Dissolution Technologies最新文献

{"title":"Quality Evaluation of Azithromycin Oral Solid Dosage Forms in Nigeria: In Vivo-In Vitro Correlation Study","authors":"Jeremiah B. Araoye, Chukwuma H. Ilomuanya, Oluwadamilola M. Kolawole, Moshood O. Akinleye, Christian Chigozie Makwe, Ndubuisi Ezumezu, Bosede Bukola Afolabi, Margaret O. Ilomuanya","doi":"10.14227/dt320125pgc30","DOIUrl":"https://doi.org/10.14227/dt320125pgc30","url":null,"abstract":"Background: Azithromycin is used for bacterial infections, such as respiratory tract and genitourinary tract infections, and has also been effective for preventing maternal sepsis during vaginal birth in some settings.The availability of low-cost azithromycin products of the required pharmaceutical quality is crucial for a successful campaign against maternal sepsis-related death.This study aimed to evaluate the quality of the azithromycin oral solid dosage forms manufactured and marketed in Nigeria.Methods: Three locally manufactured generic products and the innovator product of azithromycin tablets/capsules were subjected to physicochemical tests in accordance with United States Pharmacopeia (USP) specifications.Dissolution profiles of the products in 0.1 N hydrochloric acid (HCl) and phosphate buffer (pH 6.0) were compared using model-dependent and model-independent approaches.The innovator and generic products with similar dissolution profiles were subjected to a 2-g single-dose randomized two-period crossover bioavailability and bioequivalence study.Results: All products met USP specifications for weight uniformity, disintegration (10-15 min), drug content (99.8-101.1%),and dissolution in phosphate buffer 6.0 (> 75% dissolution in 45 min); However, one product failed the test for friability.The kinetic model with the best fit for the products was the Korsmeyer-Pappas model (R 2 = 0.7137-0.9562).Only one product (AZI-E) had a comparable dissolution profile to the innovator brand (similarity and difference factors were 68 and 7, respectively), and bioavailability and bioequivalence studies showed it was bioequivalent to the innovator product.Conclusion: Product AZI-E was the most promising locally manufactured azithromycin formulation (AZI-E) that has potential to reduce maternal sepsis in Nigeria when compared with the innovator brand.Continuous pharmacovigilance is advocated to safeguard public health.","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"32 2","pages":"GC30-GC41"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://doi.org/10.14227/dt320125pgc30","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147881801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of NanoDis as an Automated Sampling Technology for In Vitro Release Testing of Nanomedicines","authors":"Georgia Taylor-Vine, Heather Mead, V. Paraskevopoulou, J. Mann","doi":"10.14227/dt300323p126","DOIUrl":"https://doi.org/10.14227/dt300323p126","url":null,"abstract":"","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"1 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66814345","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":"Dissolution Method Development for Regulatory Approval: A Comprehensive Review and Case Study","authors":"P. Parshuramkar, D. Khobragade, P. Kashyap","doi":"10.14227/dt300323p162","DOIUrl":"https://doi.org/10.14227/dt300323p162","url":null,"abstract":"","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"1 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66814456","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":"Investigating the Influence of HPMC K4M and Eudragit L 100-55 on Guanfacine-Loaded Extended-Release Tablets","authors":"Rakesh Patel, Himanshu Paliwal, A. Patel","doi":"10.14227/dt300123p22","DOIUrl":"https://doi.org/10.14227/dt300123p22","url":null,"abstract":"(Eudragit L100-55) were used as a hydrophilic matrix to prepare extended-release tablet formulations to release drug","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"1 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66813944","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":"Effect of Mannitol Particle Size on Melatonin Dissolution and Tablet Properties using a Quality by Design Framework","authors":"B. Mesut, Yağmur Pirinçci Tok, Busra Alkan, M. Vefai, Mazen Al-Mohaya, Y. Özsoy","doi":"10.14227/dt300123p12","DOIUrl":"https://doi.org/10.14227/dt300123p12","url":null,"abstract":"The objective of the current study was to develop an optimized formulation for orally disintegrating tablets (ODTs) containing melatonin. Different particle sizes of mannitol (i.e., filler) were used to study the effects on dissolution and tablet properties using a quality by design (QbD) approach. The quality target product profile was identified, then critical quality attributes (CQAs) were determined. Risk assessment was performed using the Failure Mode Effect Analysis (FMEA) method to identify and rank critical material attributes and process parameters. Thirty-four formulations were prepared and tested. Box-Behnken design (BBD) with response surface methodology was applied to assess the effect of independent factors on CQAs. Finally, the most suitable formulation in terms of tablet properties was determined with Minitab. Specification tests were applied to confirm that the optimized formula met USP requirements. Mannitol with a small particle size had the fastest disintegration time and dissolution rate in ODT formulations containing melatonin.","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"1 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66814032","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":"Report on the Virtual Workshop: A Quest for Biowaiver, Including Next Generation Dissolution Characterization and Modeling","authors":"J. Srebro, Andreas M. Abend, P. Dorożyński, N. Fotaki, G. Garbacz, V. Gray, J. Mann, Margareth R. C. Marques, A. Mendyk, X. Pepin, S. Polak, Sandra Suarez-Sharp","doi":"10.14227/dt300223p100","DOIUrl":"https://doi.org/10.14227/dt300223p100","url":null,"abstract":"www.dissolutiontech.com 100 INTRODUCTION The virtual workshop, “A Quest for Biowaiver, Including Next Generation Dissolution Characterization and Modelling,” was held on November 16–17th, 2022, via the MS Teams platform. The conference was co-sponsored by Jagiellonian University Medical College (JUMC) in Cracow, Poland and the American Association of Pharmaceutical Scientists (AAPS). The workshop was chaired by Vivian Gray (AAPS) and Prof Aleksander Mendyk (JUMC), with the support of the co-chairs Prof Nikoletta Fotaki (AAPS), Prof Jie Shen (AAPS), and Dr Jakub Szlęk (JUMC).","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"1 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66814120","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":"Comparative Dissolution Study of Various Brands of Valsartan Tablets Marketed in Pakistan","authors":"Muhammad Mohsin Ansari, Muhammad Zain Amin, U. Ashraf, Muhammad Noman Ehsan, Muhammad Farhan, Aasil, Hina Ahsan","doi":"10.14227/dt300323pgc1","DOIUrl":"https://doi.org/10.14227/dt300323pgc1","url":null,"abstract":"","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"1 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66814131","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 2023","authors":"Margareth R. C. Marques, M. Liddell","doi":"10.14227/dt300223p110","DOIUrl":"https://doi.org/10.14227/dt300223p110","url":null,"abstract":"","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"56 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66814153","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":"Improved Melatonin Dissolution Properties: A Way Forward for Treating Children with Sleep Disorders","authors":"Jeovanis Gil, J. Malm, G. Marko‐Varga","doi":"10.14227/dt300223p66","DOIUrl":"https://doi.org/10.14227/dt300223p66","url":null,"abstract":"Sleep problems, in particular the difficulty in initiating and maintaining sleep are important comorbidities in children and adolescents with attention deficit hyperactivity disorder (ADHD), accompanied by a range of negative consequences for both patients and their caregivers. Melatonin, a naturally occurring hormone that is important for coordinating the body's sleep-wake cycle, has been used to treat insomnia in children with ADHD. This study compares the dissolution properties of two melatonin tablets (1 and 5 mg Mellozzan and Melatonin AGB). Results showed that Mellozzan dissolved rapidly (90% within 5 minutes) in all pH levels tested, whereas Melatonin AGB dissolved slower (60% within 30 minutes). The fast dissolution properties of melatonin observed in Mellozzan indicates that this formulation is preferable for the treatment of children where the dissolution step is critical to reach the desired clinical effect.","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"1 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66814183","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":"Dissolution Specifications for Ibuprofen Soft Gelatin Capsules: A Proposal","authors":"Lourdes Mayet-Cruz, Juan M. Rodríguez, Emily Juárez-López, H. Jung-Cook","doi":"10.14227/dt300223p74","DOIUrl":"https://doi.org/10.14227/dt300223p74","url":null,"abstract":"USA. Analytical grade monobasic sodium phosphate, sodium hydroxide, potassium hydroxide, anhydrous ethanol, phosphoric acid, and methanol were acquired from J.T.Baker. Water was obtained from a Milli-Q Reference (Millipore-Merck) system.","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"1 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66814216","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}