BMC Pharmacology & Toxicology最新文献

{"title":"Lipid-coated mesoporous silica nanoparticles loaded with Thymoquinone as a novel treatment for experimental autoimmune encephalomyelitis in rats.","authors":"Heba M Fahmy, Amena S El-Feky, Mostafa M Ahmed, Ayman S Mohamed, Engy Shams-Eldin, Taiseer M Abd El-Daim, Amira B Mustafa, Mai W Abd Alrahman, Faten F Mohammed, Mohammed M Fathy","doi":"10.1186/s40360-026-01133-z","DOIUrl":"10.1186/s40360-026-01133-z","url":null,"abstract":"<p><strong>Aims: </strong>Crossing the blood-brain barrier (BBB) remains a significant challenge for delivering therapeutic agents to the central nervous system. This study aimed to evaluate the potential of a novel nanoformulation-mesoporous silica nanoparticles (MSN) coated with a lipid bilayer (LB)-to enhance the delivery and potential remyelinating effects of Thymoquinone (TQ).</p><p><strong>Methods: </strong>The formulations were characterized by transmission electron microscopy and dynamic light scattering for zeta potential and particle size determination. The experimental autoimmune encephalomyelitis (EAE) model is used as an established animal model for multiple sclerosis (MS). Our experiment consists of five groups of male Wistar rats: a standard control group, an EAE-induced group, and three treated groups after being induced with EAE: (Thymoquinone) TQ-treated group (60 mg/kg TQ), MSN-treated group (60 mg/kg MSN), and LB-MSN-treated group (60 mg/kg MSN loaded with TQ and coated with lipid bilayer).</p><p><strong>Key findings: </strong>The LB-MSN formulation was associated with a modulation of oxidative stress markers in specific brain areas. Notable increases in reduced glutathione were observed in the cortex (26.53%) and hippocampus (22.82%), alongside a modest increase in catalase in the medulla (7.90%). These biochemical changes correlated with improvements in exploratory behavior in the open field test. Furthermore, neuropathological assessment of various brain regions and sciatic nerves revealed evidence of axonal remyelination in treated groups.</p><p><strong>Significance: </strong>The findings suggest that the LB-MSN formulation may enhance the delivery and therapeutic profile of TQ, primarily through its association with anti-inflammatory and remyelinating effects.</p><p><strong>Conclusion: </strong>LB-MSN shows potential as a drug delivery system for the management of EAE.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"27 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13527971/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148863537","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacokinetic and bioequivalence study of enteric-coated omeprazole capsule in healthy Chinese subjects under fasting and fed conditions.","authors":"Fucai Zhang, Jingyi Xie, Yong Li, Wenlu Feng, Jianfen Su, Nan Mao","doi":"10.1186/s40360-026-01203-2","DOIUrl":"10.1186/s40360-026-01203-2","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to evaluate the bioequivalence of a generic enteric-coated omeprazole capsule compared with the reference product (Losec^®) in healthy Chinese subjects.</p><p><strong>Method: </strong>The fasting study was conducted using a randomized, single-centre, single-dose, two-period, two-sequence crossover design. The fed study was a randomized, single-centre, single-dose, four-period, two-sequence fully replicate crossover design. Healthy subjects were randomized and received either the test or the reference drug under fasting or fed conditions. The plasma concentration of enteric-coated omeprazole capsule at different time points was measured using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Bioequivalence of the two formulations was evaluated through pharmacokinetic parameters and relative bioavailability.</p><p><strong>Results: </strong>In the fasting study, the geometric mean ratios (GMRs) of C_max, AUC_0-t, and AUC_0-∞ were 101.33%, 101.81%, and 101.76%, respectively, with all 90% confidence intervals (CIs) falling within the bioequivalence range of 80.00-125.00%. Under fed conditions, high intra-subject variability was observed for C_max (CV = 46.79%) and AUC_0-t (CV = 31.61%). The reference-scaled average bioequivalence (RSABE) method showed GMR point estimates of 113.31% for C_max and 105.68% for AUC_0-t (both within 80.00-125.00%), with upper 95% confidence bounds below zero. The GMR for AUC_0-∞ was 108.18%, and its 90% CI (102.63-114.02%) also met the bioequivalence criteria. No serious adverse events were reported.</p><p><strong>Conclusion: </strong>The two enteric-coated omeprazole capsules were bioequivalent under both fasting and fed conditions and were well tolerated in healthy subjects.</p><p><strong>Trial registration: </strong>The trial was registered with the China Centre for Drug Testing and Registration ( http://www.chinadrugtrials.org.cn/index.html , 10/05/2022, CTR20221098 and CTR20220627).</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"27 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13525694/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148849612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Inhalation arsine poisoning: clinical features and treatment experience of 12 cases from a single incident.","authors":"Wei Hu, Juan Yang, Xiaoxia Lu, Lili Bai, Xiaobo Peng, Mingfei Peng, Xigang Zhang, Yanqing Liu","doi":"10.1186/s40360-026-01199-9","DOIUrl":"10.1186/s40360-026-01199-9","url":null,"abstract":"<p><strong>Background: </strong>Arsine poisoning is a rare but life-threatening condition characterized by severe hemolysis. Clinical data on its management remain limited. This study describes the clinical features, diagnostic approach, and treatment experience of 12 patients from a single arsine poisoning incident.</p><p><strong>Methods: </strong>Clinical data from the 12 patients were retrospectively collected. Presenting symptoms, diagnostic findings, and treatment strategies were summarized.</p><p><strong>Results: </strong>Ten of the 12 patients survived. Arsenic was detected in cleaning wastewater and in the red blood cells of four patients, and, together with clinical hemolysis, supported the diagnosis of arsine poisoning. Common symptoms included headache, nausea, vomiting, abdominal pain, dizziness, chest tightness, and hematuria; headache, nausea, and vomiting frequently co-occurred. All patients received high-dose methylprednisolone, vitamin C + B6, and chelation therapy. The two non-survivors additionally received mechanical ventilation, therapeutic plasma exchange, dialysis, methylene blue, and transfusions; they died on day 3 from progressive cardiovascular failure secondary to acute hemolysis. Five other patients underwent therapeutic plasma exchange and dialysis and ultimately survived.</p><p><strong>Conclusions: </strong>This case series highlights the clinical presentation, diagnostic workflow, and management of arsine poisoning in a well-characterized patient cluster. Early recognition and timely intervention may facilitate clinical management. The findings are descriptive and limited by the retrospective design and small sample size.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"27 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13543425/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148886032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effect of CoQ10 supplementation on cardiovascular risk factors in patients with prediabetes and type 2 diabetes mellitus: a grade-assessed systematic review and dose-response meta-analysis.","authors":"Farzaneh Rezagholizadeh, Soroosh Rezvani, Fatemeh Hosseini Oskouie, Nazgol Bahreini, Seyyed Mostafa Arabi, Reyhaneh Sadeghian, Hadi Fakhari, Reza Bagheri, Damoon Ashtary-Larky, Elham Rastgoo, Matin Ghanavati, Omid Asbaghi","doi":"10.1186/s40360-025-01002-1","DOIUrl":"10.1186/s40360-025-01002-1","url":null,"abstract":"<p><strong>Background: </strong>Previous research has shown that cardiovascular events are more prevalent among type 2 diabetes mellitus (T2DM) patients; therefore, it is vital to reduce cardiovascular risk factors in this population. Randomized controlled trials (RCTs) investigating the effects of coenzyme Q10 (CoQ10) supplementation on cardiovascular risk factors have reported inconsistent findings. As a result, we intended to assess the effects of CoQ10 supplementation on lipid and glucose profiles, blood pressure, oxidative stress, and inflammation in patients with prediabetes and T2DM.</p><p><strong>Methods: </strong>A systematic literature search was carried out using electronic databases, including PubMed, Web of Science, and Scopus, from inception to May 2025to identify eligible RCTs evaluating the effect of CoQ10 supplementation on cardiovascular risk factors. We used STATA software to combine the individual study results for all outcomes studied. Heterogeneity tests of the selected trials were performed using the I2 statistic. All analyses were performed using random-effects models to account for potential between-study heterogeneity, and pooled data were determined as the weighted mean difference with a 95% confidence interval.</p><p><strong>Results: </strong>Of 4894 records, 20 eligible RCTs were included in the current meta-analysis. Our meta-analysis of the pooled findings showed that CoQ10 supplementation significantly reduced triglycerides (p=0.001), fasting blood sugar (p<0.001), hemoglobin A1c (p=0.004), Homeostatic Model Assessment for Insulin Resistance (p=0.028) and C-reactive protein (P<0.001), while increasing high-density lipoprotein (p= 0.003). However, CoQ10 supplementation did not significantly affect total cholesterol, low-density lipoprotein, systolic and diastolic blood pressure, and malondialdehyde.</p><p><strong>Conclusions: </strong>Overall, the results demonstrated that CoQ10 supplementation may improve several cardiovascular risk factors in patients with prediabetes and T2DM. However, further research with long-term interventions and diverse dosages is required.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"27 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13508260/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148817212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of elevated linezolid trough concentrations with hyperlactatemia in elderly patients: a multicenter observational study in China.","authors":"Yaping Yuan, Tingting Liu, Xia Wu, Xiaoxiao Duan, Cheng Zhao, Junshuai Zhao, Jiaxin Liu, Chao Wang, Xiaomin Chen, Weiqiao Rao, Zhimei Duan, Guoxin Mo, Qingkao Zhang, Xiangqun Fang, Lixin Xie, Hongxia Li","doi":"10.1186/s40360-026-01196-y","DOIUrl":"10.1186/s40360-026-01196-y","url":null,"abstract":"<p><strong>Background: </strong>The association between hyperlactatemia (HLA) and linezolid concentrations in elderly patients remains poorly understood. This study aimed to explore the associations among linezolid trough concentrations, HLA, and clinical outcomes in elderly patients.</p><p><strong>Methods: </strong>Elderly patients receiving linezolid treatment at four tertiary hospitals in Beijing between May 2021 and June 2023 were enrolled. Linezolid concentrations and arterial lactate levels were dynamically monitored, and risk factors for HLA and mortality were analyzed to develop a clinical prediction model.</p><p><strong>Results: </strong>A total of 231 patients were studied, among whom 116 (50.2%) developed HLA. The median average trough concentration (C_ave) of linezolid was higher in the HLA group than in the non-HLA group (31.9 vs. 26.8 mg/L, P = 0.01). C_ave of linezolid increased with age and was positively correlated with arterial lactate levels (r = 0.766, P < 0.001) after adjusting for confounding factors. C_ave of linezolid (OR = 1.225 [per 10 mg/L], P = 0.017) and respiratory failure (OR = 1.934, P = 0.022) were independently correlated with HLA, with an AUC of 0.709 (sensitivity 65.8%, specificity 72.5%). The optimal cutoff value of C_ave of linezolid for predicting increased HLA risk was 22.4 mg/L. Elevated linezolid concentration was independently associated with 30-day mortality in exploratory analyses (OR = 1.029, P = 0.026).</p><p><strong>Conclusion: </strong>Elevated linezolid concentration was independently associated with higher arterial lactate levels, and was exploratorily associated with 30-day mortality in elderly patients. Given the observational design and the limited number of events, these findings should be considered hypothesis-generating. Routine combined monitoring of linezolid concentration and arterial lactate is recommended to guide timely dosage adjustment and reduce adverse outcomes.</p><p><strong>Clinical trial registration: </strong>Chinese Clinical Trial Registry (trial registration number: ChiCTR2100045707; April 23, 2021).</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"27 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13615579/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149058321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Synergistic modulation of endoplasmic reticulum stress pathway, oxidative DNA damage and apoptosis by β-amyrin and metformin in mitigating hyperglycemia-induced renal damage using adult zebrafish model.","authors":"Tamsheel Fatima Roohi, K L Krishna, Faiyaz Shakeel","doi":"10.1186/s40360-026-01142-y","DOIUrl":"10.1186/s40360-026-01142-y","url":null,"abstract":"","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"27 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13459437/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148705326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Liposomal amphotericin B as an antifungal prophylaxis in bilateral lung transplantation: a safety analysis.","authors":"Annalisa Boscolo, Nicolò Sella, Sabrina Congedi, Irene Paiusco, Elisa Pistollato, Alessia Zanaga, Francesca Chiapperini, Francesco Zarantonello, Giulia Mormando, Giulia Pagliarini, Alessandro De Cassai, Tommaso Pettenuzzo, Andrea Dell'Amore, Paolo Navalesi","doi":"10.1186/s40360-026-01189-x","DOIUrl":"10.1186/s40360-026-01189-x","url":null,"abstract":"<p><strong>Background: </strong>Lung transplantation (LT) is the definitive treatment for end-stage chronic respiratory failure. Despite improvements in surgical and perioperative care, fungal infections remain a major complication in LT recipients, and antifungal prophylaxis with liposomal amphotericin B (L-AmB) is commonly used. However, evidence on the safety of L-AmB administration in LT recipients remains limited. This retrospective observational study aimed to assess the profile of renal, hepatic and hematologic safety, and the incidence of hypersensitivity adverse events following prophylactic L-AmB use in LT recipients.</p><p><strong>Methods: </strong>A retrospective, single-center observational study of adult patients (≥ 18 years) who underwent their first bilateral LT at the University Hospital of Padua (Italy), between January 2020 and March 2025. All patients received intravenous L-AmB (3 mg/kg/day for 5 days) as postoperative antifungal prophylaxis. Adverse effects were assessed based on acute kidney injury (AKI), liver toxicity, hematotoxicity, and infusion reactions. Laboratory values were collected at baseline, on days 1, 2, 3, 7, and 14 post-L-AmB initiation.</p><p><strong>Results: </strong>189 LT recipients were screened and 140 enrolled. Concerning safety profile, AKI occurred in 55 (39%) patients, with serum creatinine peaking at 48 h (p = 0.025), as compared to baseline. Mild transaminase elevations occurred in 86% of patients within the first 48 h, and bilirubin increased in 10%, with no episodes of acute liver failure. Anemia (85%) and transient thrombocytopenia (9%) were observed. Hypokalemia was found in 28%. Renal replacement therapy was needed in 2%. No infusion-related or allergic reactions to L-AmB were observed. According to the institutional fungal surveillance protocol, no proven, probable, or possible invasive fungal infections were documented during the observation period. However, the present study was not designed to assess the prophylactic efficacy of L-AmB.</p><p><strong>Conclusions: </strong>In this cohort of bilateral LT recipients receiving standardized L-AmB prophylaxis, no discontinuation, dose adjustment, infusion reaction, or proven fungal infection was documented. Renal, hepatic, hematologic, and electrolyte abnormalities were frequent; but cannot be specifically attributed to L-AmB in the absence of a comparator group, given the multifactorial pathophysiology of the early post-transplant period. These findings underscore the importance of vigilant monitoring of organ function during L-AmB administration in this vulnerable population.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"27 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13571325/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148954952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug-drug interaction between ticagrelor and fazamorexant: pharmacokinetic alterations in healthy subjects from a phase I, open-label, fixed-sequence study.","authors":"Xingxing Huang, Yuzhu Chen, Lu Jin, Yanyan Kong, Fengxia Bao, Ruwei Wang","doi":"10.1186/s40360-026-01186-0","DOIUrl":"10.1186/s40360-026-01186-0","url":null,"abstract":"<p><strong>Purpose: </strong>Fazamorexant, a dual orexin receptor antagonist (DORA) targeting insomnia, demonstrated in vitro metabolism via CYP3A4. Thus, the effects of CYP3A4 inhibitors on the pharmacokinetics, safety, and tolerability of fazamorexant were investigated.</p><p><strong>Methods: </strong>In this single-center, open-label, non-randomized, fixed-sequence study, 24 healthy subjects received a single oral dose of fazamorexant (20 mg) alone on D1, followed by a 6-day regimen of the CYP3A4 weak inhibitor ticagrelor (90 mg twice daily, Days 2 to 7) to reach steady state, with a second dose of fazamorexant co-administered on Day 6. Area under the plasma concentration-time curve from time zero to infinity (AUC_0-inf), maximum plasma concentration (C_max), time to C_max (T_max), and other relevant pharmacokinetic parameters were derived from plasma concentrations of fazamorexant collected at prespecified time points. Adverse events (AEs) were recorded.</p><p><strong>Results: </strong>CYP3A4 weak inhibition by ticagrelor (90 mg, twice daily) increased the C_max of fazamorexant by approximately 14% (90% confidence interval (CI): 100.92-129.07), whereas AUC_0-t (90% CI: 86.44-125.58), AUC_{0- inf} (90% CI: 85.60-124.53) and T_max (P = 0.665) remained essentially unchanged. Fazamorexant, whether given alone or in combination with ticagrelor, was generally safe and well tolerated.</p><p><strong>Conclusion: </strong>Overall, co-administration of CYP3A4 weak inhibitors with fazamorexant is not expected to result in clinically significant drug interactions, and no dosage adjustment is required when these agents are used concomitantly.</p><p><strong>Trial registration: </strong>This trial was registered on the Drug Clinical Trial Registration and Information Disclosure Platform (registration number CTR20242889, accessible at https://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml?keywords=CTR20242889 ) on 5 August 2024, and on ClinicalTrials.gov (NCT06671470, accessible at https://clinicaltrials.gov/ct2/show/NCT06671470 ) on 31 October 2024. The ClinicalTrials.gov registration was retrospective.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148547664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and validation of a GC-MS method for the determination of ethylene glycol and diethylene glycol in pharmaceutical syrups.","authors":"Muhammad Amirul Amil, Muhammad Shahariz Mohamad Adzib, Nur Baizura Bujang, Kok Zheng Gan, Sara Khalida Jamal Khair, Malissa Wani Mohammad Amini, Ahmad Zariq Syafiq Zaire, Ahmad Yusri Mohd Yusop","doi":"10.1186/s40360-026-01184-2","DOIUrl":"10.1186/s40360-026-01184-2","url":null,"abstract":"<p><p>Contamination of pharmaceutical syrups with ethylene glycol (EG) and diethylene glycol (DEG) has led to serious poisoning incidents worldwide, highlighting the necessity for strong regulations and reliable testing methods. A gas chromatography-mass spectrometry (GC-MS) method was developed and validated in accordance with ICH Q2(R2) guidelines. The method was developed for pharmaceutical syrup matrices and validated using multiple commercially available products, supporting its applicability for routine regulatory surveillance. It exhibited excellent linearity, with r² of 0.9991 for EG and 0.9963 for DEG. The detection (LOD) and quantification (LOQ) limits were 0.02% v/v and 0.06% v/v, respectively, below the regulatory limit of 0.10% set by the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia. Accuracy ranged from 94.2% to 108.4%, and the %RSD for intermediate precision was 1.4% for EG and 2.5% for DEG, confirming the method's reproducibility. When the validated method was applied to 51 pharmaceutical syrup samples available in the Malaysian market as part of post-market surveillance, 13 samples were detected to have EG. Of these, 11 samples had EG concentrations between the LOD and the LOQ, while two samples (PS-13 and PS-26) had measurable levels at 0.09% v/v. DEG was not detected in any sample. Therefore, this study emphasises the importance of regulatory surveillance, supported by validated analytical testing, to ensure the quality and safety of pharmaceutical syrups. Strengthening local surveillance mechanisms will further strengthen NPRA's regulatory capacity and safeguard public health.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"27 1","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13670457/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149179250","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Elucidating metabolic dysfunction induced by titanium dioxide in intestinal epithelial cells using an integrative approach of metabolomics and transcriptomics.","authors":"Xinchen Wang, Shilong Jiang, Zhengyu Gu","doi":"10.1186/s40360-026-01185-1","DOIUrl":"10.1186/s40360-026-01185-1","url":null,"abstract":"<p><strong>Background: </strong>Titanium dioxide (TiO₂) is widely present in a variety of food and personal care products, leading to frequent human exposure primarily via oral ingestion. Although the oral bioavailability of TiO₂ nanoparticles is generally considered low, the gastrointestinal tract represents the primary site of exposure and may undergo local molecular and metabolic disturbances following repeated contact.</p><p><strong>Methods: </strong>In this study, we investigated the impact of TiO₂ exposure on gene expression and cellular metabolism in intestinal epithelial cells using integrated transcriptomic and metabolomic approaches.</p><p><strong>Results: </strong>Transcriptomic analysis identified differentially expressed genes associated with disruptions in cellular components, molecular functions, and biological processes, collectively pointing to mechanisms underlying TiO₂-induced cytotoxicity. Metabolomic profiling further revealed that TiO₂ exposure perturbed key metabolic pathways, as evidenced by significant alterations in critical metabolites-including acetylcholine, glutathione, cytosine, deoxyadenosine, and pantothenic acid-indicative of broad metabolic dysfunction. Notably, integrative correlation analysis demonstrated that TiO₂ disrupts lipid metabolism, amino acid metabolism, nucleotide metabolism, energy metabolism, and redox homeostasis.</p><p><strong>Conclusions: </strong>In conclusion, our findings elucidate the metabolic mechanisms driving TiO₂-induced intestinal toxicity. Moreover, this work underscores the power of integrated transcriptomic-metabolomic analysis as a robust strategy for mechanistic toxicological evaluation and risk assessment of nanomaterial exposure.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2026-07-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148547629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}