布洛芬法莫替丁联合定剂量速释片的处方及质量设计评价

M. Alam, Shahidul Islam, K. Sikdar, Asm Monjur Al Hossain
{"title":"布洛芬法莫替丁联合定剂量速释片的处方及质量设计评价","authors":"M. Alam, Shahidul Islam, K. Sikdar, Asm Monjur Al Hossain","doi":"10.3329/BPJ.V24I2.54712","DOIUrl":null,"url":null,"abstract":"Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed by the physicians for the management of pain due to their anti-inflammatory and analgesic properties. Long term use of NSAIDs causes gastrointestinal (GI) toxicity and the common GI disorders are indigestion, ulcers or bleeding. Therefore, the production of local oral tablets containing NSAIDs and gastro-protectant is inevitable. In this experiment, combination of ibuprofen 600 mg and famotidine 20 mg tablets were prepared by direct compression technique, which is unique in Bangladesh. To pursue the study Design of Experiments (DoE) approach was implemented to create fifteen trial formulations where Polyvinylpyrrolidone (PVPK30) 1%-3%, Microcrystalline Cellulose (Avicel PH-102) 1%-7% and Starch-1500 1%-13% were considered as independent variables and the responses were depicted in friability and disintegration time which were found 0.21–0.45% and 1.8–20.5 minutes respectively. Out of fifteen formulation trials (F-1 to F-15), seven formulations (F-3, F-6, F-8, F-9, F-10, F-13 and F-14) had met the acceptable criteria and one formulation (F-9) with independent variables PVP-K30 2.00%, Avicel PH-102 4.75% and Starch-1500 6.5% was selected because of its better disintegration, dissolution and friability profile. Data obtained from in-vitro dissolution tests were fitted to different kinetic models such as zero order, first order, Higuchi, Hixson-Crowell and Korsmeyer-Peppas models. Also, a compatibility study was conducted using Fourier Transform Infrared Spectroscopy (FTIR), Thermogravimetric Analysis (TGA) and X-Ray Diffraction (XRD). Furthermore, Scanning Electron Microscopy (SEM) was performed to analyze surface morphology. Finally, the selected formulation was compared to FDA regulated QC parameters and proved its superiority over conventional market products. \nBangladesh Pharmaceutical Journal 24(2): 133-148, 2021","PeriodicalId":8695,"journal":{"name":"Bangladesh Pharmaceutical Journal","volume":"450 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2021-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Formulation and Evaluation of Fixed-Dose Combination Immediate Release Tablets of Ibuprofen and Famotidine through Quality by Design Approach\",\"authors\":\"M. Alam, Shahidul Islam, K. Sikdar, Asm Monjur Al Hossain\",\"doi\":\"10.3329/BPJ.V24I2.54712\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed by the physicians for the management of pain due to their anti-inflammatory and analgesic properties. Long term use of NSAIDs causes gastrointestinal (GI) toxicity and the common GI disorders are indigestion, ulcers or bleeding. Therefore, the production of local oral tablets containing NSAIDs and gastro-protectant is inevitable. In this experiment, combination of ibuprofen 600 mg and famotidine 20 mg tablets were prepared by direct compression technique, which is unique in Bangladesh. To pursue the study Design of Experiments (DoE) approach was implemented to create fifteen trial formulations where Polyvinylpyrrolidone (PVPK30) 1%-3%, Microcrystalline Cellulose (Avicel PH-102) 1%-7% and Starch-1500 1%-13% were considered as independent variables and the responses were depicted in friability and disintegration time which were found 0.21–0.45% and 1.8–20.5 minutes respectively. Out of fifteen formulation trials (F-1 to F-15), seven formulations (F-3, F-6, F-8, F-9, F-10, F-13 and F-14) had met the acceptable criteria and one formulation (F-9) with independent variables PVP-K30 2.00%, Avicel PH-102 4.75% and Starch-1500 6.5% was selected because of its better disintegration, dissolution and friability profile. Data obtained from in-vitro dissolution tests were fitted to different kinetic models such as zero order, first order, Higuchi, Hixson-Crowell and Korsmeyer-Peppas models. Also, a compatibility study was conducted using Fourier Transform Infrared Spectroscopy (FTIR), Thermogravimetric Analysis (TGA) and X-Ray Diffraction (XRD). Furthermore, Scanning Electron Microscopy (SEM) was performed to analyze surface morphology. Finally, the selected formulation was compared to FDA regulated QC parameters and proved its superiority over conventional market products. \\nBangladesh Pharmaceutical Journal 24(2): 133-148, 2021\",\"PeriodicalId\":8695,\"journal\":{\"name\":\"Bangladesh Pharmaceutical Journal\",\"volume\":\"450 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2021-07-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Bangladesh Pharmaceutical Journal\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3329/BPJ.V24I2.54712\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Bangladesh Pharmaceutical Journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3329/BPJ.V24I2.54712","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

非甾体抗炎药(NSAIDs)由于其抗炎和镇痛的特性,经常被医生开处方用于治疗疼痛。长期使用非甾体抗炎药会引起胃肠道(GI)毒性,常见的胃肠道疾病是消化不良、溃疡或出血。因此,生产含有非甾体抗炎药和胃保护剂的局部口服片剂是不可避免的。本实验采用孟加拉国独有的直接加压法制备布洛芬600 mg与法莫替丁20 mg片剂。以聚乙烯吡啶酮(PVPK30) 1% ~ 3%、微晶纤维素(Avicel PH-102) 1% ~ 7%、淀粉-1500 1% ~ 13%为自变量,采用实验设计(DoE)的方法创建了15个试验配方,以脆性和崩解时间分别为0.21 ~ 0.45%和1.8 ~ 20.5 min来描述反应。在15个配方试验(F-1 ~ F-15)中,有7个配方(F-3、F-6、F-8、F-9、F-10、F-13、F-14)符合可接受标准,其中1个配方(F-9)因其崩解、溶出和易碎性较好,自变量为PVP-K30 2.00%, Avicel PH-102 4.75%, Starch-1500 6.5%。体外溶出试验数据拟合为零阶、一阶、Higuchi、Hixson-Crowell和Korsmeyer-Peppas动力学模型。并用傅里叶变换红外光谱(FTIR)、热重分析(TGA)和x射线衍射(XRD)对其相容性进行了研究。此外,用扫描电子显微镜(SEM)分析了表面形貌。最后,将所选配方与FDA规定的QC参数进行比较,证明其优于市场常规产品。孟加拉药学杂志24(2):133-148,2021
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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
Formulation and Evaluation of Fixed-Dose Combination Immediate Release Tablets of Ibuprofen and Famotidine through Quality by Design Approach
Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed by the physicians for the management of pain due to their anti-inflammatory and analgesic properties. Long term use of NSAIDs causes gastrointestinal (GI) toxicity and the common GI disorders are indigestion, ulcers or bleeding. Therefore, the production of local oral tablets containing NSAIDs and gastro-protectant is inevitable. In this experiment, combination of ibuprofen 600 mg and famotidine 20 mg tablets were prepared by direct compression technique, which is unique in Bangladesh. To pursue the study Design of Experiments (DoE) approach was implemented to create fifteen trial formulations where Polyvinylpyrrolidone (PVPK30) 1%-3%, Microcrystalline Cellulose (Avicel PH-102) 1%-7% and Starch-1500 1%-13% were considered as independent variables and the responses were depicted in friability and disintegration time which were found 0.21–0.45% and 1.8–20.5 minutes respectively. Out of fifteen formulation trials (F-1 to F-15), seven formulations (F-3, F-6, F-8, F-9, F-10, F-13 and F-14) had met the acceptable criteria and one formulation (F-9) with independent variables PVP-K30 2.00%, Avicel PH-102 4.75% and Starch-1500 6.5% was selected because of its better disintegration, dissolution and friability profile. Data obtained from in-vitro dissolution tests were fitted to different kinetic models such as zero order, first order, Higuchi, Hixson-Crowell and Korsmeyer-Peppas models. Also, a compatibility study was conducted using Fourier Transform Infrared Spectroscopy (FTIR), Thermogravimetric Analysis (TGA) and X-Ray Diffraction (XRD). Furthermore, Scanning Electron Microscopy (SEM) was performed to analyze surface morphology. Finally, the selected formulation was compared to FDA regulated QC parameters and proved its superiority over conventional market products. Bangladesh Pharmaceutical Journal 24(2): 133-148, 2021
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
期刊最新文献
Community-based Descriptive Cross-sectional Study on Prevalence, Clinical Manifestation, Beliefs and Management Approach of Gastroesophageal Reflux Disease (GERD) Among Young Bangladeshi Population Sedentary Lifestyle and Prospective Health Risks: A Pilot Study Among Bangladeshi Corporate Professionals Characterization of Lactic Acid Bacteria (LAB) Isolated from Homemade Fermented Kimchi in Bangladesh Clinical Evidence of Multi-drug Resistant, Extensively Drug Resistant and Pan-drug Resistant Acinetobacter sp. in Bangladesh Design and Evaluation of Hair Growth - Hair Fall Oil Formulation from Botanicals
×
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