International Journal of Pharmaceutics最新文献

{"title":"Nebulized liposomal drug delivery: a SWOT analysis in drug development","authors":"Junli Zhu ,&nbsp;Qian Chen ,&nbsp;Wenhao Wang ,&nbsp;Chuanbin Wu ,&nbsp;Xin Pan ,&nbsp;Zhengwei Huang","doi":"10.1016/j.ijpharm.2025.125962","DOIUrl":"10.1016/j.ijpharm.2025.125962","url":null,"abstract":"<div><div>This critical review provided a detailed strengths, weaknesses, opportunities, and threats (SWOT) analysis of nebulized liposomal formulations, focusing on the strengths and translational potential. The formulations have notable strengths, such as enhancing targeting, solubility, and stability. However, several weaknesses, including nebulization leakage, safety, and large-scale production, have limited their commercial application. This SWOT analysis highlighted some new opportunities includings artificial intelligence to facilitate overcoming these limitations. Besides, certain threats become obstacles hindering the development of the formulations. Review focuses on analyzing nebulized liposomal formulations from four aspects, and corresponding solutions are provided for different aspects. Through SWOT analysis, nebulized liposomal formulations can be used to promote the industrial production <em>via</em> the rational application of novel technologies based on the enhancement of strengths and the overcoming of weaknesses. Drawing on contemporary pre-clinical and clinical investigations of liposomes, SWOT analysis can more effectively enhance the likelihood of clinical translation for nebulized liposomes and promote their commercial applications.</div></div>","PeriodicalId":14187,"journal":{"name":"International Journal of Pharmaceutics","volume":"683 ","pages":"Article 125962"},"PeriodicalIF":5.2,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144717910","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dynamic negative pressure enhances MSC-derived exosomes treatment for vessel injury-related erectile dysfunction by facilitating cavernous diffusion","authors":"Chen Feng ,&nbsp;Ruiyu Li ,&nbsp;Guanbo Wang ,&nbsp;Shuai Liu ,&nbsp;Qiang Fu","doi":"10.1016/j.ijpharm.2025.125999","DOIUrl":"10.1016/j.ijpharm.2025.125999","url":null,"abstract":"<div><div>Exosomes (Exos) have demonstrated significant efficacy in the treatment of erectile dysfunction (ED). However, their clinical application is limited by immediate dilution and rapid release upon entry into the bloodstream, reducing targeted delivery efficiency. Moreover, there is a dearth of research on the use of exosomes for vessel injury-related erectile dysfunction (VI-ED). A dynamic negative pressure (DNP) system was developed to validate the facilitative effect of DNP on targeted Exos infiltration into the corpus cavernosum. Using a high-fat diet and surgical intervention, we established a VI-ED model and employed DNP for exosomes delivery to VI-ED rats to validate the efficacy of Exos in ameliorating erectile dysfunction and elucidate their specific mechanisms both in vivo and in vitro. Negative pressure can facilitate the infiltration of MSC-derived Exos into the penile corpus cavernosum. Compared with sustained negative pressure, DNP exhibits twofold greater delivery efficiency (p &lt; 0.05), thereby enhancing the targeted delivery efficiency of Exos. Moreover, Exos delivered by DNP promote vascular remodeling and inhibit phenotypic transformation through the modulation of the PTEN/PI3K/AKT signaling pathway. The findings of this study demonstrate that DNP, as a noninvasive delivery modality, facilitates the targeted infiltration of Exos and augments the therapeutic efficacy of VI-ED.</div></div>","PeriodicalId":14187,"journal":{"name":"International Journal of Pharmaceutics","volume":"682 ","pages":"Article 125999"},"PeriodicalIF":5.2,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144717908","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and application of an AI-empowered acoustic monitoring system for misuse detection in dry powder inhalers","authors":"Ziyi Fan ,&nbsp;Yuqing Ye ,&nbsp;Jiale Chen ,&nbsp;Ying Ma ,&nbsp;Jesse Zhu","doi":"10.1016/j.ijpharm.2025.125997","DOIUrl":"10.1016/j.ijpharm.2025.125997","url":null,"abstract":"<div><div>Misuse and poor inhalation techniques remain persistent issues in pulmonary drug delivery via dry powder inhalation. While acoustic-based monitoring has been a feasible strategy, existing approaches often depend on smartphones for signal collection, or wired connections for data transmission, limiting their scalability and practicality in real-world settings. More importantly, few studies have specifically focused on the detection of incorrect DPI usage via digital monitoring systems, and current methods still face limitations in accuracy. Therefore, in this study, an AI-empowered acoustic monitoring system was developed, combining edge sensing and cloud analytics to support continuous signal acquisition and misuse detection. Comprehensive featuring engineering and machine learning analysis have been performed to investigate their influence on inhalation activity recognition. The results suggested that feature fusion could significantly enhance classification performance, with the Support Vector Classifier (SVC) showing 99.5 % overall accuracy during cross-validation and 100% accuracy on the test set, along with rapid training and high stability. This proposed digital system achieves a near-perfect categorization on the inhalation-related events, and effectively detects unexpected exhalation into inhalers, showing strong potential in real-life applications for improved respiratory disease management.</div></div>","PeriodicalId":14187,"journal":{"name":"International Journal of Pharmaceutics","volume":"682 ","pages":"Article 125997"},"PeriodicalIF":5.3,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144714181","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The impact of glidant addition on continuous blending of active pharmaceutical ingredients.","authors":"Tom Verbeek, Alexander De Man, Bernd Van Snick, Martin Otava, Thomas De Beer, Ashish Kumar, Chris Vervaet, Valérie Vanhoorne","doi":"10.1016/j.ijpharm.2025.125927","DOIUrl":"https://doi.org/10.1016/j.ijpharm.2025.125927","url":null,"abstract":"<p><p>Continuous manufacturing (CM) of solid dosage forms in the pharmaceutical industry offers several advantages over batch processing. The most straightforward CM pathway within the pharmaceutical industry is continuous direct compression (CDC), which consists of three main consecutive steps: loss-in-weight feeding, continuous blending and tableting (die-filling and compaction) (Snick et al., 2017; Karttunen et al., 2019). However, as the majority of the newly developed APIs are cohesive materials with a mean particle size of ¡ 100 μm, a wide particle size distribution (PSD) and a high tendency to agglomerate, making them difficult to handle on CM lines (Yang et al. 2005; Jallo et al. 2012; Chen et al. 2019). In this research paper, the impact of a diverse selection of glidants on the continuous blending unit was assessed. Two cohesive APIs (acetaminophen micronized and metoprolol tartrate) and three different glidants (Aerosil^{protect relax special {t4ht=®}} 200, Aerosil^{protect relax special {t4ht=®}} R972 and Syloid^{protect relax special {t4ht=®}} 244 FP) were included. Via multivariate data analysis, quantitative relationships were established between glidant concentration, blending responses (hold-up mass(HM), bulk residence time (BRT), blender fill fraction (BFF %) and relative standard deviation of the blend uniformity (RSD_BU)), blend properties and process settings. The dry-coating of APIs with small quantities of glidants efficiently improved the flowability of cohesive powders, thereby optimizing the gravimetric feeding performance. Dry powder coating of the API altered its bulk properties which affected the bulk properties of the final blend as well as the blending responses (HM, BRT, BFF %). This was mainly attributed to the changes in basic flow energy (BFE), conditioned bulk density (CBD), flowability rate index (FRI) and flow function coeffient (ffc), which are all correlated to HM, BRT and BFF %. It was also observed that glidants did not improve RSD_BU during continuous blending within the investigated experimental space. Moreover, adding higher concentrations of glidants can even increase RSD_BU due to fluidization segregation and less paddle interactions. However, overall the RSD_BU values obtained with the continuous blender were relatively low.</p>","PeriodicalId":14187,"journal":{"name":"International Journal of Pharmaceutics","volume":" ","pages":"125927"},"PeriodicalIF":5.3,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144717927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dual cross-linked hydrogels as promising materials for drug delivery","authors":"Carsten Damm,&nbsp;Achim Goepferich","doi":"10.1016/j.ijpharm.2025.125929","DOIUrl":"10.1016/j.ijpharm.2025.125929","url":null,"abstract":"<div><div>Hydrogels have long found their place as versatile materials for drug delivery due to their biocompatibility, tunable properties and tissue-like mechanical behavior. Despite these advantages they suffer from a multitude of drawbacks, ranging from lacking injectability and low mechanical strength to short drug release times. These factors limit their potential clinical applications. Dual cross-link hydrogels are a versatile tool to address these shortcomings. By combining covalent with dynamic-covalent and physical cross-linking they create smarter, stronger and more versatile hydrogels, broadening their applicability. This review aims to bridge the gap between traditional hydrogels and emerging dual cross-linked hydrogels by providing an overview of the chemistries involved. We discuss the most popular cross-linking strategies and how these can be used to address specific challenges in hydrogel design. Furthermore we highlight how recent research has utilized these promising materials to enable the application of hydrogels in ever more demanding environments.</div></div>","PeriodicalId":14187,"journal":{"name":"International Journal of Pharmaceutics","volume":"683 ","pages":"Article 125929"},"PeriodicalIF":5.2,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144717907","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Dynamics of insertion and extraction of hollow pyramidal microneedles: experiments and numerical modelling","authors":"Rahul Nadda ,&nbsp;Diganta Bhusan Das ,&nbsp;Tahir Emre Yalcin ,&nbsp;Abraham M. Abraham ,&nbsp;Eneko Larrañeta ,&nbsp;Ryan F. Donnelly","doi":"10.1016/j.ijpharm.2025.125989","DOIUrl":"10.1016/j.ijpharm.2025.125989","url":null,"abstract":"<div><div>The present study aimed to investigate the dynamics of HMNs’ insertion and extraction utilising HMN fabrication, laboratory experiments and numerical simulations. In particular, the study aims to develop an experimentally validated mathematical model to investigate the mechanics of the insertion and extraction of hollow pyramidal MNs, considering the nonlinear material behaviour of HMNs and skin. This study reveals good consistency between the experimental and computational results, providing confidence on the validity of the developed mathematical model. The model was then used to conduct detailed numerical simulations of the insertion and extraction of hollow pyramidal MN within a multi-layered skin model under different conditions, allowing us to assess the impacts of several key parameters (e.g., the base radius, length, and tip radius of HMNs) on the insertion and extractions dynamics of the HMNs. Overall, the findings of this paper indicate that HMN length &lt;600 µm, base diameter &lt;300 µm, tip diameter &lt;30 µm, needle spacing &gt;800 µm, and number of HMNs &lt;9 can significantly lower the forces required for insertion and extraction for the chosen pyramidal MN, while maintaining their mechanical and structural integrity.</div></div>","PeriodicalId":14187,"journal":{"name":"International Journal of Pharmaceutics","volume":"682 ","pages":"Article 125989"},"PeriodicalIF":5.3,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144703950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developing, fabrication and functionalization of soy bioactive peptides-nano particles therapeutic nano composites: A review","authors":"Khalid Amin ,&nbsp;Jiaxin Li ,&nbsp;Bo Lyu ,&nbsp;Sainan Wang ,&nbsp;Hongling Fu ,&nbsp;Bin Liu ,&nbsp;Hansong Yu","doi":"10.1016/j.ijpharm.2025.125983","DOIUrl":"10.1016/j.ijpharm.2025.125983","url":null,"abstract":"<div><div>Nanoparticles (NPs) therapeutics has emerged as advanced systems for personalized therapeutics. However, they encounter several obstacles in attaining exact specificity and sensitivity for disease therapies. Therefore, the development of NPs with novel approaches is critically important to improve their therapeutic efficacy. One intellectual approach is assembling and compositing them with active biomaterials like smart disease targeting peptides. Bioactive peptides derived from soybeans, are reported to involve in several physiological functions like reducing chronic diseases such as cancer, cardiovascular disease (CVD) obesity, insulin-resistance/type II diabetes, immune disorders and inflammatory diseases. Therefore, the conjugation of soy bioactive peptides with nanoparticles is a promising strategy towards engineered therapeutic nano systems. However, these conjugates of soy peptides-nanoparticles composites (SPNCs) are highly under considered. Engineered nanoparticles with peptides, captured attention as innovative therapeutic platforms. Consequently, SPNCs engineered nanostructure, have the high potential for future therapeutics as their composite/hybrid features of therapeutic NPs and soy bioactive peptides, can not only enhance their therapeutic behaviors but also can resolve their challenges they face as an individual. In this review for the first time, multimodal SPNCs with acclaimed therapeutic abilities are discussed which set a foundational understanding for the future nanotherapeutics. The foundational details of soy peptides, NPs and their chemistries and corresponding interactions with disease modes are discussed. Finally, precise guidelines for accuracy techniques to engineer SPNCs with efficient therapeutic abilities are explored. This study established the groundwork for advancement of composite soy bioactive peptides with NPs to achieve therapeutic SPNCs with high target specific abilities.</div></div>","PeriodicalId":14187,"journal":{"name":"International Journal of Pharmaceutics","volume":"682 ","pages":"Article 125983"},"PeriodicalIF":5.3,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144707441","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to “Transethosomal system for enhanced transdermal delivery and therapeutic effect of caryophyllene oxide” [Int. J. Pharm. 670 (2024) 125111]","authors":"Hiba Natsheh ,&nbsp;Mohammad Qneibi ,&nbsp;Naim Kittana ,&nbsp;Nidal Jaradat ,&nbsp;Mohyeddin Assali ,&nbsp;Bahaa Shaqour ,&nbsp;Murad Abualhasan ,&nbsp;Abdallatif Mayyala ,&nbsp;Yaqeen Dawoud ,&nbsp;Tala Melhem ,&nbsp;Sawsan Abd Alhadi ,&nbsp;Osama Hammoudi ,&nbsp;Abdullah Samaro ,&nbsp;Ahmed Mousa ,&nbsp;Sosana Bdir ,&nbsp;Mohammad Bdair ,&nbsp;Samia Aldwaik","doi":"10.1016/j.ijpharm.2025.125904","DOIUrl":"10.1016/j.ijpharm.2025.125904","url":null,"abstract":"","PeriodicalId":14187,"journal":{"name":"International Journal of Pharmaceutics","volume":"682 ","pages":"Article 125904"},"PeriodicalIF":5.3,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144686576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"In-line Raman-based quantification of the anhydrous content in a fully integrated continuous powder-to-granule line","authors":"Petra Záhonyi,&nbsp;Dániel Fekete,&nbsp;Erzsébet Moharos,&nbsp;Zsombor Kristóf Nagy,&nbsp;Edina Szabó","doi":"10.1016/j.ijpharm.2025.125995","DOIUrl":"10.1016/j.ijpharm.2025.125995","url":null,"abstract":"<div><div>This research is based on a fully integrated continuous twin-screw wet granulation line from powder feeding to dried granules. One of its crucial steps is continuous drying, which can influence the crystal form and thus, the quality of the granules. Therefore, the main objective of this research was to develop a Raman spectroscopic method for monitoring the crystal form transition in-line and real-time during the continuous process while applying different drying temperatures. Dextrose was used as a model material due to its high industrial relevance as an active pharmaceutical ingredient and excipient. The real-time monitoring of the granules’ crystal form demonstrated that drying at higher temperatures (100 °C and 120 °C) resulted in partial dehydration of the initial <em>α</em>-<span>d</span>-glucose monohydrate. Raman spectroscopy combined with multivariate data analysis proved suitable for real-time quantification of anhydrous content with a root mean square error of 3.3 % w/w. The results were validated by various conventional, off-line analytical techniques, which further confirmed the reliability of the model and the detected anhydrous content. This work shows the high predictive performance of Raman spectroscopy for in-line and real-time anhydrous content monitoring in a fully integrated continuous powder-to-granule line, enhancing process understanding and ensuring high and consistent product quality.</div></div>","PeriodicalId":14187,"journal":{"name":"International Journal of Pharmaceutics","volume":"682 ","pages":"Article 125995"},"PeriodicalIF":5.3,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144695125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ascorbyl palmitate/hyaluronan-modified poloxamer 407 nanoparticles for the topical delivery of fisetin to counteract UVB-induced skin photoaging: A novel anti-aging formulation","authors":"Asmaa H. Elwan ,&nbsp;Soha M. El-Masry ,&nbsp;Doaa A. Habib ,&nbsp;Mariam Zewail","doi":"10.1016/j.ijpharm.2025.125988","DOIUrl":"10.1016/j.ijpharm.2025.125988","url":null,"abstract":"<div><div>Fisetin (FIS) has recently been the focal point of multiple studies. Yet, its skin delivery has not been fully investigated due to its low aqueous solubility and high lipophilicity. Herein, FIS-loaded Poloxamer 407 (P407) nanoparticles were modified with Ascorbyl Palmitate (AS) and Hyaluronan (HYA), providing a multimodal approach to preventing UVB-induced skin photoaging. Optimal FIS-AS-HYA-P407 nanoparticles demonstrated a particle size of 214.10 ± 0.32 nm with a zeta potential of −16 ± 0.83 mV, a high entrapment efficiency of 95.61 ± 0.52 %, and a sustained release reaching 68.05 ± 3.32 % over 24 h. FT-IR and DSC confirmed the formation of the nanoparticles and the compatibility of the components. FIS-AS-HYA-P407 nanoparticles penetrated the skin with a flux of 9.23 ± 0.59 µg/cm²/h in 8 h. Confocal microscopy proved the skin penetration of the nanoparticles up to 80 µm with high FIS distribution. The nanoparticles were biocompatible due to the lack of irritation and exhibited potent <em>in vitro</em> antioxidant effects, as confirmed by the DPPH assay. The <em>in vivo</em> study on Wistar rats demonstrated the photoprotective ability of FIS-AS-HYA-P407 nanoparticles via reducing TNFα, NF-κB, and MMP9 and elevating SOD and CAT levels, showing remarkable anti-inflammatory, anti-aging, and antioxidant potential. JNK protein expression was reduced in skin samples pretreated with FIS-AS-HYA-P407 nanoparticles compared to FIS suspension, signifying a high photoprotective outcome. The novelty of this work is attributed to the formulation of FIS for the first time with HYA and AS in P407 nanoparticles to counteract UVB skin damage and photoaging.</div></div>","PeriodicalId":14187,"journal":{"name":"International Journal of Pharmaceutics","volume":"682 ","pages":"Article 125988"},"PeriodicalIF":5.3,"publicationDate":"2025-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144695127","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}