Comparative study of anti-inflammatory activity of some branded generic and generic non-steroidal anti-inflammatory drugs

Vedavathi Thavva, V. Jayanti, Joseph Weinberg
{"title":"Comparative study of anti-inflammatory activity of some branded generic and generic non-steroidal anti-inflammatory drugs","authors":"Vedavathi Thavva, V. Jayanti, Joseph Weinberg","doi":"10.3109/10601333.2010.551403","DOIUrl":null,"url":null,"abstract":"Generic drugs play a very important role in health care. A study was undertaken to ascertain the equality or inequality between generics and branded generics. NSAIDs are the most commonly used drugs. So these drugs were chosen for the study. Selected branded generic and generic products of ibuprofen, nimesulide, and diclofenac sodium were tested by oral administration of their suspensions to different groups of rats. Freshly prepared drug suspensions equivalent to doses of 40, 10, and 5 mg/kg of ibuprofen, nimesulide, and diclofenac sodium, respectively, were administered orally to the rats and anti-inflammatory activity was measured by the carrageenan-induced rat paw edema model employing Zeitlin’s apparatus to measure the paw thickness. Statistical analysis by t-test, of the activity at the point of maximum difference indicated that with respect to anti-inflammatory activity generic ibuprofen and generic diclofenac sodium are better than branded generic ibuprofen and branded generic diclofenac sodium, respectively, and generic nimesulide is similar to branded generic nimesulide. All the products studied meet the Pharmacopoeial requirements. Hence it may be concluded that branded generic and generic NSAIDs, tested in this study, are of the same efficacy and inter-changeability among branded generics, and switching between branded generics and generics would not result in any difference in efficacy.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"8 1","pages":"27 - 33"},"PeriodicalIF":0.0000,"publicationDate":"2011-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Research and Regulatory Affairs","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3109/10601333.2010.551403","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

Abstract

Generic drugs play a very important role in health care. A study was undertaken to ascertain the equality or inequality between generics and branded generics. NSAIDs are the most commonly used drugs. So these drugs were chosen for the study. Selected branded generic and generic products of ibuprofen, nimesulide, and diclofenac sodium were tested by oral administration of their suspensions to different groups of rats. Freshly prepared drug suspensions equivalent to doses of 40, 10, and 5 mg/kg of ibuprofen, nimesulide, and diclofenac sodium, respectively, were administered orally to the rats and anti-inflammatory activity was measured by the carrageenan-induced rat paw edema model employing Zeitlin’s apparatus to measure the paw thickness. Statistical analysis by t-test, of the activity at the point of maximum difference indicated that with respect to anti-inflammatory activity generic ibuprofen and generic diclofenac sodium are better than branded generic ibuprofen and branded generic diclofenac sodium, respectively, and generic nimesulide is similar to branded generic nimesulide. All the products studied meet the Pharmacopoeial requirements. Hence it may be concluded that branded generic and generic NSAIDs, tested in this study, are of the same efficacy and inter-changeability among branded generics, and switching between branded generics and generics would not result in any difference in efficacy.
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
一些品牌仿制药与非甾体类仿制药抗炎活性的比较研究
仿制药在医疗保健中发挥着非常重要的作用。进行了一项研究,以确定仿制药和品牌仿制药之间的平等或不平等。非甾体抗炎药是最常用的药物。所以我们选择了这些药物进行研究。选择布洛芬、尼美舒利和双氯芬酸钠的品牌仿制药和仿制药,通过对不同组大鼠口服其混悬液进行试验。分别口服40、10、5 mg/kg剂量的布洛芬、尼美舒利、双氯芬酸钠等新鲜制备的药物混悬液,采用角拉胶诱导大鼠足部水肿模型,采用Zeitlin仪测量足部厚度,测定抗炎活性。通过t检验对最大差异点的活性进行统计分析,表明仿制布洛芬和仿制双氯芬酸钠的抗炎活性分别优于品牌仿制布洛芬和仿制双氯芬酸钠,仿制尼美舒利与品牌仿制尼美舒利相似。所研究的产品均符合药典要求。由此可见,本研究检测的非甾体抗炎药品牌仿制药与非甾体抗炎药在品牌仿制药之间具有相同的疗效和互换性,品牌仿制药与仿制药之间的切换不会导致疗效的差异。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
自引率
0.00%
发文量
0
期刊最新文献
Changes to protocol in the regulation of adverse drug reactions – historical and current European view Policy and regulations in light of the human body as a ‘superorganism’ containing multiple, intertwined symbiotic relationships Community pharmacists’ knowledge and perceptions on risk management plans in the Southern Region of Portugal Increasing the odds of effective drug development: Elevating regulatory affairs professionals to strategic partners Current regulatory challenges and approaches in the registration of herbal drugs in Europe
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1