Dissolution Technologies最新文献_第3页

Using a Laser Monitoring Technique for Dissolution and Thermodynamic Study of Celecoxib in 2-Propanol and Propylene Glycol Mixtures 用激光监测技术研究塞来昔布在2-丙醇和丙二醇混合物中的溶解和热力学

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2023-01-01 DOI: 10.14227/dt300223p80

V. Jouyban-Gharamaleki, F. Martínez, M. Kuentz, E. Rahimpour, A. Jouyban

{"title":"Using a Laser Monitoring Technique for Dissolution and Thermodynamic Study of Celecoxib in 2-Propanol and Propylene Glycol Mixtures","authors":"V. Jouyban-Gharamaleki, F. Martínez, M. Kuentz, E. Rahimpour, A. Jouyban","doi":"10.14227/dt300223p80","DOIUrl":"https://doi.org/10.14227/dt300223p80","url":null,"abstract":"In the current work, a laser monitoring technique was used to study dissolution and solubility of celecoxib (CBX) in 2-propanol and propylene glycol mixtures at temperatures of 293.2–313.2 K. The solubility data were fitted to mathematical models, i.e., the van’t Hoff model, the mixture surface model, the Jouyban-Acree and Jouyban-Acree-van’t Hoff equations, and the modified Wilson model. Model accuracy was evaluated by mean relative deviation (MRD%) for back-calculated solubility values. The thermodynamic behavior of CBX dissolution was evaluated according to the van’t Hoff and Gibbs equations. CBX exhibited maximum solubility in 2-propanol with a mass fraction of 0.8 at all temperatures. CBX dissolution was identified as an endothermic and enthalpy-driven process, which was more favorable in mixtures with high drug solubilizing capacity. The various models described solubility data from the laser monitoring technique adequately, and the studied cosolvent mixtures have the potential to be used in analytical pharmaceutical development or as intermediate bulk solutions for CBX products.","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":"66814228","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 Performance Tests for Continuous Manufacturing: The Impact on the Current Compendial Framework from the Viewpoint of the USP New Advancements in Product Performance Testing Expert Panel 连续生产的体外性能测试:从USP产品性能测试专家小组的新进展的角度对现行药典框架的影响

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2023-01-01 DOI: 10.14227/dt300123p6

Hanlin Li, lshai Nir, Andre Hermans, R. Fahmy, Xujin Lu, Carrie A. Coutant

{"title":"In Vitro Performance Tests for Continuous Manufacturing: The Impact on the Current Compendial Framework from the Viewpoint of the USP New Advancements in Product Performance Testing Expert Panel","authors":"Hanlin Li, lshai Nir, Andre Hermans, R. Fahmy, Xujin Lu, Carrie A. Coutant","doi":"10.14227/dt300123p6","DOIUrl":"https://doi.org/10.14227/dt300123p6","url":null,"abstract":"As continuous manufacturing (CM) evolves from an emerging to widely adopted technology by industry in drug product manufacturing, the compendiaI framework in product performance testing is also being evaluated for its applicability in CM. As such, the CM Working Group of the New Advancements in Product Performance Testing (NAPPT) Expert Panel was convened in 2019 to review the current standard for product performance testing, identify gaps in its applicability to CM, and recommend the development of new standards to support the adoption of advancing technologies industry-wide. This Stimuli article discusses the challenges and limitations of the current performance testing by dissolution for CM applications. It also presents recommendations on alternatives or surrogate methods, including in/at-line process analytical technology methods, with a decision tree to support users in identifying an option that is fit for their process. The Expert Panel seeks stakeholder feedback on the recommendations presented in this Stimuli article, and requests additional comments on the perceived challenges and limitations of performance testing.","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":"66814589","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: 3

In-Vitro Product Performance of Parenteral Drug Products: View of the USP Expert Panel 肠外用药产品的体外产品性能:USP专家小组的观点

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2022-01-01 DOI: 10.14227/dt290422p204

D. D'Arcy, M. Wacker, S. Klein, Vivek Shah, M. D. Burke, G. Hunter, Hao Xu

{"title":"In-Vitro Product Performance of Parenteral Drug Products: View of the USP Expert Panel","authors":"D. D'Arcy, M. Wacker, S. Klein, Vivek Shah, M. D. Burke, G. Hunter, Hao Xu","doi":"10.14227/dt290422p204","DOIUrl":"https://doi.org/10.14227/dt290422p204","url":null,"abstract":"Performance testing of parenteral products represents a broad arena of product types, test equipment, and analytical challenges. This Stimuli article is one in a series of Stimuli articles on product performance testing focused on common methodological approaches used and challenges encountered in the field of performance testing of injectable products. The article is complementary to In Vitro Release Test Methods for Parenteral Drug Preparations <1001> and takes into account the contents and acknowledges current trends in test apparatus and conditions, medium selection, and separation techniques. Limitations of current practices are presented, and recommendations highlight the need for biorelevant and predictive test environments, test standardization, and an understanding of the impact of the test conditions on the release kinetics and interpretation of test results. dx.doi.org/10.14227/DT290422P204 Reprinted with permission. © 2022 The United States Pharmacopeial Convention. All rights reserved. Correspondence should be addressed to: Desmond G. Hunt, Senior Principal Scientist, Science-General Chapters, US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790 email: dgh@usp.org.","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":"66813615","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: 3

The Combination of Liqui-Mass System and Pelletization to Improve Pharmaceutical Properties of Hydrochlorothiazide 液质法制备与制粒相结合改善氢氯噻嗪的药物性能

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2022-01-01 DOI: 10.14227/dt290322p128

Matthew Lam, A. Nokhodchi

{"title":"The Combination of Liqui-Mass System and Pelletization to Improve Pharmaceutical Properties of Hydrochlorothiazide","authors":"Matthew Lam, A. Nokhodchi","doi":"10.14227/dt290322p128","DOIUrl":"https://doi.org/10.14227/dt290322p128","url":null,"abstract":"Liqui-Pellet technology has recently been developed and has shown to be promising in achieving a rapid drug release rate with water insoluble drugs. At present, only naproxen and ketoprofen have been applied to an oral solid dosage form for immediate release. The present investigation aims to explore the drug release performance of the poorly water-soluble hydrochlorothiazide (HCTZ) using the Liqui-Pellet technology. Various non-volatile co-solvents such as Tween 80, PG, Kolliphor EL, and PEG 200 were used to make HCTZ Liqui-Pellet formulations to investigate the influence of Liqui-Pellet technology on the drug release profile. Saturation solubility studies showed HCTZ was most soluble in PEG 200 (156 mg/mL), which is also reflected in the drug release data where HCTZ Liqui-Pellet containing PEG 200 had the most enhanced drug dissolution profile. A binary mixture of carriers consisting of Avicel PH-101 and Neusilin US2 was investigated, as this mixture has been shown to improve drug release rate in a previous study. Surprisingly, the binary mixture of carriers did not improve the drug release rate in this study. The best formulation reached 100% drug release at approximately 40 min. Other physicochemical analysis tests showed the Liqui-Pellets’ flow property, robustness, and size distribution are generally acceptable and pose no major issue in terms of manufacturing. In conclusion, the Liqui-Mass system combined with extrusion-spheronization is a viable approach to enhance HCTZ dissolution.","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":"66813453","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

Review: Application of Bioequivalence Testing of Medicines in Peru 综述:药品生物等效性试验在秘鲁的应用

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2022-01-01 DOI: 10.14227/dt290422p220

Angel T. Alvarado, V. Gray, A. M. Muñoz, María Saravia, María R. Bendezú, H. Chávez, Jorge A. García, R. Ybañez-Julca, Andres Chonn-Chang, Patricia Basurto, Mario Pineda-Pérez, Alberto Salazar

引用次数: 0

Pharmaceutical Equivalence of Losartan Potassium Tablets in Argentina 阿根廷氯沙坦钾片的药物等效性

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2022-01-01 DOI: 10.14227/dt290222pgc2

M. A. Varillas, Marta I. V. Brevedan, N. G. Gonzalez Vidal

{"title":"Pharmaceutical Equivalence of Losartan Potassium Tablets in Argentina","authors":"M. A. Varillas, Marta I. V. Brevedan, N. G. Gonzalez Vidal","doi":"10.14227/dt290222pgc2","DOIUrl":"https://doi.org/10.14227/dt290222pgc2","url":null,"abstract":"Losartan potassium (LOK) is an antihypertensive agent from the group of selective angiotensin AT1 receptor antagonists, widely used in the form of tablets for oral administration. The available data for BCS classification are confusing, though class III or IV are most likely. The quality attributes of solid oral dosage forms of LOK immediate-release tablets (50 mg) available in the Argentine pharmaceutical market were evaluated according to the Argentine Pharmacopoeia and United States Pharmacopeia (i.e., storage conditions information, price per tablet, average weight, assay, uniformity of dosage units, hardness, disintegration time, and in vitro dissolution). The dissolution efficiency (DE) results were compared using one way analysis of variance. All evaluated samples were within the acceptable limits for disintegration time, hardness, assay, uniformity of dosage units, and in vitro dissolution (in Stage 1). A statistically significant difference in DE was recorded for samples C, D, E, F, and G compared to the reference formulation (sample H). These samples had higher DE values than the reference; there were no statistically significant differences between the samples. Therefore, the evaluated samples of LOK from the Argentine market can be considered pharmaceutical equivalents.","PeriodicalId":11380,"journal":{"name":"Dissolution Technologies","volume":"45 1","pages":""},"PeriodicalIF":0.6,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"66813429","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

Simulated Lymphatic Fluid for In-Vitro Assessment in Pharmaceutical Development 模拟淋巴液在药物开发中的体外评估

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2022-01-01 DOI: 10.14227/dt290222p86

Malaz Yousef, Chulhun Park, T. Le, Nadia Bou Chacra, Neil Davies, R. Löbenberg

引用次数: 2

Predictive Dissolution Models for Real-Time Release Testing: Development and Implementation - Workshop Summary Report 实时释放测试的预测分解模型:开发与实现-研讨会总结报告

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2022-01-01 DOI: 10.14227/dt290322p150

N. Zaborenko, Tessa M. Carducci, A. Ryckaert, H. Mandula, Matthew J. Walworth, Casey J. Smith, Sandra Suarez-Sharp, Melanie Dumarey, S. Manteiga, Sarah Nielsen, S. Altan, Adriene Malsbury, B. Nickerson, Yanmei Lan

{"title":"Predictive Dissolution Models for Real-Time Release Testing: Development and Implementation - Workshop Summary Report","authors":"N. Zaborenko, Tessa M. Carducci, A. Ryckaert, H. Mandula, Matthew J. Walworth, Casey J. Smith, Sandra Suarez-Sharp, Melanie Dumarey, S. Manteiga, Sarah Nielsen, S. Altan, Adriene Malsbury, B. Nickerson, Yanmei Lan","doi":"10.14227/dt290322p150","DOIUrl":"https://doi.org/10.14227/dt290322p150","url":null,"abstract":"To date, few examples of dissolution models for real-time release testing (RTRT) have been approved for commercial drug products or published in literature. Thus, a structured approach has not been established by which a novice to the field could design, develop, validate, and implement an RTRT dissolution model. Moreover, with scant examples available, there has not been a body of work by which to learn of general regulatory expectations for such models. To address these gaps and to encourage conversation between regulatory and industrial experts on these topics, a virtual (web-based) workshop entitled “Predictive Dissolution Models for Real-Time Release Testing: Development and Implementation” was held November 11–12, 2021. This article summarizes key points from the podium presentations, panel discussions, and breakout sessions focusing on (1) the current best practices to establish predictive model specifications; (2) designing models to predict the “safe space” of a release test and creating models utilizing process analytical technology (PAT); and (3) exploring the strategy of compliant regulatory submissions, including model validation and post-approval lifecycle management. Industrial case studies were presented showcasing attempted approaches to and successful implementations of RTRT of dissolution for drug product manufacturing. Dissolution Profiles from Process Parameters, Formulation, and Spectroscopic of how certain affect linkage their variation and the effect on different parameters of the PDM. Spectroscopic PAT can capture individual tablet differences and incorporate it into","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":"66813531","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: 1

Influence of Storage Conditions on Pharmaceutical Equivalence and Similarity of Hydrochlorothiazide Tablets in Argentina 贮藏条件对阿根廷氢氯噻嗪片等效性和相似性的影响

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2022-01-01 DOI: 10.14227/dt290422pgc1

Marta I. V. Brevedan, M. A. Varillas, N. G. Gonzalez Vidal

{"title":"Influence of Storage Conditions on Pharmaceutical Equivalence and Similarity of Hydrochlorothiazide Tablets in Argentina","authors":"Marta I. V. Brevedan, M. A. Varillas, N. G. Gonzalez Vidal","doi":"10.14227/dt290422pgc1","DOIUrl":"https://doi.org/10.14227/dt290422pgc1","url":null,"abstract":"Similarity studies are used with the intention to establish interchangeability of certain formulations in vitro, without the need to carry out in vivo studies. This interchangeability between formulations should be conserved during the product shelf life, as an integral part of the pharmaceutical stability. Hydrochlorothiazide (HCTZ), a widely used diuretic, is classified as a class 3 drug in the Biopharmaceutics Classification System (BCS). An immediate-release (IR) solid oral formulation containing a class 3 drug is a candidate for biowaiver if it meets the requirement of ῾ very rapid dissolution’ (i.e., ≥ 85% dissolved within 15 minutes). This research aimed to compare four solid oral IR HCTZ formulations (50 mg), commercially available in Argentina, with respect to pharmaceutical similarity and stability. To assess for similarity, dissolution profiles were compared both at time zero (T0) and after 12 months of storage (T12) at pH 1.2, 4.5, and 6.8. To assess for stability, critical quality attributes (CQAs) of the samples were evaluated at T12 of storage (25 °C, 60% relative humidity). At T12, all samples met the requirements for CQAs (i.e., assay, friability, disintegration, uniformity, and dissolution). The reference formulation had the fastest dissolution rate, and sample D was the slowest. Two multisource formulations exhibited statistical differences with respect to the reference sample, both at T0 and T12.","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":"66813864","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

Contribution of Multivariate Analysis to the In Vitro Dissolution Profile for Testing Clopidogrel Drugs Similarity 多变量分析对氯吡格雷药物相似度测定体外溶出度谱的贡献

IF 0.6 4区医学

Dissolution Technologies Pub Date : 2022-01-01 DOI: 10.14227/dt290322p138

Khabbaz Choukri, El Orche Aimen, Cheikh Amine, Bouchafra Houda, Moulay El Abbes Faouzi, Cherrah Yahya, Boussen Ratiba, M. Bouatia

引用次数: 0