Expert opinion on drug delivery最新文献

Advances and challenges in inner ear drug delivery: limitations and therapeutic perspectives. 内耳给药的进展和挑战：局限性和治疗前景。

IF 5.4

Expert opinion on drug delivery Pub Date : 2026-10-20 DOI: 10.1080/17425247.2026.2748110

Blanca Cervantes, Silvia Murillo-Cuesta, Jose M Zubeldia, Ana Castro, Isabel Varela-Nieto

{"title":"Advances and challenges in inner ear drug delivery: limitations and therapeutic perspectives.","authors":"Blanca Cervantes, Silvia Murillo-Cuesta, Jose M Zubeldia, Ana Castro, Isabel Varela-Nieto","doi":"10.1080/17425247.2026.2748110","DOIUrl":"https://doi.org/10.1080/17425247.2026.2748110","url":null,"abstract":"Introduction: Hearing loss is a major global health burden, with age-related hearing loss affecting hundreds of millions of people worldwide. Despite significant therapeutic advances, effective treatment remains hampered by the challenge of delivering drugs to the inner ear, an anatomically inaccessible and tightly protected organ.Areas covered: This narrative review was based on an extensive search of major biomedical databases and focuses on the anatomical and physiological barriers that limit inner ear drug delivery, current and emerging administration routes, and advanced delivery systems, including hydrogels, nanoparticles, microdevices and implantable platforms. Particular attention is given to the factors governing nanocarrier performance and to the key challenges for clinical translation, such as species-dependent pharmacokinetics, manufacturing reproducibility, GMP-compatible scale-up and regulatory requirements. Studies published between 2001 and 2026 were identified through PubMed, Embase, Web of Science and ClinicalTrials.gov.Expert opinion: Despite rapid preclinical innovation, clinical translation remains uneven. Systemic sodium thiosulfate provides the strongest regulatory proof of clinically meaningful otoprotection, whereas recent intracochlear gene therapy establishes an important benchmark for localized treatment. For nanomedicine, progress will depend less on platform novelty than on rational structure-property design, reproducible cochlear exposure, cell-resolved biodistribution, large-animal validation, GMP-compatible manufacturing, patient stratification and clinical trial design.","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2026-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149225783","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}

引用次数: 0

Respiratory drug delivery: physiological, technical, and regulatory considerations for dissolution testing of orally inhaled dry powder aerosols. 呼吸给药：口服吸入干粉气雾剂溶出度测试的生理、技术和法规考虑。

IF 5.4

Expert opinion on drug delivery Pub Date : 2026-10-20 DOI: 10.1080/17425247.2026.2751858

Zhengqi Xu, Abhimata Paramanandana, Hak-Kim Chan

{"title":"Respiratory drug delivery: physiological, technical, and regulatory considerations for dissolution testing of orally inhaled dry powder aerosols.","authors":"Zhengqi Xu, Abhimata Paramanandana, Hak-Kim Chan","doi":"10.1080/17425247.2026.2751858","DOIUrl":"10.1080/17425247.2026.2751858","url":null,"abstract":"Introduction: Pharmaceutical development of dry‑powder inhaler (DPI) products has traditionally relied on aerodynamic performance metrics. However, these parameters do not capture the post-deposition fate of inhaled particles, where dissolution impacts mucociliary clearance, macrophage uptake, retention, and systemic absorption, particularly for poorly soluble drugs. Consequently, there is increasing interest in understanding the dissolution behavior of orally inhaled drug products.Areas covered: This review critically examines the unique physiological environment of the lungs and the interactions of inhaled drugs with surfactants and mucins, highlighting why the respiratory tract cannot be regarded as a miniaturized gastrointestinal tract. It also discusses the dynamic interplay between dissolution and pulmonary clearance, alongside key methodological challenges in dissolution testing, including sample collection, apparatus design, dissolution media, and data analysis. Literature published between 1968 and 2026 was identified through searches of PubMed, Scopus, Google Scholar, and Web of Science databases.Expert opinion: Widespread implementation of dissolution testing is hindered by the lack of standardized methodologies on aerosol collection, dissolution apparatuses, hydrodynamic conditions, and physiologically relevant dissolution media that can accurately replicate the lung environment. Future progress will require harmonized regulatory guidance, validated testing platforms for routine quality control, and advanced biorelevant airway models for in vitro-in vivo relationship.","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-21"},"PeriodicalIF":5.4,"publicationDate":"2026-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149221244","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}

引用次数: 0

Redefining minoxidil therapy for androgenetic alopecia: from advanced drug delivery to precision treatment. 重新定义米诺地尔治疗雄激素性脱发：从先进的药物输送到精确的治疗。

IF 5.4

Expert opinion on drug delivery Pub Date : 2026-10-19 DOI: 10.1080/17425247.2026.2751877

Ingrid Araujo de Santana Santos, Patricia Medeiros-Souza, Tais Gratieri, Guilherme Gelfuso, Marcilio Cunha-Filho

{"title":"Redefining minoxidil therapy for androgenetic alopecia: from advanced drug delivery to precision treatment.","authors":"Ingrid Araujo de Santana Santos, Patricia Medeiros-Souza, Tais Gratieri, Guilherme Gelfuso, Marcilio Cunha-Filho","doi":"10.1080/17425247.2026.2751877","DOIUrl":"https://doi.org/10.1080/17425247.2026.2751877","url":null,"abstract":"Introduction: Minoxidil remains a cornerstone of pharmacological therapy for androgenetic alopecia (AGA), yet conventional topical formulations are constrained by pharmaceutical, biological, and patient-related limitations that compromise their real-world efficacy. Meanwhile, the rapid adoption of low-dose oral minoxidil (LDOM) is reshaping the therapeutic landscape and challenging the traditional paradigm of topical drug delivery.Areas covered: This Perspective critically examines the limitations of conventional topical minoxidil, recent advances in topical drug-delivery technologies, and the resurgence of LDOM, including emerging clinical evidence and ongoing development programs. Pharmaceutical innovations aimed at optimizing oral therapy, including individualized dosing, alternative administration routes, personalized manufacturing, and combination strategies, are also discussed. Expert opinion: Future innovation should move beyond the pursuit of a universally superior minoxidil formulation toward matching the appropriate route, formulation, dose, and therapeutic strategy to individual patients. Rather than competing alternatives, topical and oral minoxidil may become complementary components of a precision-treatment framework integrating pharmaceutical technology, predictive biomarkers, pharmacogenetics, artificial intelligence, and digital health. We propose that this transition toward precision minoxidil therapy may define the next generation of AGA management.","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2026-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149225760","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}

引用次数: 0

'Harmful' or 'excipients of concern'? Rethinking terminology and risk in pediatric excipients. “有害”还是“令人担忧的辅料”？重新思考儿科辅料的术语和风险。

IF 5.4

Expert opinion on drug delivery Pub Date : 2026-10-15 DOI: 10.1080/17425247.2026.2748106

Eleanor Dakin, Stephen Tomlin, Carolina Costa Vicente Silva, Alpakumari Chavda, Amiee Allen, Smita Salunke

{"title":"'Harmful' or 'excipients of concern'? Rethinking terminology and risk in pediatric excipients.","authors":"Eleanor Dakin, Stephen Tomlin, Carolina Costa Vicente Silva, Alpakumari Chavda, Amiee Allen, Smita Salunke","doi":"10.1080/17425247.2026.2748106","DOIUrl":"10.1080/17425247.2026.2748106","url":null,"abstract":"Introduction: Excipients, though often overshadowed by active pharmaceutical ingredients, are essential for the successful formulation of medicinal products. They serve critical roles, such as enhancing drug stability, ensuring proper delivery, and facilitating patient compliance. However, the perception of excipients has become increasingly polarized, with some being labeled as 'Harmful' or 'Dangerous' without a thorough and balanced analysis of contributing factors.Areas covered: This commentary seeks to address this growing concern. A targeted PubMed and Embase literature search was conducted for relevant publications that categorize excipients as dangerous, often without consideration of contextual factors like patient age group, dosage form, disease severity, and exposure levels to the excipients in question. This blanket labeling, instead of providing a well-rounded analysis of risk-versus-benefit and safety data for the pediatric population, may spread fear rather than help clinicians make informed decisions. By analyzing the methodologies and assumptions underlying these studies, this commentary highlights the gaps and biases that may lead to miscommunication and unwarranted fear in the healthcare community.Expert opinion: Shifting from terms such as 'harmful,' 'hazardous,' or 'dangerous' to 'excipients of concern' reflects a more balanced, evidence-based approach. It recognizes the complexities of excipient use, enabling informed decisions prioritizing safety and efficacy.","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-11"},"PeriodicalIF":5.4,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149170384","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}

引用次数: 0

Inhalation therapies in interstitial lung diseases. 间质性肺疾病的吸入疗法。

IF 5.4

Expert opinion on drug delivery Pub Date : 2026-10-15 DOI: 10.1080/17425247.2026.2748249

Stefanos Smyrniotis, Ioannis Tomos, Katerina M Antoniou, Ioulia Tseti, Vassilis Aidinis

{"title":"Inhalation therapies in interstitial lung diseases.","authors":"Stefanos Smyrniotis, Ioannis Tomos, Katerina M Antoniou, Ioulia Tseti, Vassilis Aidinis","doi":"10.1080/17425247.2026.2748249","DOIUrl":"10.1080/17425247.2026.2748249","url":null,"abstract":"Introduction: Fibrosing interstitial lung diseases (ILDs), including Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF), impose substantial clinical and societal burdens due to irreversible lung function decline, limited therapeutic options, and poor survival. Current oral antifibrotics, while effective in slowing progression, are hampered by severe gastrointestinal side effects and high discontinuation rates, emphasizing the need for better-tolerated treatments.Areas covered: This review summarizes the therapeutic limitations of existing antifibrotics, emphasizing the challenges posed by systemic exposure. We discuss recent and ongoing clinical trials with inhaled antifibrotics, the associated inhalable formulation challenges and characteristics required to align drug performance with the pathobiology of pulmonary fibrosis. We further outline advances in device technologies and drug delivery strategies for efficient drug deposition to the lungs, together with the emerging preclinical pipeline involving biologics and nanoparticles.Expert opinion: The transition to inhaled antifibrotic therapy represents a promising evolution in ILD management. By achieving high local drug concentrations with markedly reduced systemic exposure, this approach has the potential to improve the limitations of oral antifibrotics. As phase-2 and phase-3 trial results emerge, the clinical success of these therapies will depend on optimized formulation and delivery strategies.","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-25"},"PeriodicalIF":5.4,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149171776","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}

引用次数: 0

A pharmacokinetic study comparing a low-dose estrogen contraceptive transdermal system with an oral contraceptive tablet in healthy adult females. 在健康成年女性中比较低剂量雌激素透皮避孕系统和口服避孕药的药代动力学研究。

IF 5.4

Expert opinion on drug delivery Pub Date : 2026-10-15 DOI: 10.1080/17425247.2026.2748749

Matthew Hummel, Mark Liu, Sandeep Jagtap, Debdipta Bose, Andrew Shaw, Tieliang Yan, Janet K Gersten

{"title":"A pharmacokinetic study comparing a low-dose estrogen contraceptive transdermal system with an oral contraceptive tablet in healthy adult females.","authors":"Matthew Hummel, Mark Liu, Sandeep Jagtap, Debdipta Bose, Andrew Shaw, Tieliang Yan, Janet K Gersten","doi":"10.1080/17425247.2026.2748749","DOIUrl":"https://doi.org/10.1080/17425247.2026.2748749","url":null,"abstract":"Background: This study evaluated the pharmacokinetics (PK) of a once-weekly low-dose estrogen contraceptive transdermal system (TDS) and a once-daily combined oral contraceptive (COC) in healthy women.Research design and methods: In this Phase 1 study, 24 healthy women aged 18-35 years were randomized to a crossover sequence of three consecutive 168-h applications of the norelgestromin (NGMN; drug load, 4.86 mg)/ethinyl estradiol (EE; drug load, 0.264 mg) TDS to the abdomen (Treatment A) or buttock (Treatment B), followed by once-daily COC (drug load 0.18 mg norgestimate/0.025 mg EE) for 7 days (Treatment C). Plasma NGMN and EE concentrations were assessed using PK parameters. Application-site irritation, residual patch analysis, and safety were also evaluated.Results: Variability in NGMN and EE exposure was lower for Treatments A and B versus Treatment C (AUCτ,ss: NGMN, 38.4% and 31.7% versus 47.0%; EE, 49.3% and 35.4% versus 51.2%) with comparable/lower Cp, ss(max) variability. EE Cp, ss(max). Normalized exposure were lower with the NGMN/EE TDS. No serious adverse events occurred. Residual patch analysis indicated delivery of ~200 µg/day NGMN and 19 µg/day EE.Conclusions: The NGMN/EE TDS demonstrated lower PK variability, EE peak concentrations and normalized EE exposure than the COC. No new safety signals were reported.","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-9"},"PeriodicalIF":5.4,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149186983","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}

引用次数: 0

Recent advancements and translational potentials of MOF-based precision strategies for breast cancer therapy. 基于mof的乳腺癌精准治疗策略的最新进展及转化潜力。

IF 5.4

Expert opinion on drug delivery Pub Date : 2026-10-14 DOI: 10.1080/17425247.2026.2747552

Yu Sun, Rongxin Guo, Tao Xu, Chenrui Jiang, Feifei Chen, Hongbin Xu, Yaping He

{"title":"Recent advancements and translational potentials of MOF-based precision strategies for breast cancer therapy.","authors":"Yu Sun, Rongxin Guo, Tao Xu, Chenrui Jiang, Feifei Chen, Hongbin Xu, Yaping He","doi":"10.1080/17425247.2026.2747552","DOIUrl":"10.1080/17425247.2026.2747552","url":null,"abstract":"Introduction: Effective diagnostic and therapeutic strategies for cancer remain limited by poor specificity, systemic toxicity, and biological barriers because of the heterogeneity of cancers. To overcome these obstacles, nanomedicines have been increasingly explored. Among the different nanoscale systems, metal-organic frameworks (MOFs) are promising platforms because of their ultra-high porosity, modular chemical composition, and tunable architecture by design. Moreover, MOFs can facilitate both drug release for cancer treatment and imaging through the combination of imaging agents and therapeutics.Areas covered: A comprehensive review of the properties, benefits, and clinical trials of MOFs for breast cancer diagnosis and treatment is lacking. We review the current status and advances of MOFs used for breast cancer diagnosis and drug delivery using publications primarily from PubMed through July 2026. We also discuss new strategies that take advantage of the unique physicochemical properties of MOFs for breast cancer theranostics.Expert opinion: Multifunctional nanoplatforms based on MOFs have promise in revolutionizing precision oncology in breast cancer. With the ongoing developments in synthetic chemistry, bioengineering, and computer modeling, MOFs may represent resources for personalized therapeutics combining diagnosis, treatment, and monitoring of response. Subsequent interdisciplinary investigations will be important in translating the preclinical findings into clinical applications.","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-16"},"PeriodicalIF":5.4,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149139856","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}

引用次数: 0

Strategies for endoplasmic reticulum-targeted delivery systems: current design principles and trends. 内质网靶向递送系统的策略：当前的设计原则和趋势。

IF 5.4

Expert opinion on drug delivery Pub Date : 2026-10-14 DOI: 10.1080/17425247.2026.2748107

Hana Cho, Han Chang Kang

{"title":"Strategies for endoplasmic reticulum-targeted delivery systems: current design principles and trends.","authors":"Hana Cho, Han Chang Kang","doi":"10.1080/17425247.2026.2748107","DOIUrl":"10.1080/17425247.2026.2748107","url":null,"abstract":"Introduction: The endoplasmic reticulum (ER) governs proteostasis, lipid biosynthesis, calcium signaling, stress responses, and antigen presentation, making it an attractive yet challenging intracellular target for therapeutic delivery.Areas covered: PubMed and Google Scholar were searched, with ER-targeting literature limited to January 2024-August 2026; no date limit was applied to foundational ER biology. We compare small-molecule motifs, peptide signals, biomimetic membranes, lipid-based formulations, physicochemical trafficking cues, and enzyme-instructed self-assembly, with particular attention to stimulator of interferon genes (STING) agonist-based ER-targeting molecules (SABER), palmitic-acid-mediated trafficking, shape-engineered exosome membrane-coated nanorods, ER-tropic polymers, and retrograde sorting combined with ER retention. A four-level evidence framework for ER-targeting claims is proposed, alongside cargo-specific design, safety, manufacturability, and translational considerations.Expert opinion: Among recent strategies, SABER has the most complete evidence for a defined protein-ligand ER docking interaction, although the docking protein is itself pharmacologically active and dynamically trafficked, which constrains both generalizability and the interpretation of ER residence. Near-term progress is more likely to come from matching validated targeting motifs to appropriate cargos and quantifying the entire delivery pathway than from increasingly elaborate nanocarrier designs. Clinically viable systems will require non-perturbing ligands, human-relevant validation models, biodegradable formulations, and biomarkers predictive of ER exposure and therapeutic response.","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-23"},"PeriodicalIF":5.4,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149139890","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}

引用次数: 0

Nanotechnology meets neurodegeneration: restoring lysosomal function with nanovectors. 纳米技术满足神经退行性变：用纳米载体恢复溶酶体功能。

IF 5.4

Expert opinion on drug delivery Pub Date : 2026-10-13 DOI: 10.1080/17425247.2026.2748109

Clara Haristoy, Rémi Kinet, Benjamin Dehay

{"title":"Nanotechnology meets neurodegeneration: restoring lysosomal function with nanovectors.","authors":"Clara Haristoy, Rémi Kinet, Benjamin Dehay","doi":"10.1080/17425247.2026.2748109","DOIUrl":"10.1080/17425247.2026.2748109","url":null,"abstract":"Introduction: Neurodegenerative diseases (NDs) remain a growing burden worldwide. Characterized primarily by degeneration of neurons in the central nervous system (CNS), driven in part by pathological protein aggregates and by alterations of the autophagy-lysosomal pathway (ALP), current therapeutic strategies only mitigate the outcomes of NDs rather than their origin, highlighting the need for the development of new targeted therapies.Areas covered: CNS-targeted nanoparticles (NPs) to tackle ALP have offered promising avenues by bypassing biological barriers, reducing pathological protein aggregates, restoring lysosomal pH and activity, upregulating autophagic flux, and contributing to neuroprotection. This report summarizes recent advances in the development of CNS‑targeted nanocarriers for autophagy as a treatment for ND.Expert opinion: Restoring ALP function is a promising disease-modifying strategy for NDs, as it helps clear toxic protein aggregates. Nanotechnology offers an effective way to deliver such therapies to the brain by overcoming the blood-brain barrier, enabling targeted, multimodal, and potentially cell-specific interventions. However, key challenges remain, including late diagnosis, the need for precise cell targeting, and concerns about long-term safety and bioaccumulation. Despite these limitations, growing research interest is expected to accelerate the development and clinical translation of these approaches.","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-13"},"PeriodicalIF":5.4,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149149462","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}

引用次数: 0

Preclinical and clinical evaluation of an ocular nanoemulsion for the treatment of dry eye disease. 治疗干眼症的眼纳米乳的临床前和临床评价。

IF 5.4

Expert opinion on drug delivery Pub Date : 2026-10-10 DOI: 10.1080/17425247.2026.2727111

Karina Vukelić, Tajana Iva Pejaković, Blanka Krivičić Hyrat, Mia Vukelić Obad, Zdravka Knežević, Cumali Değirmenci, Emil Ahmadlı, Melis Palamar Onay, Evren Homan Gökçe, Sakine Tuncay Tanrıverdi, Özgen Özer

{"title":"Preclinical and clinical evaluation of an ocular nanoemulsion for the treatment of dry eye disease.","authors":"Karina Vukelić, Tajana Iva Pejaković, Blanka Krivičić Hyrat, Mia Vukelić Obad, Zdravka Knežević, Cumali Değirmenci, Emil Ahmadlı, Melis Palamar Onay, Evren Homan Gökçe, Sakine Tuncay Tanrıverdi, Özgen Özer","doi":"10.1080/17425247.2026.2727111","DOIUrl":"10.1080/17425247.2026.2727111","url":null,"abstract":"Background: The efficacy, safety, and ocular retention of a novel preservative-free nanoemulsion eye drop formulation (VSLB) containing castor oil and sodium hyaluronate for dry eye disease (DED) were evaluated.Research design and methods: A preclinical evaluation using a scopolamine-induced dry eye rat model and a prospective, randomized, double-masked clinical study involving 64 human subjects with moderate-to-severe DED were conducted. Tear film breakup time (TFBUT), ocular surface disease index (OSDI), Meibomian gland assessment, and pre-ocular residence time were measured.Results: VSLB significantly improved TFBUT from <2 s on day 2 to 10.83 ± 1.5 s at day 28, comparable to marketed product and healthy controls in rats. Ocular residence time for VSLB remained detectable in 3 out of 6 animals, compared to 0 in placebo. In the clinical phase, mean TFBUT in the VSLB group increased from 4.26 ± 2.14 s (baseline) to 6.36 ± 2.73 s at day 15 and 6.00 ± 2.93 s at day 30. The OSDI score, the Meibomian gland expressibility score, and secretion quality were also improved. No serious adverse events were reported.Conclusion: VSLB demonstrated a promising therapeutic profile by tear-film stabilization and symptomatic relief. Its preservative-free, lipid-enhancing formulation with prolonged ocular residence suggests a safe and effective treatment option for DED.Trial registration: Clinical trial registration: www.clinicaltrials.gov identifier is NCT06323395.","PeriodicalId":94004,"journal":{"name":"Expert opinion on drug delivery","volume":" ","pages":"1-15"},"PeriodicalIF":5.4,"publicationDate":"2026-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149120592","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}

引用次数: 0