BMC Pharmacology & Toxicology最新文献

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Drugs and gut microbiome interactions-an emerging field of tailored medicine. 药物和肠道微生物组的相互作用是一个新兴的定制医学领域。
IF 2.9 3区 医学
BMC Pharmacology & Toxicology Pub Date : 2023-08-30 DOI: 10.1186/s40360-023-00684-9
Imran Khan
{"title":"Drugs and gut microbiome interactions-an emerging field of tailored medicine.","authors":"Imran Khan","doi":"10.1186/s40360-023-00684-9","DOIUrl":"10.1186/s40360-023-00684-9","url":null,"abstract":"<p><p>Gut dwelling microbes provide profound biochemical advantages to the host, including nutrient and drug absorption, metabolism, and excretion. It is an emerging understanding that drug-response bias (particularly for orally intake medicine) is related to variation in the microbial composition in the gut. This Editorial at BMC Pharmacology and Toxicology introduces our collection which is discussing the role of gut microbes in modulating drugs' efficacy and bioavailability.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10469409/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10139627","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}
引用次数: 1
Berberine-loaded albumin nanoparticles reverse aflatoxin B1-induced liver hyperplasia. 黄连素白蛋白纳米粒子逆转黄曲霉毒素B1诱导的肝增生。
IF 2.9 3区 医学
BMC Pharmacology & Toxicology Pub Date : 2023-08-10 DOI: 10.1186/s40360-023-00683-w
Sarah M Khedr, Doaa A Ghareeb, Shadia A Fathy, Germine M Hamdy
{"title":"Berberine-loaded albumin nanoparticles reverse aflatoxin B1-induced liver hyperplasia.","authors":"Sarah M Khedr, Doaa A Ghareeb, Shadia A Fathy, Germine M Hamdy","doi":"10.1186/s40360-023-00683-w","DOIUrl":"10.1186/s40360-023-00683-w","url":null,"abstract":"<p><p>Hepatocellular carcinoma (HCC) can be produced from aflatoxin B1 (AFB1) administration. Although berberine (BER) acts as an anticancer agent and can counteract the AFB1 effect, it has low bioavailability. Nanotechnology can overcome this problem. This research aimed to synthesize berberine nanoparticles (NPs) and then estimate their therapeutic effect compared to that of berberine against aflatoxin-induced hepatotoxicity. The desolvation method was used to prepare BER-NPs. Aflatoxicosis was induced by 5 consecutive intraperitoneal injections (IP) of 200 µg/kg/day AFB dissolved in dimethylsulfoxide (DMSO). After the induction period, two treatments were performed: the first with 100 mg/kg BER and the second with 10 mg/kg BER-NPs. Liver, kidney, and diabetic profiles were estimated by using standardized methods. Hepatic oxidative stress, inflammatory, cancer cell proliferation, and invasion markers were used by ELISA and qPCR techniques. The TEM image shows that both BSA NPs and BER-BSA NPs had spherical, regular, and uniform shapes. The BER encapsulation efficiency % was 78.5. The formed-BER-BSA NPs showed a loading capacity % of 7.71 and the synthesis yield % of 92.6. AFB1 increases pro-oxidant markers, decreases antioxidant systems, stimulates inflammatory enzymes, inhibits anti-inflammatory markers, decreases tumor suppressor enzymes, increases oncogenes, increases glycolytic activity, prevents cell death, and promotes cell growth. Most of the biochemical markers and hepatic architecture were normalized in the BER-BSA NP-treated group but not in the BER-treated group. Altogether, the obtained data proved that treatment with BER-NPs was more efficient than treatment with berberine against aflatoxicoses induced in rats.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10413506/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10331184","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}
引用次数: 0
Medication overdose data analysis: a review of medication error reports in the FDA adverse event reporting system (FAERS). 药物过量数据分析:美国食品药品监督管理局不良事件报告系统(FAERS)中药物错误报告的回顾。
IF 2.9 3区 医学
BMC Pharmacology & Toxicology Pub Date : 2023-08-04 DOI: 10.1186/s40360-023-00681-y
Jiaqi Ni, Xinru Tang, Li Chen
{"title":"Medication overdose data analysis: a review of medication error reports in the FDA adverse event reporting system (FAERS).","authors":"Jiaqi Ni, Xinru Tang, Li Chen","doi":"10.1186/s40360-023-00681-y","DOIUrl":"10.1186/s40360-023-00681-y","url":null,"abstract":"<p><strong>Background: </strong>drug overdose is a common type of medication error, which caused significant patient injuries and economic losses. To determine which drugs are reported most frequently in association with drug overdose, a comprehensive search was conducted in the FDA Adverse Event Reporting System (FAERS) database. The study also sought to determine the top 10 drugs reported with drug overdose.</p><p><strong>Methods: </strong>FAERS database was searched for drug overdose records submitted from the first quarter of 2017 to the fourth quarter of 2021. Descriptive analyses were conducted based on the total counts and percentages of reports associated with the drug. Subgroup analyses were performed on drugs of different pharmacological classifications.</p><p><strong>Results: </strong>A total of 170,424 drug overdose reports were retrieved. The results revealed that antipyretics and analgesics took the highest risk for overdose, with 63,143 (37.05%) cases reported. Among them, opioids were associated with the most drug overdose events. The top 10 drug classes relating to drug overdose in FAERS were opioid analgesic, anilide antipyretic analgesic, 5-HT reuptake inhibitors, bronchodilators, monoclonal antibodies and antibody-drug conjugates, benzodiazepines, antipsychotics, GABA derivatives, antimanic agents, and propionic acid derivatives.</p><p><strong>Conclusion: </strong>to reduce the occurrence of drug overdose events, some methods could be considered including applying a pre-prescription review system, drug safety education, developing warning lists, etc.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10403938/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9948649","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}
引用次数: 0
Retraction Note: Transdermal delivery of allopurinol-loaded nanostructured lipid carrier in the treatment of gout. 注:别嘌呤醇负载的纳米结构脂质载体经皮递送治疗痛风。
IF 2.9 3区 医学
BMC Pharmacology & Toxicology Pub Date : 2023-07-12 DOI: 10.1186/s40360-023-00680-z
Zakir Ali, Fakhar Ud Din, Fatima Zahid, Saba Sohail, Basalat Imran, Salman Khan, Maimoona Malik, Alam Zeb, Gul Majid Khan
{"title":"Retraction Note: Transdermal delivery of allopurinol-loaded nanostructured lipid carrier in the treatment of gout.","authors":"Zakir Ali,&nbsp;Fakhar Ud Din,&nbsp;Fatima Zahid,&nbsp;Saba Sohail,&nbsp;Basalat Imran,&nbsp;Salman Khan,&nbsp;Maimoona Malik,&nbsp;Alam Zeb,&nbsp;Gul Majid Khan","doi":"10.1186/s40360-023-00680-z","DOIUrl":"https://doi.org/10.1186/s40360-023-00680-z","url":null,"abstract":"","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10337063/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10173764","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}
引用次数: 0
Retraction Note: Anti-hyperalgesic properties of a flavanone derivative Poncirin in acute and chronic inflammatory pain models in mice. 注:黄酮衍生物ponciin在小鼠急性和慢性炎症性疼痛模型中的抗痛觉过敏特性。
IF 2.9 3区 医学
BMC Pharmacology & Toxicology Pub Date : 2023-06-30 DOI: 10.1186/s40360-023-00679-6
Ruqayya Afridi, Ashraf Ullah Khan, Sidra Khalid, Bushra Shal, Hina Rasheed, Muhammad Zia Ullah, Omer Shehzad, Yeong Shik Kim, Salman Khan
{"title":"Retraction Note: Anti-hyperalgesic properties of a flavanone derivative Poncirin in acute and chronic inflammatory pain models in mice.","authors":"Ruqayya Afridi,&nbsp;Ashraf Ullah Khan,&nbsp;Sidra Khalid,&nbsp;Bushra Shal,&nbsp;Hina Rasheed,&nbsp;Muhammad Zia Ullah,&nbsp;Omer Shehzad,&nbsp;Yeong Shik Kim,&nbsp;Salman Khan","doi":"10.1186/s40360-023-00679-6","DOIUrl":"https://doi.org/10.1186/s40360-023-00679-6","url":null,"abstract":"","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10311818/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10120726","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}
引用次数: 1
Efficacy and safety of proxalutamide (GT0918) in severe or critically ill patients with COVID-19: study protocol for a prospective, open-label, single-arm, single-center exploratory trial. proxalutamide (GT0918)治疗COVID-19重症或危重症患者的疗效和安全性:一项前瞻性、开放标签、单臂、单中心探索性试验的研究方案
IF 2.9 3区 医学
BMC Pharmacology & Toxicology Pub Date : 2023-06-15 DOI: 10.1186/s40360-023-00678-7
Dawei Yang, Minjie Ju, Hao Wang, Yichen Jia, Xiaodan Wang, Hao Fang, Jia Fan
{"title":"Efficacy and safety of proxalutamide (GT0918) in severe or critically ill patients with COVID-19: study protocol for a prospective, open-label, single-arm, single-center exploratory trial.","authors":"Dawei Yang, Minjie Ju, Hao Wang, Yichen Jia, Xiaodan Wang, Hao Fang, Jia Fan","doi":"10.1186/s40360-023-00678-7","DOIUrl":"10.1186/s40360-023-00678-7","url":null,"abstract":"<p><strong>Background: </strong>The rapid worldwide spread of COVID-19 has caused a global health challenge with high mortality of severe or critically ill patients with COVID-19. To date, there is no specific efficient therapeutics for severe or critically ill patients with COVID-19. It has been reported that androgen is related to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Proxalutamide as an androgen receptor antagonist has shown potential treatment effects on COVID-19 patients. Thus, this trial is designed to investigate the efficacy and safety of proxalutamide in severe or critically ill patients with COVID-19.</p><p><strong>Methods: </strong>This single-arm, open-label, single-center prospective exploratory trial is planned to recruit 64 severe or critically ill patients with COVID-19 in China. Recruitment started on 16 May 2022 and is foreseen to end on 16 May 2023. Patients will be followed-up until 60 days or death, whichever comes first. The primary outcome is the 30-day all-cause mortality. Secondary endpoints included 60-day all-cause mortality, rate of clinical deterioration within 30 days after administration, time to sustain clinical recovery (determined using an 8-point ordinal scale), mean change in the Acute Physiology and Chronic Health Evaluation II scores, change in oxygenation index, changes in chest CT scan, percentage of patients confirmed negative for SARS-CoV-2 by nasopharyngeal swab, change in Ct values of SARS-CoV-2 and safety. Visits will be performed on days 1 (baseline), 15 or 30, 22, and 60.</p><p><strong>Discussion: </strong>The trial is the first to investigate the efficacy and safety of proxalutamide in severe or critically ill patients with COVID-19. The findings of this study might lead to the development of better treatment for COVID-19 and provide convincing evidence regarding the efficacy and safety of proxalutamide.</p><p><strong>Trial registration: </strong>This study was registered on 18 June 2022 at the Chinese Clinical Trial Registry (ChiCTR2200061250).</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10268455/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9654339","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}
引用次数: 0
Longitudinal follow-up of zearalenone and deoxynivalenol mycotoxins in breast milk in the first five months of life. 出生后5个月母乳中玉米赤霉烯酮和脱氧雪腐菌醇真菌毒素的纵向随访。
IF 2.9 3区 医学
BMC Pharmacology & Toxicology Pub Date : 2023-05-30 DOI: 10.1186/s40360-023-00677-8
Bülent Güneş, Suzan Yalçın, Sıddika Songül Yalçın
{"title":"Longitudinal follow-up of zearalenone and deoxynivalenol mycotoxins in breast milk in the first five months of life.","authors":"Bülent Güneş,&nbsp;Suzan Yalçın,&nbsp;Sıddika Songül Yalçın","doi":"10.1186/s40360-023-00677-8","DOIUrl":"https://doi.org/10.1186/s40360-023-00677-8","url":null,"abstract":"<p><strong>Objectives: </strong>There is a possibility for exposed lactating mammalians to transfer some contaminants to their milk. This study aimed to determine the levels and changes of Zearalenone (ZEN), Deoxynivalenol (DON) mycotoxins for the first five months in human milk.</p><p><strong>Methods: </strong>Voluntary lactating mothers having infants with gestational length ≥ 37 weeks were enrolled between August 2017 and June 2018 in Şanlıurfa. Mothers and infants with chronic health problems were not included in the study. Human milk samples were taken at three different times; on enrollment (Day 6-10, visit 1), between 4 and 6 weeks postpartum (visit 2), and between 14 and 19 weeks postpartum (visit 3). Mycotoxin levels in human milk were measured utilizing Helica brand commercial kit.</p><p><strong>Results: </strong>Nineteen voluntary mothers and their breastfed infants with three human milk samples completed the study. The mean ages of mothers and infant (± SD) were 27.4 (± 5.4) years and 7.6 (± 0.9) days on enrollment. Median levels of ZEN and DON in human milk samples were 0.39 and 16.7 ng/mL, respectively. None of the cases had a ZEN daily intake higher than 250 ng/kg bw per day. However, three fourth of the cases had DON intake higher than > 1000 ng/kg bw per day. When adjusted for infant weight for age and sex, both ZEN levels and daily intake were decreased progressively from visit 1 to visit 3 (p < 0.001). DON levels and daily intake at visit 2 were found to be significantly lower in samples of visit 3 than that taken in visit 2 (p = 0.004 and p < 0.001, respectively).</p><p><strong>Conclusions: </strong>Breast milk monitoring study revealed that ZEN and DON mycotoxins were present in the mother-infant environment. Contamination levels changed during the lactation period.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10228084/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9631516","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}
引用次数: 0
A phase I study comparing the biosimilarity of the pharmacokinetics and safety of recombinant humanized anti-vascular endothelial growth factor monoclonal antibody injection with Avastin® in healthy Chinese male subjects. 在中国健康男性受试者中比较重组人源抗血管内皮生长因子单克隆抗体注射液与阿瓦斯汀®的药代动力学生物相似性和安全性的I期研究。
IF 2.9 3区 医学
BMC Pharmacology & Toxicology Pub Date : 2023-05-27 DOI: 10.1186/s40360-023-00673-y
Hongtao Li, Xiangdi Zhao, Jing Xie, Xingyu Zhu, Yue Su, Cuixia He, Jiaxiang Ding, Minhui Zhu, Yuanyuan Xu, Ying Wang, Rongfang Shan, Bingyan Liu, Yuzhou Ding, Yuanyuan Liu, Huan Zhou, Yunqiu Xie
{"title":"A phase I study comparing the biosimilarity of the pharmacokinetics and safety of recombinant humanized anti-vascular endothelial growth factor monoclonal antibody injection with Avastin<sup>®</sup> in healthy Chinese male subjects.","authors":"Hongtao Li,&nbsp;Xiangdi Zhao,&nbsp;Jing Xie,&nbsp;Xingyu Zhu,&nbsp;Yue Su,&nbsp;Cuixia He,&nbsp;Jiaxiang Ding,&nbsp;Minhui Zhu,&nbsp;Yuanyuan Xu,&nbsp;Ying Wang,&nbsp;Rongfang Shan,&nbsp;Bingyan Liu,&nbsp;Yuzhou Ding,&nbsp;Yuanyuan Liu,&nbsp;Huan Zhou,&nbsp;Yunqiu Xie","doi":"10.1186/s40360-023-00673-y","DOIUrl":"https://doi.org/10.1186/s40360-023-00673-y","url":null,"abstract":"<p><strong>Background: </strong>The biosimilar landscape for malignancies continues to grow, with several biosimilars for reference product bevacizumab currently available. Bevacizumab has been shown to be well tolerated; however, the safety of recombinant humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody injection remains unclear. This study aimed to compare the pharmacokinetics (PK), safety, and immunogenicity of recombinant humanized anti-VEGF monoclonal antibody injection to that of Avastin® in healthy Chinese male volunteers.</p><p><strong>Methods: </strong>A randomized, double-blind, single-dose, and parallel-group study was performed on 88 healthy men who randomly (1:1) received either the test drug as an intravenous infusion of 3 mg/kg or Avastin®. The primary PK parameter was area under the serum concentration-time curve (AUC) from time zero to last quantifiable concentration (AUC<sub>0-t</sub>). Secondary endpoints included maximum observed serum concentration (C<sub>max</sub>), AUC from 0 extrapolated to infinity (AUC<sub>inf</sub>), safety, and immunogenicity. Serum bevacizumab concentrations were measured using a validated enzyme-linked immunosorbent assay (ELISA).</p><p><strong>Results: </strong>The baseline characteristics were similar among the two groups. The 90% confidence interval (CI) for the geometric mean ratio of AUC<sub>0-t</sub>, C<sub>max</sub> and AUC<sub>inf</sub> between the test group and reference group were 91.71%-103.18%, 95.72%-107.49% and 91.03%-103.43%, respectively. These values were within the predefined bioequivalence margin of 80.00%-125.00%, demonstrating the biosimilarity of the test drug and Avastin®. Eighty-one treatment-emergent adverse events were reported, with a comparable incidence among the test group (90.91%) and the reference group (93.18%). No serious adverse events were reported. The incidence of ADA antibodies in the two groups was low and similar.</p><p><strong>Conclusion: </strong>In healthy Chinese men, PK similarity of recombinant humanized anti-VEGF monoclonal antibody injection to Avastin® was confirmed, with comparable safety and immunogenicity. Subsequent studies should investigate recombinant humanized anti-VEGF monoclonal antibody injection in patients setting.</p><p><strong>Trial registration: </strong>Registered 08/10/2019, CTR20191923.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10223897/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9684613","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}
引用次数: 0
In vitro comparative quality evaluation of different brands of carbamazepine tablets commercially available in Dessie town, Northeast Ethiopia. 埃塞俄比亚东北部德西镇市售不同品牌卡马西平片的体外质量比较评价。
IF 2.9 3区 医学
BMC Pharmacology & Toxicology Pub Date : 2023-05-25 DOI: 10.1186/s40360-023-00670-1
Biset Asrade, Ejigu Tessema, Abebe Tarekegn
{"title":"In vitro comparative quality evaluation of different brands of carbamazepine tablets commercially available in Dessie town, Northeast Ethiopia.","authors":"Biset Asrade,&nbsp;Ejigu Tessema,&nbsp;Abebe Tarekegn","doi":"10.1186/s40360-023-00670-1","DOIUrl":"https://doi.org/10.1186/s40360-023-00670-1","url":null,"abstract":"<p><strong>Background: </strong>Good-quality drugs that fulfill the regulatory parameters and are produced per the current good manufacturing practice (cGMP) standards are very critical for the best therapeutic outcomes. However, the variety of branded drugs circulation in the market often put clinicians and pharmacists in a difficult situation of choice due to the possibility of interchangeability among brands, so we should ascertain the quality of the various brands of drugs, available in the drug market. The purpose of the study was to evaluate the quality and physicochemical equivalence of six brands of carbamazepine tablets that are commercially available in Dessie town, Northeast Ethiopia.</p><p><strong>Methods: </strong>An experimental study design was used. Six different brands of carbamazepine tablets were purchased from community pharmacies in Dessie town, Northeast Ethiopia, which were selected using simple random sampling methods. Identification, weight variation, friability, hardness, disintegration, dissolution test, and assay for the content of active ingredients were evaluated according to the procedures described in the United States Pharmacopeia (USP) and British Pharmacopeia (BP), and the results were compared with USP and BP standards. The difference (f1) and similarity (f2) factors were calculated to assess in vitro bioequivalence requirements.</p><p><strong>Results: </strong>The identification test results revealed that all samples contained the stated active pharmaceutical ingredients and all brands of carbamazepine tablets complied with the official specification for weight variation, friability, and hardness tests. The percentage concentration of carbamazepine was found in the range of 97.85 to 102.09, which met the USP specification of 92% to 108% of the stated amount. Similarly, all samples fulfilled disintegration time (i.e., ≤ 30 min) except brand CA1 (34.183 min) and dissolution tolerance limits (i.e., Q ≥ 75% at 60 min), which was found in the range of 91.673% -97.124%. The difference factor (f1) values were < 15 and the similarity factor (f2) values were > 50 for all the tested brands of carbamazepine tablets.</p><p><strong>Conclusion: </strong>The present study revealed that all brands of carbamazepine 200 mg tablets met the quality control parameters as per pharmacopoeial specifications except the disintegration test of brand CA1, and could be used each brand interchangeably to achieve the desired therapeutic effect.</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10210453/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9986652","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}
引用次数: 0
Prescription characteristics associated with drug overdose risk among adults prescribed benzodiazepines: a cohort study. 开具苯并二氮杂卓处方的成年人中与药物过量风险相关的处方特征:一项队列研究。
IF 2.9 3区 医学
BMC Pharmacology & Toxicology Pub Date : 2023-05-19 DOI: 10.1186/s40360-023-00674-x
Donovan T Maust, Amy S B Bohnert, Julie Strominger, Jason E Goldstick
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