Chloé Stoll, Anne Combedazou, Laurie Brunet-Manquat, Camélia Tabet, Cécile Frolet
{"title":"Feasibility of switching between different autoinjector designs: positive insights from formative Comparative Use Human Factors studies.","authors":"Chloé Stoll, Anne Combedazou, Laurie Brunet-Manquat, Camélia Tabet, Cécile Frolet","doi":"10.1080/17425247.2025.2514222","DOIUrl":"10.1080/17425247.2025.2514222","url":null,"abstract":"<p><strong>Background: </strong>Users may switch drug-device products when transitioning to generic versions. For autoinjectors, such switches can involve user interface differences, particularly in the activation mechanism, requiring either a push-on-skin step or button activation. It is essential to demonstrate that the use of a generic product remains safe and effective. This article provides preliminary usability data on various autoinjector designs, focusing on generic drug-device combination products.</p><p><strong>Research design and methods: </strong>Two formative Comparative Use Human Factors studies assessed the usability of a 3-step candidate generic button-activated autoinjector compared to RLD autoinjectors: study 1 compared it to a 4-step button-activated while study 2 compared it to a 2-step push-on-skin.</p><p><strong>Results: </strong>In study 1, 80% of participants (12/15) performed similarly with both devices. The error rate for the 3-step candidate generic autoinjector was 20% (3/15), compared to 13.3% (2/15) for the 4-step. In study 2, 90% of participants (10/11) performed similarly with both devices, with a 9% (1/11) error rate for the 3-step candidate generic autoinjector and 0% for the 2-step.</p><p><strong>Conclusion: </strong>These studies offer preliminary evidence supporting the feasibility of switching between different autoinjector activation mechanisms without introducing new risks. The main driver of usability results appears to be user familiarity rather than design differences.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-14"},"PeriodicalIF":0.0,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144259678","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":"Adverse effects of intravenous LNP-mediated mRNA therapy in clinical trials: a systematic review and meta-analysis.","authors":"Wenhan Wu, Ziwei Wang","doi":"10.1080/17425247.2025.2517363","DOIUrl":"10.1080/17425247.2025.2517363","url":null,"abstract":"<p><strong>Introduction: </strong>Intravenous LNP-mediated mRNA therapy holds promise for treating various diseases, yet its safety, particularly regarding adverse events, remains a critical concern. This review systematically evaluates the adverse effects associated with this therapeutic approach.</p><p><strong>Methods: </strong>A comprehensive search of PubMed was conducted for clinical trials on intravenous LNP-mediated mRNA therapies. Data extraction focused on study design, participant demographics, and adverse events. Meta-analysis was performed to assess the incidence of treatment-emergent adverse events (TEAEs) and common manifestations. The risk of bias was assessed using the ROBINS-I tool.</p><p><strong>Results: </strong>A total of six phase 1/2 clinical trials on intravenous LNP-mediated mRNA therapies were included, with sample sizes ranging from 6 to 38 participants. The pooled incidence of TEAEs was 92.2% (95% CI: 77.7%-99.4%). Sensitivity analysis indicated that excluding one study with a single smaller dose reduced heterogeneity to 6.8%. The incidence of severe TEAEs was 9.2% (95% CI: 0%-38.1%) and showed substantial heterogeneity (I<sup>2</sup> = 89.87%), which was likely influenced by factors such as higher doses, multiple administrations, and patient-specific conditions like comorbidities.</p><p><strong>Conclusion: </strong>While low-dose, single-dose intravenous LNP-mediated mRNA therapies generally have a manageable safety profile, higher doses or repeated administrations may increase the risk of severe adverse events.</p><p><strong>Protocol registration: </strong>www.crd.york.ac.uk/prospero identifier is CRD42025643741.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-9"},"PeriodicalIF":0.0,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144236280","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 developments with pH-responsive lyotropic liquid crystalline lipid nanoparticles for targeted bioactive agent delivery.","authors":"Natinael Koyra, Haitao Yu, Calum J Drummond, Jiali Zhai, Brendan Dyett","doi":"10.1080/17425247.2025.2518225","DOIUrl":"https://doi.org/10.1080/17425247.2025.2518225","url":null,"abstract":"<p><strong>Introduction: </strong>Lyotropic liquid crystalline lipid nanoparticles (LNPs) are a platform technology with broad-ranging potential in bioactive agent delivery applications. Their biomimetic properties impart the capacity to encapsulate large biomolecules and to overcome traditional biological barriers.</p><p><strong>Areas covered: </strong>The properties of lyotropic liquid crystalline LNPs can vary significantly between phases. We briefly introduce key concepts related to their formation and self-assembly and how ionization at the lipid-water interface, i.e. pH-responsiveness, can be leveraged to alter the properties of the nanoparticles. In this review, we summarize recent advances mainly from the past five years that highlight the role and impact of incorporating ionizable lipids, copolymers, and drug molecules in pH-responsive nanocarriers for the delivery of bioactive agents.</p><p><strong>Expert opinion: </strong>The development of pH-responsive lipid nanoparticles (pR_LNPs) is at the forefront of the new wave of mRNA therapeutics. The complexity of the biological journey faced by the nanoparticle and the broad spectrum of disease targets is sparking a surge in research activity. The accelerating development of new ionizable lipid materials to enhance mRNA delivery potential may benefit from closer consideration - or in tandem development - of self-assembly, interface ionization, and artificial intelligence integration.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144259679","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}
Hana Kadavil, Sandi Ali Adib, Alia Marei, Noora H Al-Qahtani, Ying Zhu, Ali A Al-Kinani, Raid G Alany, Husam M Younes
{"title":"Tyrosine kinase inhibitors and their promising role in treating diabetic retinopathy and other retinal vascular diseases: overview of their routes of administration, pharmacokinetics, formulations, and drug delivery applications.","authors":"Hana Kadavil, Sandi Ali Adib, Alia Marei, Noora H Al-Qahtani, Ying Zhu, Ali A Al-Kinani, Raid G Alany, Husam M Younes","doi":"10.1080/17425247.2025.2516668","DOIUrl":"10.1080/17425247.2025.2516668","url":null,"abstract":"<p><strong>Introduction: </strong>Tyrosine Kinase Inhibitors (TKIs) are emerging as a promising alternative to protein-based anti-vascular endothelial growth factors (anti-VEGF) in treating diabetic retinopathy (DR) and other retinal vascular diseases (RVD). TKIs exhibit broader inhibition of tyrosine kinase pathways, superior tissue penetration, and favorable pharmacokinetics and chemical stability, which may reduce the need for injection frequency. Despite those advantages, their ocular administration and clinical efficacy still face many challenges, but they also open many opportunities.</p><p><strong>Areas covered: </strong>This review evaluates current ocular drug delivery platforms for TKIs for intravitreal or suprachoroidal administration. It discusses TKIs' physicochemical properties and their relevance to their pharmacokinetics and clinical effectiveness. It also examines emerging technologies, such as nanotechnology and innovative polymer systems, that enhance bioavailability and prolong the drug release of TKIs.</p><p><strong>Expert opinion: </strong>The future of DR treatment lies in integrating TKIs with advanced drug delivery systems, tissue engineering, 3D printing, and other interdisciplinary innovations. Combining nanotechnology, biomaterials, regenerative medicine, and AI tools will enable targeted, prolonged, and stable delivery, overcoming current therapy limitations and offering safer, personalized, and more effective treatments. As research progresses, these advancements may revolutionize RVD management and provide hope to millions of patients globally.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-27"},"PeriodicalIF":0.0,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144236281","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":"Polyphenol-conjugated polysaccharide nanoplatforms for enhanced therapeutic efficacy.","authors":"Somesh Narayan, Kalpana Nagpal, Pradeep Kumar","doi":"10.1080/17425247.2025.2514714","DOIUrl":"10.1080/17425247.2025.2514714","url":null,"abstract":"<p><strong>Introduction: </strong>Polyphenols represent a broad class of natural chemical compounds comprising, but not limited to, tannins, phenolic acids, flavonoids, flavanones, flavanols, anthocyanins, and their related polymerized derivatives. Polyphenols are an important component of various commercial, naturally derived products with therapeutic properties. However, their full therapeutic potential is restricted by inherently low solubility and limited dispersibility in the aqueous phase.</p><p><strong>Areas covered: </strong>This special report provides a focused viewpoint of various polyphenols conjugated with polysaccharides such as chitosan, dextran, curdlan, alginate, gellan, and pectin. The advantages and performance of conjugating polysaccharides to polyphenols are presented and discussed. Further to this, nanoplatforms of polyphenol-conjugated polysaccharides with enhanced therapeutic efficacy and physicochemical properties are discussed.</p><p><strong>Expert opinion: </strong>Conjugation of polyphenols with polysaccharides, using various chemical conjugation techniques, may provide an amenable solution to the envisaged polyphenol efficacy challenge. The conjugation of polyphenols with polysaccharides offers multiple advantages, including improved aqueous solubility, enhanced protection against oxidative degradation, and targeted delivery through ligand-functionalized nanocarriers. This approach not only improves the pharmacokinetic profile of polyphenols but also maximizes their therapeutic efficacy while minimizing off-target toxicity. Furthermore, polysaccharide-polyphenol conjugates hold immense potential in functional foods, nutraceuticals, and pharmaceutical formulations, where enhanced bioactivity and controlled release are desired.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-19"},"PeriodicalIF":0.0,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144210551","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}
Ilaria Andreana, Nicole Zoratto, Chiara Di Meo, Pietro Matricardi, Barbara Stella, Silvia Arpicco
{"title":"An overview of hyaluronic-acid nanoparticles for cancer cell targeted drug delivery.","authors":"Ilaria Andreana, Nicole Zoratto, Chiara Di Meo, Pietro Matricardi, Barbara Stella, Silvia Arpicco","doi":"10.1080/17425247.2025.2515266","DOIUrl":"10.1080/17425247.2025.2515266","url":null,"abstract":"<p><strong>Introduction: </strong>Hyaluronic acid (HA) has been widely explored in cancer drug delivery due to its biocompatibility, biodegradability and excellent cargo properties. Recently, HA-based formulations have gained renewed interest thanks to the HA involvement in many CD44-overexpressing tumors, offering potential for active targeting, tumor microenvironment modulation, and immune response regulation.</p><p><strong>Areas covered: </strong>This review explores the role of HA and its receptor in cancer progression and as a strategy for active therapeutic targeting. It also outlines the current status of HA-based formulations in clinical cancer therapy, emphasizing their clinical outcomes. The use of HA-drug conjugates, HA-based and -decorated nanoparticles (NPs), in chemotherapy, gene therapy, and theranostics is reviewed. Additionally, recent advancements in the role of HA in immune system modulation are discussed. All presented systems are herein evaluated for their ability to selectively target CD44-overexpressing cancer cells, with a focus on their in vivo biodistribution and therapeutic efficacy.</p><p><strong>Expert opinion: </strong>Despite significant research, a few HA-based technologies have progressed to clinical trials, with only one showing promising results. Key challenges include high production costs, industrial scale-up feasibility, the need to preserve receptor recognition, and the off-target accumulation of HA in the liver and spleen barriers that must be addressed for successful clinical translation.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-18"},"PeriodicalIF":0.0,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144201241","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}
Gabriela Lopes Gama E Silva, Aryanne Adametz Escarrone Puejo, Breno de Almeida Bertassoni, Bruna Coelho de Almeida, Tatielle Do Nascimento, Eduardo Ricci-Júnior
{"title":"Graphene quantum dots for breast cancer treatment.","authors":"Gabriela Lopes Gama E Silva, Aryanne Adametz Escarrone Puejo, Breno de Almeida Bertassoni, Bruna Coelho de Almeida, Tatielle Do Nascimento, Eduardo Ricci-Júnior","doi":"10.1080/17425247.2025.2514715","DOIUrl":"10.1080/17425247.2025.2514715","url":null,"abstract":"<p><strong>Introduction: </strong>Graphene quantum dots (GQDs) have emerged as promising nanomaterials for controlled drug delivery and breast cancer treatment, thanks to their biocompatibility, large surface area, and tunable optical properties.</p><p><strong>Areas covered: </strong>This review explores their synthesis, characterization, and application in breast cancer therapy, highlighting their role as drug carriers and theranostic platforms.</p><p><strong>Expert opinion: </strong>Some studies suggest that the efficiency of drug release depends on factors such as pH, mechanical stress, light exposure and temperature, which vary according to the type of nanocarrier and the experimental conditions. Moreover, combining GQDs with other nanomaterials enhances stability, selectivity, and therapeutic efficacy. These advancements underscore their potential as an innovative approach for targeted treatment and cancer diagnosis.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-13"},"PeriodicalIF":0.0,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144192571","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}
Jiayi Yang, Xinyi Ai, Chenming Zhang, Teng Guo, Nianping Feng
{"title":"Application of plant-derived extracellular vesicles as novel carriers in drug delivery systems: a review.","authors":"Jiayi Yang, Xinyi Ai, Chenming Zhang, Teng Guo, Nianping Feng","doi":"10.1080/17425247.2025.2487589","DOIUrl":"10.1080/17425247.2025.2487589","url":null,"abstract":"<p><strong>Introduction: </strong>Plant-derived extracellular vesicles (P-EVs) are nanoscale, lipid bilayer vesicles capable of transporting diverse bioactive substances, enabling intercellular and interspecies communication and material transfer. With inherent pharmacological effects, targeting abilities, high safety, biocompatibility, and low production costs, P-EVs are promising candidates for drug delivery systems, offering significant application potential.</p><p><strong>Areas covered: </strong>A comprehensive review of studies on P-EVs was conducted through extensive database searches, including PubMed and Web of Science, spanning the years 1959 to 2025. Drawing on animal and cellular model research, this review systematically analyzes the pharmacological activities of P-EVs and their advantages as drug delivery carriers. It also explores P-EVs' drug loading methods, extraction techniques, and application prospects, including their benefits, clinical potential, and feasibility for commercial expansion.</p><p><strong>Expert opinion: </strong>Establishing unified preparation standards and conducting a more comprehensive analysis of molecular composition, structural characteristics, and mechanisms of P-EVs are essential for their widespread application. Greater attention should be given to the potential synergistic or antagonistic effects between P-EVs as carriers and the drugs they deliver, as this understanding will enhance their practical applications. In conclusion, P-EVs-based drug delivery systems represent a promising strategy to improve treatment efficacy, reduce side effects, and ensure drug stability.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"787-803"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143756871","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}
Idejan P Gross, Ana Luiza Lima, Livia L Sá-Barreto, Guilherme M Gelfuso, Marcilio Cunha-Filho
{"title":"Recent advances in cutaneous drug delivery by iontophoresis.","authors":"Idejan P Gross, Ana Luiza Lima, Livia L Sá-Barreto, Guilherme M Gelfuso, Marcilio Cunha-Filho","doi":"10.1080/17425247.2025.2490267","DOIUrl":"10.1080/17425247.2025.2490267","url":null,"abstract":"<p><strong>Introduction: </strong>Iontophoresis has been extensively studied for topical and transdermal drug delivery to stimulate the absorption of molecules that would hardly pass through the outermost layer of the skin passively. Recent research has focused on its combination with nanoparticle-based systems or microneedles to expand its therapeutic applications.</p><p><strong>Areas covered: </strong>This review explores the fundamental principles of iontophoresis, focusing on key factors influencing its drug transport mechanisms, and provides a discussion of the field's current state. A comprehensive analysis of articles published or available online in 2024 was conducted, categorizing studies by their application areas, drug delivery systems, iontophoretic conditions, and experimental limitations.</p><p><strong>Expert opinion: </strong>The findings reveal a recent focus on wound healing and skin repair, and advancements in treating inflammation, pain, and skin cancer. Market translation requires standardized experimental protocols, particularly for iontophoretic parameters and preclinical models, along with the development of cost-effective commercial devices. Additionally, while advancements in cutaneous drug delivery have increasingly benefited from machine learning approaches, their application to iontophoresis remains underexplored. With the growing interest in associating iontophoresis with the Internet of Things, such an integration, if combined with AI tools, could offer promising opportunities for personalized, real-time treatments in modern dermatology, and therapeutic systems.</p>","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"857-874"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143813250","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":"Nanominerals: a multifaceted biomaterial for regenerative medicine and drug delivery.","authors":"Aishik Chakraborty, Wei Luo, Arghya Paul","doi":"10.1080/17425247.2025.2491642","DOIUrl":"10.1080/17425247.2025.2491642","url":null,"abstract":"","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"763-768"},"PeriodicalIF":0.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144003923","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}