Frontiers in drug delivery最新文献

{"title":"Design and optimization of mucoadhesive chitosan microspheres for oesophageal delivery of fluconazole.","authors":"H N Shivakumar, Ayush Parmar, Rushikesh Shinde, Sanjana S P","doi":"10.3389/fddev.2026.1962873","DOIUrl":"10.3389/fddev.2026.1962873","url":null,"abstract":"<p><strong>Background: </strong>Oesophageal candidiasis remains challenging to treat owing to rapid transit of conventional oral formulations through the oesophagus, resulting in inadequate local drug delivery and reduced therapeutic efficacy. To address these limitations, the present study aimed to develop fluconazole-loaded chitosan microspheres (FCZ-CMs)-based orodispersible tablets (ODTs) that rapidly disintegrate in the oral cavity while releasing mucoadhesive microspheres capable of adhering to oesophageal mucosa, enabling sustained localized drug delivery.</p><p><strong>Methods: </strong>FCZ-CMs were developed by the emulsion cross-linking method using a 2<sup>3</sup> full factorial design to optimize particle size (PS), entrapment efficiency (EE), drug release (DR), and <i>ex vivo</i> oesophageal retention (ORT). Optimised FCZ-CMs (F9) were extensively characterized by Infrared spectroscopy (FTIR), scanning electron microscopy (SEM), differential scanning calorimetry (DSC), X-ray diffractometry (XRD), and <i>in vitro</i> drug release studies. Further, the ODTs developed by direct compression of F9 were evaluated for wetting time (WT), disintegration time (DT), drug content (DC), % drug release at 60 min (%DR), similarity (<i>f</i> <sub><i>1</i></sub> <i>/f</i> <sub><i>2</i></sub> ), and stability under real-time and accelerated conditions.</p><p><strong>Results: </strong>The optimised FCZ-CMs (F9) exhibited a PS (31.81 ± 1.14 μm), EE (84.12% ± 2.15%), DR (58.46% ± 1.89% at 60 min), and ORT (51.22% ± 2.11% at 30 min), demonstrating excellent suitability for localized oesophageal delivery. FTIR confirmed drug-polymer compatibility, SEM revealed spherical microspheres with a crenated surface morphology favourable for mucoadhesion, while DSC and XRD demonstrated reduced crystallinity of FCZ within the chitosan matrix. The ODTs loaded with F9 displayed high DC (99.14% ± 0.58%), short WT (19.62 ± 0.51s), and DT (23.83 ± 0.86s). The dissolution profile of ODTs remained comparable to that of F9 (<i>p > 0.05</i>), with drug release of 53.16% ± 1.24% at 60 min and similarity factor (<i>f</i> <sub><i>2</i></sub> = 80) and difference factor (<i>f</i> <sub><i>1</i></sub> <i>= 8</i>), confirming that the compression process did not significantly alter the release behaviour of the optimised microspheres. The formulation also remained stable under both real-time and accelerated storage conditions.</p><p><strong>Conclusion: </strong>The optimised ODTs successfully translated the performance of FCZ-CMs into a patient-friendly, oesophageal-targeted drug delivery system without compromising their controlled-release or mucoadhesive characteristics. The use of a simple, reproducible, and scalable direct compression process, together with preservation of microsphere functionality following tablet compression, highlights the translational potential of this platform for localized treatment of oesophageal candidiasis and deserves further clinical investigation.</p","PeriodicalId":73079,"journal":{"name":"Frontiers in drug delivery","volume":"6 ","pages":"1962873"},"PeriodicalIF":4.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13669121/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149217245","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}

{"title":"Engineering the oxidative myocardium: ROS-responsive biomaterials for precision cardiovascular delivery in ischemia-reperfusion injury and post-infarction remodeling.","authors":"Hossein Omidian, Kwadwo A Mfoafo, Luigi X Cubeddu","doi":"10.3389/fddev.2026.1929035","DOIUrl":"10.3389/fddev.2026.1929035","url":null,"abstract":"<p><p>Myocardial ischemia-reperfusion injury (MIRI) and post-infarction remodeling are characterized by dynamic oxidative stress that varies across myocardial regions and disease stages. Reactive oxygen species (ROS)-responsive and redox-modulating biomaterials seek to exploit this environment through stimulus-triggered release or degradation, ROS scavenging, targeted delivery, local retention, and stage-specific repair. This review critically evaluates preclinical strategies for MIRI, myocardial infarction, and post-infarction remodeling. Major platform classes differ substantially in mechanism and translational feasibility: injectable hydrogels offer local retention and spatiotemporal control but often require invasive administration; systemic nanoparticles and liposomes enable tissue-, cell-, or organelle-level targeting but require stronger biodistribution and clearance data; nanozymes provide sustained catalytic redox activity but raise persistence and safety concerns; and cell-, nucleic-acid-, or gas-based systems introduce additional manufacturing and regulatory complexity. Mechanistically, redox interaction represents the initiating action, followed by proximal mitochondrial and cell-death regulation, inflammatory modulation, and later effects on angiogenesis, fibrosis, and ventricular remodeling. Although preclinical studies demonstrate cardioprotective and repair-promoting effects, direct cross-platform comparisons remain limited. Translation is constrained by heterogeneous models, inconsistent definitions of ROS responsiveness, incomplete pharmacokinetic and safety characterization, sparse large-animal validation, and limited manufacturing evidence. ROS-responsive cardiovascular biomaterials therefore remain promising but clinically unproven precision-delivery strategies.</p>","PeriodicalId":73079,"journal":{"name":"Frontiers in drug delivery","volume":"6 ","pages":"1929035"},"PeriodicalIF":4.4,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13623321/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149083108","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}

{"title":"Correction: A two-tier protection strategy for oral delivery of GLP-1 peptides: lipid-based formulation combined with enteric capsules.","authors":"Camille Dumont, Vanessa Gonzalez, Paula Klatt, Sandrine Picco, Delphine Nombret, Marine Agisson, Euengla Uku, Thibault Saurel, Vincent Jannin","doi":"10.3389/fddev.2026.1973549","DOIUrl":"https://doi.org/10.3389/fddev.2026.1973549","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.3389/fddev.2026.1770094.].</p>","PeriodicalId":73079,"journal":{"name":"Frontiers in drug delivery","volume":"6 ","pages":"1973549"},"PeriodicalIF":4.4,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13655527/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149186501","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}

{"title":"Synthesis, characterisation, and <i>in vitro</i> assessment of hyaluronic acid-coated solid lipid nanoparticles entrapping dexamethasone palmitate designed for intra-articular administration.","authors":"Jinxin Zhang, Rumi Khandelia, Bridget Hogg, Ahmad Z Bahlool, Tom Hodgkinson, Sally-Ann Cryan, John O'Byrne, David J Brayden","doi":"10.3389/fddev.2026.1809275","DOIUrl":"10.3389/fddev.2026.1809275","url":null,"abstract":"<p><p>Osteoarthritis (OA) is the major cause of pain and disability worldwide, particularly affecting the knee joint. Although intra-articular (IA) treatments including corticosteroids and hyaluronic acid (HA), are commonly used to manage symptoms, their therapeutic effects are often short-lived, necessitating repeated injections. In this study, HA-coated solid lipid nanoparticles (HA-DXP-SLNs) entrapping with the glucocorticoid prodrug, dexamethasone palmitate (DXP) was developed as dual-function nanocarrier system for IA delivery. Using a scalable microfluidics platform, monodisperse SLNs of ∼90 nm in diameter were produced with high DXP encapsulation efficiency (88%) and loading capacity (6% w/w). In phosphate buffered saline (PBS), DXP-SLNs exhibited a biphasic release profile with an initial burst followed by sustained release of DXP, which was further moderated by HA surface coating. HA coatings of the SLNs enhanced particle stability, shifted particle surface charge from positive to negative, and enabled uptake by patient-derived primary osteoarthritic chondrocytes (hOAAC). Incubation in murine plasma demonstrated enzymatic conversion of DXP to dexamethasone (DEX), which accumulated in plasma over 72 h. HA-DXP-SLNs suppressed prostaglandin E₂ production by LPS-stimulated THP-1 monocytes and by hOAAC more effectively than uncoated DXP-SLNs, while maintaining cell viability. These findings indicate that the HA coating of SLNs contributes to <i>in vitro</i> therapeutic efficacy of the overall SLNs, as well as to particle stabilisation. HA-DXP-SLNs therefore represent a promising nanocarrier for prolonged IA corticosteroid delivery in knee OA, with the potential to reduce the frequency of current IA corticosteroid and HA administration.</p>","PeriodicalId":73079,"journal":{"name":"Frontiers in drug delivery","volume":"6 ","pages":"1809275"},"PeriodicalIF":4.4,"publicationDate":"2026-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13585733/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149009408","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}

{"title":"Hyaluronidase-enhanced delivery in gene therapy and regenerative medicine for improved vector, cell, and cargo access.","authors":"Patrick E Sewell, Christopher Jensen","doi":"10.3389/fddev.2026.1906950","DOIUrl":"10.3389/fddev.2026.1906950","url":null,"abstract":"<p><p>Efficient delivery of gene therapy vectors and regenerative cargo to the central nervous system (CNS) is limited by the hyaluronic acid (HA)-rich extracellular matrix (ECM). Adeno-associated virus (AAV) particles, mesenchymal stem cells (MSCs), multilineage-differentiating stress-enduring (MUSE) cells, and small extracellular vesicles (sEVs) must traverse the HA-rich ECM of the nasal submucosa, the perineural and perivascular compartments, and brain parenchyma to reach CNS targets. Dense ECM imposes viscosity, steric, and hydrodynamic barriers that limit tissue penetration, and perineuronal nets impose an additional HA-based barrier around subsets of neurons. Hyaluronidase enzymes transiently depolymerize HA, reducing tissue viscosity and increasing interstitial permeability through a well-defined, reversible mechanism. Recombinant human hyaluronidase PH20 (rHuPH20) is FDA-approved as a subcutaneous delivery adjunct, demonstrating that controlled ECM modulation is clinically feasible and safe. Preclinical studies demonstrate that hyaluronidase pretreatment enhances intranasal CNS delivery of AAV vectors and sEVs, with quantified improvements in olfactory bulb and cortical distribution. Intranasal MSC and MUSE cell delivery is similarly enhanced: 100 USP units of hyaluronidase applied 30 min before cell administration significantly increased MSC delivery to the olfactory bulb and total brain area in rodent models (p = 0.02). MUSE cells, which express sphingosine-1-phosphate receptor 2 (S1PR2) and home actively to sites of neuroinflammation via the S1P-S1PR2 axis, achieve selective CNS distribution after intranasal administration in Parkinson's disease models, outperforming non-MUSE MSCs and restoring dopaminergic neuron markers and motor function. This narrative review synthesizes the mechanistic basis, evidence tiers, practical intranasal dosing and technique protocols, safety considerations, and translational knowledge gaps for hyaluronidase as a CNS delivery adjunct across viral gene therapy, non-viral platforms, gene-modified cell products, and sEV-based therapeutics. We distinguish established, off-label, and investigational applications, and provide practical guidance for clinicians developing hyaluronidase-augmented CNS programs.</p>","PeriodicalId":73079,"journal":{"name":"Frontiers in drug delivery","volume":"6 ","pages":"1906950"},"PeriodicalIF":4.4,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13582306/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148992811","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}

{"title":"Case report: Caplacizumab without plasma exchange for severe thrombotic thrombocytopenic purpura.","authors":"Sarah Maryon Hayes, Daniel F Pease, Christine M Wiese, Marshall Mazepa","doi":"10.3389/fddev.2026.1894135","DOIUrl":"10.3389/fddev.2026.1894135","url":null,"abstract":"<p><p>A 45-year-old female Jehovah's Witness presented with transient expressive aphasia, blurred vision, and dizziness for several hours. A complete blood count (CBC) showed anemia (hemoglobin: 6.3 g/dL), thrombocytopenia (platelet count: 21 × 10³/µL), and undetectable haptoglobin. The peripheral smear revealed schistocytes, confirming microangiopathic hemolytic anemia; immune-mediated thrombotic thrombocytopenic purpura (iTTP) was confirmed with an ADAMTS13 level of less than 5% and a positive ADAMTS13 inhibitor screen. Treatment with high-dose corticosteroids was urgently initiated, but the patient and her husband declined plasma exchange based on their beliefs as Jehovah's Witnesses. The patient acutely decompensated, requiring intubation, with worsening of laboratory values (hemoglobin: 3.8 g/dL; platelet count: 9 × 10³/µL), elevated serum troponin, and renal and hepatic compromise. In addition to rituximab and intravenous immune globulin, caplacizumab therapy was undertaken. The patient's condition improved clinically, but from a laboratory value perspective, 1 month after caplacizumab initiation, her ADAMTS13 level remained less than 5%. Further immunosuppression with intravenous cyclophosphamide was initiated, which resulted in complete normalization of ADAMTS13 activity. This is the first report of caplacizumab use in a Jehovah's Witness patient with TTP with severe neurological compromise to the point of necessitating intubation and with this degree of anemia. With the eventual addition of cyclophosphamide therapy, we observed complete recovery of this critically ill patient without the use of plasma exchange in the treatment course.</p>","PeriodicalId":73079,"journal":{"name":"Frontiers in drug delivery","volume":"6 ","pages":"1894135"},"PeriodicalIF":4.4,"publicationDate":"2026-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13562035/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148957470","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}

{"title":"Harnessing liposomal delivery to boost polyphenols' potential in chronic wound therapy.","authors":"Lisa Myrseth Hemmingsen, Marte Kristensen, Cecilie Thanh Loan Dang, Mari Salamonsen, Elizabeth G Aarag Fredheim, Nataša Škalko-Basnet","doi":"10.3389/fddev.2026.1839747","DOIUrl":"10.3389/fddev.2026.1839747","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic wounds pose a significant clinical challenge due to impaired healing, persistent inflammation, and susceptibility to infection, often by antimicrobial-resistant bacteria. Therefore, active compounds should ideally act both as antimicrobials with limited potential for resistance development and offer other beneficial wound-healing properties. Polyphenols, such as chlorogenic acid (CGA) and quercetin (QCT), exhibit those properties, but are limited by poor stability or low bioavailability.</p><p><strong>Methods: </strong>In this study, liposomal formulations of CGA (CGA-LP) and QCT (QCT-LP) were tailored to overcome delivery barriers to wound sites. Liposomes were characterized by size, size distribution, zeta potential, entrapment efficiency, and stability.</p><p><strong>Results and discussion: </strong><i>In vitro</i> release studies for CGA-LP and QCT-LP demonstrated sustained payload release of ∼30% and ∼50%, respectively, over 24 h. Antioxidant activity of both compounds was assessed using DPPH and ABTS·⁺ assays, confirming the radical scavenging potential of CGA comparable to vitamins C and E, while QCT showed high DPPH activity, but limited ABTS·⁺ activity. Biocompatibility studies on murine macrophages revealed no cytotoxicity for either formulation. Antibacterial activity was assessed via broth microdilution for both formulations and isothermal microcalorimetry for CGA-LPs. Only QCT-LP potent measurable inhibitory effects against <i>Staphylococcus aureus</i> in the broth microdilution assay; however, effects on metabolic activity were observed for CGA-LPs. These findings suggest that liposomal entrapment could protect polyphenols and prolong or tailor their release, potentially offering a promising strategy for chronic wound therapy and addressing challenges associated with oxidative stress and bacterial infections.</p>","PeriodicalId":73079,"journal":{"name":"Frontiers in drug delivery","volume":"6 ","pages":"1839747"},"PeriodicalIF":4.4,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13541760/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148898135","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}

{"title":"Engineering a medical device for intranasal immunisation: ensuring targeted delivery and formulation stability.","authors":"Gonçalo Farias, Arnaud Bude, Nektaria Karavas, Christelle Rossignol, Isabelle Lantier, Julie Suman, Nicolas Aubrey, Isabelle Dimier-Poisson, Mathieu Epardaud","doi":"10.3389/fddev.2026.1875011","DOIUrl":"10.3389/fddev.2026.1875011","url":null,"abstract":"<p><strong>Introduction: </strong>The efficacy of nasal vaccination critically depends on the delivery method, which must ensure precise and reproducible deposition of the vaccine within the nasal cavity to effectively stimulate mucosal immune structures such as the nasalx{2011}associated lymphoid tissue (NALT). Transitioning from prex{2011}clinical models to human applications is challenging because of anatomical and physiological differences in nasal structure and airflow dynamics.</p><p><strong>Methods: </strong>We developed a nasalx{2011}spray device specifically designed for human nasal immunization. The device delivers a broad, homogeneous spray that is confined to the nasal cavity, thereby avoiding the lower respiratory tract and minimizing the risk of pulmonary exposure. It was engineered to be compatible with a wide range of vaccine formulations, preserving their physicochemical properties, stability, and delivery efficacy. To overcome the limitations of conventional rodent models, the device was validated using (i) inx{2011}vitro human nasal cavity replicas (nasal casts) and (ii) an inx{2011}vivo rabbit model, which is more appropriate for regulatory and translational studies.</p><p><strong>Results: </strong>The spray system achieved consistent, homogeneous deposition throughout the nasal cavity without spillx{2011}over into the lower airways. Compatibility tests confirmed that the device does not alter the physicochemical characteristics or stability of a representative complex vaccine formulation. Validation in nasal casts and the rabbit model demonstrated reproducible delivery performance and supported the devicex{2019}s suitability for human use.</p><p><strong>Discussion: </strong>The presented transitory delivery platform offers a scalable, safe, and formulationx{2011}compatible solution for intranasal vaccine administration. By ensuring targeted deposition and preserving vaccine integrity, the device reinforces the potential of mucosal immunization strategies across diverse indications and facilitates the translation of nasal vaccines from prex{2011}clinical research to clinical application.</p>","PeriodicalId":73079,"journal":{"name":"Frontiers in drug delivery","volume":"6 ","pages":"1875011"},"PeriodicalIF":4.4,"publicationDate":"2026-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13529731/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148876500","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}

{"title":"The biological memory buffer hypothesis: can programmable nanocarriers shape cellular memory to improve the durability of mRNA vaccines and gene therapies?","authors":"Okechukwu Paul-Chima Ugwu, Chinyere Nneoma Ugwu, Godson Emeka Anyanwu, Mariam Basajja, Maryann Chiamaka Ebuoh","doi":"10.3389/fddev.2026.1902184","DOIUrl":"10.3389/fddev.2026.1902184","url":null,"abstract":"<p><strong>Introduction: </strong>Messenger RNA vaccines and gene therapies enable rapid and programmable biological intervention, but their therapeutic durability remains variable. Existing nanomedicine research primarily evaluates delivery efficiency, targeting, RNA protection and early protein expression, which do not fully explain why some biological effects persist while others rapidly decline.</p><p><strong>Methods: </strong>This Hypothesis and Theory article presents a narrative conceptual synthesis of peer-reviewed literature on lipid nanoparticle delivery, mRNA vaccinology, RNA therapeutics, genome editing, trained innate immunity, epigenetic regulation and regenerative medicine. Evidence was integrated to develop an operational and falsifiable framework for evaluating the contribution of nanocarriers to therapeutic durability.</p><p><strong>Results: </strong>We propose the Biological Memory Buffer Hypothesis, according to which programmable nanocarriers may influence biological systems that encode, maintain or recall therapeutic information after RNA delivery. The framework distinguishes payload persistence from biological-outcome persistence and introduces three measurable constructs: therapeutic memory engineering, nanocarrier memory capacity and the therapeutic persistence window. It further proposes matched-cargo and matched-early-exposure experiments, candidate monophasic and biphasic decay models, a minimum durability reporting set and safety monitoring for maladaptive innate immune imprinting.</p><p><strong>Discussion: </strong>The framework does not assume that adaptive immune memory, trained immunity, epigenetic regulation and regenerative repair share a single molecular mechanism. Rather, it treats them as distinct biological substrates with a common functional relevance to durability. The hypothesis is falsifiable: failure to detect reproducible carrier-attributable differences under matched conditions would argue against nanocarrier memory capacity as an independent determinant. Incorporating longitudinal, tissue-specific and host-stratified durability measurements may support the rational development of longer-lasting RNA vaccines and gene therapies.</p>","PeriodicalId":73079,"journal":{"name":"Frontiers in drug delivery","volume":"6 ","pages":"1902184"},"PeriodicalIF":4.4,"publicationDate":"2026-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13447438/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148690326","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}

{"title":"Microplastics matter: practical implications of the EU REACH restriction for the pharmaceutical industry.","authors":"Pauline Henrica Maria Janssen, Willem Antoon Rijpkema, Lorina Bisharat, Marlijn Orbons, Maarten Jaspers, Bastiaan Hendricus Jozef Dickhoff","doi":"10.3389/fddev.2026.1854462","DOIUrl":"10.3389/fddev.2026.1854462","url":null,"abstract":"<p><p>Synthetic polymer microparticles (SPMs), commonly referred to as microplastics, are subject to increasing restrictions due to their environmental persistence and uncertainty about potential human health effects. These substances are regulated under Regulation (EC) No 1907/2006 (REACH). Commission Regulation (EU) 2023/2055 amends REACH by introducing a restriction on SPMs in Annex XVII, including phased information and reporting obligations for in-scope uses. Although medicinal products are derogated from the market ban, these obligations have practical implications for pharmaceutical supply chains. Medicinal products containing SPMs are subject to specific reporting obligations under the REACH regulation. These obligations apply when the excipients meet the SPM definition and cannot be excluded based on criteria such as being naturally occurring, or due to their solubility or demonstrated degradability. This paper presents an operational decision-making framework that interprets the EU REACH restriction on SPM for pharmaceutical excipients and drug-delivery systems. The framework integrates regulatory definitions with testing strategies, supplier qualification processes, and downstream compliance workflows. An industry case example illustrates a combined approach using portfolio screening and biodegradation testing. This can generate evidence to support compliance decisions while preserving formulation performance.</p>","PeriodicalId":73079,"journal":{"name":"Frontiers in drug delivery","volume":"6 ","pages":"1854462"},"PeriodicalIF":4.4,"publicationDate":"2026-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13275469/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148297179","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}