Expert Opinion On Drug Delivery[JOURNAL]
Sun
200 papers
Dry powder inhaler selection in COPD: integrating device design, formulation performance, and patient inspiratory capability.
Pirozynski M
Expert Opin Drug Deliv · 2026 Jul · PMID 42391132 · Publisher ↗
INTRODUCTION: Appropriate dry powder inhaler (DPI) selection is essential for effective COPD management because pulmonary drug delivery depends on interactions between formulation properties, device design, and patient c...
INTRODUCTION: Appropriate dry powder inhaler (DPI) selection is essential for effective COPD management because pulmonary drug delivery depends on interactions between formulation properties, device design, and patient capability. This review proposes a Formulation - Device - Patient (FDP) matching framework to support individualized DPI selection. AREAS COVERED: A structured search of PubMed and Google Scholar identified publications on COPD, DPI selection, inspiratory flow, device resistance, aerosol performance, inhaler technique, usability, and formulation - device interactions. Evidence shows that DPIs differ substantially in internal resistance, inspiratory-flow requirements, dose-preparation mechanisms, aerosolization characteristics, handling complexity, and feedback systems, and therefore should not be considered interchangeable. Appropriate device selection requires assessment of inspiratory capability alongside manual dexterity, cognitive function, comorbidities, prior inhaler experience, patient preference, and inhaler technique. The review also highlights the limitations of direct cross-device comparisons and cautions against interpreting in vitro aerosol-performance metrics as indicators of clinical superiority. EXPERT OPINION: DPI selection should move beyond device-centered prescribing toward individualized formulation - device - patient matching. The proposed FDP framework provides a practical model for individualized DPI selection by integrating formulation characteristics, device engineering, and patient capability rather than relying on inspiratory flow or device characteristics alone.
Letter to the Editor: 'saving money but costing lives: the lack of integrated dose counters on pressurised metered dose inhalers'.
Kraut RY, Katz M, Babenko O
Expert Opin Drug Deliv · 2026 Jul · PMID 42384555 · Publisher ↗
INTRODUCTION: Oral mucositis (OM) remains a common and clinically significant complication of chemotherapy and radiotherapy. Current management is largely supportive, and effective local therapies remain limited. Hydroge...
INTRODUCTION: Oral mucositis (OM) remains a common and clinically significant complication of chemotherapy and radiotherapy. Current management is largely supportive, and effective local therapies remain limited. Hydrogel-based delivery systems have attracted interest because they may improve mucosal retention, protect ulcerated tissue, and enable sustained local drug release. METHODS: A systematic review of preclinical animal studies evaluating hydrogel-based interventions for oral mucositis was conducted. PubMed, Embase, and the Cochrane Library were searched, with additional gray literature screening. Data on formulation characteristics, experimental models, therapeutic outcomes, and methodological quality were extracted. Risk of bias was assessed using the SYRCLE tool. RESULTS: Eighteen studies met the inclusion criteria. Most formulations reduced lesion severity, improved histological healing, and attenuated inflammatory or oxidative markers. Multifunctional systems combining mucoadhesion with anti-inflammatory, antioxidant, or antimicrobial activity tended to show broader effects than conventional gels. However, study design, outcome reporting, and translational endpoints were heterogeneous. CONCLUSIONS: Current preclinical evidence supports hydrogels as promising local drug delivery platforms for oral mucositis. Greater standardization of models and clinically relevant endpoints will be important to support translation into human studies. PROTOCOL REGISTRATION: https://www.crd.york.ac.uk/prospero/, identifier CRD420251072050.
Response to letter to the editor: 'Saving money but costing lives: the lack of integrated dose counters on pressurised metered dose inhalers'.
Gilchrist FJ, Clayton S, Carroll WD
Expert Opin Drug Deliv · 2026 Jul · PMID 42383925 · Publisher ↗
Abstract loading — click title to view on PubMed.
Mechanism-guided metal complex therapeutics for biofilm-driven wound infections and transdermal delivery.
Maji S, M N S, Paramasivam S … +4 more , Rajaramon S, Sujith S, Solomon AP, Pasupuleti M
Expert Opin Drug Deliv · 2026 Jul · PMID 42381547 · Publisher ↗
INTRODUCTION: Chronic wound infections remain a major healthcare challenge due to persistent polymicrobial biofilms and the increasing prevalence of antimicrobial resistance. Conventional antimicrobial therapies often fa...
INTRODUCTION: Chronic wound infections remain a major healthcare challenge due to persistent polymicrobial biofilms and the increasing prevalence of antimicrobial resistance. Conventional antimicrobial therapies often fail to eradicate biofilms, highlighting the need for innovative therapeutic strategies. Metal complexes have emerged as promising candidates owing to their multitarget antimicrobial and antibiofilm activities and potential for localize wound treatment. AREAS COVERED: This review examines the role of metal complexes in combating biofilm-associated wound infections. Their mechanisms of action, including membrane disruption, redox imbalance, quorum-sensing inhibition, metabolic interference, and biofilm matrix destabilization, are discussed. The review further explores the integration of metal complexes into advanced transdermal and wound patch platforms, including polymeric matrices, nanocomposite systems and stimuli-responsive delivery systems designed to enhance localized drug release, improve wound retention, and minimize systemic toxicity. Current preclinical and translational developments are also highlighted. EXPERT OPINION: Metal-complex-based transdermal therapeutics represent a promising next-generation approach for managing chronic biofilm-mediated wound infections and overcoming antimicrobial resistance. However, successful clinical translation requires addressing challenges related to toxicity, formulation stability, manufacturing scalability, regulatory approval, and long-term safety. Future interdisciplinary efforts integrating microbiology, materials science, and clinical research will be essential to advance these technologies from laboratory to clinical practice.
Next-generation strategies for PROTAC formulation: mechanistic insights and advanced formulation technologies.
Maurya AK, Padrela L, Agrawal AK … +2 more , Kumar A, Kumar D
Expert Opin Drug Deliv · 2026 Jun · PMID 42378065 · Publisher ↗
INTRODUCTION: Proteolysis-targeting chimeras (PROTAC) are an innovative treatment approach that selectively breaks down disease-relevant proteins by utilizing the ubiquitin-proteasome system. Other than PROTAC, Molecular...
INTRODUCTION: Proteolysis-targeting chimeras (PROTAC) are an innovative treatment approach that selectively breaks down disease-relevant proteins by utilizing the ubiquitin-proteasome system. Other than PROTAC, Molecular glue, Lysosome-Targeting Chimaera (LYTAC), GlueTAC, Autophagy-Targeting Chimaera (AUTAC), Autophagosome Tethering Compound (ATTEC), and Antibody-based PROTAC (AbTAC) are emerging targeted protein degradation (TPD) techniques, of which PROTAC offers several benefits. AREAS COVERED: This review discusses the development of proteolysis-targeting chimeras (PROTACs) for targeted protein degradation, highlighting their mechanism of action via the ubiquitin - proteasome system. It examines key physicochemical and pharmacokinetic challenges that limit clinical translation. Advanced formulation strategies, including nanoformulations and amorphous solid dispersions, prodrug improve solubility, bioavailability, and therapeutic efficacy. Additionally, characterization techniques are summarized, and the review outlines recent progress and critical considerations for the successful clinical translation of PROTAC-based therapeutics. Relevant articles from PubMed, Scopus, and Web of Science, spanning publications up to 2026, were gathered. EXPERT OPINION: PROTACs represent a transformative therapeutic modality, enabling selective protein degradation beyond conventional inhibition. Future research should focus on improving bioavailability, targeted delivery, and stability, while advancing prodrug strategies, E3 ubiquitin ligase selectivity, oral formulations, and predictive models for clinical translation. Additionally, it should emphasize scalable manufacturing, regulatory frameworks, and integration with emerging targeted protein degradation technologies.
Drug penetration in solid tumors: influence of drug size and capillary architecture.
Salavati H, Lai M, Pichardo-Almarza C … +2 more , Kimko H, Ceelen W
Expert Opin Drug Deliv · 2026 Jul · PMID 42376952 · Publisher ↗
INTRODUCTION: Macromolecular and nanoparticulate drug carriers are increasingly important in oncology due to improved targeting and reduced systemic toxicity; however, their delivery to solid tumors is often limited by s...
INTRODUCTION: Macromolecular and nanoparticulate drug carriers are increasingly important in oncology due to improved targeting and reduced systemic toxicity; however, their delivery to solid tumors is often limited by size-dependent transport barriers. METHODS: We present a computational modeling framework that couples microvascular blood flow, transvascular exchange, interstitial fluid flow, and macromolecule transport to investigate the interplay between drug properties, particularly particle size, and tumor capillary structural characteristics. A stochastic capillary network generation algorithm was developed to produce realistic microvascular networks with heterogeneous vessel radius, branching patterns, and permeability properties. RESULTS: Simulations show an inverse relationship between particle size and penetration and quantify how pore radius and pore area fraction modulate extravasation and tissue dispersion. CONCLUSIONS: Overall, the framework may serve as a prototype in silico tool for drug formulation design, supporting the selection of molecular formats and sizes that distribute more efficiently within tumors under tumor-specific biophysical constraints.
Beyond bioequivalence: a critical overview of the innovator AmBisome as the reference standard for liposomal amphotericin B generics.
Bridi Cavassin F, Mihailenko Chaves Magri M
Expert Opin Drug Deliv · 2026 Jun · PMID 42359827 · Publisher ↗
INTRODUCTION: The advent of liposomal amphotericin B (L-AmB, commercialized as AmBisome) technology represented a paradigm shift in antifungal drug delivery, substantially reducing the severe, well-known nephrotoxicity h...
INTRODUCTION: The advent of liposomal amphotericin B (L-AmB, commercialized as AmBisome) technology represented a paradigm shift in antifungal drug delivery, substantially reducing the severe, well-known nephrotoxicity historically associated with the conventional deoxycholate formulation (D-AmB). Despite this advance, the expiration of the innovator's patent has spurred the global development of generic liposomal preparations, raising critical biopharmaceutical and clinical safety concerns. AREAS COVERED: This article reviews the literature and regulatory landscape of L-AmB and its nanosimilars. A comprehensive search was performed using PubMed, Embase, and Web of Science (1990-2026), focusing on NBCDs, bioequivalence, and clinical safety. The scope includes an evaluation of marketed generic formulations, their regulatory registrations, and published comparative studies. We also discuss the clinical consequences of administering unstable generics during high-dose protocols. EXPERT OPINION: While recognizing the urgent need for affordable generic alternatives to democratize access in low- and middle-income countries (LMICs), we emphasize the necessity for stringent, internationally harmonized regulatory standards beyond conventional bioequivalence. Safeguarding biopharmaceutical fidelity is an indispensable clinical imperative to protect vulnerable patients from the severe hidden costs of therapeutic failure and drug-induced toxicity.
Hydrogel-based drug delivery systems for oral mucositis: a systematic review of preclinical models and translational perspectives.
Cotomacio CC, Calarga CC, Alves Noronha de Abreu JP … +1 more , Simões A
Expert Opin Drug Deliv · 2026 Jun · PMID 42330085 · Publisher ↗
INTRODUCTION: Oral mucositis (OM) remains a common and clinically significant complication of chemotherapy and radiotherapy. Current management is largely supportive, and effective local therapies remain limited. Hydroge...
INTRODUCTION: Oral mucositis (OM) remains a common and clinically significant complication of chemotherapy and radiotherapy. Current management is largely supportive, and effective local therapies remain limited. Hydrogel-based delivery systems have attracted interest because they may improve mucosal retention, protect ulcerated tissue, and enable sustained local drug release. METHODS: A systematic review of preclinical animal studies evaluating hydrogel-based interventions for oral mucositis was conducted. PubMed, Embase, and the Cochrane Library were searched, with additional gray literature screening. Data on formulation characteristics, experimental models, therapeutic outcomes, and methodological quality were extracted. Risk of bias was assessed using the SYRCLE tool. RESULTS: Eighteen studies met the inclusion criteria. Most formulations reduced lesion severity, improved histological healing, and attenuated inflammatory or oxidative markers. Multifunctional systems combining mucoadhesion with anti-inflammatory, antioxidant, or antimicrobial activity tended to show broader effects than conventional gels. However, study design, outcome reporting, and translational endpoints were heterogeneous. CONCLUSIONS: Current preclinical evidence supports hydrogels as promising local drug delivery platforms for oral mucositis. Greater standardization of models and clinically relevant endpoints will be important to support translation into human studies. PROTOCOL REGISTRATION: https://www.crd.york.ac.uk/prospero/, identifier CRD420251072050.
Rethinking the evaluation of intra-articular drug delivery systems for osteoarthritis.
Yao Q, Zhang Y, Chen R
Expert Opin Drug Deliv · 2026 Jul · PMID 42322098 · Publisher ↗
Abstract loading — click title to view on PubMed.
Current trends in semaglutide therapy and strategies to improve its bioavailability.
Nayak S, Dessai AD, Nayak UY
Expert Opin Drug Deliv · 2026 Jun · PMID 42288971 · Publisher ↗
INTRODUCTION: A GLP-1 Receptor Agonist, semaglutide, is given in the management of type 2 diabetes mellitus and obese individuals. However, oral semaglutide exerts very low bioavailability due to multiple gastrointestina...
INTRODUCTION: A GLP-1 Receptor Agonist, semaglutide, is given in the management of type 2 diabetes mellitus and obese individuals. However, oral semaglutide exerts very low bioavailability due to multiple gastrointestinal and biopharmaceutical barriers. Delivery of oral semaglutide becomes difficult due to instability in GI fluids, degradation through proteolysis by various enzymes, and mucus diffusion limitation; epithelial permeability restricts the oral absorption of the drug, due to which the oral bioavailability of semaglutide is exceedingly low. This review identifies methods that enhance oral bioavailability as well as treatment efficacy of semaglutide. AREAS COVERED: This review provides a broad perspective on the drug and the various formulation strategies that can be developed to increase semaglutide's oral bioavailability, encompassing work on enteric coating, gut-targeted delivery, etc. Databases searched include Scopus, google scholar, PubMed, clinicaltrials.gov etc. This review also discussed and summarized all patents and clinical trials related to semaglutide formulations. EXPERT OPINION: Although various formulation approaches have been explored to improve semaglutide's oral bioavailability, this review proposes novel and promising strategies for gut-targeted delivery and enteric coating. These methods aim to prevent semaglutide from acidic degradation or neutralization in the stomach and from enzymatic degradation, thereby enhancing its intestinal uptake.
Ligand-functionalized liposomal vesicles in breast cancer: advances in targeted nanotherapeutics.
Sharma R, Dua K, Subramaniyan V … +1 more , Singh TG
Expert Opin Drug Deliv · 2026 Jun · PMID 42252702 · Publisher ↗
INTRODUCTION: Breast cancer (BC) remains one of the most prevalent malignancies worldwide, characterized by molecular heterogeneity, therapeutic resistance, and high recurrence rates that limit the success of conventiona...
INTRODUCTION: Breast cancer (BC) remains one of the most prevalent malignancies worldwide, characterized by molecular heterogeneity, therapeutic resistance, and high recurrence rates that limit the success of conventional treatments. Although chemotherapy and targeted therapies have improved patient outcomes, their effectiveness is often compromised by off-target toxicity, poor tumor selectivity, and multidrug resistance. Liposomal nanocarriers improves drug stability and circulation while enhancing passive tumor accumulation via the EPR effect. However, conventional liposomes exhibit limited cellular internalization and inadequate tumor penetration. AREA COVERED: This review discusses ligand-functionalized liposomes for active targeting in BC. Surface modification with antibodies, peptides, aptamers, carbohydrates, and small molecules enables selective binding to overexpressed receptors, improving cellular uptake and intracellular drug delivery. The literature was screened using PubMed, ScienceDirect, Google Scholar, and Scopus. Recent advances in multifunctional systems, including dual-targeting strategies, stimuli-responsive release mechanisms, and combination therapies, are also examined. CONCLUSION: Ligand-modified liposomes show strong potential to enhance therapeutic precision, pharmacokinetics, and safety. These have the potential of targeted delivery, decreased toxicity, and improved therapeutic effects. However, challenges such as tumor heterogeneity, large-scale manufacturing, and regulatory constraints must be addressed for successful clinical translation.
Predicting clinical efficacy of lung gene delivery in people with cystic fibrosis: which and models best predict outcomes in human lungs?
Munir M, Wiyana J, Werder RB … +6 more , Butcher NJ, Burow R, McCarron A, Yu Q, Waters SA, Kaminskas LM
Expert Opin Drug Deliv · 2026 Jun · PMID 42240557 · Publisher ↗
INTRODUCTION: Despite over three-decades of work, no inhalable nucleic acid delivery system for cystic fibrosis (CF) has advanced beyond Phase II due to a lack of congruence between positive outcomes from and preclinica...
INTRODUCTION: Despite over three-decades of work, no inhalable nucleic acid delivery system for cystic fibrosis (CF) has advanced beyond Phase II due to a lack of congruence between positive outcomes from and preclinical work, and lung function improvements in people with CF. AREAS COVERED: We review publications covering and animal models for CF research from databases including Web of Science and PubMed. Data were used to evaluate the performance of inhaled nucleic acid delivery systems for CF and examine why positive outcomes in these models fail to predict clinical responses. EXPERT OPINION: The field should recalibrate expectations regarding the proportion of epithelial cell correction required for meaningful clinical improvement since the threshold for sustained improvement in lung function in humans may be substantially higher. No single model can predict clinical responses. Translation robustness depends on integrating multiple systems that collectively interrogate delivery, persistence, safety and functional restoration of lung function in clinically meaningful settings. Appropriate air-liquid interface models that accurately recapitulate the CF airways are important starting points, followed by delivery and functional evaluation in CF animal models that closely resemble human lung physiology and disease phenotype, including pigs and ferrets.
Biomarker-driven and AI-assisted nanomedicine for breast cancer: advancing precision drug delivery from bench to bedside.
Barar J, Ansari R, Omidi Y
Expert Opin Drug Deliv · 2026 Jun · PMID 42234571 · Publisher ↗
INTRODUCTION: Breast cancer remains the most prevalent malignancy among women worldwide, with its pronounced molecular heterogeneity demanding therapeutic strategies that transcend conventional systemic chemotherapy towa...
INTRODUCTION: Breast cancer remains the most prevalent malignancy among women worldwide, with its pronounced molecular heterogeneity demanding therapeutic strategies that transcend conventional systemic chemotherapy toward tumor-selective, molecularly precise interventions. The convergence of biomarker science, engineered nanomedicine, and artificial intelligence (AI) offers a transformative framework for realizing this goal. AREAS COVERED: This review examines how molecular biomarkers (e.g. mucin glycoproteins, human epidermal growth factor receptor 2 (HER2), circulating tumor cells, and circulating tumor DNA) serve dual roles as diagnostic identifiers and active targeting ligands directing engineered nanocarriers. We critically evaluate biomarker-guided nanoplatforms (liposomal, polymeric, metallic, and protein-based architectures), stimuli-responsive drug release strategies, and AI-driven microfluidic manufacturing for scalable, good manufacturing practice-compliant nanoparticle production. Literature was retrieved from PubMed/MEDLINE, Scopus, and Web of Science (2000-2026), supplemented by ClinicalTrials.gov data. EXPERT OPINION: Near-term clinical impact is most realistically achieved through AI-assisted biomarker interpretation and multi-analyte liquid biopsy integration rather than novel nanoformulations, whose translational attrition remains high. Bridging the bench-to-bedside gap requires prospective biomarker-stratified clinical trials, co-developed companion diagnostics, and federated AI architectures as advances that will progressively replace static histological subtype classification with a continuously updated, molecularly individualized treatment paradigm for breast cancer.
Tumor stroma and its role in therapy resistance: mechanisms and therapeutic opportunities.
Luong D, Shah SHR, Sivasoorian SS … +1 more , Iyer AK
Expert Opin Drug Deliv · 2026 Jun · PMID 42228989 · Publisher ↗
INTRODUCTION: The tumor microenvironment (TME), composed of cancer, immune, and stromal cells together with the extracellular matrix, plays critical roles in tumor initiation, progression, metastasis, and therapeutic res...
INTRODUCTION: The tumor microenvironment (TME), composed of cancer, immune, and stromal cells together with the extracellular matrix, plays critical roles in tumor initiation, progression, metastasis, and therapeutic resistance. Although immune-targeted therapies, including immune checkpoint inhibitors and CAR-T cells, have transformed cancer treatment, stromal cells are increasingly recognized as key regulators of tumor biology. AREAS COVERED: Stromal cells regulate tumor metabolism, immune evasion, angiogenesis, and drug resistance. They originate from surrounding tissues or cellular transdifferentiation and may exert tumor-promoting or tumor-suppressive effects depending on context. Current strategies target stromal components such as hyaluronic acid and laminin for drug delivery or remodel the stroma to improve therapeutic response. Stromal-targeted delivery systems enhance penetration, specificity, safety, and biocompatibility, with promising clinical outcomes. Cancer-associated fibroblasts, mesenchymal stem cells, tumor-associated adipocytes, endothelial cells, and pericytes also represent emerging therapeutic targets. Relevant studies published through April 2025 were identified using PubMed, Scopus, and Web of Science. EXPERT OPINION: Targeting the tumor stroma represents a promising direction in oncology by improving drug delivery while advancing understanding of tumor biology and treatment resistance, supporting development of more effective, context-specific therapies.
Evaluation of blood-brain barrier models in central nervous system new drug development: methodological challenges and translational perspectives.
Lee CU, Park DB, Lee E … +8 more , Kim SJ, Seong YJ, Hwang Y, Won H, Choi SB, Ku B, Lee DW, Lee SY
Expert Opin Drug Deliv · 2026 Jun · PMID 42223152 · Publisher ↗
INTRODUCTION: Central nervous system (CNS) drug development remains challenging because effective delivery across the blood-brain barrier (BBB) is difficult to predict preclinically. BBB models are increasingly used to...
INTRODUCTION: Central nervous system (CNS) drug development remains challenging because effective delivery across the blood-brain barrier (BBB) is difficult to predict preclinically. BBB models are increasingly used to evaluate barrier properties and drug transport, but platform variability and limited standardization hinder consistent interpretation and translational use. AREAS COVERED: This review summarizes major cell-based BBB models for CNS drug development, focusing on static, dynamic, microfluidic, induced pluripotent stem cell-derived, and three-dimensional (3D) BBB platforms. Emphasis is placed on model applicability for permeability assessment, transporter activity, exposure kinetics, spatial distribution, and translational prediction. Relevant literature was searched using PubMed, Web of Science, and Google Scholar up to 2025. EXPERT OPINION: Although BBB models have advanced substantially, no single system fully reproduces the complexity of the BBB. The major limitation is persistent inconsistency across models, which complicates interpretation and limits confidence in their translational application. Static models are practical but provide only partial representation of BBB function, whereas stem cell-based and microfluidic platforms offer greater physiological relevance but face reproducibility and scalability challenges. Future progress should prioritize context-of-use-driven model selection, tiered validation, and harmonized reporting to support reliable decision-making in CNS drug development.
Oxygen therapy beyond prescription: reframing LTOT as a precision drug delivery system.
Torres-Castro R, Otto-Yáñez M, Casas A … +7 more , Alsina-Restoy X, Gallardo HP, Vera-Uribe R, Embid C, Rodríguez-Charadía D, Blanco I, Vilaró J
Expert Opin Drug Deliv · 2026 Jun · PMID 42217233 · Publisher ↗
INTRODUCTION: Chronic respiratory diseases are a major global health burden, and oxygen therapy remains a cornerstone treatment for chronic hypoxemia. However, the effectiveness of long-term oxygen therapy (LTOT) depends...
INTRODUCTION: Chronic respiratory diseases are a major global health burden, and oxygen therapy remains a cornerstone treatment for chronic hypoxemia. However, the effectiveness of long-term oxygen therapy (LTOT) depends not only on indication but also on the interaction between device performance, patient physiology, and real-world use. Variability in delivery systems, inadequate titration, and poor adherence often lead to mismatches between prescribed and delivered oxygen doses. AREAS COVERED: This review synthesizes current evidence on LTOT as a drug-delivery system, focusing on device characteristics, delivery performance, and patient-device matching across rest, exertion, and sleep. It examines stationary and portable systems, as well as home high-flow nasal cannula (HFNC). Key challenges such as pulse-dose variability, device limitations, adherence, and safety are addressed. Evidence from clinical trials, physiological studies, registries, and guidelines is integrated to show how delivery systems and patient factors influence effectiveness. EXPERT OPINION: LTOT should be reframed as a precision drug delivery system rather than a simple flow-based prescription. Device-specific titration, confirmation of adequate oxygenation with the prescribed device under the intended conditions of use, and individualized matching are essential. Future strategies should prioritize objective monitoring, advanced technologies, and scalable education to reduce the gap between prescription and real-world effectiveness.
Bioconjugates for breast cancer theranostics: improving target selectivity and treatment efficacy.
Jain N, Kaul S, Verma R … +4 more , Sharma A, Pandey M, Chaudhary A, Nagaich U
Expert Opin Drug Deliv · 2026 Jun · PMID 42216243 · Publisher ↗
INTRODUCTION: Breast cancer is the most common cancer diagnosed globally, with various levels of heterogeneity. The current treatment strategy for breast cancer includes surgery, chemotherapy, radiation, hormone, targete...
INTRODUCTION: Breast cancer is the most common cancer diagnosed globally, with various levels of heterogeneity. The current treatment strategy for breast cancer includes surgery, chemotherapy, radiation, hormone, targeted, and immunotherapy. These strategies are combined according to the stage, patient factors, and molecular subtype of breast cancer to enhance survival and diminish the recurrence of cases. Several adverse effects and challenges are associated with these therapies, which render the patient uncomfortable and non-compliant. AREAS COVERED: Bioconjugate-based therapy is one of the advanced therapies emerging to diagnose and treat breast cancer, in which conjugation is done between various molecules, such as monoclonal antibodies and cytotoxic drugs, radionuclides, enzymes, polymers, ligands, and nanoparticles, using linkers. This review aims to critically discuss bioconjugate's recent research advancements in breast cancer theranostics, highlighting their strengths and gaps toward clinical translation, along with patents and clinical trials. PubMed, Scopus, and Google Scholar were used to search the literature in the last five years (2021 to present). EXPERT OPINION: The outcomes of the findings are promising; however, more studies need to be done to establish the mechanistic pathway, long-term toxicity, safety, efficacy, and stability of the bioconjugates for breast cancer to move toward clinical settings.
Quality by design in advanced anticancer therapeutics: bridging design space, manufacturing, and clinical performance.
Gonçalves MBS, Hoffmann P, Pereira-Silva M … +1 more , Mascarenhas-Melo F
Expert Opin Drug Deliv · 2026 May · PMID 42154276 · Publisher ↗
INTRODUCTION: Anticancer therapies increasingly rely on complex formulations and potent compounds with narrow therapeutic windows, making consistent product quality and performance essential. Quality by Design (QbD), sup...
INTRODUCTION: Anticancer therapies increasingly rely on complex formulations and potent compounds with narrow therapeutic windows, making consistent product quality and performance essential. Quality by Design (QbD), supported by ICH Q8-Q10 guidelines, offers a systematic framework integrating formulation design, process understanding, and product quality throughout development, particularly for modern oncology therapeutics. A literature search in PubMed and Google Scholar identified studies published 2016 onwards, prioritizing high-quality (Q1-Q2) journals, yielding 83 references. AREA COVERED: This review discusses how QbD principles guide anticancer drug development, highlighting Quality Target Product Profiles, Critical Quality Attributes, and design space in controlling variability affecting bioavailability, therapeutic index, and clinical outcomes. It examines how Process Analytical Technology, mechanistic modeling, and digital twins support robust manufacturing and scale-up of complex oncology formulations. Selected examples, including imatinib- and paclitaxel-based therapies, illustrate how QbD-informed strategies influence formulation optimization, process robustness, and lifecycle management. EXPERT OPINION: The next phase of oncology drug development will likely depend on integrating QbD with predictive modeling, real-time release testing, and continuous manufacturing to manage targeted therapy complexity. QbD should evolve from a compliance framework into a translational tool linking formulation attributes with performance, enabling more reliable development and lifecycle management of precision oncology therapeutics.
An overview of targeted drug delivery systems specific for fibroblast growth factor receptors and their co-receptors.
Ciura K, Porębska N, Opaliński Ł
Expert Opin Drug Deliv · 2026 May · PMID 42128811 · Publisher ↗
INTRODUCTION: The growing number of patients diagnosed with cancer highlights the need for development of new therapeutic strategies. Targeted therapies, especially DDSs, have attracted increasing interest in recent year...
INTRODUCTION: The growing number of patients diagnosed with cancer highlights the need for development of new therapeutic strategies. Targeted therapies, especially DDSs, have attracted increasing interest in recent years, mostly because of selective delivery of cytotoxic agents to cancer cells and overcoming some of cancer resistance mechanisms. AREAS COVERED: FGFRs and their co-receptors, especially HSPGs, represent attractive molecular targets for DDSs due to their dysregulation across multiple cancer types. To date, nearly 60 DDSs targeting FGFRs and/or HSPGs have been reported in the literature, spanning a wide range of cytotoxic efficacy and developmental stages. Several of these candidates have entered Phase I of clinical trials, but none has yet received FDA approval. In this review, we provide a comprehensive overview of DDSs targeting FGFRs and HSPGs in cancer. We highlight FGFRs and HSPGs as promising molecular targets for future drug delivery strategies in oncology. Literature in this review was identified through PubMed up to March 2026, with selection focused on studies related to targeted drug delivery systems specific for fibroblast growth factor receptors and their co-receptors. EXPERT OPINION: FGFR/HSPG-targeted DDSs show potential mainly within targeted therapies, but clinical translation is limited by target expression in normal tissues and insufficient efficacy of current ADCs. Future progress depends on better target validation, co-expression analysis, and development of multivalent or PDC-based strategies integrated with molecular patient stratification.
Targeting the brain: alternative administration routes and drug delivery systems for antidepressant therapy.
Figueiredo I, Bicker J, Vitorino C … +1 more , Fortuna AC
Expert Opin Drug Deliv · 2026 Jul · PMID 42059872 · Publisher ↗
INTRODUCTION: Although numerous antidepressants are clinically available, they are characterized by slow therapeutic onset, systemic effects, and limited brain exposure, which is restricted by the blood-brain barrier (BB...
INTRODUCTION: Although numerous antidepressants are clinically available, they are characterized by slow therapeutic onset, systemic effects, and limited brain exposure, which is restricted by the blood-brain barrier (BBB). AREAS COVERED: Alternative administration routes namely intranasal, ocular, and intratympanic delivery, are emerging as promising strategies for a direct drug targeting of the central nervous system. Data were obtained from PubMed, Web of Science, Scopus, and regulatory agencies, 2010-2025. Intranasal route enables rapid brain delivery through the olfactory and trigeminal pathways, bypassing the BBB and avoiding systemic degradation. Ocular delivery allows drugs to reach the retina and optic nerve, providing access to deeper brain structures, while intratympanic route facilitates drug passage into the inner ear and subsequently into the cerebrospinal fluid through its connection to the cochlear perilymph, circumventing the BBB. EXPERT OPINION: Innovative drug delivery systems have the potential to enhance drug stability, brain permeability, and enable sustained and targeted release. By integrating these technologies with novel administration routes, which allow direct brain delivery, it may be possible to enhance cerebral biodistribution, speed therapeutic onset, reduce systemic side effects. This is a crucial area of ongoing research, offering the potential for safer, more effective, and patient-centered treatments for depression.
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