AAPS Open最新文献_第7页

Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment. 会议报告:考虑疫苗稳定性以实现快速开发和部署。

AAPS Open Pub Date : 2021-01-01 Epub Date: 2021-12-01 DOI: 10.1186/s41120-021-00042-1

Mark Alasandro, Dilip Choudhury, Kim Huynh-Ba, Jianmei Kochling, Christopher Latoz, Laure Larkin, Lori McCaig, Nanda Subbarao, Yan Wu, Yajie Zhang

{"title":"Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment.","authors":"Mark Alasandro, Dilip Choudhury, Kim Huynh-Ba, Jianmei Kochling, Christopher Latoz, Laure Larkin, Lori McCaig, Nanda Subbarao, Yan Wu, Yajie Zhang","doi":"10.1186/s41120-021-00042-1","DOIUrl":"https://doi.org/10.1186/s41120-021-00042-1","url":null,"abstract":"The Stability Community of the American Association of Pharmaceutical Scientists (AAPS) held a virtual workshop on \"Vaccine Stability Considerations to Enable Rapid Development and Deployment\", on March 24-25, 2021. The workshop included distinguished speakers and panelists from across the industry, academia, regulatory agencies, as well as health care leaders. This paper presents a review of the topics covered. Specifically the challenges in accelerating vaccine development and analytical characterization techniques to establish shelf-life were covered. Additionally, vaccine stability modeling using prior knowledge stability models and advanced kinetic analysis played a key in the EUA approaches discussed during the workshop. Finally, the role of stability studies in addressing the challenges of vaccine distribution and deployment during the pandemic were a focus of presentations and panel discussions. Although the workshop did not have any presentation topics directly dedicated to the mRNA vaccines, the techniques discussed are generally applicable. The mRNA vaccine developers were represented in the panel discussions, where experts involved in the EUA approval/deployment stages for this vaccine type could discuss the challenges as applied to their vaccines.","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8632204/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39696505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Designing an ideal alcohol-based hand sanitizer: in vitro antibacterial responses of ethanol and isopropyl alcohol solutions to changing composition. 设计一种理想的酒精基洗手液:乙醇和异丙醇溶液对改变组成的体外抗菌反应。

AAPS Open Pub Date : 2021-01-01 Epub Date: 2021-11-22 DOI: 10.1186/s41120-021-00038-x

Ifeanyi T Nzekwe, Onyedika I Agwuka, Moses U Okezie, Daniel O Fasheun, Petra O Nnamani, Chukwuma O Agubata

{"title":"Designing an ideal alcohol-based hand sanitizer: in vitro antibacterial responses of ethanol and isopropyl alcohol solutions to changing composition.","authors":"Ifeanyi T Nzekwe, Onyedika I Agwuka, Moses U Okezie, Daniel O Fasheun, Petra O Nnamani, Chukwuma O Agubata","doi":"10.1186/s41120-021-00038-x","DOIUrl":"https://doi.org/10.1186/s41120-021-00038-x","url":null,"abstract":"This study aimed to achieve an in vitro quantification of the effects of composition and formulation factors on the killing rates of alcohol-based hand sanitizers. The killing rates of 85% ethyl alcohol (ET) and isopropyl alcohol (IPA) were studied under different conditions such as pH, electrolyte concentration, or inclusion of herbal extracts (cucumber, carrot, and aloe vera), a quaternary ammonium compound, or thickener over different time intervals. Changes in the activities were retested after 3 months as an indication of stability. From two-way ANOVA, both the time of exposure and the sanitizer type affected the activity against Staphylococcus aureus (P = 0.001 for both alcohols), whereas for Escherichia coli, time of exposure was significant (P = 0.027), while sanitizer type was less significant (P = 0.063). Extreme pHs, the presence of ions, and the inclusion of additives such as benzalkonium chloride (BAC), plant extracts, or carbomer impacted the 3-month activity of the samples differently. Important differences existing in the activities of ET and IPA, as a function of formulation factors or use conditions have been quantified using in vitro methods. Formulations should best be tailored for particular purposes and the all-purpose hand sanitizer may not exist.Supplementary information: The online version contains supplementary material available at 10.1186/s41120-021-00038-x.","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8606244/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39674035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Utilization of risk-based predictive stability within regulatory submissions; industry’s experience 在提交的监管文件中利用基于风险的预测稳定性;行业的经验

AAPS Open Pub Date : 2020-05-11 DOI: 10.1186/s41120-020-00034-7

Megan McMahon, Helen Williams, Elke Debie, Mingkun Fu, R. Bujalski, F. Qiu, Y. Wu, Hanlin Li, Jin Wang, Cherokee Hoaglund-Hyzer, Donnie Pulliam

引用次数: 10

AAPS Open Pub Date : 2019-09-10 DOI: 10.1186/s41120-019-0033-9

T. Stangler, M. Schiestl

引用次数: 6

Drug manufacturing and access to medicines: the West African story. A literature review of challenges and proposed remediation 药品生产和药品获取:西非的故事。挑战和建议的补救措施的文献综述

AAPS Open Pub Date : 2019-08-05 DOI: 10.1186/s41120-019-0032-x

Abigail Ekeigwe

引用次数: 15

Substandard and falsified medicine screening technologies 不合格和伪造的药物筛选技术

AAPS Open Pub Date : 2019-07-08 DOI: 10.1186/s41120-019-0031-y

Lukas Roth, Kevin B. Biggs, D. Bempong

引用次数: 16

Development and evaluation of taste masked dry syrup formulation of potassium chloride. 氯化钾掩味干糖浆配方的研制与评价。

AAPS Open Pub Date : 2019-01-01 Epub Date: 2019-01-22 DOI: 10.1186/s41120-019-0030-z

Madhur Kulkarni, Brijesh Vishwakarma, Samik Sen, Sandhya Anupuram, Abhijit A Date

{"title":"Development and evaluation of taste masked dry syrup formulation of potassium chloride.","authors":"Madhur Kulkarni, Brijesh Vishwakarma, Samik Sen, Sandhya Anupuram, Abhijit A Date","doi":"10.1186/s41120-019-0030-z","DOIUrl":"https://doi.org/10.1186/s41120-019-0030-z","url":null,"abstract":"Potassium chloride (KCl) syrup is widely used for the oral treatment of the hypokalemia. However, it is associated with unacceptable taste. In the present study, we sought to develop a palatable and easy to reconstitute KCl dry syrup as a commercially viable alternative to currently available KCl syrup. We explored the potential of Eudragit E100 as a taste-masking polymer to coat and improve the palatability of the KCl. With the help of fluid bed processor, KCl was coated with the solution containing varying amounts of Eudragit E100 (4, 6, 10 and 15%). Coating with 10% polymer solution enabled optimal fluid bed processing, higher entrapment of the KCl (81%) and better in vitro release profile in 0.1 N HCl and pH 6.8 phosphate buffer. A dry syrup formulation containing Eudragit E100 coated KCl with good physical and chemical stability in dry and reconstituted state was developed. The palatability of the optimized formulation and commercially available KCl syrup was evaluated using the Electronic Taste Sensing Machine. The developed formulation showed~ 2-fold better taste-masking compared to the commercial KCl syrup. Thus, present investigation describes the development of an effective alternative to the current KCl syrup that can offer better palatability, stability and patient compliance.","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s41120-019-0030-z","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37129822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 3

ANVISA: an introduction to a new regulatory agency with many challenges ANVISA:介绍一个面临许多挑战的新监管机构

AAPS Open Pub Date : 2018-12-01 DOI: 10.1186/s41120-018-0029-x

Kim Huynh-Ba, Alexandra Beumer Sassi

引用次数: 15

The journey to AAPS 2020: a reflection from strategic planning to PharmSci 360 AAPS 2020之旅:从战略规划到药学科学360的反思

AAPS Open Pub Date : 2018-11-03 DOI: 10.1186/S41120-018-0028-Y

J. Polli, C. McCurdy, D. Wurster, Binodh S Desilva, A. Bak, R. Bendayan, B. Meibohm, Allen C. Templeton, William Weiser, for the Aaps Leadership

引用次数: 3

Improving the safety of disposable auto-injection devices: a systematic review of use errors 提高一次性自动注射装置的安全性:对使用错误的系统回顾

AAPS Open Pub Date : 2018-10-18 DOI: 10.1186/s41120-018-0027-z

T. Weinhold, Marzia Del Zotto, Jessica Rochat, Jessica Schiro, S. Pelayo, R. Marcilly

引用次数: 14