{"title":"Summary Report on Workshop on In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) Methods","authors":"K. Thakker","doi":"10.14227/dt280421p450","DOIUrl":"https://doi.org/10.14227/dt280421p450","url":null,"abstract":"","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"1 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66813332","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}
{"title":"A Data Set to Verify Volume and Sample Removal Correction Calculations for Dissolution Testing","authors":"Alger D. Salt","doi":"10.14227/DT280221P16","DOIUrl":"https://doi.org/10.14227/DT280221P16","url":null,"abstract":"Software in the form of a spreadsheet, computer program, or web-based application is typically used to perform the appropriate mathematical corrections to dissolution profile data to correct for the amount of sample solution removed from the dissolution vessels at each time interval. Because the sample solutions contain analyte and because removal changes the volume of dissolution medium remaining in the vessels, such corrections are sometimes necessary to determine accurate values. This article presents results from a mental exercise where a theoretical dissolution profile was constructed. These data can be used to verify the accuracy of such calculations.","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"28 1","pages":"16-20"},"PeriodicalIF":0.6,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66812857","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}
{"title":"Questions and Answers August 2021","authors":"Margareth R. C. Marques, M. Liddell","doi":"10.14227/dt280321p46","DOIUrl":"https://doi.org/10.14227/dt280321p46","url":null,"abstract":"","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"1 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66813236","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}
Daniela Amaral Silva, K. J. Curo Melo, N. Davies, N. Bou-Chacra, H. Ferraz, R. Löbenberg
{"title":"A BCS-Based Biowaiver Approach Using Biphasic Dissolution Test","authors":"Daniela Amaral Silva, K. J. Curo Melo, N. Davies, N. Bou-Chacra, H. Ferraz, R. Löbenberg","doi":"10.14227/dt280421p40","DOIUrl":"https://doi.org/10.14227/dt280421p40","url":null,"abstract":"Biowaivers based on the Biopharmaceutics Classification System (BCS) class can be used to establish therapeutic equivalence based on dissolution tests, which can be used as a surrogate to determine if two pharmaceutical equivalent products are interchangeable (i.e., bioequivalent). The objective of the present study was to use a biphasic dissolution system to replicate a study in which the authors followed compendial methods to examine the in vitro performance of widely used drug products. Furthermore, since biphasic dissolution studies are mainly applied to poorly soluble drugs, the present study was conducted to broaden its application to highly soluble drugs. The approach taken in this manuscript was to have scientific insight and mechanistic understanding rather than a strict regulatory application. In the initial study, none of the tested metronidazole products were (in vitro) equivalent to the comparator pharmaceutical product (CPP) or to other manufacturers. We hypothesized that whereas in vitro equivalence was not achieved in compendial methods, the partitioning profile to the organic phase in the biphasic system could signal in vitro equivalence between the tested drug products and CPP. In the aqueous phase of the biphasic system, the tested metronidazole products followed a similar pattern as obtained in the compendial buffer; however, this was not the case for the organic phase partition profiles. All the tested products had a good correlation to the CPP, which could indicate in vitro equivalence between these products. This could potentially allow for a biowaiver application. Hence, the application of biphasic dissolution to highly soluble drugs might be beneficial to estimate the product’s in vivo behavior. Further clinical studies would be needed to confirm these findings to guarantee their interchangeability.","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"1 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66813321","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}
{"title":"Questions and Answers May 2021","authors":"Margareth R. C. Marques, M. Liddell","doi":"10.14227/DT280221P43","DOIUrl":"https://doi.org/10.14227/DT280221P43","url":null,"abstract":"","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"28 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66813384","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}
{"title":"Questions and Answers November 2021","authors":"Margareth R. C. Marques, M. Liddell","doi":"10.14227/dt280421p54","DOIUrl":"https://doi.org/10.14227/dt280421p54","url":null,"abstract":"","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"1 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66813427","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}
A. Najmi, Mohammed Al Bratty, B. Al-Bassam, Rami Ali Aseri, Turki Suliman Wadani, Abdulrahman Ibrahim Al-Muntashiri, H. A. Alhazmi, M. Sultan, S. Javed
{"title":"Evaluation of In Vitro Equivalence of Commonly Available Generic Brands of Amlodipine Tablets in Saudi Arabia Under Biowaiver Conditions","authors":"A. Najmi, Mohammed Al Bratty, B. Al-Bassam, Rami Ali Aseri, Turki Suliman Wadani, Abdulrahman Ibrahim Al-Muntashiri, H. A. Alhazmi, M. Sultan, S. Javed","doi":"10.14227/DT280221PGC1","DOIUrl":"https://doi.org/10.14227/DT280221PGC1","url":null,"abstract":"When a medicine is not able to treat the disease for which it was intended, as in case of substandard and falsified drug products, it may prolong the disease and in worst scenario, the patient may die because of the untreated illness or the product itself. To ensure the quality and safety of medicine, WHO recommends timely evaluation of pharmaceutical quality. The present study is an attempt to evaluate the pharmaceutical properties and in vitro drug release of four generic brands and one innovator product (Norvasc) of amlodipine tablets (5 mg) according to USP and WHO guidelines. The products passed the compendial specifications of weight variation (˂ 5% deviation), friability (˂ 1% weight loss), and assay (90–110% of labeled amount). The tablets were fast-disintegrating, as complete disintegration observed in 1.20–1.64 min. The dissolution profiles of the generic products were equivalent to the innovator brand in pH 1.2 HCl and acetate buffer (pH 4.5) without statistical treatment (≥ 85% release in 15 min). In phosphate buffer (pH 6.8), ≥ 85% of drug dissolved in 30 min and in vitro equivalence was established by calculating the difference factor (f1 ˂ 15), similarity factor (f2 ˃ 50), and dissolution efficiency (± 10%). The tested brands met WHO BCS-based biowaiver criteria for in vitro dissolution testing, which ensured their pharmaceutical and therapeutic equivalence without in vivo screening and interchangeability with the innovator product.","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"3 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66813461","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}
Thalita Martins da Silva, Marcelo Chaves, B. F. C. Patricio, H. Rocha
{"title":"Comparison of Efavirenz Release in Biorelevant Dissolution Media Using Manual Sampling and In Situ UV Fiber Optic System","authors":"Thalita Martins da Silva, Marcelo Chaves, B. F. C. Patricio, H. Rocha","doi":"10.14227/dt280321p6","DOIUrl":"https://doi.org/10.14227/dt280321p6","url":null,"abstract":"There has been a growing interest in the use of biorelevant dissolution media in drug formulations research and development. Biorelevant media mimic the physiological conditions of the human gastrointestinal tract, which allows for a more discriminating dissolution test. That is even more important for poorly soluble drugs, like efavirenz and other class II (Biopharmaceutical Classification System) drugs. Traditionally, these media were used in the compendial standard dissolution apparatus; however, reduced automation of the conventional tests could be, in general, costly, high-labor, and error-prone. Thus, the use of in situ ultraviolet (UV) fiber optic probes has been applied in research and development and in quality control routines for drug manufacturing. The present study aims to assess the suitability of an in situ UV dynamic monitoring system for characterization of dissolution behavior of 600-mg efavirenz immediate-release coated tablets in different biorelevant media by comparison with traditional manual sampling. The biorelevant media used were fasted and fed state simulated intestinal fluid (FaSSIF, FaSSIF-V2, FeSSIF, FeSSIF-V2) and SLS (0.5%). Both sampling methods were similar for FaSSIF, FaSSIF-V2, and SLS. For FeSSIF and FeSSIF-V2, the results were statistically different due to high concentration of oxidation phospholipids and degradation lipids in these media. These results support the use of dynamic monitoring of dissolution in FaSSIF, FaSSIF-V2, and SLS, and inform understanding of the rate-limiting steps, which may improve quality and accuracy in data acquisition for dissolution tests with biorelevant media.","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"1 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66813272","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}
{"title":"Book Review: “In Vitro Drug Release Testing of Special Dosage Forms,” Advances in Pharmaceutical Technology Series, Edited by Fotaki and Klein","authors":"G. Martin","doi":"10.14227/DT280221P42","DOIUrl":"https://doi.org/10.14227/DT280221P42","url":null,"abstract":"","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"28 1","pages":"42-42"},"PeriodicalIF":0.6,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66813375","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}
{"title":"Preparation and Characterization of ZGDHu-1 Nanoparticles","authors":"Lei Shi, Yong-li Liu, Kunlin Wu, Ruiz Si","doi":"10.14227/dt280321p40","DOIUrl":"https://doi.org/10.14227/dt280321p40","url":null,"abstract":"The purpose of this study was to establish the preparation process of ZGDHu-1 nanoparticles and to study its physicochemical properties. The nanoparticles were prepared using a high-pressure homogenization method. Natural phospholipid and soybean oil were used as drug carriers, and Cremophor EL was used as surfactant. The resulting nanoparticles had a spherical shape, with a mean ± SD particle size of 106.8 ± 15.9 nm, polydispersity index (PDI) of 0.136 ± 0.011, zeta potential of -63.97 ± 3.57 mV, encapsulation efficiency of 86.95%, and in vitro cumulative release rate of 84.67% in 24 hours. The nanoparticle preparation process was simple and reproducible. The nanoparticles had good physicochemical properties and in vitro release was improved by increasing solubility. This study provides a method for improving in vitro release for development of ZGDHu-1 nanoparticle formulations.","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"35 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66813181","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}