Bharath Raj Madhanagopal, Arun Richard Chandrasekaran
{"title":"DNA nanocarriers for nucleic acid drug delivery.","authors":"Bharath Raj Madhanagopal, Arun Richard Chandrasekaran","doi":"10.1080/17425247.2025.2565418","DOIUrl":"10.1080/17425247.2025.2565418","url":null,"abstract":"","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-4"},"PeriodicalIF":5.4,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12462906/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145093237","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Matthew A Hummel, Andrew Shaw, Mark Shiyao Liu, Amarnath Jaiswal, Jeffrey P Smith, Todd Bertoch
{"title":"Comparison of the pharmacokinetics of MR-107A-02, a novel fast-absorbing formulation of meloxicam, versus standard meloxicam reference: a phase I study.","authors":"Matthew A Hummel, Andrew Shaw, Mark Shiyao Liu, Amarnath Jaiswal, Jeffrey P Smith, Todd Bertoch","doi":"10.1080/17425247.2025.2561710","DOIUrl":"10.1080/17425247.2025.2561710","url":null,"abstract":"<p><strong>Background: </strong>MR-107A-02 is a novel faster dissolving oral formulation of meloxicam to provide rapid absorption and faster onset of action in acute pain settings. This study compared the single-dose pharmacokinetics of MR-107A-02 tablets to reference meloxicam (Mobic®) tablets under fasting conditions.</p><p><strong>Research design and methods: </strong>A single-dose, randomized, two-period crossover study was conducted at a single center in India. Healthy adult volunteers, aged 18-45 years, were randomized to receive a single, oral dose of 15 mg (1 × 15 mg) of MR-107A-02 or reference. Plasma samples were analyzed for meloxicam using LC-MS/MS. Pharmacokinetic parameters were derived using non-compartmental analysis, and 90% geometric confidence intervals for test/reference ratios were calculated. Safety was assessed through adverse event (AE) monitoring.</p><p><strong>Results: </strong>Eighteen adult male volunteers were randomized and 16 completed the study. MR-107A-02 showed faster absorption, with a geometric mean C<sub>max</sub> value of 2734.342 (ng/mL) compared to reference 1592.102 (ng/mL) and a significantly shorter median T<sub>max</sub> (hour) (0.75 vs 4.00). There were no AEs, or serious AEs reported.</p><p><strong>Conclusions: </strong>MR-107A-02 demonstrated more rapid absorption than reference, as evidenced by a higher C<sub>max</sub>, and shorter T<sub>max</sub> values. These findings highlight the potential utility of oral MR-107A-02's fast-release design in an acute pain setting.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-8"},"PeriodicalIF":5.4,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145077054","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":"Development of ROS-responsive liposomes toward targeted drug delivery.","authors":"Mayesha B Mustafa, Jinchao Lou, Michael D Best","doi":"10.1080/17425247.2025.2556013","DOIUrl":"10.1080/17425247.2025.2556013","url":null,"abstract":"<p><strong>Introduction: </strong>Elevated levels of reactive oxygen species (ROS), which are key mediators in different pathophysiological conditions, provide a unique opportunity for achieving targeted drug delivery. As such, ROS-responsive liposomes that undergo variable structural changes have emerged as promising tools for drug delivery purposes. These approaches show strong prospects for enhancing the selectivity of delivery to diseased cells through nanoparticle activation by aberrant ROS concentrations.</p><p><strong>Area covered: </strong>This review describes elegant strategies for engineering ROS-responsive liposomes through lipid switch oxidation. These platforms exhibit improvements, including ROS-triggered release of encapsulated cargo, detachment of medicinal agents through prodrug strategies, programmed activation of cellular delivery, and photodynamic therapies. We describe how lipid switch design features can be leveraged to achieve these varying applications.</p><p><strong>Expert opinion: </strong>ROS-responsive liposomes provide an adaptable approach for targeted therapy in environments associated with higher oxidative stress. We discuss how the attributes of each platform position these systems for overcoming practical issues, including stability, scalability, and clinical efficacy, as well as strategies for maximizing properties through continued innovation. In general, ROS-responsive liposome stability must be carefully tuned to be sufficiently stable to survive circulation but become activated within a window of ROS concentration that differentiates between diseased and healthy cells.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-17"},"PeriodicalIF":5.4,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144983902","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}
Saba Khan, Azka Gull, Masheera Akhtar, Bushra Gull, Abul Kalam Najmi, Rabea Parveen, Javed Ali, Sana Khan
{"title":"Explicit analysis of <i>in vivo</i>, meterological and statistical hurdles in successful clinical translation of targeted nanomedicines and plausible remedial strategies.","authors":"Saba Khan, Azka Gull, Masheera Akhtar, Bushra Gull, Abul Kalam Najmi, Rabea Parveen, Javed Ali, Sana Khan","doi":"10.1080/17425247.2025.2556979","DOIUrl":"10.1080/17425247.2025.2556979","url":null,"abstract":"<p><strong>Introduction: </strong>The potential of nanomedicine in alleviating different disorders is immense, but its clinical translation rate is severely debilitated, despite promising preclinical study outcomes. For therapeutically successful targeted delivery of nanomedicines, it is crucial to understand why well-designed nanomedicines often fail during clinical trials.</p><p><strong>Areas covered: </strong>This review comprehensively explores the multifactorial reasons behind the poor clinical success rate of nanomedicines, including pathophysiological complexity, limitations in statistical analysis, inadequate animal models, variability in the EPR effect, and manufacturing challenges. Special focus is placed on the misinterpretation and misuse of statistical tools in preclinical studies, which significantly reduces data interpretation and clinical predictability. The review is based on an in-depth literature survey of recent advances and failures in nanomedicine translation, with an emphasis on incorporating simulation models and synthesized data to overcome the challenges of statistics.</p><p><strong>Expert opinion: </strong>Addressing translational gaps requires a multidisciplinary approach, refined preclinical models, robust statistical frameworks, and adaptive clinical designs that are essential. Innovative tools, such as CTGAN and personalized trial strategies, can bridge the preclinical-clinical divide. To realize the full potential of nanomedicine, it is crucial to resolve foundational issues in experimental design, data interpretation, analytical frameworks, and regulatory compliance.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-23"},"PeriodicalIF":5.4,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145006962","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":"From stem cell transplantation to stem cell-based drug delivery systems targeting hematological malignancies: recent advances and clinical considerations.","authors":"Ping Zhang, Ruyi Lin, Jianqing Gao, Guifang Ouyang","doi":"10.1080/17425247.2025.2556320","DOIUrl":"10.1080/17425247.2025.2556320","url":null,"abstract":"<p><strong>Introduction: </strong>Hematopoietic stem cell transplantation (HSCT) is a promising treatment option for hematological malignancies. Despite its curative potential, it faces clinical challenges, including relapse and graft-versus-host disease (GVHD). Systemic toxicity due to chemotherapy is a significant problem in patients with hematological malignancies. Stem cell-based drug delivery can precisely deliver drugs to tumor sites, thereby increasing local drug toxicity, which may alleviate relapse and systemic toxicity.</p><p><strong>Areas covered: </strong>This review integrates and critically examines the recent clinical advances in HSCT and its challenges. Autologous HSCT is constrained by the risk of relapse, whereas allogeneic HSCT is limited by donor availability and GVHD complications. Additionally, we highlight both the immunomodulation of mesenchymal stem cells (MSCs) in GVHD and the therapeutic potential of induced pluripotent stem cells (iPSCs). Furthermore, we explored stem cell-based drug delivery systems focusing on three primary strategies: (1) stem cells as intrinsic carriers, (2) stem cell-derived extracellular vesicles (EVs), and (3) stem cell membrane-derived biomimetic vesicles.</p><p><strong>Expert opinion: </strong>While stem cell therapies hold promise, issues include the heterogeneity of stem cell sources, complexity of the cultivation process, and long-term safety issues. Future research should focus on large-scale technologies, stem cell engineering techniques, and combination therapies to facilitate clinical translation.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-18"},"PeriodicalIF":5.4,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145024955","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":"Metallic and lipid nanoparticles against multidrug resistant <i>Candida</i>: advances and translational hurdles.","authors":"Manoj Dalabehera, Rudra Narayan Subudhi, Joshua Boateng, Yahya E Choonara, Shubham Chaudhari, Dinesh Kumar Chellappan, Neha Kanojia, Khumblani Mnqiwu, Thakur Gurjeet Singh, Poonam Negi","doi":"10.1080/17425247.2025.2556014","DOIUrl":"10.1080/17425247.2025.2556014","url":null,"abstract":"<p><strong>Introduction: </strong>Among the many ongoing difficulties, <i>Candida</i> infections present significant clinical hurdles due to the rapid development of resistance, recurrent episodes, and the limited effectiveness of conventional therapies. In recent decades, metallic nanoparticles (MNPs) and lipid nanoparticles (LNPs) have shown a specific impact (>84% <i>Candida</i> biofilm inhibition in preclinical models) by addressing the critical challenges of mitigating drug side effects and multidrug resistance (MDR).</p><p><strong>Areas covered: </strong>This paper provides an in-depth overview of synthesis, fabrication, mechanistic insights, preclinical and clinical practices for MNPs and LNPs, discussing and highlighting their therapeutic efficacy against resistant <i>Candida</i> species over traditional methods. The literature was sourced from peer-reviewed journals and databases, including PubMed, Scopus, Web of Science, WIPO, and Clinical Trials up to May 2025.</p><p><strong>Expert opinion: </strong>In this portion the potential of hybrid MNP-LNP systems with surface modification enables functionalization by targeting ligands and more specific binding toward fungal cells to enhance the therapeutic index. In addition, combining drug-loaded MNPs and LNPs with artificial intelligence (AI), photodynamic, gene, or immune therapies offers a comprehensive and innovative solution for MDR <i>Candida</i>. However, addressing regulatory complexity still needs to be considered toward optimizing the stability and scalability of MNPs and LNPs for clinically meaningful translation.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-23"},"PeriodicalIF":5.4,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144983829","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":"Drug depots for obesity targeting metabolism, appetite, and inflammation.","authors":"Muhammad Fayyaz, Andrew M Smith","doi":"10.1080/17425247.2025.2554718","DOIUrl":"10.1080/17425247.2025.2554718","url":null,"abstract":"","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-7"},"PeriodicalIF":5.4,"publicationDate":"2025-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144983900","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}
Haoran Wang, Guoyue Wei, Jie Yin, Mingyuan Yang, Lingjun Tong, Jiong-Wei Wang
{"title":"Clinical insights into extracellular vesicles for targeted myocardial drug delivery.","authors":"Haoran Wang, Guoyue Wei, Jie Yin, Mingyuan Yang, Lingjun Tong, Jiong-Wei Wang","doi":"10.1080/17425247.2025.2555488","DOIUrl":"10.1080/17425247.2025.2555488","url":null,"abstract":"<p><strong>Introduction: </strong>The heart is a highly dynamic organ with limited regenerative capacity and a unique microvascular environment, which restricts the accumulation and retention of systemically administered therapeutics. Despite notable progress in nanomedicine and targeted drug delivery technologies, achieving efficient and specific drug delivery to cardiac tissue remains a formidable challenge.</p><p><strong>Areas covered: </strong>Extracellular vesicles (EVs) represent a novel therapeutic strategy for cardiovascular diseases, offering a versatile platform to integrate therapeutics, targeting moieties, and sensing elements for the detection, prevention, and treatment of cardiovascular diseases (CVD). This review highlights the recent progress in employing EVs as carriers for targeted myocardial drug delivery and explores their potential for clinical translation. A literature search was conducted using PubMed, focusing on studies categorized under EVs, cardiovascular diseases, and myocardium-targeted delivery. Current progress of EVs in clinical applications was evaluated based on the data from ClinicalTrials.gov.</p><p><strong>Expert opinion: </strong>EVs offer significant promise for clinical myocardial drug delivery. Some key considerations for clinical application of EVs include modulating immune clearance, establishing scalable production with stringent quality control, and refining surface engineering strategies. Facilitating EV clinical translation requires focused strategies to overcome current barriers, especially by integrating bioengineering and biomaterial-based targeting to enhance myocardial delivery efficiency.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-17"},"PeriodicalIF":5.4,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144983871","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}
Yujie Lu, Ilyas Essadki-Aittaji, Jiaqi Gao, Abraham M Abraham, Qonita Kurnia Anjani, Ana B Cobo-González, Fernando Iglesias-Martín, Lalitkumar K Vora, Mónica Millán-Jiménez, Eneko Larrañeta, Juan Domínguez-Robles
{"title":"Implantable and injectable drug delivery systems for pain management.","authors":"Yujie Lu, Ilyas Essadki-Aittaji, Jiaqi Gao, Abraham M Abraham, Qonita Kurnia Anjani, Ana B Cobo-González, Fernando Iglesias-Martín, Lalitkumar K Vora, Mónica Millán-Jiménez, Eneko Larrañeta, Juan Domínguez-Robles","doi":"10.1080/17425247.2025.2549847","DOIUrl":"https://doi.org/10.1080/17425247.2025.2549847","url":null,"abstract":"<p><strong>Introduction: </strong>Pain is a widespread global health issue, significantly affecting quality of life and contributing to disability. It is estimated that between 20% and 30% of the global population suffer from some form of non-cancer chronic pain. Around 80% of surgical patients report postoperative acute pain, with less than 50% achieving adequate pain control. Despite these statistics, the management of pain still remains a significant challenge for clinicians, with many patients experiencing poorly controlled pain or adverse effects related to analgesic medication.</p><p><strong>Areas covered: </strong>This literature review outlines current pain management strategies, focusing on non-oral postoperative pain therapies, including injectable drug delivery systems (such as in situ forming implants, micro- and nano-based formulations) and implantable drug delivery systems. Emphasis is placed on solid implantable devices designed for sustained drug delivery, which can offer more efficient localized drug delivery at the pain site.</p><p><strong>Expert opinion: </strong>While pharmacological treatments, including oral opioids and nonsteroidal anti-inflammatory drugs, are commonly used, implantable controlled release systems are emerging as more effective alternatives. These systems provide localized pain relief with reduced systemic exposure, minimizing side effects, opioid use, and the risk of addiction, offering a promising solution for improved postoperative pain management.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-24"},"PeriodicalIF":5.4,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144983833","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":"Recent advances and future directions of propolis delivery.","authors":"Marcos Luciano Bruschi","doi":"10.1080/17425247.2025.2554716","DOIUrl":"https://doi.org/10.1080/17425247.2025.2554716","url":null,"abstract":"<p><strong>Introduction: </strong>Propolis is a gum-resinous compound produced by bees for hive protection. It displays complex chemical composition, dependent on the plant sources, and important biological activities, contributing to a wide range of pharmacological effects (e.g. antimicrobial, anti-inflammatory, healing and immunostimulant). Propolis shows poor aqueous solubility and low bioavailability. Thus, delivery systems have been proposed for the administration of propolis by different routes like oral, buccal, topical, local, vaginal, transmucosal, nasal, endodontics and intra-periodontal pocket.</p><p><strong>Areas covered: </strong>From extracts and ointments, formulations for propolis delivery improved their physicochemical properties. The use of biocompatible, biodegradable, environmentally responsive materials, nanotechnology, and propolis by-product resulted in smart systems: films, micro/nanoparticles, lipid systems, carbon nanotubes, emulsion, and self-emulsifying systems, bioadhesive and environmentally responsive systems, microneedles, liquid crystals, sensors and electrospun fibers.</p><p><strong>Expert opinion: </strong>Ensuring the efficacy and safety of propolis requires characterization, standardization, and quality control. Challenges like composition variability, limited bioavailability, and inconsistent extraction hinder its optimal use. Nanotechnology improves bioavailability and controlled release, while emerging strategies like microneedles and 3D/4D printing enhance precision and versatility. By integrating nanotechnology and additive manufacturing, researchers can develop safer, more effective delivery systems, expanding propolis applications and fostering innovation in pharmaceutical and biomedical fields.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-20"},"PeriodicalIF":5.4,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144983911","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}