Drug Development and Industrial Pharmacy最新文献

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Prediction drug release profile from chitosan nanoparticles: integration of experimental data and machine learning models. 壳聚糖纳米颗粒药物释放预测:实验数据和机器学习模型的集成。
IF 2.2 4区 医学
Drug Development and Industrial Pharmacy Pub Date : 2025-10-03 DOI: 10.1080/03639045.2025.2569573
Ali Rastegari, Homa Faghihi, Mahta Mobinikhaledi
{"title":"Prediction drug release profile from chitosan nanoparticles: integration of experimental data and machine learning models.","authors":"Ali Rastegari, Homa Faghihi, Mahta Mobinikhaledi","doi":"10.1080/03639045.2025.2569573","DOIUrl":"10.1080/03639045.2025.2569573","url":null,"abstract":"<p><strong>Background: </strong>Integration of artificial intelligence such as machine learning into pharmaceutical sciences has become increasingly necessary since rapid progress of novel drug delivery systems and increasing demand to accelerate research while reducing time and cost. According to the controllable nature of nanoparticle characteristics, ML algorithms offer a promising approach to predict critical properties of drug delivery systems including drug release profiles.</p><p><strong>Objective: </strong>This study aimed to develop and investigate the machine learning models for prediction of cumulative drug release profile from chitosan nanoparticles, based on different physicochemical parameters in formulation.</p><p><strong>Methods: </strong>In this study, we extracted experimental data from 115 research articles published between 2000 and 2020 with focus on chitosan nanoparticles prepared by ionic gelation method. For prediction of cumulative drug release profiles at multiple time points, after curating 190 datapoints with appropriate physicochemical parameters, we developed and evaluated two supervised ML models including Random Forest Regression and XGBoost using R<sup>2</sup> and MSE as evaluation parameters. Additionally, to improve model performance, we used feature importance analysis to identify and remove less influential variables.</p><p><strong>Results: </strong>The results demonstrated that Random Forest Regression consistently outperformed XGBoost at the most time points. Furthermore, some variables like release medium temperature and drug solubility were excluded in a refined models since minimum contribution in model accuracy. The refined models showed improvement in prediction performance.</p><p><strong>Conclusion: </strong>These findings highlight the value of ML-based modeling in pharmaceutical formulation and emphasis its potential as a powerful tool for design and optimization of nanobased drug delivery systems.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-9"},"PeriodicalIF":2.2,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198595","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Solubility enhancement of raloxifene hydrochloride by in situ micronization technique: physicochemical characterization and pharmacokinetic studies. 用原位微粉化技术增强盐酸雷洛昔芬的溶解度:理化性质和药代动力学研究。
IF 2.2 4区 医学
Drug Development and Industrial Pharmacy Pub Date : 2025-10-03 DOI: 10.1080/03639045.2025.2566748
Ladan Dayani, Jaleh Varshosaz, Jaber Emami Bafrani, Nahal Shamaeizadeh, Seyyed Abolfazl Mostafavi
{"title":"Solubility enhancement of raloxifene hydrochloride by <i>in situ</i> micronization technique: physicochemical characterization and pharmacokinetic studies.","authors":"Ladan Dayani, Jaleh Varshosaz, Jaber Emami Bafrani, Nahal Shamaeizadeh, Seyyed Abolfazl Mostafavi","doi":"10.1080/03639045.2025.2566748","DOIUrl":"10.1080/03639045.2025.2566748","url":null,"abstract":"<p><strong>Significance: </strong>Raloxifene hydrochloride (RH) treats osteoporosis in postmenopausal women. However, due to its limited bioavailability efforts have been focused on enhancing its solubility and bioavailability.</p><p><strong>Objective: </strong>In this study <i>in situ</i> micronization have been explored to improve drug solubility through reducing particle size and enhancing saturation solubility, dissolution rate, and pharmacokinetic properties.</p><p><strong>Methods: </strong>D-α-tocopheryl polyethylene glycol succinate (TPGS), Solotul HS15, Cremophor<sup>®</sup> CO40, and HPMC K4M were chosen as solubility enhancing agents to produce nanocrystals <i>via</i> the solvent change method. The study assessed particle size, saturation solubility, and drug release rate across different formulations containing various stabilizers and concentrations.</p><p><strong>Results: </strong>Nanoparticles stabilized by 0.1% TPGS depicted the smallest particle size (467.60 ± 37.89 nm), the highest drug release in 2 h (99.61 ± 6.72%) and saturation solubility (834.11 ± 16.73 µg/mL) in comparison to pure RH and other stabilizers. Nanoparticles of RH showed C<sub>max</sub> of 1.86 ± 1.1 µg/mL compared to the pure crystals of RH, which showed maximum serum concentration of 0.52 ± 0.68 µg/mL. The AUC<sub>0-24</sub> was also inclined about four times more in nanoparticles compared to the pure drug while T<sub>max</sub> was the same in both groups.</p><p><strong>Conclusions: </strong>The obtained results demonstrated <i>in situ</i> micronization technique by solvent change method was successful in improving RH bioavailability.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-12"},"PeriodicalIF":2.2,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145185006","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Arctium minus (Hill) Bernh. extract-loaded polycaprolactone and bilayer polycaprolactone/polyvinyl alcohol electrospun nanofiber scaffolds as bioactive wound dressings. 牛蒡减去(Hill) Bernh。提取物负载聚己内酯和双层聚己内酯/聚乙烯醇电纺纳米纤维支架作为生物活性伤口敷料。
IF 2.2 4区 医学
Drug Development and Industrial Pharmacy Pub Date : 2025-10-01 Epub Date: 2025-07-04 DOI: 10.1080/03639045.2025.2528062
Tugba Eren Boncu, Cigdem Yucel, Selen Ilgun, Gokce Seker Karatoprak
{"title":"<i>Arctium minus (Hill) Bernh.</i> extract-loaded polycaprolactone and bilayer polycaprolactone/polyvinyl alcohol electrospun nanofiber scaffolds as bioactive wound dressings.","authors":"Tugba Eren Boncu, Cigdem Yucel, Selen Ilgun, Gokce Seker Karatoprak","doi":"10.1080/03639045.2025.2528062","DOIUrl":"10.1080/03639045.2025.2528062","url":null,"abstract":"<p><strong>Objective: </strong>It was aimed to formulate blank and <i>Arctium minus</i> extract-loaded Polycaprolactone (PCL) and bilayer Polycaprolactone/Polyvinyl alcohol (PCL/PVA) electrospun herbal nanofiber scaffolds as bioactive wound dressings.</p><p><strong>Methods: </strong>Electrospinning was used to produce nanofiber scaffolds and characterization studies of nanofibers (morphology, diameter) and the scaffolds (release, encapsulation efficiency, cytotoxicity, cell adhesion and proliferation, <i>in-vitro</i> wound healing, antioxidant activity) were carried out. MTT assay was used to determine the cytotoxicity of the fiber scaffolds on L929 mouse fibroblast cell line. Cell adhesion and proliferation were determined by imaging the cells seeded on scaffolds with scanning electron microscopy and fluorescent microscope. Wound healing assay was performed by creating an artificial wound (gap) to simulate the wound in the cell environment. The antioxidant efficacy of the extract produced from the scaffolds was assessed using 1,1-diphenyl-2-picrylhydrazyl (DPPH●) and 2,2-Azino-bis3-ethylbenzothiazoline-6-sulfonic acid(ABTS●+) assays.</p><p><strong>Results: </strong>All nanofibers were smooth and bead-free in the diameter range of 877.9-1257.9 nm, and had favorable encapsulation efficiency (91.9-97.5%), suitable <i>in-vitro</i> release. While the viability was between 71.4% and 73.6% in blank scaffolds, it increased up to 94.8-99.8% in extract-loaded scaffolds. However, all scaffolds can be used safely. All scaffolds (except blank PCL) provided a suitable environment for cell adhesion and proliferation. Both extract-loaded fiber scaffolds accelerated wound healing by improving cell migration. The amount of extract released was increased through formulation, demonstrating a strong capacity to scavenge DPPH● and ABTS●+ radicals.</p><p><strong>Conclusion: </strong>In conclusion, <i>A. minus</i> extract-loaded PCL and PCL/PVA lead to significant enhancement in viability, adhesion, proliferation and <i>in-vitro</i> wound healing, indicating that they can be used as effective and safe wound dressings.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1285-1298"},"PeriodicalIF":2.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144539513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Nanoemulsion-based polyherbal mouthwash of cinnamon and clove oil: physicochemical characterization, molecular docking, and antimicrobial evaluations. 肉桂丁香油纳米乳基多草药漱口水:理化特性、分子对接和抗菌评价。
IF 2.2 4区 医学
Drug Development and Industrial Pharmacy Pub Date : 2025-10-01 Epub Date: 2025-06-28 DOI: 10.1080/03639045.2025.2524063
Ahmed L Alaofi, Nazrul Haq, Mudassar Shahid, Ibrahim A Alsarra, Faiyaz Shakeel
{"title":"Nanoemulsion-based polyherbal mouthwash of cinnamon and clove oil: physicochemical characterization, molecular docking, and antimicrobial evaluations.","authors":"Ahmed L Alaofi, Nazrul Haq, Mudassar Shahid, Ibrahim A Alsarra, Faiyaz Shakeel","doi":"10.1080/03639045.2025.2524063","DOIUrl":"10.1080/03639045.2025.2524063","url":null,"abstract":"<p><strong>Objective: </strong>Different oils were used to develop nanoemulsion-based polyherbal mouthwashes (PHMs) of <i>Cinnamon zeylanicum</i> hydroalcoholic extract, and then their antibacterial activities against a range of oral pathogenic bacteria were assessed. Standard chlorhexidine acetate (CHD-A) was used as a control.</p><p><strong>Methods: </strong>Different PHMs of <i>C. zeylanicum</i> extract based on nanoemulsions were obtained and the influence of various oils such as clove oil (CO), eucalyptus oil (EO), rose oil (RO), peanut oil (PO), and sesame oil (SO) on physicochemical and antibacterial characteristics of PHMs was studied. PHMs were characterized for the following parameters: droplet size, polydispersity index (PDI), refractive index (RI), transmittance (T), and pH. The optimized product was evaluated for size and shape on its surface using transmission electron microscopy (TEM).</p><p><strong>Results: </strong>Nanoemulsion-based PHM prepared using CO showed the best physicochemical and antimicrobial properties compared to those prepared using EO, RO, PO, and SO. TEM investigation of an optimized formulation showed spherical-shaped droplets of formulation within the nanosize distribution of droplets. Against all oral infections, the antibacterial effects of the formulation made with CO (COPHM) were shown to be significantly greater than those of the formulation made with EO, RO, PO, and SO, as well as CHD-A. The formulation COPHM has been optimized as the final formulation based on minimum droplet size (31.41 nm), lowest PDI (0.141), ideal RI (1.336), highest %T (99.41), ideal pH (6.48), and largest antibacterial effects.</p><p><strong>Conclusion: </strong>These results suggested the potential of nanoemulsion-based PHM in treating a range of diseases caused by oral pathogens.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1218-1229"},"PeriodicalIF":2.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144495179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Molecular dynamics and surfactant study for enhancing the formation and anti-oral cancer efficacy of D-limonene nanoemulsions. 促进d -柠檬烯纳米乳形成及抗口腔癌疗效的分子动力学和表面活性剂研究。
IF 2.2 4区 医学
Drug Development and Industrial Pharmacy Pub Date : 2025-10-01 Epub Date: 2025-07-01 DOI: 10.1080/03639045.2025.2523524
Yotsanan Weerapol, Suwisit Manmuan, Sontaya Limmatvapirat, Jitnapa Sirirak, Poomipat Tamdee, Apichaya Sukontachard, Sukannika Tubtimsri
{"title":"Molecular dynamics and surfactant study for enhancing the formation and anti-oral cancer efficacy of D-limonene nanoemulsions.","authors":"Yotsanan Weerapol, Suwisit Manmuan, Sontaya Limmatvapirat, Jitnapa Sirirak, Poomipat Tamdee, Apichaya Sukontachard, Sukannika Tubtimsri","doi":"10.1080/03639045.2025.2523524","DOIUrl":"10.1080/03639045.2025.2523524","url":null,"abstract":"<p><strong>Objective: </strong>D-Limonene (D-LMN) is a potential anti-oral cancer agent. The incorporation of D-LMN into a nanoemulsion enhances its potential efficacy against oral cancer cells by improving its aqueous compatibility. This study evaluated the impact of surfactant type and concentration on their properties through experimental and molecular dynamics studies.</p><p><strong>Methods: </strong>D-LMN nanoemulsions were produced using different polyoxyethylene nonionic surfactants. The nanoemulsions were compared on droplet size, size distribution, zeta potential, droplet morphology, stability, interaction among molecules, anticancer activity, and cell death mechanism. Molecular dynamics simulations were also conducted to elucidate the dynamics of the components.</p><p><strong>Results: </strong>Cremophor RH40 and Tween 60 yielded a nanoemulsion with a small droplet size (<100 nm). Cremophor RH40 also produced the nanoemulsion with the narrowest size distribution. Two-dimensional nuclear Overhauser effect spectroscopy-nuclear magnetic resonance and molecular dynamic simulation studies revealed that Cremophor RH40 effectively produced nanoemulsions with small droplets and high stability. The nanoemulsions formulated with Tween 60 exhibited more potent inhibitory effects against oral cancer cells than those with Cremophor RH40. However, surfactant type did not influence the mechanism underlying the apoptotic.</p><p><strong>Conclusions: </strong>This study demonstrated that surfactants with an intermediate hydrophilic-lipophilic balance of approximately 15, particularly those with large polar heads and multiple hydrocarbon chains, were suitable for the production of anti-oral cancer D-LMN nanoemulsions by phase-inversion temperature technique.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1184-1202"},"PeriodicalIF":2.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144474245","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Microneedle-based wearable sensors: a new frontier in real-time biomarker monitoring. 基于微针的可穿戴传感器:实时生物标志物监测的新前沿。
IF 2.2 4区 医学
Drug Development and Industrial Pharmacy Pub Date : 2025-10-01 Epub Date: 2025-07-26 DOI: 10.1080/03639045.2025.2529437
Sanket Nandkumar Patil, Swapnil N Jain, Sakshi N Patil, Yogesh V Bhise
{"title":"Microneedle-based wearable sensors: a new frontier in real-time biomarker monitoring.","authors":"Sanket Nandkumar Patil, Swapnil N Jain, Sakshi N Patil, Yogesh V Bhise","doi":"10.1080/03639045.2025.2529437","DOIUrl":"10.1080/03639045.2025.2529437","url":null,"abstract":"<p><strong>Objective: </strong>To explore the mechanisms, applications, and future potential of microneedle-based wearable sensors for continuous, minimally invasive monitoring of biomarkers in interstitial fluid (ISF), highlighting their role in revolutionizing healthcare diagnostics and personalized medicine.</p><p><strong>Significance: </strong>Microneedle-based sensors offer a groundbreaking alternative to conventional invasive techniques by enabling real-time monitoring of critical biomarkers such as glucose, lactate, electrolytes, pH, and oxygen. Their ability to access ISF-biochemically similar to blood-allows for accurate physiological assessment without the need for blood draws, thereby improving patient compliance and enabling broader clinical and non-clinical applications.This review synthesizes findings from recent studies on the design, sensing mechanisms (enzymatic, electrochemical, and potentiometric), and fabrication technologies of microneedle-based sensors. It evaluates current research trends, clinical trials, and advances in materials science aimed at overcoming existing limitations in sensor stability, manufacturing scalability, and cost.</p><p><strong>Results: </strong>Microneedle-based sensors have demonstrated promising results in applications including diabetes management, athletic performance monitoring, and assessment of metabolic and hydration status. Innovations in biocompatible materials and sensor integration have improved precision and functionality. However, issues related to sensor longevity, calibration accuracy, and environmental robustness remain under active investigation.</p><p><strong>Conclusions: </strong>Microneedle-based wearable sensors represent a transformative approach in continuous health monitoring, offering significant benefits in noninvasive diagnostics and personalized medicine. Ongoing research and development efforts are expected to address current challenges, paving the way for wider clinical adoption and integration into routine healthcare practice.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1149-1166"},"PeriodicalIF":2.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144706706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Advances in novel drug delivery systems: a focus on nanoparticles and mucoadhesive technologies. 新型给药系统的进展:纳米颗粒和黏附技术的重点。
IF 2.2 4区 医学
Drug Development and Industrial Pharmacy Pub Date : 2025-10-01 DOI: 10.1080/03639045.2025.2564364
Ravi Sangavi, Sulekha Khute, Paranthaman Subash
{"title":"Advances in novel drug delivery systems: a focus on nanoparticles and mucoadhesive technologies.","authors":"Ravi Sangavi, Sulekha Khute, Paranthaman Subash","doi":"10.1080/03639045.2025.2564364","DOIUrl":"10.1080/03639045.2025.2564364","url":null,"abstract":"<p><strong>Objective: </strong>To explore the advancements and therapeutic potential of nanocarrier-based drug delivery systems in improving drug administration, targeting efficiency, and patient outcomes, particularly in complex disease management.</p><p><strong>Significance: </strong>Traditional drug delivery methods often suffer from limited targeting ability, poor bioavailability, and increased side effects. Nanocarriers, such as liposomes, dendrimers, polymeric nanoparticles, and solid lipid nanoparticles, offer innovative solutions by enabling site-specific delivery, controlled release, and enhanced therapeutic indices, thereby transforming pharmaceutical care.</p><p><strong>Methods: </strong>This review examines the current literature and recent innovations in nanocarrier design and application. It highlights stimulus-responsive systems (e.g. pH- or temperature-sensitive nanocarriers) and assesses their roles in treating conditions such as cancer, rheumatoid arthritis, and neurological disorders. This study also analyzes technological trends and translational challenges in clinical applications, including regulatory and safety concerns.</p><p><strong>Results: </strong>Recent developments in nanotechnology have enabled the creation of multifunctional, targeted, and stimuli-responsive nanocarriers capable of delivering therapeutic agents with improved precision and efficacy. These systems significantly enhance drug absorption and retention at the target site, provide sustained release, and minimize systemic side effects of the drug. Preclinical and early clinical data support their effectiveness in overcoming the limitations of conventional therapies.</p><p><strong>Conclusions: </strong>Nanocarrier-based drug delivery systems represent a paradigm shift in therapeutic strategies, offering precision-targeted treatment with improved efficacy and safety. Despite regulatory and translational challenges, continued research and innovation are accelerating their path to clinical adoption, establishing nanocarriers as the cornerstone of personalized medicine in cancer therapy.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-16"},"PeriodicalIF":2.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145112137","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Critical Review of Chromatographic Techniques for Impurity Profiling and Stability-Indicating Analysis of Ceftriaxone Sodium. 头孢曲松钠杂质分析及稳定性分析的色谱技术综述。
IF 2.2 4区 医学
Drug Development and Industrial Pharmacy Pub Date : 2025-10-01 DOI: 10.1080/03639045.2025.2569570
Abeer Srour, Basima Arous, Mhd Amer Al-Mardini
{"title":"A Critical Review of Chromatographic Techniques for Impurity Profiling and Stability-Indicating Analysis of Ceftriaxone Sodium.","authors":"Abeer Srour, Basima Arous, Mhd Amer Al-Mardini","doi":"10.1080/03639045.2025.2569570","DOIUrl":"https://doi.org/10.1080/03639045.2025.2569570","url":null,"abstract":"<p><strong>Objective: </strong>This review critically evaluates chromatographic methodologies for impurity profiling and stability-indicating analysis of ceftriaxone sodium, with particular focus on polymerized impurities that pose significant patient safety concerns.Significance: Ceftriaxone sodium, a widely prescribed third-generation cephalosporin, exhibits broad-spectrum antibacterial activity and convenient once-daily dosing. However, impurities-particularly polymerized forms-pose safety risks such as hypersensitivity and anaphylaxis. In contrast to earlier review focused on drug determination, this work emphasizes impurity profiling and highlights gaps in current analytical practice.</p><p><strong>Methods: </strong>A systematic literature survey was conducted across official pharmacopoeias and major databases (ScienceDirect, Scopus, PubMed, Google Scholar) using keywords: ceftriaxone sodium, impurity profile, polymerized impurities, ceftriaxone stability, and ceftriaxone degradation.</p><p><strong>Results: </strong>Reversed-phase HPLC with C18 columns was the predominant technique (93%), most commonly coupled with UV detection at 254 nm. Isocratic elution was applied in 82% of methods, with acetonitrile as the preferred organic modifier; ion-pairing agents were used in 39% of cases, and 20 µL was the most commonly used injection volume (54%). Only 14% of studies addressed polymerized impurities, with the Chinese Pharmacopoeia uniquely mandating gel filtration chromatography for their assessment.</p><p><strong>Discussion: </strong>Current impurity profiling strategies have limitations in detecting polymerized forms due to their low abundance, variable polymerization degrees, poor stability, and interference from co-existing molecules.</p><p><strong>Conclusions: </strong>There is an urgent need for robust, sensitive, and polymer-specific analytical approaches to improve impurity profiling, and safeguard patient safety. Future studies should incorporate greenness (AGREE), risk (RAPI), and analytical performance (BAGI) metrics to identify sustainable and reliable strategies for ceftriaxone impurity assessment.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1-11"},"PeriodicalIF":2.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Quality by design (QbD)-driven formulation of sildenafil citrate microparticles using quasi-emulsion technique for pulmonary delivery: an in vitro study. 设计质量驱动的准乳状技术枸橼酸西地那非微颗粒肺给药处方:体外研究。
IF 2.2 4区 医学
Drug Development and Industrial Pharmacy Pub Date : 2025-10-01 Epub Date: 2025-07-06 DOI: 10.1080/03639045.2025.2525957
Ashwini K Diwate, Vaishali Y Londhe
{"title":"Quality by design (QbD)-driven formulation of sildenafil citrate microparticles using quasi-emulsion technique for pulmonary delivery: an <i>in vitro</i> study.","authors":"Ashwini K Diwate, Vaishali Y Londhe","doi":"10.1080/03639045.2025.2525957","DOIUrl":"10.1080/03639045.2025.2525957","url":null,"abstract":"<p><strong>Objective: </strong>The goal of this research was to create inhalable microparticles to ensure the continuous delivery of sildenafil citrate (SC) to treat pulmonary arterial hypertension (PAH). This was done to address the limitations of SC, including its short half-life and systemic side effects.</p><p><strong>Methods: </strong>To create the inhalable microparticles, a particle engineering method called the quasi-emulsion solvent diffusion method was utilized. The study employed quality by design (QbD), a regulatory-based approach, to enhance the final product's quality. The optimization of microparticles was achieved using central composite design to enhance micromeritics properties and sustain drug release profiles. Characterization studies, including FTIR, differential scanning calorimetry (DSC), scanning electron microscopy, XRD, and surface morphology analysis, were conducted to evaluate the microparticles. Aerodynamic properties were measured to predict where particles will be deposited in the respiratory tract.</p><p><strong>Results: </strong>The optimized formulated microparticles had an acceptable mean particle size and an entrapment efficiency greater than 90%. The optimized microparticles demonstrated a sustained drug release of 80.42 ± 0.23% over 24 h. Aerodynamic properties showed a mass median aerodynamic diameter of 3.45 ± 0.0 µm, a fine particle fraction of 21%, and 77.29 ± 2.9% of the dose recovered from the inhaler. Modified tapped density measurements indicated improved flow properties of the microparticles.</p><p><strong>Conclusion: </strong>The QbD approach was successfully employed to formulate inhalable microparticles for sustained pulmonary delivery. The optimized microparticles exhibited enhanced micromeritics properties and sustained drug release profiles, making them a promising option for the treatment of PAH.</p>","PeriodicalId":11263,"journal":{"name":"Drug Development and Industrial Pharmacy","volume":" ","pages":"1257-1268"},"PeriodicalIF":2.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144539515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Ehretia microphylla Lam.: unveiling pharmacognostic, physicochemical, phytochemical and toxicity insights. 小叶ehtiera Lam。揭示生药学,物理化学,植物化学和毒性的见解。
IF 2.2 4区 医学
Drug Development and Industrial Pharmacy Pub Date : 2025-10-01 Epub Date: 2025-07-21 DOI: 10.1080/03639045.2025.2532139
Surya Suresh, Karthiyayini Ramaswamy, Yangchen Dolma Kom
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