalgae as a multifunctional agent capable of modulating TAM, offering novel strategies to enhance TME and improve the efficacy of cancer therapies.</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"219 ","pages":"Article 115519"},"PeriodicalIF":15.2,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143418423","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}

{"title":"3D printing of pharmaceutical dosage forms: Recent advances and applications","authors":"Tobias Auel ,&nbsp;Aaron Felix Christofer Mentrup ,&nbsp;Lee Roy Oldfield ,&nbsp;Anne Seidlitz","doi":"10.1016/j.addr.2024.115504","DOIUrl":"10.1016/j.addr.2024.115504","url":null,"abstract":"<div><div>Three-dimensional (3D) printing, also referred to as additive manufacturing, is considered to be a game-changing technology in many industries and is also considered to have potential use cases in pharmaceutical manufacturing, especially if individualization is desired. In this review article the authors systematically researched literature published during the last 5 years (2019 – spring 2024) on the topic of 3D printed dosage forms. Besides all kinds of oral dosage forms ranging from tablets and capsules to films, pellets, etc., numerous reports were also identified on parenteral and cutaneous dosage forms and also rectal, vaginal, dental, intravesical, and ophthalmic preparations. In total, more than 500 publications were identified and grouped according to the site of administration, and an overview of the manuscripts is presented here. Furthermore, selected publications are described and discussed in more detail. The review highlights the very different approaches that are currently used in order to develop 3D printed dosage forms but also addresses remaining challenges.</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"217 ","pages":"Article 115504"},"PeriodicalIF":15.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142849155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Next generation concepts in dermal delivery, theranostics, and preclinical testing","authors":"Sarah Hedtrich,&nbsp;Marcelo Calderón","doi":"10.1016/j.addr.2024.115482","DOIUrl":"10.1016/j.addr.2024.115482","url":null,"abstract":"","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"217 ","pages":"Article 115482"},"PeriodicalIF":15.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142742416","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}

{"title":"Recent advances in 3D bioprinted neural models: A systematic review on the applications to drug discovery","authors":"Amanda Orr ,&nbsp;Farnoosh Kalantarnia ,&nbsp;Shama Nazir ,&nbsp;Behzad Bolandi ,&nbsp;Dominic Alderson ,&nbsp;Kerrin O’Grady ,&nbsp;Mina Hoorfar ,&nbsp;Lisa M. Julian ,&nbsp;Stephanie M. Willerth","doi":"10.1016/j.addr.2025.115524","DOIUrl":"10.1016/j.addr.2025.115524","url":null,"abstract":"<div><div>The design of neural tissue models with architectural and biochemical relevance to native tissues opens the way for the fundamental study and development of therapies for many disorders with limited treatment options. Here, we systematically review the most recent literature on 3D bioprinted neural models, including their potential for use in drug screening. Neural tissues that model the central nervous system (CNS) from the relevant literature are reviewed with comprehensive summaries of each study, and discussion of the model types, bioinks and additives, cell types used, bioprinted construct shapes and culture time, and the characterization methods used. In this review, we accentuate the lack of standardization among characterization methods to analyze the functionality (including chemical, metabolic and other pathways) and mechanical relevance of the 3D bioprinted constructs, and discuss this as a critical area for future exploration. These gaps must be addressed for this technology to be applied for effective drug screening applications, despite its enormous potential for rapid and efficient drug screening. The future of biomimetic, 3D printed neural tissues is promising and evaluation of the <em>in vivo</em> relevance on multiple levels should be sought to adequately compare model performance and develop viable treatment options for neurodegenerative diseases, or other conditions that affect the CNS.</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"218 ","pages":"Article 115524"},"PeriodicalIF":15.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143071566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Visualizing kinetics of diffusional penetration in tissues using OCT-based strain imaging","authors":"Y.M. Alexandrovskaya ,&nbsp;A.A. Sovetsky ,&nbsp;E.M. Kasianenko ,&nbsp;A.L. Matveyev ,&nbsp;L.A. Matveev ,&nbsp;O.I. Baum ,&nbsp;V.Y. Zaitsev","doi":"10.1016/j.addr.2024.115484","DOIUrl":"10.1016/j.addr.2024.115484","url":null,"abstract":"<div><div>We report a new application of the recently developed technique, Optical Coherence Elastography (OCE) to quantitatively visualize kinetics of osmotic strains due to diffusive penetration of various osmotically active solutions into biological tissues. The magnitude of osmotic strains may range from fractions of one per cent to tens per cent. The visualized spatio-tempotal dynamics of the strains reflect the rates of osmotic dehydration and diffusional penetration of the active solute, which can be controlled by concentration of the solution components. Main features of the OCE-visualized diffusion-front dynamics well agree with Fick’s theory yielding diffusivity coefficients consistent with the literature data. The OCE technique may be used to study diffusion of a broad variety of osmotically-active substances − drugs, cosmetic agents, preservative solutions, so-called optical clearing agents enhancing the depth of optical visualization, etc. The corresponding experimental examples, some results of theoretical interpretations and numerical simulations are given.</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"217 ","pages":"Article 115484"},"PeriodicalIF":15.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142804675","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}

{"title":"Monitoring kinetic processes of drugs and metabolites: Surface-enhanced Raman spectroscopy","authors":"Zhewen Luo ,&nbsp;Haoran Chen ,&nbsp;Xinyuan Bi ,&nbsp;Jian Ye","doi":"10.1016/j.addr.2024.115483","DOIUrl":"10.1016/j.addr.2024.115483","url":null,"abstract":"<div><div>Monitoring the kinetic changes of drugs and metabolites plays a crucial role in fundamental research, preclinical and clinical application. Raman spectroscopy (RS) is regarded as a fingerprinting technique that can reflect molecular structures but limited in applications due to poor sensitivity. Surface-enhanced Raman spectroscopy (SERS) significantly amplifies the detection sensitivity by plasmonic substrates, facilitating the identification and quantification of small molecules in biological samples, such as serum, urine, and living cells. This review will focus on advances in how SERS has been utilized to monitor the dynamic processes of small molecule drugs and metabolites in recent years. We first provide readers with a comprehensive overview of the mechanism and practical considerations of SERS, including enhancement theory, substrate design, sample pretreatment, molecule–substrate interactions and spectral analysis. Then we describe the latest advances in SERS for the detection and analysis of metabolites and drugs in cells, dynamic monitoring of drug in various biological matrices, and metabolic profiling for health assessment in biological fluids. We believe that high-performance SERS substrates, standardized technical regulations, and artificial intelligence spectral analysis will boost sensitive, accurate, reproducible, and universal molecular detection in the future. We hoped this review could inspire researchers working in related fields to better understand and utilize SERS for the analytical detection of drugs and metabolites.</div></div>","PeriodicalId":7254,"journal":{"name":"Advanced drug delivery reviews","volume":"217 ","pages":"Article 115483"},"PeriodicalIF":15.2,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142820779","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}