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Questions and Answers August 2022 2022年8月

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2022-01-01 DOI: 10.14227/dt290322p174

Margareth R. C. Marques, M. Liddell

引用次数: 0

Comparison of In Vitro Phosphate-Binding Studies of Sevelamer Carbonate Using Incubator Shaker and USP Dissolution Apparatus II 用培养摇床和USP溶出仪研究碳酸七维拉默体外与磷酸盐结合的比较

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2022-01-01 DOI: 10.14227/dt290222p78

Natasha Stella Tibon, R. Allada, Sudhakar Vakkala, Prakash Muthudoss, S. Shahnawaz

引用次数: 0

Overview of the Activities of the USP Expert Panel on New Advancements in Product Performance Testing USP专家小组关于产品性能测试新进展的活动概述

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2022-01-01 DOI: 10.14227/dt290322p122

R. Skwierczynski, V. Gray, James De Muth

引用次数: 2

Dissolution Best Practices and International Harmonization - AAPS Workshop Report 溶解最佳做法和国际协调- AAPS研讨会报告

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2022-01-01 DOI: 10.14227/dt290422p230

V. Gray, Andreas M. Abend, M. Alasandro, P. Armenante, Tessa M. Carducci, B. Crist, Fashen Li, Xujin Lu, Margareth R. C. Marques, Kevin Moore, B. Nickerson

引用次数: 0

Comparative Analysis of Commercially Available Acetaminophen Tablets in Saudi Arabia 沙特阿拉伯市售对乙酰氨基酚片的比较分析

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2022-01-01 DOI: 10.14227/dt290322pgc2

A. Alwadi, Ghosoun M. Arafeh, Mohammad S. Almehlesi, H. Maswadeh, I. M. Salman, O. Ameer

{"title":"Comparative Analysis of Commercially Available Acetaminophen Tablets in Saudi Arabia","authors":"A. Alwadi, Ghosoun M. Arafeh, Mohammad S. Almehlesi, H. Maswadeh, I. M. Salman, O. Ameer","doi":"10.14227/dt290322pgc2","DOIUrl":"https://doi.org/10.14227/dt290322pgc2","url":null,"abstract":"Acetaminophen is a widely used oral analgesic and antipyretic medication; however, quality control parameters may differ across various brands. The aim of the present study was to evaluate and compare critical quality attributes, including in-vitro dissolution characteristics, of five acetaminophen tablet brands (labeled A–E) from the Saudi market and determine their pharmaceutical equivalence. All brands were tested for conformity with the United States Pharmacopoeia (USP) standards, through evaluation of weight variation, hardness, friability, disintegration, and dissolution. Dissolution profiles were compared using model-dependent and independent approaches relative to the innovator brand A (Panadol). All tested brands passed the weight variation and friability tests with deviations of less than 5% from the average weight and less than 1% weight loss, respectively, with the exception of brand C showing relatively higher friability (1.13%). All brands displayed variable disintegration times; however, all were compliant with USP specifications. All studied tablets released less than 80% of the drug within 30 minutes; however, brands B and C had lower drug release rates, area under the curve (AUC), and dissolution efficiency (DE) compared with the innovator. Brand E, on the other hand, had a higher drug release rate, AUC, DE, and mean dissolution time (MDT), and thus was pharmaceutically inequivalent to the innovator. All tested brands exhibited a non swellable matrix diffusion-controlled dissolution as assessed by the Korsmeyer-Peppas model of drug-release kinetics. In conclusion, all acetaminophen brands were able to pass USP specifications to justify interchangeability. Minor variations in in-vitro dissolution characteristics could reflect inherent manufacturing compounding differences.","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"5 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66814083","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}

引用次数: 0

Therapeutic Equivalence Evaluated Through In Vitro Studies of Multi-Source Drugs: A Moxifloxacin Case Study in Lima, Peru 通过多源药物体外研究评估治疗等效性:秘鲁利马莫西沙星案例研究

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2022-01-01 DOI: 10.14227/dt290122pgc1

V. Chumpitaz-Cerrate, L. Moreno-Exebio, E. Ruiz-Ramírez, César Franco-Quino, M. Flores-Rodríguez, L. Chávez-Rimache

{"title":"Therapeutic Equivalence Evaluated Through In Vitro Studies of Multi-Source Drugs: A Moxifloxacin Case Study in Lima, Peru","authors":"V. Chumpitaz-Cerrate, L. Moreno-Exebio, E. Ruiz-Ramírez, César Franco-Quino, M. Flores-Rodríguez, L. Chávez-Rimache","doi":"10.14227/dt290122pgc1","DOIUrl":"https://doi.org/10.14227/dt290122pgc1","url":null,"abstract":"This study aimed to determine the therapeutic equivalence of four multi-source drugs containing moxifloxacin (400 mg tablets) in vitro studies to establish their interchangeability with the reference product. Four multi-source products were acquired in pharmaceutical establishments in metropolitan Lima, each from different manufacturing sites (two products from India, one from Brazil, and one from Peru). The reference product was Avelox (400 mg) coated tablets (Bayer AG, Germany). Quality control and dissolution profile tests were performed. For dissolution tests, a validated ultraviolet-visible spectrophotometry method was used to determine the percentage of drug released. The similarity factor (f2) analysis was used to establish therapeutic equivalence of the drug release curves. The dissolution rates were considered equivalent if the values of f2 were between 50 and 100. Concerning the quality control tests, the moxifloxacin content was 98.5% in the reference product and 97.1–100.0% in the multisource products. Three out of four multi-source products passed the f2 test at pH 1.2. Therefore, there is at least one moxifloxacin multi-source product circulating in Peru, manufactured in India, that does not is not interchangeable with the reference product.","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"1 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66813240","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}

引用次数: 0

Book Review: “Analytical Testing for the Pharmaceutical GMP Laboratory” 书评:《药品GMP实验室分析检测》

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2022-01-01 DOI: 10.14227/dt290422p228

G. P. Martin

引用次数: 0

Comparative Evaluation of Amlodipine Besylate Generic Tablet and Capsule Brands in Riyadh, Saudi Arabia 沙特利雅得市苯磺酸氨氯地平仿制片与胶囊品牌比较评价

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2022-01-01 DOI: 10.14227/dt290422pgc2

Doaa R. Adam, Nuran Al Rayes, Raghad Fatoum, Ghosoun M. Arafeh, T. Adam, A. Kola-Mustapha

{"title":"Comparative Evaluation of Amlodipine Besylate Generic Tablet and Capsule Brands in Riyadh, Saudi Arabia","authors":"Doaa R. Adam, Nuran Al Rayes, Raghad Fatoum, Ghosoun M. Arafeh, T. Adam, A. Kola-Mustapha","doi":"10.14227/dt290422pgc2","DOIUrl":"https://doi.org/10.14227/dt290422pgc2","url":null,"abstract":"The objective of this study was to evaluate the physicochemical quality control parameters and pharmaceutical equivalence of amlodipine besylate generic tablets and capsules with the innovator brands (Norvasc and Amlor, respectively) available in Riyadh, Saudi Arabia. Five brands of amlodipine besylate tablets and capsules (5 mg) were compared via quality control tests according to the United States Pharmacopoeia (i.e., hardness, thickness, diameter, weight variation, uniformity of dosage content, friability, disintegration, dissolution by ultraviolet spectrophotometry, and Fourier-transform infrared spectroscopy (FTIR)). All selected brands were found to comply with USP-NF specifications concerning weight variation, hardness, friability, disintegration time, FTIR, and drug content analysis. The dissolution profiles for all products satisfied the USP-NF specifications. Regarding, model-dependent data, all the tested brands followed the Higuchi model of release. Using the model-independent approach (i.e., similarity factor analysis), all products were considered similar except for one generic product (ABC-3). All brands had no significant difference in mean dissolution efficiency compared to the innovator, except ABC-3.","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"1 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66813880","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}

引用次数: 0

In Vitro Bioequivalence of Acetylsalicylic Acid and Implications in Public Health 乙酰水杨酸的体外生物等效性及其对公共卫生的影响

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2022-01-01 DOI: 10.14227/dt290322pgc1

María R. Bendezú, Jorge A. García, H. Chávez, A. M. Muñoz, J. Jáuregui, Miguel Mucha, R. Losno, María Saravia, Angel T. Alvarado

{"title":"In Vitro Bioequivalence of Acetylsalicylic Acid and Implications in Public Health","authors":"María R. Bendezú, Jorge A. García, H. Chávez, A. M. Muñoz, J. Jáuregui, Miguel Mucha, R. Losno, María Saravia, Angel T. Alvarado","doi":"10.14227/dt290322pgc1","DOIUrl":"https://doi.org/10.14227/dt290322pgc1","url":null,"abstract":"Acetylsalicylic acid is one of the most prescribed medications in the world. It is used for prevention of acute myocardial infarction, colorectal cancer, antipyretic, and as an analgesic. This study aimed to investigate the in vitro bioequivalence of three formulations of acetylsalicylic acid, simulating physiological conditions of the dissolution medium, and analyzing its possible implication for public health. A spectrophotometric method for the quantification of acetylsalicylic acid at 265 nm was used. The dissolution test was performed using a USP apparatus 2 (paddle) with 900 mL of medium at 37 ± 0.5 °C and 75 rpm. At pH 4.5 and 6.8, the three formulations did not meet the criteria of very fast or fast dissolution (85% in ≤ 15 or 30 min, respectively). Generic A has a similarity factor ( f 2 ) of 50 at pH 4.5 and 80.7 at pH 6.8; generic C f 2 values were 31.2 at pH 4.5 and 72.4 at pH 6.8. Generic B did not meet the acceptance range of the similarity factor (50 − 100) at pH 4.5 and 6.8. For all products tested, the dissolution efficiency was greater than 79%, and the mean dissolution time was 5.5–15.9 min. Based on the in vitro dissolution results, Generic A is bioequivalent with the innovator, whereas generics B and C are not. However, the dissolution profiles of generics A and C are similar to the innovator at pH 6.8, which is the appropriate dissolution medium for this drug.","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"1 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66814023","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}

引用次数: 0

Highlights from the 2020 AAPS 360 Annual Meeting 2020 AAPS 360年会的亮点

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2021-01-01 DOI: 10.14227/DT280221P36

V. Gray, D. Diaz, J. Dressman, Y. Tsume, N. Fotaki

引用次数: 1