Journal of Pharmaceutical Innovation最新文献

{"title":"In Silico and Hansen Solubility Parameters-Guided HME-3D Printed Tablets: Boosting Aceclofenac Solubility and Dissolution","authors":"Prashant Nayak,&nbsp;Bhoomika Rao M,&nbsp;Aman Pratap Singh,&nbsp;Bhargav E,&nbsp;Muralidhar Pisay","doi":"10.1007/s12247-026-11058-z","DOIUrl":"10.1007/s12247-026-11058-z","url":null,"abstract":"<div><h3>Purpose</h3><p>The restricted aqueous solubility of BCS-II drugs leads to significant biopharmaceutical variability, limiting dissolution and therapeutic efficacy. This study shows an integrated experimental-computational platform to improve the solubility of Aceclofenac (AF), where Hansen solubility and In-Silico binding efficiencies are checked to select the optimal polymer for stable and molecular-level Amorphous Solid Dispersions.</p><h3>Methods</h3><p>The drug and excipient screening was done using the in-silico binding energy and Hansen solubility parameters. Eudragit, PVA, and HPMC E5 showed better compatibility in the initial screening. AF, along with selected carriers, was processed in the Hot Melt Extrusion (HME). The prepared dispersions were subjected to 3D printing for the preparation of tablets. The solid dispersions and prepared tablets were subjected to various solid and liquid characterisations.</p><h3>Results</h3><p>From the characterizations data, it was noticed that the AF was no longer in the crystalline form. The HME processed the drug-polymer physical mixture into a uniform filament exhibiting maximum amorphous content, as confirmed by FTIR, DSC, XRD, solubility, and Dissolution studies. The HME-assisted AF dispersions were then converted to an oral tablet dosage form using a novel 3D printing technology. The ICH stability studies proved that there was less than 5% loss with a sustained supersaturation state.</p><h3>Conclusion</h3><p>The organic solvent-free HME, followed by 3D printing tablets, eliminates the conventional tablet formulation battle, delivering patient-centric and scalable tablets with guaranteed physical stability.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148986945","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}

{"title":"Effect and Mechanism of Acanthopanax senticosus Stem in Promoting Wound Healing","authors":"Qiujun Du,&nbsp;Liyang Wang,&nbsp;Zhaoping Meng,&nbsp;Zixian Guo,&nbsp;Kai Zhao,&nbsp;Hanqing Yi,&nbsp;Wei Zhang,&nbsp;Wenfei Liu,&nbsp;Xiangcai Meng","doi":"10.1007/s12247-026-11048-1","DOIUrl":"10.1007/s12247-026-11048-1","url":null,"abstract":"<div><h3>Background</h3><p><i>Acanthopanax senticosus</i>(<i>A. senticosus</i>) is a medicinal and edible herb. Based on the theory that it promotes wound healing by improving microcirculation, this study aims to clarify its mechanism of action and core pharmacodynamic substances, thereby providing support for clinical translation.</p><h3>Methods</h3><p>Bioactive compounds and targets of <i>A. senticosus</i> were screened via HERB and PubChem. Wound healing- and microcirculation-related targets were obtained from GeneCards, DisGeNET, and OMIM. Core targets were screened by PPI network, followed by GO and KEGG pathway enrichment. Molecular docking was performed using ChemOffice 20.0. A mouse full-thickness skin wound model was established. ELISA detected serum TNF-α, IL-6, IL-10, TGF-β1, FGF-2, EGF, VEGF and ATP. Histological staining compared wound repair effects of ASW, ASG and ASP.</p><h3>Results</h3><p>Forty active components of <i>A. senticosus</i> could act on 159 common targets related to wound healing and microcirculation. The core targets included STAT3, EGFR, SRC, AKT1, HSP90AA1, BCL2, PIK3CA, ERBB2, JUN, and HIF1A, which were mainly enriched in the PI3K‑Akt, HIF‑1, and focal adhesion pathways. All treatment groups significantly inhibited pro‑inflammatory factors and upregulated anti‑inflammatory and repair‑related factors. Among these, the ASG group exhibited the optimal effect, with a wound healing rate of 91.52 ± 2.00% on day 10.</p><h3>Conclusion</h3><p><i>A. senticosus</i> effectively elevates wound healing rate and improves tissue repair quality, with remarkable pro-healing activity. Total glycosides are the core pharmacodynamic substances and the findings are applicable to clinical wound repair.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148987050","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}

{"title":"Integrated Multi-Omics and Single-Cell Analyses Identify PCDHGB4 as a Prognostic Biomarker and Oncogenic Regulator in Pan-Squamous Cell Carcinoma","authors":"Haiyue Sun,&nbsp;Xiang Lv,&nbsp;Shaolin Liu,&nbsp;Zhijun Chen,&nbsp;Yangchun Feng","doi":"10.1007/s12247-026-11050-7","DOIUrl":"10.1007/s12247-026-11050-7","url":null,"abstract":"<div><h3>Background</h3><p>Protocadherin gamma subfamily B member 4 (PCDHGB4) encodes a protein associated with wound healing; however, its role in pan-cancer, particularly in squamous cell carcinoma (SCC), remains unclear.</p><h3>Methods</h3><p>TCGA data were used to assess the prognostic value and mutation characteristics of PCDHGB4. Single-cell and spatial transcriptomics analyses were performed to examine its expression patterns. Functional roles were evaluated using in vitro proliferation and metastasis assays, along with overexpression and knockdown experiments in SCC cell lines.</p><h3>Results</h3><p>PCDHGB4 was identified as a prognostic biomarker in SCC. Its alterations were associated with patient survival across cancers. Single-cell analyses revealed that PCDHGB4 expression is enriched in malignant cells and is associated with tumor progression. Immune infiltration analysis suggested a suppressive effect on immune cell distribution in SCC. Pathway analyses indicated activation of oncogenic signaling, and experimental validation confirmed that PCDHGB4 regulates the PI3K-AKT pathway in SCC cells.</p><h3>Conclusion</h3><p>PCDHGB4 is a potential biomarker for pan-cancer, especially SCC, and may promote tumor progression through oncogenic signaling and modulation of the tumor immune microenvironment.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148986947","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}

{"title":"In Vitro Anti-Inflammatory Evaluation, Gene Expression, HR-LC–MS Profiling, and in silico Molecular Docking of Active Fraction from Rauvolfia densiflora Benth. ex Hook.f. (Apocynaceae)","authors":"P. Q. Sabin,&nbsp;T. P. Girija","doi":"10.1007/s12247-026-11018-7","DOIUrl":"10.1007/s12247-026-11018-7","url":null,"abstract":"<div><h3>Purpose</h3><p>The study aimed to evaluate the anti-inflammatory potential of the active fraction obtained from the methanolic stem extract of <i>Rauvolfia densiflora</i> Benth. ex Hook.f., specifically identifying which fraction had significant activity and characterising their biological and molecular effects.</p><h3>Methods</h3><p>A total of 30 fractions were separated from the methanolic stem extract using column chromatography; fractions 21–30 were selected for further analysis due to clear TLC profiles. Preliminary bioactivity screening was conducted using a protein denaturation inhibition assay to determine anti-inflammatory potential. The most active fraction was further evaluated using a cyclooxygenase (COX) inhibition assay. HR-LC–MS analysis was performed on the active fraction to identify its chemical constituents. Gene expression analysis was conducted in RAW 264.7 macrophage cells to assess impacts on inflammatory genes (COX-2, iNOS, NF-κB). Molecular docking studies were employed to assess the binding affinities of the identified compounds toward the COX-2 active site.</p><h3>Result</h3><p>Among the fractions, the 28th fraction exhibited the most pronounced in vitro anti-inflammatory activity. At a concentration of 100 µg/mL, it inhibited protein denaturation by 60.65%, corresponding to an IC₅₀ value of 69.37 µg/mL. Similarly, this fraction demonstrated 60.56% inhibition of cyclooxygenase (COX) activity at 100 µg/mL, with an IC₅₀ of 67.09 µg/mL. High-resolution liquid chromatography–mass spectrometry (HR-LC–MS) analysis tentatively identified 14 phytochemical constituents. Among these, five compounds—quinine, yohimbine, ajmalicine, aspidospermatine, and luteolin—have been previously reported to possess anti-inflammatory properties. In RAW 264.7 macrophages treated with the active fraction, mRNA expression of key inflammatory mediators was markedly downregulated: COX-2 (0.10 log₂ fold change), inducible nitric oxide synthase (iNOS; 0.84 log₂ fold change), and nuclear factor kappa B (NF-κB; 0.05 log₂ fold change) relative to control conditions. Molecular docking analyses indicated favourable binding interactions between the identified compounds and the COX-2 active site. Among the ligands tested, luteolin exhibited the strongest predicted affinity, with a binding energy of − 9.4 kcal/mol.</p><h3>Conclusion</h3><p>The 28th fraction of the methanolic stem extract of <i>R. densiflora</i> demonstrated significant in vitro anti-inflammatory activity, supported by both biochemical assays and molecular analyses. Bioactive constituents within this fraction modulated inflammatory pathways, suppressed the expression of key inflammatory genes, and exhibited favourable binding to COX-2. These findings suggest the fraction has potential as a source of anti-inflammatory drug leads.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148986386","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}

{"title":"Extraction and Characterization of Lemon-derived Exosome-like Nanoparticles (LELNs) using a PEG-6000-Based Method: Comparison of Two Protocols and Evaluation of Physicochemical Properties","authors":"Saeedeh Kheiripour,&nbsp;Masoud Fereidoni","doi":"10.1007/s12247-026-11030-x","DOIUrl":"10.1007/s12247-026-11030-x","url":null,"abstract":"<div><h3>Purpose</h3><p>Lemon-derived exosome-like nanoparticles (LELNs) have emerged as promising natural nanocarriers for drug delivery due to their high biocompatibility, low toxicity, and intrinsic therapeutic properties. However, standardized extraction and control of their characteristics remain challenging. This study aimed to compare two PEG-6000-based extraction protocols and investigate the impact of harvest season on the physicochemical properties of LELNs.</p><h3>Methods</h3><p>Two extraction methods were developed and compared: Method A (0.45 µm filtration prior to PEG-6000 precipitation) and Method B (pH adjustment to 5 prior to precipitation). Additionally, the effect of harvest season on LELNs isolated using Method A was investigated over one year. Particle size, zeta potential, morphology, and chemical composition were evaluated using DLS, TEM, AFM, and FTIR, respectively.</p><h3>Results</h3><p>Method A produced smaller nanoparticles with a mean diameter of 85 nm, while Method B exhibited a higher negative zeta potential (-39 mV). Significant seasonal variations were observed: nanoparticle size increased from autumn to summer, the polydispersity index decreased to 0.044, and zeta potential reached -38.61 mV. FTIR analysis revealed increased polar groups and glycolipids in summer samples, consistent with higher colloidal stability.</p><h3>Conclusion</h3><p>Method A produced smaller, uniform nanoparticles, whereas Method B offered higher colloidal stability. Harvest season also affected LELN properties: summer samples showed greater stability and uniformity, while autumn samples exhibited distinct characteristics. Overall, both extraction protocol and harvest season significantly influence LELN physicochemical properties, particularly size, uniformity, and colloidal stability. These findings underscore the importance of extraction conditions and harvest timing.</p><h3>Graphical abstract</h3><div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148987051","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}

{"title":"Formulation and Optimization of Ion-Activated Gellan Gum–Xanthan Gum In Situ Nasal Gel for Enhanced Delivery of Cyclobenzaprine Hydrochloride Through the Nose to Brain Delivery System","authors":"Paresh R. Mahaparale,&nbsp;Rishikesh Chakor,&nbsp;Sonali Mahaparale,&nbsp;Mohd Sayeed Shaikh","doi":"10.1007/s12247-026-11085-w","DOIUrl":"10.1007/s12247-026-11085-w","url":null,"abstract":"<div><p>Cyclobenzaprine (CBP) is a centrally acting skeletal muscle relaxant that is limited use by high first-pass metabolism, low oral bioavailability and dose dependent side effects. Present study was designed to develop and optimize an in situ nasal gel of CBP for direct nose-to-brain drug delivery using gellan gum as the main gelling polymer and xanthan gum as a mucoadhesive viscosity enhancer for enhancing the drug permeation through the olfactory and trigeminal neural pathways to reach the brain avoiding the blood brain barrier and hepatic first pass metabolism. A 3² full factorial design was used with gellan gum (0.4–0.8% w/v) and xanthan gum (0.1–0.2% w/v) as independent variables, with cumulative drug permeation and mucoadhesive strength as dependent responses. Results of the ANOVA were found to be statistically significant for both responses (<i>p</i> &lt; 0.05) for both polymers. All formulations showed an immediate ion activated sol-to-gel transition, non-Newtonian pseudoplastic rheological behaviour, and non-Fickian drug permeation kinetics following Korsmeyer-Peppas model. Optimized formulation F5 (0.6% w/v gellan gum; 0.15% w/v xanthan gum) achieved a cumulative drug permeation of 86.90 ± 0.87% at 7 h, a mucoadhesive strength of 6370 ± 232.54 dynes/cm², a gel strength of 42 ± 1.35 s, and a pH of 5.8 ± 0.03. Histopathological examination confirmed no damage to the mucosa and accelerated stability studies showed no significant physicochemical changes. An ex-vivo validated in-situ nasal gel is a promising platform for sustained delivery of CBP to the brain and should be evaluated further in vivo for nose-to-brain delivery for skeletal muscle spasm.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149132856","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}

{"title":"Application of Box-Behnken Design and Greenness Assessment to an Established UPLC Method for Quantitative Analysis of Asciminib","authors":"Vavilala Ganesh,&nbsp;Allenki Vyshnavi,&nbsp;Vakiti Bhavani Chandra,&nbsp;Madduluri Shiva Kailash,&nbsp;Vasudha Bakshi,&nbsp;Soorammagari Sunayana,&nbsp;Dandamudi Santhoshi Priya","doi":"10.1007/s12247-026-11054-3","DOIUrl":"10.1007/s12247-026-11054-3","url":null,"abstract":"<div><h3>Background</h3><p>An eco-friendly and systematic quality by design (QbD) was used to build an ultraperformance liquid chromatographic (UPLC) method for the quantitative evaluation of asciminib.</p><h3>Methods</h3><p>Critical procedural factors were identified and optimized using Design of Experiments (DoE) to ensure the method’s reliability and robustness. Peak area was considered as the analytical response, while the proportion of acetonitrile in the mobile phase, flow rate and analyte concentration were selected as independent variables. Chromatographic separation was achieved using a Waters UPLC system (Model 2695) equipped with a PDA detector (Model 2996) under optimized conditions: C18 column (50 × 4.6 mm, 1.7 μm), mobile phase of 0.1% trifluoroacetic acid in water and acetonitrile (75:25, v/v), flow rate of 0.3 mL/min, and detection at 260 nm.</p><h3>Results</h3><p>The method demonstrated a retention time of 0.925 min with excellent efficiency. Validation according to ICH guidelines confirmed good linearity (5–30 µg/mL, R² = 0.999), precision (%RSD 0.49–0.86), accuracy (recovery 100.06–100.6%), and robustness. The LOD and LOQ were determined to be 0.23 µg/mL and 0.69 µg/mL, respectively.</p><h3>Conclusion</h3><p>The new method’s greenness was verified using the AGREE, Complex GAPI, and BAGI tools, and it was determined to adhere to the green chemistry principles. Thus, a reliable, effective and environmentally friendly method was developed by combining QbD and DoE with green chemistry tools.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148987049","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}

{"title":"Continuous Downstream Processing in Biopharmaceutical Manufacturing: A Review","authors":"Srinivasulu Katakam,&nbsp;Erik Hefti","doi":"10.1007/s12247-026-10914-2","DOIUrl":"10.1007/s12247-026-10914-2","url":null,"abstract":"<div><h3>Purpose</h3><p>Continuous manufacturing has emerged as a promising alternative to conventional batch processing, offering potential improvements in efficiency, product quality, and sustainability. This review evaluates the economic, quality, sustainability, and scalability implications of continuous downstream processing in biopharmaceutical manufacturing and identifies lessons applicable to life-science industries.</p><h3>Methods</h3><p>A literature review was conducted using PubMed, ScienceDirect, and SpringerLink databases to identify peer-reviewed articles, industrial case studies, and regulatory guidance documents published between 2010 and 2025.</p><h3>Results</h3><p>Continuous downstream processing reduces manufacturing costs and improves equipment efficiency. Process Analytical Technology (PAT) enables real-time quality control, reducing variability and improving product purity and yields. Continuous systems lower material, water, and energy consumption while improving scalability and operational flexibility across life-science industries.</p><h3>Conclusions</h3><p>Continuous downstream processing is a technically viable and cost-effective technology for biopharmaceutical production. Implementation challenges, including validation complexity and workforce readiness, can be mitigated with emerging technologies such as digital twins and AI-enhanced PAT systems. Cross-industry evidence supports modular adoption strategies to accelerate implementation.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12247-026-10914-2.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148986463","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Novel Small Molecule VK-SN-04-419 Suppresses Exosome Biogenesis and Induces Anticancer Activity in Triple-Negative Breast Cancer","authors":"Ankush Bansode,&nbsp;Pooja Jagdale,&nbsp;Rashed Qureshi,&nbsp;S. Anil Dharavath,&nbsp;Swathi Lakshmi,&nbsp;Anamika Sharma,&nbsp;Vinay Kumar Kacchupalli,&nbsp;Santosh Kumar Guru","doi":"10.1007/s12247-026-11007-w","DOIUrl":"10.1007/s12247-026-11007-w","url":null,"abstract":"<div><p>Breast cancer remains one of the leading causes of cancer-related mortality worldwide, with triple-negative breast cancer (TNBC) representing the most aggressive subtype due to the absence of hormone receptors and limited targeted therapeutic options. Recent studies have highlighted the pivotal role of tumour-derived exosomes in promoting cancer progression, metastasis, and therapy resistance. In the present study, we investigated the anticancer and anti-exosomal potential of a novel small-molecule compound, VK-SN-04-419, in human TNBC MDA-MB-231 cells using comprehensive in vitro and in silico approaches. Molecular docking analysis revealed a strong binding affinity of VK-SN-04-419 toward key proteins involved in exosome biogenesis and cancer progression, suggesting its potential mechanism of action at the molecular level. Functional assays demonstrated that VK-SN-04-419 significantly inhibited cell proliferation in a time-dependent manner, with decreasing IC₅₀ values observed at 24, 48, and 72 h. The compound also markedly suppressed colony formation and cell migration, indicating inhibition of long-term clonogenicity and metastatic potential, Western blot and RT-PCR analyses demonstrated dose-dependent downregulation of exosome-associated markers at the protein and transcriptional levels, while analysis of the isolated exosome fraction confirmed corresponding alterations in exosomal protein expression validating disruption of exosome biogenesis and release. Additionally, VK-SN-04-419 induced concentration-dependent cell-cycle perturbation, characterized by G0/G1 arrest at lower concentrations and S-phase accumulation at higher concentrations, accompanied by apoptosis. These cell-cycle alterations and apoptotic changes were evidenced by flow cytometric analysis and DAPI staining. Importantly, the compound significantly inhibited tumour growth in a 3D MDA-MB-231 organoid model, highlighting its translational relevance. Collectively, these findings identify VK-SN-04-419 as a promising anti-exosomal and anticancer candidate for TNBC.</p><h3>Graphical Abstract</h3><div><figure><div><div><picture><source><img></source></picture></div></div></figure></div></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148986219","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}

{"title":"Stability-Indicating RP-UPLC Analysis of Semaglutide: Integrating Green Analytical Chemistry Principles in Bulk and Pharmaceutical Formulations","authors":"Dandamudi Santhoshi Priya,&nbsp;Shivakumar Gubbiyappa,&nbsp;Kusuma Praveen Kumar,&nbsp;Kiran Gangarapu","doi":"10.1007/s12247-026-10993-1","DOIUrl":"10.1007/s12247-026-10993-1","url":null,"abstract":"<div><h3>Aim and Objectives</h3><p>The aim of this study was to develop and validate a simple, precise, sensitive and stability-indicating method for the separation and determination of semaglutide in pharmaceutical formulations, in compliance with ICH Q2(R1) guidelines and Green Analytical Chemistry principles.</p><h3>Methods</h3><p>Chromatographic separation was achieved using a Phenyl XBD column (100 × 2.6 mm, 1.7 μm) with a mobile phase of 0.1% formic acid and acetonitrile (70:30 v/v) at a flow rate of 0.5 mL/min. Detection was performed at 294 nm, and retention time (RT) of semaglutide was observed at 1.729 min. Linearity was evaluated across 2–12 µg/mL, precision was assessed using %RSD, and sensitivity was determined through LOD and LOQ values.</p><h3>Results</h3><p>The method showed excellent linearity with R² = 0.999. System and method precision were confirmed with %RSD values ranging from 0.35 to 0.72. Recovery studies demonstrated values between 100.06% and 100.6%. The method exhibited high sensitivity with LOD of 0.083 µg/mL and LOQ of 0.61 µg/mL. Stress degradation studies confirmed complete separation of degradants formed under acid, alkali hydrolysis and oxidation, with good resolution, establishing the method’s stability-indicating nature.</p><h3>Conclusion</h3><p>The validated method is precise, accurate, and robust for semaglutide analysis under varied stress conditions. Importantly, it aligns with Green Analytical Chemistry principles by minimizing solvent use, employing a safer aqueous-organic mobile phase, and reducing environmental impact without compromising analytical performance.</p></div>","PeriodicalId":656,"journal":{"name":"Journal of Pharmaceutical Innovation","volume":"22 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148986239","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}